Stockwinners Market Radar for December 09, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service |
LLY | Hot Stocks17:46 EST Eli Lilly to present Phase 3 results for Jaypirca at ASH meeting - Eli Lilly and Company announced results from the Phase 3 BRUIN CLL-321 trial evaluating pirtobrutinib, a non-covalent Bruton's tyrosine kinase inhibitor in adult patients with chronic lymphocytic leukemia or small lymphocytic lymphoma previously treated with a covalent BTK inhibitor. The study's primary endpoint of progression-free survival was met at primary analysis, demonstrating pirtobrutinib was superior to investigator's choice of idelalisib plus rituximab or bendamustine plus rituximab, based on independent review committee assessment. Today's updated results corresponding to the final prespecified analysis, demonstrate consistent improvement in PFS for patients treated with pirtobrutinib, with a reduction in risk of relapse, disease or death by 46% compared to IdelaR or BR. These data will be presented in an oral presentation at the 66th American Society of Hematology Annual Meeting and Exposition. "These results demonstrate the ability of pirtobrutinib to deliver clinically meaningful outcomes in a post-covalent BTK inhibitor setting, which is especially remarkable given the poor prognosis for the patient population enrolled in BRUIN CLL-321," said Jeff Sharman, M.D., Disease Chair, Lymphoma Research Executive Committee, SCRI at Willamette Valley Cancer Institute and Research Center, and one of the principal investigators of the BRUIN CLL-321 trial. "These data also show that pirtobrutinib can significantly prolong the time to next treatment with a median of approximately two years. Coupled with the safety results, the BRUIN CLL-321 data are important as we consider treatment sequencing for this setting."
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RGTI | Hot Stocks17:44 EST Rigetti Computing director Clifton sells 125,000 common shares - In a regulatory filing, Rigetti Computing director Michael Clifton disclosed the sale of 125,000 common shares of the company on December 9 at a price of $5.03 per share.
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MDB | Hot Stocks17:40 EST MongoDB says expects to see sequential decline in non-Atlas revenue in Q4 - Says in terms of Atlas consumption, expects to see a typical seasonal slowdown in Q4 driven by underlying application usage moderating during the holiday season. Says since Atlas consumption remained lower on a year-over-year basis in Q3, expects to see continued deceleration of Atlas year-over-year growth in Q4. Says expects to see a sequential decline in non-Atlas revenue in Q4, which is contrary to normal pattern. Says experienced a significant additional benefit from multi-year deals in Q3, which is not expected to recur in Q4. Says reallocating a portion of go-to-market resources from the mid-market to the enterprise channel. Says expects to see significantly fewer mid-market direct sales customer net additions and as a result, slower direct sales customer growth going forward. Comments taken from Q4 earnings conference call.
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IVZ | Hot Stocks17:25 EST Invesco announces November-end AUT $1.86T - Invesco "reported preliminary month-end assets under management of $1,856.5 billion, an increase of 4.8% versus previous month-end. The firm delivered net long-term inflows of $11.0 billion in the month. Non-management fee earning net inflows were $9.2 billion and money market net inflows were $14.9 billion. AUM was positively impacted by favorable market returns which increased AUM by $52 billion. FX decreased AUM by $3.0 billion. Preliminary average total AUM for the quarter through November 30 were $1,805.4 billion, and preliminary average active AUM for the quarter through November 30 were $1,021.0 billion."
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FSLY | Hot Stocks17:23 EST Fastly director Bergman sells almost $1.3M in company shares - Fastly director Artur Bergman disclosd the sale of 120,142 shares of company stock at $10.47 per share between Decemeber 5 and Decemeber 6, for a total transaction amount of $1,258,127.
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MNTS | Hot Stocks17:16 EST Momentus announces a 1-for-14 reverse stock split - Momentus announced it has effectuated a 1-for-14 reverse stock split of its Class A common stock that will become effective on December 12 at 5:00 p.m. Eastern Time. The company's common stock will continue to trade on the Nasdaq Global Select Market under the symbol "MNTS" and will begin trading on a split-adjusted basis at the opening of the market on December 13. The new CUSIP number for the common stock following the Reverse Stock Split will be 60879E309.
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NRDY | Hot Stocks17:12 EST Nerdy CEO buys $657.2K in common stock - In a regulatory filing, Nerdy disclosed that its CEO Charles Cohn bought 426.8K shares of common stock on Nerdy on December 5th in a total transaction size of $657.2K. Shares of Nerdy are up 14% afterhours at $1.87.
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NOC | Hot Stocks17:10 EST Northrop Grumman awarded $801.05M Air Force contract - Northrop Grumman was awarded a ceiling $801.05M indefinite-delivery/indefinite-quantity contract for combat air forces distributed mission operations services. This contract provides for virtual, distributed training to Air Force trainers worldwide including daily team training to large scale exercises. Work will be performed in Orlando, Florida, and is expected to be completed by Dec. 11, 2034. This contract was a competitive acquisition, and three offers were received. FY25 operation and maintenance funds in the amount of $5,526 are being obligated at the time of award. The Air Force Lifecycle Management Center is the contracting activity.
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MSTR | Hot Stocks17:05 EST MicroStrategy acquires 21,550 bitcoins from December 2 to December 8 - In a regulatory filing from before the market opened, the company disclosed that, during the period between December 2 and December 8, it had sold an aggregate of 5.42M shares under a sales agreement for aggregate net proceeds to the company of approximately $2.13B. The company also announced that, during the period between December 2 and December 8, it acquired approximately 21,550 bitcoins for approximately $2.1B in cash, at an average price of approximately $98,783 per bitcoin, inclusive of fees and expenses. The bitcoin purchases were made using proceeds from the issuance and sale of shares under the sales agreement. As of December 8, the company, together with its subsidiaries, held an aggregate of approximately 423,650 bitcoins, which were acquired at an aggregate purchase price of approximately $25.6B and an average purchase price of approximately $60,324 per bitcoin, inclusive of fees and expenses.
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CENX | Hot Stocks16:47 EST Century Aluminum VP Gudlaugsson sells $477K in company shares - Century Aluminum VP, Gunnar Gudlaugsson, disclosed the sale of 20,000 shares of company stock at $23.85 per share on Decemebr 5, for a transaction amount of $477,000.
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TCS | Hot Stocks16:46 EST NYSE to commence delisting proceedings against The Container Store - The NYSE announced that the staff of NYSE Regulation has determined to commence proceedings to delist the common stock of The Container Store Group from the NYSE. Trading in the company's common stock will be suspended immediately. NYSE Regulation reached its decision to delist the company's common stock pursuant to Section 802.01B of the NYSE's Listed Company Manual because the company had fallen below the NYSE's continued listing standard requiring listed companies to maintain an average global market capitalization over a consecutive 30 trading day period of at least $15M. The company has a right to a review of this determination by a committee of the board of directors of the NYSE. The NYSE will apply to the SEC to delist the company's common stock upon completion of all applicable procedures, including any appeal by the company of the NYSE Regulation staff's decision.
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TJX | Hot Stocks16:43 EST TJX CEO Herrman sells over $950K in company shares - The CEO of TJX Ernie Herrman disclosed the sale of 7,533 shares of company stock at $126.18 per share on December 5, for a total transaction amount of $950,551.
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WKHS | Hot Stocks16:38 EST Workhorse Group's independent accounting firm declines reappointment - In a regulatory 8-K filing, the company states: "On December 3, 2024, Workhorse Group was notified by Grant Thornton LLP that the Former Auditor declined to stand for reappointment as the Company's independent registered public accounting firm for the fiscal year ended December 31, 2024. The Former Auditor served as the Company's independent registered public accounting firm since 2018. The reports of the Former Auditor on the Company's financial statements for the fiscal years ended December 31, 2023 and 2022 did not contain an adverse opinion or disclaimer of opinion and were not qualified or modified as to uncertainty, audit scope or accounting principles, except that the report on the financial statements of the Company for the fiscal year ended December 31, 2023 included an explanatory paragraph indicating that there was substantial doubt as to the Company's ability to continue as a going concern. During the Company's fiscal years ended December 31, 2023 and 2022 and the subsequent interim period through December 3, 2024, there (i) have been no disagreements with the Former Auditor on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreements, if not resolved to the satisfaction of the Former Auditor, would have caused the Former Auditor to make reference to the subject matter of such disagreements in its reports on the Company's financial statements and (ii) were no reportable events within the meaning of Item 304(a)(1)(v) of Regulation S-K, other than the material weaknesses in the Company's internal control over financial reporting identified by the Company's management."
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TOL | Hot Stocks16:34 EST Toll Brothers sees Q1 deliveries 1,900-2,100 units - Sees Q1 average delivered price per home $925,000-$945,000. Sees Q1 tax rate 22%
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MDB | Hot Stocks16:34 EST MongoDB jumps 10% to $386.51 after Q3 results beat, FY25 guidance raised
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RHHBY PSTX | Hot Stocks16:33 EST Roche commences tender offer for outstanding Poseida shares at $9 per share - Roche (RHHBY) announced that it has commenced a tender offer for all of the outstanding shares of common stock of Poseida Therapeutics, Inc. (PSTX) at a price of $9.00 per share in cash, plus a non-tradeable contingent value right to receive certain contingent payments of up to an aggregate of $4.00 per share in cash. The tender offer is being made pursuant to the previously announced merger agreement dated as of November 25, 2024 among Roche Holdings, Inc., an indirect wholly owned subsidiary of Roche Holding Ltd, Blue Giant Acquisition Corp., a wholly owned subsidiary of Roche Holdings, Inc., and Poseida. The tender offer period will expire at one minute following 11:59 p.m., New York City time on 7 January, 2025, unless the offer is extended. Roche has filed a tender offer statement on Schedule TO with the United States Securities and Exchange Commission. Blue Giant Acquisition Corp. is the acquirer in the tender offer. The Offer to Purchase contained within the Schedule TO sets out the terms and conditions of the tender offer.
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DOV | Hot Stocks16:32 EST Dover CFO Brad Cerepak to retire, Christopher Woenker to succeed - Dover announced that Brad Cerepak, Senior Vice President and CFO, has notified the company that he plans to retire on January 31, 2025. Christopher Woenker, CFO of the company's Engineered Products and Climate & Sustainability Technologies segments, will succeed Cerepak as Senior Vice President and CFO, effective January 31, 2025. As part of the company's transition plan, Woenker will remain in his current segment CFO roles while working closely with Cerepak through the 2024 fiscal year financial closing. Woenker will report to the Chairman and CEO, Richard Tobin. Woenker joined the company in March 2013, first serving as manager and then director in the Financial Planning and Analysis function.
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CR | Hot Stocks16:31 EST Crane names Alex Alcala as new COO - Crane Company promoted Alejandro Alcala to Chief Operating Officer, effective immediately. In this role, Alex will provide both strategic and operational oversight of all Crane business segments, as well as the Crane Business System organization. Alex joined Crane in 2013 as President of Crane Pumps & Systems and was then promoted to President of Crane ChemPharma & Energy in 2014.
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NTB | Hot Stocks16:31 EST N.T. Butterfield board approves $100M ordinary share repurchase program - The Bank of N.T. Butterfield & Son Limited announced that its Board of Directors has approved a $100M ordinary share repurchase program pursuant to which the Bank is authorized to purchase up to 2.7M of its ordinary shares through December 31, 2025. Michael Collins, Chairman and Chief Executive Officer said: "I am pleased to announce a new share repurchase program for 2025. Our capital management priorities continue to focus on supporting a quarterly cash dividend, funding organic growth, and positioning the Bank for potential acquisitions. Subject to market conditions, our new share repurchase authorization provides us with an additional method to effectively deploy capital in 2025." The new Share Repurchase Program will come into effect on January 1, 2025 with the termination of the current 2.1 million share repurchase program that was announced on July 22, 2024.
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PHR | Hot Stocks16:30 EST Phreesia jumps 6% to $22.83 after Q3 results, updated guidance
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DRI GPI | Hot Stocks16:29 EST Darden appoints Daryl Kenningham to board of directors - Darden Restaurants (DRI) announced the Board of Directors has appointed Daryl Kenningham as its newest member, effective immediately. With his appointment, the company increased the size of the Board from nine to 10 members. Kenningham has served as President and CEO of Group 1 Automotive (GPI) since January 2023.
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SMAR | Hot Stocks16:28 EST Smartsheet shareholders approve acquisition by Blackstone and Vista Equity - Smartsheet "announced that Smartsheet shareholders overwhelmingly approved the Merger Proposal for the Company's proposed acquisition by funds managed by Blackstone and Vista Equity Partners. This approval satisfies the shareholder vote condition for the consummation of the acquisition, originally announced in September 2024. In addition, shareholders also voted in favor of the executive compensation plan related to the acquisition, further validating their support for the Company's leadership and strategic direction."
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ORCL | Hot Stocks16:27 EST Oracle down 6% to $178.50 after Q2 results narrowly miss estimates
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CNS | Hot Stocks16:25 EST Cohen & Steers reports preliminary AUM of $91.4B as of November 30 - Cohen & Steers reported preliminary assets under management of $91.4B as of November 30, an increase of $1.7B from assets under management of $89.7B at October 31. The increase was due to market appreciation of $1.9B, partially offset by distributions of $151M and net outflows of $98M.
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ORCL | Hot Stocks16:24 EST Oracle reports Q2 Cloud revenue $5.9B, up 24% - Reports: Q2 Cloud Revenue (IaaS plus SaaS) $5.9 billion, up 24% in both USD and constant currency; Q2 Cloud Infrastructure (IaaS) Revenue $2.4 billion, up 52% in both USD and constant currency; Q2 Cloud Application (SaaS) Revenue $3.5 billion, up 10% in both USD and constant currency; Q2 Fusion Cloud ERP (SaaS) Revenue $0.9 billion, up 18% in both USD and constant currency; Q2 NetSuite Cloud ERP (SaaS) Revenue $0.9 billion, up 20% in USD and 19% in constant currency.
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BKD | Hot Stocks16:22 EST Brookdale Senior Living announces November occupancy of 79.5% - November 2024 Observations: November weighted average occupancy increased 110 basis points year-over-year to 79.5% in 2024. Demonstrating an improvement to recent years, November weighted average occupancy increased 10 basis points sequentially from October. Month end occupancy exceeded 80% for the fourth consecutive month. Fourth quarter-to-date move-ins and move-outs improved to the prior year comparable period supporting a 100 basis point weighted average occupancy increase over 2023 fourth quarter-to-date.
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YEXT | Hot Stocks16:21 EST Yext down 10% at $7.67 after Q3 results and guidance
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NBTX | Hot Stocks16:21 EST Nanobiotix completes dose escalation-expansion parts of NBTXR3 in PC - Nanobiotix announced the completion of the dose escalation and dose expansion parts of a Phase 1 study evaluating radiotherapy or T R -activated NBTXR3 or JNJ-1900 for patients with locally advanced pancreatic cancer or LAPC, or borderline resectable pancreatic cancer or BRPC . The Phase 1 study is being conducted by The University of Texas MD Anderson Cancer Center or MD Anderson. Patients with LAPC or BRPC often receive initial treatment with cytotoxic chemotherapy followed by RT +/- concurrent or maintenance chemotherapy...Following these encouraging results from the study, MD Anderson submitted and received US FDA clearance for a new, additional study cohort evaluating the combination of NBTXR3 and standard-of-care concurrent chemoradiation. The new cohort has launched, and recruitment is ongoing. "The results we have observed in this Phase 1 study give us confidence that NBTXR3 could have a significant impact for these patients," said Louis Kayitalire, MD, Chief Medical Officer at Nanobiotix. "We look forward to the data from the new cohort and believe the combination of NBTXR3 and concurrent chemoradiation could produce even more favorable outcomes for patients with locally advanced or borderline resectable pancreatic cancer." Nanobiotix expects full results from the completed dose escalation and dose expansion parts of the study to be presented by MD Anderson at a medical congress in 1H 2025.
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ARE | Hot Stocks16:21 EST Alexandria Real Estate raises quarterly dividend to $1.32 from $1.30 per share - Alexandria Real Estate Equities announced that its Board of Directors declared a quarterly cash dividend of $1.32 per common share for the fourth quarter of 2024. The dividend is payable on January 15, 2025 to stockholders of record on December 31, 2024. The common stock dividend for the year ending December 31, 2024 of $5.19 per common share represents an increase of 23c, or 5%, over the year ended December 31, 2023.
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ADSK | Hot Stocks16:21 EST Autodesk director Norrington sells 1,778 common shares - In a regulatory filing, Autodesk director Lorrie Norrington disclosed the sale of 1,778 common shares of the company on December 6 at a price of $305.92 per share.
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HRTG | Hot Stocks16:20 EST Heritage Insurance announces $10M share repurchase program - Heritage Insurance Holdings announced that its Board of Directors authorized a new share repurchase plan of $10M commencing upon the December 31 expiration of the prior $10M share repurchase program.
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KRYS | Hot Stocks16:19 EST Krystal Biotech announces no major objections from CHMP on B-VEC approval - Krystal Biotech announced that the European Medicines Agency's, or EMA's, Committee for Medicinal Products for Human Use, or CHMP, cancelled the Oral Explanation regarding the company's marketing authorization application for beremagene geperpavec-svdt, or B-VEC, for the treatment of dystrophic epidermolysis bullosa, or DEB, that was scheduled for December 6 and asked the company to submit written responses to the remaining outstanding issues. There are no major objections outstanding from the EMA with respect to the full approval of B-VEC. The company now anticipates a CHMP opinion in Q1 2025 while the launch timelines remain unchanged with a commercial launch in Germany still planned for Q2 2025.
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HSII | Hot Stocks16:19 EST Heidrick & Struggles names Nirupam Sinha as CFO - Heidrick & Struggles announced the appointment of Nirupam Sinha as CFO, effective January 6, 2025. Sinha currently serves as CFO of Checkout.com LLC, a globally regulated payments company. He was previously Global Head of Product at T. Rowe Price Group, and also led the Wealth & Asset Management and Corporate Business Functions Practices at McKinsey & Company.
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EPRT | Hot Stocks16:18 EST Essential Properties Realty Trust ups quarterly dividend 2% to 29.5c per share - Essential Properties Realty Trust announced that its Board of Directors declared a quarterly cash dividend of 29.5c per share of common stock for the fourth quarter of 2024. On an annualized basis the fourth quarter 2024 dividend of 29.5c equals $1.18 per share, an increase of 2c per share compared to the previous annualized dividend. The dividend is payable on January 14, 2025, to stockholders of record as of the close of business on December 31, 2024.
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LLY | Hot Stocks16:18 EST Eli Lilly announces $15B share repurchase program, 15% dividend increase - The board of directors of Eli Lilly and Company approved a new $15B share repurchase program. The company's prior $5B share repurchase program was completed in the fourth quarter of 2024. Additionally, for the seventh consecutive year, the board has announced a 15% increase in its quarterly dividend and declared a dividend for the first quarter of 2025 of $1.50 per share. The dividend is payable on March 10, 2025, to shareholders of record at the close of business on February 14, 2025.
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CE | Hot Stocks16:17 EST Celanese names Scott Richardson CEO - Celanese Corporation announced that Scott Richardson, currently Celanese's Chief Operating Officer, has been appointed Chief Executive Officer and will join the Company's Board of Directors, effective January 1, 2025. Richardson will succeed Lori Ryerkerk, who is stepping down as Chairman, CEO and director of Celanese at the end of the year. Celanese has elected Edward Galante, an independent director on Celanese's Board since 2013, as Chair of the Board, effective upon Ryerkerk's departure. Over his two decades of service at Celanese, Scott Richardson has served in a number of key management roles, including Chief Operating Officer, Chief Financial Officer and leadership positions overseeing Celanese's leading global Engineered Materials and Acetyl Chain businesses. Richardson was intimately involved in creating and implementing the EM and AC operating models that work together as a strategic pair to create value. "It is an incredible honor to be named CEO-elect of Celanese, and I am grateful to our Board of Directors for entrusting me with this responsibility," said Richardson. "Celanese is known for tenacious execution, even during difficult times, and I am confident we have all the critical components to create value for our shareholders, customers, employees and partners. I am fully committed to driving the changes needed in light of today's challenges, including our relentless efforts to improve our cost structure and drive cash generation. By executing our action plan and controlling what we can control, we are working to position Celanese to capitalize on its significant upside potential, resilient free cash flow and long-term value creation."
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PTGX | Hot Stocks16:17 EST Protagonist Therapeutics announces data from REVIVE study at ASH - Protagonist Therapeutics announced details from a poster presentation with final data from the rusfertide Phase 2 REVIVE study. Rusfertide, a mimetic of the natural hormone hepcidin, has potential therapeutic value in the treatment of polycythemia vera, or PV, and other disease indications. The data were presented at the 66th American Society of Hematology, or ASH. Final results show that rusfertide, when added to therapeutic phlebotomy with or without cytoreductive therapy achieved long term durable control of hematocrit below the 45% threshold for over three years. Prior to enrollment, the estimated mean phlebotomy rate in patients who enrolled on study was greater than5/year: In Part 1, the EPHL was less than1/year in patients who received rusfertide. In Part 2, the EPHL was less than1/year and approximately 6.1/year in the rusfertide and placebo groups, respectively. For patients who continued to Part 3, the EPHL remained at less than1/year. Increased mean corpuscular volume and showed continued improvement and normalization of serum ferritin levels. Platelet levels increased following initiation of rusfertide therapy and stabilized over time; mean leukocyte counts remained stable throughout the study. The Myeloproliferative Neoplasm Symptom Assessment Form was used to assess mean change from baseline in the individual symptom score in patients with moderate or severe symptoms at baseline. In patients who had moderate or severe symptoms at baseline, there were significant improvements from baseline in fatigue, early satiety, abdominal discomfort, inactivity, problems with concentration, night sweats, and itching at the end of Part 3. Overall, 18 patients experienced serious adverse events, or SAEs; most SAEs were unrelated and likely associated with the underlying disease. One patient developed acute myeloid leukemia after treatment discontinuation. After more than 150 patient-years of rusfertide exposure, malignancies were reported in 11 patients; all of these patients had risk factors that may have contributed to development of these malignancies. There was no obvious correlation between increased exposure to rusfertide and malignancies reported. Seven thrombotic events occurred in 6 patients; all had high-risk PV. No thrombotic events have been reported in patients with low-risk PV,
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CPIX | Hot Stocks16:17 EST Cumberland announces FDA approves sNDA for Acetadote product - Cumberland Pharmaceuticals announced the FDA has approved a supplemental New Drug Application for its Acetadote product. Acetadote is an intravenous formulation of N-acetylcysteine indicated to prevent or lessen liver injury after ingestion of potentially toxic quantities of acetaminophen.
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CASY | Hot Stocks16:16 EST Casey's General Stores reports Q2 inside SSS up 4.0% - The company states: "Inside same-store sales increased 4.0% compared to prior year, and 7.1% on a two-year stack basis, with an inside margin of 42.2%. Total inside gross profit increased 12.0% to $619.7 million compared to the prior year. Same-store operating expenses excluding credit card fees were up 2.3%, favorably impacted by a 1% reduction in same-store labor hours."
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MTN | Hot Stocks16:15 EST Vail Resorts to invest $198M-$203M in core capital in FY25 - Vail Resorts is committed to enhancing the guest experience and supporting the Company's growth strategies through significant capital investments. For calendar year 2025, the Company plans to invest approximately $198 million to $203 million in core capital, before $45 million of growth capital investments at its European resorts, including $41 million at Andermatt-Sedrun and $4 million at Crans-Montana, and $6 million of real estate related capital projects to complete multi-year transformational investments at the key base area portals of Breckenridge Peak 8 and Keystone River Run, and planning investments to support the development of the West Lionshead area into a fourth base village at Vail Mountain. Including European growth capital investments, and real estate related capital, the Company plans to invest approximately $249 million to $254 million in calendar year 2025. Projects in the calendar year 2025 capital plan described herein remain subject to approvals.
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MTN | Hot Stocks16:13 EST Vail Resorts backs FY25 Resort Reported EBITDA guidance - The company's Resort Reported EBITDA guidance for the year ending July 31, 2025 is unchanged from the prior guidance provided on September 26, 2024. The Company is updating its guidance for net income attributable to Vail Resorts, Inc., which it now expects to be between $240 million and $316 million, up from the prior guidance range of $224 million to $300 million. The primary difference is due to a $17 million increase from the gain on sale of real property related to the resolution of the October 2023 Eagle County District Court final ruling and valuation regarding the Town of Vail's condemnation of the Company's East Vail property that was planned for Vail Resorts' incremental affordable workforce housing project, a transaction that has been recorded as Real Estate Reported EBITDA. Additionally, the guidance is updated to include a decrease in expected interest expense of approximately $2 million which assumes that interest rates remain at current levels for the remainder of fiscal 2025. These changes have no impact on expected Resort Reported EBITDA. The Company continues to expect Resort Reported EBITDA for fiscal 2025 to be between $838 million and $894 million, including approximately $27 million of cost efficiencies and an estimated $15 million in one-time costs related to the multi-year resource efficiency transformation plan, and an estimated $1 million of acquisition and integration related expenses specific to Crans-Montana. As compared to fiscal 2024, the fiscal 2025 guidance includes the assumed benefit of a return to normal weather conditions after the challenging conditions in fiscal 2024, more than offset by a return to normal operating costs and the impact of the continued industry normalization, impacting demand. Additionally, the guidance reflects the negative impact from the record low snowfall and related shortened season in Australia in the first quarter of fiscal 2025, which negatively impacted demand and resulted in a $9 million decline of Resort Reported EBITDA compared to the prior year period. After considering these items, we expect Resort Reported EBITDA to grow from price increases and ancillary spending, the resource efficiency transformation plan, and the addition of Crans-Montana for the full year.
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YEXT | Hot Stocks16:13 EST Yext raises FY25 adjusted EBITDA view to $67.0M-$67.5M from $66.0M-$67.0M
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ZUO | Hot Stocks16:13 EST Zuora withdraws all previously provided guidance given Silver Lake deal - The company said, "Given the proposed acquisition of Zuora, we will not be holding a conference call or live webcast to discuss Zuora's third quarter of fiscal 2025 financial results, we will not be providing any forward looking guidance, and we are withdrawing all previously provided goals, outlook, and guidance."
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FATE | Hot Stocks16:11 EST Fate Therapeutics presents new data from FT819 study - Fate Therapeutics presented new clinical and translational data from the company's FT819 Phase 1 Autoimmunity study for moderate-to-severe systemic lupus erythematosus, or SLE, at the American Society of Hematology, or ASH, annual meeting being held in San Diego. The first three study patients, each of whom presented with active lupus nephritis, or LN, despite having been treated with multiple standard-of-care therapies, received fludarabine-free conditioning followed by a single dose of FT819 at 360 million cells. There were no dose-limiting toxicities, no events of any grade of cytokine release syndrome, immune effector-cell associated neurotoxicity syndrome, or graft-versus-host disease and rapid, deep, and sustained elimination of CD19+ B cells in the periphery was observed during the first month of treatment. FT819 is the company's off-the-shelf, CD19-targeted, 1XX CAR T-cell product candidate comprised of CD8ass+ T cells with a memory phenotype and high CXCR4 expression to promote tissue trafficking. The ongoing multi-center, Phase 1 clinical trial for patients with moderate-to-severe SLE is designed to evaluate the safety, pharmacokinetics, and anti-B cell activity of FT819. The first three patients, all of whom presented with active LN despite having been treated with multiple standard-of-care therapies, received fludarabine-free conditioning consisting of either cyclophosphamide alone or bendamustine alone, followed by a single dose of FT819 at 360M cells. In all three patients, FT819 was detected in the peripheral blood and rapid, deep, and sustained elimination of CD19+ B cells in the periphery was observed during the first month of treatment. All three patients remain on-study, and there have been no DLTs and no events of any grade of CRS, ICANS, or GvHD. Based on these clinical observations, the company is initiating dose expansion in up to 10 patients at this first dose level, and is also escalating dose to 720M cells. The company's FT819 Phase 1 Autoimmunity study also includes a second treatment arm to assess the safety, pharmacokinetics, and anti-B cell activity of a single dose of FT819 as an add-on to maintenance therapy without conditioning chemotherapy in patients with SLE. The first patient has now been treated in this second arm, which is being conducted in parallel with the study's conditioning arm. The first patient treated in the Phase 1 Autoimmunity study presented with active LN and severe disease, which was marked by renal BILAG A disease activity score based on biopsy, SLEDAI-2K score of 20, FACIT-Fatigue score of 33 and PGA score of 2.5. Following administration of fludarabine-free conditioning and treatment with a single dose of FT819 at 360 million cells, the patient was discharged from the hospital without notable adverse events, or AEs, after a protocol-required three-day stay. Rapid elimination of CD19+ B cells in the periphery was observed following treatment, and B-cell recovery by Month 3 was predominantly comprised of naive, non-class switched B cells with near-complete elimination of switched memory B cells and deep depletion of plasmablasts, indicative of an immune reset. The patient reported that her debilitating fatigue had entirely resolved without further treatment, and treatment with methylprednisolone was discontinued at Month 3. The patient achieved DORIS clinical remission, including with resolution of arthritis and active urinary sediment and with a substantial reduction in proteinuria, as of Month 6 follow-up. The patient continues on-study, in DORIS clinical remission, and remains free of all immunosuppressive therapy. The company also highlighted the scientific progress of its proprietary iPSC-derived CAR T-cell product platform at the ASH Annual Meeting. In an oral presentation entitled "Off-the-shelf Product Candidate Incorporates Novel Sword & Shield Technology Designed to Promote Functional Persistence without Conditioning Chemotherapy", the Company compared its novel Sword & Shield technology, which utilizes a 4-1BB-targeted CAR alongside the complete knock-out of CD58 to both target and evade host alloreactive immune cells, to other host immune evasion strategies. In preclinical studies of allogeneic models, the Company showed that its Sword and Shield Technology specifically engaged with alloreactive T cells and supported functional persistence while avoiding the killing of general host T cells and activated anti-tumor T cells. This unique observation was not seen with other approaches that are either too broad and undesirably eliminate most of the host immune system or have limited coverage and cannot adequately protect the allogeneic cell product. In a second presentation entitled "Development of Induced Pluripotent Stem Cell-Derived T Cells Exhibiting Phenotypic and Functional Attributes of Primary CAR T Cells", the company conducted a series of high-resolution analyses to show stimulated iPSC-derived T cells elicit primary T-cell like activation, proliferation, transcriptional and functional program engagement, and iPSC-derived CAR T cells uniquely emulate antigen-mediated response similar to primary-derived autologous CAR T cells.
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MDB | Hot Stocks16:10 EST MongoDB COO, CFO Michael Gordon to step down - Michael Gordon, MongoDB's COO and CFO, will be stepping down at the end of the company's fiscal year on January 31, 2025, and afterwards will serve as an advisor to ensure a smooth transition. The company has commenced an executive search process for a new CFO and will evaluate internal and external candidates. Serge Tanjga, MongoDB's Senior Vice President of Finance, will serve as interim CFO starting February 1st if a permanent successor has not been named by that date.
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TCS | Hot Stocks16:08 EST Container Store trading halted, news pending
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CMRX | Hot Stocks16:06 EST Chimerix to submit dordaviprone NDA to FDA, seeks accelerated approval - Chimerix announced that, following extensive dialogue with the FDA, the company plans to submit a complete new drug application, or NDA, seeking accelerated approval for dordaviprone as a treatment for recurrent H3 K27M-mutant diffuse glioma in the United States before year-end.
