Stockwinners Market Radar for October 16, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

ADTN

Hot Stocks

20:48 EDT Adtran CEO says strong USD had negative impact on international revenue - Adtran CEO Tom Stanton states: "While revenue and GAAP operating margin continue to be challenging as customers remain focused on reducing inventory levels and managing capital expenses, our Q3 non-GAAP operating margin was at the upper end of our guidance, helped by the planned reduction in our operating expenses and improved non-GAAP gross margins. Additionally, the strengthened U.S. dollar had a negative impact on revenue generated outside of the U.S. Moving forward through the end of this year, we will continue to focus on aligning our operating model to reflect the current environment. Finally, during the third quarter, ADTRAN continued to add new customers in both Europe and the U.S., further strengthening our market share position and, with our broad portfolio and geographic reach, uniquely positioning us to benefit from what we anticipate to be a return to normalized spending."
NRIX

Hot Stocks

20:02 EDT Cathie Wood's ARK Investment bought 140K shares of Nurix Therapeutics today
ACHR

Hot Stocks

20:02 EDT Cathie Wood's ARK Investment bought 188K shares of Archer Aviation today
HOOD

Hot Stocks

19:04 EDT Robinhood exec sells $849K in common stock - In a regulatory filing, Robinhood disclosed that its Chief Creative Officer Baiju Bhatt sold 90K shares of common stock on October 12th in a total transaction size of $849K.
MRK

Hot Stocks

19:03 EDT FDA approves Merck's Keytruda for treatment of resectable NSCLC - Merck announced that the U.S. Food and Drug Administration has approved KEYTRUDA, Merck's anti-PD-1 therapy, for the treatment of patients with resectable non-small cell lung cancer in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. With this approval, KEYTRUDA has six indications in NSCLC, across both metastatic and earlier stages of NSCLC. The approval was based on data from the Phase 3 KEYNOTE-671 trial evaluating KEYTRUDA in combination with chemotherapy as neoadjuvant treatment followed by surgery and continued adjuvant treatment with KEYTRUDA as a single agent, for patients with resectable stage II, IIIA or IIIB NSCLC per the American Joint Committee on Cancer eighth edition. In the study, the KEYTRUDA regimen demonstrated statistically significant improvements in event-free survival and overall survival, the study's dual primary endpoints, versus neoadjuvant placebo plus chemotherapy followed by adjuvant placebo alone. The EFS results, which were from the first interim analysis, were published in June 2023 in the New England Journal of Medicine. The detailed OS results will be presented at the European Society for Medical Oncology Congress 2023 in Madrid, Spain, on October 20, 2023.
GORO

Hot Stocks

18:36 EDT Gold Resource reports preliminary Q3 sold ounces - Gold Resource reported preliminary Q3 results that includes the sale of 3,982 ounces of gold and 208,905 ounces of silver resulting in total gold equivalent ounces of 6,532. Additionally, the company sold 2,571 tons of zinc, 245 tons of copper, and 947 tons of lead. Allen Palmiere, CEO said "The quarter has presented some challenges beyond our control including decreased metal prices and the strengthening of the Mexican peso against the US Dollar. Production during the quarter was on par with the last four quarters, however average grade decreased as was expected in our 2023 mine plan. We continue to identify and implement opportunities for cost reductions and operational efficiencies. We continue to be encouraged by the positive results of our 2023 drill program at the Don David Gold Mine that demonstrate the potential to increase our resources and reserves that could lead to future increased production."
ASAN

Hot Stocks

18:10 EDT Asana CEO buys $6.2M in common stock - In a regulatory filing, Asana disclosed that its CEO Dustin Moskovitz bought 348K shares of common stock on October 12th in a total transaction size of $6.2M.
VYX NATL

Hot Stocks

17:37 EDT NCR Voyix completes spin-off from NCR Atleos - NCR Voyix (VYX) announced that it has completed the separation of its ATM-focused business, including its self-service banking, payments & network, and telecommunications and technology businesses. The spin-off was effected through a pro rata distribution of all outstanding shares of NCR Atleos Corporation (NATL) common stock to holders of Voyix's common stock and is intended to qualify as a tax-free distribution for federal income tax purposes. Atleos common stock will begin trading "regular way" on the New York Stock Exchange under the ticker symbol "NATL" and Voyix common stock will trade "regular way" on the New York Stock Exchange under the ticker symbol "VYX" at market open on October 17, 2023. As a result of the spin-off, Voyix's focus will be on digital commerce, continuing to operate its retail, restaurant and digital banking businesses.
RIO

Hot Stocks

17:35 EDT Rio Tinto reports Q3 Pilbara iron ore production 83.5 Mt, down 1% from last year - Reports Q3 Bauxite production 13.9 Mt, up 2% y/y Reports Q3 Aluminum production 828 kt, up 9% y/y. Reports Q3 Mined Copper 169 kt, up 5% y/y. Rio Tinto Chief Executive Jakob Stausholm said: ""We delivered another quarter of progress and maintained momentum at our Pilbara iron ore operations. We continued to make good headway ramping up our Oyu Tolgoi high-grade underground copper mine, our Kitimat aluminium smelter returned to full production, and we safely restarted the smelter and refinery at Kennecott after completing the largest rebuild in its history. We have more to do as we work towards sustainable performance improvements across our business. We took real steps to build our portfolio of materials needed for the future, signing agreements that will see us take a leading position in recycled aluminium in North America and agreeing to enter a joint venture with Codelco to explore for copper in Chile. We also completed further infrastructure agreements with our partners for the world class Simandou iron ore project. We are making strong progress towards building the Rio Tinto of the future, striking a balance between disciplined performance in evolving market conditions, investing to generate valuable long-term growth and delivering attractive shareholder returns." "
NATL NCR

Hot Stocks

17:34 EDT NCR Atleos completes spin-off from NCR Voyix - NCR Atleos (NATL) announced the completion of its separation from NCR Corporation (NCR) which is now known as NCR Voyix, and Atleos' launch as an independent public company. The spin-off was effected through a pro rata distribution of all outstanding shares of Atleos common stock to holders of Voyix's common stock and is intended to qualify as a tax-free distribution for federal income tax purposes. Atleos common stock will begin trading "regular way" on the New York Stock Exchange under the ticker symbol "NATL" at market open on October 17, 2023. As a result of the spin-off, Atleos' focus will be on banking services and ATMs, including Self-Service Banking, Payments & Network and Telecommunications and Technology businesses.
FATP

Hot Stocks

17:31 EDT Fat Projects Acquisition extends period to consumate business combination - Fat Projects Acquisition deposited into its trust account an aggregate of $24,279.65 representing 5c per share for each of its 485,593 outstanding publicly held Class A ordinary shares. The deposit enables the company to extend the period of time it has to consummate its initial business combination by one month from October 15 to November 15. The extension is the seventh of up to nine one-month extensions permitted under the company's governing documents. The funds came from a non-interest-bearing loan from an affiliate of the company's Sponsor and co-CEOs. The extension provides the company with additional time to complete its initial business combination with Avanseus Holdings, a Singapore private company limited by shares. FATP and Avanseus entered into a Business Combination Agreement August 26, 2022 that provides for a series of transactions, pursuant to which, among other things, Avanseus' shareholders will exchange all of their outstanding Avanseus shares in consideration for newly issued FATP Class A Ordinary Shares, with Avanseus thereby becoming a wholly owned subsidiary of FATP. In connection with the Business Combination, FATP will change its corporate name to "Avanseus Holdings Corporation".
MRO

Hot Stocks

17:03 EDT Marathon Oil signs five-year LNG sales agreement in Equatorial Guinea - Marathon Oil has entered into a five-year firm LNG sales agreement with Glencore Energy UK, a subsidiary of Glencore, for a portion of its equity natural gas produced from the Alba Field in Equatorial Guinea, effective Jan. 1, 2024. Separately, due to the expected arbitrage between LNG and methanol pricing, Marathon Oil expects to optimize its E.G. integrated gas operations in 2024 by redirecting a portion of Alba Unit natural gas from the local methanol facility to the LNG facility.
SFBS

Hot Stocks

16:56 EDT ServisFirst falls 13% to $45.78 after Q3 results
ALDX

Hot Stocks

16:49 EDT Aldeyra says FDA noted substantive review issues related to NDA for reproxalap - In a regulatory filing, earlier this morning, the company stated: "On October 16, 2023, Aldeyra Therapeutics announced that it received minutes from a late-cycle review meeting with the U.S. Food and Drug Administration relating to the new drug application for reproxalap for the treatment of the signs and symptoms of dry eye disease. The Minutes identified substantive review issues in connection with the NDA for reproxalap. The FDA stated that "[i]t does not appear that you have data to support the clinical relevance of the ocular signs to support your dry eye indication." In subsequent communications between Aldeyra and the FDA, Aldeyra has submitted responses to the FDA that Aldeyra believes to be sufficient to mitigate the identified issues, but the FDA has not directly opined on the sufficiency of the information submitted, has no legal obligation to review the information submitted by Aldeyra, and has indicated that Aldeyra needs to conduct an additional clinical trial to satisfy efficacy requirements. As such, based on the time remaining in the NDA review cycle, the FDA may not be in the position to approve the NDA for reproxalap on or about the Prescription Drug User Fee Act target action date of November 23, 2023 or afterwards, and it may issue a Complete Response Letter and require that Aldeyra conduct additional clinical trials and submit the results of those clinical trials before the application will be reconsidered."
LTRX

Hot Stocks

16:45 EDT Lantronix announces passing of chairman Paul Folino - Lantronix announced that Paul Folino, chairman of the Lantronix board of directors, passed away on Saturday, October 14. Folino was not standing for re-election to the board of directors at Lantronix's 2023 annual meeting of stockholders, being held on November 7. Jason Cohenour, a current member of the board of Lantronix, has been named interim chairman of the board.
CRNC

Hot Stocks

16:42 EDT Cerence CEO Ortmanns sells 54,212 common shares - In a regulatory filing, Cerence CEO Stefan Ortmanns disclosed the sale of 54,212 common shares of the company on October 13 at a price of $17.97 per share.
GMDA

Hot Stocks

16:41 EDT Gamida Cell reports preliminary data from phase 1 study of GDA-201 - Gamida Cell announced new early data in 10 patients with CD20 positive non-Hodgkin lymphoma enrolled in the first three cohorts in an ongoing multicenter Phase 1 study of natural killer cell therapy candidate GDA-201. The study is designed to evaluate safety and determine the maximum tolerated dose. Enrolled patients were heavily pretreated with a median of six prior lines of therapy, including CAR-T cell therapy (six patients) and hematopoietic stem cell transplant. Preliminary results showed marked shrinkage of target lesions in five patients; efficacy evaluation showed two patients with complete response, two with partial response, and one with stable disease. No dose-limiting toxicities were reported in the 10 patients treated with doses up to 1x108 cells/kg GDA-201 in combination with rituximab.
NTCT

Hot Stocks

16:38 EDT NetScout falls 17% to $22.93 after cutting FY24 guidance
SOVO CPB

Hot Stocks

16:34 EDT Sovos Brands stockholders approve acquisition by Campbell for $23 per share - Sovos Brands (SOVO) announced that its stockholders, at a Special Meeting of Stockholders held earlier approved the previously announced acquisition of the Company by Campbell Soup Company (CPB) 92.38% of the Company's outstanding shares were voted, with 99.99% of the votes cast in favor of the proposal. Under the terms of the merger agreement, Campbell will acquire all the outstanding shares of Sovos Brands, Inc. for $23. per share in cash. The Company will be filing the final voting results on a Form 8-K with the Securities and Exchange Commission. The closing of the transaction remains subject to various closing conditions, including regulatory approval. The Company expects that the transaction will close during the fourth quarter of 2023, assuming that the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 relating to the merger has expired or been terminated in this period.
SRE

Hot Stocks

16:30 EDT Sempra Energy president Kevin Sagara to resign - According to a regulatory filing, on October 12, 2023, Kevin C. Sagara provided notice that he will resign as the Executive Vice President and Group President of Sempra effective December 1, 2023. Additionally, on October 12, 2023, Kevin C. Sagara provided notice that he will resign as the Chairman of the Board and as a director of Southern California Gas Company, a subsidiary of Sempra, effective December 1, 2023.
RAD

Hot Stocks

16:18 EDT NYSE to commence delisting proceedings against Rite Aid - The New York Stock Exchange LLC announced that the staff of NYSE Regulation has determined to commence proceedings to delist the common stock of Rite Aid Corporation - ticker symbol RAD - from the NYSE. Trading in the company's common stock will be suspended immediately. NYSE Regulation reached its decision that the Company's common stock is no longer suitable for listing pursuant to Listed Company Manual Section 802.01D after the Company's October 16, 2023 disclosure that the Company has filed voluntary petitions to commence proceedings under chapter 11 of title 11 of the United States Code in the United States Bankruptcy Court for the District of New Jersey. In reaching its delisting determination, NYSE Regulation noted that the restructuring term sheet contemplates that the Company's equity holders are expected to receive no recovery.
CNO

Hot Stocks

16:18 EDT CNO Financial appoints Michellen Wildin as Chief Accounting Officer - CNO Financial has named Michellen Wildin Senior VP of Accounting effective October 23, and Chief Accounting Officer effective January 1, 2024. Wildin most recently served as senior vice president, financial planning and analysis at F&G Annuities & Life, where she was a member of the company's Executive Committee. Previously, she held executive leadership positions at New York Life, including serving as vice president, corporate budget and expense analytics and CFO of NYL Direct. She has also held senior-level accounting, finance, strategy and operations roles at Aviva and ING. Wildin will succeed John Kline as CAO, who is retiring from CNO on December 31, 2023, after a 30-year career with the company. Kline will remain CAO through the end of the year to ensure a seamless transition.
YMAB

Hot Stocks

16:12 EDT Y-mAbs announces publication of naxitamab-based chemoimmunotherapy data - Y-mAbs Therapeutics announced the publication of naxitamab-based chemoimmunotherapy in patients with chemoresistant high-risk neuroblastoma, or HR-NB, in the journal Cancers. Approximately 50% of HR-NB patients are unable to achieve a complete response, or CR, or very good partial response, or VGPR, at the end of induction, or EOI, and have poor long term outcomes. This analysis investigated the combination of humanized anti-GD2 mAb naxitamab, irinotecan, temozolomide and sargramostim-HITS-in patients with HR-NB who did not achieve a CR/VGPR to induction. Cycles were administered 3-5 weeks apart and the primary endpoint was overall response rate. Patients who received HITS immediately after induction had higher response rates and superior estimated three-year overall survival compared with those who received the same combination regimen later in the course of treatment. Safety results showed that the findings were consistent with previous studies for naxitamab and HITS. The HITS combination did not appear to exacerbate the rate nor the intensity of infusion-related toxicities of naxitamab when observed as a stand-alone treatment. For more information on this critical development in the treatment paradigm for patients with high-risk neuroblastoma, the online publication is available here. Researchers at Memorial Sloan Kettering Cancer Center developed Danyelza, which is exclusively licensed by MSK to Y-mAbs. MSK has institutional financial interests in the compound and Y-mAbs.
PLRX

Hot Stocks

16:11 EDT Pliant Therapeutics appoints Mishima Gerhart as Chief Regulatory Officer - Pliant Therapeutics announced the appointment of Ms. S. Mishima Gerhart as Chief Regulatory Officer. Ms. Gerhart will lead the Company's regulatory and quality strategies and activities.
SGML

Hot Stocks

16:08 EDT Sigma Lithium completing third green lithium shipment by October 20 - Sigma Lithium readied the third shipment of 20,000 tons of Triple Zero Green Lithium at Vitoria Port. The company shall complete delivering the material by truck to Port of Vitoria by October 20th, when it will be ready to load the third shipment. The company's Triple Zero Green Lithium is produced at its Greentech lithium plant at its Grota do Cirilo Project in Brazil, the first lithium project in the world without a tailings dam.
CPSI

Hot Stocks

16:07 EDT Computer Programs closes acquisition of Viewgol for $36M - CPSI "announced it has closed its acquisition of Viewgol, a provider of ambulatory revenue cycle management, analytics and complementary outsourcing services. Exclusive of synergies resulting from the transaction and incremental amortization expense related to the acquired intangible assets, Viewgol is expected to generate GAAP net income of approximately $1.5 million and Adjusted EBITDA of approximately $4.5 million in 2024. The exact timing of synergy realization is difficult to predict, and the incremental amortization expense related to the acquired intangible assets is dependent upon completion of a business valuation for purposes of allocating the purchase price; as such, the Company is unable to estimate the full impact of the transaction on CPSI's expected 2024 GAAP results at this time. CPSI intends to provide an update to full-year 2023 guidance for the combined company on its third quarter earnings call. Under the terms of the agreement, the purchase price is $36 million in cash, with an additional earnout of up to approximately $31.5 million based on a combination of achieving certain profitability metrics for 2024 and the creation of additional offshore resources supporting TruBridge. McDermott, Will, & Emery, Grant Thornton, and Willis Towers Watson acted as advisors for CPSI. Brentwood Capital Advisors, Morris, Manning, & Martin, and Meredith CPAs acted as advisors to Viewgol."
NVAX

Hot Stocks

15:27 EDT Novavax remains 'confident' in rollout of updated COVID-19 vaccine in U.S. - Novavax said it remains confident in the ongoing rollout of its updated XBB protein-based non-mRNA COVID-19 vaccine in the U.S. Following arrival in pharmacies and healthcare provider offices, and first doses administered last week, Novavax's vaccine is now widely available throughout the U.S. Novavax believes it is too soon to evaluate U.S. vaccination rates given that vaccinations will continue in the coming weeks. Novavax is encouraged by broad availability of its vaccine in the U.S. market and looks forward to gathering additional data as the season unfolds. In the European Union, Novavax continues to work in close partnership with the European Medicines Agency as they review the file for its updated COVID-19 vaccine for use in individuals aged 12 and older which is based on the global data package that has already supported U.S. Emergency Use Authorization. As part of the ongoing review process, Novavax has responded to additional questions from the EMA's Committee for Medicinal Products for Human Use; CHMP has acknowledged receipt of this additional information and Novavax is currently awaiting feedback. Post-approval, Novavax expects to meet its full supply commitment for doses of its vaccine to European countries that have requested it through the Company's advanced purchase agreement and is on track to provide these doses in line with the APA requirements. Novavax values EMA's continued partnership and continues to work on the shared goal of bringing an updated protein-based non-mRNA COVID-19 vaccine to member states in the coming weeks. The company will provide an update on its upcoming Q3 earnings call in early November 2023.
VSTO

Hot Stocks

14:22 EDT Vista Outdoor to sell Sporting Products unit to Czechoslovak Group for $1.91B - The Czechoslovak Group announced that it has entered into a definitive agreement to acquire Vista Outdoor Inc.'s Sporting Products business for a total consideration of $1.91B, valuing the business at approximately 5x Fiscal Year 2024E EBITDA, including estimated standalone costs. CSG will partner with the existing management to pursue the continued growth path envisaged for the Sporting Products business over the coming years. Headquartered in Anoka, Minnesota, Vista Outdoor's Sporting Products business is a leading ammunition manufacturer in the U.S. commercial and law enforcement markets. It employs approximately 4,000 employees across its four U.S. factories and owns leading ammunition brands including CCI, Federal, HEVI-Shot, Remington and Speer. The proposed transaction would be CSG's largest acquisition to date after a long series of smaller acquisitions focused on the European market, including the acquisition of Fiocchi Munizioni in 2022. It also represents the largest acquisition in the history of the Czech defense industry. The transaction is expected to close in calendar year 2024, subject to shareholder approval, receipt of necessary regulatory approvals and other customary closing conditions. Upon closing, Sporting Products will become a wholly owned subsidiary of CSG, operating as a private company. Jason Vanderbrink will remain CEO of the Sporting Products business and the U.S. headquarters will remain in Anoka, Minnesota.
SSU

Hot Stocks

14:08 EDT Signa Sports says unconditional equity commitment letter terminated by Signa - Signa Sports United N.V. announced it has received a termination notice with respect to the unconditional Equity Commitment Letter from SIGNA Holding GmbH, an affiliate of the company's largest shareholder SIGNA International Sports Holding GmbH. "The company has entered into a binding equity commitment letter dated June 26, 2023 with unconditional commitments by SIGNA Holding to provide the company with additional liquidity of EUR 150 million in the period from September 1, 2023 to September 30, 2025, supplemented by a side letter dated September 27, 2023, to cover the operational financing needs of SSU and to secure the going concern of SSU. Of the original EUR 150 million commitment, EUR 143 million remains undrawn to date. SIGNA Holding has terminated the Equity Commitment Letter today. After many years of mutually trusted collaboration and reliable financing between the company and SIGNA Holding, SSU has relied on the binding and unconditional nature of the Equity Commitment Letter to continue to draw funds to meet its near-term obligations and for its going concern assessment of the company and its subsidiaries. The company considers the termination of the Equity Commitment Letter by SIGNA Holding unjustified. While the company regrets the termination of the Equity Commitment Letter, it will take the appropriate legal steps in the interests of all its shareholders, creditors and employees," Signa Sports United stated.
NFE

Hot Stocks

13:50 EDT New Fortress Energy sees FY24 adjusted EBITDA about $2.4B - Sees FY23 adjusted EBITDA about $1.6B. Says earnings increasing "significantly" in both size and quality. Says company focusing on long-term downstream customer earnings. Sees terminal earnings growing from about $850M this year to about $2.2B next year. Says targeting valued of FCCM could exceed $13B. Guidance taken from October 2023 Company Update presentation slides.
GM

Hot Stocks

13:49 EDT General Motors provides wage increase details of latest offer to UAW - General Motors announced that it has added wage tables to its site to "help team members understand the new hourly wages they would earn immediately upon ratification of the proposed offer, plus every year of the agreement." On its site, GM states: "All GM U.S. UAW-represented team members will receive an immediate wage increase upon ratification of the proposed offer. All active seniority employees have the opportunity to reach max wages by the end of the proposed contract." Reference Link
ABCM DHR

Hot Stocks

13:18 EDT Milner urges shareholders to disregard ISS report, vote against Abcam deal - Jonathan Milner, who identifies himself as the founder and one of the largest shareholders in Abcam plc (ABCM) with ownership of 6.16% of the company, issued the following statement in response to a report from Institutional Shareholder Service, or ISS: "I unequivocally oppose the conclusions drawn in the ISS report and its subsequent recommendation. I believe that Danaher's $24 per share offer is a stark undervaluation of Abcam's true worth. Accepting $24 per share, devoid of a strategic premium, is the wrong price at the wrong time, a move that blatantly overlooks Abcam's intrinsic value... It's important to highlight the real shareholder value that my advocacy has unlocked. While the ISS report itself acknowledges the positive impact, let's not overlook the facts: the share price soared from roughly $16 to over $20, a significant 25% rise, in the wake of my campaign being made public. I believe that voting against the transaction would be a far better outcome for shareholders, returning the company to the position it previously held as a premium-rated life sciences company with a long track record of impeccable execution and an absolute focus on shareholder value."
VBLT NTBL

Hot Stocks

13:06 EDT VBL Therapeutics closes merger with Notable Labs, to begin trading under 'NTBL' - Notable Labs, a clinical stage therapeutic platform company developing predictive precision medicines for cancer patients, announced the completion of its merger transaction with VBL Therapeutics (VBLT) and associated financing. The combined company will focus on the advancement of Notable's proprietary Predictive Precision Medicines Platform, or "PPMP," and therapeutic pipeline focused on cancer patients with high unmet medical needs while completing the development of Volasertib for the treatment of acute myeloid leukemia, or AML, in platform-predicted responders as the flagship program. The ordinary shares of the combined company, renamed Notable Labs, are expected to commence trading on The Nasdaq Capital Market, on a 1-for-35 reverse split basis, under the ticker symbol "NTBL" and a new CUSIP number at the open of market trading on October 17, the company stated. "This is an important milestone for Notable as we continue to advance the demonstrated value of the PPMP. The merger will add additional capital to accelerate our continued development of Volasertib for the treatment of AML in PPMP-predicted responding patients. As a publicly traded company, we will continue to evaluate potential additional programs and assets where PPMP is especially suited for risk-reducing and fast-tracking therapeutic development," said Thomas Bock, M.D., Chief Executive Officer of Notable.
BIOC

Hot Stocks

12:58 EDT Biocept filed voluntary petition for Chapter 7 bankruptcy relief - In a regulatory filing, Biocept disclosed that after considering strategic alternatives, the company filed a voluntary petition for relief under the provisions of Chapter 7 of Title 11 of the United States Code in the United States Bankruptcy Court for the District of Delaware on October 13. "The proceeding under the Petition is styled as 'In Re: Biocept, Inc.' As a result of filing the Petition, a Chapter 7 trustee will be appointed by the Bankruptcy Court to administer the bankruptcy estate of the company and to perform the duties set forth in Section 704 of the Code. The assets of the company will be liquidated and any claims paid in accordance with the Code," the filing stated. "Antonino Morales, Marsha A. Chandler, Bruce E. Gerhardt, Quyen Dao-Haddock, Ivor Royston, and Linda Rubinstein tendered their resignations as members of the Company's Board of Directors which resignations were effective on October 13, 2023, prior to filing the Petition. The resignations of Mr. Morales, Ms. Chandler, Mr. Gerhardt, Ms. Dao-Haddock, Mr. Royston and Ms. Rubinstein are not the result of any disagreements with the company regarding the company's operations, policies, or practices. Each of the Members have resigned due to the company's filing of the Petition which effectively eliminates the powers of the company's Board of Directors. Following the resignations of the Members, the company will have no members serving on its Board of Directors. In addition to his resignation from the company's Board of Directors, Mr. Morales tendered his resignation as the company's President and Chief Executive Officer effective on October 13," the filing added.
ISPO