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ORCL | Hot Stocks16:06 EST Oracle reports Q2 Total Remaining Performance Obligations up 49% to $97B
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BMEA | Hot Stocks16:04 EST Biomea Fusion announces preliminary COVALENT-103 study data - Biomea Fusion announced preliminary data from the ongoing Phase I COVALENT-103 study evaluating BMF-500, the company's investigational covalent FLT3 inhibitor developed using the proprietary Fusion System. As of the data cut off, November 20, 20 patients with R/R acute leukemia had been enrolled in the dose-escalation portion of the study, all of whom received at least one dose of BMF-500. Among these, the study enrolled 13 patients with confirmed FLT3-mutations, of which 10 harbored FLT3-ITD mutations and 3 had FLT3-TKD mutations. All patients with FLT3-mutations had progressed following treatment with gilteritinib, and 5 had received at least 2 prior FLT3 inhibitors. The study enrolled 5 patients with wild-type FLT3 and 2 patients with an unknown FLT3 mutation status. The median number of prior lines of therapies among the enrolled patients was 4. No QT prolongations or related cytopenias were observed and no dose-limiting toxicities, or DLTs, were reported as of the data cut off. BMF-500 was generally well tolerated, and dose escalation is continuing per protocol. Pharmacokinetic/pharmacodynamic data confirmed on-target FLT3 inhibition, as BMF-500 and its metabolites showed bone marrow penetration and near complete FLT3 inhibition as early as Day 1 of dosing, as well as dose-proportional FLT3 inhibition. Preliminary data supports BMF-500's potential as a transformative therapy for patients with FLT3 mutated R/R acute leukemia. During dose escalation, BMF-500 achieved a first CRi at the end of Cycle 2, in 1 of 2 (50%) FLT3 mutated patients dosed at 100 mg twice daily, while the other patient experienced a clearance of peripheral blasts, greater than 50% reduction in bone marrow blasts and reduced transfusion frequency. The majority (5 of 6) of efficacy evaluable FLT3-mutated patients experienced a reduction of their bone marrow blasts. Other evidence of clinical activity such as: clearance or reduction of peripheral blasts, reduction of transfusion frequency, reduction in use of hydroxyurea were observed.
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INTU AMZN | Hot Stocks16:01 EST Intuit, Amazon expand strategic partnership - Intuit (INTU) and Amazon (AMZN) announced a multi-year strategic partnership to empower millions of Amazon sellers to manage their finances, stay compliant, access capital, and grow their business. By leveraging Intuit's AI-driven expert platform, millions of Amazon sellers will be able to discover and access Intuit's platform seamlessly, benefiting from powerful financial insights like profitability, cash flow, and estimated tax liabilities to fuel their growth. QuickBooks will become Amazon's preferred partner for financial management solutions integrated directly in Amazon Seller Central, the Amazon site where sellers manage their businesses. "Intuit and Amazon are providing financial tools for millions of Amazon sellers to thrive in Amazon's store," said Intuit CEO Sasan Goodarzi. "We know businesses that use Intuit's QuickBooks platform have a nearly 20-point higher success rate than those who don't. We're proud to partner with Amazon to bring the benefits of our AI-driven expert platform to help sellers boost their revenue and profitability, save time, and grow with confidence."
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CHSN | Hot Stocks16:00 EST Chanson International Holding trading resumes
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CHSN | Hot Stocks15:03 EST Chanson International Holding trading halted, volatility trading pause
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GOOG GOOGL | Hot Stocks14:54 EST Google announces latest quantum chip Willow, reducing errors exponentially - Hartmut Neven, Founder and Lead, Google Quantum AI said in a blog post, in part, earlier on Monday: "The Willow chip is a major step on a journey that began over 10 years ago....As part of Google Research, our team has charted a long-term roadmap, and Willow moves us significantly along that path towards commercially relevant applications...Today in Nature, we published results showing that the more qubits we use in Willow, the more we reduce errors, and the more quantum the system becomes. We tested ever-larger arrays of physical qubits, scaling up from a grid of 3x3 encoded qubits, to a grid of 5x5, to a grid of 7x7 - and each time, using our latest advances in quantum error correction, we were able to cut the error rate in half. In other words, we achieved an exponential reduction in the error rate. This historic accomplishment is known in the field as "below threshold" - being able to drive errors down while scaling up the number of qubits. You must demonstrate being below threshold to show real progress on error correction, and this has been an outstanding challenge since quantum error correction was introduced by Peter Shor in 1995...The next challenge for the field is to demonstrate a first "useful, beyond-classical" computation on today's quantum chips that is relevant to a real-world application. We're optimistic that the Willow generation of chips can help us achieve this goal. So far, there have been two separate types of experiments. " Reference Link
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ZETA... | Hot Stocks14:19 EST Zeta Global CEO says Omnicom, IPG announcement 'positive one for industry' - Zeta Global (ZETA) released a statement following Omnicom's (OMC) announcement that it has entered into a definitive agreement to acquire the Interpublic Group of Companies (IPG): "Earlier today, Zeta Global hosted its Zeta Data Summit, where among many other topics, David Steinberg, Zeta's Co-Founder, Chairman, and CEO, was asked about today's Omnicom and IPG news. David A. Steinberg, Co-Founder, Chairman, and CEO, said: 'Expanding on my earlier comments, we are proud of our extensive relationships with the top Holdcos, including both Omnicom and IPG, and believe that today's announcement is a positive one for the industry and Zeta. Like everyone else, we will be watching closely as this progresses and offer support as needed.'"
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SNY | Hot Stocks14:15 EST Sanofi: Sarclisa combinations demonstrate significant benefits in NDMA patients - New data from three oral presentations, which demonstrated significant clinical benefit with Sarclisa-based quadruplets in newly diagnosed multiple myeloma or NDMM patients were featured at the 66th American Society of Hematology or ASH,Annual Meeting & Exposition in San Diego, CA, US. The presentations, including results from the IMROZ and German-speaking Myeloma Multicenter Group or GMMG -HD7 phase 3 studies, showcased deep and durable responses and improved long-term outcomes with Sarclisa when added to current standard-of-care NDMM regimens. Chief Medical Officer, Global Head of Development at Sanofi "...Results from key studies evaluating Sarclisa combinations further reinforce our confidence in this strategy and speak to the potential benefit of Sarclisa as a backbone therapy for newly diagnosed multiple myeloma, regardless of transplant eligibility.",,,The IMROZ phase 3 study demonstrated that Sarclisa in combination with standard-of-care bortezomib, lenalidomide and dexamethasone VRd followed by Sarclisa-Rd, improved progression-free survival PF and led to a rapid and greater depth of response compared to VRd alone, as shown by minimal residual disease or MRD negativity rate over time, in TI NDMM patients. MRD negativity represents a measure of malignant cells left in the bone marrow after treatment and has been increasingly used as a surrogate endpoint for PFS in MM research. Numerous independent studies have shown a correlation between MRD negativity, deeper treatment responses and improved long-term outcomes....The use of Sarclisa in combination with RVd is investigational and has not been evaluated by any regulatory authority. Submission of an application for this combination in the EU is anticipated in the coming months.
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SNY | Hot Stocks14:11 EST Sanofi says Sarclisa combos showed benefits in multiple myeloma patients - Sanofi says new data from three oral presentations demonstrated significant clinical benefit with Sarclisa-based quadruplets in newly diagnosed multiple myeloma patients. Sarclisa-VRd demonstrated a consistent benefit at every time point up to 60 months and led to the highest minimal residual disease negativity rate of a newly diagnosed multiple myeloma patient regimen with a bortezomib, lenalidomide and dexamethasone backbone, when evaluating exclusively transplant-ineligible patients, according to Sanofi. Higher minimal residual disease negativity rates were observed at both the end of initiation and during maintenance, with 58.1% of patients in the intention-to-treat population treated with Sarclisa-VRd achieving minimal residual disease negativity versus 43.6% of patients in the control arm, according to the company.
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DIS | Hot Stocks13:50 EST Disney CFO says 'could' license other companies' content for Disney+
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DIS | Hot Stocks13:48 EST Disney CFO says will raise prices further on streaming services - Disney CFO Hugh Johnston says Disneyworld booking are still up for next summer, but the company "expects impact" to Disneyworld from the opening of the rival Epic Universe park. Johnston is participating in a question-and-answer session at the UBS Global Media and Communications Conference.
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DIS | Hot Stocks13:46 EST Disney CFO says FY25 operating income growth weighted to second half - Hugh Johnston, Chief Financial Officer of Walt Disney Company, is participating in a question-and-answer session at the UBS Global Media and Communications Conference.
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GSK | Hot Stocks13:35 EST GSK says median overall survival not reached in multiple myeloma study - GSK announced "statistically significant and clinically meaningful" overall survival results from a planned interim analysis of the DREAMM-7 trial evaluating belantamab mafodotin in combination with bortezomib plus dexamethasone versus daratumumab in combination with bortezomib plus dexamethasone as a second line or later treatment for relapsed or refractory multiple myeloma. With a median follow up of 39.4 months, the analysis shows a statistically significant 42% reduction in the risk of death among patients receiving the belantamab mafodotin combination versus the daratumumab-based comparator, the company said in a statement). Although the median overall survival was not reached in either arm of the study, the projected median overall survival for bortezomib plus dexamethasone is 84 months compared to 51 months for bortezomib plus dexamethasone, it added. The three-year overall survival rate was 74% in the belantamab mafodotin combination arm and 60% in the daratumumab combination arm. The survival benefit favoring bortezomib plus dexamethasone was seen as early as four months and was sustained over time, according to GSK. Reference Link
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AFMD | Hot Stocks13:33 EST Affimed reports 'promising' Phase 1 efficacy, safety data for AFM28 - Affimed N.V. announced the oral presentation of data on AFM28 at the 66th ASH Annual Meeting and Exposition. The data, derived from the first-in-human Phase 1 study of AFM28, showed "promising results in R/R AML, with signs of clinical efficacy and a well-managed safety profile at doses up to 300 mg weekly," the company stated. The study included 29 heavily pretreated R/R AML patients across six AFM28 dose levels. The median number of prior treatment lines was two and 86% of patients had an adverse risk profile according to the 2022 guidelines from the European LeukemiaNet. AFM28 was administered intravenously once a week across six dose levels, ranging from 25 mg to 300 mg. AFM28 was well tolerated, and the most common treatment-emergent adverse events were IRRs, observed in 45% of patients. All IRRs were mild to moderate. One patient demonstrated grade 1 cytokine release syndrome. No neurotoxicity or signs for immune-effector related side effects were seen. One of six patients treated at 250 mg showed a CR and stayed on treatment for 6.5 months. At the 300 mg dose level, 1 CR and 3 CRi were seen in 10 evaluable patients for a CRcR of 40%. Four of 10 patients are still on treatment with the option to deepen responses. The AFM28 Phase 1 study is on-going. "Achieving a 40% composite complete remission rate with AFM28 in R/R AML is a significant milestone, especially in this difficult-to-treat patient population. Importantly, we see activity independent of mutational status, including patients with negative prognostic molecular profiles. Safety has been manageable which provides the basis for further development of AFM28 either as single agent or in combination regimens," said Dr. Andreas Harstrick, MD, Chief Medical Officer at Affimed.
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TMUS | Hot Stocks13:14 EST T-Mobile CEO says Q4 'going great,' confident in guidance - T-Mobile CEO Mike Sievert, while presenting at the UBS Global Media and Communications Conference, stated according to a transcript of the event that the "good news is we recently reguided just a few weeks ago and said we'd be at 3 million or so postpaid phone net. I can tell you that that's looking we're very confident in that. It's been a great quarter so far. The only thing I would caution, and I can just hear myself saying this in prior years as well, is that this quarter's back end loaded. So while I'm here to tell you, it's going great, we're confident in our guidance, investors should be cautious because there's a lot of risk in the back half. Most of this quarter is still in front of us, if you will, because of the shaping of Q4 is a little different than most quarters, but we feel great about it."
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DELL NVDA | Hot Stocks13:03 EST Dell Technologies expanding strategic relationship with CoreWeave - Dell Technologies (DELL) is expanding its strategic relationship with AI hyperscaler, CoreWeave, as the first to ship Dell PowerEdge XE9712 server racks with Nvidia (NVDA) GB200 NVL72 to support CoreWeave's Cloud Services Platform, the companies announced. "CoreWeave will receive liquid-cooled, fully-integrated Dell IR7000 racks with Dell PowerEdge XE9712 servers, supported by Dell's AI professional services to optimize CoreWeave's data center design. The agreement builds on work between the two companies to meet the growing demand for high-performance cloud environments for generative AI developments. The Dell AI Factory with NVIDIA solutions bring together Dell's infrastructure and services capabilities with NVIDIA accelerated computing, networking, and AI software," the companies stated.
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NSC | Hot Stocks13:01 EST Norfolk Southern appoints Ann Adams as CHRO - Norfolk Southern has named Ann Adams as Chief Human Resources Officer, with responsibility for human resources and labor relations, reporting to CEO Mark George. In addition, PC Bryant has been named Vice President Human Resources, reporting to Adams. Adams joined Norfolk Southern in 2001 as a Manager in Human Resources.
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NTES... | Hot Stocks12:59 EST NetEase's 'Marvel Rivals' hits 10M players in first 72 hours - NetEase (NTES) said its latest free-to-play multiplayer game "Marvel Rivals" achieved 10M players in the game's first 72 hours of availability. The game is available for PC, PlayStation 5 (SONY), and Xbox Series X/S (MSFT). Reference Link
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TMUS | Hot Stocks12:57 EST T-Mobile CEO says Q4 'back end loaded' with 'a lot of risk' - T-Mobile CEO Mike Sievert, while presenting at the UBS Global Media and Communications Conference, said the company's Q4 is "back end loaded" with "a lot of risk in the back half." The stock is down 5%, or $13.32, to $230.46 in afternoon trading.
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TMUS | Hot Stocks12:56 EST T-Mobile falls after CEO says Q4 'back end loaded' with 'risk'
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X NPSCY | Hot Stocks12:43 EST Nippon Steel rebuts USW in letter to U.S. Steel employees - Nippon Steel (NPSCY) shared a letter to U.S. Steel (X) employees, saying in part: "We had hoped that continued discussions with the USW leadership would result in their support for the transaction. Our goal has been to listen to their concerns and to build on our commitments to spend $2.7 billion in capital investments at unionized facilities, share our world-class technological innovations, and secure union jobs so that American steelworkers at U. S. Steel can manufacture the most advanced steel products in the United States for American customers. During our recent discussions with the USW leadership, we listened carefully to the USW's requests for further details on our future plans....No less than $1 billion will be spent at Mon Valley Works...Approximately $300 million will be spent at Gary Works...Nippon Steel also intends to maintain the operation of all blast furnaces currently operating and to schedule six blast furnaces (two at Mon Valley and four at Gary) for relining or major repair by 2030 in order to extend their useful lives for many years to come." Reference Link
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RIGL | Hot Stocks12:36 EST Rigel Pharmaceuticals announces initial data from Phase 1b study of R289 - Rigel Pharmaceuticals announced initial data from its ongoing Phase 1b study evaluating R2891, an oral prodrug of R835, a potent and selective dual inhibitor of IRAK1 and IRAK4, in patients with relapsed or refractory lower-risk myelodysplastic syndrome. The data is being presented today by Dr. Guillermo Garcia-Manero at the 66th American Society of Hematology Annual Meeting and Exposition being held December 7-10, in San Diego, California and virtually. Rigel's open-label, Phase 1b study of R289 is enrolling patients with lower-risk MDS who are R/R to prior therapies. The primary objective of the study is to assess the safety and tolerability of R289 with secondary objectives to assess preliminary efficacy of R289 and characterize its pharmacokinetic profile. Key highlights from the interim data as of October 25, 2024, include: 22 patients were enrolled. The median age was 76; the median number of prior therapies was 3; 73% and 77% of patients had received a hypomethylating agent or luspatercept, respectively; and 73% of patients were high transfusion burden at baseline. The median time on therapy was 4.6 months. R289 was generally well-tolerated in this heavily pretreated LR-MDS patient population, the majority of whom were HTB. The most common treatment emergent adverse event were diarrhea and fatigue, and chills, nausea and pruritus, which were all Grade 1/2. The most frequent Grade 3/4 adverse events were anemia, platelet count decreased, pneumonia and alanine aminotransferase increased. One patient discontinued study drug due to hyperuricemia and a second patient discontinued study due to Grade 3 aspartate aminotransferase/Grade 4 ALT increase. R835 exposure increased with increasing R289 dose. At doses greater than or equal to500 mg QD, R835 plasma concentrations at steady state in some patients were greater than or equal to those correlating with 50% or 90% lipopolysaccharide-induced cytokine inhibition previously observed in a healthy volunteer study. For the 18 efficacy evaluable patients, hematologic responses occurred in 40% of evaluable transfusion dependent patients receiving R289 doses greater than or equal to500 mg QD. Red blood cell-transfusion independence greater than or equal to8 weeks was achieved by three patients; two HTB patients achieved RBC-TI greater than24 weeks. The median duration of RBC-TI was 29 weeks. One HTB patient receiving 500 mg QD achieved a minor hematologic improvement-erythroid response, with a 64% reduction in RBC transfusions compared to baseline. Additional supporting data: The patients achieving RBC-TI had peak hemoglobin increases exceeding 2.0 g/dL compared to baseline. There were no RBC-TI/HI-E responses in evaluable transfusion dependence patients receiving R289 doses of 250 mg QD and 250 mg BID. R289 was recently granted Fast Track designation by the U.S. Food and Drug Administration for the treatment of patients with previously-treated transfusion dependent LR-MDS.
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PSTX | Hot Stocks12:31 EST Poseida Therapeutics highlights interim Phase 1 results for P-BCMA-ALLO1 - Poseida Therapeutics will highlight interim clinical data from its Phase 1 trial of P-BCMA-ALLO1 in patients with relapsed/refractory multiple myeloma, including new profiling of patient responses from Arm C, an optimized lymphodepletion arm. The P-BCMA-ALLO1 data are being presented, along with two additional Company poster presentations covering new preclinical data for P-CD19CD20-ALLO1 and a patient case study demonstrating the reactivation of a Poseida autologous CAR-T therapy with a T-cell engager, at the 66th ASH Annual Meeting and Exposition being held in San Diego on December 7-10, 2024. P-BCMA-ALLO1 is an investigational non-viral, stem cell memory T cell-rich allogeneic CAR-T cell therapy in Phase 1/1b clinical development for the treatment of patients with RRMM. P-CD19CD20-ALLO1 is an investigational, non-viral TSCM-rich allogeneic CAR-T cell therapy in Phase 1 clinical development for the treatment of patients with B-cell malignancies and is the Company's first dual CAR-T program. P-BCMA-ALLO1 and P-CD19CD20-ALLO1 are being developed in collaboration with Roche. P-BCMA-ALLO1 Phase 1 Data: The poster presentation will highlight Phase 1 clinical data first presented at the 21st International Myeloma Society Annual Meeting in September 2024. The data showed a 91% overall response rate in Arm C, including a 100% ORR in B-cell maturation antigen-naive patients, and an 86% ORR in those who had received at least one prior BCMA- and/or G protein-coupled receptor class C group 5 member D-targeting treatment modality, along with differentiated safety results with no dose-limiting toxicities, low rates of cytokine release syndrome and immune effector cell neurotoxicity syndrome, all Grade 2 or less, and no graft vs. host disease or Parkinsonism. No patients required anti-myeloma bridging therapy or prophylaxis with steroids or tocilizumab, and there was no invasive apheresis; an average manufacturing wait time, from treatment decision to clinical response, was only 3.5 weeks. The patients in this study had more advanced disease than the myeloma patients studied in clinical trials of approved autologous CAR-T therapies, and in the intent-to-treat population, 100% of patients were infused with P-BCMA-ALLO1. New profiling of patient responses from Arm C are included in the ASH poster presentation. The data from this analysis show consistent P-BCMA-ALLO1 cellular expansion and persistence across different subgroups, including patients that are typically more challenging to treat. Key highlights suggest that P-BCMA-ALLO1: Cellular kinetics were not impacted by prior BCMA/GPRC5D-targeted therapy Expands and persists in patients with extramedullary disease P-CD19CD20-ALLO1 Preclinical Data Preclinical data has demonstrated that P-CD19CD20-ALLO1 delivers high in vitro potency and strong in vivo antitumor activity for either CD19 or CD20 single-positive target cells, as well as double-positive targets. New preclinical data included in the poster presentation show that compared to CD19-single targeting or CD20-single targeting CAR-T cells, P-CD19CD20-ALLO1: Achieved higher and more durable killing of tumor cells over three rechallenges, even in the presence of only one tumor antigen Exhibited higher cytotoxicity Produced higher and more sustained levels of effector cytokines that play an important role mediating the immune system response to cancers Showed higher in vivo antitumor efficacy than the CD19-single targeting CAR-T cells The Company's P-CD19CD20-ALLO1 Phase 1 clinical trial is enrolling patients with selected B-cell malignancies, with initial clinical data anticipated in 2025. CAR-T Reactivation with T-cell Engager Case Study The case study highlights the reactivation of an autologous Poseida CAR-T therapy with a T-cell engager in a patient with relapsed multiple myeloma. The patient attained and remained in stringent complete response over 12 months after CAR-T reactivation. This case highlights the potential of Poseida's TSCM-based CAR-T therapies to deliver a strong anti-myeloma response with long-term remission and CAR-T cell persistence. The Company believes this is the first time that a T-cell engager has been seen to reactivate a CAR-T therapy.
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ABBV | Hot Stocks12:29 EST AbbVie to present results from two clinical trials of epcoritamab - AbbVie announced new results from two ongoing clinical trials evaluating epcoritamab, a CD3xCD20 bispecific T-cell-engaging antibody administered subcutaneously, in adult patients with diffuse large B-cell lymphoma at the 66th Annual Meeting and Exposition of the American Society of Hematology. Arm 1 of the Phase 1b/2 EPCORE NHL-2 multi-arm trial evaluates fixed-duration investigational epcoritamab in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone in untreated high-risk DLBCL patients with International Prognostic Index scores of 3 to 5. Results from this arm of the study showed an overall response rate of 100% and a complete response rate of 87%. Among complete responders, an estimated 83% remained in remission after two years. Separately, three-year follow-up results from the Phase 2 EPCORE NHL-1 trial evaluating epcoritamab monotherapy in challenging-to-treat adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy showed that among the 41% of patients who achieved a CR, an estimated 52% were still responding at three years. EPCORE NHL-2 Results in First-Line DLBCL: The EPCORE NHL-2 trial enrolled 46 evaluable patients considered to have high-risk DLBCL, identified by International Prognostic Index scores of 3 to 5, a range associated with poor long-term outcomes. The IPI is a key tool used by oncologists to predict the prognosis of aggressive B-cell lymphomas.9 At screening, 35% of patients had bulky disease, and 21% had double-hit/triple-hit DLBCL, which are aggressive subtypes caused by major genetic mutations. A minimal residual disease analysis from blood samples showed that 91% of patients achieved MRD negativity, indicating no detectable disease as defined by ctDNA. The most common treatment-emergent adverse events were neutropenia, anemia, cytokine release syndrome, fatigue, nausea, pyrexia, and injection-site reaction. Four patients discontinued epcoritamab due to TEAEs; fatal TEAEs occurred in two patients. CRS events were mostly low grade and mainly occurred after the first full dose. All CRS cases resolved, and none led to discontinuation. Immune effector cell-associated neurotoxicity syndrome occurred in two patients and resolved in a median of 2.5 days without leading to discontinuation. EPCORE NHL-1 Results in Third-Line LBCL: Three-year follow-up results from the Phase 2 EPCORE NHL-1 trial evaluated epcoritamab monotherapy in 157 patients with R/R LBCL after two or more lines of prior therapy and showed that epcoritamab continues to deliver durable responses in challenging-to-treat patients. Additional data results include: The ORR was 59%, and CR was 41%. Median duration of response was 20.8 months and median duration of CR was 36.1 month. A MRD analysis from blood sample showed that 45.4% of patients achieved MRD negativity, as defined by ctDNA. The most common TEAEs were CRS, fatigue, and pyrexia; CRS rates remained unchanged since prior reports. Fatal TEAEs were reported in 20 patients; 10 patients had Grade 5 COVID-19. 73% of patients who received epcoritamab for two or more years did not experience a Grade 3 or higher infection after two years. Incidence of Grade 3 or higher cytopenias was highest during the first eight weeks of treatment and rates were within 0-13% in subsequent 12-week time periods up to week 144. Immunoglobulin G levels decreased by a median of ~20% after the start of epcoritamab treatment and remained stable over time.
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CRSP | Hot Stocks12:24 EST Crispr Therapeutics presents data on CTX112 at ASH Meeting - CRISPR Therapeutics presented data from the Company's ongoing Phase 1/2 dose escalation clinical trial evaluating the safety and efficacy of CTX112, a next-generation CD19 allogeneic CAR T cell therapy, in relapsed or refractory CD19-positive B-cell malignancies at the 2024 American Society of Hematology Annual Meeting. Additionally, the Company announced that the U.S. Food and Drug Administration granted Regenerative Medicine Advanced Therapy designation to CTX112 for the treatment of R/R follicular lymphoma and marginal zone lymphoma. The Phase 1/2 clinical trial is an open-label, multicenter study evaluating the safety and efficacy of CTX112 in relapsed or refractory B-cell malignancies. Eligible disease subtypes include large B-cell lymphoma, follicular lymphoma grade 1-3a, marginal zone lymphoma, and mantle cell lymphoma/ CTX112 was infused after a standard course of lymphodepleting chemotherapy. Data were presented from 12 subjects treated during the dose escalation with CTX112 doses ranging from 30 x 106 CAR+ T cells. The study population was enriched for patients with high-risk characteristics, including: primary refractory disease or early relapse to first-line therapy; high tumor burden; and high disease prognostic index score or elevated lactate dehydrogenase. CTX112 was well tolerated across all dose levels. There were no reported dose limiting toxicities and no reported Grade greater than or equal to3 infections. All grade 3 or 4 cytopenias following lymphodepleting chemotherapy resolved to Grade 2 or better within 1 month of CTX112 infusion. There were no reported cases of Graft versus Host Disease. All cases of cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome were Grade 1 or 2 per the American Society for Transplantation and Cellular Therapy criteria. Objective and complete responses were seen at all dose levels and in all treated NHL subtypes. Responses were also seen in patients with poor prognostic factors including primary refractory disease, early relapse, and high baseline tumor burden. Five patients have achieved responses lasting for more than 6 months, including one patient whose 6-month response was confirmed after the data cut-off date. One patient treated at DL1 remains in complete remission over a year after initial CTX112 infusion. The clinical efficacy of CTX112 is supported by a clearly differentiated pharmacokinetic profile for an allogeneic CAR T cell therapy. The mean peak concentration and total exposure were significantly higher at DL3 and DL4 vs. DL1 and DL2. This dose dependence suggests the possibility of deeper and more durable responses as the trial moves from dose escalation to dose optimization. Comparing DL3, the addition of Regnase-1 and TGFbetaR2 edits results in 7-fold higher peak concentration and 9.7-fold higher mean area under the curve for CTX112 relative to CTX110. Furthermore, at DL4, both Cmax and AUC are showing significantly more consistent and predictable increases. This suggests that the novel CRISPR/Cas9 potency edits are leading to higher CAR T cell expansion and functional persistence without enhanced or increased lymphodepleting chemotherapy doses. These preliminary data demonstrate that CTX112 has the potential to provide meaningful clinical benefit with a well-tolerated safety profile. Given the inherent difficulties of manufacturing a CAR T therapy from a patient's own diseased cells, allogeneic cellular therapy approaches have greater potential to address the unmet need in this patient population.
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IRON | Hot Stocks12:19 EST Disc presents clinical, translational data across portfolio at ASH meeting - DISC-0974: DISC-0974+Ruxolitinib Mouse Model: Wild-type mice were randomized to receive doses of placebo, ruxolitinib, DBIO-100, or a combination of ruxolitinib and DBIO-100. Results showed: Ruxolitinib treatment alone reduced hemoglobin by 1.2 g/dL in wild-type mice, inducing anemia; Adding treatment with DBIO-100 had a positive impact on anemia, increasing hemoglobin by 0.8 g/dL and further enhancing serum iron availability; These results highlight the potential for DISC-0974 to treat anemia of myelofibrosis in patients where disease-directed therapies such as ruxolitinib can significantly contribute to the development of anemia. DISC-0974 in a Mouse Model of Inflammatory Bowel Disease: The effect of DISC-0974 on improving anemia in a dextran sodium sulfate-induced colitis mouse model was evaluated. Results showed: Treatment with DBIO-100 suppressed hepcidin, increased serum iron, increased hemoglobin by up to 6 g/dL, and effectively alleviated anemia in IBD mice; Treated mice also experienced protective effects against IBD, evidenced by attenuated weight loss, decreased disease activity index score, preserved colon length, improved colon histopathology, and reduced markers of inflammation; These results highlight the potential value of DISC-0974 in treating anemia of chronic inflammatory diseases, such as IBD, and add to the body of evidence supporting the application of DISC-0974 to broadly address anemia of inflammation. DISC-3405: Healthy Volunteer Study: Complete SAD/MAD data from the Phase 1 trial of DISC-3405 in healthy volunteers were presented. In the SAD portion of this trial, healthy males and females ages 18 to 65 were given a single dose of placebo or DISC-3405 at 75 mg intravenously, 37.5 mg subcutaneously, 75 mg SC, 150 mg SC, or 300 mg SC. The MAD portion included placebo, 75 mg SC, and 150 mg SC cohorts dosed every 4 weeks for a total of 2 doses. Results showed: DISC-3405 produced dose-related increases in serum hepcidin with corresponding reductions in serum iron across all dose levels; DISC-3405 resulted in deep reductions in serum iron that were sustained and support a once-monthly SC dosing regimen; Single and repeat dosing of DISC-3405 demonstrated meaningful reductions in hematologic parameters, including reticulocyte hemoglobin, hemoglobin, and hematocrit; DISC-3405 was generally well-tolerated at all evaluated dose levels, with no serious adverse events, greater than Grade 2 AEs, or AEs leading to study withdrawal; These results support Disc's plans to advance the DISC-3405 program into a Phase 2 study in polycythemia vera in 2025. SCD Mouse Model: The effect of DISC-3405 in the Townes mouse model of SCD was evaluated. Results showed: Treatment with 10 mg/kg dose of a mouse analog of DISC-3405 resulted in iron restriction and a significant decrease in hemoglobin S concentration without affecting red blood cell counts; Also observed a significant decrease in lactate dehydrogenase, suggesting decreased hemolysis, and decrease in white blood cells, suggesting reduced inflammation; These results highlight the potential value of DISC-3405 in providing therapeutic benefits to SCD patients by reducing HbS concentration within red blood cells.
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IRON | Hot Stocks12:16 EST Disc Medicine presents clinical, translational data acroos portfolio at ASH meet - Disc Medicine spotlights 8 posters presented at the ASH 2024 annual meeting in San Diego, CA. This year's presentations included updates from the BEACON and AURORA trials of bitopertin in patients with erythropoietic protoporphyria and the Phase 1 SAD/MAD trial of DISC-3405 in healthy volunteers. Additionally, Disc presented a real-world patient survey highlighting the disease burden of EPP and multiple preclinical models highlighting the potential benefits of bitopertin, DISC-0974, and DISC-3405 in existing and new indications. The collection of data supports Disc's continued advancement of all three clinical candidates and provides evidence for expansion opportunities in new indications. In addition to its poster presentations, Disc presented complete results from the Phase 1b trial of DISC-0974 in anemia of myelofibrosis yesterday, December 8, in an oral presentation. These results demonstrated positive impact on clinically meaningful measures of anemia across a broad range of patient types and support advancement of the program into a Phase 2 trial in MF anemia, which is now initiated. Bitopertin, DISC-0974, and DISC-3405 are investigational agents and are not approved for use as therapies in any jurisdiction worldwide. Bitopertin: Disc is advancing development and registrational activities for bitopertin in EPP, with the potential for accelerated approval using PPIX as a surrogate endpoint. AURORA: The AURORA study is a randomized, double-blind, placebo-controlled Phase 2 clinical trial that enrolled 75 adult subjects with EPP. Subjects were randomized 1:1:1 to receive 20 mg of bitopertin 60 mg of bitopertin, or placebo orally once daily for 17 weeks. Updated analyses show that bitopertin reduced PPIX in all prespecified subgroups across demographic and baseline patient characteristics; Previously presented analyses showed that reductions in PPIX were associated with improvements in multiple clinical outcomes, including measures of sunlight tolerance, reductions in phototoxic reactions, and patient-reported quality of life. BEACON: The BEACON study is a Phase 2, randomized, open-label, multiple dose clinical trial that enrolled 22 adults and 4 adolescents with EPP. Subjects were randomized 1:1 to receive 20 mg of bitopertin or 60 mg of bitopertin orally once daily for 24 weeks. Updated analyses show that bitopertin significantly reduced protoporphyrin IX at low and high doses and in both adult and adolescent populations; Bitopertin had a meaningful impact on light tolerance, with similar benefit shown across adult and adolescent populations; Reductions in PPIX were associated with improvements in multiple measures of sunlight tolerance; Bitopertin was generally well tolerated and showed a similar safety profile in adults and adolescents. EPP LIGHT Study: The EPP LIGHT Study is a patient survey study seeking to comprehensively describe the burden of disease in adults and adolescents with EPP. Across adult and adolescent respondents, EPP symptoms impact all facets of life including ability to be out in the sun for prolonged periods of time, ability to undertake daily activities, deficits in emotional functioning, and absenteeism at work and school; 68% of adults and 45% of adolescents experienced pain from a phototoxic reaction after less than30 minutes in direct sunlight, and recovery time was an average of 5.5 +/- 4.8 days for adults and 5.1 +/- 3.0 days for adolescents; 75% of adults and 46% of adolescents reported feeling depressed or sad and respondents reported substantially lower satisfaction with social roles and higher feelings of social isolation than the general population; 23% of employed adults reported missing work in the past month due to EPP; 24% of adults and 42% of adolescents attending school at the time of the study reported missing school in the past month due to EPP. Phototoxicity Study in Mouse Model of EPP: The effects of an orally bioavailable glycine transporter 1 inhibitor, DISC-C, on PPIX levels and skin phototoxicity induced by UV/blue light were evaluated in EPP mice. Results showed: Treatment with a mouse analog of bitopertin caused a 37-40% decrease in PPIX levels in red blood cells; GlyT1 inhibition significantly reduced skin lesions after light exposure; treated mice developed skin lesions in 9.2% of exposed skin area vs. 51.2% in placebo; Percentage of area with skin lesions correlated with PPIX levels, supporting PPIX as the pathological driver of phototoxicity in EPP
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GMAB | Hot Stocks12:12 EST Genmab announces results from ongoing clinical trials of epcoritamab - Genmab announced new long-term results from two ongoing clinical trials evaluating epcoritamab, a T-cell engaging bispecific antibody administered subcutaneously, in adult patients with diffuse large B-cell lymphoma. Results from Arm 1 of the Phase 1b/2 EPCORE NHL-2 trial, evaluating fixed-duration epcoritamab in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, demonstrated an overall response rate of 100 percent and a complete response rate of 87 percent in high-risk patients with previously untreated DLBCL. Among complete responders, 83 percent remained in remission after two years. Separately, results from the Phase 2 EPCORE NHL-1 trial, evaluating epcoritamab monotherapy in challenging-to-treat adult patients with relapsed or refractory large B-cell lymphoma, showed that among the 41 percent of patients who achieved a CR, an estimated 52 percent were still responding at three years. Both analyses were presented at the 66th Annual Meeting and Exposition of the American Society of Hematology. EPCORE NHL-2 Results in First-Line DLBCL: The EPCORE NHL-2 trial enrolled 46 patients considered to have high-risk DLBCL, identified by International Prognostic Index scores of 3 to 5, a range associated with poor long-term outcomes. The IPI is a key tool used by oncologists to predict the prognosis of aggressive B-cell lymphomas. At screening, 35 percent of patients had bulky disease and 21 percent of evaluable patients had double-hit/triple-hit LBCL based on gene rearrangements identified by central analysis. With a median follow-up of 27.4 months, 87 percent of patients remained alive at two years and 74 percent were progression free. At two years, a minimal residual disease analysis showed MRD negativity was achieved in 91 percent of evaluable patients, indicating no detectable disease. Epcoritamab in combination with R-CHOP is being studied further in the ongoing, randomized, Phase 3 EPCORE DLBCL-2 trial. The most common treatment-emergent adverse events were neutropenia, anemia, cytokine release syndrome, fatigue, nausea, pyrexia, and injection-site reaction. Four patients discontinued epcoritamab due to TEAEs; fatal TEAEs occurred in two patients. CRS events were mostly low grade and mainly occurred after the first full dose. All CRS cases resolved, and none led to discontinuation. Immune effector cell-associated neurotoxicity syndrome occurred in two patients and resolved in a median of 2.5 days without leading to discontinuation. Use of epcoritamab + R-CHOP in first-line DLBCL is not approved in the U.S. or in the EU or in any other territory. The safety and efficacy of epcoritamab for use as a combination therapy in DLBCL have not been established. EPCORE NHL-1 Results in Third-Line LBCL: Three-year follow-up results from the Phase 2 EPCORE NHL-1 trial evaluated epcoritamab monotherapy in 157 patients with R/R LBCL and demonstrated that epcoritamab continues to deliver durable responses in challenging-to-treat patients. The ORR was 59 percent, and the CR rate was 41 percent. Median duration of response was 20.8 months and median duration of CR was 36.1 months. 52 percent of patients who experienced a CR were still responding at three years. Of the 119 patients who were MRD-evaluable, 54 achieved MRD-negativity. In a cycle 3-day 1 landmark analysis, 3-year PFS rates were 52 percent among MRD-negative patients and 18 percent among MRD-positive patients. The most common TEAEs were CRS, fatigue, and pyrexia; CRS rates remained unchanged since prior reports. Fatal TEAEs were reported in 20 patients; 10 patients had Grade 5 COVID-19. Seventy-three percent of patients treated with epcoritamab for two or more years did not experience a Grade 3 or higher infection after two years. Incidence of Grade 3 or higher cytopenias was highest during the first eight weeks of treatment and rates were within 0-13 percent in subsequent 12-week time periods up to week 144. Immunoglobulin G levels decreased by a median of approximately 20 percent after the start of epcoritamab treatment and remained stable over time.
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ACHC | Hot Stocks12:11 EST Acadia down 1% following NY Times expose on 'fraud and fakery' at clinics - Shares of Acadia Healthcare are down 37c, or 1%, to $40.75 in Monday midday trading following the publications of a New York Times investigation over the weekend that alleged "fraud and fakery" found at Acadia Healthcare's chain of 165 methadone clinics.
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EDIT | Hot Stocks12:07 EST Editas Medicine reports updated clinical data from RUBY trial of Reni-cel - Editas Medicine will present updated safety and efficacy data in 28 patients living with severe sickle cell disease treated with renizgamglogene autogedtemcel in the Phase 1/2/3 RUBY clinical trial. The data will be presented by Dr. Rabi Hanna, M.D., Department of Pediatric Hematology Oncology and Blood and Marrow Transplantation, Cleveland Clinic Children's, during a poster presentation at the American Society of Hematology Annual Meeting in San Diego, CA, at 6:00 p.m. PT. In the RUBY trial as of the data cutoff date, reni-cel was well-tolerated and continued to demonstrate a safety profile consistent with myeloablative busulfan conditioning and autologous hematopoietic stem cell transplant by all patients. Patients were at a median of 9.5 months post-reni-cel infusion, with 11 patients having greater than1 year follow-up. Since reni-cel treatment, 27 of the 28 patients were free of vaso-occlusive events. Patients were observed to have early normalization of total hemoglobin, with a mean total hemoglobin increasing from 9.8 g/dL at baseline to 13.8 g/dL at Month 6. Patients were also observed to have rapid and sustained improvements in fetal hemoglobin greater than or equal to40% and mean corpuscular concentration of HbF per F-cells, well above the anti-sickling threshold. In addition, sustained clinically meaningful improvements were observed in patient-reported outcome domains for pain, physical function, and social roles and activities. Patients were a median of 9.5 months post-reni-cel infusion, with 11 patients having greater than1 year follow-up. Of 28 patients, 27 were VOE-free post-reni-cel infusion. Reni-cel administration led to early, robust increases and sustained levels of total Hb and HbF. At month 6, the mean total Hb was 13.8 g/dL with a mean HbF percentage of 48.1%. The mean percentage of F-cells increased early and was sustained at greater than90% from month 4 through last follow-up. MCH-F of HbF-containing red cells increased early, with mean value of 16.3 pg/F-cells at month 4 visit and sustained above the anti-sickling threshold of 10 pg/F-cell through last follow-up. Markers of hemolysis, including absolute reticulocyte count, indirect bilirubin, lactate dehydrogenase, and haptoglobin, improved or normalized by Month 6 and were generally maintained or improved as of last follow-up. Sustained clinically meaningful improvements were observed in pain, physical, and social patient-reported outcome domains following treatment with reni-cel. Reni-cel was well-tolerated and demonstrated a safety profile consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant by all evaluated RUBY trial patients. After reni-cel infusion, all evaluable patients achieved successful engraftment; with median time to neutrophil engraftment of 23 days and median time to platelet engraftment of 25 days, which is important for limiting infection and bleeding risk. Two serious adverse events assessed by the investigators as possibly related to reni-cel treatment have been reported in the RUBY trial.
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APTO | Hot Stocks12:04 EST Aptose Biosciences announces clinical data on tuspetinib - Aptose Biosciences featured a wealth of clinical data for Aptose's lead compound tuspetinib in a poster presentation at the 66th American Society of Hematology Annual Meeting in San Diego. Poster title: "Phase 1 Safety and Efficacy of Tuspetinib Plus Venetoclax Combination Therapy in Study Participants with Relapsed or Refractory Acute Myeloid Leukemia Support Exploration of Triplet Combination Therapy of Tuspetinib Plus Venetoclax and Azacitidine for Newly Diagnosed AML" Key Findings and Messages: TUS+VEN+AZA triplet trial is proceeding in newly diagnosed AML patients. TUS+VEN retains activity in the difficult-to-treat prior-VEN AML population. TUS+VEN is active in FLT3 wildtype, representing ~70% of AML patients. TUS+VEN is well tolerated and can be safely co-administered. TUS+VEN is active across broad populations of R/R AML. Combination of TUS with VEN may avoid VEN resistance. TUS+VEN+AZA triplet may establish a more effective, mutation agnostic standard of care for chemotherapy ineligible AML patients. Tuspetinib, being developed by Aptose and originally created by Hanmi Pharmaceutical Co., is being advanced as the TUS+VEN+AZA triplet for frontline therapy of newly diagnosed AML patients ineligible for intensive chemotherapy. TUS is a once daily, oral, multi-kinase inhibitor selectively targeting kinases that drive AML cell proliferation. In the Phase 1/2 APTIVATE trial of relapsed/refractory AML patients, TUS single agent and the TUS+VEN doublet demonstrated excellent safety and broad efficacy across AML genetic subgroups - including those with adverse mutations in TP53 and RAS genes, and those with mutated or unmutated FLT3 genes. Highlights of the ASH poster presentation: TUS as Single Agent: 60% and 42% CR/CRh with 80 mg TUS in FLT3 mutated and all-comer VEN-naive AML 33% CRc & 42% ORR in FLT3 mutated and VEN-naive patients. Includes 40, 80, 120, and 160 mg TUS dose as a single agent. Includes those who failed prior therapy with venetoclax. Includes those with mutated or unmutated FLT3, those who failed prior-HSCT, priorFLT3i, prior-chemotherapy, prior-HMA. TUS once daily orally as a single agent achieved CR/CRh responses at four different dose levels with no dose limiting toxicities. TUS showed a favorable safety profile with no DLTs through 160 mg per day, and no drug related discontinuations, no QTc, no differentiation syndrome, and no deaths. TUS/VEN Combination Therapy: 40% ORR with 80 mg TUS + 400 mg VEN in FLT3 mutated patients. Among these 83% had failed prior-VEN treatment and 50% had failed both prior-VEN and FLT3i treatment. TUS+VEN achieved responses among diverse R/R AML with adverse mutations in VEN-naive, prior-VEN, FLT3WT, FLT3MUT, prior-FLT3. TUS+VEN showed favorable safety and tolerability with no new or unexpected safety signals, no drug related CPK elevations, no differentiation syndrome, and no deaths
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NIO | Hot StocksNio is up 15.3%, or 70c to $5.32.
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BEKE | Hot StocksKE Holdings is up 16.3%, or $3.08 to $21.89.
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TWI | Hot StocksTitan International is up 31.2%, or $2.17 to $9.12.
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DUST | Hot StocksDirexion Daily Gold Miners Bear 3X ETF is down -9.9%, or -$6.01 to $54.80.
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RDW | Hot StocksRedwire is down -11.6%, or -$1.63 to $12.44.
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SG | Hot StocksSweetgreen is down -11.7%, or -$4.90 to $37.14.
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MANH | Hot Stocks11:54 EST Manhattan Associates' DFIO solution selected by Lamps Plus - Manhattan Associates announced that Lamps Plus has implemented Manhattan's Demand Forecasting and Inventory Optimization solution to improve forecast accuracy and visibility into replenishment cycles while maintaining demanding customer expectations.
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ZTEK | Hot Stocks11:34 EST Zentek regains Nasdaq compliance - Zentek received a written notification from the Nasdaq Stock Market that the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2), as the minimum bid price of the Company's common stock has been above $1.00 per share for the last 11 consecutive business days.
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WTKWY MSFT | Hot Stocks11:24 EST Wolters Kluwer appoints Mark Sherwood as EVP, CIOMicrosoft - Wolters Kluwer (WTKWY) has appointed Mark Sherwood as Executive Vice President & Chief Information Officer. Mr. Sherwood will oversee the overall enterprise technology infrastructure of Wolters Kluwer with a focus on advancing the digital DNA, delivering next generation enterprise IT capabilities, transforming operations with AI and enhancing the workplace and customer experience. Sherwood joins Wolters Kluwer from Microsoft (MSFT), where he most recently led the Infrastructure and Engineering Services global team.
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CNI | Hot Stocks11:19 EST CN reaches tentative collective agreement with Unifor - CN announced a new tentative four-year collective agreement has been reached with Unifor. The union represents approximately 3,300 employees at CN in Canada, working in different mechanical, clerical, and intermodal functions. No details of the tentative agreement will be released publicly until the agreement is ratified. The current collective agreement with Unifor expires on December 31, 2024.
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CNI | Hot Stocks11:16 EST CN reaches tenative collective agreement with Unifor - CN announced a new tentative four-year collective agreement has been reached with Unifor. The union represents approximately 3,300 employees at CN in Canada, working in different mechanical, clerical, and intermodal functions. No details of the tentative agreement will be released publicly until the agreement is ratified. The current collective agreement with Unifor expires on December 31, 2024.
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VEON | Hot Stocks11:04 EST Veon launches initial $30M phase of share buyback program - VEON's Board of Directors has approved the commencement of the first phase of its previously announced share buyback program with respect to the Company's American Depositary Shares. This first phase of the buyback will be in the amount of up to $30M. This $30M first phase is part of VEON's larger plan to execute a share buyback program of up to $100M. The buybacks will be conducted on the open market pursuant to a 10b5-1 plan signed with a registered broker-dealer, and in compliance with Rule 10b-18.
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AORT | Hot Stocks11:01 EST Artivion reports hackers stole files during cybersecurity incident - In a regulatory filing, Artivion said, "Artivion identified and began taking measures to address a cybersecurity incident on November 21, 2024. Artivion's response measures included taking certain systems offline, initiating an investigation, and engaging external advisors, including legal, cybersecurity, and forensics professionals to assess, contain, and remediate the incident. The incident involved the acquisition and encryption of files. The Company is working to securely restore its systems as quickly as possible and to evaluate any notification obligations. As of the date of this filing, we believe that the incident has not had a material impact on the Company's overall financial condition or results of operations and that the incident is not reasonably likely to have a material impact on its financial conditions or results of operations. The Company continues to provide its products and services to customers, but the incident has caused disruptions to some order and shipping processes, as well as to certain corporate operations, which have largely been mitigated. The Company has and will continue to incur expenses related to its response to this incident, and the Company believes it has adequate insurance coverage. However, the Company believes that it will incur additional costs that will not be covered by insurance. The Company remains subject to various risks due to the incident, including the impact of delays in restoration, and, as a result, cannot provide assurances that the incident will not be determined to have a material impact in the future."
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CMCSA | Hot Stocks10:18 EST Comcast Cable CEO sees Q4 broadband subscriber loss of just over 100,000 - Comcast Cable CEO says hurricanes will impact about 10,000 broadband losses in Q4. Comcast Cable CEO says competition remained "intense" in Q4. Comcast is presenting at the UBS Global Media & Communications Conference. During the presentation, shares of are down about 6% to $40.70. Reference Link
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JAGX | Hot Stocks10:11 EST Jaguar Health to present data on crofelemer for CTD in breast cancer patients - Jaguar Health's Napo Pharmaceuticals announced that the data from the recently conducted analysis of the prespecified subgroup of adult patients with breast cancer from the Phase 3 OnTarget trial, which indicate that crofelemer achieved significant results in this subgroup, will be the subject of a poster presentation on December 11, 2024 during the 12:30 - 2:00 p.m. CST Poster Session 1 at the San Antonio Breast Cancer Symposium, which takes place December 10-13, 2024 in San Antonio, Texas. Patients with breast cancer accounted for the majority of participants in this unprecedented prophylactic clinical trial recently conducted by Napo for diarrhea in adult patients with solid tumors receiving targeted therapy with or without standard chemotherapy. "We look forward to this presentation at SABCS. A full study report on the breast cancer subgroup analysis is expected to be submitted to a peer-reviewed journal," said Lisa Conte, Jaguar's president and CEO. "The content of the presentation will serve as the basis of the briefing package we plan to submit to the U.S. Food and Drug Administration to request a meeting to discuss possible pathways to make crofelemer available as efficiently as possible to breast cancer patients. Additional analyses of OnTarget prespecified subgroups are ongoing, and we believe data from additional analyses may result in future submissions to peer-reviewed forums." As previously announced, the initial top line results from the OnTarget study showed that the multicenter, double-blind, placebo-controlled pivotal clinical trial did not meet its primary estimand for the prespecified analysis of all tumor types. The subgroup analysis in adult breast cancer patients indicates that crofelemer achieved significant results in this subgroup. A second poster presentation related to the OnTarget trial, based on data from the placebo arm of the study, will also take place during Poster Session 1 at SABCS on December 11, 2024.
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HSY | Hot Stocks10:10 EST Hershey trading resumes
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HON EADSY | Hot Stocks10:06 EST Avianca selects Honeywell's portfolio of avionics tech for use in A320neo fleet - Honeywell announced that Avianca has selected its portfolio of avionics technologies and mechanical systems for use in its new Airbus A320neo fleet. The adoption of Honeywell's latest cockpit technologies will help Avianca improve operational efficiencies and maximize situational awareness for its pilots. It also supports Honeywell's portfolio alignment to three powerful megatrends, including the future of aviation. Additionally, Honeywell will provide 131-9A auxiliary power units for Avianca's 138 new aircraft. Honeywell's 131-9A APU generates electrical power for the aircraft while on the ground, which helps to ensure passenger comfort prior to starting the main engines.
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MDLZ HSY | Hot Stocks10:06 EST Mondelez made preliminary approach Hershey, Bloomberg reports
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HSY | Hot Stocks10:05 EST Hershey trading halted, volatility trading pause
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MDLZ | Hot Stocks10:04 EST Mondelez partners with ISN to expand contractor management - ISN has selected ISNetworld as its primary contractor information management system for the Give & Go business unit. ISN will help Mondelez streamline contractor safety and compliance through contractor oversight, training, compliance tracking, and performance evaluations.
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LGTY | Hot Stocks10:01 EST 2717 Partners calls on Logility board to conduct strategic alternatives review - 2717 Partners, a significant shareholder of Logility Supply Chain Solutions, sent a letter to the Company's Board of Directors calling for it to explore strategic alternatives, including a sale of Logility. The firm said, in part, "We are writing to the Board of Directors of Logility Supply Chain Solutions with the hope of working constructively with you to do just that. As a significant shareholder of Logility, we have strong conviction in the Company. Indeed, Logility was one of the first investments 2717 executed following our launch. We invested in the Company because we believed Logility had tremendous upside potential that we could help management and the Board unlock. Further, management had made several strategic decisions over the prior two years that we hoped would be a net positive and consistent with a long-term value creation plan, including removing the controlling shareholder structure, pursuing a divestment of the corporate headquarters, divesting The Proven Method, re-branding, expanding and investing in system integrator relationships, and pursuing tuck-in M&A. Unfortunately, however, these decisions have not instilled confidence in the public markets. Instead, there remains a gap between Logility's current valuation and its intrinsic value...The market has spoken. As fiduciaries to Logility shareholders - including pension funds, college savings plans, and 401(k)s of hard-working Americans - the Board must immediately form a special committee of independent directors and hire an investment bank to explore strategic alternatives, including a sale of Logility, to maximize the value of shareholders' investments...We believe the Board and management have been given enough time to realize success for the Company and its stakeholders-now, it is time for change. We call on the Board to form a special committee of independent directors and to retain an investment bank to explore strategic alternatives, including a sale of Logility. We hope that the Board sees our perspective and is open to engaging with us on this topic."
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BAESY | Hot Stocks10:01 EST BAE Systems unit awarded $12M contract from DARPA - The U.S. Defense Advanced Research Projects Agency has awarded BAE Systems' FAST Labs research and development organization a $12M contract as part of the High Operational Temperature Sensors program. The HOTS program will help develop microelectronic sensor technologies capable of high-bandwidth, high-dynamic-range sensing at extreme temperatures. Under the terms of the contract, BAE Systems will design and build a new pressure sensor module - consisting of an integrated transducer and signal-conditioning microelectronics - able to operate with high performance at 800 degrees C or 1,472 degrees F. Work on this program will take place at BAE Systems' facilities in Nashua, New Hampshire and Merrimack, New Hampshire. It will also include collaboration with subcontractors The Penn State Applied Research Laboratory, Purdue University and Kampanics, LLC, and supplier GE Aerospace's research center.
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LU | Hot StocksLufax is up 17.4%, or 45c to $3.00.
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TWI | Hot StocksTitan International is up 21.6%, or $1.50 to $8.45.
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BBAI | Hot StocksBigBear.ai is up 22.9%, or 78c to $4.16.
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ACHR | Hot StocksArcher Aviation is down -6.3%, or -52c to $7.76.
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EVTL | Hot StocksVertical Aerospace is down -6.5%, or -55c to $7.87.
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DUST | Hot StocksDirexion Daily Gold Miners Bear 3X ETF is down -9.4%, or -$5.71 to $55.10.
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SUN | Hot Stocks09:54 EST Sunoco LP sees FY25 adjusted EBITDA $1.90B-$1.95B, up 25% y/y at midpoint - Sees FY25 operating expenses of $900M-$925M. Comments taken from investor presentation slides.Reference Link
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M | Hot Stocks09:53 EST Macy's rallies after activists provide shareholder value recommendations - Barington Capital and Thor Equities, who are shareholders of Macy's, earlier today published a presentation recommending that Macy's make changes to its capital allocation strategy and consider other structural actions to improve shareholder value. "Due to long-term challenges in the department store sector and previous management missteps, Macy's valuation has suffered markedly over the past decade with its shares down approximately 70%. Despite numerous attempts at implementing strategic plans under multiple leadership teams to overhaul Macy's value proposition, the one constant of all these ineffective actions has been Macy's reliance on spending enormous amounts of the Company's cash flows on capital expenditure projects...Barington and Thor propose that Macy's consider the following recommendations to improve shareholder value: Reduce capital expenditures to 1.5%-2% of total sales from ~4% currently; Repurchase a minimum of $2-$3 billion in stock over the next three years; Create a separate internal real estate subsidiary to optimize the return potential of the Company's valuable owned real estate assets; Evaluate strategic alternatives for the Company's higher growth Bloomingdale's and Bluemercury luxury operations; and add Barington and Thor representatives to the Macy's board." Shares of Macy's are up 4% to $17.09 in early trading.
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ZSPC | Hot Stocks09:53 EST zSpace, Inc. trading resumes
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BEKE | Hot StocksKE Holdings is up 12.3%, or $2.31 to $21.13.
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TWI | Hot StocksTitan International is up 14.1%, or 98c to $7.93.
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ZSPC | Hot Stocks09:48 EST zSpace, Inc. trading halted, volatility trading pause
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BBAI | Hot StocksBigBear.ai is up 19.2%, or 65c to $4.03.
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OMC | Hot StocksOmnicom is down -5.7%, or -$5.89 to $97.53.
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ACHR | Hot StocksArcher Aviation is down -6.0%, or -49c to $7.79.
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DUST | Hot StocksDirexion Daily Gold Miners Bear 3X ETF is down -8.2%, or -$4.97 to $55.84.
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RENT | Hot Stocks09:40 EST Rent the Runway trading resumes
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DXYZ | Hot Stocks09:38 EST DESTINY TECH100 INC trading resumes
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CARV | Hot Stocks09:37 EST Dream Chasers urgers Carver Bancorp shareholders to vote for its board nominees - Dream Chasers Capital Group urged shareholders of Carver Bancorp to vote for change ahead of this week's Annual Meeting of Shareholders.The deadline to vote electronically is 11:59 PM on Wednesday, December 11, 2024, ahead of the Annual Meeting the following day.In an open letter, Dream Chasers encouraged all shareholders to vote FOR Mr. Jeffrey "Jeff" Anderson and Mr. Jeffrey Bailey for election to the Board of Directors and to vote WITHHOLD on the two Directors that are up for re-election. "The final countdown for Carver's future is now," said Greg Lewis, CEO. "Either we are going to double down on the status quo of not delivering for the community or shareholders at Carver, or we will turn the page with two successful, qualified and focused directors to drive change. Whether you're an institutional or retail shareholder, we can all agree that new ideas and energy are necessary."We have heard from a large number of shareholders who are excited about the possibility of change at Carver because they believe in the Company and want it to serve the community as well as possible. To me, the biggest tragedy is that successive Carver Boards have had the opportunity to transform the bank into a national champion providing business loans, mortgages, and stock market investments to African Americans to build wealth and have squandered that chance. All this Board has to show after ten years at the helm is a once promising 75-year-old bank with $9.4 million in market capitalization and a $1.831 stock price. But I don't think it is ever too late. Mr. Anderson and Mr. Bailey will bring new voices, energy and experience to the Board, and will help get Carver back on track for growth and profitability. With your support, Carver's best days are ahead."
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RADX | Hot Stocks09:36 EST RADX Stock trading resumes
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CCL | Hot Stocks09:35 EST Princess Cruisies reports 'record-breaking' Black Friday-Cyber Monday bookings - Princess Cruisesy announced record-breaking bookings over the 4-day period covering the Black Friday through Cyber Monday period, fueled by strong demand for upcoming sailings in 2025 and beyond. The unprecedented performance saw bookings increase 32% over the same period in 2023. Cyber Monday, in particular, shattered expectations, with bookings surging 136% compared to the prior year. Bookings for this period were strong for both 2025 and 2026 sailings, with bookings for 2026 itineraries up 66% compared to bookings for 2025 voyages made during the same period in 2023. "The overwhelming response from our guests and worldwide strength of our brand reflects the growing enthusiasm for cruise travel and the unparalleled experience Princess Cruises delivers," said Gus Antorcha, president of Princess Cruises. "With the strong demand in this period for both 2025 and 2026 voyages, it's clear our guests are planning further ahead than ever before to secure their dream vacations at sea. Plus, with our Better than Best Price Guarantee, our guests are recognizing the value of booking early in complete confidence."
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MBLY | Hot Stocks09:33 EST Mobileye releases presentations for Capital Markets Day in Germany - Mobileye released the slides for presentations given at the December 9 Capital Markets Day being held in Munich, Germany. "They are meant to be viewed in combination with the verbal presentations given by the Mobileye management team that can be accessed through the replay that will be provided after the event," the company stated. Reference Link
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DXYZ | Hot Stocks09:33 EST DESTINY TECH100 INC trading halted, volatility trading pause
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BNED | Hot Stocks09:32 EST Barnes & Noble Education 'believes it can drive meaningful operating' FCF - The company said, "Barnes & Noble Education is focused on driving material improvements in its profitability and further improving its already strong financial foundation. Management is working on simplifying its operations to better focus on its core physical and virtual bookstore businesses. Go-forward savings from recently completed and in-progress initiatives are now estimated at over $20 million. The Company recently completed a $40 million At-the-Market sales agreement with BTIG, LLC. The proceeds of this capital raise will reduce go-forward annual interest expense by nearly $4 million per year, reduce risk, accelerate our ability to win new customers, and enhance our strategic and balance sheet optionality. In the medium-term, management is seeking to reduce annual interest expenses to around $10 million or less. The Company's budget goals continue to target a material improvement in fiscal year 2025 GAAP operating results and Adjusted EBITDA versus last year. Based on current estimates of capital expenditures and significantly reduced interest costs from last fiscal year, BNED believes it can drive meaningful operating free cash flow, which will be used to further de-lever its balance sheet."
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RADX | Hot Stocks09:31 EST RADX Stock trading halted, volatility trading pause
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RENT | Hot Stocks09:30 EST Rent the Runway trading halted, volatility trading pause
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RDDT | Hot Stocks09:28 EST Reddit testing AI-powered Reddit Answers feature in the U.S. - In a company blog post, Reddit said, "In line with our mission to empower communities and provide human perspectives to everyone, starting today, we're rolling out a test of Reddit Answers, a new way to get the information, recommendations, discussions, and hot takes people are looking for - on any topic - from real conversations and communities across all of Reddit. With Reddit Answers, redditors can ask questions and receive answers using a new, AI-powered conversational interface. Once a question is asked, curated summaries of relevant conversations and details across Reddit will appear, including links to related communities and posts. Redditors can easily read relevant snippets and answers inline from real redditors, jump into the full conversations, and go deeper in their search with their own or suggested follow-up questions. People know that Reddit has answers, advice, and perspectives on almost anything they're looking for, and AI-powered search is part of our longer-term vision to improve the search experience on Reddit - making it faster, smarter, and more relevant. Reddit Answers is initially rolling out to a limited number of users in the U.S., with support currently in English; we plan to expand to additional languages and locations in the future." Reference Link
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LTC | Hot Stocks09:22 EST LTC Properties names Wendy Simpson chairman, Pam Kessler and Clint Malin co-CEOs - LTC Properties announced that Wendy Simpson has been appointed executive chairman of board of directors, Pam Kessler and Clint Malin have been promoted to co-CEO, and Cece Chikhale has been promoted to CFO. The appointments are part of the company's succession plan and are effective December 31. The company said it is conducting a search for a new chief investment officer to succeed Clint Malin, who will retain that function until a successor is named.
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MULN | Hot Stocks09:18 EST Mullen Automotive's Bollinger Motors partners with Broadway Ford Truck Center - Mullen Automotive's Bollinger Motors has named St. Louis, Missouri-based Broadway Ford Truck Center as an official Bollinger Motors dealer, strengthening its Midwest presence.