Hot Stocks

12:36 EDT Inspirato announces 1-for-20 reverse stock split - Inspirato announced that it will effect a reverse stock split of its Class A common stock, Class B Non-Voting common stock and Class V common stock at a ratio of 1-for-20, effective as of the close of trading on October 16, 2023. The reverse stock split is being conducted in order to regain compliance with the minimum $1.00 bid price per share requirement of Nasdaq's Marketplace Rule 5450(a)(1). The Company's Class A Common Stock is expected to begin trading on a reverse-split-adjusted basis on Nasdaq as of the open of trading on October 17, 2023 under the existing ticker symbol "ISPO." The Company's stockholders previously approved a proposal to allow the Board of Directors, in its discretion, to effect a reverse stock split, determine the final reverse stock split ratio and to determine when to proceed with the reverse stock split at its Special Meeting of Stockholders on September 26, 2023. The CUSIP number for the Company's Class A Common Stock will change to 45791E206 following the reverse stock split. The CUSIP number for the Company's publicly traded warrants will not change.
MANU

Hot Stocks

12:00 EDT Manchester United falls -7.9% - Manchester United is down -7.9%, or -$1.57 to $18.41.
KLG

Hot Stocks

12:00 EDT WK Kellogg falls -9.4% - WK Kellogg is down -9.4%, or -$1.01 to $9.77.
VSTO

Hot Stocks

12:00 EDT Vista Outdoor falls -23.7% - Vista Outdoor is down -23.7%, or -$7.76 to $25.04.
GHI

Hot Stocks

12:00 EDT Greystone Housing Impact rises 9.8% - Greystone Housing Impact is up 9.8%, or $1.46 to $16.36.
AKA

Hot Stocks

12:00 EDT a.k.a. Brands rises 10.2% - a.k.a. Brands is up 10.2%, or 53c to $5.73.
ETWO

Hot Stocks

12:00 EDT E2open rises 25.7% - E2open is up 25.7%, or 63c to $3.08.
KO PDRDY

Hot Stocks

11:48 EDT Coca-Cola, Pernod Ricard to debut Absolut Vodka & Sprite ready-to-go cocktail - The Coca-Cola Company (KO) and Pernod Ricard (PDRDY) announced a global relationship to debut Absolut Vodka & Sprite as a ready-to-drink pre-mixed cocktail in 2024. The pre-mixed cocktail will be available in versions with Sprite and Sprite Zero Sugar, with the initial launch planned for select European countries in early 2024, including the United Kingdom, the Netherlands, Spain and Germany. "We keep consumers at the center of everything we do as we continue to develop our portfolio as a total beverage company," said James Quincey, Chairman and CEO of The Coca-Cola Company. "We are expanding in the alcohol ready-to-drink space, including products that use select brands from our core portfolio. We are excited about our new relationship with Pernod Ricard and look forward to the introduction of Absolut & Sprite."
AMAM

Hot Stocks

11:36 EDT Ambrx Biopharma trading resumes
MSFT

Hot Stocks

11:25 EDT Microsoft's LinkedIn laying off 668 employees across several teams - LinkedIn Corporate Communications stated in an October update notice: "Talent changes are a difficult, but necessary and regular part of managing our business. The changes we shared with our team today will result in a reduction of approximately 668 roles across our engineering, product, talent and finance teams. While we are adapting our organizational structures and streamlining our decision making, we are continuing to invest in strategic priorities for our future and to ensure we continue to deliver value for our members and customers. We are committed to providing our full support to all impacted employees during this transition and ensuring that they are treated with care and respect." Reference Link
AMAM

Hot Stocks

11:21 EDT Ambrx Biopharma trading halted, volatility trading pause
AHG

Hot Stocks

10:32 EDT Akso Health regains Nasdaq compliance - Akso Health received a letter from the Nasdaq Listing Qualifications Department notifying the Company that it had regained compliance with the minimum bid price requirement. On October 26, 2022, the Company received a notification that it's American Depositary Shares failed to maintain a minimum bid price of $1.00 over the previous 30 consecutive business days, as required by Nasdaq Listing Rules of The Nasdaq Stock Market. The closing bid price of the Company's ADS was at $1.00 per share or greater from September 15, 2023 to October 10, 2023. Accordingly, the Company has regained compliance with Nasdaq Capital Market Minimum Bid Price Requirement per Listing Rule 5550(a)(2) and this matter is now closed.
GEHC

Hot Stocks

10:17 EDT GE HealthCare receives FDA clearance of Allia IGS Pulse - GE HealthCare announced US FDA 510(k) clearance of Allia IGS Pulse - the latest addition to the company's image guided system offerings. Allia IGS Pulse features a new imaging chain engineered to provide exceptional imaging at the right dose for visible impact in complex cardiology interventions regardless of patient size.
SPOT

Hot Stocks

10:16 EDT Spotify launches dedicated Merch Hub in app - In a company blog post, Spotify said, "When new merch drops, fans don't hesitate. We've seen that in the days and weeks after an artist releases shirts, totes, hats, vinyl, and more, fans flock to their Spotify profiles to get what's new. So to give the fans what they want-and make it easier than ever for listeners to browse and shop for merch from their favorite artists-we're unveiling a dedicated Merch Hub in the Spotify app. Sporting merch from your favorite artists is a vital part of music culture, and our new Merch hub provides personalized merch recommendations based on your listening habits. Previously, we made artist merch available from individual artist profiles, the Now Playing view, and release pages. Instead of having to browse artist by artist, this update makes it easier than ever to access all artist merch in one place. From the hub, you can browse, click on available items to learn more, and then purchase through the artist's Spotify store, powered by Shopify." Reference Link
BGLC

Hot Stocks

10:13 EDT Bionexus Gene Lab names Chi Yuen Leong as CEO and director - Bionexus Gene Lab approved the appointment of Chi Yuen Leong as the Chief Executive Officer and a director, effective October 12. Leong has no family relationship with any director or executive officer of the company. He was not involved in any transaction with the company during the past two years. Leong served as the president and director from the company's inception to August 2022 and has been working with and guiding Bionexus Gene Lab's listing on OTC and Nasdaq. Leong entered into an employment agreement with the company dated October 12 and agreed to receive an annual compensation of $24,000.
CMI

Hot Stocks

10:02 EDT Cummins teams with industry partners on open telematics architecture - Cummins (CMI) announced its collaboration with the Eclipse Foundation, Microsoft (MSFT), and industry partners to release a new and innovative approach to develop telematics software for commercial vehicles. The Open Telematics Framework is being designed to allow companies to accelerate time to market and reduce costs. It allows each company to write their telematics application once and deploy it to any telematics hardware running the Open Telematics Framework. This write once, run anywhere approach will eliminate the complex customization and reprogramming efforts that have historically burdened telematics application developers. It also incorporates the latest cybersecurity capabilities.
MTRN

Hot Stocks

10:01 EDT Materion to supply advanced materials for MARVEL microreactor project - Materion Corporation has entered into a purchase agreement to supply beryllium and beryllium oxide materials for a nuclear microreactor test bed being developed by Idaho National Laboratory. This test bed will support microreactor development, including the U.S. Department of Energy's Microreactor Applications Research Validation and Evaluation Project, or MARVEL. The purchase agreement will commence in 2023. "With the increasing focus on developing transportable clean energy solutions, Materion is pleased to be part of the MARVEL project that will fast track development and commercialization of microreactors and supporting infrastructure," said Clive Grannum, president of Materion Performance Materials. "In addition to INL, Materion is working closely with all our nuclear energy customers, both current and prospective, to align our products with the evolving requirements of the industry today and into the future."
GNTY

Hot Stocks

10:00 EDT Guaranty Bancshares falls -6.5% - Guaranty Bancshares is down -6.5%, or -$1.83 to $26.56.
MANU

Hot Stocks

10:00 EDT Manchester United falls -12.2% - Manchester United is down -12.2%, or -$2.44 to $17.54.
VSTO

Hot Stocks

10:00 EDT Vista Outdoor falls -14.6% - Vista Outdoor is down -14.6%, or -$4.80 to $28.00.
KOLD

Hot Stocks

10:00 EDT ProShares UltraShort Bloomberg Natural Gas rises 5.4% - ProShares UltraShort Bloomberg Natural Gas is up 5.4%, or $2.51 to $49.31.
TRN

Hot Stocks

10:00 EDT Trinity Industries rises 5.4% - Trinity Industries is up 5.4%, or $1.19 to $23.10.
SNAP

Hot Stocks

10:00 EDT Snap rises 9.5% - Snap is up 9.5%, or 82c to $9.51.
THRN

Hot Stocks

09:50 EDT L Catterton completes acquisition of Thorne HealthTech - L Catterton announced the completion of its acquisition of Thorne HealthTech. The tender offer to purchase all of the issued and outstanding shares of Thorne's common stock in exchange for $10.20 per Share, net to the seller in cash, without interest and less any required withholding taxes, expired as scheduled at one minute past 11:59 p.m., Eastern Time, on October 12, 2023 and was not extended. L Catterton previously announced that, as of the Expiration Time, 52,596,517 Shares were validly tendered and not validly withdrawn in the Offer, representing 97.3% of the issued and outstanding Shares as of the Expiration Time. In accordance with the terms of the Offer, L Catterton and its affiliate, Healthspan Merger Sub, Inc., accepted for payment all such Shares that were validly tendered and not validly withdrawn pursuant to the Offer. Following completion of the Offer, L Catterton completed the acquisition of Thorne through the previously planned second-step merger. Thorne's common stock will be delisted from the Nasdaq Global Select Market and deregistered under the Securities Exchange Act of 1934, as amended.
PRTA

Hot Stocks

09:47 EDT Prothena extends rally, up 14% to $50.42 after Bloomberg report
MANU

Hot Stocks

09:47 EDT Manchester United falls -8.9% - Manchester United is down -8.9%, or -$1.77 to $18.21.
BITI

Hot Stocks

09:47 EDT Biotie Therapies falls -10.8% - Biotie Therapies is down -10.8%, or -$2.30 to $18.94.
VSTO

Hot Stocks

09:47 EDT Vista Outdoor falls -16.3% - Vista Outdoor is down -16.3%, or -$5.36 to $27.44.
TAL

Hot Stocks

09:47 EDT TAL Education rises 5.8% - TAL Education is up 5.8%, or 52c to $9.43.
CX

Hot Stocks

09:47 EDT Cemex rises 6.7% - Cemex is up 6.7%, or 41c to $6.57.
BITO

Hot Stocks

09:47 EDT ProShares Bitcoin Strategy ETF rises 10.4% - ProShares Bitcoin Strategy ETF is up 10.4%, or $1.41 to $15.03.
PRTA

Hot Stocks

09:46 EDT Prothena trading resumes
PRTA

Hot Stocks

09:42 EDT Prothena trading halted, volatility trading pause
PRTA

Hot Stocks

09:41 EDT Prothena jumps 11% to $49.05 after Bloomberg says exploring sale
ALDX

Hot Stocks

09:39 EDT Aldeyra trading resumes
RCM

Hot Stocks

09:37 EDT Jehoshaphat Research short R1 RCM, says stock 'practically uninvestible' - In a recently published report, Jehoshaphat Research says it is short R1 RCM. "We believe its financial accounting is so misrepresentative, its corporate governance so surprisingly bad, and the reflexivity of its business model so misunderstood that its stock is practically uninvestible today. Our forensic accounting concerns have been reinforced by conversations we've had with former RCM and Cloudmed employees. We see idiosyncratic downside beginning to play out in the next several months as accounting games reach a natural exhaustion point on an overleveraged company -- and the lockup on 33% of RCM's shares expires in two months. We believe that it's entirely reasonable that the stock will revisit the lows of $7 per share following Q3 2022 earnings," it reads. Shares of R1 RCM are down about 2% to $12.95 in Monday morning trading. Reference Link
ALDX

Hot Stocks

09:34 EDT Aldeyra trading halted, volatility trading pause
RCM

Hot Stocks

09:32 EDT R1 RCM down 4% in early trading after Jehoshaphat short call
MRNA PFE

Hot Stocks

09:27 EDT Moderna 'comfortable' with guidance for $6B-$8B in FY23 COVID-19 vaccine sales - After Pfizer (PFE) announced that it now anticipates full-year 2023 revenues to be in the range of $58B-$61B, versus its previous guidance range of $67B-$70B "solely due to its COVID products," Moderna (MRNA) issued the following statement on anticipated 2023 COVID-19 sales: "Moderna remains comfortable that its guided wide range of $6B to $8B for anticipated revenues from sale of its COVID-19 vaccine for the full year 2023, as provided in its second quarter earnings release dated August 3, 2023, reflects the uncertainty of U.S. vaccination rates. As noted previously, if the U.S. market for COVID-19 vaccines is approximately 50 million administered doses, Moderna still expects to be in the bottom half of the disclosed range; if the U.S. market is approximately 100 million administered doses, Moderna still expects to be in the top half of the disclosed range. Moderna believes it is still too early in the U.S. vaccination season to accurately project where vaccination rates will land for the full year. Moderna anticipates that it will have improved visibility about the expected U.S. market size after seeing full vaccination trends through October 2023. Moderna will provide an update at its earnings call on November 2, 2023."
MULN

Hot Stocks

09:24 EDT Mullen Automotive 'on track' to produce 150 Class 3 EV trucks through December - Mullen Automotive announces a commercial vehicle production update for both Class 3 EV cab chassis trucks and Class 1 EV cargo vans. As previously forecasted, the Company is currently on track to produce 150 Class 3 EV trucks through December 2023. The Company is also on track to begin Class 1 EV cargo van production and deliveries in Q4 2023. Mullen's Class 3 production plans for the remainder of 2023 are on schedule with an estimated 150 vehicles projected to be produced and delivered to Randy Marion Automotive Group. The first ten Class 3 vehicles were delivered to RMA on Sept. 28, 2023. In total, Mullen expects to deliver more than 150 Class 3 vehicles to Randy Marion this year and to fulfill the balance of the 1,000 Class 3 vehicle purchase order in calendar year 2024, where the production schedule has been set at 850 trucks. As previously reported, Class 3 production capacity at the Tunica facility is currently planned at 3,000 annually per shift, allowing units to be added to the schedule as additional customers are confirmed. Class 1 EV cargo van production is on track to begin in Q4 2023 with the Company producing an estimated 300 vehicles. The total Class 1 EV cargo van production for CY 2024 is planned for 6,000 vehicles allowing the RMA purchase order to be fulfilled. Class 1 production capacity at the Tunica, Mississippi, facility is currently planned at 10,000 annually per shift. As electric vehicle adoption rates increase, Mullen intends to add a second shift for Class 1 production, which will increase capacity to 20,000 total vehicles per year. In summary, the following reflects total planned commercial vehicle production for calendar years 2023 and 2024: 2023 CY estimated commercial vehicle production: 150 Class 3 EV cab chassis trucks; 300 Class 1 EV cargo vans. 2024 CY estimated commercial vehicle production: 850 Class 3 EV cab chassis trucks; 6,000 Class 1 EV cargo vans.
VVPR

Hot Stocks

09:22 EDT VivoPower announces cessation of further sale of shares under purchase agreement - VivoPower International's Board of Directors has resolved not to provide further notices for the Company to sell ordinary shares to White Lion Capital pursuant to the Ordinary Share Purchase Agreement signed on October 6, 2023. Under the terms of the Purchase Agreement, upon receipt of purchase notices from the Company, White Lion is obligated to purchase up to $2,300,000 in ordinary shares from time to time until the earlier of December 23, 2023 or the date on which White Lion has purchased ordinary shares in an amount equal to the Commitment Amount. As of October 16, 2023, White Lion had purchased an aggregate of 50,000 ordinary shares pursuant to the Purchase Agreement. The shares to be issued and sold to White Lion under the Purchase Agreement were offered by the Company pursuant to a registration statement on Form F-3, previously filed and declared effective by the U.S. Securities and Exchange Commission on December 23, 2020, the base prospectus filed as part of the Registration Statement, and the prospectus supplement dated October 6, 2023/
VUZI

Hot Stocks

09:22 EDT Vuzix announces orders from three Tier-1 aerospace and defense contractors - Vuzix announced it has recently received and partially delivered against additional follow-on and new design orders from three Tier-1 aerospace and defense contractors with which it has been working. The revenue associated with these OEM orders is in the mid six-figure range. The Company expects to receive additional NRE orders for subsequent phases from some of these contractors. Once final customer-accepted product designs have been achieved, they could ultimately lead to production program orders. In at least one case, these deliveries are pre-production components. For the first customer, Vuzix is delivering a customized waveguide-based optics engine that is intended to be used in head borne systems designed for military applications. For the second customer, a global Tier-1 aerospace and defense firm, Vuzix has received a follow-on order for additional pre-production units for their customized avionics waveguide-based head mounted display system, as well as a new design order for a different waveguide-based display. For the third customer, a US-based leader in technologically advanced and intelligent solutions for the global aerospace and defense industry, Vuzix is continuing to deliver assets for the Phase 2 development of a cost efficient, lightweight heads-up display, or HUD, for a unique HMD based application.
WRAP MSFT

Hot Stocks

09:13 EDT Wrap Technologies announces appointment of new directors to board - Wrap Technologies (WRAP) announced the appointment of Vice Admiral Timothy Szymanski and Rajiv Srinivasan to serve on the Company's Board of Directors. The Company has also appointed Scot Cohen, Co-Founder, as Executive Chairman of the Board. The addition of this leadership fortifies the Company's commitment to the mental well-being of public safety officers and the community at large. Vice Admiral Timothy Szymanski has led and served in many Navy and Joint Special Operations assignments as a Navy Special Warfare Officer for over 36 years. Szymanski is a Principal of Pallas Advisors, a strategic advisory firm specializing in navigating complex national and international security dynamics, which he joined in August 2023. Rajiv Srinivasan is a sales and general management professional in the technology and software industry. He has served in senior sales & management roles at Microsoft (MSFT) and in enterprise and global account management at MobileIron.
ERIC

Hot Stocks

09:13 EDT Ericsson selected by Appalachian Wireless - Ericsson announced that Appalachian Wireless, an East Kentucky Network, or EKN, company, has chosen Ericsson for a multi-year Radio Access Network, or RAN, modernization project to bring world-class 5G technologies to underserved communities in Appalachia. The partnership marks a step forward in connectivity and technological advancement for the mountainous region, where Appalachian Wireless is the sole network provider for many households and businesses. Appalachian Wireless aims to be the first regional carrier to implement 5G standalone to bridge the digital divide in rural America.
PODC LVO

Hot Stocks

09:10 EDT PodcastOne signs multi-year partnership with Chaudry's podcast series - PodcastOne (PODC), a subsidiary of LiveOne (LVO), announced that it has obtained the exclusive distribution and sales rights to the podcast Nighty Night hosted by New York Times best-selling author and attorney Rabia Chaudry. "We have been long-time fans of Rabia, for her work as an esteemed podcast host and for her work as a revered advocate. Rabia and her work with Adnan Sayed told through the podcast Serial, put podcasting on the map for mainstream audiences. We are thrilled that she is joining us at PodcastOne and look forward to welcoming her to our family of podcasters," said Kit Gray, President and Co-Founder of PodcastOne.
MU

Hot Stocks

09:10 EDT Micron announces Micron 7500 NVMe SSD - Micron Technology announced the Micron 7500 NVMe SSD for data center workloads. The 7500 SSD is the world's only mainstream data center SSD to feature 200+ layer NAND, utilizing Micron's 232-layer NAND and enabling up to 242% better random write performance than competitive drives.1 The SSD also delivers sub-1 millisecond latency for 6x9s quality-of-service in mainstream drives, creating a new class of SSDs perfectly suited to deliver the consistency required in the cloud. The Micron 7500 SSD is designed to meet the demands of storage-intensive data center workloads, such as artificial intelligence, databases, content delivery, real-time analytics, social media platforms, cloud computing and virtualization. Its remarkable QoS and performance provide rapid, reliable responsiveness for these demanding workloads. For example, the drive improves RocksDB performance by up to 2.1 times versus competitive SSDs.
EMRAF

Hot Stocks

09:09 EDT TRC amends tender offer for Emera - TRC Capital Investment Corporation announced that based on current market conditions, TRC has amended the terms of its tender offer for up to 2,000,000 common shares of Emera Incorporated and has decreased the offer price payable to $46.00 per share from $48.88 per share. TRC also announced that it has extended its offer until 12:01 a.m. Toronto time on October 31, 2023, unless further extended. As of close of business on Friday, October 13, 2023, no shares had been tendered. TRC will accept for payment and will pay for all shares validly tendered prior to the expiration date and not properly withdrawn in accordance with the terms of the offer. TRC will not be required to accept for payment or pay for any shares and may terminate the offer if certain conditions which, in the reasonable judgment of TRC in any such case, makes it inadvisable to proceed with the offer or with such acceptance for payment or payment. Stockholders of the Company who have already tendered their shares and have not withdrawn such shares need not take any additional action with respect to TRC's amended tender offer. These stockholders will receive the decreased offer price of $46.00 per share in TRC's tender offer. TRC has amended its tender offer materials to reflect the decreased offer price and other relevant changes.
IMMX

Hot Stocks

09:09 EDT Immix Biopharma completes third NXC-201 engineering batch - Immix Biopharma announced the successful completion of its 3rd engineering batch of BCMA-targeted chimeric antigen receptor T, CAR-T, cell therapy NXC-201 at its U.S. manufacturing site. "We believe the completion of our 3rd U.S. engineering batch represents an important threshold to demonstrate our U.S. manufacturing capability for NXC-201 IND submission in the United States," said Ilya Rachman, M.D. PhD, Chief Executive Officer of Immix Biopharma. "NXC-201's 100% observed overall response rate across 9 relapsed/refractory AL Amyloidosis patients, where NXC-201 has received orphan drug designation from the FDA, makes this an important milestone in bringing NXC-201 to U.S. patients."
FLIC RKT

Hot Stocks

09:08 EDT First of Long Island partners with Rocket Mortgage to expand financing options - The First National Bank of Long Island, the subsidiary of The First of Long Island Corporation (FLIC), announced that Rocket Mortgage, the nation's largest retail mortgage lender and a part of Rocket Companies (RKT), will be the preferred residential mortgage provider for First National Bank LI clients. Through this relationship, the Bank's clients will receive special discounts and dedicated resources to help them achieve their dream of owning a home. "This partnership with Rocket Mortgage will provide our clients with expanded lending solutions and the quick turn-around needed to finance a home in an ever-changing real estate market," said Chris Becker, President and CEO of First National Bank LI. "We are committed to providing innovative ways to best serve our clients and are pleased to expand our product offerings through this partnership. Rocket Mortgage will provide special closing cost discounts for our community while ensuring a customer-first experience through its dedicated team of mortgage bankers."
CHKP

Hot Stocks

09:07 EDT Check Point launches Check Point Horizon Playblocks - In the face of rapidly spreading cyberattacks and the consistent persistence of attackers using multiple vectors, Check Point Software Technologies launches Check Point Horizon Playblocks, a security automation and collaboration platform that automatically contains attacks and prevents them from spreading, all powered by collaboration between security people, processes and technologies. Horizon is Check Point's prevention-first security operations security suite, which includes the Managed Detection/Prevention and Response SOC service, the Extended Detection/Prevention and Response SOC platform and now Playblocks, the security collaboration platform for security teams.
NOK

Hot Stocks

09:07 EDT Nokia, Mila bring 10G broadband to Iceland with fiber network upgrade - Nokia announced it has been selected as the sole supplier by Mila to upgrade its fiber network to support new multi-gigabit services it plans to offer its more than 60,000 customers across Iceland. Nokia's multi-PON solution will initially be deployed in the capital city of Reykjavik before being expanded to other cities and regions. Leveraging Nokia's multi-PON fiber broadband solution, Mila will establish a future-ready network that is capable of addressing growing consumer demand for more capacity and enhanced broadband services. The deployment, which includes the upgrade of existing Nokia fiber access nodes and optical line terminals, will be completed in 2024
PUBM

Hot Stocks

09:06 EDT PubMatic, FreeWheel announce integration of PubMatic's activate - PubMatic announced a new integration partnership with FreeWheel, a global technology platform for the television advertising industry. Through this enhanced integration, PubMatic's Activate will now have direct access - through FreeWheel - to premium publisher connected television ad inventory. This new partnership will bring about two key benefits and new capabilities for the TV ad ecosystem: Ad buyers working with PubMatic will now have an enhanced and streamlined ability to transact across a larger and more diversified pool of premium CTV ad inventory. FreeWheel publishers will have access to unique campaign budgets only available through Activate. In doing so, the two companies aim to provide increased interoperability, efficiency and transparency for buyers and sellers of premium CTV ad inventory at scale.
LPLA

Hot Stocks

09:06 EDT LPL Financial: Infinity Wealth joins broker-dealer, RIA, custodial platforms - LPL Financial announced that five financial advisors with Infinity Wealth Group have joined LPL Financial's broker-dealer, RIA and custodial platforms. The team reported having served approximately $265 million in advisory, brokerage and retirement plan assets, and joins LPL from Cadaret, Grant & Co., Inc. Based in Northern New Jersey, the team is led by advisor Robert Doran, branch manager and President of Infinity Wealth Group. After 10 years with IBM, in his last position as a financial analyst, he started his own business as an independent financial advisor in 1992. After personally witnessing downsizing, re-engineering and mass layoffs throughout Corporate America, Doran decided to build a practice that specializes in retirement planning and wealth management.
LGF.A LGF.B

Hot Stocks

09:05 EDT Neuberger Berman urges Lionsgate to eliminate dual-class share structure - Neuberger Berman announced that it has submitted a proposal calling on the Board of Directors of Lions Gate Entertainment to take all reasonable and necessary steps to eliminate the dual-class share structure of the company. The Proposal will be presented to shareholders for a vote as Proposal 6 at the company's 2023 Annual General and Special Meeting of Shareholders, which is scheduled for November 28, 2023. Neuberger Berman, on behalf of its clients, has been an investor in Lions Gate since 2016. The Proposal requests that the Board take all reasonable and necessary steps to ensure that each outstanding share of common stock has one vote. Lions Gate's dual-class structure has existed since the company's merger with Starz in 2016. Neuberger Berman strongly believes that the planned separation of the Starz business should be implemented in a manner that positions the company that will hold the remaining Starz business and the company that will hold the separating Studio business with governance structures that align the voting and economic interests of all shareholders.
FTNT...