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ARTL | Hot Stocks09:17 EST Artelo presents Phase 1 data with ART27.13 in cancer-related anorexia - Artelo Biosciences announced the presentation of preliminary data on ART27.13, the Company's benzimidazole derivative, being studied for cancer-related anorexia. The data was presented by the Principal Investigator, Professor Barry J. A. Laird, Chair of Palliative and Supportive Care, University of Edinburgh and Consultant Physician in Palliative Medicine, Edinburgh Cancer Centre, at the 17th International Conference on Sarcopenia, Cachexia, & Wasting Disorders, held December 6-8, 2024 in Washington D.C. Artelo is evaluating ART27.13 in the Cancer Appetite Recovery Study, a randomized, placebo-controlled Phase 1/2 trial in cancer-related anorexia, which is currently enrolling the Phase 2 of the study. In the Phase 1 of CAReS, ART27.13 was orally administered at 150 to 650 microgram doses in multiple centers throughout the UK and Ireland. The investigational drug was well tolerated with only mild to moderate adverse events observed in a minority of participants. No serious or life-threatening adverse events were recorded. Importantly, at one month of treatment, two-thirds of participants showed evidence the drug was impacting their weight loss with either stabilization or reversal of weight loss associated with their cancer. Open to enrollment in fifteen sites across five countries, the Phase 2 of CAReS is accruing participants at a 650 microgram dosage with planned escalation at 4-week intervals up to a dose of 1300 micrograms per day. In CAReS, all participants receive ART27.13 once-daily for up to 12 weeks and the endpoints include lean body mass, weight gain, quality of life and safety. The Phase 2 portion will also evaluate any impact on activity levels using a monitor attached to the patient's wrist. The study is expected to complete enrollment during the first half of 2025.
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SJW | Hot Stocks09:16 EST SJW Group appoints Douwe Busschops as CIO - SJW Group announced the appointment of Douwe Busschops as CIO, effective today. In this role, Busschops will focus on the integration and optimization of technology systems to enhance operational efficiency, customer experience, and long-term business growth. Busschops joins SJW Group from Veolia North America, where he served as vice president and CIO for the Municipal Water division
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LEXX | Hot Stocks09:15 EST Lexaria Bioscience engages CRO for human pilot study of DehydraTEHC-liraglutide - Lexaria Bioscience announced the engagement of a contract research organization to design and execute a human pilot study evaluating DehydraTECH-liraglutide against Saxenda injectable liraglutide. As reported on November 20th in Lexaria's 12-week rodent study with unlimited food available, DehydraTECH-processed liraglutide - administered orally - demonstrated a 5.88% weight reduction and 11.54% blood sugar reduction compared to baseline. The Rybelsus control, which was expected to outperform liraglutide, instead produced a 5.65% increase in body weight and 0.41% blood sugar reduction compared to baseline during the same 12 weeks. As a result of the stronger than expected performance of DehydraTECH-processed liraglutide, the Company has made the decision to investigate further with human study GLP-1-H25-5 expected to be conducted with 8-10 healthy volunteers. The goal of the Study will be to demonstrate safety and test pharmacokinetic performance in humans with an oral version of DehydraTECH-processed liraglutide. If positive, it could support a future decision to investigate DehydraTECH-liraglutide in a future Phase I registered trial. Development of the Study protocol is underway and Lexaria and the CRO are evaluating options for selection of the clinical site and jurisdiction in which to perform this Study, which has not yet been determined. Further updates will be provided in due course when Lexaria has obtained the necessary ethics board approval before the Study can begin.
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ACAD | Hot Stocks09:10 EST Acadia Pharmaceuticals appoints Thomas Garner Chief Commercial Officer - Acadia Pharmaceuticals announced that Thomas Andrew Garner has been appointed Chief Commercial Officer, effective today. Mr. Garner will spearhead Acadia's commercial strategy and operations, driving the Company's plans for sustained growth and expansion of its product portfolio and pipeline across U.S. and international markets. Mr. Garner will report to Catherine Owen Adams, Acadia's CEO, and serve on the executive leadership team. "Tom is an accomplished commercial executive with a demonstrated history of driving brand growth across a wide range of therapeutic areas and global businesses," said Catherine Owen Adams, CEO. "His experience includes a breadth of successful brand launches, including those in neuropsychiatric and rare cardiac diseases. We are thrilled to welcome him into this pivotal commercial leadership role as we continue our launch of DAYBUE in the US, while also preparing for launches outside the U.S and building a strong foundation for the potential introduction of new therapies in the future."
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NICH... | Hot Stocks09:09 EST Nitches, Inc. announces growth in InTheZone Labs' affiliate program - Nitches announced growth in InTheZone Labs' affiliate program. The company said, "Over the past weekend, we onboarded more than 25 new affiliates through ShareASale and the Awin network. This expansion enhances our ability to connect with a broader audience and aligns with our mission of delivering premium nutraceutical products to consumers worldwide. We are thrilled to announce that InTheZone Labs has partnered with Honey by PayPal, a leading online savings platform with a community of over 29 million members globally. Our store is now live on Honey's website, offering exclusive deals to their vast user base. Integration is currently underway, and full functionality is expected in the coming days. This collaboration marks a pivotal moment for InTheZone Labs as we join forces with a platform renowned for its innovation and reach. Honey was acquired by PayPal in January 2020 for $4 billion, making it PayPal's largest acquisition to date...InTheZone Labs is excited to announce that we have received approval from Amazon Selling Partner Support to list our products across all Amazon stores globally. Currently, we are integrating inventory and customizing product pages. Listings are pending compliance checks, and we look forward to providing updates as soon as our products are officially live on Amazon."
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SOAR | Hot Stocks09:08 EST Volato withdraws S-1 registration statement, anticipates positive Q4 net income - Volato Group announced the withdrawal of its S-1 registration statement. This decision reflects the company's continued progress in strengthening its financial position, marking another milestone in its turnaround efforts. The company remains on track to deliver positive net income in Q4 driven by strategic initiatives that have already resulted in improved financial performance. In the third quarter, Volato reported $40.3M in revenue, up $36.6M year-over-year, and achieved a positive Adjusted EBITDA of $3.2M These results highlight the success of the company's efforts to enhance operational efficiency and financial health. "Withdrawing the S-1 validates the strength of our turnaround, reinforcing that our approach is working and delivering meaningful results for investors," said Matt Liotta, CEO of Volato Group. "This action underscores our belief in the company's ability to meet its financial goals, ensuring long-term value creation for our shareholders." Volato's ongoing improvements, including its continuing partnership with flyExclusive and targeted cost management, reflect the company's commitment to enhancing shareholder value while continuing to meet customer needs with excellence and reliability.
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FRGT NSRGY | Hot Stocks09:07 EST Freight Technologies selected by Nestle Mexico to provide logistics services - Freight Technologies (FRGT) announced that global food and beverage leader, Nestle Mexico (NSRGY), has selected Fr8App to support its domestic logistics operations. Javier Selgas, CEO of Fr8Tech, stated, "We are honored to have been selected by Nestle Mexico for such an important role in servicing their vital logistics operations. This significant achievement is the result of our ongoing dedication to safety, reliability, and proficiency across our offerings, as well as our capacity to meet the rigorous quality standards and high levels of customer service expected from respected global leaders, such as Nestle. Our team is excited to support the success of Nestle's domestic logistics operations and is fully prepared to meet and exceed their expectations."
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TNFA | Hot Stocks09:07 EST TNF Pharmaceuticals announces topline results from MYMD-1 study - TNF Pharmaceuticals announced that topline results from a Phase 2a study of its lead drug candidate MYMD-1 was presented at a international congress of global experts in sarcopenia and related disorders held December 6-8 in Washington, D.C. The presentation, 'Isomyosamine for the Treatment of Sarcopenia in Elderly Population,' describes the results of a double-blind, placebo-controlled study in patients aged 65 years or older with chronic inflammation associated with sarcopenia/frailty. Subjects in the trial who were given once daily oral doses of MYMD-1 showed significant decreases in several biomarkers attributed to chronic inflammation, including tumor necrosis factor-alpha, Interleukin-6 and soluble TNF-a receptor 1 at several timepoints throughout the 28 days of treatment. No serious adverse events were reported.
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WYY | Hot Stocks09:06 EST WidePoint partners with 22Vets Technologies for Smart City IoT program - WidePoint announced a new contract award in partnership with 22Vets Technologies. WidePoint will deliver Non-Federal Issuer for PIV-Interoperable credentials in support of a global energy service company's new Smart City Internet of Things program.
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GNSS | Hot Stocks09:06 EST Genasys announces $3.35M renewal agreement for Indian Navy - Genasys announced a three-year, $3.35 M follow-on maintenance agreement for LRAD systems deployed by the Indian Navy. This is the third agreement under which the Indian Navy's LRADs are serviced through Genasys at in-country maintenance centers. "Since 2010, we have received $13.8 M in LRAD maintenance agreements for India's Navy," said Richard Danforth, Chief Executive Officer of Genasys. "International LRAD business continues to rebound as is evidenced with this agreement as well as the EU, Middle East, APAC, and West Africa orders announced earlier this calendar year. LRAD deployments are increasing around the world in defense, law enforcement, critical infrastructure protection, and maritime, border, and homeland security applications."
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GOVX | Hot Stocks09:06 EST GeoVax Labs receives Notice of Allowance for cancer vaccine patent - GeoVax Labs announced that the U.S. Patent and Trademark Office has issued a Notice of Allowance for Patent Application No. 17/876,682 to GeoVax, titled "Vaccinia Viral Vectors Encoding Chimeric Virus Like Particles." The allowed claims add to GeoVax's intellectual property protection related to its vector platform for expressing a tumor associated antigen, TAA, in virus-like particles, VLPs, from a recombinant Modified Vaccinia Ankara, MVA, viral vector, further demonstrating the GeoVax technical expertise.
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TTOO | Hot Stocks09:05 EST T2 Biosystems announces plans to license technology to expand its leadership - T2 Biosystems announced plans to license its proprietary technology to expand its leadership in direct-from-whole-blood detection of sepsis-causing pathogens. T2 Biosystems' proprietary technology is a key component of its FDA-cleared products, including the first and only products able to detect sepsis-causing pathogens directly from whole blood.
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NPWR CRC | Hot Stocks09:04 EST Net Power, California Resources sign MOU to develop power solutions in CA - California Resources (CRC) and its carbon management business, Carbon TerraVault, announced the signing of a Memorandum of Understanding, MOU, with Net Power Inc. (NPWR), to develop Net Power's ultra-low emission power plants in California, CA. Under the terms of the MOU, the parties plan to conduct feasibility studies on locating Net Power's facilities in proximity to CTV's underground storage vaults, which would reduce carbon dioxide transportation costs and midstream investments for CTV's operations. The parties plan to facilitate the initial deployment of up to 1 gigawatt of power capacity from Net Power's new modular plants in Northern California, resulting in up to 3.6 million metric tons per annum of CO2 emissions for permanent sequestration in CTV's nearby reservoirs. Each of Net Power's utility-scale modular plants is expected to require less than 20 acres, generate up to 250 megawatts, and be deployable in multi-plant configurations.
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TENB | Hot Stocks09:04 EST Tenable announces new features for Tenable Security Center - Tenable announced new vulnerability intelligence, risk prioritization and web application scanning features for Tenable Security Center, the world's #1 vulnerability management solution managed on-premises. Tenable Security Center identifies, investigates and prioritizes vulnerabilities, providing customers with a risk-based view of their security and compliance posture for their on-premises environments. Equipped with Tenable Vulnerability Intelligence, organizations have contextualized vulnerability data at their fingertips to effectively know, expose and close their critical vulnerabilities. Now available in Tenable Security Center, the curated database streamlines processes, providing enhanced visibility and threat context necessary to close critical risk.
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PPTA UAMY | Hot Stocks09:03 EST Perpetua Resources announces continued cooperation with U.S. Antimony - Perpetua Resources (PPTA) announced its wholly owned subsidiary, Perpetua Resources Idaho, has agreed to conduct metallurgical testing of antimony concentrate samples from Perpetua's Stibnite Gold Project with Montana-based United States Antimony (UAMY). The Stibnite Gold Project has an antimony reserve of 148M pounds, making it one of the largest reserves of antimony not under Chinese influence and the only U.S. domestic reserve. The Project is expected to supply about 35% of total U.S. antimony demand in the first six years of operations, based on the 2023 USGS antimony commodity summary.
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LMFA | Hot Stocks09:03 EST LM Funding closes purchase of 15MW mining site - LM Funding America announced the acquisition of the business assets of a 15 MW mining site in Oklahoma from Tech Infrastructure JV I, a joint venture majority-owned by Arthur, for $7.3M. LM Funding initially financed the JV's site development with loans and accrued interest totaling $3.8M. At closing of the acquisition of the assets of the site, LM Funding applied this credit to the purchase price and paid approximately $1M in cash to the JV. LM Funding escrowed an additional $2.5M of the purchase price to ensure the continuing obligations of the JV under the purchase agreement, including the January 10, 2025, exit of a third-party miner using 5MW at the site. The land on which the mining facility is located is leased from a third-party under a 5-year ground lease, and as a part of the transaction, the Company acquired an option to purchase the underlying land from the third-party landlord. LM Funding expects to utilize the full 15MW of $0.04 power for its current mining fleet. In Q1 2025, LM Funding is expected to have 562 petahash combined mining capacity at the Oklahoma site.
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CRKN | Hot Stocks09:02 EST Crown Electrokinetics plans to build, co-own reverse osmosis plant in Mexico - Crown Electrokinetics announced that its Water Solutions division plans to construct and co-own a state-of-the-art reverse osmosis, RO, water treatment plant in Cabo San Lucas, Mexico for the desalination of water collected from its proprietary design slant wells. The new RO plant will be built and owned in partnership with locally based, 529 Capital, a leading real estate development firm in the Baja Peninsula. Together, they will provide a new reliable supply of clean, safe drinking water to the region.
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GSK | Hot Stocks09:01 EST GSK announces NMPA of China accepted review of NDA for Blenrep - GSK announced that the National Medical Products Administration, NMPA, of China has accepted for review a new drug application, NDA, for Blenrep in combination with bortezomib plus dexamethasone as a treatment for relapsed or refractory multiple myeloma. Earlier this year, the NMPA granted priority review for this application as well as Breakthrough Therapy Designation for the BVd combination, which is intended to expedite development of investigational drugs with potential for substantial improvement over available therapies.
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BDNNY LUNMF | Hot Stocks08:59 EST Boliden to buy Neves-Corvo, Zinkgruvan mines from Lundin for up to $1.52B - Lundin Mining (LUNMF) has signed a definitive agreement to sell its Neves-Corvo operation in Portugal and Zinkgruvan operation in Sweden to Boliden (BDNNY) for up to $1.52B in total consideration. Under the terms of the agreement, Lundin Mining will receive upfront cash consideration of $1.37 billion upon closing, based on a cash-free and debt-free enterprise value of $1.3 billion as of an August 31, 2024 lock box date. In addition, Lundin Mining will receive up to $150 million in contingent cash consideration upon satisfaction of certain conditions outlined below. The Transaction is not subject to shareholder approval or any financing conditions. The proceeds from the Transaction will strengthen the Company's balance sheet and support its growth plans in the Vicuna District. Boliden has agreed to acquire 100% of the shares of Somincor-Sociedade Mineira de Neves-Corvo and 100% of the shares of each of Zinkgruvan Mining Aktiebolag and North Atlantic Natural Resources Aktiebolag from subsidiaries of Lundin Mining for up to $1.52 billion in cash, consisting of $1.37 billion in upfront cash consideration at closing and up to $150 million in contingent consideration. Total consideration at closing may also be subject to other customary adjustments in the event of non-permitted leakage from the Lock-Box. The terms of the agreement incorporate a Lock-Box completion mechanism, with the purchase price based on a cash-free and debt-free enterprise value of $1.3 billion, and assuming a normalized level of working capital. Based on the Lock-Box financial statements as of August 31, 2024, the upfront cash consideration to be paid at closing is $1.37 billion. The upfront cash consideration will also accrue interest at a 5% annual interest rate from August 31, 2024 to closing and is payable to the Company at closing. Neves-Corvo Contingent Payment Up to $100 million in contingent payments at Neves-Corvo is tied to underlying copper and zinc prices. Boliden will pay Lundin Mining 60% of the incremental revenue realized in each of the three calendar years between 2025 and 2027 where the average realized price on a semi-annual calendar period exceeds $4.50/lb copper and/or $1.30/lb zinc as per the London Metal Exchange reference prices. Incremental revenue is calculated using total payable sales volumes of copper and/or zinc for the semi-annual calendar period and tax affected using Portugal's current corporate income tax rate. Zinkgruvan Contingent Payment Up to $50 million in contingent payments at Zinkgruvan is tied to underlying zinc prices. Boliden will pay Lundin 50% of the incremental revenue realized in each of the two calendar years between 2025 and 2026 where the average realized zinc price on an annual calendar year exceeds US$1.40/lb zinc, as per the LME reference prices, provided a minimum annual production of 135 million pounds of payable zinc is achieved. Incremental revenue is calculated using total payable sales volumes of zinc for an annual calendar year period and tax affected using Sweden's current corporate income tax rate. The Zinkgruvan Contingent Payment is subject to a maximum payout of $25 million per calendar year. Indicative Timeline The Transaction is anticipated to close in mid-2025, subject to the completion of customary conditions and regulatory approvals, including but not limited to merger control approvals by the EU Commission and approval of the Swedish Inspectorate of Strategic Products under the Swedish FDI Act, and the change of control approval by the Portuguese Directorate-General for Energy and Geology under the Neves-Corvo Concession Contract.
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M | Hot Stocks08:57 EST Macy's issues statement following Barington presentation - Macy's issued the below statement following the press release and presentation issued by Barington Capital Group and Thor Equities: "The Macy's, Inc. Board of Directors and management team are committed to delivering sustainable, profitable growth and driving shareholder value. We have consistently demonstrated open-mindedness, including with respect to regularly reviewing the Company's strategy and capital allocation framework and exploring all paths to enhance value. We remain confident in our Bold New Chapter strategy, which continues to gain traction across all three of its pillars, and we expect to share further details regarding our progress when we report our full third quarter results and provide our fourth quarter and full year outlook. We will continue to act in the best interests of the Company and all Macy's, Inc. shareholders and we look forward to engaging with our shareholders, including Barington and Thor, as we further advance our initiatives and execute toward our long-term goals."
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CMCSA WBD | Hot Stocks08:56 EST Comcast, Warner Bros. Discovery announce multi-year distribution pact in Ireland - Comcast (CMCSA) and Warner Bros. (WBD) announced long-term agreements that will deliver WBD's portfolio of content to Xfinity and Sky UK and Ireland customers using Comcast's global technology platform across linear television, apps, and streaming services. Comcast has entered into renewal agreements that further the companies' longstanding distribution relationship with WBD's portfolio of linear cable networks for Xfinity TV customers, including TNT, TBS, CNN, Discovery, Food Network, HGTV, TLC, and Investigation Discovery. In addition, the agreements provide continued carriage of HBO and expand Comcast's rights to package the ad-supported versions of Max and Discovery+ in its streaming bundles. Comcast will also continue to offer WBD content as part of its U.S. NOW TV streaming services. The companies also announced that Sky UK and Warner Bros. Discovery have broadened their collaboration to bring Warner Bros. Discovery television and movies to Sky UK and NOW customers through a new long-term partnership in the UK and Ireland. The agreement will now include a new, non-exclusive ad-supported Max app when WBD launches the service in the UK and Ireland in early 2026. The Max ad-supported service will be bundled for Sky UK and Ireland customers, providing highly anticipated new shows on the service and more WBD content complementing Sky's position in seamless aggregation. In addition, NOW UK and Ireland Entertainment members will also receive bundled access to the ad-supported version of Max integrated into Sky's NOW experience alongside other top content. Financial terms of the agreements were not disclosed.
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RVNC | Hot Stocks08:51 EST Revance, Crown Laboratories announce amended and restated merger agreement - Crown Laboratories and Revance announced that they have amended and restated the merger agreement entered into by the parties on August 11, pursuant to which the companies will seek to merge the two organizations. Under the terms of the amended and restated merger agreement, which has been unanimously approved by Revance's board of directors, Crown will commence a tender offer to acquire all outstanding shares of Revance's common stock for $3.10 per share in cash. The parties entered into the amended and restated merger agreement in response to, among other things: Revance receiving notice from Teoxane alleging breach by Revance of its exclusive distribution agreement with Teoxane. Revance and Teoxane's settlement of such alleged breach, including by entry into a sixth amendment to the U.S. distribution agreement, pursuant to which the parties agreed, among other things, to certain revised brand guidelines and minimum purchase commitments through 2029 and the "ANZ Distribution Agreement," pursuant to which Teoxane will act as Revance's exclusive distributor and licensee in Australia and New Zealand. Revance's recent commercial performance relative to prior 2024 financial guidance. Revance's prospects as a standalone company including, but not limited to consideration of the company's capital structure and operating expense profile, and the potential actions that would be required by the company to preserve its cash position including reductions in operating expenditures that the company believes would have a negative impact on revenue growth and the likelihood that the company would be required to refinance its outstanding indebtedness and/or raise additional equity capital which could be highly dilutive and uncertain. The transaction is expected to close in the first quarter of 2025. Following completion of the merger, Revance will be wholly owned by Crown and Revance's stock will no longer be publicly traded on Nasdaq. The transaction is subject to stockholders validly tendering shares representing at least a majority of the voting power of Revance and the satisfaction of other customary closing conditions. Following the successful closing of the tender offer, Crown will acquire any shares of Revance that are not tendered in the tender offer through a second-step merger for the same consideration as paid in the tender offer. Revance's board of directors unanimously recommends that Revance's stockholders tender their shares in the tender offer which is expected to be commenced on December 12.
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NBN | Hot Stocks08:50 EST Northeast Bank commences ATM offering of voting common stock - Northeast Bank has entered into an equity distribution agreement with Piper Sandler & Co. and Keefe, Bruyette & Woods for the offer and sale from time to time of shares of its voting common stock having an aggregate offering price of up to $75,000,000.00 in an at-the-market offering. All of the Shares to be sold in the offering will be offered by the Bank. The Bank intends to use the net proceeds from the offering for general corporate purposes, including the support of additional growth. The Shares will be offered through Piper Sandler and KBW, as the distribution agents. Sales of the Shares, if any, will be made from time to time in negotiated transactions at market prices prevailing at the time of a sale or at negotiated prices, or as otherwise agreed with the distribution agents, and, as a result, sale prices may vary. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or the actual size or terms of the offering.
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SONN | Hot Stocks08:49 EST Sonnet announces safety data following SON-1010 monotherapy dose escalation - Sonnet BioTherapeutics announced that the results of SON-1010 at the highest dose have been formally evaluated by the Safety Review Committee in the Phase 1 SB101 clinical trial of SON-1010 in adult patients with advanced solid tumors. SB101 is the Company's open-label, adaptive-design dose-escalation study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of SON-1010 administered to patients with advanced solid tumors. The study has enrolled 24 subjects to date. Primary outcome measures for the study were to evaluate the safety and tolerability of SON-1010 and establish the MTD. Additionally, the Company announced the release of a "What This Means" segment to discuss the data. SON-1010 is the Company's proprietary version of recombinant human interleukin-12, configured using genetic fusion to Sonnet's Fully Human Albumin Binding platform, which extends the half-life and bioactivity of the IL-12 component due to binding native albumin in the serum and also targets the tumor microenvironment by strong binding to gp60 and Secreted Protein Acidic and Rich in Cysteine. All enrolled patients have had advanced solid tumors. The final 1200 ng/kg dose-escalation cohort was increased in size to 6 patients to enhance the assessment of PK and PD at the MTD. The SB101 trial employed a 'desensitizing' first dose of 300 ng/kg to take advantage of the known tachyphylaxis with rhIL-12, with the intention of minimizing toxicity and allowing for higher maintenance doses. No dose-limiting toxicities or related serious adverse events have occurred to date. The safety and toxicity profile that has developed is typical for a Phase 1 oncology trial, with the majority of adverse events being reported as mild. All AEs seen to date have been transient, with no evidence of cytokine release syndrome. Of the 24 patients dosed to date, 17 had SD at the first follow-up CT, 12 of whom were progressing at study entry. 10 of the 21 evaluable patients remained stable at four months, suggesting SON-1010 clinical benefit, and one of those patients in the highest dose cohort, who has clear cell sarcoma, had a PR with a 45% reduction in tumor size by RESIST criteria. As previously disclosed, one patient in the first dose cohort with endometrial sarcoma who was progressing at study entry had evidence of improvement after 11 months, with smaller tumors and complete resolution of ascites. This patient later progressed at 23 months and started chemotherapy.
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SLS | Hot Stocks08:47 EST Sellas Life Sciences reports OS, ORR data from Phase 2 trial of SLS009 - SELLAS Life Sciences Group announced additional data from the expansion cohorts in the Phase 2 trial of SLS009, a highly selective CDK9 inhibitor, in relapsed/refractory acute myeloid leukemia. Key Highlights from the updated topline data: As of December 4, 2024, data cutoff, 14 patients were enrolled in Cohort 3 and 14 in Cohort 4 and 5, of which 9 were evaluable at the time of analysis. At latest follow-up, the mOS has not been reached yet but has exceeded 7.7 months in Cohort 3. This is particularly significant as the expected mOS for patients in this setting is typically 2.5 months. In expansion cohorts 4 and 5, in patients with AML-myelodysplasia-related changes with ASXL1 mutation and mutations and cytogenic changes other than ASXL1 the ORR was 56% in 9 evaluable for efficacy patients. SLS009 was well-tolerated with no new safety signals observed to date as the regimen remains safe in additional patients enrolled to date. The Phase 2 clinical trial of SLS009 is an open-label, single-arm, multi-center study designed to evaluate the safety, tolerability, and efficacy of SLS009 in combination with venetoclax and azacitidine at two dose levels, 45 and 60 mg. In the 60 mg dose cohort patients were randomized into either a 60 mg dose once per week or a 30 mg dose two times per week. The trial was expanded to include two additional cohorts, one with ASXL1 mutated AML patients and one with patients with myelodysplasia-related molecular abnormalities other than ASXL1. In addition to response and survival analyses, the study aims to identify biomarkers for the target patient population and enrichment for further trials.
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CLIR | Hot Stocks08:42 EST ClearSign regains Nasdaq compliance - ClearSign announces that it has received a notice from the Listing Qualifications Department of the Nasdaq Stock Market on December 6, informing ClearSign that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing on Nasdaq.
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TAOP | Hot Stocks08:41 EST Taoping signs non-binding letter of intent to acquire 100% of Yunti - Taoping announced that it has signed a non-binding letter of intent to acquire 100% of the equity of Shenzhen Yunti Internet of Things Co., Ltd., a Chinese company based in Shenzhen, Guangdong Province. Taoping's acquisition of Yunti, if consummated, is expected to open new revenue growth opportunities for the company, while further consolidating and expanding the company's market share in the lucrative elevator equipment and service industry. Under the letter of intent, Yunti's shareholders agree to transfer their ownership of Yunti to the company in exchange for newly issued ordinary shareholders of the company. The final valuation and timeline of the acquisition will be determined based on a mutually agreed upon independent third party's comprehensive evaluation of Yunti. The parties expect to close and integrate the acquisition over the next 12 months. The non-binding letter of intent does not create an obligation on the part of either party to consummate any transaction. The proposed transaction is subject to a definitive agreement to be negotiated between the parties, conditioned upon further financial and legal due diligence and approval of the company's Board of Directors, as well as other customary closing conditions, such as any required regulatory approvals. There is no assurance that any transaction will be concluded.
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PPTA UAMY | Hot Stocks08:41 EST Perpetua Resources, US Antimony sign testing agreement - United States Antimony Corporation (UAMY) entered into a formal Metallurgical Testing Agreement with Perpetua Resources Corp. (PPTA) to evaluate stibnite-rich material from Perpetua's Stibnite Gold Project located in Idaho. Through the agreement, Perpetua will supply samples of antimony ore and assay work for evaluation at USAC's Montana facility. The purpose of the testing is to allow both companies to evaluate antimony product specifications that may be able to be commercially produced from Perpetua ore at USAC's processing plant. The companies, however, have not entered into any joint agreements for commercial production at this evaluation stage.
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FET | Hot Stocks08:41 EST Forum Energy announces $75M share repurchase pact, sale-leaseback deals - Forum Energy Technologies announced that its Board of Directors has authorized a program for the repurchase of outstanding shares of FET's common stock having an aggregate purchase price of up to $75M. ...In addition, it may be executed using open market purchases pursuant to Rule 10b-18 under the Securities Exchange Act of 1934, as amended, in privately negotiated agreements pursuant to Rule 10b5-1 plans or other transactions...In the fourth quarter, FET completed sales of two manufacturing facilities located in Texas. Net proceeds totaled approximately $20M. The properties remain an integral part of FET's operations and long-term lease agreements were executed in connection with the transaction.
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VEEE | Hot Stocks08:40 EST Twin Vee PowerCats appoints Shawn Erb as director of sales, dealer relations - Twin Vee PowerCats announced that Shawn Erb has joined Twin Vee as its Director of Sales and Dealer Relations. In this role, Mr. Erb will lead the Company's sales operations, cultivate strong relationships with new and existing dealers across the United States and globally, and manage the sales, distribution, and support for the Company's product lines. Mr. Erb's new position is effective immediately. Most recently, Mr. Erb was the National Sales Manager for Four Winn's Boats, where he directed and managed the sales and business development strategy for Four Winn's & Wellcraft Brands in the Americas.
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POST | Hot Stocks08:39 EST Post Holdings reports avian influenza at third-party contracted facility - Post Holdings provided information regarding an avian influenza incident at one of Michael Foods' third-party contracted egg-laying facilities. Post also affirmed its non-GAAP Adjusted EBITDA guidance for fiscal year 2025. A Michael Foods third-party contracted egg-laying flock in Iowa tested positive for avian influenza. The facility houses approximately 4.5M egg-laying hens, or approximately 12% of Post's controlled supply, inclusive of owned and third-party contracted farms.
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GIC | Hot Stocks08:39 EST Global Industrial introduces new HydroMax Air Compressor - Global Industrial Company announced its latest innovation in pneumatics: the two-stage, silent, variable speed, water-cooled, and Wi-Fi enabled HydroMax Air Compressor. The new Global Industrial HydroMax Two-Stage Silent Air Compressor is designed to deliver a safer, more efficient pneumatic system. This air compressor operates at a very low noise level even at full power, enabling teams to work comfortably and safely nearby. Its variable-speed, soft-start motor minimizes energy draw while providing a powerful 10 HP output, reducing operational expenses by using only the energy required. The HydroMax also features an automotive-style water-cooled system that prevents overheating, increasing the longevity and reliability of the air compressor.
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XPL | Hot Stocks08:38 EST Solitario announces drilling results from Golden Crest Project - Solitario Resources announced its "most compelling drilling results to date" on its Golden Crest Project. Significant gold mineralization was intersected over a substantial thickness in the lower Deadwood rock formation in drill hole GC-008. The entire lower Deadwood formation was mineralized with an average gold grade of approximately 1.0 gram per tonne over its entire 41.0-meter length. Importantly, gold grades were increasing with depth, with the last two meters of core averaging 3.4 gpt, the highest grades encountered before the hole was terminated due to technical drilling difficulties. The lower Deadwood formation hosts the majority of Tertiary gold mineralization in the historic Homestake-Wharf gold district situated several miles east of Solitario's land position. GC-008 represents the first mineralization ever discovered in Lower Deadwood outside of the historic district. Chris Herald, CEO, stated: "I cannot overstate the importance of these assay results. GC-008 represents a new Wharf-style discovery and is our most significant gold intercept to date. GC-008 was our first drill hole to test a major structural zone that has been traced on Solitario's property position well over 12 kilometers in length and approximately 500 meters wide. This exceptionally large structural/stratigraphic zone appears to be a very fertile mega-target that only has one drill hole and is open ended in all directions, including depth. This structural zone is suspected to have deep roots and is believed to be an important conduit to Tertiary-aged gold mineralization. GC-008 was designed to test this zone at the most receptive stratigraphic horizon - the lower Deadwood Formation. The historic Wharf district has an estimated total gold endowment of over 10 million ounces. Approximately half of this endowment occurred as high-grade mineralization, often over an ounce per tonne, and the other half was lower grade averaging about a gram per tonne. The lower grade mineralization formed a large halo around the higher-grade structures. We believe this intercept represents the lower-grade halo surrounding potentially high-grade structures."
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ARE | Hot Stocks08:37 EST Alexandria Real Estate announces $500M stock repurchase program - Alexandria Real Estate Equities announced that the company's Board of Directors authorized a common stock repurchase program. Under the program, the company may purchase up to $500M of its outstanding shares of common stock until December 31, 2025.
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PTC MSFT | Hot Stocks08:36 EST PTC names Robert Dahdah as Chief Revenue Officer - PTC (PTC) announced that it has appointed Robert Dahdah as Executive Vice President, Chief Revenue Officer. Dahdah joins PTC from Microsoft (MSFT), where he served as Corporate Vice President of Global Healthcare and Life Sciences. Dahdah will be responsible for global sales and customer success for PTC's Digital Thread group and the overall execution of the company's vertical-focused go-to-market strategy.
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BLMZ | Hot Stocks08:36 EST BloomZ partners with Foom to expand into webtoon industry - BloomZ announced a strategic business alliance with Foom to expand its presence into the webtoon industry. Foom has a proven track record of adapting renowned manga IPs, such as Dororo and Captain Harlock, into webtoon formats. Foom also holds strong relationships across Asia and the Middle East regions through its partnership with South Korea's Gatchi Communication Co. Ltd. By combining BloomZ's visual storytelling experience through its anime production and VTuber experience and Foom's webtoon planning and production capabilities, the partnership aims to deliver innovative webtoon content that reaches a global audience.
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SHOT | Hot Stocks08:35 EST Safety Shot announces Sure Shot now available on leading e-commerce platform - Safety Shot announced that its innovative alcohol-reducing dietary supplement, Sure Shot, is now available for purchase on the online store of a leading e-commerce platform. This platform is owned and operated by one of the largest big-box stores in the US, boasting a massive online presence and extensive distribution network. This expansion into the digital marketplace marks a significant step in Safety Shot's growth strategy, broadening its reach and providing consumers with greater accessibility to its products.
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SABR | Hot Stocks08:35 EST Sabre expands relationship with Thai Airways - Sabre announced an expansion of its longstanding relationship with Thai Airways. The national carrier of Thailand has selected Sabre's advanced Fares Manager and Fares Optimizer solutions to enhance its pricing capabilities and drive incremental revenue opportunities. This agreement further strengthens the alliance between Sabre and Thai Airways, which already includes a long-term distribution agreement. By adopting Sabre Fares Manager together with Fares Optimizer, Thai Airways is poised to streamline its fares management processes, respond more effectively to market dynamics, enhance analyst productivity, and optimize pricing strategies to maintain a competitive edge.
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PODC LVO | Hot Stocks08:34 EST PodcastOne launches 'PodcastOne Pro' - PddcastOne (PODC), a subsidiary of LiveOne (LVO), has officially launched PodcastOne Pro, a full service solution that specializes in transforming podcasts into polished on-air productions for brands and professionals. PodcastOne Pro offers customizable services, with a la carte options to meet exact production needs, or a full 360 degrees solution. Services include access to top-of-the-line podcasting studios and equipment, strategy, program production, editing, guest booking, distribution, paywall options and promotion across PodcastOne's existing network of podcasts.
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HTCR | Hot Stocks08:34 EST HeartCore Enterprises announces new digital customer experience initiatives - HeartCore Enterprises announced a series of strategic initiatives designed to elevate the customer experience, enhance the value offered to current HeartCore CMS clients, and promote cross-selling opportunities. Building on its recent expansion of its CMS platform offering into a Software-as-a-Service model and strategic shift to multi-year software licensing agreements, HeartCore will further invest in customer success by forming a dedicated team of sales and technical members to engage existing customers to maximize the use of CMS functionalities and provide customized support for their digital transformation efforts. Starting from October 2024, HeartCore activated 'Health Check,' a process of conducting on-site customer visits to offer consultations and garner comprehensive feedback. These efforts have provided valuable insights into CMS usage, facilitated system upgrades and overhaul strategies, and optimized solutions tailored to individual client needs. Additionally, the Company plans to explore cross-selling opportunities by actively recommending its WAF security product, which forms the foundation of Health Check. This strategy also emphasizes identifying prospects for website design projects and consulting engagements, with the ultimate goal of securing full-scale renewal projects, including site redesigns and improvements. 25.9% of the Company's direct and partner clients have utilized HeartCore's software services for over a decade. By continuing to invest in customer experience, proactively engaging clients, conducting Health Checks and leveraging cross-selling opportunities through this initiative, the Company projects 12% sales growth in FY 2025 from existing CMS customers.
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CARM | Hot Stocks08:34 EST Carisma Therapeutics announces restructuring, 34% workforce reduction - Carisma Therapeutics announced a strategic reprioritization of its pipeline, cessation of development of CT-0525, and a reduction in the workforce by 34%. These measures will enable Carisma to focus its resources on advancing its in vivo macrophage engineering platform for the development of fibrosis, oncology and autoimmune disease therapies. This decision aligns Carisma's efforts with next-generation, high-potential programs addressing significant unmet patient needs while enhancing operational efficiency. "Following a comprehensive review of our portfolio, we have made the strategic decision to prioritize advancing our in vivo macrophage engineering platform," said Steven Kelly, President and Chief Executive Officer of Carisma. "The compelling data generated by both the Moderna-partnered in vivo CAR-M oncology programs as well as our internal liver fibrosis program underscore the potential to revolutionize treatment paradigms with an innovative and patient-centric approach." "These strategic initiatives, re-directing our investments to the in vivo macrophage engineering platform, discontinuing development of our anti-HER2 program and reducing our workforce, aim to streamline our operations and reduce operating expenses over time," Kelly continued. "While these decisions are very challenging, they are made in the best interest of our shareholders. We remain deeply grateful for the significant contributions of the employees departing Carisma." As part of the strategic restructuring, Carisma will reduce its workforce by 34%. The company expects the reduction in workforce to be substantially complete and to pay the majority of related reduction in workforce amounts by the end of the first quarter of 2025. The company is committed to supporting affected employees through this transition. As part of the workforce reductions, our Chief Financial Officer, Richard Morris, our General Counsel, Eric Siegel, and our Senior Vice President, Human Resources, Terry Shields, will leave the company effective December 31, 2024. Carisma expresses gratitude for their contributions. The company expects to incur approximately $2.7M in connection with the reduction in the workforce, which primarily represents one-time employee termination benefits directly associated with the workforce reduction.
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ACHV | Hot Stocks08:34 EST Achieve Life Sciences appoints Oki as Chief Financial Officer - Achieve Life Sciences announced that Mark Oki has joined the company as its Chief Financial Officer, effective December 5, 2024. Oki will oversee the company's financial strategy and operations, including accounting, investor relations, information technology, legal and other key administrative functions, ensuring effective planning and execution to support organizational objectives.
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IDT | Hot Stocks08:33 EST NRSInsights reports November same-store sales increased 6.6% year-over-year - As of November 30, 2024, the NRS retail network comprised approximately 33,600 active terminals nationwide, scanning purchases at approximately 29,200 independent retailers including convenience stores, bodegas, liquor stores, grocers, tobacco, and sundries sellers nationwide, predominantly serving urban consumers. Same-store sales increased 6.6% year-over-year. In the previous month, same-store sales had increased 3.7% year-over-year. Same-store sales increased 1.5% compared to the previous month. Same-store sales in October 2024 had decreased (0.5)% compared to the previous month. For the three months ended November 30, 2024, same-store sales increased 3.5% compared to the corresponding three months a year ago. The number of units sold increased 4.5% year-over-year. In the previous month, the number of units sold had increased 2.8% year-over-year. Units sold decreased (0.4)% compared to the previous month. Units sold in October 2024 had decreased (0.5)% compared to the previous month. The average number of transactions per store increased 3.2% year-over-year. In the previous month, transactions had increased 1.6% year-over-year. Transactions decreased (2.5)% compared to the previous month. Transactions in October 2024 had decreased (0.7)% compared to the previous month.
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RVNC | Hot Stocks08:32 EST Revance, Crown Laboratories enter amended, restated merger agreement - Crown Laboratories and Revance Therapeutics announced that they have amended and restated the merger agreement entered into by the parties on August 11, 2024, pursuant to which the companies will seek to merge the two organizations. Under the terms of the amended and restated merger agreement, which has been unanimously approved by Revance's Board of Directors, Crown will commence a tender offer to acquire all outstanding shares of Revance's common stock for $3.10 per share in cash. The transaction is expected to close in the first quarter of 2025. Following completion of the merger, Revance will be wholly owned by Crown and Revance's stock will no longer be publicly traded on Nasdaq. The transaction is subject to stockholders validly tendering shares representing at least a majority of the voting power of Revance and the satisfaction of other customary closing conditions. Following the successful closing of the tender offer, Crown will acquire any shares of Revance that are not tendered in the tender offer through a second-step merger for the same consideration as paid in the tender offer. Revance's Board of Directors unanimously recommends that Revance's stockholders tender their shares in the tender offer which is expected to be commenced on December 12, 2024.
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BKYI | Hot Stocks08:30 EST BIO-key announces new passwordless options at 2024 Gartner IAM Summit - BIO-key was proud to be recognized in two Gartner reports in the past twelve months. Both reports emphasize the importance of adopting passwordless authentication to mitigate security risks. To support organizations in their journey to passwordless, BIO-key has introduced additional options with its MobileAuth offering, demonstrating its commitment to secure and user-friendly authentication solutions. BIO-key's MobileAuth biometric options include PalmPositive and FacePositive, which protect users from identity fraud and unauthorized access. Once biometrics are registered, only the authorized user can authenticate, significantly reducing the risk of fraud. Unlike Apple Touch ID or Face ID, which allow multiple users to register on a device, MobileAuth restricts access to a single authorized user for apps managed by the PortalGuard IDaaS solution. This ensures that no other users, "SIM-swappers," or hackers with phished credentials can gain access-only the intended user can authenticate. BIO-key also supports push-token and on-device biometrics for those users where convenience is more important than security.
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OESX | Hot Stocks08:29 EST Orion Energy partners with energy management service provider - Orion Energy Systems announces a new relationship with a prominent energy management service provider that serves over 6,500 customer locations across the county. Orion expects this relationship to generate revenue of $2 - $5 million per year, with initial revenue anticipated in its fiscal 2025 fourth quarter ending March 31, 2025.
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CCLD | Hot Stocks08:28 EST CareCloud files special meeting proxy to accelerate growth - CareCloud announced the solicitation of proxies from its common stock shareholders to approve an increase in its authorized shares. This increase is designed to support the Company's growth initiatives and corporate objectives. The board-supported proposal seeks to increase the Company's authorized shares of Common Stock from 35 million to 85 million. This increase is intended to provide the flexibility needed for strategic growth initiatives, including future acquisitions, and to enable the potential conversion of the Company's outstanding Series A Preferred Stock to Common Stock. Additionally, it supports investments in organic growth and other corporate priorities.
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LMFA | Hot Stocks08:28 EST LM Funding enters into warrant exercise transaction of $5.1M in proceeds - LM Funding America has entered into a warrant exercise agreement with a single institutional investor that is an existing holder of its common stock warrants wherein the investor agreed to exercise 1,736,370 outstanding common stock warrants to purchase an aggregate of 1,736,370 shares of common stock for cash at the exercise price of $2.98 per share. The Existing Warrants were previously issued in a private placement which closed in August 2024. In consideration for the immediate exercise of the Existing Warrants, the exercising holder received new unregistered common stock warrants to purchase an aggregate of 3,472,740 shares of common stock. The New Warrants will have an exercise price of $2.95 per share and will be immediately exercisable for a period of five years from the issuance date. The gross proceeds of the exercise of the Existing Warrants to the Company, before deducting estimated expenses and fees, are expected to be approximately $5.1 million. Maxim Group LLC is acting as warrant inducement agent and financial advisor in connection with the transaction.
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BTCM | Hot Stocks08:27 EST BIT Mining completes first phase of acquisitions in Ethiopia - BIT Mining Limited announced that it has completed the first phase of previously-announced acquisition of crypto mining data centers and Bitcoin mining machines in Ethiopia. To complete the first phase of the acquisition, the company has made a cash payment of $2.265M and issued an aggregate number of 369,031,800 Class A ordinary shares to the sellers in exchange for a 35-megawatt operational and electrified crypto mining data center and 17,869 BTC mining machines. The second phase of the acquisition, which involves transfer of the remaining data centers to the company, will close upon completion of construction of the remaining data centers, which is expected to occur in March or April 2025. Upon closing of the second phase, the company will issue an additional 45,278,600 Class A ordinary shares as consideration.
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FRSX | Hot Stocks08:27 EST Foresight Autonomous signs commercial cooperation agreement with KONEC - Foresight Autonomous announced the signing of a commercial cooperation agreement with KONEC, a leading South Korean Tier-One automotive supplier, to bring to market advanced 3D perception solutions to be integrated into the vehicles and machinery of KONEC's customers and business partners in the Republic of Korea. These solutions are designed for a wide range of sectors, including passenger vehicles, commercial vehicles such as trucks and buses, autonomous logistics vehicles, geofenced autonomous vehicles, as well as agriculture and heavy machinery. Pursuant to the terms of the agreement, KONEC forecasts commercial sales of $1.5 million by 2027, with anticipated revenues from various advanced solutions, including supply of products, software license fees, non-recurring engineering services, and development fees, projected to grow up to $7 million by 2029. KONEC has already placed orders to achieve its sales target for 2024 and has exclusivity for 2025.
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LFSWF | Hot Stocks08:27 EST Lifeist Wellness announces 'Mikra Wellness Giveaway' Holiday Campaign - Lifeist Wellness' Mikra Cellular Sciences is launching a marketing initiative for the holiday season: The Mikra Wellness Giveaway. Mikra's latest campaign, designed to reward loyal customers and drive new customer acquisition, will run from today, December 9, 2024, to January 15, 2025, and include those purchases of Mikra's scientifically formulated supplements made on wearemikra.com. Mikra's holiday promotion provides a unique opportunity for customers to celebrate the season of giving by sharing their Mikra experience with family, friends, and their social networks. Participation in the campaign is simple, visit wearemikra.com: Purchase Mikra products: Every purchase made during the campaign period will automatically earn customers an entry into the giveaway. Share on social media: Sharing Mikra-related posts on social platforms increases participants' chances of winning. Refer family, friends, and relatives: Each referral to Mikra earns additional entries into the giveaway, encouraging participants to spread the word about Mikra's innovative health and wellness solutions. At the end of the campaign one lucky winner will receive a grand prize of a one-year supply of Mikra products along with exclusive Mikra branded gear. The campaign's goal is to foster deeper engagement with Mikra's loyal customer base while expanding its reach to new audiences during the holiday season.
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OPTT | Hot Stocks08:26 EST Ocean Power secures $3M in purchase order commitments for WAM-V USV's - Ocean Power Technologies announced a new partnership, with $3M of purchase order commitments over 36 months in Latin America. This increases by $1.5M the previously announced $1.5M of purchases orders in Latin America. The WAM-V USV's will be deployed in hydrographic applications and by utilizing their adaptability and reliability will provide our customer with an unrivaled versatile multi-application solution. This order not only underscores the growing demand for OPT's innovative solutions but also solidifies the Company's position as a leader in the maritime artificial intelligence robotics sector.
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GWAV | Hot Stocks08:26 EST Greenwave Technology awarded contract valued at $15M-$35M with Core Tree Care - Greenwave Technology is on track to generate $15M-$35M in revenue through a contract with Core Tree Care, related to a prime contract with the Army Corps of Engineers. This high-value contract highlights Greenwave's ability to secure strategic partnerships in critical infrastructure recovery efforts.
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LTRN | Hot Stocks08:25 EST Lantern Pharma doses first patient in LP-300 trial - Lantern Pharma announced that the first patient has been enrolled and dosed in Taiwan for its Phase 2 Harmonic clinical trial evaluating LP-300 in never-smoker patients with non-small cell lung cancer who have progressed after receiving treatment with tyrosine kinase inhibitors.
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ATOS | Hot Stocks08:24 EST Atossa Therapeutics presents data from research investigating Z-Endoxifen - Atossa Therapeutics announced the presentation of research investigating the anti-cancer activity of (Z)-endoxifen and its byproducts at the American Association for Cancer Research, AACR, Special Conference in Cancer Research, taking place in Toronto from December 9-11. The poster, titled, "Anti-cancer activity of (Z)-endoxifen-related compounds in ERalpha+ breast cancer," outlines results from a study investigating four (Z)-endoxifen byproducts for their anti-estrogenic and anti-tumor effects in estrogen receptor-positive breast cancer cell lines, including those with ESR1 mutations associated with endocrine resistance. Notably, compounds AT416E and AT402E demonstrated strong anti-proliferative activity, with AT416E also showing enhanced inhibition of cell migration and invasion. All four byproducts exhibited greater anti-proliferative effects than (Z)-endoxifen in estrogen-deficient conditions, while (Z)-endoxifen remained the most potent at inducing cell cycle arrest and apoptosis, reinforcing its potential as a therapeutic agent.
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SNEX | Hot Stocks08:23 EST StoneX Group announces changes to its executive management team - StoneX Group announces changes to its executive management team. At its recently concluded meeting of the StoneX Board of Directors, several changes to StoneX's executive management team were approved. These changes include: Sean O'Connor, StoneX's current Chief Executive Officer, will become Executive Vice-Chairman of the Board of Directors; Philip Smith, currently a member of StoneX's executive committee responsible for the Commercial and Payments business segments, will become Group Chief Executive Officer; and Charles Lyon, currently a member of StoneX's executive committee responsible for the Institutional business segment, will become Group President.
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CLAR | Hot Stocks08:22 EST Clarus' Rhino-Rack acquires certain assets of RockyMounts, terms not disclosed - Clarus announced that Rhino-Rack, a brand in Clarus's Adventure segment, has acquired certain assets of RockyMounts, a Colorado-based brand specializing in bicycle transport products. For over 30 years, RockyMounts has designed innovative roof and hitch rack solutions, attracting a dedicated following of customers thanks to the products' distinct style and exceptional durability. Founded by Bobby Noyes in Boulder, Colorado in 1993, RockyMounts is known for making well designed and dependable premium bicycle racks and other accessories compatible with vehicles of all sizes, including SUVs, vans and trucks. Its award-winning products can be found in local and national retailers across North America. The terms of the transaction were not disclosed, and it was funded using cash on hand.
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SLNH HPE | Hot Stocks08:22 EST Soluna Holdings reports Q3 year-to-date revenue $29.7M - Soluna Holdings (SLNH) announced financial results for the third quarter ended September 30. John Belizaire, CEO of Soluna, said, "Soluna continues to move at a fast pace and has achieved several important milestones this quarter including, launching our Soluna Cloud AI business and strategic partnership with Hewlett Packard Enterprises HPE (HPE) , securing financing for our Project Dorothy expansion and breaking ground and securing $25 M of growth capital. Project Kati has reached several important milestones and Project Rosa is accelerating with the signing of Term Sheets for power and land this quarter. Our financial results continue to build strongly with the company achieving its highest third quarter year-to-date revenue, $29.7 M."
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CRML | Hot Stocks08:22 EST Critical Metals conirms high-grade rare earth material at its Tanbreez Project - Critical Metals provided a project update for the Tanbreez Greenland Rare Earth Mine, one of the world's largest rare earth assets located in Southern Greenland. "The Tanbreez Project continues to demonstrate its immense upside potential, as the Critical Metals Corp team advances our pre-production plans for this foundational rare earth asset," said Tony Sage, CEO and Executive Chairman of Critical Metals Corp. "On the heels of China's recent decision to restrict the exports of certain rare earth materials, Critical Metals Corp is poised to support western countries with materials essential for producing clean energy applications and supporting their defense industries. Earlier this year, we discovered that the Tanbreez Project contains one of the world's highest concentration of Gallium, and these new results continue to showcase how the asset possesses high-grade rare earth material."
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FWONA FWONK | Hot Stocks08:21 EST Liberty Media names Robert Bennett vice chairman - Liberty Media announced that Robert Bennett has been named vice chairman of the board of directors of Liberty Media effective January 1, 2025. Bennett has been a director of Liberty Media since 1994 and a member of its executive committee for 15 years. He will continue to serve on the executive committee with John Malone and Chase Carey.
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MYGN | Hot Stocks08:21 EST Myriad announces its Prolaris test is still classified as 'Advanced Tool' - Myriad Genetics announced that its Prolaris prostate cancer prognostic test continues to be classified by the National Comprehensive Cancer Network, NCCN, as an 'Advanced Tool' in the fight against prostate cancer. Like other gene expression-based tests, Prolaris for many years has been included in NCCN guidelines with category 2A level of evidence, meaning its inclusion has support from at least 85% of members on the NCCN prostate panel. "The updated NCCN Prostate Cancer Guidelines continue to solidify Prolaris' market position," said Paul J. Diaz, President and CEO, Myriad Genetics. "While there have been certain mischaracterizations regarding the updated guidelines leading to confusion, extensive published evidence shows that Prolaris is a clinically recognized and effective tool in managing patients with prostate cancer. We are confident that our highly engaged clinicians will continue to see the guidelines as an additional reason to incorporate Prolaris in treatment decisions."
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MDAI | Hot Stocks08:21 EST Spectral AI enhances technical file for updates to Deepview system in the UK - Spectral AI announced the completion of enhancements to its technical file to support significant software updates for its DeepView SnapShot M and DeepView AI-Burn system in the UK. These upgrades, informed by real-world experience and frontline feedback from clinicians, are designed to enhance product performance and usability in the UK, further solidifying the Company's commitment to delivering and commercializing cutting-edge solutions in critical care settings. This regulatory milestone ensures Spectral AI can implement the updated software on its DeepView SnapShot M and AI-Burn systems currently deployed in the UK, where the devices are authorized as two separate products. The enhanced software reflects invaluable input from frontline users, enabling improvements in diagnostic accuracy, workflow integration, and patient care. These updates represent Spectral AI's dedication to incorporating direct clinician feedback into its technology, ensuring it meets the demands of real-world healthcare environments. The formal enhancement to the technical file also assists Australian burn centers as Spectral AI is operating under the country's unique access program, the Approved Prescriber Program. This move ensures that Australian healthcare providers will be provided with access to Spectral AI's most advanced diagnostic technology.
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OPTX | Hot Stocks08:19 EST Syntec Optics secures $2.1M in new orders for space optics - Syntec Optics announced that it has secured over $2.1 million in orders for its ultra-high-precision space optics. The company will utilize its dedicated production cell to continue delivering products. "Continued orders demonstrate the sustained demand for our advanced optics solutions in the Low Earth Orbit satellite market," said Syntec Optics CFO Dean Rudy. "Our continued commitment to vertical integration, including in-house preform production, allows us to meet the demanding requirements of monthly satellite launches."
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LPLA | Hot Stocks08:19 EST LPL Financial: Francisco Blanco joins broker-dealer, RIA, custodial platforms - LPL Financial announced that financial advisor Francisco J. Blanco has joined LPL Financial's broker-dealer, RIA and custodial platforms. Blanco reported having approximately $200 million in advisory, brokerage and retirement plan assets and joins from JP Morgan Chase. With the move, Blanco merged with existing firm Stonebrook Wealth Management, founded in 2019 by fellow JP Morgan veteran Joe Mazzucco. The merger results in the formation of Stonebrook Wealth Partners. Based in Fort Lauderdale, FL., Blanco provides tailored financial planning and investment strategies to his clients and specializes in areas such as retirement planning, tax-efficient investing and estate investment planning. His approach is centered around building lasting relationships, understanding each client's unique goals and developing personalized solutions that align with their long-term objectives. Often leveraging his extensive network of professionals for the benefit of his clients, Blanco is fully committed to intentionally helping his clients navigate their entire financial journey with confidence and transparency.
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SVRE | Hot Stocks08:18 EST SaverOne 2014 launches new pilot project in Italy with Trans Italia - SaverOne 2014 announce the launch of a new pilot project with Trans Italia, a prominent Italian logistics and transportation company well known for its eco-friendly, efficient, and intermodal transport solutions throughout Italy and beyond. "This pilot project with Trans Italia demonstrates our increase in traction within Italy," said Ori Gilboa, CEO of SaverOne. "We are thrilled to collaborate with a forward-thinking company like Trans Italia to demonstrate the value of our technology in improving the safety of their fleet and reducing distracted driving amongst their drivers. We believe this pilot will pave the way for increased adoption of our solutions within Italy and across Europe."
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NVEE | Hot Stocks08:18 EST NV5 Global acquires Southport Engineering Associates - NV5, a provider of technology, certification, and consulting solutions, announced that it completed the acquisition of Southport Engineering Associates, a provider of turnkey energy efficiency, engineering design, and owner representation consulting on December 4, 2024. The acquisition was made with a combination of cash and stock and will be immediately accretive to NV5's earnings.
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OR | Hot Stocks08:17 EST Osisko Gold announces renewal of normal course issuer bid - Osisko Gold Royalties announced that the Toronto Stock Exchange has approved the Corporation's notice of intention to make a normal course issuer bid. Under the terms of the NCIB Program, Osisko may acquire up to 9,331,275 of its common shares from time to time in accordance with the normal course issuer bid procedures of the TSX. The NCIB Program will be conducted through the facilities of the TSX or through alternative trading systems in Canada, if eligible, and will conform to their regulations. Purchases under the NCIB Program will be made by means of open market transactions or such other means as a securities regulatory authority may permit, including pre-arranged crosses, exempt offers and private agreements under an issuer bid exemption order issued by a securities regulatory authority. Repurchases under the NCIB Program may commence on December 12, 2024 and will terminate on December 11, 2025 or on such earlier date as the NCIB Program is completed. Daily purchases will be limited to 73,283 Common Shares, other than block purchase exemptions, representing 25% of the average daily trading volume of the Common Shares on the TSX for the six-month period ending November 30, 2024, being 293,134 Common Shares.
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AMTM | Hot Stocks08:16 EST Amentum awarded $105M Navy contract - Amentum has been awarded a $105M contract to support Naval Surface Warfare Center Crane Airborne Electronic Attack Systems Division, or AEASD, to develop the next generation of Electronic Warfare and Intelligence, Surveillance, and Reconnaissance mission and survivability systems. Amentum will replace aging or obsolete components and systems and install technology to enhance the capabilities of EW and ISR systems, delivering expertise in protecting U.S. national security. Under this contract, Amentum will perform RDT&E engineering to enhance the total lifecycle management of advanced surveillance systems, including vehicle integration, platform integration, sensor integration, supply chain security, obsolescence analysis, and anti-tamper technologies. Amentum will use its Integrated Digital Engineering Approach, or IDEA, to identify critical enabling technologies and develop new approaches and opportunities for technology transfer and integration to keep pace with continually emerging and evolving threats. This will drive continued technological superiority by incorporating quick-reaction analysis and rapid engineering development principles.
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WKSP | Hot Stocks08:16 EST Worksport debuts products on 'Fox & Friends Weekend' - Worksport provided a post-broadcast update following Worksport's appearance on FOX & Friends Weekend, hosted by Will Cain, Rachel Campos-Duffy, and Charlie Hurt. During the nationally televised segment, Worksport's CEO, Steven Rossi, spotlighted the Company's forthcoming mobile power generation system and American-made tonneau covers, underscoring its commitment to innovation, domestic manufacturing, and sustainable solutions. "Our recent feature on FOX & Friends Weekend served as a remarkable springboard, allowing us to debut our COR & SOLIS product to a national audience," said Steven Rossi, CEO of Worksport Ltd. "We received highly positive feedback from the producers and look forward to securing additional national media opportunities as we continue to build brand credibility and expand our market reach. With the support of renowned host Charlie Hurt, we showcased our brand's unique innovations on the channel's 'Made in America' segment. This appearance reaffirmed our commitment to American manufacturing and underscored the transformative potential of our next-generation products. As we move toward 2025, our strategies-ranging from ramped-up U.S. production to cutting-edge solar and portable power technologies-are expected to drive significant revenue growth, improve margins, and enhance shareholder value."
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WNS | Hot Stocks08:16 EST WNS Holdings extends strategic engagement with Canopius, no terms - WNS Holdings announced that it has extended its transformation-led strategic engagement with Canopius Group Canopius , a leading global specialty and P&C lines e insurer. Under this extension, WNS will consolidate Canopius' existing relationships by implementing proprietary, technology-led solutions which will enhance operational efficiency, accelerate innovation, and drive market differentiation. WNS will also work with Canopius to develop digital solutions that empower its underwriters and claims professionals with tools to optimize their day-to-day business. The WNS comprehensive suite of digital solutions will enable Canopius to harness the full potential of data-driven insights - refining specialty insurance processes to drive business growth and maintaining a competitive edge in an evolving marketplace.
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SENS | Hot Stocks08:14 EST Senseonics provides update on Eversense 365 launch - Senseonics provided commercial updates related to the Eversense 365 launch. "2024 has been a landmark year for Senseonics, achieving our long-term goal of commercializing the Eversense 365 product, providing people with diabetes a convenient and accurate solution for monitoring blood glucose for an entire year with a single sensor," said Tim Goodnow, PhD, President and Chief Executive Officer of Senseonics. "We are excited to see the strong early performance indicators that we believe reflect the commercial potential of this ground-breaking product. Patient and provider leads and new interest from health systems have all increased significantly following 365 launch, and we expect that a heightened level of interest will drive our results for 2025. We intend to provide updates on the ongoing 365 launch, as well as on our product portfolio development, pump-connectivity, additional health care systems, and our ex-US commercial launch of Eversense 365 over the course of 2025."
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SATL | Hot Stocks08:14 EST SynMax expands 'Oil-Nat Gas; contract with Satellogic, no terms - Satellogic announced an expansion of its contract with SynMax, a leading U.S. satellite data analytics firm. SynMax will leverage Satellogic's high-frequency, high-resolution imagery to enhance its Hyperion platform, delivering unparalleled oil and natural gas production monitoring for hedge funds and financial analysts. Under the contract, Satellogic will triple the number of wellheads monitored by SynMax across North America to more than 100, providing imagery multiple times per week. Hyperion's near real-time insights into drilling rig and frac crew activity give analysts an edge in predicting short-term changes in oil and natural gas production on a per-wellhead basis.
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BNOX | Hot Stocks08:14 EST Bionomics publishes resuls from Phase 2 ATTUNE study of BNC210 - Bionomics announced that the results from its Phase 2 ATTUNE study have been published in the NEJM Evidence. The data were also presented yesterday at the 63 Annual Meeting of the American College of Neuropsychopharmacology as part of the inaugural "Promising Targets" session. Key results from the publication include: Clinician-Administered PTSD Scale for DSM-5 total score improvement was observed with BNC210 compared with placebo at Week 12 with improvement seen as early as Week 4. Clinically meaningful and statistically significant improvements were also observed with BNC210 vs placebo in: Depressive symptoms measured on the Montgomery-Asberg Depression Rating Scale. Sleep measured on the Insomnia Severity Index. Treatment-emergent adverse events occurred in 70 patients in the BNC210 group and 56 in the placebo group. The most common AEs were headache, nausea, fatigue, and hepatic enzyme elevations. The Company is planning to initiate the Phase 3 trial in PTSD in the second half of 2025. BNC210 is also being evaluated in a Phase 3 AFIRM-1 study in social anxiety disorder with anticipated readout in Q3 2025.