Hot Stocks

09:05 EDT Fortinet expands global SASE points-of-presence with Google Cloud - Fortinet (FTNT) announced the expansion of its SASE Points-of-Presence, POPs, to new locations through a partnership with Google Cloud (GOOG;GOOGL). The partnership allows Fortinet to leverage Google Cloud's global network edge locations closest to their regions of presence, which deliver dedicated interconnect and 99.99% service availability, to accelerate the expansion of Fortinet's Universal SASE solution. "By leveraging Google Cloud, Fortinet Universal SASE is even better positioned to serve a more extensive global footprint, ensuring that customers can seamlessly connect and secure their hybrid workforces to critical applications," said Michael Xie, Founder, President, and Chief Technology Officer of Fortinet. "This partnership will expand our global POP resources and accelerate customer adoption of Fortinet's Universal SASE solution. And because our SD-WAN solution is natively integrated with our SASE offering, Fortinet's global SD-WAN customers now have an even broader ability to easily adopt integrated cloud-delivered security to implement a comprehensive Universal SASE solution."
PHOT

Hot Stocks

09:05 EDT GrowLife releases Kind Coffee Cooperative product - GrowLife announced the release of its newest product, Kind Coffee Cooperative. Developed by RPG Coffee in partnership with Bridgetown Mushrooms, a wholly owned subsidiary of the Company, the new product will benefit kindness.org and is now available to pre-order.
AAPL

Hot Stocks

09:04 EDT Apple announces expansion of Apple Store online in Chile, new shopping options - Customers in Chile can now shop Apple's full lineup of products and services online with Apple Specialists who are available to provide exceptional service and help discover the best of Apple Apple announced the expansion of the Apple Store online in Chile. Customers throughout the country can shop Apple's full lineup of products and services, and receive best-in-class support, delivered by online team members eager to share their knowledge and expertise... customers in Chile can visit apple.com/cl or download the Apple Store app and shop directly with Apple. Starting October 20, customers will be able to pre-order the all-new iPhone 15, featuring a durable, color-infused back glass; contoured edges; the Dynamic Island ; a 48MP Main camera; and USB-C; and iPhone 15 Pro, featuring a titanium design; a new Action button; powerful camera upgrades; and A17 Pro for next-level performance and mobile gaming. And by shopping through Apple Store online, customers are able to choose from a range of affordable financing options. "We're thrilled to be expanding in Chile with the launch of the Apple Store online," said Deirdre O'Brien, Apple's senior vice president of Retail. "We love creating magical experiences for our customers, and whether they're looking to unleash creativity or embrace an entrepreneurial spirit, we now have an incredible Apple experience for everyone in Chile who wants to discover and shop for our amazing products, including the all new iPhone 15 lineup and Apple Watch Series 9."
MOB

Hot Stocks

09:04 EDT Mobilicom announces it has secured two follow-on orders - Mobilicom announced it has secured two follow-on orders, including one order from a large Tier-1 customer. One of Mobilicom's current customers, a Tier-1 global leader in the defense and aerospace market, and one of the largest drone manufacturers in the world, placed an order for Mesh Networking to be embedded into a new platform solution. The customer had previously purchased SkyHopper Datalinks. Another current Mobilicom customer, a maker of remote controlled weapons stations, placed a repeat order for more Mobile Ground Control Stations. "Security, defense, and highly targeted military operations are increasingly deploying autonomous, uncrewed, and aerial systems. Recent events underscore the need for preparedness. Mobilicom is proud to have a key role in bringing the most advanced cybersecure drone systems to those who secure peace and protect the innocent," stated Mobilicom CEO and Founder Oren Elkayam.
ATIF

Hot Stocks

09:03 EDT ATIF Holdings subsidiary signs agreement with Rawrr - ATIF Holdings announces that its subsidiary, ATIF Business Management, has entered into a definitive agreement with Rawrr, to provide corporate advisory services. Under the terms of the agreement, the Company will provide corporate advisory services to Rawrr and help engage third parties to perform audit, valuation, investor relations and other services. With this cooperation, ATIF will provide comprehensive guidance and escort for enterprises in the capital path according to their development needs, and help Rawrr to list on the NASDAQ capital market as soon as possible.
FBIO

Hot Stocks

09:03 EDT Fortress Biotech subsidiary announces option agreement with City of Hope - Helocyte, a subsidiary company of Fortress Biotech, announced that it executed an exclusive option agreement with City of Hope for patent rights to use Triplex, a cytomegalovirus vaccine, in combination with cytomegalovirus-specific, Anti-Human Immunodeficiency Virus Chimeric Antigen Receptor T Cells for the treatment of adults living with HIV. Triplex was initially developed by City of Hope, one of the largest cancer research and treatment organizations in the United States, and exclusively licensed to Helocyte in 2015. Additionally, the California Institute for Regenerative Medicine recently awarded a $11.3 million grant to City of Hope to fund a Phase 1 clinical trial. The Phase 1 trial is expected to enroll up to 12 healthy individuals living with HIV-1 on stable anti-retroviral therapy who have maintained viral suppression for at least 48 weeks. The study will include three dose-escalating cohorts, along with an expansion cohort. Other cohorts will include further vaccination of subjects with Triplex to drive continued proliferation of the CAR. The trial will initially enroll at City of Hope and University of California at San Diego.The clinical study will build upon preclinical data published in Molecular Therapy - Methods & Clinical Development which demonstrated the potential efficacy of combining a CMV vaccine and CMV/HIV CAR T cell therapy to eradicate HIV. To date, the engineering of T cells to express HIV-specific CAR T cells has failed to demonstrate meaningful clinical benefits. This is believed to be due in part to the effectiveness of highly active ART, which reduces HIV viral load to a level that prevents the activation of CAR T cells.
SGPYY

Hot Stocks

09:02 EDT Sage Intacct Payroll by ADP launches in Canada - Sage has launched Sage Intacct Payroll in partnership with ADP Canada. The solution has been available in the US market since June 2022. Sage Intacct Payroll powered by ADP offers payroll and HR functionalities to help medium businesses work smarter as they scale and grow. It is the only market-leading payroll solution that works seamlessly with Sage Intacct, the cloud financial management platform.
STIM

Hot Stocks

09:01 EDT Neuronetics announces publication on best practices for TMS treatment outcomes - Neuronetics announced that clinical findings from the NeuroStar Outcomes Registry are published in the premier journal in the field of neuromodulation, Brain Stimulation: Basic, Translational, and Clinical Research in Neuromodulation. The data reveal a robust association between the number of treatment sessions received and improved depression outcomes, providing actionable evidence for clinicians prescribing transcranial magnetic stimulation therapy to treat major depressive disorder. Findings from this study of over 7,000 patients demonstrate that patients who received a full course of 36 TMS sessions had an 82% greater improvement in remission rate and a 43% greater improvement in response rate compared to patients who ended their TMS course with fewer than 30 sessions. Historically, TMS therapy is discontinued by either the patient or the practitioner at various points of treatment, but the findings published in Brain Stimulation demonstrate that stopping treatment before 36 sessions is associated with significantly reduced treatment effectiveness. In addition to the significant dose response for a majority of patients, the analysis from the study also revealed that some patients who have a slower initial response may benefit from extended treatment beyond 36 treatments.
LRHC

Hot Stocks

09:01 EDT La Rosa Holdings acquires Real Estate brokerage franchisee - La Rosa announced that it has acquired a controlling interest in the Company's franchisee - La Rosa Realty Lake Nona, located in Orlando, Florida. Lake Nona generated revenue in excess of $9.8M and positive net income in 2022. The franchisee provides residential and commercial real estate brokerage services. It also provides coaching and support services to agents on a fee basis. "We are excited to welcome the franchisee into the corporate organization," said Joe La Rosa, CEO of La Rosa Holdings Corp. "We believe that not only does this acquisition expand our footprint in Florida, but it will also increase our top line revenue. With future planned franchisee acquisitions, we expect both our top line and bottom line to improve considerably as our current infrastructure is set up to support five times our current agent count. We have a brokerage model which is agent centric with 100% commission. In our view, our agent-centric commission model enables our sales agents to obtain higher net commissions than they would otherwise receive from many of our competitors in our local markets. We provide our real estate brokers and sales agents who are seeking financial independence with a turnkey solution and support them in growing their brokerages while they fund their own businesses. This enables us to maintain a low fixed-cost business model with several recurring revenue streams, yielding relatively high margins and cash flow. Moreover, we believe that our proprietary technology, training, and the support that we provide to our agents at a minimal cost to them is one of the best offered in the industry. Our strategy is to drive exponential growth to capitalize on the changing agency model trends occurring in the industry."
CAT

Hot Stocks

09:01 EDT Caterpillar names Joseph Creed as COO - Caterpillar announced that Joseph Creed, group president of Energy & Transportation, has been appointed to the newly created position of COO, effective Nov. 1, 2023. In this newly created position, Creed will report to Jim Umpleby, chairman and CEO. Creed joined Caterpillar in 1997 and has held numerous positions of increased responsibility across multiple divisions of Caterpillar.
HUMA

Hot Stocks

08:59 EDT Humacyte publishes preclinical study on HAV to treat Tetralogy of Fallot - Humacyte announced publication of a preclinical study showing the potential for its investigational small-diameter Human Acellular Vessel to treat Tetralogy of Fallot, a heart condition that affects one in every 2,000 babies born each year. The publication in the open-access Journal of Thoracic and Cardiovascular Surgery, entitled "Evaluation of tissue-engineered human acellular vessels as a Blalock-Taussig-Thomas shunt in a juvenile primate model," describes a preclinical study in which researchers from Humacyte and Nationwide Children's Hospital implanted 3.5mm diameter HAVs into a juvenile large-animal model of pediatric heart disease. The 3.5mm HAV was implanted between the subclavian and pulmonary arteries, to mimic a commonly-performed surgical procedure used to treat babies born with Tetralogy of Fallot, one of the most common pediatric heart conditions. The study assessed the HAV's patency, structure, and blood flow from one week to six months after the implant. The 3.5mm HAVs remained patent for up to six months, and evidence of HAV repopulation by host cells was observed, similar to what has been observed in human patients implanted with 6.0mm HAVs. This study also demonstrates the successful extension of Humacyte's manufacturing platform, from the production of 6.0mm vessels to 3.5mm vessels. Humacyte's 3.5mm HAV is also currently being tested in large-animal models of adult coronary artery bypass grafting to assess the potential of the Humacyte platform to make vessels treating a range of heart conditions, spanning from pediatric to adult. The 6.0mm HAV has accumulated more than 1,000 patient-years of experience worldwide in a series of clinical trials in multiple indications, including vascular trauma repair, arteriovenous access for hemodialysis, and peripheral artery disease. The 3.5mm HAV is being studied in preclinical models in several different potential indications. The HAV is an investigational product and has not been approved for sale by the FDA or any other regulatory agency.
VEEE

Hot Stocks

08:57 EDT Twin Vee PowerCats' Aquasport begins shipping boats from Tennessee factory - Twin Vee Powercats announced that its subsidiary, AquaSport Co., is now shipping boats from its factory in White Bluff, Tennessee. Aquasport currently builds seven different models at its 150,000-square-foot manufacturing facility in Tennessee, ranging from 21-feet to 30-feet.
HHS

Hot Stocks

08:56 EDT Harte Hanks CFO Lauri Kearnes to depart, David Garrison named interim - Harte Hanks announced the appointment of David Garrison as Interim CFO, effective October 23, 2023. Lauri Kearnes is stepping down as CFO but will continue to advise the Company as needed through year end to support a smooth transition. Kearnes' departure is not related to any disagreement with the Company on any matter relating to the Company's operations, policies, or practices. Garrison joins Harte Hanks from Digital Lumens Incorporated, an IoT lighting fixture and factory automation technology company that was spun out of Osram Sylvania, where he served as CFO for the last two years. Harte Hanks has already initiated a formal search process to select a permanent Chief Financial Officer to advance the company's current growth plans and new market goals
WLDS

Hot Stocks

08:53 EDT Wearable Devices joins Khronos Group as a voting right member - Wearable Devices announced that the Company has joined Khronos Group's OpenXR working group as a member with voting rights. OpenXR seeks to simplify alternate reality/virtual reality software development and enable applications to reach a wider array of hardware platforms without having to port or rewrite code. Guy Wagner, Chief Scientist Officer and Co-Founder of Wearable Devices, commented, "We're excited to join Khronos Group's OpenXR working group and contribute to the development of true cross-platform XR applications alongside industry leaders. XR is rapidly gaining popularity in the tech industry, and Wearable Devices is uniquely positioned with our technology to define the input standard for spatial computing and extended reality devices. We look forward to contributing to the OpenXR platform and broadening the scope and capabilities of extended reality experiences."
SHOT

Hot Stocks

08:52 EDT Safety Shot enters agreement with Masvidal who will serve as brand ambassador - Safety Shot announced it has entered an agreement with mixed martial arts, MMA, superstar Jorge Masvidal who will serve as a brand ambassador for Safety Shot, the first patented beverage on Earth that helps people feel better faster by reducing blood alcohol content and boosting clarity. "We are super excited to extend our agreement with Gamebred Bareknuckle to include Jorge's brand ambassadorship. He has earned the respect and admiration of millions and we welcome his support of Safety Shot," stated Safety Shot's CEO, Brian John.
SLS

Hot Stocks

08:51 EDT Sellas Life Sciences announces initial topline Phase 2a data of SLS009 - SELLAS Life Sciences announced positive initial topline data at the 45 mg dose level from its ongoing Phase 2a clinical trial of its novel and highly selective CDK9 inhibitor, SLS009, in combination with venetoclax and azacitidine in patients with relapsed/refractory acute myeloid leukemia who did not respond or stopped responding to venetoclax-based therapies. Topline data for the recommended Phase 2 dose is expected later this quarter. A total of five patients with r/r AML who failed venetoclax-based therapies have been enrolled to date at the 45 mg dose level. The first patient enrolled in the study achieved a complete response, remains alive and is currently in the fifth month of treatment after relapsing on venetoclax, and the second patient is alive and in the fourth month of treatment. All patients enrolled were alive at the time of their last follow-up and four continue treatment. Anti-leukemic effects have been observed in all patients without any significant safety issues to date. Patients with AML that fail venetoclax-based therapies have limited treatment options and a poor prognosis with a median overall survival of approximately 2.5 months. "This initial outcome that includes a complete response, anti-leukemic activity in all patients, good safety profile across the patients and indications of extended survival for our enrolled patients still continuing treatment, we believe opens multiple registrational opportunities for SLS009. We will be exploring these options in the coming weeks as we treat patients with the recommended Phase 2 dose, 60 mg, in this study," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "While these results are early, they are extremely encouraging and consistent with the Phase 1 study results, and further strengthen our initial proposition that the addition of CDK9 inhibition in combination with BCL-2 inhibition and hypomethylating agents could provide patients with a triple hit to increase response rates and survival outcomes without sacrificing safety and tolerability due to the specificity of SLS009. We look forward to providing additional updates this quarter from this study."
MMV

Hot Stocks

08:51 EDT MultiMetaVerse receives letter of approval from Nasdaq - MultiMetaVerse Holdings announced that it has received a letter of approval from the Listing Qualifications Department of the Nasdaq Stock Market on October 13 for its application to transfer the listing of its class A ordinary shares and warrants. The Company previously submitted an application to Nasdaq to transfer the listing of its class A ordinary shares and warrants from the Nasdaq Global Market to the Nasdaq Capital Market. The transfer will be effective at the opening of business on October 17, 2023. The class A ordinary shares and warrants of the Company will continue to trade under the symbol "MMV" and "MMVWW", respectively.
BKSY

Hot Stocks

08:50 EDT BlackSky wins Air Force research contract - BlackSky won a U.S. Air Force Research Laboratory AFWERX Direct to Phase 2 contract, funded by the Space Development Agency, to build an automated target recognition service that will gather and combine radio frequency and electro-optical satellite sensor data to track mobile assets in real-time and securely distribute actionable intelligence to remote devices and analysts worldwide.
TTNMF

Hot Stocks

08:50 EDT Titanium Transportation announces normal course issuer bid - Titanium Transportation Group announces that the Toronto Stock Exchange has accepted Titanium's notice to make a normal course issuer bid to purchase for cancellation up to 2,236,184 common shares in the capital of the Company in total, being 5% of the issued and outstanding Common Shares as at the day prior to Titanium's notice to the TSX, to be transacted through the facilities of the TSX. The actual number of Common Shares that may be purchased pursuant to the Bid will be determined by management of the Company. The Bid will commence on October 18, 2023 and will terminate on October 17, 2024, or such earlier time as the Bid is completed or terminated at the option of Titanium. Purchases pursuant to the Bid will be made by Canaccord Genuity Corp. on behalf of the Company. Decisions regarding the timing of purchases under the Bid will be determined by Management based on market conditions, share price and other factors. Management may elect to not purchase any Common Shares under the Bid, or may elect to suspend or discontinue the Bid at any time. Any purchases pursuant to the Bid will be financed from the working capital of Titanium.
TOPS

Hot Stocks

08:49 EDT TOP Ships announces compliance with NASDAQ minimum bid price requirement - TOP Ships announced that NASDAQ notified the Company that it has regained compliance with the minimum bid price requirement for the Nasdaq Capital Market, set forth in Nasdaq Listing Rule 5550(a)(2).
CJET

Hot Stocks

08:49 EDT Chijet Motor expands reach to rural areas, leveraging new policies - Chijet Motor announce the successful culmination of its recent rural marketing events for NEV, representing a significant initiative by Chijet Motor to execute on its expansion strategy. This achievement underscores the success of Chijet Motor's strategic initiative to penetrate rural areas with its high-quality NEV offerings. Leveraging the Chinese government's push for NEV adoption in rural regions, Chijet Motor's products have gained substantial traction among rural consumers. Known for their exceptional quality, cost-effectiveness, and versatile usage scenarios, Chijet Motor's NEV products have resonated with consumers in suburban and rural markets across China. Chijet Motor's marketing team has capitalized on the opportunities presented by government policies, such as the Chinese National Development and Reform Commission and the National Energy Administration's 'NEV Going Rural' campaign.
CUEN

Hot Stocks

08:48 EDT Cuentas signs LOI to acquire WHEN Group - Cuentas signed a letter of intent to acquire control of WHEN Group, pending Nasdaq and shareholder approval and other specified conditions, through a share exchange with WHEN's principal shareholder, leaving Cuentas uniquely debt-free and well positioned to grow its mobile and FinTech lines. The WHEN Group was founded by Israeli engineers and international professionals with deep background in Cyber security and data threat remediation in both government and private sectors. From business and personal privacy to fin-tech security, WHEN has been developing solutions that utilize advanced pattern recognition and AI to create a security screening environment that can detect and defend against a range of threats and attacks on telecom, banking, and other communication infrastructure. Upon closing of the acquisition, Cuentas intends to begin integrating WHEN's portfolio of Cyber Security solutions into the Cuentas Mobile Platform as well as offering WHEN's advanced solutions to Cuentas' fintech partners. Cuentas' Management has been working with WHEN to identify immediate opportunities to provide WHEN solutions not only to the CUENTAS mobile platform, but also to the businesses and industries that Cuentas serves in the U.S. and around the world. Additionally, the parties are planning on deploying WHEN's proprietary software to protect families concerned with external cyber threats at home, enabling the monitoring of a child and his environmental behavioral patterns that will alert parents to potential tragedies caused by cyberbullying, pedophiles, other predators, and depression / state of mind. In consideration of the acquisition of the 75% stake in WHEN, Cuentas will issue to UCG, Inc. the principal shareholder of WHEN, such number of common shares of CUEN which will represent on the date of issuance 50% of Cuentas' issued and outstanding capital, in exchange for UCG's stake in WHEN. Subject to the terms of the agreement, WHEN Group management, including Major Gen. Danny Yatom, a former Director of Israeli Mossad, and current President of WHEN, and Giora Rosensweig, CEO with major experience in cyber security and artificial intelligence, will be joining the Cuentas Board of Directors and Executive Management. While the companies will initially continue to operate independently, management from both teams believe the synergies between the companies can pave the way to even deeper relationships. Cuentas' Board of Directors has approved the transaction and the Companies expect to complete the transaction this year. The closing is contingent on several factors, including without limitation, the approval of Nasdaq and the shareholders of Cuentas approving the transaction.
RUM

Hot Stocks

08:48 EDT Rumble will be exclusive RNC livestreamer for third Republican primary debate - Rumble announced that in partnership with the Republican National Committee, RNC, NBC News, Salem Radio Network, and the Republican Jewish Coalition, it will serve as the exclusive RNC livestream provider for the third debate of the Republican presidential primaries. The debate will be held in Miami, Florida on November 8, 2023, and will be hosted and broadcast on television by NBC News. As the RNC's exclusive online home for the debate, Rumble will feature the event on the platform's homepage and make it available for viewers across the country on the RNC's Rumble channel. "The third debate marks a major milestone for Rumble, and we are thrilled to bring the debate stage online and help promote open dialogue once again," said Rumble CEO and Chairman Chris Pavlovski. "As the premier platform for all candidates in the 2024 elections, we're excited to offer viewers another chance to watch democracy in action, and we expect a huge turnout for the exclusive livestream event," he continued.
RVSN

Hot Stocks

08:46 EDT Rail Vision says operations 'remain unaffected' by Israel situation - Rail Vision expressed its deepest sympathies and heartfelt condolences to all those affected by the recent tragic events in Israel. "We are deeply saddened by the distressing situation unfolding in our country," stated Shahar Hania, CEO of Rail Vision. "We empathize with every individual impacted and strongly condemn the acts of violence that have occurred. We are confident in the strength of our people and our nation. Our focus remains on serving our communities, employees, and customers and contributing to a peaceful and prosperous future for all." Despite the challenging circumstances, Rail Vision has ensured that its operations remain unaffected. Rail Vision is dedicated to ensuring the safety and well-being of its employees, customers, and the communities it serves. The Company has robust contingency plans to maintain business continuity and is working closely with local authorities and stakeholders to monitor ongoing events.
NXL

Hot Stocks

08:45 EDT Nexalin Technology announces publication of deep-brain stimulation study - Nexalin Technology announced the publication of a research article titled, "Evidence of a large current of transcranial alternating current stimulation directly to deep brain regions," in Nature's Molecular Psychiatry. The study revealed for the first time, that Nexalin's non-invasive, deep frequency stimulation medical device can directly stimulate the deep intracranial nuclei, areas of the brain frequently associated with trauma and mental health disease. The study also demonstrated that Nexalin's non-invasive Deep Intracranial Frequency Stimulation has the potential to treat neuropsychiatric disorders associated with the hippocampus, insula, amygdala, and other deep nuclei. Mark White, CEO of Nexalin Technology, stated, "It is an honor to see this deep-brain study published in a leading peer-reviewed journal, which reinforces the growing body of clinical evidence supporting the potential of our non-invasive, frequency-based, deep-brain stimulation devices in helping address the global mental health epidemic. The future of neuro-stimulation relies on depth of penetration in a safe and effective manner. Historically, all neurostimulators have limited penetration because of safety and side effects which limits efficacy. We believe Nexalin's new advanced proprietary waveform can eliminate issues with risk and safety while increasing efficacy. The research results have significant scientific value, ushering in a new era of non-invasive neural stimulation, which we believe demonstrates Nexalin is becoming a world leader in this field."
CLS

Hot Stocks

08:45 EDT Celestica launches DS5000 800GbE switch - Celestica aunched its DS5000 high-performance 800GbE switch, delivering speed and agility for data center and enterprise-class access deployments. We are seeking approval to release the DS5000 into the open source domain as the first Open Compute Project-inspired commercial 800G Ethernet switch contribution to the OCP Networking group.
APRE

Hot Stocks

08:44 EDT Aprea Therapeutics presents initial clinical data on ATRi, ATRN-119 - Aprea Therapeutics announced highlights of two posters presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, October 14, 2023 in Boston, MA. The data in the posters include first-in-human clinical data from the ongoing Phase 1 dose escalation trial of ATR inhibitor, ATRN-119 LINK to Poster, and pre-clinical data from the WEE1 inhibitor, ATRN-1051 LINK with planned IND submission Q4 2023. ATRN-119 is in an ongoing Phase 1/2a dose escalation trial in solid tumors to determine the recommended Phase 2 dose, with a daily dosing administration over a 56-day cycle. To date, no hematologic or liver function toxicities in these heavily pretreated solid tumor patients have been observed across the first three cohorts at dose levels of 50mg, 100mg, and 200mg NCT04905914. The efficacy findings are still early in the dose escalation portion of the trial and there was one Stable Disease patient at the 50mg low dose cohort determined at end of cycle 1. The company is actively enrolling cohort 4 at 350mg and anticipates dose expansion of the trial in Q2 2024. The second poster presented focused on ATRN-1051, the WEE1 inhibitor, and highlights the selectivity of ATRN-1051 with low off-target activity against PLK1, PLK2 and PLK3, a family of kinases that promote M phase entry, a critical phase in the cell cycle. The selectivity of ATRN-1051 relative to the WEE1 class is also highlighted by its limited effects on red blood cell counts, hERG inhibition, and body weight loss in the pre-clinical data. PLK off-target activity has been a challenge for other WEE1 inhibitors in this class, as this off-target activity substantially counters the effects of WEE1 inhibition.
LIXT