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ATYR | Hot Stocks08:13 EST aTyr Pharma to present preclinical research on ATYR0101 at symposia on Firbosis - aTyr Pharma announced that the Company will present two posters related to its tRNA synthetase candidate ATYR0101 at the Keystone Symposia on Fibrosis: Inflammation, Drivers, and Therapeutic Resolution, which is scheduled to take place December 8 - 11, 2024, in Whistler, British Columbia, Canada. ATYR0101 is a fusion protein derived from a proprietary extracellular domain of aspartyl-tRNA synthetase, DARS, that binds to latent transforming growth factor beta binding protein 1, LTBP-1, to induce myofibroblast apoptosis. "We are excited by these findings that further demonstrate the way in which ATYR0101 binds a known fibrosis target with pronounced effects in preclinical models of lung and renal fibrosis," said Sanjay Shukla, M.D., M.S., President and Chief Executive Officer of aTyr. "These findings suggest that ATYR0101 has the potential to be a next generation anti-fibrotic for lung and kidney fibrosis with a differentiated mechanism of action compared to current standard of care that could potentially treat advanced fibrotic conditions."
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ENPH NEE | Hot Stocks08:11 EST Enphase Energy collaborates with NextEnergy in the Netherlands - Enphase Energy announced a collaboration with NextEnergy. This strategic relationship will enable NextEnergy customers with Enphase solar and battery systems to participate in the grid imbalance energy marketplace in the Netherlands, which can help maximize their return on investment and reduce the system payback period.
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AMRC RSG | Hot Stocks08:11 EST Ameresco, Republic Services JV achieves commercial operation at Illinois plant - Ameresco (AMRC) announced that its newly formed joint venture with Republic Services (RSG) has achieved commercial operation at their landfill gas, or LFG, to renewable natural gas, or RNG, plant located at Republic Services' Roxana Landfill in Edwardsville, Illinois in November. The Roxana RNG facility captures naturally occurring landfill gas and processes it into pipeline-quality RNG, a low-carbon transportation fuel. This project beneficially uses previously flared LFG to create RNG that will displace fossil fuel in a nearby Energy Transfer natural gas transmission pipeline. The facility, which is one of the largest of its type in North America, is designed to process 6,000 SCFM of raw landfill gas per minute.
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DAY | Hot Stocks08:11 EST Dayforce announces two major milestones in Dayforce experience - Dayforce announced two major milestones in the Dayforce on-demand pay experience. Dayforce Wallet has delivered over $5 billion USD through on-demand pay, early direct deposit, and paycard to employees. This achievement highlights the platform's growing adoption and its critical role in providing employees with greater financial flexibility. Additionally, Dayforce is expanding on-demand pay with new direct to bank capabilities, enabling employees to route their pay directly to any personal bank account simply and securely.
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CGNT | Hot Stocks08:11 EST Cognyte announces a $20+million follow on deal in EMEA for public safety - Cognyte Software announced a $20-plus million agreement with a longstanding national security customer in the Europe-Middle East-Africa EMEA region. This latest order expands the agency's capacity and enhances their solution with advanced AI-based capabilities, enabling faster, more accurate investigations and proactive risk mitigation. The agency, responsible for protecting national interests, assets and public safety, sought this expansion to address growing data complexity driven by evolving technology such as 5G adoption. Cognyte's cutting-edge analytics empower the agency to process massive data volumes more efficiently, enhancing the ability to identify and neutralize emerging threats and improve investigation success rates. Cognyte's AI capabilities provide critical insights into illicit activities such as terrorism, drug trafficking and weapons smuggling, enabling agencies to respond before incidents unfold... "This agreement underscores the confidence that national security agencies place in Cognyte to deliver innovative solutions that address the evolving security challenges," said Gil Cohen, Chief Product Officer at Cognyte. "Our cutting-edge AI capabilities and strong, long-term relationships with customers are helping drive new business opportunities and playing a critical role in helping our national security agency customers enhance their investigative processes and safeguard citizens worldwide." About Cognyte
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ELAB | Hot Stocks08:10 EST Elevai Labs subsidiary announces FDA regulatory pathway for EL-22 - Elevai Labs, subsidiary Elevai Biosciences, announced the next steps in its regulatory strategy for EL-22, aimed at treating obesity and preserving muscle mass. In collaboration with KCRN Research, the Company is preparing for a pre-IND meeting with the FDA, anticipated in the first quarter of 2025. This meeting will establish the development pathway for EL-22, clarifying any additional preclinical requirements and adjustments to Chemistry, Manufacturing, and Controls before IND submission.
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VITL | Hot Stocks08:10 EST Vital Farms, Black Seed Bagels partner with Pebble Bar for cocktail - Vital Farms and Black Seed Bagels are pairing up with Pebble Bar to serve the limited-time 'Pebble Egg & Cheese' cocktail this holiday season. The imaginative cocktail is inspired by Black Seed Bagels' 'BEC' made with Vital Farms eggs. Vital Farms egg white, Black Seed Bagels eau-de-vie, bacon-infused bourbon, and more are dry shaken together to create a festive libation available at Pebble Bar starting December 9th and lasting until the ball drops on 2024.
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WINT | Hot Stocks08:09 EST Windtree Therapeutics announces new istaroxime patent filing - Windtree Therapeutics announced that it has filed a new istaroxime PCT patent application entitled, "ISTAROXIME DERIVATIVES THEREOF FOR PREVENTING OR REDUCING THE RISK OF ACUTE MYOCARDIAL ARRHYTHMIA." The patent filing expands upon data obtained from animal model testing and the istaroxime human clinical trials in acute heart failure and early cardiogenic shock, including the latest positive Phase 2b istaroxime study in ECS patients. Istaroxime has also shown beneficial effects in rat studies with ischemia-reperfusion induced arrhythmias. Istaroxime-metabolite derivatives have shown superior properties in these models indicating their potential as promising therapeutics for the treatment of patients with ischemia needing improvement in cardiac function.
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EVAX | Hot Stocks08:08 EST Evaxion Biotech announces strategic milestones for 2025 - Evaxion Biotech announces its strategic milestones for 2025 after having now achieved almost all the milestones set for 2024. The 2025 milestones reflect Evaxion's high activity level, broad pipeline and strong external interest in potential partnerships around both our AI-Immunology platform and pipeline assets. As such, the milestones underscore our continued anticipated strategic progress. Evaxion's overriding priorities are execution upon our business development strategy, continuation of the ongoing EVX-01 phase 2 trial, the ongoing strengthening of our AI-Immunology platform and further advancement of our research activities, including progressing our ERV-based precision vaccine concept towards clinical development. Finally, the focus is, of course, on advancing our existing partnerships, including bringing the MSD collaboration, entered in September 2024, to option exercise. AI-Immunology: Launch of automated lead vaccine candidate design module; H2. Business development and partnerships: At least two new agreements; 2025. EVX-01: All patients completed EVX-01 dosing; H1. EVX-01: Supplemental phase 2 biomarker and immunogenicity data; H1. EVX-01: Two-year phase 2 clinical efficacy readout; H2. Precision ERV cancer vaccines: Selection of lead vaccine candidate; H2. MSD vaccine collaboration: MSD option exercise, up to $10 million option exercise fee; H2. EVX-V1: Lead antigens selected for CMV vaccine candidate; H2 .Infectious diseases: Two new pipeline candidates; 1 in H1, 1 in H2.
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AORT | Hot Stocks08:08 EST Artivion: FDA grants HDE for use of AMDS Hybrid Prosthesis - Artivion announced that the U.S. FDA has granted a Humanitarian Device Exemption for use of the AMDS Hybrid Prosthesis in acute DeBakey Type I dissections in the presence of malperfusion. The AMDS is the world's first aortic arch remodeling device for use in the treatment of acute DeBakey Type I aortic dissections.
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FHB | Hot Stocks08:08 EST First Hawaiian completes investment portfolio restructuring - First Hawaiian announced the completion of a restructuring related to its available-for-sale investment securities portfolio. The Company executed the sale of $293 million of its lower-yielding available-for-sale debt securities for an estimated after-tax loss of $19.7 million. Proceeds from the sale were reinvested in $293 million of debt securities currently yielding 309 basis points more than the securities that were sold. The transaction is projected to increase net interest income by approximately $8.6 million and net interest margin by approximately 4 basis points in 2025. The transaction is projected to increase net interest income by approximately $0.5 million and net interest margin by approximately 1 basis point in the fourth quarter of 2024.
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GNS | Hot Stocks08:07 EST Genius Group increased its Bitcoin purchases for its Treasury by $2.2M - Genius Group announced that it had increased its Bitcoin purchases for its Bitcoin Treasury by an additional $2.2 million to 191 Bitcoin for $18 million, at an average price of $92,728 per Bitcoin. The Company's announced on November 12 of its "Bitcoin-first" strategy that it is committing 90% or more of its current and future reserves to be held in Bitcoin, with an initial target of $120 million in Bitcoin. Following its initial purchase of $10 million in Bitcoin in the week of the announcement, in the four subsequent weeks it has been adding an average of $2 million per week to its Bitcoin reserve.
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GNRC | Hot Stocks08:06 EST Generac names Amanda Teder as Chief Marketing Officer - Generac Holdings announced the promotion of Amanda Teder to Chief Marketing Officer. Amanda previously served as Executive Vice President of Marketing. Prior to joining Generac in 2022, Amanda served as vice president of B2B2C Marketing, North America for Michelin.
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CRNX | Hot Stocks08:06 EST Crinetics announces FDA acceptance of NDA for paltusotine - Crinetics Pharmaceuticals announced the U.S. Food and Drug Administration, FDA, accepted its New Drug Application, NDA, for investigational candidate paltusotine for the treatment and long-term maintenance therapy of acromegaly in adults. If approved, paltusotine will be the first and only once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist available for adults living with acromegaly. "With our patient-centered clinical development of paltusotine, we were guided by an unwavering ambition to deliver a new generation of treatment that provides a once-daily, oral alternative to the currently marketed peptide analog drugs," said Scott Struthers, Ph.D., Founder and Chief Executive Officer of Crinetics. "We look forward to working with the FDA throughout the review of our new drug application, as we also prepare for a potential commercial launch by building out our infrastructure and engaging with payers and the endocrinology community."
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EVLV MSI | Hot Stocks08:06 EST Evolv Motorola Solutions appoints John Kedzierski as CEO - Evolv (EVLV) announced that its board of directors has appointed John Kedzierski as the company's new CEO, president and as a member of the board, effective December 16. Kedzierski will succeed Michael Ellenbogen, who has been serving as the company's interim president and CEO since October. Ellenbogen will continue to serve as the company's chief innovation officer and a member of the board. Previously, he spent more than 23 years at Motorola Solutions (MSI), most recently as senior VP of global enterprise sales.
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HLIT | Hot Stocks08:06 EST Harmonic, Sercomm announce strategic collaboration on DOCSIS 4.0 - Sercomm and Harmonic announced an exclusive technology collaboration to advance DOCSIS 4.0 unified technologies. As part of this partnership, Sercomm will introduce its new DOCSIS 4.0 Unified Amplifiers, benefiting from Harmonic's expertise in FDX and unified nodes. The collaboration between Sercomm and Harmonic will not only enable symmetrical upstream and downstream data speeds but also improve interoperability between network components, reducing integration complexities for service providers. This seamless interoperability allows operators to maximize their existing infrastructure as they transition to DOCSIS 4.0, ensuring faster, more reliable deployments with minimized risks.
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MGTX | Hot Stocks08:05 EST MeiraGTx granted RMAT designation by U.S. FDA to AAV2-hAQP1 - MeiraGTx announced that the U.S. Food and Drug Administration, FDA, has granted Regenerative Medicine Advanced Therapy, RMAT, designation to AAV2-hAQP1 for the treatment of Grade 2/3 radiation-induced xerostomia, RIX. "This RMAT designation underscores the strength of our data indicating the potential of our AAV2-hAQP1 therapy to significantly improve the lives of patients who suffer from xerostomia following radiation treatment. The requirements for receiving an RMAT designation include that the drug candidate is an advanced regenerative medicine, in this case a gene therapy; that the therapy is targeting a serious condition, in this case, Grade 2 and Grade 3 late xerostomia caused by radiotherapy for cancers of the upper aerodigestive tract; and that the applicant has presented preliminary clinical evidence demonstrating that the drug candidate has the potential to address an unmet need in the serious condition," said Alexandria Forbes, Ph.D., president and chief executive officer of MeiraGTx.
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PTVE APO | Hot Stocks08:04 EST Novolex to acquire Pactiv Evergreen for $18.00 per share in cash - Novolex and Pactiv Evergreen have entered into a definitive agreement to combine, creating a leading manufacturer in food, beverage and specialty packaging products. The combination brings together two highly complementary businesses that will offer a broad product platform, establishing one of the most diverse substrate offerings in the packaging industry. The asset base will include an extensive manufacturing footprint and an expansive distribution network, enhancing the combined company's ability to serve customers ranging from large, blue-chip brands to small businesses that serve millions of consumers every day. Under the terms of the agreement, Novolex will acquire Pactiv Evergreen for $18.00 per share in an all-cash transaction valued at $6.7 billion, inclusive of Pactiv Evergreen's net debt as of September 30, 2024. The transaction consideration represents a 49% premium to the two-month unaffected volume weighted average trading price as of December 2, 2024, the last trading day prior to media reports regarding a potential transaction. Upon the completion of the transaction, Pactiv Evergreen will become a privately held company, and its common stock will no longer be listed on Nasdaq. The combined company will be led by Novolex Chairman and CEO Stan Bikulege. This transaction is supported by funds managed by affiliates of Apollo (APO), the majority shareholder of Novolex since 2022, and Canada Pension Plan Investment Board, which will contribute approximately $1 billion and will become a significant minority shareholder in the post-merger company. The transaction has been approved by the Pactiv Evergreen Board of Directors and is subject to receipt of regulatory approvals and other customary closing conditions. The transaction has also been approved by Packaging Finance Limited, in its capacity as the majority shareholder of Pactiv Evergreen, and no other shareholder approval is required. The transaction is not subject to a financing condition and is expected to close in mid-2025.
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ACXP | Hot Stocks08:04 EST Acurx updates Phase 3 readiness for ibezapolstat in C. difficile Infection - Acurx Pharmaceuticals announced updates on Phase 3 Readiness for Ibezapolstat in C. difficile Infection based on recent FDA and EMA communications. Acurx's Executive Chairman, Bob DeLuccia, stated: "We are very pleased with these latest favorable communications from both regulatory agencies and in our opinion are a testament to the strength of our clinical data to date, our robust regulatory submissions, and adherence to current regulatory guidance." He further added: "We anticipate, and are confident, that with final EMA advice for our ibezapolstat Phase 3 trials for adult patients with CDI and the pediatric development plans from both regulatory agencies, Acurx will have a clear international roadmap for conduct of our Phase 3 program and, if successful, requirements for US NDA submission and EU Marketing Authorization." Acurx has previously announced that it had a successful FDA End-of-Phase 2 Meeting and Phase 3 Readiness for ibezapolstat for the Treatment of C. difficile Infection. Agreement with FDA was reached on key elements to move forward with its international Phase 3 clinical trial program. Agreement was also reached with FDA on the complete non-clinical and clinical development plan for filing of a New Drug Application for marketing approval. Planning continues to advance ibezapolstat into international Phase 3 clinical trials for treatment of C. difficile Infection. Acurx is also preparing to submit requests for regulatory guidance to initiate clinical trials in the European Union, to be followed by requests to be submitted in the United Kingdom, Japan and Canada. Key elements for the two Phase 3, non-inferiority, pivotal trials were confirmed and included agreement on the protocol design, patient population, primary and secondary endpoints, and size of the registration safety database. Based on FDA recommendations, and in anticipation of an EMA Scientific Advice Meeting, the primary efficacy analysis will be performed using a Modified Intent-To-reat population consistent with EMA requirements. This will result in an estimated 450 subjects in the mITT population, randomized in a 1:1 ratio to either ibezapolstat or standard-of-care vancomycin, enrolled into the initial Phase 3 trial. The trial design not only allows determination of ibezapolstat's ability to achieve Clinical Cure of CDI as measured 2 days after 10 days of oral treatment, but also includes assessment of ibezapolstat's potential effect on reduction of CDI recurrence in the target population. In the event non-inferiority of ibezapolstat to vancomycin is demonstrated, further analysis will be conducted to test for superiority.
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CLAR | Hot Stocks08:02 EST Clarus appoints Mark Besca to board of directors - Clarus announced that the Company's Board of Directors appointed Mr. Mark Besca to serve on the Board, effective as of December 5, 2024. With Mr. Besca's appointment, the Board will be comprised of seven directors, six of whom are independent. Mr. Besca was also appointed to the Audit Committee of the Company's Board. Since 2020, Mr. Besca has been a member of the board of directors and Audit Committee Chair of Markel Group Inc., a New York Stock Exchange listed financial holding company with diverse operations. Prior to his retirement in 2020, he spent 40 years at EY serving as lead and senior advisory audit partner to some of the largest public companies in the media and entertainment, consumer products and airline industries.
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ABBV | Hot Stocks08:02 EST AbbVie reports 'positive' results from Phase 3 TEMPO-2 trial - AbbVie announced positive topline results from its pivotal Phase 3 TEMPO-2 trial evaluating investigational tavapadon as a flexible-dose monotherapy in early Parkinson's disease. Tavapadon is the first and only D1/D5 partial agonist under investigation as a once-daily treatment for Parkinson's disease. The TEMPO-2 trial evaluated the efficacy, safety and tolerability of a flexible-dose (5 mg to 15 mg, once daily) treatment with tavapadon as a monotherapy in adults with early Parkinson's disease. The trial met its primary endpoint - patients treated with tavapadon experienced a statistically significant reduction from baseline compared to placebo in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale Parts II and III combined score at week 26.1 The TEMPO-2 trial also met the key secondary endpoint, demonstrating a statistically significant and clinically meaningful improvement in motor aspects of experiences of daily living in the tavapadon group (5-15 mg) compared to placebo at week 26 "The positive results across all three Phase 3 TEMPO trials underscore the potential of tavapadon as a first-in-class D1/D5 partial agonist for the treatment of Parkinson's disease," said Primal Kaur, M.D., MBA, senior vice president, immunology, neuroscience, eye care and specialty development, AbbVie. "With these data in hand, we look forward to working with regulatory agencies to assess next steps, bringing us one step closer to providing tavapadon for those living with this chronic, debilitating disease." The safety profile observed in the TEMPO-2 trial was consistent with prior clinical trials. The majority of adverse events reported were mild to moderate in severity.
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KOP | Hot Stocks07:56 EST Koppers Holdings announces retirement of two senior leaders - Koppers Holdings announced the retirement of two senior leaders who, respectively, established sustainability and safety as central priorities of the company. Leslie Hyde, Senior Vice President and Chief Sustainability Officer, will retire effective March 31, 2025, and Joseph Dowd, Global Vice President Zero Harm, will retire effective February 28, 2025. Effective immediately, both will serve as Assistant to the CEO in order to help ensure a smooth transition.
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HCVI | Hot Stocks07:51 EST Hennessy Capital Investment VI, Namib Minerals file registration statement - Namib Minerals, Greenstone, and HCVI announced the filing of the Registration Statement with the SEC on Friday, December 6, 2024. This filing represents a key milestone in connection with their previously announced proposed business combination, which is expected to result in Namib Minerals listing its ordinary shares and warrants on Nasdaq under the ticker symbols "NAMM" and "NAMMW," respectively, subject to approval of its listing application. While the Registration Statement has not yet become effective and the information contained therein is subject to change, it provides important information about Namib Minerals, Greenstone, HCVI, and the proposed business combination. Upon completion of the transaction, Namib Minerals will own Greenstone's mining and exploration assets and plans to accelerate its growth strategy and build out its portfolio of mining assets. Located strategically in the Bulawayo Greenstone Belt of Southern Zimbabwe, Greenstone's cash flow generating How mine has produced over 1.8Moz of gold between 1941 and 2023. Restart efforts at the Mazowe and Redwing mines, historically producing gold mines currently on care and maintenance, aim to diversify Namib Minerals' production scale upon the mines' recommencement. The Mazowe and Redwing mines have total measured and indicated resource estimates of 291koz at 7.77 g/t Au and 1,188koz at 3.83 g/t Au, respectively, and inferred resource estimates of 915koz at 8.65 g/t Au and 1,328koz at 2.61 g/t Au, respectively, based on technical report summaries for each mine prepared in compliance with Subpart 1300 of Regulation S-K promulgated by the SEC. Greenstone also currently holds interests in 13 battery metals exploration permits in the DRC, including six initial diamond drilling holes that show potential for copper and cobalt. Located in the resource-rich Haut Katanga and Lualaba Provinces, these assets position Namib Minerals to capitalize on the rising global demand for battery metals. The proposed business combination implies a pro forma combined enterprise value of Namib Minerals at approximately $602 million, excluding additional earnout consideration, assuming no further redemptions of HCVI's public shares and $60 million in targeted PIPE funding to be obtained prior to the closing of the transaction. The boards of directors of HCVI, Greenstone, and Namib Minerals have approved the proposed transaction, which is expected to be completed in the first quarter of 2025, subject to, among other things, the approvals by stockholders of HCVI and Greenstone and satisfaction or waiver of the other conditions set forth in the business combination agreement, dated June 17, 2024. At closing of the proposed business combination, Greenstone's existing shareholders will exchange their equity in Greenstone for approximately 74% of the equity of Namib Minerals. Net proceeds from the transaction are expected to enable Namib Minerals to invest further into the How mine, while also contributing to the restart of production at the Mazowe and Redwing mines, each in Zimbabwe, and to help fund the expansion of operations into the DRC.
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LDTC TXN | Hot Stocks07:49 EST LeddarTech enters into amendments to credit facility, bridge financing - LeddarTech Holdings (LDTC) announced that LeddarTech and Texas Instruments (TXN) have entered into a strategic collaboration agreement and a software license agreement to enable a comprehensive, integrated platform solution for advanced driver assistance systems and autonomous driving markets. Under the license agreement, TI has agreed to make advanced royalty payments to catalyze joint commercialization. In connection with the collaboration and license agreements with TI and the advanced royalty payments provided thereunder, LeddarTech entered into: a fourteenth amending agreement with Federation des caisses Desjardins du Quebec with respect to the amended and restated financing offer dated as of April 5, 2023, pursuant to which Desjardins has agreed to, among other things: temporarily postpone payment of interest for the months of July through December 2024 until the earlier of the date of the final disbursement of one or several equity investments in the borrower for minimum gross proceeds amount of $35,000,000 in the aggregate, and January 31, 2025 assuming the disbursement to LeddarTech of the full first installment of the TI Pre-paid Royalty Fee; and temporarily suspend the minimum cash covenant under the Desjardins Credit Facility until the earlier of December 13, 2024, and the date of disbursement to LeddarTech of the full first installment of the TI Pre-paid Royalty Fee, after which time LeddarTech will be required to maintain a minimum cash balance of C$1,000,000 until the earlier of the Short-Term Outside Date, and January 31, 2025, and a minimum cash balance of C$5,000,000 at all times after such date. a second amending agreement with the initial bridge lenders and certain members of management and the board of directors with respect to the bridge financing offer dated as of August 16, 2024 pursuant to which the Bridge Lenders have agreed, among other things, to extend the maturity of the bridge loan to December 13, 2024, which date will automatically be extended upon the disbursement by TI to LeddarTech of the full first installment of the TI Pre-paid Royalty Fee, to the earlier of January 31, 2025 and the business day following the Short-Term Outside Date. The Fourteenth Amending Agreement to the Desjardins Credit Facility also provides for a monthly payment by LeddarTech to Desjardins of C$125,000 until the Short-Term Outside Date, which payments will be due and payable on the earlier of the Short-Term Outside Date and December 13, 2024, provided that if the full first installment of the TI Pre-paid Royalty Fee is received on or before December 13, 2024, the deferral will extend to the earlier of the Short-Term Outside Date, and January 31, 2025.
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ADCT | Hot Stocks07:48 EST ADC Therapeutics: Updated data from Phase 2 Zynlonta study published in Lancet - ADC Therapeutics announced updated data from the investigator-initiated Phase 2 clinical trial evaluating ZYNLONTA in combination with rituximab to treat relapsed or refractory follicular lymphoma were published in the December issue of The Lancet Haematology, following an oral presentation of the data at the recent 66th American Society of Hematology Annual Meeting and Exposition. "We are excited by the publication of these results in The Lancet Haematology demonstrating ZYNLONTA's robust clinical activity in follicular lymphoma, particularly in patients classified as high-risk POD24 and those with high tumor burden where there remains significant unmet need," said Mohamed Zaki, MD, PhD, Chief Medical Officer of ADC Therapeutics. "In addition, encouraging data from another investigator-initiated trial of ZYNLONTA as a single agent to treat marginal zone lymphoma were also presented at ASH. Collectively, we believe these data underscore ZYNLONTA's promise for patients with indolent B-cell lymphomas and add to a growing body of evidence showing the potential of ZYNLONTA beyond diffuse large B-cell lymphoma."
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SLN | Hot Stocks07:44 EST Silence Therapeutics announces additional results from SANRECO study - Silence Therapeutics announced additional results from the Phase 1 open label portion of the SANRECO study of divesiran, a siRNA targeting TMPRSS6, in patients with polycythemia vera were presented at the American Society of Hematology annual Mmeeting being held in San Diego, California. Initial results from the SANRECO Phase 1 study were presented in June and showed that all doses of divesiran substantially reduced phlebotomy frequency and lowered hematocrit in 16 phlebotomy dependent PV patients regardless of baseline HCT levels. Additional data presented at ASH further support those findings and included 19 PV patients with a combined history of 79 phlebotomies prior to enrolment. Following divesiran dosing, only five phlebotomies occurred during the 18-week treatment period - all were in patients who entered the study with high baseline HCT levels. Two phlebotomies occurred in the 16-week follow-up period following the last administered dose. Consistent with results reported in June, there was a sustained reduction in HCT during the treatment period and favorable effects on indices of iron metabolism. Hepcidin levels increased and were sustained within physiological levels in all dose groups, demonstrating consistent target engagement. Importantly, divesiran continues to be well tolerated to-date with no dose-limiting toxicities.
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GSK | Hot Stocks07:44 EST GSK announces U.S. FDA accepted its submission for use of Nucala in COPD - GSK announced the US Food and Drug Administration, FDA, has accepted for review, data from the MATINEE study to support the regulatory review process to obtain a new indication for the use of Nucala, as an add-on maintenance treatment for patients with chronic obstructive pulmonary disease, COPD, with an eosinophilic phenotype. The Prescription Drug User Fee Act, PDUFA, date is 7 May 2025. The submission is based on data from the MATINEE study, which evaluated the efficacy and safety of mepolizumab in 804 patients with COPD who have evidence of type 2 inflammation characterised by blood eosinophil count. The MATINEE study met its primary endpoint with the addition of mepolizumab to inhaled maintenance therapy, achieving a statistically significant and clinically meaningful reduction in the annualised rate of moderate/severe exacerbations versus placebo with patients treated for 52-104 weeks.
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HIVE | Hot Stocks07:42 EST Hive Digital announces 103 bitcoin produced in November - HIVE Digital Technologies has released its unaudited production results for November 2024. Bitcoin Production: HIVE mined 103 BTC, bringing its HODL portfolio to 2,713 BTC, a 67% increase year-over-year. Mining Capacity: Maintained an average mining capacity of 5.3 Exahash per Second with fleet efficiency at 22.3 Joules per Terahash, reaching a peak hashrate of 5.7 EH/s. Operational Efficiency: Achieved an average daily production rate of 3.42 BTC, equivalent to 19.3 Bitcoin per Exahash. Bitcoin Valuation: HIVE's Bitcoin holdings were valued at over $261 million as of November 30, 2024, based on a BTC closing price of approximately $96,400.
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SLG TRV | Hot Stocks07:42 EST SL Green Realty inks lease with Travelers Insurance at 485 Lexington Avenue - SL Green Realty (SLG) announced that The Travelers Insurance Company (TRV) has executed a 122,788 square foot renewal at 485 Lexington Avenue. The company will remain on a portion of the seventh floor and all of the eighth and ninth floors for an additional 10 years. This transaction increases SL Green's office leases signed year to date to 3,518,829 square feet while maintaining a pipeline of more than 900,000 square feet.
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INDB EBTC | Hot Stocks07:42 EST Independent Bank, Enterprise Bancorp sign $562M merger agreement - Independent Bank (INDB) and Enterprise Bancorp (EBTC) have signed a definitive merger agreement pursuant to which Enterprise will merge into Independent and Enterprise Bank will merge into Rockland Trust in a cash and stock transaction for total consideration valued at approximately $562M in aggregate, or $45.06 per share based on the Independent closing price of $71.77 on December 6. The merger agreement provides that Enterprise shareholders will receive 0.60 shares of Independent common stock and $2.00 in cash for each share of Enterprise common stock they hold. The transaction is intended to qualify as a tax-free reorganization for federal income tax purposes and to provide a tax-free exchange for Enterprise shareholders for the Independent common stock portion of the merger consideration they will receive. Independent anticipates issuing approximately 7.5M shares of its common stock and paying an aggregate amount of $27.1M in cash in the merger. The merger is expected to close in the second half of 2025 subject to customary closing conditions, including regulatory approvals and approval of Enterprise shareholders. No vote of Independent shareholders is required. The merger is expected to be approximately 16% accretive to Independent's earnings per share in 2026, the first full year of combined operations, assuming full phase-in of cost savings. Independent anticipates the transaction will meet its three year or less tangible book value earn back hurdle rate. Combined merger-related charges are expected to be approximately $61.2M before tax, in the aggregate. As part of the transaction, Independent plans to raise approximately $250M in subordinated debt prior to the transaction closing. Post close, board chair and Enterprise Bank founding member, George Duncan, will become an advisor to the independent board and Larochelle will serve as a consultant for Rockland Trust for one year. Additionally, Independent will appoint two Enterprise directors to its board following the merger. The boards of directors of each company have unanimously approved the transaction. Enterprise's directors and executive officers who currently own, in the aggregate, about 20.4% of Enterprise's outstanding shares have signed voting agreements pursuant to which they have agreed to vote their shares in favor of the merger.
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CCM | Hot Stocks07:42 EST Concord Medical: Application for proton therapy equipment registration approved - Concord Medical Services announced that the National Medical Products Administration of the People's Republic of China has granted approval to the application for the Registration Certificate for Medical Device for the proton therapy equipment made by the company's equipment supplier on December 6, 2024. As previously disclosed in the Company's annual report for the fiscal year ended December 31, 2023, Guangzhou Concord Cancer Center, a PRC subsidiary of the company offering comprehensive cancer care services, has completed the installment of the proton equipment in September 2020 and commenced its clinical trial in November 2022. Guangzhou Hospital has also subsequently obtained the large medical equipment procurement license for its proton equipment in September 2024. Upon obtaining the approval for the Registration Certificate, Guangzhou Hospital plans to start its proton therapy treatment services at its earliest convenience after necessary preparations.
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IDXX | Hot Stocks07:41 EST Idexx Laboratories announces 5M share increase in share repurchase pact - IDEXX Laboratories announced that the Company's Board of Directors authorized an increase in its ongoing share repurchase program, authorizing the repurchase of up to five million additional shares of the Company's common stock. Repurchases may be made at management's discretion from time to time in the open market or in negotiated transactions. These shares are in addition to the 1.3 M shares remaining under the Company's ongoing share repurchase program as of December 3 pursuant to previous Board authorizations. The share repurchase program has no specified expiration date and may be suspended or discontinued at any time.
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SBFM | Hot Stocks07:39 EST Sunshine Biopharma announces novel inhibitor for SARS Coronavirus - Sunshine Biopharma has developed an orally active protease inhibitor with dose-dependent antiviral activity in mice infected with SARS Coronavirus. There are still unmet medical needs for agents to combat SARS-CoV-2 infections. SARS-CoV-2 is the etiologic agent of COVID-19 and one of three types of Coronavirus that cause Severe Acute Respiratory Syndrome. SARS-CoV-2 undergoes mutation at a rapid rate, which leads to the continuous emergence of variants of concern posing a significant threat to public health. In addition, certain populations, such as immunocompromised patients who are susceptible to severe and prolonged infections, may not respond well to current therapies or vaccines. For high-risk patients, blocking early infection at home may prevent rapid disease progression and reduce hospitalization. PLpro is an alternative therapeutic target for developing antiviral compounds against proteolytic processing activity of SARS-CoV-2. PLpro is a virus encoded protease essential for viral replication and is responsible for suppression of the human immune system following infection, leading to a more severe disease outcome. In August 2024, Sunshine Biopharma published initial research results on its PLpro inhibitors library in the Journal of Medicinal Chemistry. Sunshine Biopharma's current lead compound was recently found to be active at sub-micromolar concentrations against PLpro and exhibited antiviral activity in SRAS-CoV-2 infected cells as well as in cells infected with several different VOC. In addition, the Company's lead compound had favorable pharmacokinetics properties in rodent species and exhibited preferred drug accumulation in the lungs over plasma. The compound was found to be orally active in a K18-human-ACE2 transgenic mouse model and to significantly reduce virus load in the lungs of infected animals in a dose-dependent manner without gross toxicities. This research is being carried out in collaboration with the University of Arizona.
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STXS | Hot Stocks07:39 EST Stereotaxis, Medtech announce catheter approved by China's NMPA - Stereotaxis and Shanghai MicroPort EP Medtech announced that the Magbot Magnetic Navigation Ablation Catheter has received regulatory approval from China's National Medical Products Administration, NMPA. The Magbot Catheter is a single-use magnetic saline-irrigated radiofrequency ablation catheter designed and developed by MicroPort EP in collaboration with Stereotaxis. The catheter works exclusively and in tight conjunction with Stereotaxis' robotic systems, including the recently NMPA-approved Genesis RMN, and MicroPort EP's Columbus 3D EP Mapping System.
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BLDP | Hot Stocks07:39 EST Ballard Power signs multi-year supply agreement with Stadler US - Ballard Power Systems announced the signing of a multi-year supply agreement with Stadler US to supply 8 megawatts of FCmove-HD+ fuel cell engines to power trains for the California Department of Transportation. The supply of the FCmove-HD+ engines will be integrated into Stadler's line of zero-emission passenger trains.
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BWMN | Hot Stocks07:38 EST Bowman selected to lead engineering on 64 MW solar system, no terms - Bowman Consulting Group announced that it has been selected by J. Ranck Electric or JRE to lead the re-mobilization of a 64 MW direct current DC solar project located in Southeast Michigan. This expansion will enhance the substations capabilities to support additional solar power generation, integrating new photovoltaic PV capacity alongside existing wind power infrastructure. Under this contract, Bowman will perform a comprehensive suite of services, including electrical engineering, civil design and system modeling to support the integration of JREs solar power installation into the US power grid....This project marks significant steps forward both in our energy services practice and in our partnership with J. Ranck Electric, said Dan Swayze, chief operating officer of Bowman. We are excited to deploy our energy engineering and design capabilities to help JRE enhance Michigans renewable energy capacity and grid stability. This assignment reinforces our commitment to delivering diversification and organic growth as we continue to expand our renewables and traditional energy portfolio nationally.
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BWMN | Hot Stocks07:38 EST Bowman selected to lead engineering on 64 MW solar system, no terms - Bowman Consulting Group announced that it has been selected by J. Ranck Electric or JRE to lead the re-mobilization of a 64 MW direct current DC solar project located in Southeast Michigan. This expansion will enhance the substations capabilities to support additional solar power generation, integrating new photovoltaic PV capacity alongside existing wind power infrastructure. Under this contract, Bowman will perform a comprehensive suite of services, including electrical engineering, civil design and system modeling to support the integration of JREs solar power installation into the US power grid....This project marks significant steps forward both in our energy services practice and in our partnership with J. Ranck Electric, said Dan Swayze, chief operating officer of Bowman. We are excited to deploy our energy engineering and design capabilities to help JRE enhance Michigans renewable energy capacity and grid stability. This assignment reinforces our commitment to delivering diversification and organic growth as we continue to expand our renewables and traditional energy portfolio nationally.
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ATER | Hot Stocks07:38 EST Aterian announces launch of three new products - Aterian announced the launch of three new products, now available for purchase on Amazon.com and Walmart.com. These products will also be available on MercadoLibre and Target+ by next week. The product launches include two additions to Aterian's PurSteam brand and one to its Mueller Living brand. The newly launched PurSteam products, the Steam Station Max and the ScrubMaster showcase the brand's commitment to innovation, quality, and meeting the evolving needs of its customers. The Cordless Portable Vacuum Sealer is the latest addition to Mueller Living's lineup of innovative, practical, and affordable kitchen solutions.
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BDRBF | Hot Stocks07:37 EST Bombardier celebrates 200th delivery of Global 7500 aircraft - Bombardier has delivered the 200th Global 7500 business jet to a customer in December. The company said, "The Global 7500 business jet has transformed business aviation with its refined design, unsurpassed performance and outstanding technological advancements."
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ASTS VOD | Hot Stocks07:37 EST AST SpaceMobile announces commercial agreement with Vodafone through 2034 - AST SpaceMobile (ASTS) and Vodafone (VOD) announced that they have entered into a definitive long-term commercial agreement through 2034. This is a significant step forward in their collaboration to expand broadband connectivity globally. This agreement establishes the framework for Vodafone to offer space-based cellular broadband connectivity in its home markets, as well as to other operators via its Partner Markets program.
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VTVT | Hot Stocks07:37 EST vTv Therapeutics receives FDA Orphan Drug Designation for azeliragon - Cantex Pharmaceuticals announced that the U.S. FDA granted Orphan Drug Designation to Cantex's azeliragon for the treatment of brain metastasis from breast cancer. This new azeliragon designation adds to azeliragon's two other Orphan Drug Designations for the treatment of pancreatic cancer and glioblastoma, received in mid-2024 and early 2023, respectively.
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LDTC TXN | Hot Stocks07:36 EST LeddarTech announces collboration agreement with Texas Instruments - LeddarTech (LDTC) announced that LeddarTech and Texas Instruments (TXN) have entered into a strategic collaboration agreement and a software license agreement to enable a comprehensive, integrated platform solution for advanced driver assistance systems, ADAS, and autonomous driving, AD, markets. Under the license agreement, TI has agreed to make advanced royalty payments to catalyze joint commercialization. The collaboration and license agreements will enable TI to market a bundled solution that features LeddarTech's LeddarVision AI-based fusion and perception software stack pre-integrated and validated on TI's TDA scalable portfolio of Arm-based processors. LeddarTech and TI have worked closely for nearly two years to integrate LeddarTech's software with TI's hardware to create an open, comprehensive, high-performance and cost-efficient solution for ADAS and AD systems that can serve the entire automotive OEM landscape and their Tier 1 suppliers.
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SLG | Hot Stocks07:35 EST SL Green Realty announces transactions at 100 Park Avenue - SL Green Realty announced a series of transactions at 100 Park Avenue, including a new 220,221 square-foot lease with global professional services firm, Alvarez & Marsal Holdings, a modification that extends and upsizes the existing $360.0 million mortgage, and the signing of a purchase option agreement to acquire its partner's 49.9% interest in the property. Alvarez & Marsal Holdings signed a new 15-year lease for 220,221 square feet covering floors 3, 4 and 7-9, which brings the building's leased occupancy to 95.8%. The tenant was represented by David Dusek of Cushman & Wakefield, while the Landlord was represented by Harry Blair, Tara Stacom, Barry Zeller, Justin Royce and Pierce Hance of Cushman & Wakefield. he Company also modified the building's existing $360.0 million mortgage. The modification extended the final maturity date to December 2027 and maintained the interest rate at 2.25% over Term SOFR. In addition, the lenders provided a new $70.0 million future funding facility to support leasing costs at the property. SL Green was advised by Adam Spies and Doug Harmon of Newmark and the lenders were advised by Doug Middleton of CBRE.
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SNDX | Hot Stocks07:35 EST Syndax announces additional positive data from AUGMENT-101 trial of Revuforj - Syndax Pharmaceuticals announced additional positive data from the AUGMENT-101 trial of Revuforj in relapsed or refractory mutant NPM1 acute myeloid leukemia and the BEAT AML trial of revumenib in combination with venetoclax and azacitidine in newly diagnosed AML patients. Revuforj is the company's oral, first-in-class menin inhibitor that is FDA approved for the treatment of relapsed or refractory acute leukemia with a lysine methyltransferase 2A gene translocation in adult and pediatric patients one year and older. Syndax announced today additional results from the Phase 2 cohort of R/R mNPM1 AML patients in the AUGMENT-101 trial, including data generated from the protocol-defined efficacy population of 64 adults and a post-hoc efficacy analysis based on all patients who met the efficacy evaluable criteria. Subgroup analyses from the Phase 2 protocol-defined R/R mNPM1 efficacy population (N=64) show that CR/CRh responses were observed across all major subgroups, including patients with multiple prior lines of therapy and prior venetoclax exposure, although the trial was not powered to evaluate differences among subgroups. The CR+CRh rate was 25% (4/16) among patients with 1 prior line of therapy, 20% (5/25) among patients with 2 prior lines of therapy, and 26% (6/23) among patients who had received three or more prior lines of therapy. The CR+CRh rate was 44% (7/16) among patients without prior venetoclax exposure and 17% (8/48) among patients with prior venetoclax exposure. Historically, AML patients who have failed prior treatment with venetoclax are unlikely to respond to subsequent therapy, with a CR rate of 6% reported for other targeted therapies after prior venetoclax therapy.2 Syndax also shared results from an expanded analysis of the R/R mNPM1 AML patients who enrolled into the Phase 2 cohort of AUGMENT-101. Among the 84 patients enrolled in the cohort, 77 met the efficacy evaluable criteria requiring patients to have blast counts greater than5% measured within 28 days prior to treatment and a centrally confirmed NPM1 mutation. In this expanded post-hoc efficacy analysis, 48% (37/77; 95% CI: 37%, 60%) achieved an overall response, and 26% (20/77; 95% CI: 17%, 37%) achieved a CR/CRh. The median duration of CR/CRh response was 4.7 months as of the September 2024 DCO. Minimal residual disease status was assessed in 19 of 20 patients who achieved CR/CRh, 63% (12/19) of whom were MRD negative.
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AVXL | Hot Stocks07:35 EST Anavex announces upcoming presentation of data from ATTENTION-AD study - Anavex Life Sciences announced its upcoming presentation of topline long-term data from the Phase IIb/III ATTENTION-AD Open-Label-Extension, OLE, trial at the J.P. Morgan 2025 Healthcare Conference, taking place January 13-16, 2025, in San Francisco, CA. The presentation will highlight new findings from the ATTENTION-AD study evaluating potential benefit of oral once daily blarcamesine in early Alzheimer's disease. The data reflect up to 144 weeks of continuous treatment in the OLE phase, following the prior 48-week double-blind Phase IIb/III study, for a total of up to 192 weeks of safety and efficacy data.
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RGEN | Hot Stocks07:34 EST Repligen launches AVIPure dsRNA Clear OPUS columns - Repligen announced the launch of AVIPure dsRNA Clear OPUS columns, a solution designed to simplify and enhance the production of mRNA therapeutics and vaccines. This novel affinity chromatography offering marries Repligen's breakthrough dsRNA purification resin with its flagship OPUS pre-packed columns. The AVIPure dsRNA Clear resin offers unmatched performance in the removal of double-stranded RNA impurities from transcribed RNA. As the market for mRNA-based biologics has expanded, so has the critical need for better dsRNA removal, to enable the highest levels of drug efficacy in patients, while reducing or preventing any undesirable immune responses. The AVIPure dsRNA Clear OPUS columns directly address this need, with a convenient, closed system for mRNA manufacturers. The AVIPure dsRNA Clear resin launch follows last week's formal completion by Repligen of its acquisition of Tantti Laboratory Inc., announced on July 29, 2024. The AVIPure dsRNA Clear resin product combines our proprietary affinity ligands with Tantti's DuloCore base bead technology. The result is a 2-3 log reduction of dsRNA impurities in just one minute of residence time in flow through mode. Unlike traditional methods, this advanced solution eliminates the need for heat or solvents, providing an easy-to-use, scalable option for manufacturers, and enabling a highly efficient, cost-effective process that ensures the production of high-purity mRNA therapeutics and vaccines. Designed for flexibility and performance, the resins come pre-packed in OPUS chromatography columns, ensuring seamless integration into biomanufacturing workflows.
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THTX | Hot Stocks07:33 EST Theratechnologies announces preliminary tolerability, efficiacy data for TH1902 - Theratechnologies announced data from Part 3 of its ongoing Phase 1b trial of sudocetaxel zendusortide, TH1902, - the company's lead investigational peptide drug conjugate - in patients with advanced ovarian cancer. Based on results demonstrating favorable tolerability and signals of efficacy, the Medical Review Committee, which includes study investigators and external experts, has unanimously recommended continued evaluation and exploration of higher doses. "We are encouraged by the tolerability and preliminary efficacy data for sudocetaxel zendusortide seen thus far in this part of the Phase 1 study, which was designed to explore dose optimization utilizing a weekly dosing schedule in a population of heavily pre-treated ovarian cancer patients," commented Christian Marsolais, Ph.D., Senior Vice President and Chief Medical Officer at Theratechnologies. "These latest results add to the growing body of evidence that our novel PDC technology can deliver a toxic payload into cancer cells with little impact on non-cancerous tissues and we believe there could be further clinical implications at a higher dose."
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OMC IPG | Hot Stocks07:32 EST Omnicom to acquire Interpublic Group in a stock-for-stock transaction - Omnicom (OMC) and The Interpublic Group of Companies (IPG) announced their Boards of Directors have unanimously approved a definitive agreement pursuant to which Omnicom will acquire Interpublic in a stock-for-stock transaction. Under the terms of the agreement, Interpublic shareholders will receive 0.344 Omnicom shares for each share of Interpublic common stock they own. Following the close of the transaction, Omnicom shareholders will own 60.6% of the combined company and Interpublic shareholders will own 39.4%, on a fully diluted basis. The transaction is expected to generate annual cost synergies of $750M. John Wren will remain Chairman & CEO of Omnicom. Phil Angelastro will remain EVP & CFO of Omnicom. Philippe Krakowsky and Daryl Simm will serve as Co-Presidents and COOs of Omnicom. Krakowsky will also be Co-Chair of the Integration Committee post-merger. Three current members of the Interpublic Board of Directors, including Philippe Krakowsky, will be welcomed to the Omnicom Board of Directors. The stock-for-stock transaction is expected to be tax-free to both Omnicom and Interpublic shareholders and is expected to close in the second half of 2025, subject to Omnicom and Interpublic shareholder approvals, required regulatory approvals, and other customary conditions. The combined company will retain the Omnicom name and trade under the "OMC" ticker symbol on the New York Stock Exchange.
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RLMD | Hot Stocks07:32 EST Relmada Therapeutics commences exploration of strategic alternatives - In connection with the decision, the Company has commenced a process to explore strategic alternatives to maximize shareholder value. As part of this process, the Company plans to consider a wide range of options with a focus on maximizing shareholder value, including, but not limited to, the sale of Company assets, a sale of the Company, a merger or a reverse merger, the acquisition of assets or rights for the development of other products, or other strategic transaction. There can be no assurance that the exploration of strategic alternatives will result in any agreements or transactions, or as to the timing of any such agreements or transactions. The Company is in the process of engaging a financial advisor to assist in the strategic review process. The Company has not set a timetable for completion of the evaluation process and does not intend to disclose further developments or guidance on the status of its exploration of strategic alternatives unless and until it is determined that further disclosure is appropriate or necessary.
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VOR | Hot Stocks07:32 EST Vor Bio announces updated data from Phase 1/2 VBP1-1 study - Vor Bio announced updated clinical data from its ongoing Phase 1/2 VBP101 study of patients with relapsed/refractory AML receiving trem-cel followed by Mylotarg. The data, which was presented in a poster at the American Society of Hematology (ASH) Annual Meeting on Sunday, December 8th, demonstrated durable engraftment, shielding from Mylotarg on-target toxicity, a broadened Mylotarg therapeutic window, and early evidence of improved relapse free survival compared to published high-risk AML comparators. The data released today included 25 patients treated with trem-cel of which 15 had received Mylotarg as of the data cut-off date of November 1, 2024. The data demonstrated: Preliminary evidence of improved relapse-free survival compared to published groups of AML patients at high risk of relapse post hematopoietic stem cell transplant. Shielding of the blood system, with maintained neutrophil and platelet counts across multiple Mylotarg doses of 0.5, 1, and 2 mg/m2. Broadened therapeutic index for Mylotarg when administered after trem-cel. Reliable engraftment, with 100% of patients achieving primary neutrophil engraftment, robust platelet recovery, and full myeloid donor chimerism at Day 28. Trem-cel continues to be manufactured with high CD33 editing efficiency
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RLMD | Hot Stocks07:31 EST Relmada Therapeutics to discontinue Reliance II, Relight Phase 3 studies - Relmada Therapeutics announced that in light of the recent data monitoring committee evaluation of the full dataset from the Reliance II Phase 3 study of the Company's REL-1017 program, the Company will discontinue the Reliance II and Relight Phase 3 studies. The Company will continue to advance the Phase 1 study of REL-P11, an investigational agent for the treatment of metabolic disease, currently in a Phase 1 first-in-human study.
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OMC IPG | Hot Stocks07:30 EST Omnicom to acquire Interpublic Group in a stock-for-stock transaction
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BP | Hot Stocks07:24 EST BP, JERA Co. to combine offshore wind businesses under new company - bp and JERA Co. have agreed to combine their offshore wind businesses to form a new standalone, equally-owned joint venture that will become one of the largest global offshore wind developers, owners and operators. The combination will create a global business, to be called JERA Nex bp, with a balanced mix of operating assets and development projects with total 13GW potential net generating capacity. Formation of JERA Nex bp is intended to accelerate development from the combined pipeline and bolster access to competitive financing. Supporting this, the partners have agreed to provide capital funding for investments committed to before end of 2030 of up to $5.8B. The companies will contribute interests comprising operating assets with around 1GW net generating capacity, a strong pipeline of high-quality development projects with around 7.5GW capacity, and further secured leases with around 4.5GW of potential capacity. JERA Nex bp will pursue value-driven development of competitive projects, as well as optimising its extensive combined portfolio. Initially it is expected to focus on progressing existing projects in North-West Europe, Australia and Japan, and to continue to mature the development pipeline of significant longer-term opportunities. The two partners have aligned expectations for the business to progress through disciplined and value-driven development, and have agreed a clear funding framework for the rest of this decade to underpin this. This includes leveraging asset revenues and accessing competitive financing itself, as well as proceeds from portfolio management. The equity investment contributed by the partners may be lower than the total agreed gross funding depending on project and venture financing and proceeds from asset farm-downs and sales. JERA Nex bp is expected to benefit from the existing relationships and partnerships that the two shareholders have worldwide, including across the supply chain. The business will also draw on and benefit from the global trading capabilities of both partners to manage and market power from its assets into various offtake channels. JERA Nex bp will be based in London. Its CEO will be nominated by JERA and the CFO by bp. On completion, offshore wind teams from both JERA and JERA Nex and staff from bp's offshore wind business will be expected to move into the new business. The parties have agreed to work to complete formation of JERA Nex bp, subject to regulatory and other approvals, with completion expected by end of the third quarter of 2025. Reference Link
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FCUV | Hot Stocks07:16 EST Focus Universal to debut Universal Smart Device, Universal IoT Platform at CES - Focus Universal announced that it will debut its universal smart devices and universal smart IoT platform in booth 9877 in the North Hall Showcase of the Las Vegas Convention Center, January 7-10, 2025. The company's universal smart device, Ubiquitor, is a solution capable of connecting to any sensor or a vast number of independent sensors, theoretically without limit. When a moderate number of sensors are connected, the cost of the Ubiquitor, averaged across sensors, becomes negligible. The effective cost approaches that of the sensors alone, which represents just a fraction of the material costs of traditional devices. Additionally, the Ubiquitor's efficiency and cost-effectiveness are evident when coupled with Focus' platform system, whereby development costs are a fraction of traditional device development requirements, resulting in substantial savings in both raw material and development costs. The universal smart platform to building IoT infrastructure eliminates redundancy in IoT hardware and software design. Instead of starting from scratch, engineers can begin their IoT projects with a foundation which is 90% complete. This approach allows different IoT devices to share 90% of the same hardware and software, significantly lowering costs and simplifying design processes.
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CTSO | Hot Stocks07:12 EST CytoSorbents announces details of Rights Offering - CytoSorbents announced the details of its anticipated Rights Offering. Investors who hold or have bought CTSO stock at the close of Nasdaq trading on Friday, December 13, 2024 will be deemed stockholders of record on December 16, 2024 and, along with certain Warrantholders, will receive a dividend at no cost of one non-transferable Subscription Right Warrant for each share of common stock owned. Each Subscription Right, when exercised before the expiration date of 5:00PM EST on January 10, 2025, enables a Unit purchase at a Unit subscription price of $1.00. Each Unit consists of one share of common stock and two transferable short-term Right Warrants to purchase up to two additional shares of common stock, if available, at specified prices described below.All net proceeds from the offering will go to the Company and be used for general corporate purposes and to satisfy a debt covenant where proceeds of $3.0 million to $5.0 million will unlock $3.0 million to $5.0 million in restricted cash currently on our balance sheet on a dollar-for-dollar basis. For example, aggregate proceeds of $5.0 million would result in increased liquidity to the Company of approximately $10.0 million in unrestricted cash, which is expected to fund the Company's operations through anticipated FDA and Health Canada decisions on our DrugSorb-ATR marketing applications in 2025, and if approved or cleared, the initial launch of the product. Each Subscription Right will provide the stockholder the opportunity, but not the obligation, to purchase a Unit at a Unit subscription price of $1.00. Each Unit consists of: One share of common stock. One Series A Right Warrant to purchase an additional share of common stock 45 days from the initial Unit subscription closing date, or February 24, 2025, at an exercise price that is 90% of the 5-day volume weighted average price prior to February 24th, but no lower than $1.00 and no higher than $2.00, irrespective of the share price at the time. One Series B Right Warrant to purchase an additional share of common stock 90 days from the initial unit subscription closing date, or April 10, 2025, at an exercise price that is 90% of the 5-day volume weighted average price prior to April 10th, but no lower than $2.00 and no higher than $4.00, irrespective of the share price at the time.
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NFYEF | Hot Stocks07:10 EST NFI Group subsidiary MCI announces new contract with Houston METRO - NFI Group subsidiary Motor Coach Industries, MCI, announced a new contract with Metro Transit Authority of Harris County, METRO, for the purchase of 100 MCI D45 CRT high-floor coaches. The initial purchase for the contract included 50 firm coaches and 50 options, which were added to MCI's Q3 2024 firm and option awards. METRO exercised the option for 50 more coaches in November bringing the total firm quantity to 100 coaches.
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PPTA | Hot Stocks07:10 EST Perpetua Resources unit, Sunshine Silver sign Memorandum of Understanding - Perpetua Resources announced its wholly owned subsidiary, Perpetua Resources Idaho, has entered into a Memorandum of Understanding to explore antimony processing opportunities with Sunshine Silver Mining & Refining Company, also based in Idaho. Testing under the MOU, which is non-binding and non-exclusive, will evaluate the technical potential for processing and refining antimony from the Stibnite Gold Project in Idaho at the Sunshine Mine Complex. The MOU will initiate third-party engineering to evaluate a flowsheet to suit different antimony ore types and follows engagement between the parties' technical and executive teams.
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NSPR | Hot Stocks07:09 EST InspireMD announces first patient enrolled in CGUARDIANS II study - InspireMD announced that the first patient has been enrolled in the company's CGUARDIANS II clinical trial evaluating its CGuard Prime Carotid Stent System in patients undergoing carotid artery stenting via the Transcarotid Artery Revascularization approach. The patient was enrolled by Dr. Patrick Muck at Good Samaritan Hospital, part of the TriHealth System in Cincinnati, Ohio. Dr. Muck serves as both the site principal investigator as well as a co-lead investigator of the CGUARDIANS II study.
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KURA | Hot Stocks07:08 EST Kura Oncology, Kyowa Kirin report data on KOMET-007 at ASH meeting - Kura Oncology and Kyowa Kirin provided encouraging clinical data from KOMET-007, a Phase 1 dose-escalation trial of ziftomenib, a highly selective oral investigational menin inhibitor, in combination with standards of care, including cytarabine/daunorubicin and venetoclax/azacitidine, in patients with NPM1-mutant and KMT2A-rearranged acute myeloid leukemia.Ziftomenib was generally well tolerated in combination at all dose levels evaluated across all cohorts in the Phase 1a dose-escalation portion of the study. No dose-limiting toxicities, evidence of ziftomenib-associated QTc prolongation, drug-drug interactions or additive myelosuppression were observed. In the 7+3 combination cohorts, on-target differentiation syndrome occurred in 2% of patients. Grade greater than or equal to3 treatment emergent adverse events occurring in greater than or equal to20% were febrile neutropenia platelet count decreased, anemia and neutropenia count decrease and white blood cell count decreased. In the ven/aza combination cohorts, on-target DS occurred in 8% of patients. Grade greater than or equal to3 treatment emergent adverse events occurring in greater than or equal to20% were platelet count decreased, anemia and febrile neutropenia. All instances of DS were manageable, and no patients discontinued participation due to DS. The Phase 1b expansion portion of KOMET-007 is now enrolling at 600 mg in all cohorts, including patients with 1L NPM1-m or KMT2A-r AML in combination with ven/aza.
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MCRB | Hot Stocks07:08 EST Seres Therapeutics granted Breakthrough Therapy designation for SER-155 - Seres Therapeutics announced that the US Food and Drug Administration has granted Breakthrough Therapy designation to SER-155, the Company's lead investigational program, for the reduction of bloodstream infections in adults undergoing allogeneic hematopoietic stem cell transplant for the treatment of hematological malignancies. In September 2024, Seres reported topline clinical data from Cohort 2 of its SER-155 Phase 1b placebo-controlled study in patients undergoing allo-HSCT, in which SER-155 was associated with a significant reduction in BSIs, a significant reduction in systemic antibiotic exposure, and lower incidence of febrile neutropenia, in each case as compared to placebo, through day 100 post-HSCT. Additionally, SER-155 was generally well tolerated, with no observed treatment-related serious adverse events. The receipt of Breakthrough Therapy designation for SER-155, the Company's second program to receive such designation, grants Seres access to FDA senior management and a commitment from FDA to work closely with the Company, facilitating an efficient drug development process. In December 2023, SER-155 received FDA Fast Track designation for reducing the risk of infection and GvHD in this patient population. The SER-155 Breakthrough Therapy designation was supported by positive data from our recent SER-155 Phase 1b clinical trial. Patients who received SER-155 experienced a significantly lower incidence of bacterial BSIs as compared with the placebo arm, representing a 77% relative risk reduction. In addition, while antibiotic starts were similar in each arm, patients administered SER-155 were treated with antibiotics for a significantly shorter duration compared to patients in the placebo arm. Further, the incidence of febrile neutropenia was reduced, and gastrointestinal pathogen domination was substantially lower compared to a historical control cohort, providing further evidence of SER-155's activity in modulating the microbiome to address critical post-transplant complications. SER-155 was well tolerated with no treatment related serious adverse events and engrafted as expected in the gastrointestinal tract. Bloodstream infections in allo-HSCT patients are frequent, serious, and potentially fatal. In clinical practice, HSCT patients who experience a BSI or febrile neutropenia are aggressively treated, often with broad-spectrum antibiotics, as infections are a leading cause of death in these patients in the first 100 days post-transplant. While prophylaxis of BSIs with antibiotics is common, antibiotics do not address the root cause as SER-155 is designed to do. Recent market research conducted by Seres characterized a significant commercial opportunity for SER-155 in allo-HSCT. Health Care Providers treating allo-HSCT patients indicated a high level of concern regarding BSIs. Additionally, HCPs stated that they would rapidly add a product providing similar efficacy to what we have observed in our SER-155 study to standard treatment protocols. The approximately 40,000 worldwide allo-HSCT patients are treated in a subset of large oncology centers across the globe, enabling rapid and efficient education of HCPs about SER-155, if approved. In addition to allo-HSCT, bloodstream infections are a common and serious complication in many other medically vulnerable populations, including autologous-HSCT patients, cancer patients with neutropenia, CAR-T recipients, individuals with chronic liver disease, solid organ transplant recipients, as well as patients in the intensive care unit and long-term acute care facilities. Seres intends to explore development of SER-155 and additional pipeline candidates for these populations. The targeted patient populations for SER-155 and Seres' other pipeline candidates could represent multiple blockbuster commercial opportunities. Seres is actively seeking a partner to provide financial resources and other capabilities to support the Company's goal to maximize the SER-155 program opportunity, while pursuing a capital-efficient development approach.
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AIRI | Hot Stocks07:07 EST Air Industries gets landing gear contract alued at over $11M from US Navy - Air Industries Group announced that it has secured a follow-on contract valued at over $11M for landing gear assemblies for the U.S. Navy E-2D Advanced Hawkeye aircraft. Air Industries has been a key supplier to the E-2 family of aircraft for decades, underscoring its long-standing role in supporting critical defense programs. Production is scheduled to commence in the second half of 2025, upon the arrival of raw materials, with delivery of finished product set to begin in the first quarter of 2026. Lou Melluzzo, Chief Executive Officer of Air Industries Group remarked: "The E-2D Advanced Hawkeye is a mission-critical platform for the US Navy, managing the airspace surrounding a Carrier Battle Group by identifying threats and coordinating aircraft movements. This contract grew in size during negotiations, reflecting the ongoing importance of the aircraft not only to the Navy but also to an expanding number of foreign military customers." Melluzzo continued: "The E-2D has been a cornerstone of Air Industries' operations for many years. This follow-on contract reaffirms our customer's trust in our capabilities, reliability, and performance. We are proud to continue supporting this vital program for both domestic and international defense needs."
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CETX | Hot Stocks07:06 EST Cemtrex awarded two projects totaling $6.7M through its AIS subsidiary - Cemtrex announced it has been awarded two project contracts totaling $6.7 million through its Advanced Industrial Services, AIS, subsidiary. The contracts are for upgrades at the Clearwater Road Wastewater Treatment Facility in Derry Township, Pennsylvania, managed through the Derry Township Municipal Authority, DTMA. The Clearwater Road Wastewater Treatment Facility, operational since 1977, has a treatment capacity of 5.02 million gallons per day. The AIS contracts encompass a general contract and HVAC contract for the addition of a new owner-supplied gasification-drying process and ancillary processes to support the new gasification-drying process. This process is integral to the facility's innovative biosolids management program, which converts residual solids from wastewater into an exceptional quality granular fertilizer. The project is expected to be completed by the calendar year end of 2025.