Hot Stocks

08:44 EDT Lixte Biotechnology, NKI, Oncode Institute expand collaboration - LIXTE Biotechnology announced that it has signed an agreement to expand its collaboration with the Netherlands Cancer Institute, NKI, and Oncode Institute to study drug synergies of LIXTE's lead clinical compound, LB-100, with immunotherapy in various cancers. The new agreement also will seek to find synthetic lethal combinations in additional cancer types. The two-year extension agreement follows successful collaboration during the past two years to identify the most promising drugs to be combined with LB-100 for treating colon cancer, as well as to identify the specific molecular mechanisms underlying the identified combinations in order to provide a rationale to test these combinations in clinical trials. Bas van der Baan, the recently appointed Chief Executive Officer and President of LIXTE, added, "The collaboration with Prof. Bernards and his team provides us with unique insights in our efforts to identify promising therapy combinations for LB-100 and a more targeted approach to cancer treatment."
PHUN

Hot Stocks

08:43 EDT VHC signs multi-year renewal of front door application with Phunware - Phunware has announced a five-year contract renewal to license its digital front door and patented location-based services to VHC Health. "The adoption of a native, mobile-centric digital front door signifies the forefront of innovation that healthcare providers must embrace to revolutionize their approach to patient care. We are pleased that VHC Health's leadership has reaffirmed their partnership with Phunware, acknowledging its critical role in delivering an exceptional patient experience," said Cody Wimbish, Phunware VP of Program Management & Customer Success.
ALLO

Hot Stocks

08:42 EDT Allogene Therapeutics appoints Geoffrey Parker as CFO - Allogene Therapeutics has appointed Geoffrey Parker as Executive Vice President, Chief Financial Officer. Mr. Parker will oversee the Company's financial operations and business strategy and will serve as a member of the Leadership Team. Before joining Allogene, Mr. Parker served as Chief Operating Officer, Chief Financial Officer and Executive Vice President of Tricida.
ACVA

Hot Stocks

08:42 EDT ACV Auctions leverages AI to introduce ClearCar - ACV introduces ClearCar as the global brand for ACV's growing suite of products that enables dealers to more effectively acquire and value consumer vehicles. "ClearCar demystifies the relation between vehicle condition and value, allowing ACV's dealer and commercial clients to have more transparent conversations with consumers. Consumers benefit from having greater visibility into how vehicle value is determined," the company says. ClearCar consists of ClearCar Price and ClearCar Capture. ClearCar Price is a digital pricing engine, a price estimation tool that resides on a dealer's website providing consumers a precise value estimate for their vehicle. ClearCar Capture is a complementary product that allows consumers to submit photos of their vehicles for further documentation of condition through an AI imaging and self-inspection tool. "We are thrilled to announce ClearCar as the brand for dealers to offer consumers a trusted and transparent way to value their vehicle. Dealers needed a solution to help them build trust while remotely purchasing vehicles from the consumers," said ACV CEO George Chamoun. "ClearCar is offered through ACV's growing dealer and commercial partners who market the offering to their end consumers."
IOVA

Hot Stocks

08:40 EDT Iovance Biotherapeutics announces clinical data for lifileucel at ESMO Congress - Iovance Biotherapeutics announced the publication of an abstract reporting clinical data for lifileucel which will be presented at the European Society for Medical Oncology ESMO Congress 2023, October 20-24, 2023 in Madrid, Spain. The abstract reports outcomes of a subset of 12 patients with advanced mucosal melanoma treated with lifileucel in the pooled consecutive cohorts from the C-144-01 trial. All patients had progressed on or after immune checkpoint inhibitor therapy. Patients with mucosal melanoma, which is rare and difficult to treat, have worse outcomes after anti-PD-1 therapy compared to patients with other melanoma subtypes. The ORR assessed by an independent review committee using RECIST v1.1 was 50%. At median study follow-up of 35.7 months, median duration of response was not reached, median progression free survival was NR, and median overall survival was 19.4 months. Treatment emergent adverse events were consistent with known safety profiles of lymphodepleting chemotherapy and interleukin-2.
BBKCF

Hot Stocks

08:38 EDT Bigg Digital Assets appoints Dan Reitzik as CEO - BIGG Digital announced an initiative that furthers the unique capabilities of its subsidiaries: Netcoins, Blockchain Intelligence Group and TerraZero Technologies. BIGG plans to set the pace for how blockchain, crypto, digital assets and virtual environments can work in tandem to greatly increase the value of all portfolio companies within the future of the Internet and digital technologies. To this end, BIGG is appointing Dan Reitzik, former CEO of DMG Blockchain Solutions.BIGG's current CEO, Mark Binns, is formally stepping down as CEO, as well as from the board of directors. Mr. Binns will continue as a consultant during a six month transitional period, as Mr. Reitzik focuses on and energizes BIGG's portfolio. All other Board members continue to serve on the Board and Lance Morginn will be supporting the Company as the newly appointed Chair of the Board.
MTEK

Hot Stocks

08:38 EDT Maris-Tech expands activity in U.S. defense market, appoints Emanuel to board - Maris-Tech announced significant steps toward expansion of its activity in the U.S. market. The Company announced the appointment of Adam Emanuel of Emanuel & Associates, Inc., located in Washington, D.C., to Maris-Tech's Advisory Board and the Company's partnership with him and Altagrove, a defense and space manufacturing company that delivers smart and innovative technology solutions to create competitive customer advantages, located in Virginia, to facilitate the marketing of its products in the U.S. governmental and defense market.
DCTH

Hot Stocks

08:36 EDT Delcath Systems announces publication on SIRT in Cancers journal - Delcath Systems announced the publication of an article entitled "Selective Internal Radiotherapy, or SIRT, and Chemosaturation Percutaneous Hepatic Perfusion, or CS-PHP, for Metastasized Uveal Melanoma: A Retrospective Comparative Study" in the peer reviewed oncology journal Cancers. CS-PHP utilizes CHEMOSAT, Delcath's proprietary European CE Marked Hepatic Delivery System, or HDS, to administer high-dose chemotherapy, or melphalan, to the liver, while controlling systemic exposure and associated side effects during a PHP procedure. Initial findings were previously presented on September 9, 2023 at the Cardiovascular and Interventional Radiological Society of Europe, or CIRSE, Annual Meeting held in Copenhagen, Denmark. Uveal melanoma usually shows a liver-dominant metastasis spread and is often treated with liver directed therapies. This retrospective study compared two cohorts of patients with liver dominant uveal melanoma treated at the University Hospitals Tubingen, Germany with multiple cycles of either CS-PHP or SIRT. Patients included in the study were treated between December 2013 and February 2020. Allocation to treatment was determined by a multidisciplinary team. Presence of extrahepatic disease at baseline favored the SIRT group , as did the hepatic tumor load. Tumor responses were evaluated by consensus reading by two experienced radiologists.
TERN

Hot Stocks

08:36 EDT Terns Pharmaceuticals announces Phase 1 trial design of TERN-701 - Terns Pharmaceuticals announced the U.S. Food and Drug Administration's clearance of the Company's Investigational New Drug application and the design of the CARDINAL Trial, Terns' global Phase 1 clinical trial to evaluate the safety, tolerability, pharmacokinetics and efficacy of TERN-701 in participants with chronic myeloid leukemia. TERN-701 is the Company's proprietary, allosteric BCR-ABL tyrosine kinase inhibitor, designed to target the BCR-ABL myristoyl pocket. "Allosteric BCR-ABL inhibitors comprise a novel class of therapy for CML that has been shown to have superior efficacy and improved safety compared to active-site inhibitors in prior studies. We are particularly pleased with our Phase 1 trial design for TERN-701 as it will recruit chronic CML patients who experienced treatment failure on at least one prior second-generation TKI. This will allow us to offer a novel investigational allosteric inhibitor to CML patients in as early as their second line of therapy, where there are currently no approved allosteric inhibitors," said Emil Kuriakose, MD, chief medical officer-oncology at Terns Pharmaceuticals.
CNNEF

Hot Stocks

08:36 EDT Canacol Energy announces exercise of warrants in Arrow Exploration - Canacol Energy filed an early warning report today in connection with the exercise on October 13, 2023 by Canacol of 18,357,602 warrants to purchase 18,357,602 common shares in the capital of Arrow Exploration Corp. , a public company listed for trading on the TSX Venture Exchange and the AIM Market of the London Stock Exchange, at an exercise price of GBP 0.09 per Common Share. The Exercised Warrants had been acquired by Canacol pursuant to a private placement completed by Arrow October 25, 2021. Prior to the exercise of the Exercised Warrants, Canacol held an aggregate of approximately 22.5% of the issued and outstanding Common Shares of Arrow on a partial diluted basis, being 41,715,205 Common Shares of Arrow and 18,357,602 warrants to purchase additional common shares of Arrow at an exercise price of GBP 0.09
WE

Hot Stocks

08:36 EDT WeWork names David Tolley as Chief Executive Officer - WeWork announced that David Tolley has been named Chief Executive Officer. Tolley has served as a WeWork Board Member since February 2023 and as interim Chief Executive Officer since May 2023. "WeWork's ability to define and lead an evolving world of work is a direct result of the tenacity and hard work of our employees who have built an exceptional product, member experience, and brand," said Tolley. "As companies continue to rethink their office strategies, and demand for flexible office space continues to grow, WeWork offers a unique suite of solutions that empower entrepreneurs and companies of all sizes to collaborate together, evolve and thrive." Tolley most recently served as Chief Financial Officer of Intelsat S.A. from 2019 to 2022. Over the course of his career, Tolley has also served as Chief Financial Officer of OneWeb, was a private equity partner at Blackstone from 2000 to 2011 and prior to that was a Vice President in the Investment Banking Division of Morgan Stanley...WeWork also announced that current WeWork Board member, Paul Keglevic, was appointed Chair of the Board of Directors, effective September 1.
CVLT

Hot Stocks

08:36 EDT Commvault names Alex Janas as Field Chief Technology Officer, Security - Commvault announced that veteran security leader Alex Janas has joined the company as its new Field Chief Technology Officer overseeing security. With Janas' appointment, Commvault is doubling down on its commitment to redefine data protection and deliver cyber resilience with industry-leading threat detection and rapid recovery capabilities. Janas comes to Commvault with nearly 20 years of private sector cybersecurity experience, as well as offensive security skills he developed as an Analyst, Operator, and Technical Director while working at the National Security Agency.
CMRA

Hot Stocks

08:34 EDT Comera Life Sciences presents SQore platform technology data - Comera Life Sciences Holdings will present research demonstrating Comera's SQore platform capabilities in the development of subcutaneous monoclonal antibody formulations at the PODD: Partnerships in Drug Delivery conference in Boston, Mass. Yuhong Zeng, Ph.D., Director of Formulation at Comera, will present data from Comera's SQore platform which is designed to transform intravenous biologics such as monoclonal antibodies nto subcutaneous formulations. Comera's SQore platform has been successfully tested with over 40 mAbs, with viscosity reductions of up to 85%. Comera uses the SQore platform to identify the driving forces for high viscosity and select excipients that inhibit attractive protein-protein interactions to lower viscosity. Comera is also presenting data from a preclinical study, previously published in the Journal of Pharmaceutical Sciences, that found that a caffeine excipient reduced viscosity of the monoclonal antibody ipilimumab without any adverse impact on antibody pharmacokinetic properties. The addition of one or more excipients, such as caffeine, selectively interrupts intermolecular interactions to reduce viscosity of high concentration mAb formulations.
BBAI

Hot Stocks

08:34 EDT BigBear.ai broadens works with U.S. Air Force - BigBear.ai announced an expanded commitment from the Air Force Research Laboratory's, AFRL, Composable Collaborative Planning BAA. To date, BigBear.ai has collaborated with AFRL to accelerate the military planning process. Traditional planning processes take up to two years to build and affirm. BigBear.ai's technology will enable the delivery of resource-informed plans in less than a month. "We are honored to be a part of the United States Military's ongoing efforts to modernize military planning and preparedness," said Mandy Long, CEO of BigBear.ai. "Our planning tools will be augmented specifically to address contested logistics challenges, resulting in dramatic improvements to risk-informed planning. We are grateful that the AFRL is continuing its commitment to BigBear.ai based on the success of our work to date."
ALHC

Hot Stocks

08:33 EDT Alignment Healthcare California, North Carolina Medicare receive high scores - Alignment Healthcare announced that its California Medicare Advantage HMO - which represents roughly 89% of its MA membership - has maintained an overall 4- out of 5-star rating from the Centers for Medicare & Medicaid Services for 2024, marking its seventh consecutive year as a 4-star or greater plan. Additionally, its North Carolina HMO achieved an overall 4.5- out of 5-star rating for 2024, its second year eligible for rating. "Our noteworthy star ratings reflect the high quality of our plans and service, but we are not done," said John Kao, founder and CEO of Alignment Healthcare. "We are committed to ensuring that all our members receive five-star quality care and service, which is why we continually push to elevate and enhance our member experience. At the heart of everything we do is our seniors, and we will continue to listen closely to our members to deliver the care they need and deserve."
FCEL

Hot Stocks

08:33 EDT FuelCell, Oando sign MOU for green hydrogen, low-carbon energy production - FuelCell Energy and Oando Clean Energy announce the signing of a memorandum of understanding to collaborate on the development of a 5 to 15-Megawatt power plant. In addition to FuelCell Energy's fuel cell and electrolyzer technology, the agreement also includes the potential for the use of FuelCell Energy's carbon capture and sequestration technologies. Unlike other carbon capture technologies that require power to capture carbon dioxide, FuelCell Energy's platforms can produce power while simultaneously capturing carbon dioxide. The signing of this MOU is an integral part of OCEL's drive to strengthen electricity access in African markets via low-carbon renewable energy sources starting in its home country, Nigeria.
IMAX

Hot Stocks

08:33 EDT Imax announces $13M debut for 'TAYLOR SWIFT: THE ERAS TOUR' - IMAX hit a high note at the global box office this weekend with a $13M debut for "TAYLOR SWIFT: THE ERAS TOUR", making it the biggest IMAX opening ever for a film by a musical artist - concert or documentary. The highly anticipated release from the global pop icon earned an impressive $11M in North America on IMAX screens - good for 11% of the overall Domestic gross - in addition to $2M oversees.
SPRC

Hot Stocks

08:32 EDT SciSparc regains compliance with Nasdaq minimum bid price notification - SciSparc reported the receipt of a formal notification from The Nasdaq Stock Market that the Company has regained compliance with Listing Rule 5550(a)(2), which requires the Company's ordinary shares to maintain a minimum bid price of $1.00 per share. The Nasdaq staff made this determination of compliance after the closing bid price of the Company's ordinary shares was at $1.00 per share or greater for the prior 10 consecutive business days. Accordingly, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2) and Nasdaq considers the prior bid price deficiency matter now closed.
MDAI

Hot Stocks

08:31 EDT Spectral AI adds additional clinical sites to DFU study - Spectral AI announced the addition of seven clinical sites that are currently enrolling to support the development of its diabetic foot ulcer application for the DeepView Wound Imaging System. The proprietary technology combines multi-spectral imaging and AI technology to provide clinicians with an immediate healing assessment of DFU's for more accurate and timely diagnosis and therapeutic intervention. Participating investigators and clinical sites include: Dr. Tony Alleman, MD, University of Tennessee Health Science Center; Dr. Ian Barron, DPM, Gentle Foot Care Hilliard and Gentle Foot Care Grove City; Dr. Stephen Frania, DPM, Foot and Ankle Specialist of Ohio; Dr. Vladimir Zeetser, DPM, Premium Podiatry and Wound Care; Dr. Charles Ananian, DPM, New Hope Podiatry Group; Dr. Karl Fulkert, DPM, Worthington Foot and Ankle.
NUE

Hot Stocks

08:31 EDT Nucor unit acquires Garden Street Iron & Metal assets - Nucor announced an acquisition on behalf of its recycling subsidiary River Metals Recycling. RMR has acquired all Cincinnati-based Garden Street Iron & Metal assets, including one feeder and one shredder yard, bringing RMR's total number of recycling facilities to 19. This is consistent with Nucor's raw materials strategy and demonstrates its commitment to expanding the regional recycling platforms supporting the company's steel mills. The 43 employees of Garden Street have been offered positions with RMR.
SILO

Hot Stocks

08:31 EDT Silo Pharma announces results on SPU-21 peptide against Rheumatoid Arthritis - Silo Pharma announced positive data from a preclinical study investigating the binding affinity and optimization of SPU-21 liposomal joint homing peptide in human synovial tissue surrounding joints and tendons. SPU-21 selectively targets inflamed synovial tissue to inhibit the progression of rheumatoid arthritis, RA. "The purpose of this study was to expand our investigation of our patented SPU-21 cyclic peptide beyond preclinical animal models to human tissue assays," said Eric Weisblum, Chief Executive Officer of Silo Pharma. "The data shows strong binding affinity to the main stromal cells in human RA synovial tissue, indicating the peptides' preferential interaction with the inflamed synovial tissue for disease-suppressive effects. We look forward to our next data readout for SPU-21 by the end of the year or early 2024." The University of Maryland, Baltimore is Silo Pharma's collaboration partner for SPU-21 development. In addition to SPU-21, Silo Pharma holds a license agreement with UMB for a central nervous system homing peptide targeting multiple sclerosis and other rare neurological diseases designated
LKQ

Hot Stocks

08:30 EDT LKQ Corp. announces extension of exchange offer - LKQ Corporation has extended the expiration date for its offer to exchange any and all of its outstanding $800 million aggregate principal amount of 5.75% senior notes due 2028 and $600 million aggregate principal amount of 6.25% senior notes due 2033 for equal principal amounts of new issues of each series of such notes registered under the United States Securities Act of 1933. The exchange offer, which was originally scheduled to expire at 5:00 p.m., New York City time, on Friday, October 13, 2023, has been extended until 5:00 p.m., New York City time, on Friday, October 20, 2023, unless further extended. All other terms, provisions and conditions of the exchange offer will remain in full force and effect. A Form S-4 registration statement filed by LKQ with the United States Securities and Exchange Commission regarding the exchange offer was declared effective by the United States Securities and Exchange Commission on September 14, 2023. As of 5:00 p.m., New York City time, on October 13, 2023, approximately $797,264,000.00 in aggregate principal amount of the 2028 original notes and approximately $599,008,000.00 in aggregate principal amount of the original 2033 notes have been tendered and not withdrawn in the exchange offer. The expiration date for the exchange offer is being extended to provide time for remaining outstanding unregistered notes to be exchanged.
NMIH

Hot Stocks

08:28 EDT National Mortgage partners with TRUE to advance digital mortgage ecosystem - National Mortgage Insurance, a subsidiary of NMI Holdings, has partnered with TRUE, the leader in lending intelligence, to streamline operational capabilities and expand homeownership opportunities by unleashing the power of AI-driven automation. The partnership combines National MI's private mortgage insurance platform that facilitates homeownership opportunities for borrowers who need down payment support with TRUE's Data Intelligence product and unique AI-powered document and data processing capabilities. By integrating TRUE's AI technology into its digital mortgage ecosystem, National MI expects to reduce its document and data processing times while dramatically accelerating loan decision timelines. By working together, National MI and TRUE will provide critical relief to all three groups by delivering seamless, faster loan responses while reducing the burden and cost of manual reviews and increasing data quality. "We have been on a mission from day one to help more people experience the stability and security of homeownership," said Ari Gross, CEO and co-founder of TRUE. "Working together with National MI to help lenders make informed lending decisions by harnessing the power of AI is an important step toward our goal. We are not only providing the latest lending decision technology; we are helping to fulfill the American dream of homeownership more efficiently."
RNAZ

Hot Stocks

08:27 EDT Transcode Therapeutics reports treatment of tumors using TTX-RIGA - TransCode Therapeutics reported successful treatment of preclinical melanoma tumors using its immunotherapy candidate, TTX-RIGA. The study showed a significant inhibition of tumor growth. In a mouse model of melanoma, systemic injection of TTX-RIGA demonstrated that the therapeutic candidate was effective in reducing primary tumor growth. It also elicited an immune response against secondary recurrent tumors, inhibiting their growth by 70%. This stands in contrast to intratumorally-administered standard RIG-I activators, which have demonstrated efficacy confined to the primary tumor. TransCode's approach is designed to achieve persistent cell-mediated immunity by targeted activation of innate immunity in cancer cells within the tumor microenvironment. TransCode believes that its approach helps establish RIG-I as a clinically relevant target in oncology for a variety of solid tumors including melanoma, glioblastoma multiforme, pancreatic, colorectal and breast cancer, and especially tumors that are prone to recurrence after initial treatment.
CATX

Hot Stocks

08:26 EDT Perspective completes recruitment for first patient cohort in VMT01 trial - Perspective Therapeutics announced the completion of recruitment for the first patient cohort in its Phase 1/2a dose escalation study of 212Pb-VMT01, its targeted alpha-particle therapy, in development for the treatment of MC1R-positive metastatic melanoma.
BNOX

Hot Stocks

08:23 EDT Bionomics announces end-of-Phase 2 meeting with FDA, solidifies plan for BNC210 - Bionomics announced the successful and favorable outcomes of an End-of-Phase 2 meeting meeting with the U.S. Food and Drug Administration, FDA, supporting the advancement of its lead asset BNC210 for the acute treatment of Social Anxiety Disorder, SAD, into Phase 3 registrational studies based on the recently completed Phase 2 PREVAIL dataset. On October 11, Bionomics received the official meeting minutes from the EoP2 meeting with the FDA held on September 13, 2023 reflecting that Bionomics has reached an agreement with the FDA on: 1) the plan to conduct two randomized, placebo-controlled studies with single administration of BNC210 during a public speaking task; 2) the use of the Subjective Units of Distress Scale measured during a public speaking challenge as the primary efficacy endpoint; 3) the doses of BNC210 to be studied in Phase 3; 4) the sample size assumptions for the Phase 3 controlled studies based on PREVAIL findings; 5) the design elements of the open label safety study required to support the new drug application; 6) the size of the safety database to support the NDA; and 7) the nonclinical toxicology studies needed to support the NDA.
ENTX

Hot Stocks

08:22 EDT Entera Bio reports rapid PD response, consistent PK data for PTH mini tablets - Entera Bio presented 2 posters at the Annual Society of Bone and Mineral Research 2023 Annual Meeting held on October 13-16, 2023 in Vancouver, BC, Canada. The lead drug candidate of Entera's EBP05 formulation, EB613 is currently being developed as the first once-daily oral anabolic therapy for the treatment of osteoporosis. Abstract Title: First Oral PTH Tablet Treatment for Osteoporosis Demonstrates Rapid Pharmacodynamic Effect on Plasma Levels of Endogenous PTH. A Phase 1 study comparing oral EB613, subcutaneous hPTH 20 g and a new generation of Entera's oral peptide delivery platform is ongoing. One of the first objectives of this study is to rapidly evaluate the pharmacodynamic effects of Entera's oral PTH tablets. This analysis relates to Entera's lead formulation. Additional data on new formulations will be released later in 2023. An increase in plasma ionized calcium should result in decreased secretion and plasma concentrations of endogenous PTH. Thus, a reduction in plasma PTH should provide an early indication of the systemic exposure and pharmacologic activity of Entera's oral PTH tablets. In the study, the mean percentage of endogenous plasma PTH 120 minutes after dosing was 59.2%, 54.3%, and 52.3% for EB613 1.5 mg, 2.5 mg and Forteo, respectively; and showed consistent effects across other early PD markers such as serum calcium, phosphorus, and 1,25-dihydroxyvitamin D. Abstract Title: Pharmacokinetic Profile of EBP05/EB613 Oral Teriparatide Tablets in Women of Post Menopausal Age Versus Young Adult Men. This retrospective analysis compares the pharmacokinetic profile of EBP05 in healthy young males versus female patients of menopausal age with hypoparathyroidism. A single administration of the same dose, 2.25 mg oral PTH, in healthy young men and women of postmenopausal age resulted in a median Cmax of 425 pg/ml vs 521 pg/ml, and a median AUC of 157 pg*hour/ml vs 158 pg*hour/ml respectively
PLM

Hot Stocks

08:20 EDT PolyMet Mining announces ISS, Glass Lewis recommendations for Glencore deal - PolyMet Mining announced that both independent proxy advisors, Institutional Shareholder Services, or ISS, and Glass Lewis, have recommended PolyMet shareholders vote for the plan of arrangement with Glencore whereby, among other things, Glencore will acquire the approximately 17.8% of the issued and outstanding common shares of PolyMet that Glencore does not currently own. PolyMet shareholders will receive an all-cash consideration of $2.11 per share under the terms of the arrangement, which represents a premium of approximately 167% to the closing price of PolyMet shares on the NYSE American on June 30, being the last trading date prior to the announcement of Glencore's non-binding Proposal to acquire the Minority Shares. The consideration also represents a premium of approximately 34% to the closing price of the company's shares on the NYSE American on June 6, being the last trading day before the announcement of the Clean Water Act Section 404 permit revocation.
JKHY

Hot Stocks

08:19 EDT Jack Henry and Member Driven Technologies extend partnership, no terms - Member Driven Technologies or MDT and Jack Henry announced that they have extended their partnership, continuing to work together to help credit unions improve member service and efficiencies through leading solutions and services. Through the partnership, MDT hosts the Symitar core processing system from Jack Henry to provide a private cloud alternative for core processing and IT needs. "MDT is a trusted leader in helping credit unions of all sizes launch and optimize digital technology to enhance the member experience and effectively compete," said Shanon McLachlan, President of Credit Union Solutions for Jack Henry. "By extending our successful, long-term partnership, MDT will further our technology modernization strategy, helping credit unions across the country leverage sophisticated cloud-based and digital tools to create a competitive differentiator."
NOTV GMDA

Hot Stocks

08:18 EDT Inotiv appoints Terry Coelho to board of directors - Inotiv announced the appointment of Terry Coelho to its Board of Directors. Ms. Coelho is replacing Richard Johnson PhD, who is leaving the Board as part of the Board's succession planning. Ms. Coelho was also appointed to serve as a member of the Compensation Committee and the Audit Committee, and as a member and the Chair of the Nominating/Corporate Governance Committee of the Board. Ms. Coelho is the CFO at Gamida Cell Ltd., a public, commercial stage biotech company.
RARE

Hot Stocks

08:17 EDT Ultragenyx announces program, updates on GTX-102, UX701, setrusumab - Ultragenyx Pharmaceutical will provide updates on its development pipeline, including setrusumab for osteogenesis imperfecta, GTX-102 for Angelman syndrome, UX701 in Wilson disease and the rest of the company's gene therapy portfolio at an Analyst Day held in New York City and by webcast. Analyst Day Updates. "UX143 monoclonal antibody for Osteogenesis Imperfecta: Interim Phase 2 data from the Phase 2/3 Orbit study show statistically significant decrease in annualized fracture rates following at least 6 months of treatment." Data presented at the American Society for Bone and Mineral Research 2023 Annual Meeting show that treatment with setrusumab reduced the annualized fracture rate by 67% and this reduction was associated with continuing large and meaningful improvements in bone mineral density. Setrusumab was generally well tolerated with no drug related serious adverse events reported and no reports of drug-related hypersensitivity. The company plans to provide updated Phase 2 data next year. "GTX-102 antisense oligonucleotide for Angelman syndrome: Data from the extension cohorts in the Phase 1/2 study show clinically meaningful improvements in multiple domains." Quantitative data show improvements across multiple clinical domains compared to natural history data, where available, and clinical changes were associated with quantitative changes in EEG. Long term data showed patients who stopped and restarted treatment reacquired previously gained developmental skills when they were re-dosed with the current regimen. There have been no additional treatment-related SAEs, including lower extremity weakness, since November 2022. Data from the dose expansion cohorts on at least 20 patients who have been on therapy for at least 6 months is anticipated in the first half of 2024. "UX701 AAV gene therapy for Wilson disease: Four of five patients in the lowest-dose cohort of the Phase 1/2/3 Cypress 2+ study show improvements in tapering standard of care": Four out of 5 patients in the low-dose Cohort 1 have had reductions in urinary copper and are tapering off of chelators and/or zinc therapy, including 2 of 3 earlier treated patients in the Cohort that are now completely off standard therapy. UX701 has been generally well tolerated with no treatment-related SAEs. The seamless study is expected to complete dosing of all 3 dose cohorts in Stage 1 at the end of 2023 and these data are expected in the first half of 2024. Company also provided update on other late-stage gene therapy candidates: DTX401 AAV gene therapy for Glycogen Storage Disease Type Ia: The Phase 3 GlucoGene study was fully enrolled in the first quarter of 2023 and the company plans to provide preliminary data in the first half of 2024. UX111 for Sanfilippo syndrome: The pivotal Transpher A study has been fully enrolled and the company plans to meet with the FDA in the fourth quarter of 2023. DTX301 AAV gene therapy for Ornithine Transcarbamylase Deficiency: The Phase 3 Enh3ance study is expected to complete enrollment in the first half of 2024.
GNS

Hot Stocks

08:16 EDT Genius Group enters joint venture with RetreatVR - Genius Group entered into a joint venture agreement to develop the Genius Metaversity 'Life Campus' with RetreatVR, the founding team of GeniusX and developers of Retreat App, a virtual reality education application on the Meta VR Store that hosts classes featuring top experts in the Metaverse. Life Campus will be the newest addition of learning content to the four current virtual campuses on Genius Group's Edtech platform, GeniusU, serving its 5.4 million students from around the world. The current campuses each deliver freemium and premium courses to their particular audience of students both digitally and via microschools at locations with GeniusU's 14,000 partners globally. Life Campus will complement these campuses by delivering courses on health, mental health, relationships, communication and life skills delivered by leading experts. The goal of the joint venture is to combine the strength of GeniusU's current platform, students and partners together with RetreatVR's courses and partners, including those already developed in virtual reality on the Meta VR store with Retreat App, featuring experts in creativity, careers, wellness, mindset, relationships, financial well-being and entrepreneurship. The joint venture will build Life Campus initially on Genius Metaversity, accessible via PC and laptop via GeniusU, and then to build it to also be accessible with the next generation of VR headsets in a combination of 2D and 3D as an app on the Meta Store and Apple Vision Pro platform. The Company and RetreatVR will also be developing Genius Group's Genie AI into an interactive AI teaching assistant in VR personalized to each student, combining the 3D avatars that RetreatVR has developed with GeniusU's Genie AI that advises each student based on their personal talents, passions, purpose and learning goals. The Company anticipates Life Campus will be market ready and open to its students on GeniusU in Q1 2024.
CRBP

Hot Stocks

08:15 EDT Corbus Pharmaceuticals presents pre-clinical characterization of CRB-701 - Corbus Pharmaceuticals announced that a poster characterizing the pre-clinical validation of CRB-701, a next generation antibody drug conjugate targeting nectin-4 was presented at the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics held in Boston on October 14th 2023. The poster, titled Development of CRB-701: A novel site-specific Nectin-4 targeting ADC, provides an overview of the pre-clinical development and validation of the differentiating features of CRB-701, including: Site specific conjugation chemistry and a stable linker that leads to low payload release in plasma. A novel nectin-4 targeting monoclonal antibody with improved speed of internalization and a pharmacokinetic profile that can support Q3W dosing in the clinic. A safety profile supports dosing at higher ADC exposures relative to enfortumab vedotin. CRB-701 demonstrates statistically significant tumor growth inhibition in preclinical models that express mid- and high-levels of nectin-4, similar to EV. However, in a low expression model, CRB-701 also exhibited statistically significant tumor growth inhibition in a primary bladder tumor model with low nectin-4 expression where EV did not. CRB-701 has a longer half-life than EV and is being dosed on a Q3W schedule in the clinic. When dosed at 1.2 mg/kg CRB-701 demonstrated notably lower levels of free MMAE.
NVEE

Hot Stocks

08:14 EDT NV5 Global awarded $7M contract for pedestrian safety improvements in NYC - NV5 Global has been awarded a $7 million contract to design pedestrian safety improvements along Lexington Avenue in New York City by the New York City Department of Design and Construction. NV5 will deliver engineering design, project management, and inspection services for the three-year project along Lexington Avenue from 41st to 49th Street and 49th Street from Lexington Avenue to 3rd Avenue. The improvements will enhance safety and provide equitable mobility for all users by providing traffic calming measures, ADA-compliant walking routes, upgrades to accessible pedestrian signals, drainage improvements, and subsurface utility infrastructure upgrades to support the recent Midtown rezoning. NV5 has provided professional design and resident engineering inspection services to the NYCDDC since the department's inception in 1996.
ENPH

Hot Stocks

08:14 EDT Enphase Energy launches IQ8 Microinverters in India - Enphase Energy announced that it has started shipping IQ8 Microinverters, with peak output AC power of 480 W, in India to support newer high-powered solar modules. "Enphase actively works with installers to ensure we're meeting the needs of their businesses and customers as part of our commitment to expand our product offerings worldwide," said Aaron Gordon, vice president and general manager of the microinverter business unit at Enphase Energy. "IQ8 Microinverters feature our most advanced technology to date that's compatible with the wide range of solar modules on the market today, and we're pleased to support the newer high-powered solar modules in India."
PCVX

Hot Stocks

08:13 EDT Vaxcyte, Lonza expand collaboration for PCV manufacturing - Vaxcyte and Lonza announced the companies have entered into a new commercial manufacturing agreement. Expanding on their existing collaboration, this agreement supports the potential global commercialization of Vaxcyte's PCV candidates, VAX-24 and VAX-31, in both the adult and pediatric populations. This agreement complements Vaxcyte's plans to utilize existing Lonza infrastructure to advance clinical development and the anticipated initial U.S. launch of VAX-24 for the adult population. Under the terms of the agreement, Lonza will provide Vaxcyte with a custom-built manufacturing suite as part of Lonza's Ibex Dedicate Biopark at its Visp site to manufacture key components, including drug substances, for Vaxcyte's PCV franchise. Beginning with VAX-24, which is moving into late-stage clinical development, Vaxcyte's dedicated manufacturing suite is expected to meet the potential long-term market demand for both the adult and pediatric populations globally. The design of the dedicated manufacturing suite is nearly complete, with equipment installation expected to begin in 2024. Lonza is anticipated to create up to 300 new jobs upon reaching peak capacity.
ACRV

Hot Stocks

08:12 EDT Acrivon Therapeutics presents data on AP platform, ACR-368 OncoSignature Assay - Acrivon Therapeutics announced data highlighting its AP3 approach to identify and evaluate biomarkers for its OncoSignature assay designed specifically to predict sensitivity to ACR-368, the company's selective small molecule inhibitor targeting CHK1 and CHK2, currently in registrational-intent Phase 2 clinical trials. The data were presented in two posters at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston this past week. The poster titled "Identification of Biomarkers Predictive of Sensitivity to the CHK1/2 Inhibitor ACR-368 Using High-Resolution Phosphoproteomics and Development of an ACR-368-Tailored Patient Responder Identification 3-Marker Test, ACR-368 OncoSignature" showed data leveraging the company's AP3 approach, including ultra-high resolution, quantitative mass spectrometry-based phosphoproteomics profiling combined with proprietary approaches to identify three classes of functionally orthogonal candidate biomarkers specifically predictive of sensitivity to ACR-368. Biomarker candidates were initially evaluated through pathway reconstitution and in cellular functional assays, after which they were assembled into the ACR-368 OncoSignature assay for further functional validation. The quantitative multiplex in situ ACR-368 OncoSignature assay was used to provide a direct readout of the activity state of the drug target signaling axis regulated by ACR-368 and that the tumor depends on for dysregulated CHK1/2-driven DNA repair and replication stress. These data support the use of the company's ACR-368 OncoSignature assay in its ongoing registrational-intent Phase 2 clinical trials, and demonstrate the distinctive, practical application of the company's AP3 platform. The poster titled "Validation of the OncoSignature Assay, an ACR-368-Tailored Response-Predictive Quantitative Multiplexed Immunofluorescent Assay for Prediction of Sensitivity to the CHK1/2 Inhibitor ACR-368 in Individual Patients with Cancer" provided data validating the ability of the AP3-derived ACR-368-specific OncoSignature assay to predict tumor response to ACR-368 in multiple blinded, prospectively-designed preclinical studies, including two separate studies on pretreatment tumor biopsies from past Phase 2 clinical trials in patients with ovarian cancer and in tumor types predicted sensitive to ACR-368, including endometrial cancer. In the two pretreatment tumor biopsy studies, the ACR-368 OncoSignature test was overall able to segregate responders from non-responders with high accuracy and enrich for responders, achieving an overall response rate of 47% and 58% with strong statistical significance. Endometrial and bladder cancers were identified as new tumor types predicted sensitive to ACR-368 in 30-40% of cases. Data in the poster confirmed the predicted efficacy in genetically non-modified, PDX models of endometrial cancer, and further demonstrated that the ACR-368 OncoSignature assay could predict sensitive from insensitive models with an AUC of 0.88 in blinded studies.
FAT

Hot Stocks

08:10 EDT Johnny Rockets opens first location in Iraq - FAT Brands announces nine openings for Johnny Rockets. The most recent new opening, in Baghdad, marks the first Iraqi location, and is operated by Alanwar Alarabiya. Since February, Johnny Rockets has also opened international locations in the following cities: Fortaleza, Brazil, Cumbica International Airport in Sao Paulo, Brazil, Santiago, Chile, Lima, Peru, Dubai, United Arab Emirates, Abu Dhabi, United Arab Emirates, Talca, Chile, and one ghost kitchen in the United Arab Emirates. Johnny Rockets around the world serve the classic fare that put the brand on the map over 35 years ago, including juicy, made-to-order burgers and hand-spun shakes.
CEG

Hot Stocks

08:10 EDT Constellation Energy has 'key role' in $1B clean hydrogen hub awarded by DOE - Constellation "is a major participant in the MachH2 hydrogen hub recently selected for up to $1B by the Department of Energy DOE as part of the bipartisan Infrastructure Investment and Jobs Act. Constellation will use a portion of the hub funding to build the world's largest nuclear-powered clean hydrogen production facility at its LaSalle Clean Energy Center in Illinois. The project will produce an estimated 33,450 tons of clean hydrogen each year and create thousands of good-paying jobs. Constellation estimates its LaSalle clean hydrogen facility will cost about $900 million, with a portion of the MachH2 award offsetting the project's cost.
CRSP

Hot Stocks

08:10 EDT Crispr Therapeutics proposes to elect Sandy Mahatme to board of directos - CRISPR Therapeutics proposes to elect Sandy Mahatme, LL.M. to its Board of Directors at the Company's next annual general meeting to be held in 2024. Mr. Mahatme currently serves as President, Chief Operating Officer and Chief Financial Officer of National Resilience Inc., a technology-focused biomanufacturing company dedicated to broadening access to complex medicines.
KTOS BA

Hot Stocks

08:09 EDT Kratos Defense announces MoU between Technical Directions, Boeing - Kratos Defense & Security Solutions (KTOS) announced a Memorandum of Understanding, MoU, between Technical Directions, TDI, a business unit within Kratos Unmanned Systems Division, and Boeing (BA) for the TDI-J85 turbine engine to provide propulsion for the Powered Joint Direct Attack Munition, JDAM. Boeing's Powered JDAM combines a 500-pound ordnance, the conventional JDAM guidance kit, with a wing kit and a Kratos TDI-J85 engine to deliver high-end range at an affordable price. The cost savings is in part due to the low-cost turbine engine technology developed and enhanced by TDI over four decades. Powered JDAM will provide low-cost stand-off capability against land and maritime threats. Leveraging the JDAM family of weapons, it is designed to be produced at scale, exportable to any of the 35 JDAM partner nations, at a cost-point that enables affordable mass. "We are proud that Boeing has selected our TDI-J85 engine for the Powered JDAM system. Incredible potential exists for this long-range, precision strike capability," said Joseph Kovasity, Senior Vice President for TDI. "At Kratos TDI, we have been singularly focused on producing small, low-cost, military-grade turbine engines at quantity in the United States with U.S. suppliers and partners. With the Kratos acquisition of TDI, we have substantially invested in manufacturability for production scale resulting in an incredibly high engine performance-to-cost ratio, while ensuring we can meet the large quantity deliveries predicted for the Powered JDAM system and program."
VSTO

Hot Stocks

08:08 EDT Vista Outdoor to sell sporting products business to CSG for $1.91B in cash - Vista Outdoor announced a definitive agreement to sell its sporting products business to Czechoslovak Group, or CSG, for an enterprise value of $1.91B in an all-cash transaction subject to customary closing conditions. This transaction represents the next step in Vista Outdoor's plan to split the company into separate entities, which was previously announced on May 5, 2022. CSG is 100% owned and led by Michal Strnad. The transaction values the Sporting Products business at an enterprise value of $1.91 billion, on a cash-free, debt-free basis with a normalized level of working capital, and is supported by $1.11 billion of fully committed debt financing with the remaining amount funded by CSG. The valuation is approximately 5x enterprise value to Sporting Products FY24 EBITDA, including estimated standalone costs. To effect the transaction, Vista Outdoor will separate its Outdoor Products business from its Sporting Products business, and CSG will merge one of its subsidiaries with Vista Outdoor (holding only the Sporting Products business), with current public stockholders of Vista Outdoor receiving shares of Outdoor Products (recently rebranded as Revelyst) and approximately $750 million in cash in the aggregate. This will be treated as a taxable sale of a stockholder's Vista Outdoor shares for the Outdoor Products shares and cash consideration they receive in the merger, allowing stockholders to recover tax basis and recognize built-in gain and loss in their Vista Outdoor shares. Relative to a divestiture of Sporting Products as an asset sale, this structure has corporate level tax of approximately $50 million versus approximately $380 million for a divestiture as an asset sale and allows for the tax-efficient return of cash to stockholders. The transaction is expected to close in calendar year 2024, subject to approval of our stockholders, receipt of necessary regulatory approvals and other customary closing conditions. Upon closing, Vanderbrink will remain CEO of the Sporting Products business and the U.S. headquarters will remain in Anoka, Minnesota. In connection with the transaction, the company's approximately 4,000 employees who represent four factories and the consumer brands CCI, Federal, HEVI-Shot, Remington and Speer will continue their heritage of community and conservation support through local and national organizations. Upon completion of the sale of the Sporting Products business to CSG, Vista Outdoor's Outdoor Products business will become Revelyst, an independent publicly traded company trading on the New York Stock Exchange under the ticker "GEAR." Revelyst will leverage meticulous craftsmanship and cross-collaboration across its portfolio of category-defining brands. Brands include Fox, Bell, Giro, CamelBak, Camp Chef, Bushnell, Simms Fishing, Foresight Sports, Bushnell Golf and more. Eric Nyman will continue as CEO of Outdoor Products and become the CEO of Revelyst upon transaction close.
CNSL

Hot Stocks

08:07 EDT Consolidated Communications acquired by Searchlight and BCI for $4.70 per share - Consolidated Communications Holdings announced that it has entered into a definitive agreement to be acquired by affiliates of Searchlight Capital Partners and British Columbia Investment Management Corporation "BCI" in an all-cash transaction with an enterprise value of approximately $3.1B, including the assumption of debt...Under the terms of the Agreement, Searchlight and BCI will acquire all of the Consolidated common stock not already owned by Searchlight for $4.70 per share in cash. The purchase price represents a premium of approximately 70% to the closing price of the Company's common stock through April 12 the last trading day prior to the submission of Searchlight and BCI's initial non-binding proposal to the Company's Board of Directors and a premium of approximately 33% to the closing price of the Company's common stock as of October 13. The transaction implies a 9.6x multiple on the Company's LTM EBITDA, pro forma for the previously disclosed sales of certain non-core operations, including the expected sale of Washington assets, as of June 30, . The proposed transaction has been unanimously approved by a special committee of independent and disinterested directors of the Board advised by independent legal and financial advisors, formed to evaluate and consider the proposal and other potential strategic alternatives. The Board of Directors of the Company, following recusals of directors affiliated with Searchlight and BCI, has approved the proposed transaction on the unanimous recommendation of the Special Committee.
EDIT

Hot Stocks

08:07 EDT Editas Medicine granted FDA RMAT designation for EDIT-301 - Editas Medicine announced that the U.S. Food and Drug Administration, FDA, granted Regenerative Medicine Advanced Therapy, RMAT, designation to EDIT-301, an investigational, gene editing medicine, for the treatment of severe sickle cell disease, SCD. "Sickle cell disease is a devastating disease that leads to anemia, pain crises, organ failure, and early death. Receiving RMAT designation for EDIT-301 for severe sickle cell disease highlights the urgent need for new treatment options for patients and supports our belief that EDIT-301 can provide life-changing clinical benefits to patients," Gilmore O'Neill, M.B., M.M.Sc., President and Chief Executive Officer, Editas Medicine. "I would like to thank the participants, their families, clinicians, and colleagues at collaborating institutions that contribute to the RUBY trial. We look forward to sharing further clinical updates including additional data for the trial prior to year-end."
BNXAF

Hot Stocks

08:06 EDT Banxa Holdings chairman Domenic Carosa to retire, Holger Arians to succceed - After a 10-year tenure as Founder and Chairman of the Board, Domenic Carosa has decided to retire from his position as Chairman and resign from the Board effective immediately. In his place, Holger Arians, the CEO, has been appointed to the Board and will assume the role of Director & Chairman of the Board. Furthermore, Matthew Cain, non-executive director, has decided to retire and will be stepping down from the Board effective immediately. Finally, Leigh Travers will join the Board as a non-executive director, representing Dominet Digital Investments, a company associated with outgoing Chairman Domenic Carosa.
DARE OGN

Hot Stocks

08:06 EDT Dare Bioscience announces first shipment of XACIATOTM - Dare Bioscience (DARE) announced the first shipment of XACIATOTM vaginal gel, 2% in connection with the first commercial sale of the product in the United States, triggering a $1.8 million milestone payment to Dare under its global license agreement with Organon (OGN). "This is a major achievement for Dare Bioscience, proving our ability to accelerate the development of much-needed, innovative medicines for women," said Sabrina Martucci Johnson, President and CEO of Dare Bioscience. "In less than five years since licensing the technology, we advanced a pivotal clinical trial, gained U.S. Food and Drug Administration approval, and ensured supply to support the launch of XACIATO. We look forward to our continued collaboration with Organon and its established sales force to offer this important treatment for bacterial vaginosis in females 12 years or older." The New Drug Application for XACIATO was supported by positive results from the DARE-BVFREE Phase 3 randomized, multi-center, double-blinded, placebo-controlled clinical trial evaluating XACIATO for the treatment of bacterial vaginosis.
MDGS

Hot Stocks

08:05 EDT Medigus says Revoltz secures partnership with HLS distributor - Medigus announced that Revoltz Ltd. which is 19.9% held by Charging Robotics Ltd., wholly subsidiary of Fuel Doctor Holdings, has entered an exclusive distribution agreement in the United State for its advanced micro-mobility EVs, with a leading distributor operating in the homeland security (HLS) and law enforcement sector. As part of the agreement, the distributor committed to purchase a minimum of 500 units of PORTO, Revoltz' state-of-the-art micro-mobility vehicles in the coming year.
CTV

Hot Stocks

08:04 EDT Innovid appoints Anthony Callini as CFO - Innovid announced the appointment of Anthony Callini as CFO, while Tanya Adreev-Kaspin, who will be leaving Innovid to pursue other opportunities, will remain for a transition period of six months. Callini has over 20 years of financial experience at growth-oriented private and public technology companies. Prior to joining the Innovid team, Callini was CFO at iZotope, an award-winning audio software technology company. Prior to that, he was CFO at Monotype, a public branding and design technology company. Callini served as the Senior Vice President of Finance at Avid Technologies, a publicly traded leading provider of media technology, and held a number of financial leadership positions at Open Solutions,, a publicly traded software and services company, including Senior Vice President, Finance and Treasurer. Prior to Open Solutions, Callini held financial leadership positions with Ernst & Young and Arthur Andersen .
RAIN

Hot Stocks

08:04 EDT Rain Oncology confirms receipt of unsolicited proposal from Concentra - Rain Oncology confirmed that it has received an unsolicited proposal from Tang Capital on behalf of Concentra Biosciences to acquire all outstanding shares of common stock of Rain for $1.25 per share in cash, plus a contingent value right representing the right to receive 80% of the net proceeds payable from any license or disposition of Rain's programs. Consistent with its fiduciary duties, Rain's Board of Directors, in consultation with its independent financial and legal advisors, will carefully review and evaluate the proposal from Concentra Biosciences. Rain's stockholders are advised to take no action at this time.
ITRN

Hot Stocks

08:03 EDT Ituran says no impact to ongoing operations in Israel, elsewhere from Hamas - Ituran addressed the status of the company's ongoing activity in Israel, against the background of the terrorist attack by Hamas on October 7 against unarmed civilians in the south of the country and the subsequent declaration of war by the Israeli government. Ituran's management affirms that the company has not seen any impact to its ongoing operations in Israel or elsewhere, and continues to make any adjustments to ensure continuity, as maybe needed. Furthermore, its headquarters are in the center of the country, just outside of Tel Aviv and not near any borders.
AMAM

Hot Stocks

08:03 EDT Ambrx Biopharma reports safety, efficacy data from Phase 1/2 APEX-01 trial - Ambrx Biopharma announced that two abstracts detailing updated safety and efficacy data from the ongoing Phase 1/2 trial, APEX-01, evaluating ARX517 for metastatic castration-resistant prostate cancer were made available as part of the 2023 European Society of Medical Oncology Congress 2023 meeting, taking place in Madrid, Spain, October 20-24, 2023. APEX-01 opened for enrollment in July 2021, and is the only ongoing clinical trial in the United States targeting PSMA with an antibody-drug conjugate. APEX-01 is a first-in-human, open-label, dose escalation and dose expansion study enrolling patients with mCRPC whose tumors have progressed on at least two prior FDA-approved treatments, including at least one second-generation androgen receptor pathway inhibitor. The inclusion criteria included one of the following: PSA progression defined by a minimum of two rising PSA values, radiographic progression by RECIST v1.1 or disease progression by the presence of new bone lesions. The two clinical abstracts submitted to ESMO regarding the APEX-01 trial used a cutoff date of May 3, 2023. Ambrx will provide more mature data with a later data cutoff date, including a significantly greater number of patients from the dose expansion portion of APEX-01, in the ESMO posters and in its associated press release. Title: APEX-01: First-in-human Phase 1/2 study of ARX517, an anti-prostate-specific membrane antigen antibody-drug conjugate, in patients with metastatic castration-resistant prostate cancer: Abstract Highlights: In dose escalation patients treated via intravenous infusion every 3 weeks at putative therapeutic doses greater than or equal to2.0 mg/kg: 7 out of 9 patients experienced a greater than or equal to50% PSA reduction; 3 out of 3 patients in Cohort 6; 2 out of 3 patients in Cohort 7; 2 out of 3 patients in Cohort 8; 5 out of 5 patients experienced a greater than or equal to50% ctDNA reduction; 3 out of 3 patients in Cohorts 6; 2 out of 2 patients in Cohort 7; Cohort 8 data not available; In 24 dose escalation patients treated from 0.32 mg/kg to 2.88 mg/kg ARX517 was well-tolerated at all doses; No treatment-related SAEs observed; No DLTs observed; Four Grade 3 treatment-related adverse events were reported in Cohort 5, Cohort 7 and Cohort 8. Title: ARX517, a next generation anti-PSMA antibody drug conjugate, demonstrates notable stability and pharmacokinetic profile in the ARX517 Phase 1/2 clinical trial. Abstract Highlights: The pharmacokinetics population consisted of 21 dose escalation patients having received ARX517 across all dose levels; ARX517 exhibited virtually overlapping total antibody and ADC PK concentration-time curves at all dose levels tested indicating strong stability of the ADC with minimal premature payload release; A long ADC terminal half-life of ~6-10 days was observed at doses greater than or equal to 1.4 mg/kg, thereby maximizing drug exposure over a dosing cycle of 3 weeks; Low concentrations of pAF-AS269 were observed at all dose levels and appeared slowly in the circulation, with Cmax observed approximately 7 days after administration
INAQ