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AJG | Hot Stocks07:06 EST Apax Funds to sell minority stake in AssuredPartners to Arthur J. Gallagher & Co - Funds advised by Apax Partners, a global private equity advisory firm, announced that they have entered into a definitive agreement to sell their minority stake in AssuredPartners to Arthur J. Gallagher & Co. as part of a $13.45B all-cash transaction. The transaction, which is subject to regulatory approvals and customary closing conductions, is expected to close during the first quarter of 2025.
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COHR | Hot Stocks07:05 EST Coherent signs PMT with U.S. Department of Commerce under CHIPS act - On Friday, December 5, 2024, it was announced that Coherent has signed a non-binding preliminary memorandum of terms, PMT, with the U.S. Department of Commerce under the CHIPS and Science Act for a proposed investment of up to $33 million to support the modernization and expansion of a state-of-the-art manufacturing cleanroom in Coherent's existing 700,000 square-foot facility in Sherman, Texas. This project will expand the world's first 150 mm indium phosphide manufacturing line by adding advanced wafer fabrication equipment to produce InP devices at scale. "This proposed investment allows Coherent to accelerate our industry leadership in InP technology and manufacturing," said Dr. Giovanni Barbarossa, Chief Strategy Officer and President, Materials Segment, for Coherent.
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CRBP | Hot Stocks07:05 EST Corbus Pharmaceuticals announces dosing of first patient in FIH study of CRB-601 - Corbus Pharmaceuticals announced the dosing of the first patient in the Phase 1 portion of the clinical study of CRB-601 for the treatment of patients with advanced solid tumors. CRB-601 is a monoclonal antibody targeting latent TGFbeta activation-by blocking the integrin alphaVbeta8. Pre-clinical data has demonstrated that CRB-601 overcomes tumor immune exclusion and enhances the activity of immune checkpoint inhibitors in vivo.
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COGT | Hot Stocks07:04 EST Cogent Biosciences announces updates results from SUMMIT - Cogent Biosciences announced updated clinical results from the Open Label Extension OLE, portion of SUMMIT, a clinical trial evaluating bezuclastinib in patients with nonadvanced systemic mastocytosis. The OLE data are being presented at the 66th American Society of Hematology Annual Meeting & Exposition taking place December 7-10, 2024 in San Diego, CA. Updated clinical data presented today show: 56% mean improvement in Total Symptom Score at 24 weeks; 76% of patients demonstrated greater than50% reduction from baseline in MS2D2 Total Symptom Score with 88% of patients exceeding 30% reduction from baseline after 24 weeks; 49% mean improvement in MC-QoL Total Score at 24 weeks. Bezuclastinib showed rapid, deep, and sustained reductions in serum tryptase over the course of 24 weeks of treatment including: 89% of patients had greater than50% decrease in serum tryptase levels by four weeks of treatment; 95% of patients with baseline tryptase greater than or equal to20ng/mL achieved less than20ng/mL by week 24; 84% of patients with baseline serum tryptase greater than11.4ng/ml achieved less than11.4ng/mL by week 24.
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OBIO | Hot Stocks07:03 EST Orchestra BioMed announces AVIM therapy program presentations - Orchestra BioMed announced two presentations at the 2024 Innovation in Cardiology Intervention meeting in Tel Aviv, Israel. The presentations will provide insights on the ongoing BACKBEAT global pivotal study, as well as an overview of the novel mechanism of action of AVIM therapy and supporting clinical evidence for the treatment of uncontrolled hypertension in patients indicated for a dual-chamber pacemaker. The presentations will be part of a broad scientific program of important developments in cardiology, in a session focused on "Device-Based Hypertension Treatment." Insights into the BACKBEAT IDE Study, presented by Avi Fischer, M.D., Senior Vice President of Medical Affairs and Innovation, Orchestra Biomed: Dr. Fischer's presentation will focus on the unmet medical need in patients who are indicated for a pacemaker and also have uncontrolled hypertension despite the use of antihypertensive medication. This group of patients is the target population for the BACKBEAT global pivotal study, which reflects the increased risks associated with elevated systolic blood pressure in older comorbid patients. AVIM Mechanism of Action & Supporting Clinical Evidence, presented by Andrea Russo, M.D., FACC, FHRS, FAHA, Professor of Medicine, Cooper Medical School of Rowan University, Academic Chief, Division of Cardiology, Director, Electrophysiology and Arrhythmia Services, Cooper University Hospital, and Co-Principal Investigator of the BACKBEAT study: Dr. Russo's session will delve into the unique mechanism of action of the AVIM therapy and robust body of supporting clinical data. Dr. Russo will detail how AVIM therapy is designed to modulate the autonomic nervous system to immediately, substantially and persistently reduce blood pressure, as demonstrated in the MODERATO I and II pilot studies.
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ICE | Hot Stocks07:03 EST ICE expands global energy offering with launch of Japanese power futures - Intercontinental Exchange announced the latest addition to its global energy offering with the launch of Japanese Power Futures. ICE has launched four Japanese Power Financial Baseload and Peakload Futures covering the Tokyo and Kansai areas respectively, allowing market participants to manage exposure to the day-ahead auction price of the Japanese Electric Power Exchange or JEPX, for these areas. "By offering Japanese Power Futures on a single platform alongside our natural gas, coal, oil, clean energy attributes and carbon contracts, ICE is providing customers with a critical edge in navigating energy markets," said Gordon Bennett, Managing Director of Utility Markets at ICE. "Secondary fuels including electricity are produced through the conversion of primary energy sources like natural gas, coal and oil, and the price of electricity is derived from the interaction of these competing input fuels, all of which trade on ICE. Natural gas and coal make up the majority of Japan's electricity generation and through trading of these contracts on ICE, customers benefit from improved price dissemination." ICE's Japanese Power Financial Futures will be offered in monthly, quarterly and seasonal contracts as well as a Calendar and Fiscal Year contract. In addition, customers can trade spreads between Tokyo and Kansai to manage positions and price differences across these regions, as well as manage exposure to regional price risks.
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AJG | Hot Stocks07:02 EST GTCR confirms sale of AssuredPartners to Arthur J. Gallagher for $13.45B cash - GTCR, a private equity firm, announced that it has signed a definitive agreement to sell AssuredPartners, a independent insurance broker, to Arthur J. Gallagher & Co. for $13.45B in an all-cash transaction. This transaction is the largest sale of a U.S. insurance broker to a strategic acquiror in the history of the industry. Based in Orlando, Florida, AssuredPartners is the 11th largest insurance broker in the U.S. The company has a team of 10,900 professionals, serving clients from strategically located offices across North America and the U.K.
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LSCC | Hot Stocks07:02 EST Lattice Semiconductor announces $100M share repurchase program - Lattice Semiconductor announced that its board of directors authorized the company to repurchase up to an additional $100M of its outstanding common stock through the end of December 2025. The company has repurchased approximately 6M shares since the fourth quarter of 2020 thereby reducing dilution by 4.3%. The 2025 repurchase program is effective immediately.
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OLMA | Hot Stocks07:02 EST Olema Oncology announces FDA clearance of IND for OP-3136 - Olema Pharmaceuticals announced that the U.S. Food and Drug Administration, FDA, has cleared its Investigational New Drug, IND, application for OP-3136, a novel small molecule that potently and selectively inhibits KAT6, a validated epigenetic target that is dysregulated in breast and other cancers.
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NXHSF | Hot Stocks07:02 EST Next Hydrogen Solutions provides update on working capital debt financing - Next Hydrogen Solutions has received a Letter of Interest from Export Development Canada, for potentially up to $5M in working capital debt financing. EDC's potential financing commitment, structure and terms are contingent upon its satisfactory completion of technical, environmental, social and governance, financial and commercial due diligence. As such, the LOI should not be construed as a financing commitment.
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PLTR | Hot Stocks07:00 EST Palantir expands contract with U.S. Special Operations Command - Palantir Technologies announced an expansion of its contract with the U.S. Special Operations Command to deliver technology solutions in support of enterprise capabilities. The one-year delivery is valued at $36.8M and establishes Palantir as the lead software integrator for USSOCOM's Mission Command System while expanding the technology solutions supporting U.S. Special Operations Forces globally. This contract award leverages Palantir's multi-vendor development ecosystem and the Ontology Software Development Kit to expedite software deployment at the edge. The expanded partnership also enables pilot projects across the broader Command, inclusive of efforts dedicated to bringing Palantir's cutting-edge artificial intelligence capabilities to USSOCOM.
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ACM | Hot Stocks06:57 EST Aecom appointed by Thames Water to new GBP 400M services framework - Aecom announced its appointment by Thames Water to a new professional services framework in the UK. This new GBP 400M framework, FA1980, covers asset, capital and engineering professional services, and brings together a series of separate Thames Water frameworks under a single package. Thames Water is the utility responsible for the water supply and waste-water treatment across much of south-east England, including London and the Thames Valley. This new framework will aid the utility's efforts to improve water and wastewater services, upgrade infrastructure, prevent leakages and pollution, and enhance the environment, as it seeks to deliver its overall 2025-2030 business plan for the UK's Asset Management Plan Period 8 regulatory period.
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DVN | Hot Stocks06:56 EST Devon Energy CEO Rick Muncrief to retire, Clay Gaspar to succeed - Rick Muncrief has announced his retirement from the position of President and CEO and member of the Board of Directors of Devon Energy, effective March 1, 2025. The board of directors has appointed Clay Gaspar, currently Devon's COO, to succeed Muncrief as President and CEO and as a member of the board, effective March 1, 2025.
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MRK | Hot Stocks06:46 EST Merck says Phase 3 KEYLYNK-001 trial met primary endpoint - Merck announced that the Phase 3 KEYLYNK-001 trial evaluating KEYTRUDA plus chemotherapy followed by maintenance with LYNPARZA, with or without bevacizumab, as a first-line treatment for people with BRCA non-mutated advanced epithelial ovarian cancer met its primary endpoint of progression-free survival. At the final analysis conducted by an independent Data Monitoring Committee, the KEYTRUDA plus LYNPARZA regimen demonstrated a statistically significant and clinically meaningful improvement in PFS for these patients compared to chemotherapy alone. The study did not reach its secondary endpoint of overall survival. The role of KEYTRUDA in the intention-to-treat population remains uncertain at this time. The safety profiles of KEYTRUDA and LYNPARZA were consistent with those observed in previously reported studies for the individual therapies. These results will be presented at an upcoming medical meeting and discussed with regulatory authorities.
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HR | Hot Stocks06:37 EST Healthcare Realty Trust announces CFO, general counsel changes - Healthcare Realty Trust announced key leadership changes. Austen Helfrich, who has served as Interim CFO since October 1, has been formally appointed as the company's permanent Executive Vice President and CFO, effective immediately. As part of a planned transition, Andrew Loope, Senior Vice President, Corporate Counsel and Secretary, will be promoted to Executive Vice President, General Counsel, and Secretary, succeeding John Bryant, effective January 1, 2025. Bryant will continue to serve as Executive Vice President and General Counsel through December 31, 2024, and will then remain with the company in the role of Senior Vice President, Legal Affairs.
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PLX | Hot Stocks06:35 EST Protalix, Chiesi announce EMA validation of pegunigalsidase Variation Submission - Chiesi Global Rare Diseases and Protalix announced that the European Medicines Agency, or EMA, has validated the Variation Submission for pegunigalsidase alfa to label a less frequent dosing regimen at a dose of 2 mg/kg body weight administered every four weeks in adult patients with Fabry disease. The currently approved dose of pegunigalsidase alfa is 1 mg/kg administered every two weeks. The variation application is supported by a revised Population-PK model and new exposure-response analyses and by the clinical data on pegunigalsidase alfa 2 mg/kg E4W from the completed Phase 3 study PB-102-F50 and its ongoing extension study CLI-06657AA1-03, that have investigated the 2 mg/kg every four weeks dosing regimen in adult patients with Fabry disease who were previously treated with agalsidase-alfa or -beta administered every two weeks. Results of the completed study PB-102-F50 were recently published in the Journal of Inherited Metabolic Disease.
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MRM | Hot Stocks06:35 EST Medirom Mother Labs receives orders for over 25,000 Mother Bracelet units - Medirom Healthcare announces that its subsidiary, Medirom Mother Labs, has received orders for over 25,000 Mother Bracelet units, including orders from Japanese companies such as NFES Technologies.
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PSN | Hot Stocks06:33 EST Parsons wins $53M three-year contract by RCRC in Saudi Arabia - Parsons announced that the company has been awarded a $53M, three-year contract by the Royal Commission for Riyadh City in Saudi Arabia for program management office services on its Main and Ring Roads Program. Under the contract, Parsons will be the PMO for all new major road development programs in Riyadh, providing overall management and control of construction activities. The program includes approximately 500km (about 310 miles) of new and improved road corridor works. Key objectives of the program are to keep the city moving during construction and also to meet the requirements associated with the growth plans for the City of Riyadh, including tackling congestion and hosting global events such as the Expo 2030 and FIFA World Cup 2034. Upon completion, the new road network will reduce hours lost in traffic, leading to improved average trip durations and enhanced connectivity across the city.
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ENTA | Hot Stocks06:32 EST Enanta announces 'positive' results from Phase 2 study of zelicapavir - Enanta Pharmaceuticals announced positive topline results from the first-in-pediatrics Phase 2 study evaluating zelicapavir in hospitalized and non-hospitalized children aged 28 days to 36 months with respiratory syncytial virus. An antiviral effect was observed for the primary and secondary virology endpoints in the overall pooled efficacy population. The primary endpoint in Part 2 of the study, which focused on virology, showed a pronounced antiviral effect with a 1.4 log decline in viral load at Day 5 compared to placebo. Additionally, a rapid and robust virologic effect was observed in a prespecified subset of patients who were randomized within 3 days of symptom onset, with a 1.2 log decline in viral load at Day 5 compared to placebo. The study also showed that zelicapavir demonstrated a favorable safety profile and was well-tolerated in this pediatric population. Zelicapavir, which received Fast Track designation from the U.S. FDA, is a novel N-protein inhibitor in development as a once-daily oral treatment for RSV.
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VHC | Hot Stocks06:32 EST VirnetX names John Anthony Jamison CTO - VirnetX announced that it has hired John Anthony Jamison as new VirnetX CTO. Most recently, Jamison was the CTO at an AI/ML start-up, OmniTeq, where he worked to developed commercial services in the fields of bioinformatics, energy and power optimization, and climate related analytics.
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TT | Hot Stocks06:31 EST Trane announces new $5B share repurchase plan - The Board of Directors of Trane Technologies authorized a new share repurchase program of up to $5B, to commence upon the completion of the company's 2022 $3B program. As of October 31, the 2022 program had approximately $1.5B remaining.
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DOW | Hot Stocks06:23 EST Macquarie Asset Management announces partnership with Dow - Macquarie Asset Management announced that a fund managed by Macquarie Asset Management has entered into a definitive agreement to acquire a 40% equity stake in select U.S. Gulf Coast infrastructure assets of Dow Inc. This new partnership, Diamond Infrastructure Solutions, will be a specialist infrastructure provider to Dow and other industrial customers at its five locations in Texas and Louisiana, offering comprehensive services to its tenants with a focus on world class efficiency, reliability and safety. As a dedicated infrastructure company, Diamond will be a new business model with greater strategic focus on operational efficiencies and new customer acquisition. Diamond is comprised of certain non-product producing assets (power and steam production, pipelines, environmental operations and general site infrastructure) located at five of Dow's manufacturing sites in the U.S. Gulf Coast: Freeport, Texas City, and Seadrift in Texas, as well as Plaquemine and St. Charles in Louisiana. Pipeline and storage assets span across the USGC with connections to major natural gas, NGL and olefin hubs. Dow expects to receive initial cash proceeds of approximately $2.4B based on the sale of its 40% minority equity stake with the potential to generate cash proceeds up to approximately $3B for a 49% minority equity stake. Macquarie Asset Management will have the option to increase its equity share to 49% within six months of closing. Dow and Macquarie Asset Management expect to close the transaction in the first half of 2025, subject to customary regulatory approvals and other closing conditions.
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IDYA | Hot Stocks06:17 EST Ideaya Biosciences nominates IDE892 as development candidate - Ideaya Biosciences announced development candidate nomination of IDE892, a MTA-cooperative PMRT5 inhibitor.
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DOW | Hot Stocks06:14 EST Dow Inc. to sell 40% stake in select Gulf Coast infrastructure assets for $2.4B - Dow announced that it has entered into a definitive agreement to sell a 40% equity stake in select U.S. Gulf Coast infrastructure assets to a fund managed by Macquarie Asset Management. This new partnership, Diamond Infrastructure Solutions, will be a specialist infrastructure provider to Dow and other industrial customers at its five locations in Texas and Louisiana, offering comprehensive services to its tenants with a focus on world class efficiency, reliability and safety. As a dedicated infrastructure company, Diamond will be a new business model with greater strategic focus on operational efficiencies and new customer acquisition. Profitable growth for Diamond will benefit both Dow and Macquarie Asset Management's future bottom-line results. Dow expects to receive initial cash proceeds of approximately $2.4B based on the sale of its 40% minority equity stake with the potential to generate cash proceeds up to approximately $3B for a 49% minority equity stake. Macquarie Asset Management will have the option to increase its equity share to 49% within six months of closing. Dow and Macquarie Asset Management expect to close the transaction in the first half of 2025, subject to customary regulatory approvals and other closing conditions.
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AJG | Hot Stocks06:10 EST Arthur J. Gallagher to acquire AssuredPartners, sees accretion - Arthur J. Gallagher announced it has signed a definitive agreement to acquire AssuredPartners. The transaction is subject to customary regulatory approvals and is expected to close during the first quarter of 2025. Founded in 2011 by GTCR, a leading private equity firm, in partnership with Jim Henderson, AssuredPartners is a U.S. insurance broker with client capabilities across commercial property/casualty, specialty, employee benefits and personal lines. AssuredPartners' 10,900 colleagues serve a wide range of customers including commercial, public entity and individuals, through approximately 400 offices located across the U.S., the U.K. and Ireland. Pro forma revenues and EBITDAC for the trailing 12 months ended September 30 were approximately $2.9B and $938M, respectively. Under the agreement, Gallagher will acquire the stock of AssuredPartners' parent company from GTCR and funds advised by Apax Partners for gross consideration of $13.45B, representing a pro forma EBITDAC multiple of 14.3x. After giving effect to an estimated $1B deferred tax asset, net consideration is approximately $12.45B. The net consideration EBITDAC multiple is 11.3x after giving effect to the deferred tax asset and estimated synergies. Gallagher expects to finance the transaction using a combination of long-term debt, short-term borrowings, free cash and common equity. The final funding does not inhibit Gallagher from continuing its ongoing tuck-in M&A strategy and contemplates Gallagher maintaining its current solid investment grade debt rating. Gallagher also expects to recognize synergies of approximately $160M and integration costs of approximately $500M, including $200M of non-cash retention awards, over the next three years. After giving effect to these assumptions, the pro forma results discussed above and the impact of expected synergies, the acquired operations would have been approximately 10% to 12% accretive to Gallagher's trailing twelve month adjusted GAAP EPS as of September 30.
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JFBR AMZN | Hot Stocks06:06 EST Jeffs' Brands wins global exclusive for drone system distribution on Amazon - Jeffs' Brands (JFBR), a data-driven e-commerce company operating on the Amazon (AMZN) Marketplace, announced that it has entered into an agreement granting it the exclusive worldwide right to distribute certain advanced drone safety systems developed by a leading drone company for a period of two years and subject to certain conditions. The innovative drone safety systems will be sold by the company exclusively through the Amazon's global marketplace. The entry into the agreement, previously announced, highlights Jeffs' Brands' commitment to leveraging its expertise in e-commerce to bring advanced technological solutions to consumers. With a focus on high standards of reliability and performance, these drone safety systems are set to address key challenges in the industry.
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YOU | Hot Stocks06:04 EST Clear Secure opens new location at Oculus, Westfield World Trade Center - Clear Secure continues to expand locations outside the airport environment to enroll and renew consumers in the Trusted Traveler program by opening a new location at the Shops at the Oculus inside the Westfield World Trade Center. The Oculus at Westfield World Trade Center is a transportation hub and shopping destination in Lower Manhattan, New York City. This marks Clear's first non-airport location in Manhattan, for TSA PreCheck enrollment and renewal services, complementing its 52 airport-based enrollment and renewal locations across the U.S. TSA PreCheck enrollment and renewal services through CLEAR are also available at select Staples stores nationwide. The launch of this new enrollment location, located on the main floor inside the mall, represents the ongoing expansion of Clear's national TSA PreCheck enrollment footprint. Throughout 2024 and 2025, Clear will continue delivering convenience to consumers by launching additional locations and extended hours of operation for enrollment and renewals.
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CTRE | Hot Stocks06:02 EST CareTrust REIT acquires Midwest skilled nursing portfolio for $97M - CareTrust REIT announced that it has acquired a 46-facility, 3,820-bed/unit skilled nursing and seniors housing portfolio located in the Midwest for a total investment amount of approximately $97M. Seven of the 46 facilities acquired are skilled nursing and assisted living campuses and an additional seven are assisted living facilities. In connection with the acquisition, the company entered into a triple-net master lease with a large skilled nursing investor and operator who will sublease the portfolio to several licensed subtenant operators. The new master lease has an initial term of 15 years with two, 5-year extension options and provides for a year 1 contractual lease yield of 11%. The master lease provides for some deferral of base rent in lease years 1 and 2 resulting in a cash rent yield of 9.0% in year 1 and 10.5% in year 2. Annual CPI-based rent escalators begin in year 4 and continue each remaining year of the lease term. The acquisition was completed in coordination with the bankruptcy and sale of all assets of the debtor/seller. The master tenant has been granted purchase options for each sub-portfolio, with most purchase options opening in lease years 4 and 5. With the exercise of each purchase option, additional rent payments to CareTrust may be triggered up to an aggregate, annual 12.5% yield on CareTrust's investment amount.
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ANGO | Hot Stocks06:01 EST AngioDynamics receives FDA 510(k) clearance for NanoKnife System - AngioDynamics announced it received U.S. FDA 510(k) clearance for the NanoKnife System for prostate tissue ablation.
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IOT | Hot Stocks05:44 EST Samsara extends long-term collaboration with Fraikin Group - Fraikin Group is extending its long-standing collaboration with Samsara as part of its increased investment in digitalizing and decarbonizing its fleet. Fraikin is integrating Samsara's AI technologies across 60,000 vehicles throughout its European operations.
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ACLX GILD | Hot Stocks05:41 EST Arcellx, Gilead announce new data from iMMagine-1 study of anitocabtagene autole - Arcellx (ACLX) announced new data from its Phase 2 pivotal iMMagine-1 study of anitocabtagene autoleucel, in patients with relapsed or refractory multiple myeloma, or RRMM. These data will be presented during an oral presentation at the 66th American Society of Hematology, or ASH, annual meeting and exposition on Monday, December 9 at 5:30 p.m. PT. Anito-cel is partnered with Kite, a Gilead (GILD) company. Additional presentations during ASH are also noted below. The Phase 2 iMMagine-1 data are from an October 31 data cutoff date, with a median follow-up of 9.5 months for the efficacy evaluable population. At the time of the data cut, 86 patients were evaluable for efficacy based on a follow-up of at least two months after treatment with anito-cel, and 98 patients were evaluable for safety based on a follow-up of at least one month after treatment with anito-cel. All patients received a single infusion of anito-cel. In the safety evaluable population, 85 of 98 patients were triple refractory, and 41 of 98 patients were penta refractory. Patients received a median of four prior lines of therapy, with 45 of 98 patients having received three prior lines. Overall response rate, or ORR, was 97% with a complete response/stringent complete response, or CR/sCR, rate of 62% and a very good partial response or higher rate of 81%, per International Myeloma Working Group criteria as investigator-assessed. Of those evaluable for minimal residual disease testing, 93.1% achieved MRD negativity at a minimum of 10-5 sensitivity. Median progression-free survival and overall survival were not reached; six-month PFS and OS rates were 93.3% and 96.5%, respectively, and 12-month PFS and OS rates were 78.5% and 96.5%, respectively. No delayed or non-ICANS neurotoxicities, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barre syndrome, have been observed to date in more than 150 patients dosed with anito-cel. Of the safety evaluable population, 86% had Grade 1 cytokine release syndrome, or CRS, including 17% of patients with no CRS. Among patients experiencing CRS, the median onset was four days. Eight percent of patients were treated as outpatient. Ninety-one percent of patients had no ICANS. Any Grade ICANS was observed in 9 patients, with all cases resolved without sequelae. Three deaths occurred due to treatment-emergent adverse events, or TEAEs. No additional treatment or therapy-related deaths or Grade 3 CRS or ICANs events have occurred to date. Cytopenias were the most common Grade 3 TEAEs; 53 patients had Grade 3 neutropenia, 20 had Grade 3 thrombocytopenia, and 22 had Grade 3 anemia. Preliminary results from the Phase 2 iMMagine-1 study demonstrate deep and durable responses with a predictable and manageable safety profile in a high-risk fourth-line or higher RRMM population, including triple- and penta-class refractory disease. Notably, no delayed or non-ICANS neurotoxicities, including no Parkinsonism, no cranial nerve palsies, and no Guillain-Barre syndrome, have been observed with anito-cel to date.
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IPHA | Hot Stocks05:33 EST Innate Pharma announces new data from TELLOMAK study - Innate Pharma announced new data highlighting the quality-of-life improvements observed in patients with cutaneous T-cell lymphoma, or CTCL, treated with lacutamab in the TELLOMAK Phase 2 clinical study. These data were presented at the 66th American Society of Hematology, or ASH, annual meeting in San Diego, California. The TELLOMAK study addresses an unmet need for patients with advanced-stage CTCL, particularly Sezary syndrome and mycosis fungoides, who often experience debilitating symptoms such as severe itching and recurrent skin infections that profoundly impact their physical and social well-being. Patients with relapsed or refractory CTCL face limited treatment options and often report lower health-related quality of life, particularly those in advanced stages. TELLOMAK's findings reveal signs that lacutamab may help alleviate some of the most distressing symptoms of this disease early on treatment. The TELLOMAK trial enrolled 163 patients with advanced CTCL, including 56 with SS and 107 with MF. The study's quality of life measures included the Visual Analogue Scale, or VAS, for itch intensity and the Skindex-29 score, a validated tool for assessing the impact of skin conditions on patient quality of life.
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AZN DSNKY | Hot Stocks05:29 EST AstraZeneca, Daiichi Sankyo announce BTD for datopotamab deruxtecan - Datopotamab deruxtecan has been granted Breakthrough Therapy Designation, or BTD, in the U.S. for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer with disease progression on or after treatment with an EGFR tyrosine kinase inhibitor and platinum-based chemotherapy. Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo (DSNKY) and AstraZeneca (AZN).
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PRTC | Hot Stocks05:26 EST PureTech Health presents data from dose escalation phase of LYT-200 trial - PureTech Health presented data from the dose escalation phase of its ongoing Phase 1b trial evaluating LYT-200, an anti-galectin-9 monoclonal antibody, in patients with relapsed or refractory acute myeloid leukemia, or AML, and myelodysplastic syndromes, or MDS, at the 2024 American Society of Hematology, or ASH, annual meeting in San Diego, California. LYT-200 is currently being evaluated both as a monotherapy and in combination with the venetoclax and hypomethylating agents, or HMA, for patients whose disease is relapsed/refractory to at least one line of prior treatment. It targets galectin-9, a glycan-binding protein that is significantly upregulated in AML and MDS and plays a role in disease development, progression, immune interference and drug resistance. Initial results show a favorable safety profile across both arms and all dose levels with no dose limiting toxicities, as well as evidence of response, hematological improvement and sustained disease management. In the monotherapy arm, patients received LYT-200 at five dose levels. Across all dose levels, LYT-200 induced clinical benefit and responses in heavily pre-treated, relapsed/refractory AML/MDS patients, even in those with complex cytogenetics and mutations such as KRAS, NRAS, BRAF as well as patients previously fully refractory to standard of care. Out of 22 evaluable patients who received monotherapy, 59% achieved stable disease or better with two partial responses. The mean duration on treatment is greater than two months, which exceeds the standard overall survival of approximately 1.7 months in venetoclax/HMA-refractory patients. When administered in combination with venetoclax/HMA, results demonstrate that LYT-200 may enhance the efficacy of standard-of-care therapies, even in relapsed or refractory patients. In the combination arm, patients received LYT-200 across three dose levels with venetoclax/HMA. Out of 15 evaluable patients who received combination therapy, 80% achieved stable disease or better, with two experiencing complete responses and one patient achieving a morphologic leukemia free state. The combination regimen has also demonstrated clinical benefit in patients with KRAS/NRAS mutations and the mean duration on treatment up until the point of data cut-off is greater than two months. Pharmacodynamic assessments of treated patients, using gene and protein analyses of patient cells, validate the LYT-200 dual mode of action, and reveal AML cellular pathways as well as specific immune cell types which may be most critical for response. Based on these data, LYT-200 will continue development in relapsed/refractory AML/MDS towards a Phase 2 clinical trial. PureTech previously announced that it intends to advance LYT-200 via its Founded Entity, Gallop Oncology.
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MXCT | Hot Stocks05:22 EST MaxCyte raises FY24 core business revenue view to 6%-8% from flat to up 5% - The company said, "MaxCyte increases 2024 revenue guidance for core business revenue and affirms SPL Program-related revenue guidance. MaxCyte now expects full year 2024 core business revenue of 6% to 8% growth compared to 2023. SPL Program-related revenue is expected to be approximately $6 million. The outlook for the full year does not include SPL Program-related revenue from Vertex/CRISPR's CASGEVY. MaxCyte continues to expect to end 2024 with approximately $185 million in cash, cash equivalents and investments."
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MXCT | Hot Stocks05:20 EST MaxCyte to reduce workforce by 15% following internal review - MaxCyte announced the completion of an internal operational review, initiated earlier this year following the appointment of Maher Masoud as president and CEO. This "bottom-up" review focused on optimizing new product development, manufacturing, commercial execution, and capital allocation to enhance efficiency and align resources with strategic priorities. As part of an effort to streamline operations, the company made adjustments to its workforce which affected 21 positions, reflecting approximately 15% of its personnel globally, including both directly employed individuals and those engaged through third-party employer-of-record arrangements. Anticipated cost savings in 2025 as a result of this action are expected to be about $5.8M. Following this adjustment, combined with other personnel decisions made throughout the year, MaxCyte expects to end the year with 116 employees, compared with 143 employees at the end of 2023.
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ORANY | Hot Stocks05:07 EST Orange and La Poste team to extend use of Paris Olympic, Paralympic equipment - Orange and La Poste announced the first initiative to extend the lifespan of network equipment used during the Paris 2024 Olympic and Paralympic Games. Several thousand Wi-Fi terminals and other advanced telecom equipment used at the Olympic and Paralympic sites will be reused by La Poste at locations in Paris and other local communities. For instance, the Maison de l'Innovation in Nantes, set to house over 800 IT professionals from La Poste, will benefit from this next-generation equipment. These devices have been used for only a short period of time and have been thoroughly verified to ensure performance, availability, and durability. These modern devices will improve the network's operational efficiency for La Poste employees, providing better connectivity and a high level of service both indoors and outdoors.
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APO SAN | Hot Stocks05:04 EST Apollo. Banco Santander partner on $370M infrastructure portfolio financing - Apollo (APO) and Santander (SAN) announced that Apollo-managed funds and affiliates have agreed to invest in an approximately $370M portfolio of infrastructure credit. The transaction was led by Apterra, an affiliate of Apollo founded in 2023 that specializes in financing solutions for infrastructure projects.
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