Hot Stocks

08:03 EDT Alpha Modus to list on Nasdaq via BCA with Insight Acquisition - Alpha Modus and Insight Acquisition announced they have entered into a business combination agreement, BCA, dated as of October 13, 2023, regarding Insight's proposed acquisition of Alpha Modus. The proposed Business Combination reflects an implied pro-forma enterprise value of approximately $175 million, plus a potential $22 million earn out for Alpha Modus stockholders and a $7.5 million earn out for Insight's sponsor both payable through the issuance of the combined company's common stock valued at $10 per share and based on share price targets for the combined company's common stock. The Business Combination is not subject to a minimum cash closing condition. Post closing, Alpha Modus shareholders would own approximately 70%, excluding the earn out, of the combined company. The closing of the proposed Business Combination is subject to a number of conditions, as set out in the BCA, including but not limited to approval of the transaction by Insight's stockholders and Alpha Modus' stockholders, the U.S. Securities and Exchange Commission declaring Insight's registration statement on Form S-4 effective and other customary closing conditions. The parties expect the proposed Business Combination will close in the first quarter of 2024.
HALO

Hot Stocks

08:02 EDT Halozyme reports results from clinical study of ENHANZE - Halozyme Therapeutics announced positive results of a clinical study demonstrating subcutaneous administration of 10 mL of a representative biologic product co-formulated with its ENHANZE drug delivery technology, in approximately 30 seconds. In the study, the biologic was delivered with Halozyme's proprietary high-volume auto-injector (HVAI) in healthy volunteers. The injection was delivered successfully to all 23 participants and was well tolerated. In the study, a representative biologic, immunoglobulin 10%, was delivered to 23 healthy volunteers. The primary endpoint of the study was achieved with all subjects receiving the completed dose with HVAI, demonstrating that 10 mL of a representative biologic product can be rapidly delivered using Halozyme's ENHANZE and HVAI technologies. Data Highlights include: 96% of participants stated that they would be willing to receive the injection again; 90% of participants indicated feeling either no pain or mild pain immediately after injection; and Erythema, swelling, and induration were generally minimal to mild and resolved by 90 minutes or less.
KHTRF

Hot Stocks

07:47 EDT Knight Therapeutics announces CMED price approval of Minjuvi in Brazil - Knight Therapeutics announced that its Brazilian affiliate, United Medical Ltd., has received pricing approval for Minjuvi from the Drugs Market Regulation Chamber, CMED. As a result, Knight expects to launch Minjuvi in Brazil in the second quarter of 2024. The approval is based on the data from L-MIND, an open label, multicenter, single arm Phase 2 study, that evaluated Minjuvi in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL. The study primary analysis results showed an objective response rate of 60%, including a complete response rate of 43% and a disease control rate of 75%."We're excited to continue to advance the approval of Minjuvi in Brazil, a new treatment option for a current unmet need. We look forward to launching Minjuvi in Brazil and obtaining approval in other key markets in Latin America," said Samira Sakhia, Knight Therapeutics President and CEO.
LQR COST

Hot Stocks

07:46 EDT LQR House delivers inaugural order to Costco - LQR House announced that through its custom marketing campaign and strategic efforts, Von Payne Whiskey is now displayed on the shelves of the retail giant, Costco.
GAME

Hot Stocks

07:45 EDT GameSquare reports 'accelerating momentum' around enterprise contract wins - GameSquare Holdings announces accelerating momentum surrounding enterprise contract wins - supporting larger average contracts and a growing pipeline of sales opportunities. Enterprise growth is attributed to the synergistic approach of combining the strengths of GameSquare's multiple SaaS companies and presenting them as a unified offering in the market. It also reflects the successful integration of Engine Gaming and Stream Hatchet, which is providing cutting-edge solutions to current and future clients. Since the strategic acquisition with Engine Gaming in April 2023, GameSquare has experienced substantial success by strategically integrating the unparalleled capabilities of Stream Hatchet's business intelligence features and Sideqik's influencer relationship management functionalities. This combined offering has resulted in the creation of a comprehensive SaaS solution tailored for brands actively engaging in the gaming sector. The strategic move since May has already produced over $275,000 in new contract annual recurring revenue wins for the third quarter, with a gross margin significantly above the Company's average. In addition, the Company has a current pipeline of over $500,000 of ARR, underscoring the heightened demand for this enhanced offering. Most notably, the average order value of enterprise deals has surged by 186% compared with the same period in 2022.
AAU

Hot Stocks

07:44 EDT Almaden Minerals reports on developments on Ixtaca mineral title applications - Almaden Minerals reports on two recent court decisions, both relating to the submission issued by Mexico's Ministry of the Economy to the second district court in Puebla State in February 2023. As reported on February 22, April 13, and September 14, 2023, Economia made the Submission to the District Court seeking to deny the two mineral title applications which were first made by Almaden in 2002 and 2008. The Submission claims that the applications contain technical faults, despite Economia's previous statements to the contrary and its acceptance of the mineral title applications and grant of the mineral titles in 2003 and 2009. By alleging technical faults in the mineral title applications, Economia appears to be arbitrarily seeking to deny the grant of the mineral titles and avoid the indigenous consultation ordered by the February 2022 decision of Mexico's Supreme Court. Such consultation would be welcomed by both the Company and surrounding community members. The two court decisions reported are summarized below: The Federal Appeals court dismisses all of the appeals filed by the Parties, including those of the Company and supporting community members, and rules the Submission is compliant with the 2022 decision of the SCJN, since the SCJN decision did not formally prevent Economia from reviewing the technical aspects of the mineral title applications; The TCC ruling also does not address the validity of the Submission and therefore safeguards the Company's right to challenge the substance and legality of the Submission through the Mexican Federal Administrative Court; As follow-up to the press release of September 14, 2023, the TFJA has now granted a definitive injunction in relation to the Submission, which prevents Economia from releasing the mineral rights covered by Almaden's mineral title applications to third parties while the trial continues, anticipated to last 18 months. By way of background, the two mineral titles previously owned by Almaden which covered the Ixtaca project were the subject of a lawsuit against the Mexican government asserting that the Mexican mining law is unconstitutional. In April 2019, the District Court issued a decision that Mexico's mining law is unconstitutional because it fails to include provisions requiring consultation of indigenous communities before granting mineral titles. This decision was appealed by Mexican authorities and the Company, as an affected third party, with the appeals being heard by the SCJN. In early 2022, the SCJN ruled that the Mexican mineral title law is constitutional, but that Economia should have provided for a consultation procedure with relevant indigenous communities prior to issuing the mineral titles. The SCJN ordered Economia to declare Almaden's mineral titles ineffective and to then conduct indigenous consultation prior to re-issuing them. The SCJN decision provided guidance to Mexican authorities regarding the procedures required to be followed by those authorities in the follow-up to its decision and performance of indigenous consultation. The decision also clarified that unless there is a significant impact on the rights of an indigenous community caused by the granting of the mineral title, such as relocation or something similar, title issuance is not dependent upon the consent of any indigenous community. The District Court was responsible for ensuring that the SCJN decision was properly implemented. As noted above, on February 22, 2023, Economia made the Submission to the District Court seeking to deny the two mineral title applications, and on April 13, 2023, Almaden reported that the District Court ruled that the Submission formally complied with the SCJN decision. However, the District Court ruling appeared to rely heavily on Economia's Submission regarding the Company's 2002 and 2008 title applications, and in its decision the District Court did not provide arguments to address the Company's challenge of the Submission. Almaden and local community members filed separate appeals of this decision to the TCC. In parallel, Almaden initiated a case in the TFJA to contest the substance and legality of the Submission. In the court decisions announced today, the TCC has denied all Parties' appeals of the District Court decision and ruled that the Submission formally complies with the SCJN decision, since in the exercise of its jurisdictional freedom Economia could determine the inadmissibility of the mineral title applications as the SCJN decision did not limit Economia's jurisdiction when reviewing technical aspects of the mineral title applications. Also, the TCC confirmed that the subject matter of the appeal was limited to verifying Economia's compliance with the SCJN decision, rather than analysing the substance or legality of the Submission itself. Almaden has been advised that as a consequence, the TCC safeguarded the Company's rights to pursue a separate legal process to examine the substance and legality of the Submission. This TCC ruling is final. In addition, the TFJA has now granted a definitive injunction to Almaden's Mexican subsidiary, Minera Gorrion which prevents Economia from releasing the mineral rights covered by the Company's mineral title applications while the administrative trial regarding the substance and legality of the Submission continues. Economia has five days from the time of its notification of this decision to appeal this ruling. Almaden has been advised that so long as the TFJA trial continues, its mineral title applications from 2002 and 2008 remain in place thus preserving the Company's preferential rights to the mineral title. The TFJA process is expected to take approximately 18 months.
NOK

Hot Stocks

07:43 EDT Nokia expands Altiplano Marketplace with five new fiber broadband apps - Nokia announced it has extended its Altiplano Marketplace with five new fiber broadband network automation applications that can help operators simplify fiber broadband network operations. As fiber broadband networks grow in complexity, operators are increasingly turning to Software Defined Networking and automation solutions that can help streamline operations, optimize resources and proactively identify potential issues. Altiplano Access Controller is a programmable domain controller and automation platform for broadband access. Altiplano's flexibility and agility enables operators to easily expand the off-the-shelf functionality, customize it to their needs and write code to build their own network automation. Nokia's Altiplano marketplace adds several new applications for operators including: Network Performance Monitor; Optical Link Certifier; PON Capacity Planner; Secure Bootstrap Server; Wholesale Network Portal.
THTX

Hot Stocks

07:41 EDT Theratechnologies finalizes amendments of credit agreement with Marathon - Theratechnologies has finalized all documentation giving effect to the amendments to certain of the terms and conditions of its credit agreement dated July 20, 2022, as amended from time to time, with certain funds and accounts for which Marathon Asset Management, L.P. acts as investment manager. The amendments to the Credit Agreement provide for, inter alia: revising the minimum liquidity requirements for all times following October 31, 2023 to be between $15 million and $20 million, based on thresholds for adjusted EBITDA over the most recently ended four fiscal quarters; revising the minimum revenue requirements to be based on adjusted EBITDA-based targets instead of quarterly revenue-based targets, beginning with the quarter ending November 30, 2023; deleting the prohibition against the Company having a going concern explanatory paragraph in the opinion of the independent registered public accounting firm of the Company that accompanies the Company's annual report. As disclosed in its September 25, 2023, press release, in consideration of the proposed amendments, the Company agreed to pay an amount equal to $600,000, or 100 basis points calculated on the outstanding principal amount of the funded debt as of October 16, 2023, which such amount was added to the outstanding principal amount of the funded debt as payment in kind ; and reprice the exercise price of the common share purchase warrants held by Marathon to $0.575 per share from $1.45 per share. Following the share consolidation completed on July 31, 2023, the exercise of four Warrants and the payment of $2.30 are required to subscribe to one common share of Theratechnologies, for up to a maximum issuance of 1,250,000 common shares. The Warrants can be exercised until February 27, 2030.
ILLM META

Hot Stocks

07:40 EDT Illumin announces integration of its journey advertising platform with Meta - illumin (ILLM) introduced new functionality for its journey advertising platform by establishing a fully integrated connection with Meta (META) to provide new Facebook and Instagram capabilities allowing end-to-end Social Advertising. With this latest product update, illumin expands connected journeys with its first social capabilities. The new feature brings Facebook and Instagram advertisements directly onto the journey advertising platform, offering consumers an enhanced experience while providing marketers with connected journey advertising intelligence. "This integration makes illumin's platform a true one-stop shop by letting advertisers manage their Open Web and Social campaigns from a singular, connected interface," said Rachel Kapcan, Chief Product Officer at illumin. "This social integration is the first step of many in creating a platform made for how marketers always wished they could work - and further solidifies illumin as the number one journey advertising provider."
XAIR

Hot Stocks

07:39 EDT Beyond Cancer presents preclinical data for UNO therapy at AACR-NCI-EORTC - Beyond Cancer announced promising new preclinical data further supporting the company's novel Ultra-High Concentration Nitric Oxide, UNO, therapy for various types of solid tumors as a single agent and in combination with checkpoint inhibitors. These data were presented in two posters at the American Association for Cancer Research-National Cancer Institute-European Organisation for Research and Treatment of Cancer, AACR-NCI-EORTC, International Conference on Molecular Targets and Cancer Therapeutics 2023, which was held October 11th - 15th in Boston, Massachusetts. Abstract #: 35782 describes a pooled analysis of preclinical studies utilizing 50,000 or 100,000 ppm UNO for 5 or 10 minutes in combination with 4-5 doses of 5 or 10 mg/kg Anti-mPD-1. The analysis showed that the combination therapy resulted in statistically significant primary and secondary tumor-free mice at day 75 compared with mice treated with anti-mPD-1 alone. In addition, the analysis showed a statistically significant improvement in survival during the same time period. Abstract #: 35688 represented an ex vivo analysis of T-cell response following administration of a 5-minute treatment of 50,000 or 100,000 ppm UNO in combination with 2-5 doses of 5 or 10 mg/kg Anti-CTLA-4. At day 5, mice treated with the combination therapy showed a statistically significant increase in the expression of proliferating T-helper cells versus mice treated with anti-mCTLA-4 alone. Mice treated with the combination therapy also demonstrated increases in cytotoxic T-cells, as well as a significant increase in active T-helper cells as represented by IFN responses. At day 7, mice treated with either UNO alone or in combination with Anti-mCTLA-4 had significant increases in the expression of central memory T-cells. Further, at day 55, in cured mice treated with the combination therapy, the expression of the antigen specific T-cells was nearly statistically significant relative to untreated mice. A separate experiment carried out to day 100, demonstrated a statistically significant expression of antigen specific cytotoxic T-cells relative to naive mice.
VIEW

Hot Stocks

07:38 EDT View Inc. announces $50M financing with real estate investors - View, Inc. announced $50 million financing in the form of a senior secured credit facility from an investor consortium comprised of strategic real estate investors Cantor Fitzgerald, RXR, Anson and Affinius.
BWAY

Hot Stocks

07:37 EDT Brainsway announces publication of study data on Deep TMS for depression - BrainsWay announced the publication of new real-world post-marketing data demonstrating the efficacy of accelerated Deep Transcranial Magnetic Stimulation, Deep TMS, for the treatment of major depressive disorder, MDD. The compelling results were published in the peer-reviewed journal, Psychiatry Research, in an article titled, "Real-World Efficacy and Safety of Various Accelerated Deep TMS Protocols for Major Depression." Deep TMS utilizes specially designed H-Coils to stimulate deep and broad cortical regions associated with depression. The standard FDA-cleared Deep TMS protocol involves one treatment session per day, five days a week for 4 weeks, followed by a maintenance period. However, there has been recent interest in "accelerated" dosing schedules which involve multiple sessions each day to allow for quicker overall treatment time. Data collected using this approach to treat depression was compiled from clinical sites and analyzed in this study. Key findings from this post-marketing study included: Accelerated Deep TMS led to an 80% response rate and a 51% remission rate across all dosing schedules, using the most rated scale; There was no statistical difference in outcomes seen between the various accelerated dosing schedules, which varied between 2, 3, 5 or 10 Deep TMS sessions per day; Subjects undergoing protocols involving more than 2 sessions per day responded and/or remitted typically within 3-5 days, and the durability of treatment was substantial. "We are firmly dedicated to identifying innovative solutions for various mental health disorders with the goal of transforming lives," said Colleen Hanlon, Ph.D., Vice President of Medical and Clinical Affairs of BrainsWay. "An accelerated protocol could potentially work better with some patients' schedules. While additional research is necessary to fully understand the benefits of accelerated protocols, these initial results are certainly promising as they suggest outcomes can be achieved which are comparable to those resulting from longer, traditional protocols."
APTO

Hot Stocks

07:37 EDT Aptose Biosciences presents clinical, preclinical data on tuspetinib - Aptose Biosciences announced that two abstracts on tuspetinib, Aptose's Phase 1/2 myeloid kinase inhibitor in development for acute myeloid leukemia, have been accepted for poster presentations at the European School of Haematology 6th International Conference: Acute Myeloid Leukemia "Molecular and Translational": Advances in Biology and Treatment, being held October 29-31, 2023, in Estoril, Portugal. Aptose is planning to hold a clinical update webcast on October 30, 2023, to provide additional up-to-date data on tuspetinib. Details will be forthcoming. Tuspetinib Myeloid Kinase Inhibitor Safety and Efficacy as Monotherapy and Combined with Venetoclax in Phase 1/2 Trial of Patients with Relapsed or Refractory Acute Myeloid Leukemia: Abstract Summary: Tuspetinib is a potent once daily oral myeloid kinase inhibitor of SYK, mutated and unmutated forms of FLT3, JAK1/2, RSK, mutant forms of KIT, and TAK1-TAB1 kinases that mediate dysregulated cellular proliferation in acute myeloid leukemia. As a single agent, TUS was well-tolerated and highly active across four dose levels among diverse AML genotypes and delivered a 42% CR/CRh across evaluable venetoclax naive patients at the 80mg daily RP2D. In the ongoing APTIVATE clinical study, tuspetinib is being evaluated clinically as monotherapy and in combination with venetoclax in a global Phase 1/2 trial of patients with R/R AML. The TUS/VEN doublet also has been well tolerated and has achieved multiple responses to date in patients who previously failed VEN, including Prior-VEN failure patients who also previously failed FLT3 inhibitors, all of whom represent emerging populations of high unmet medical need. Notably, TUS targets VEN resistance mechanisms and appears to re-sensitize Prior-VEN failure patients to VEN. Tuspetinib Oral Myeloid Kinase Inhibitor Creates Synthetic Lethal Vulnerability to Venetoclax: Abstract Summary: Tuspetinib, a once daily oral agent, simultaneously suppresses a limited set of key oncogenic signaling pathways that mediate resistance to acute myeloid leukemia drugs by potently inhibiting SYK, mutated and unmutated forms of FLT3, JAK1/2, RSK, mutant forms of KIT, and TAK1-TAB1 kinases. TUS as a single agent produces complete remissions in relapsed/refractory AML patients, and the tuspetinib/venetoclax combination doublet achieves multiple responses among very difficult to treat AML subpopulations in the ongoing Phase 1/2 APTIVATE trial. We investigated the effects of TUS on key elements of the phosphokinome and apoptotic proteome in both parental and TUS-resistant AML cells. In parental cells, TUS acutely inhibits key oncogenic signaling pathways and shifts the balance of pro- and anti-apoptotic proteins in favor of apoptosis, suggesting that it may generate vulnerability to VEN. Indeed, acquired TUS resistance generated a synthetic lethal vulnerability to VEN of unusually high magnitude. Concurrent administration of TUS and VEN may eliminate cells that carry this form of TUS resistance at the start of therapy and discourage the emergence of TUS resistance during treatment.
CGTX

Hot Stocks

07:36 EDT Cognition Therapeutics presents new data at CTAD conference - Cognition Therapeutics announced upcoming presentations from studies of CT1812, the Company's lead candidate for the treatment of adults with early, mild and moderate Alzheimer's disease at the Clinical Trials on Alzheimer's Disease, CTAD, conference being held October 24-27, 2023 virtually and in person in Boston, MA. An oral late-breaking presentation will also discuss the Phase 2 study design of the company's ongoing START study, which is enrolling adults with early Alzheimer's disease. Participants in START will be permitted to be on stable background therapy with lecanemab, an FDA-approved anti-amyloid antibody. "The approval of monoclonal antibody therapies against amyloid beta protofibrils represents an important milestone in Alzheimer's drug development, but industry experts agree that combination treatments will likely be required to achieve greater impact on the disease," explained Anthony Caggiano, MD, Ph.D., Cognition's CMO and head of R&D. "To this end, we and our colleagues at the National Institute of Aging and the Alzheimer's Clinical Trials Consortium made the strategic decision to allow participants to enroll in the ongoing Phase 2 START study who are being administered lecanemab. We believe this will allow us to assess the benefit of CT1812 in real-world conditions."
GILD KITE

Hot Stocks

07:36 EDT Gilead and Kite present data across multiple difficult-to-treat cancers at ESMO - Gilead Sciences (GILD) and Kite, a Gilead Company, will present new data, including three oral presentations, at the European Society for Medical Oncology or ESMO Congress 2023. New clinical data for Trodelvy, sacituzumab govitecan-hziy, continue to support its use in metastatic triple-negative breast cancer or mTNBC and pre-treated HR+/HER2- metastatic breast cancer, mBC, and demonstrate the expanding body of evidence for Trodelvy in small cell lung cancer and head and neck cancer. Kite will also present analyses supporting the use of Yescarta axicabtagene ciloleucel in relapsed/refractory large B-Cell lymphoma LBCL. "Our data at ESMO 2023 reflect a broad clinical development program in difficult-to-treat cancers," said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. "Trodelvy has the potential to impact many patients with cancer across multiple indications, as demonstrated by presentations featuring new data in extensive-stage small cell lung cancer, metastatic urothelial cancer and previously treated head and neck cancer, along with new analyses in metastatic breast cancer."
SVM

Hot Stocks

07:35 EDT Silvercorp Metals reports Q2 gold production up 105% from last year - Silvercorp Metals reports production and sales figures for the Q2. The Company expects to release its Q2 unaudited financial results on November 9 after market close. Q2 operational results include: gold production of 2,458 ounces, an increase of 105% over Q2 of FY23; silver equivalent production of approximately 1.8M ounces; and lead and zinc production of approximately 16.1M pounds and 4.6M pounds, an 11% and 23% decrease over Q2 FY23, respectively.
LFVN

Hot Stocks

07:35 EDT LifeVantage sends letter to stockholders, urge to vote FOR director candidates - LifeVantage sent a letter to stockholders and released an investor presentation detailing the actions taken by the Company's Board of Directors over the last three years to rebuild the senior leadership team, develop a new strategic plan and reposition the Company for profitable growth. Ttwo stockholders are seeking to replace half the independent directors on the Board. The Board encourages all stockholders to vote "FOR" the Company's seven director candidates using the WHITE proxy card at the Company's upcoming 2024 annual meeting of stockholders, scheduled to be held on November 6, 2023. "Over the last three years, the Board of Directors of LifeVantage Corporation has taken actions to rebuild the senior leadership team and develop a comprehensive new strategy to address the Company's challenges and opportunities. The culmination of these actions is our new LV360 strategy, which we announced in January 2023. As you undoubtedly know, this year has been exceptional for LifeVantage and our stockholders. Through October 12, 2023, our stock has generated total shareholder returns of more than 100%, making LifeVantage one of the best performing stocks in the United States this year. Today, we released a presentation describing how the Board and senior leadership team redirected the Company's strategy and operations to produce these exceptional results...The Board took decisive action to rebuild the senior leadership team and develop a new strategy to reposition the Company... The Board deliberately and systematically strengthened the business in preparation for the launch of our new LV360 strategy... The Company's transformation is driving improved results and delivering value for stockholders... A group of stockholders launched a misguided, costly and disruptive proxy contest at a critical time in the Company's transformation... The Radoff-Sudbury Group's nominees would not be additive to our Board."
CTO

Hot Stocks

07:35 EDT CTO Realty Growth sells community shopping center in Texas for $14.8M - CTO Realty Growth announced the closing of the sale of Westcliff Shopping Center, a 134,750 square foot single community shopping center located in Fort Worth, Texas. The Property was sold for $14.8 million, representing an exit cap rate of 5.2% and generating a loss on sale of approximately $0.9 million. The Company expects to utilize the sales proceeds as part of a Section 1031 like-kind exchange. Following the completion of the 1031 Exchange, the Company intends to use available proceeds to repay a portion of the outstanding balance under its revolving unsecured credit facility. With the closing of this transaction, the Company has approximately $36.1 million of proceeds held in 1031 restricted cash accounts.
OMER

Hot Stocks

07:34 EDT Omeros reports narsoplimab trial did not meet primary endpoint - Omeros provided an update regarding the interim analysis outcome in ARTEMIS-IGAN, the company's Phase 3 trial evaluating narsoplimab for the treatment of immunoglobulin A, or IgA nephropathy. The primary endpoint is reduction in proteinuria assessed by 24-hour urine protein excretion at 36 weeks compared to placebo in the intent-to-treat population of 180 IgA nephropathy patients with high baseline proteinuria. Topline results show that narsoplimab did not achieve statistically significant improvement over placebo. The UPE reduction in the placebo group was markedly greater than that reported in trials of other agents in IgA nephropathy. Based on the absence of statistical significance and as previously agreed with FDA, Omeros will not submit an application for approval of narsoplimab in this indication and will discontinue the ARTEMIS-IGAN clinical trial.
APCX

Hot Stocks

07:33 EDT AppTech Payments to acquire FinZeo, terms not disclosed - AppTech Payments has signed a definitive agreement for the purchase of Alliance Partners, LLC, the owners of FinZeo, a software development company centered around the movement of money, nationally and globally. This transaction aligns with AppTech's recent initiatives, reinforcing the company's commitment to developing innovative technologies, driving global expansion through strategic partners, and exploring M&A opportunities to create revenue synergies and expand product offerings. FinZeo was founded in 2018 and is dedicated to delivering innovative payment and banking technology solutions for businesses of all sizes. By integrating the FinZeo platform, AppTech believes it can augment its technology offerings, furnishing users with cutting-edge tools accessible via online portals or through an API. FinZeo's API enables AppTech to efficiently integrate with software providers and Independent Software Vendors, facilitating rapid technology implementation. The onboarding process for ISVs will be streamlined with the support of video tutorials, a dedicated customer center, and a sandbox API environment. With the assimilation of FinZeo, AppTech evolves into a Payment Facilitator, propelling the company's aggregation model. The management of AppTech believes that the closing of this strategic acquisition can help propel enhancements to AppTech's Commerce platform, clearing the project roadmap and positioning the Company at the forefront of technological progress. FinZeo enables capabilities to now span all banking-as-a-service products, such as virtual accounts and cards, and encompass money transmitter licenses, thus complementing AppTech's existing product suite. This transaction is intended to be completed by October 31, 2023, subject to the satisfaction of customary closing conditions.
PTN

Hot Stocks

07:32 EDT Palatin presents poster on PL8177 ulcerative colitis treatment at UEG - Palatin Technologies announced the presentation of a poster entitled Cellular and Molecular Impact of the Melanocortin Receptor Agonist PL8177 in DSS Induced Colitis in Rats at the United European Gastroenterology Week, or UEG, being held in Copenhagen, Denmark. Lead author Paul S. Kayne, Vice President Biological Sciences at Palatin Technologies, presented the poster. The poster is currently available on the UEG 2023 Conference website. The poster presents data from a series of oral PL8177 dose-ranging studies in the DSS colon inflammation model and includes histological, genomic, and proteomic data. Compared to vehicle and the positive control mesalazine, PL8177 showed significant improvements in inflamed colon health, including relative increases in colon cells needed for a healthy colon. PL8177 treatment showed clear evidence of resolving pathological inflammation by repolarizing colon macrophages from a pro-inflammatory to a pro-inflammation resolving state. Oral PL8177 caused diseased colons to move towards a healthy state and to resolve damaging inflammation. By resolving inflammation rather then blocking it, PL8177 may provide efficacy without the safety concerns of immunosuppressive treatments for patients suffering with inflammatory bowel disease.
CFRX

Hot Stocks

07:32 EDT ContraFect announces FDA clearance of CF-370 IND application - ContraFect announces that the U.S. Food and Drug Administration, FDA, has notified the company that it has completed the safety review of its Investigational New Drug, IND, application for CF-370 for the treatment of hospital-acquired bacterial pneumonia, HABP, and ventilator-associated bacterial pneumonia, VABP, and concluded that the company may proceed with its Phase 1 clinical study. This milestone is significant for ContraFect and historic in the field of non-traditional antibacterial therapies, as CF-370 will be the first engineered lysin therapeutic targeting Gram-negative pathogens to enter a human clinical trial. CF-370 has demonstrated potent in vitro activity against Pseudomonas aeruginosa, Acinetobacter baumannii, Klebsiella pneumoniae, Escherichia coli and Enterobacter cloacae and across numerous animal models of pneumonia, including efficacy against multi-drug resistant strains. ContraFect is a global innovator in the discovery and development of DLAs, leading the field with an intellectual property portfolio which includes thirty U.S. patents, one hundred and fifty-four issued foreign patents and two hundred and forty-six pending U.S. and international patent applications. The company's discovery platform and functional expression library are designed to enable the construction and identification of novel therapeutic proteins that can penetrate the outer membrane of Gram-negative bacteria, resulting in lysis and prokaryotic cell death. CF-370 represents the first product candidate to be developed using the company's proprietary technologies.
CLSD

Hot Stocks

07:21 EDT Clearside Biomedical presented key data from Phase 1/2a OASIS trial - Clearside Biomedical announced that key data from the Phase 1/2a OASIS clinical trial were presented at The Retina Society 56th Annual Scientific Meeting. The results of the trial demonstrate the key benefits of Clearside's patented suprachoroidal delivery platform and its lead drug candidate, CLS-AX being developed for the treatment of neovascular age-related macular degeneration. The presentation, entitled, "Safety and Tolerability of CLS-AX via Suprachoroidal Injection in nAMD Patients with Persistent Activity Following Anti-VEGF Therapy" was delivered by David M. Brown, MD, Retina Consultants of Texas. Dr. Brown's presentation summarized the data from Clearside's 3-month Phase 1/2a OASIS clinical trial and Extension Study through 6 months. Axitinib was described as a highly potent, pan-VEGF TKI to treat wet AMD which has shown 10x more potency than other TKS in preclinical studies. The advantages of suprachoroidal delivery directly targeting the site of disease at the back of the eye were featured through multiple preclinical studies comparing equivalent doses of axitinib injected suprachoroidally versus intravitreally. In the OASIS and Extension Study, participants with wet AMD who were sub-responders with active disease at screening were followed for up to 6 months after CLS-AX treatment. This patient population is important because enrolling difficult to treat anti-VEGF sub-responders allowed observation of possible signs of biologic effect while minimizing false signals. The studies demonstrated an excellent safety profile at all doses and timepoints with no serious adverse events, no dose limiting toxicities, and no adverse events from inflammation. In addition, signs of biologic effect with stable mean best corrected visual acuity and stable mean central subfield thickness to the 6-month timepoint were observed. Importantly, CLS-AX exhibited early signs of durability and reduction in treatment burden with a 77-85% reduction in injection frequency at higher doses in cohorts 3 and 4.
BMR NVDA

Hot Stocks

07:20 EDT Beamr Imaging announces latest beta service powered by NVIDIA NVENC - Beamr announced its latest beta service, which is now powered by NVIDIA NVENC, coupled with Beamr's Content Adaptive Bitrate technology, offering accelerated storage optimization at scale. Since its IPO, Beamr has moved from completion of its technology's integration with NVIDIA GPUs to availability of its solution on AWS in 6 months. This third Beta version has a new user interface for manual video optimization, an API for large-scale automation, and support for NVIDIA GPUs for large-scale, cost-effective automation at high speed on AWS. Beamr is committed to democratizing video optimization and making it available to everyone at low cost. Today, Beamr is unveiling its pricing plan for the launch of the Beamr SaaS platform. Users can process video content at the incredibly competitive rate of only $0.05 for each GB processed. Beamr believes this pricing model ensures affordability and flexibility for content providers of all sizes. Beamr customers can anticipate substantial savings, with an average of a 30% reduction in storage and networking costs, all while benefiting from highly affordable processing rates. To further enhance the customer experience, Beamr has introduced a savings calculator tool, empowering users to forecast their storage and networking savings accurately.
OMGA

Hot Stocks

07:19 EDT Omega Therapeutics presents new preclinical data on OTX-2101 - Omega Therapeutics announced new preclinical data supporting the potential of OTX-2101, a c-MYC-targeting epigenomic controller, MYC-EC, being developed for the treatment of non-small cell lung cancer, NSCLC, in combination with immune checkpoint inhibitors or EGFR inhibitors at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics which took place in Boston, Mass., October 11 - 15, 2023. Key Findings: Analysis of biopsy data from NSCLC patients treated with anti-PD1 or EGFR inhibitors found that high MYC mRNA levels correlated with a shorter time to disease progression, establishing a rationale to evaluate MYC-targeting epigenomic controllers in a combination treatment setting. Combination of a MYC-targeting epigenomic controller with immune checkpoint or EGFR inhibitor enhanced anti-tumor activity. Treatment with a MYC-EC plus an anti-PD-L1 antibody resulted in enhanced anti-tumor activity in a syngeneic mouse model of NSCLC. Combination of MYC-EC with EGFR inhibitor, osimertinib, synergistically reduced tumor cell viability in vitro and significantly inhibited tumor growth in vivo in a human xenograft model of NSCLC.
XTRAF

Hot Stocks

07:18 EDT Xtract One lands contracts with three multi-national companies - Xtract One announces its next phase of growth with targeted and strategic international expansion. Xtract One has landed contracts with three significant multi-national companies, including a global entertainment organization, for deployment of SmartGateway at their venue. This three-year deal, totaling over $5.1 million includes hardware, software, installation, and support components. Using that initial customer deal as a launchpad into global markets, the Company has taken a strategic and intentional approach of partnering with key global customers and establishing agreements with resellers and install partners to support and help scale into these markets. These strategic partnerships have generated further interest from similar entertainment organizations, professional sports franchises, and other international organizations.
IKT

Hot Stocks

07:17 EDT Inhibikase Therapeutics highlights analysis from 201 trial of risvodetinib - Inhibikase Therapeutics highlighted an analysis of eleven unblinded participants from the 201 Trial evaluating risvodetinib in untreated Parkinson's disease. These participants were withdrawn from the trial following the FDA's temporary clinical hold in November, 2022 that was lifted in January, 2023. The Company also provided an update on the enrollment progress and recruitment tools being used in the ongoing 201 Trial. In August 2023, Inhibikase presented an analysis of the primary and secondary endpoints performed on these eleven participants at the Movement Disorders Society Congress. At the End of Study timepoint, participants administered the 200 mg dose had a combined Part 2 and Part 3 score that was lower by an average of -8.7 points. By contrast, the combined placebo score increased by an average of +1.7 points, a -10.4 point spread between actively treated versus placebo participants. Patients administered 50 or 100 mg experienced an average change of +1.7 and -1.3 points, respectively, for the combined score. The 201 Trial is a 12-week double-blinded study across three doses plus a placebo group, 1:1:1:1 randomized. The trial is planned to extend every enrolled participant into a 12-month extension study without placebo, but this extension study is not yet implemented. Enrollment is progressing, with 27 of 34 planned sites consenting, screening and enrolling participants. 37 people are either undergoing informed consent, being screened or have been enrolled in the trial, and three participants have completed the full 12-week regimen. The 201 Trial patient portal has been visited by more than 9,000 people since launch in September, 2023, with 5 or more new people becoming pre-qualified daily.
STRM

Hot Stocks

07:15 EDT Streamline Health appoints Bryant Reeves as interim CFO - The Company announced the appointment of Bryant "B.J." Reeves as the Company's Interim Chief Financial Officer, effective October 13, 2023. Mr. Reeves will succeed Thomas J. Gibson as Interim Chief Financial Officer of the Company, and Mr. Gibson will remain available to the Company through October 31, 2023 to ensure an orderly transition. Reeves joined Streamline Health in 2020 and has held various roles in finance and accounting and most recently served as the Company's Chief of Staff.
SMMT

Hot Stocks

07:15 EDT Summit Therapeutics appoints Manmeet Soni as COO - Summit Therapeutics announced that Manmeet Soni has been appointed as the company's COO, effective immediately. Soni will remain a member of the company's board of directors. Soni has over 20 years of financial and operational leadership experience and joins Summit from Reata Pharmaceuticals, where he was president, COO & CFO. In conjunction with his appointment as COO, Soni is also purchasing shares of the company worth $5M via a private placement. In his role as COO, Soni will be responsible for all commercial activities, finance, manufacturing, legal, information technology, and human resources. Also, Summit announced that, effective immediately, the following elevated appointments have been made: Dave Gancarz as chief business and strategy officer. Urte Gayko as chief regulatory, quality and pharmacovigilance officer. Fong Clow as chief biometrics officer Allen Yang as chief medical officer.
STRM

Hot Stocks

07:14 EDT Streamline Health appoints Benjamin Stilwill as CEO - The Company also announced certain management changes and transitions in connection with the strategic restructuring. Effective October 13, 2023, Benjamin Stilwill has been appointed to the position of Chief Executive Officer of the Company. Mr. Stilwill will succeed Wyche T. "Tee" Green, III as Chief Executive Officer of the Company, with Mr. Green transitioning to the role of Executive Chairman at that time. Following his transition to the role of Executive Chairman, Mr. Green has agreed to forego a salary and will continue to serve as a director and as Chairman of the board of directors of the Company. Mr. Stilwill most recently served as Streamline's President and, prior to that, as CEO of the Company's eValuator business.
XAIR

Hot Stocks

07:14 EDT Beyond Air receives Innovative Technology contract from Vizient - Beyond Air announced that the LungFit PH system has received an Innovative Technology contract from Vizient. The contract was awarded based on the recommendation of the LungFit PH system by hospital experts who serve on one of Vizient's customer-led councils, and it signifies to Vizient customers unique qualities that potentially bring improvement to the health care industry. "We're very happy and honored to be awarded an Innovative Technology contract from Vizient for our LungFit device. This validates the customer experience and feedback we have received to date," said Steve Lisi, Chairman and Chief Executive Officer of Beyond Air. "Our revolutionary generator-based delivery system is a transformative technology with the potential to change how nitric oxide is used to the benefit of both patients and hospitals, and we are very excited by this opportunity to expand our reach through the robust Vizient customer network."
STRM

Hot Stocks

07:13 EDT Streamline Health suspends guidance related to Booked SaaS ACV - The Company is suspending previous guidance related to Booked SaaS ACV and anticipates providing updates on future expectations in conjunction with the release of its fiscal third quarter 2023 financial results.
STRM

Hot Stocks

07:13 EDT Streamline Health receives termination notice from legacy client - The Company announced the receipt of a termination notice from a legacy client with an effective date of December 31, 2023. At the time of receipt of the termination notice, the Company was recognizing approximately $4.5 million in annualized revenue from the legacy client. As a result of this termination notice, the Company's management assessed various options and determined to accelerate the implementation of the Company's planned restructuring initiatives.
FRLN

Hot Stocks

07:12 EDT Freeline to present new clinical data for FLT201 at ESGCT Congress - Freeline Therapeutics announced that it will present new clinical data from its ongoing Phase 1/2 GALILEO-1 trial of FLT201, its adeno-associated virus gene therapy candidate, in patients with Gaucher disease Type 1 at the European Society of Gene & Cell Therapy, ESGCT, 30th Annual Congress being held October 24-27, 2023 in Brussels, Belgium. The oral presentation will include data on safety, tolerability, GCase enzyme activity, substrate, and hemoglobin and platelet levels from the first two patients treated with FLT201.
STRM

Hot Stocks

07:12 EDT Streamline Health executes restructuring, reduces force by 26 employees - Streamline Health Solutions is executing a strategic restructuring. The strategic restructuring initiatives are designed to reduce expenses and preserve cash while maintaining the Company's ability to expand its high-margin SaaS business. As part of the strategic restructuring initiatives, the Company has implemented a reduction in force of approximately 26 employees. Streamline expects to record a one-time restructuring expense of approximately $0.8 to $1.2 million related to the reduction in force, which includes severance payments and benefits to affected employees. The Company expects the expense associated with the strategic restructuring to be substantially recognized by the end of fiscal 2023. As a result of these strategic restructuring initiatives, the Company expects to realize annualized cost savings of approximately $5.8 million.
EYPT

Hot Stocks

07:11 EDT EyePoint appoints Duty to board of directors, promotes Elston to EVP - EyePoint Pharmaceuticals announced the appointment of Stuart Duty to its Board of Directors and the promotion of George Elston to Executive Vice President, EVP. Stuart Duty is an experienced financial executive with over 30 years of experience in finance and investment banking. Duty was most recently a Senior Managing Director at Guggenheim Securities, LLC. Elston joined EyePoint in 2019 as Chief Financial Officer & Head of Corporate Development.
TLRY

Hot Stocks

07:10 EDT Tilray supports trial to study medical cannabis in glioblastoma cancer treatment - Tilray Medical announced their contribution to an independent clinical trial to research the efficacy of medical cannabis as a treatment for glioblastoma, a severe form of brain cancer. The clinical trial will be conducted in Spain, recruiting 30 patients from eight specialized neuro-oncology medical sites, in partnership with renowned scientists from the Spanish Research Group of Neuro-Oncology and the Complutense University of Madrid, with Tilray Medical providing the pharmaceutical-grade medical cannabis for the trial for administration to patients. The trial is funded by the Medical Cannabis Bike Tour Foundation charity and is scheduled to commence at University Hospital 12 de Octubre, on September 5, 2023. Led by esteemed coordinating investigator Dr. Juan Manuel Sepulveda Sanchez from GEINO, the clinical trial is a Phase I, open-label, multicenter, intrapatient dose-escalation to evaluate the safety and profile of Tilray Medical's T10:C10 extract, in conjunction with temozolomide and radiotherapy for newly-diagnosed Glioblastoma patients.
NVO

Hot Stocks

07:10 EDT Novo Nordisk to acquire ocedurenone from KBP Biosciences for up to $1.3B - Novo Nordisk A/S and KBP Biosciences PTE., Ltd. announced that Novo Nordisk has agreed to acquire ocedurenone for uncontrolled hypertension with potential application in cardiovascular and kidney disease from KBP Biosciences for up to $1.3B U.S. dollars. Ocedurenone is an orally administered, small molecule, non-steroidal mineralocorticoid receptor antagonist that is currently being examined in the phase 3 trial CLARION-CKD in patients with uncontrolled hypertension and advanced chronic kidney disease, or CKD. The CLARION-CKD phase 3 trial has been initiated in the US, Europe and Asia with the first patient dosed at the end of 2021 and will continue as planned with a total of more than 600 patients expected to be randomised by more than 150 sites. Novo Nordisk expects to initiate phase 3 trials in additional cardiovascular and kidney disease indications in the coming years, aiming to maximize the full potential of ocedurenone. "We look forward to adding ocedurenone to our pipeline as it will complement our current development programmes in cardiovascular disease and chronic kidney disease. This deal is closely aligned with our strategic focus on expanding from our core in diabetes into other serious chronic diseases, including through novel drug modalities, to help many more patients living with unmet medical needs," said Camilla Sylvest, executive vice president, Commercial Strategy & Corporate Affairs at Novo Nordisk. The closing of the acquisition is subject to receipt of applicable regulatory approvals and other customary conditions and is expected to happen before the end of 2023. The transaction will not impact Novo Nordisk's previously communicated operating profit outlook for 2023 or the ongoing share buy-back program. Novo Nordisk will fund the acquisition from financial reserves.
BOLT

Hot Stocks

07:09 EDT Bolt Biotherapeutics to present clinical data from Phase 1/2 study of BDC-1001 - Bolt Biotherapeutics announced that updated clinical data from its Phase 1/2 dose-escalation study of BDC-1001 will be presented in a mini-oral presentation at the European Society for Medical Oncology, ESMO, Congress 2023, being held in Madrid, Spain and virtually from October 20-24, 2023. BDC-1001 is an investigational Immune-Stimulating Antibody Conjugate in development for the treatment of patients with human epidermal growth factor receptor 2-positive cancer. The ESMO presentation will include new results from the recently completed first-in-human Phase 1/2 dose-escalation study of BDC-1001 in patients with advanced HER2-expressing solid tumors. "The upcoming presentation at ESMO builds on the positive data we presented at ASCO 2023 with additional insights into efficacy, safety, and biomarkers. These data provide further support for the recommended Phase 2 dose being used in the ongoing Phase 2 study of BDC-1001," said Edith A. Perez, Chief Medical Officer of Bolt Biotherapeutics. "We are proud of the significant progress we have made with BDC-1001 and these latest data reinforce that Boltbody(TM) ISACs can activate a patient's immune system to fight cancer. We continue to advance BDC-1001 through the Phase 2 clinical studies in four HER2-positive solid tumor types."
BMBOY

Hot Stocks

07:09 EDT OTC Markets welcomes Grupo Bimbo to OTCQX - OTC Markets Group announced Grupo Bimbo has qualified to trade on the OTCQX Best Market. Grupo Bimbo S.A.B. de C.V. upgraded to OTCQX from the Pink market.
TLSA

Hot Stocks

07:07 EDT Tiziana Life Sciences announces six-month clinical results of foralumab - Tiziana Life Sciences announced six-month data showing positive clinical improvements related to Modified Fatigue Impact Scale, MFIS, scores and similar important clinical measures of physical function in foralumab-treated, non-active Secondary Progressive Multiple Sclerosis, na-SPMS, patients participating in an Expanded Access, EA, Program. This follows on from previously announced positive six-month PET scan data which was presented at ECTRIMS 2023. "I am pleased to see the continued clinical response to intranasal foralumab from patients enrolled in our expanded access na-SPMS program," stated Dr. Tanuja Chitnis, M.D., Principal Investigator and Professor of Neurology at Harvard Medical School and senior neurologist at Brigham and Women's Hospital, a founding member of Mass General Brigham Healthcare System. "Notably, in this latest clinical update for patients EA 3 through EA 6, we have seen improvement in the Modified Fatigue Impact Scale scores in three out of four patients, which is significant since fatigue is a major complaint in this population. We have also seen various degrees of improvement in the Expanded Disability Status Scale, Timed 25-Foot Walk Test, pyramidal function scores and NeuroQoL Fatigue scores in a disease state that typically shows a decline in function over time."
NCNA

Hot Stocks

07:07 EDT NuCana presents data from ongoing NuTide:701 study of NUC-7738 - NuCana announced a presentation on the ongoing NuTide:701 study of NUC-7738 at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics 2023 that took place October 11-15, 2023 in Boston, Massachusetts. The NuTide:701 study is in the Phase 2 part investigating NUC-7738 both as a monotherapy in solid tumors and in combination with the anti-PD-1 therapy pembrolizumab in patients with metastatic cutaneous melanoma. All patients had exhausted standard available therapies. NUC-7738 has been well tolerated both as a monotherapy and in combination with pembrolizumab. Encouraging signs of efficacy, including tumor volume reductions and prolonged time on treatment have been observed in both the monotherapy and combination cohorts. In the combination cohort of melanoma patients, who had all been previously treated with anti-PD-1 based therapy, numerous patients achieved tumor volume reductions and prolonged time on treatment. One patient who was refractory to the anti-PD-1 plus anti-CTLA-4 therapy combination of nivolumab plus ipilimumab achieved a 50% reduction in tumor volume on NUC-7738 plus pembrolizumab and remains on treatment. Seven of the eleven patients recruited to date remain on treatment. Patient tumor biopsy data showed that, following treatment with NUC-7738 plus pembrolizumab, expression of PD-1 was reduced and CD8+ T-cells increased, indicating that NUC-7738 may have the ability to potentiate immunotherapy. This finding provides a rationale as to why NUC-7738 plus pembrolizumab may be effective in patients who have progressed on prior immunotherapy.
KMDA

Hot Stocks

07:05 EDT Kamada announces multiple recent achievements related to CYTOGAM - Kamada announced multiple recent achievements related to CYTOGAM, which is indicated for the prophylaxis of cytomegalovirus disease associated with transplantation of kidney, lung, liver, pancreas and heart, and is the sole U.S. Food and Drug Administration approved immunoglobulin product for this indication. Kamada announced that CYTOGAM manufactured at the Company's facility in Beit Kama, Israel, is now available for commercial sales in the U.S. This follows the recent FDA approval of the technology transfer process of CYTOGAM from its previous manufacturer, CSL Behring. The availability of Kamada-manufactured CYTOGAM in Canada is expected later this year. The results of an investigator-initiated five-year retrospective study, consisting of 325 lung-transplant patients, evaluating the real-world use of CYTOGAM in combination with anti-viral agents for the prevention of CMV disease in high-risk CMV mismatch lung transplant recipients. The poster presentation concluded by indicating that the use of a proactive multimodality CMV prophylaxis consisting of antivirals and immune augmentation with CMV immunoglobulin may improve outcomes among high-risk CMV mismatch lung transplant recipients. "The prevention of CMV disease is an area of significant unmet medical need and a leading cause for organ rejection and severe transplantation complications," said Amir London, Kamada's Chief Executive Officer. "The results presented by Dr. Torres align with previously published data regarding the survival benefit of high-risk CMV mismatched lung transplant patients receiving a prophylaxis regimen that includes CYTOGAM and an antiviral vs. antiviral monotherapy. In addition, the significant milestone of launching our internal commercial manufacturing of CYTOGAM further validates our investment in this critical life-saving product, and our commitment to serving the transplant community."
WDOFF

Hot Stocks

07:05 EDT Wesdome Gold Mines reports Q3 gold production of 27,760 ounces - Anthea Bath, President and CEO commented, "As expected, combined production in Q3 was slightly lower than Q2 as a result of planned mill maintenance at Eagle River. At Kiena, ramp development continues to track ahead of schedule, positioning us well to develop and access higher grade reserves in H1 2024. We are also pleased to announce that towards the end of the quarter, we received the necessary permit required to drive an exploration ramp at Presqu'ile. This authorization allows us to assess the continuity of the mineralization and test the down plunge extension of the deposit. With an uptick in production expected in the fourth quarter, our year to date performance of 87,119 ounces has us tracking to the mid-point of our 110,000 - 130,000 ounce guidance range. The Company also announces that it has issued its fourth annual Environmental, Social, and Governance Report, which provides an overview of the company's ESG strategies, policies, risk management approach and commitments. The report also outlines year-over-year Company performance from 2018-2022 across these key sustainability objectives. We are proud of our accomplishments over the last year and remain committed to strong sustainability performance in the future."
KYMR

Hot Stocks

07:04 EDT Kymera Therapeutics presents preclinical data on MDM2 degrader activity - Kymera Therapeutics reported preclinical data highlighting the therapeutic potential in liquid and solid tumors of potent and selective heterobifunctional degraders of MDM2, including KT-253. The data was presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics on October 11-15, 2023, in Boston, Massachusetts and will also be shared at the 10th International MDM2 Workshop taking place October 15-18, 2023, in Tokyo, Japan. MDM2 is a crucial regulator of the most common tumor suppressor, p53. p53 remains intact in approximately 50% of cancers, meaning that it retains its ability to modulate cancer cell growth. While small molecule inhibitors have been developed to stabilize and upregulate p53 expression, they cannot overcome the induced feedback loop that increases MDM2 protein levels, which can repress p53 and thereby limit their efficacy. In preclinical studies, MDM2 degraders have demonstrated the ability to overcome the MDM2 feedback loop observed with MDM2 SMIs and rapidly induce cell death in sensitive p53 wild-type cancer cell lines, even with brief compound exposure. This may enable an improved therapeutic index, which could result in a superior efficacy and safety profile over MDM2 SMIs. The Company previously presented data on KT-253, its lead MDM2 degrader, showing greater than 200-fold higher growth inhibition potency in vitro against p53 wild-type cancer cell lines compared with MDM2 SMI and a favorable pharmacological profile. Results shared at the 10th International MDM2 workshop show potent in vivo activity of a single dose of KT-253 in models of AML and ALL as well as activity in combination with clinical and sub-clinical doses of venetoclax in a venetoclax-resistant AML model. KT-253 is currently being evaluated in a Phase 1 trial in liquid and solid tumors and the Company plans to share data regarding proof-of-mechanism from its Phase 1 trial later this year. Work completed in collaboration with the Dana-Farber Cancer Institute and presented at both congresses support MDM2 degradation as a promising therapeutic approach in Merkel cell carcinoma, a high-grade neuroendocrine carcinoma of the skin. These data demonstrate in vitro efficacy of an MDM2 degrader, KTX-049, against p53 wild-type MCC cell lines that was achieved with brief compound exposure. In two MCC PDX models, KT-253 demonstrated tumor regressions with weekly as well as every three-week dosing whereas an MDM2 SMI only showed modest tumor growth inhibition.
TKR

Hot Stocks

07:04 EDT Timken to acquire iMECH, terms undisclosed - Timken has reached an agreement to acquire Engineered Solutions Group, based in Houston, Texas. iMECH manufactures thrust bearings, radial bearings, specialty coatings and other components primarily used in the energy industry. The business employs approximately 70 people and projects revenue of approximately $30M for calendar year 2023. Timken will fund the transaction with a combination of cash on hand and its existing revolving credit facility. The deal is subject to customary closing conditions and is expected to close in the fourth quarter. Timken will fund the transaction with a combination of cash on hand and its existing revolving credit facility. The deal is subject to customary closing conditions and is expected to close in the fourth quarter.
TNXP

Hot Stocks

07:03 EDT Tonix completes clinical stage of Phase 2 UPLIFT study of TNX-601 - Tonix Pharmaceuticals announced the completion of the clinical phase of the Phase 2 potential registration-quality, double-blind, randomized, multicenter, placebo-controlled UPLIFT1 study of TNX-601 ER2 as a potential treatment for major depressive disorder. Topline results from the intention-to-treat sampl are expected in early November 2023. "Because of its unique mechanism, tianeptine avoids some of the treatment-limiting side effects of traditional antidepressants, including sexual dysfunction and weight gain," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "Tianeptine restores connectivity between neurons, or neuroplasticity, and limits the effects of oxidative stress in the brain in animal models of depression. In contrast to traditional antidepressants which alter the levels of neurotransmitters in the synapse, tianeptine directly induces mature neurons to sprout new connections and also induces formation of new neurons."
DNA

Hot Stocks

07:03 EDT Ginkgo Bioworks and Zenfold Sustainable Technologies announce collaboration - Ginkgo Bioworks and Zenfold Sustainable Technologies, a company focused on developing and manufacturing specialty ingredients using sustainable technologies and precision fermentation, announced a collaboration to leverage Ginkgo Enzyme Services in its effort to discover an enzyme critical to the manufacturing of veterinary products. This partnership aims to replace traditional chemical processes in veterinary active ingredient production with a sustainable biological method.
TRVN

Hot Stocks

07:02 EDT Trevena reports favorable TRV045 safety, tolerability data - Trevena reported topline safety and tolerability data for the two Phase 1 proof-of-concept studies of TRV045, a novel sphingosine-1 phosphate receptor modulator selective for the S1P receptor subtype 1. TRV045 POC Studies: The Target Engagement POC study was a randomized, double-blind, placebo-controlled, single dose four-way cross-over study. Each subject received three different single doses of TRV045 and placebo on four separate visits across the study duration. Subjects in both studies were enrolled outside of the United States, and the studies were not conducted under the Investigational New Drug Application for TRV045. TRV045 Safety and Tolerability Data: There were no drug-related adverse events reported in either POC study, and no serious adverse events were reported in either POC study. Of the adverse events, 98% were reported as mild in the Target Engagement POC study, and 99% were reported as mild in the TMS POC study. The most common adverse events reported were headaches, somnolence, dizziness and fatigue. In screening and follow-up physical exams there were no clinically significant observations. Laboratory results also showed no clinically significant reduction in total lymphocyte count, no clinically significant changes in heart rate or blood pressure, and no clinically significant changes in ECG interval measures. As previously announced, TRV045 demonstrated a statistically significant, dose-dependent analgesic effect in capsaicin-induced model of neuropathic pain in the Target Engagement POC study. In the TMS POC study, TRV045 provided statistically significant evidence of CNS activity on day 4 as measured by EEG power spectral analysis.
LYRA

Hot Stocks

07:02 EDT Lyra Therapeutics appoints Ronan O'Brien as CLO - Lyra Therapeutics announced the appointment of Ronan O'Brien, as Chief Legal Officer, effective October 16, 2023. Most recently Mr. O'Brien served as General Counsel, Chief Compliance Officer & Secretary of Pear Therapeutics.
BHVN

Hot Stocks

07:02 EDT Biohaven reported preclinical data from study of taldefgrobep alfa - Biohaven announced the presentation of preclinical data demonstrating the ability of taldefgrobep alfa to significantly reduce fat mass while increasing lean mass in an obese mouse model. Separately, data supporting the correlation between change in waist circumference and change in total body weight among adults living with overweight and obesity treated with approved anti-obesity medications were reported. Both sets of data were presented on October 15, 2023 at The Obesity Society's annual ObesityWeek conference held in Dallas, TX. The poster presentations hightlight the potential benefit of taldefgrobep in the treatment of adults living with overweight and obesity and suggest anthropometric measures of central obesity, such as waist circumference or waist-to-height ratio, may be considered as effective alternative estimations of therapeutic effect. In a mouse model of diet-induced obesity, untreated mice exhibited an increase in fat mass of 31%, while the taldefgrobep-treated mice demonstrated increases in lean mass of 25% from baseline and lost 11% of their baseline fat compared to vehicle treated mice. Insulin and leptin levels were consistently lower in taldefgrobep-treated mice compared to untreated.
TECH

Hot Stocks

07:02 EDT Bio-Techne: Wallingford, CT facility has received ISO 13485:2023 certification - Bio-Techne announced that its Wallingford, CT facility has received ISO 13485:2023 certification for its quality management system, demonstrating the company's commitment to producing products for clinical applications. The company's Wallingford site manufacturers Bio-Techne's cartridge-based Simple Plex immunoassays for its automated Ella multiplexing immunoassay platform, a rapid and hands-free precision biomarker detection system.
CVS

Hot Stocks

07:00 EDT CVS Health CFO Shawn Guertin to take leave of absence - CVS Health announced several leadership updates, effective immediately. Executive VP, CFO and president of Health Services Shawn Guertin will be taking a leave of absence from his role due to unforeseen family health reasons. Senior VP of corporate finance, Tom Cowhey, has been appointed interim CFO. CEO of Oak Street Health, Mike Pykosz, has been named interim president of Health Services. Cowhey joined CVS Health in February of 2022. He previously served as CFO of Surgery Partners Inc., and before that spent more than a decade at Aetna in various strategy and finance roles.
CVS

Hot Stocks

06:58 EDT CVS Health CFO Shawn Guertin takes personal leave of absence - In a regulatory filing, CVS Health said that effective October 13, Shawn Guertin, the company's EVP and CFO, has begun a personal leave of absence for unforeseen family medical reasons. In connection with Guertin's leave, the company's Board of Directors appointed Thomas Cowhey, SVP, Corporate Finance, to serve as the company's interim CFO, effective October 13.
IDYA

Hot Stocks

06:57 EDT Ideaya Biosciences announces expansion of darovasertib, crizotinib combination - Ideaya Biosciences announced initiation of a Phase 2 expansion of the darovasertib and crizotinib combination in GNAQ/11 metastatic cutaneous melanoma.
GSK

Hot Stocks

06:48 EDT GSK announces CHMP of EMA adopted positive opinion of Jemperli - GSK announced the Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, has adopted a positive opinion recommending approval of Jemperli in combination with carboplatin-paclitaxel, for the treatment of adult patients with mismatch repair deficient/microsatellite instability-high, MSI-H, primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy. Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "We are pleased with this positive CHMP opinion and the potential for dostarlimab with chemotherapy to treat patients with this very challenging form of endometrial cancer. If approved, dostarlimab plus chemotherapy will be the first new treatment option in decades for these patients in the European Union, offering long-awaited new hope for improved long-term outcomes. This opinion further reinforces our confidence in dostarlimab's important role in the immuno-oncology treatment landscape."
MRK

Hot Stocks

06:47 EDT Merck: EC approves KEYTRUDA as adjuvant treatment for NSCLC - Merck announced that the European Commission has approved KEYTRUDA, Merck's anti-PD-1 therapy, as a monotherapy for the adjuvant treatment of adults with non-small cell lung cancer who are at high risk of recurrence following complete resection and platinum-based chemotherapy. The decision marks fifth approval for KEYTRUDA in lung cancer in the EU.
VTNR

Hot Stocks

06:37 EDT Vertex Energy names BofA Securities as strategic financial advisor - Vertex Energy announced that it has formally named BofA Securities as Vertex's strategic financial advisor to assist with the Company's renewable fuels and sustainable products growth strategy. During this engagement, the Company expects to review various potential strategic transaction opportunities aimed at strengthening the balance sheet to support growth acceleration and asset development in line with the Company's forward trajectory as an energy transition company. There can be no assurance that this process will result in any transaction. Vertex has not set a timetable for the completion of this process and does not intend to comment further unless or until the Board of Directors has approved a definitive course of action, or it is determined that other disclosure is necessary or appropriate.
AAC

Hot Stocks

06:35 EDT Ares Acquisition announces effectiveness of registration statement - Ares Acquisition announced that on October 13, 2023, the U.S. SEC declared effective the Registration Statement on Form S-4, as amended, AAC had filed in connection with the previously announced proposed business combination with X-Energy Reactor Company, LLC, a Delaware limited liability company. Assuming satisfaction of the conditions to the closing of the Business Combination, including approval of the Business Combination by AAC's shareholders, the post-Business Combination company intends to list its securities on the New York Stock Exchange under the proposed symbols "XE" and "XEW", respectively. The NYSE listing is subject to the closing of the Business Combination and fulfillment of all NYSE listing requirements.
NEM

Hot Stocks

06:33 EDT Newmont announces end of strike at Penasquito Mine in Mexico - Newmont announces it has reached a definitive agreement with the National Union of Mine, Metal, and Allied Workers of the Mexican Republic to end the strike initiated by the Union on June 7, 2023, at the company's Penasquito mine located in the Mexican state of Zacatecas. On October 13, 2023, Newmont and the Union submitted the Agreement to the Mexican Labor Court, which gave its approval, thus ending the strike. The strike was initiated by the Union demanding the company pay additional profit sharing, equivalent to double the amount agreed upon one year ago, along with other alleged violations of the Collective Bargaining Agreement. Key terms of the Agreement include: Newmont will not pay any additional incremental profit sharing for 2022. This was the basis for the strike, and the profit sharing paid by the company this year fully complied with Mexican law and the Collective Bargaining Agreement. If, as a consequence of the strike, the Penasquito mine reports no profit in 2023, then Newmont agrees to pay an additional bonus in Q2 next year, equivalent to two months' wages as the company recognizes the hardship employees have experienced given the duration of the strike. Newmont will pay employees a fixed amount, roughly equivalent to 60% of wages lost, since the strike began on June 7, 2023. This payment is intended to mitigate the financial impact that the strike, initiated by the Union, has had on the company's workforce. In addition, as part of the separate, annual wage negotiations under the Collective Bargaining Agreement, Newmont and the Union have agreed to an 8% wage increase, in line with Mexican mining industry wage increases for 2023. These wage negotiations were not part of the Union's claims as grounds for taking the strike action. Newmont's priority is to safely return the workforce to this Tier 1 operation while ensuring an orderly ramp-up in production. It is expected to take several weeks to achieve stable production levels and a status update will be provided during the company's Q3 earnings call on October 26, 2023.
SUAC

Hot Stocks

06:31 EDT ShoulderUp Technology Acquisition signs LoI with Airspace Experience - ShoulderUp Technology Acquisition announced that it has entered into a non-binding letter of intent, or LoI, for a potential business combination with Airspace Experience Technologies, a pioneer in the urban mobility market. The Company anticipates entering into a definitive agreement by the end of the year. However, no assurances can be made that the Company will successfully negotiate and enter into a definitive agreement for a business combination or that the Company will be successful in completing the business combination.
AZN

Hot Stocks

06:18 EDT AstraZeneca says Tagrisso plus chemo sNDA granted Priority Review in U.S. - AstraZeneca's supplemental New Drug Application, or sNDA, for Tagrisso in combination with chemotherapy has been accepted and granted Priority Review 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, or NSCLC, the company announced.
ENLT

Hot Stocks

06:17 EDT Enlight Renewable begins operation at Genesis Wind in Israel - Enlight Renewable Energy announced the start of commercial operations at Genesis Wind, the largest renewable energy project in Israel. Genesis Wind was connected to Israel's electricity grid in June, and as of October 13 began selling electricity. Initially, 34 of the project's 39 turbines have reached commercial operations, comprising a generation capacity of 180 MW. The remaining five turbines are expected to be operational after the completion of final tests, raising capacity to 207 MW. Genesis Wind was built with a total investment of approximately $340M and is expected to generate estimated revenues of approximately $49M-$51M and estimated EBITDA of approximately $39M-$41M in the first full year of operation. Genesis Wind is expected to provide clean electricity equivalent to the annual consumption of approximately 70,000 households and avert an estimated 180,000 tons of CO2 emissions annually. As part of the project, a new 27 kilometer underground high-voltage transmission cable was built connecting the Golan Heights to Israel's national grid. This in turn will enable the development of additional renewable energy projects in the region.
AIMAU

Hot Stocks

06:08 EDT Aimfinity Investment Corp. I enters merger agreement with Docter Inc. - Aimfinity Investment Corp. I and Docter Inc., a Taiwanese non-invasive blood glucose watch developer, announced that they have entered a definitive merger agreement pursuant to which a newly established subsidiary of Aimfinity will become a publicly listed company combining Aimfinity and Docter upon the closing of the transaction contemplated therein. Upon closing, the combined company expects to list its ordinary shares on Nasdaq. As provided in the Merger Agreement, the merger consideration is $60,000,000, payable by newly-issued shares of the Combined Company valued at $10.00 per share. Additional earnout shares may be issuable to Docter stockholders after closing, upon achievement of certain sales targets in 2024 and 2025. Following the closing, assuming no redemption by existing public shareholders of Aimfinity, the Aimfinity shareholders will have approximately 51.92% equity interest in the Combined Company and the Docter Stockholders will have approximately 48.08% equity interest in the Combined Company. If, however, there is a maximum redemptions of existing public shareholders of Aimfinity resulting in remaining balance of trust account of $5,000,000, the Aimfinity shareholders will have approximately 29.45% equity interest in the Combined Company and the Docter stockholders will have approximately 70.55% equity interest in the Combined Company. The boards of directors of both Docter and Aimfinity have unanimously approved the Proposed Transaction, which is expected to be completed in the first quarter of 2024, subject to, among other things, approval by the Aimfinity shareholders and the Docter stockholders respectively, and satisfaction of the conditions provided in the Merger Agreement, including regulatory approvals and other customary closing conditions, including a registration statement in connection with the Proposed Transaction being declared effective by the U.S. SEC and the listing application being approved by the Nasdaq Capital Markets LLC.
NCR

Hot Stocks

06:05 EDT NCR Corp. changes name to NCR Voyix Corporation - NCR Corporation announced a change of its name to NCR Voyix Corporation. This change reflects the company's planned separation into two independent, publicly traded companies, NCR Voyix, focused on digital commerce, and NCR Atleos, focused on ATMs. The separation is expected to be completed on October 16, 2023, at the close of business. The name change became effective on October 13, 2023. The company's stock will begin trading on the New York Stock Exchange under the new ticker symbol "VYX" on October 17, 2023.
ESTA

Hot Stocks

06:05 EDT Establishment Labs receives FDA clearance for Motiva Flora Tissue Expander - Establishment Labs Holdings announced that the FDA has granted 510k clearance for the Motiva Flora SmoothSilk Tissue Expander. The Flora SmoothSilk Tissue Expander offers several proprietary innovations, including Establishment Labs' patented SmoothSilk surface technology. SmoothSilk has been shown to produce the least amount of inflammation and foreign body response compared to other implant surfaces.1 Flora also includes an RFID-enabled, non-magnetic port, labeled as MR Conditional by the FDA. By being magnet-free, Flora avoids the interference that magnets can cause during MRI and may improve the precision of radiation oncology treatment. All other commercially available breast tissue expanders include magnets. In a blinded head-to-head study where patients were randomized to receive Flora in one breast and a U.S. commercially available tissue expander in the other, patients reported significantly higher aesthetic and comfort scores, as well as less breast pain, discomfort, and nipple sensitivity with Flora. Surgeons reported higher satisfaction with lower pole expansion as well as with the footprint created by Flora. The capsule tissue around the Flora expander was thinner and the peri-prosthetic fluid was significantly lower than with the comparative device.
PAX

Hot Stocks

06:03 EDT Patria Investments to acquire private equity solutions business from abrdn - Patria Investments announced an agreement for the carve-out acquisition of a private equity solutions business from abrdn. Upon closing, the acquired platform together with this existing business will form a new vertical - Global Private Markets Solutions. On a pro forma basis, GPMS is positioned to launch with an aggregate FEAUM of over $9B and will be led by Marco D'Ippolito. This vertical will further develop a complementary pillar of growth to serve as a gateway for Latin American investors to access private markets on a global scale. Transaction includes total consideration of up to ~GBP 100M payable to the seller in cash, with GBP 80 million as base value and GBP 20 million contingent on certain performance factors. Timing of payments includes GBP 60 million payable at closing, GBP 20 million payable at 24 months from closing, and up to GBP 20 million payable at 36 months from closing pending certain performance factors. The initial payment of GBP 60 million will be financed through a bank credit facility maturing 36 months after closing. The transaction is expected to close in the first half of 2024 pending regulatory approvals, and is expected to be accretive to Patria shareholders in 2024.
IRWD

Hot Stocks

06:02 EDT Ironwood presented data from the Phase II STARS Nutrition program at UEG Week - Ironwood Pharmaceuticals presented positive final data from the company's Phase II STARS Nutrition program during United European Gastroenterology, or UEG, Week. This multicenter study of nine patients was designed to evaluate the safety, pharmacokinetics, and efficacy of apraglutide, an investigational next-generation, long-acting synthetic GLP-2 analog, on intestinal absorption in adult patients who have Short Bowel Syndrome with Intestinal Failure, or SBS-IF, and Colon-in-Continuity, or CIC. Positive interim results from this study were first announced in October 2022. The data from STARS Nutrition were featured at UEG Week during a late-breaker oral presentation titled "The Long-Acting GLP-2 Analog Apraglutide Provides Clinical Benefit For Patients With Short Bowel Syndrome With Intestinal Failure And Colon In Continuity At 52 Weeks." The presentation highlighted that apraglutide had an acceptable safety profile, which was the primary study objective, and that apraglutide improved intestinal absorption as indicated by 50% parenteral support (PS) volume and energy content decrease, resulting in one or more days off PS. PS reduction was observed as early as week four and was maintained until the end of the study. 78% of patients gained one or more days off PS with all patients achieving clinical response.
F

Hot Stocks

05:59 EDT Ford recalls 238K Explorers over rollaway risk - Ford is recalling around 238,364 2020-2022 Explorer vehicles because the rear axle horizontal mounting bolt may fracture and cause the driveshaft to disconnect, the NHTSA said this weekend. Dealers will replace a bushing and the rear axle bolt. They also will inspect the rear axle cover for damage near the bolt hole and replace the cover if damage is found. The company is not aware of any crashes or injuries, though it knows of 396 reports of rear axle bolt failures, and fewer than 5% caused loss of power or let vehicles roll while they were in park.
TMUS

Hot Stocks

05:47 EDT T-Mobile, Deutsche Telekom complete 5G Standalone testing - T-Mobile US and Deutsche Telekom Global have completed testing of 5G Standalone, or 5G SA, roaming, leveraging Deutsche Telekom Global Carrier's Security Edge Protection Proxy, or SEPP, to complete the world's first hosted SEPP 5G SA roaming T-Mobile US and Sunrise and a direct SEPP to SEPP interconnect with AIS Thailand. 5G SA roaming grants customers on participating networks the ability to travel internationally and continue accessing the best 5G experience available with 5G SA.
TECK

Hot Stocks

05:46 EDT Teck Resources reports Q3 steelmaking coal sales were 5.2M tons - Teck Resources provided unaudited Q3 steelmaking coal sales volumes and realized prices. The company said, "Our third quarter steelmaking coal sales were 5.2 million tonnes, below our guidance of 5.6 - 6.0 million tonnes due to slower than anticipated supply chain recovery following the impacts of B.C. wildfires and the labour disruption at B.C. ports, and plant challenges. We implemented a plant improvement initiative in the second and third quarter and are seeing improved plant performance in the fourth quarter. The realized steelmaking coal price in the third quarter averaged US$229 per tonne. We expect to report a positive steelmaking coal provisional pricing adjustment of $23 million in the third quarter. Our third quarter 2023 financial results are scheduled for release on October 24, 2023."
RAD

Hot Stocks

05:44 EDT Rite Aid initiates process under Chapter 11, receives $3.45B in new financnig - Rite Aid announced it has reached an agreement in principle with certain of its senior secured noteholders on the terms of a financial restructuring plan that will allow the company to accelerate its ongoing business transformation. Implementing the contemplated restructuring plan will significantly reduce the company's debt, increase its financial flexibility and enable it to execute on key initiatives. In connection with this, Rite Aid has initiated a voluntary court-supervised process under Chapter 11 of the U.S. Bankruptcy Code. Rite Aid is continuing to deliver healthcare products and services across its retail and online platforms for the nearly one million customers it serves daily. The court-supervised process provides an orderly and efficient forum for Rite Aid to: finalize and build consensus for the agreement in principle the company has reached with certain of its senior secured noteholders; accelerate the company's store footprint optimization plan; implement a proposed transaction under which MedImpact would acquire Elixir Solutions, subject to the outcome of a court-approved marketing process; access additional liquidity and resolve litigation claims in an equitable manner. In connection with this process, Rite Aid has received a commitment for $3.45B in new financing from certain of its lenders. This financing is expected to provide sufficient liquidity to support the Company throughout this process. The company has reached an agreement in principle with certain of its senior secured noteholders on the terms of a financial restructuring that would significantly reduce the Company's debt. Rite Aid intends to use the court-supervised process to finalize the agreement in principle, build additional consensus for the financial restructuring plan it contemplates and implement it as quickly and efficiently as possible. Rite Aid regularly evaluates its store portfolio. In connection with the court-supervised process, the company will continue assessing its footprint and close additional underperforming stores. These efforts will further reduce the company's rent expense and are expected to strengthen its overall financial performance. The Company will also transfer associates at impacted stores to other Rite Aid locations where possible. Rite Aid has entered into an agreement with MedImpact, pursuant to which MedImpact will acquire Rite Aid's Elixir Solutions business. Under the terms of the agreement, MedImpact will serve as the "stalking horse bidder" in a court-supervised sale process under section 363 of the U.S. Bankruptcy Code. Accordingly, the proposed transaction is subject to higher and better offers, court approval and other customary conditions. Elixir Solutions is operating normally and continuing to serve clients, plan sponsors, members and customers as usual. Elixir Insurance is not included in Rite Aid's Chapter 11 process or the proposed transaction with MedImpact, and it is continuing to operate and serve members as usual. Rite Aid and certain of its subsidiaries, including those that comprise Elixir Solutions, have filed voluntary petitions for reorganization under Chapter 11 of the U.S. Bankruptcy Code in the U.S. Bankruptcy Court for the District of New Jersey. Elixir Insurance is not included in the Chapter 11 process. The Company has filed a number of customary motions with the Court seeking authorization to support its operations, including the payment of employee wages, salaries and benefits without interruption. The Company expects to receive court approval for these requests shortly. The company intends to pay vendors and suppliers in full for goods and services provided on or after the filing date.
RAD

Hot Stocks

05:40 EDT Rite Aid appoints Jeffrey Stein as CEO - Rite Aid has appointed Jeffrey Stein as CEO, chief restructuring officer, or CRO, and a member of the board of directors, effective immediately. Stein succeeds Elizabeth Burr, who has served as interim CEO of Rite Aid since January. Burr will continue to serve on the company's board. Stein brings more than three decades of experience as a leader and executive director at both public and private companies. Stein has particular expertise in turnaround strategies, evaluating financing alternatives, analyzing capital investment programs, managing litigation matters and assessing asset acquisition and disposition opportunities. As announced in a separate press release today, Rite Aid has initiated a voluntary court-supervised process under Chapter 11 of the U.S. Bankruptcy Code. The company is continuing to operate in the ordinary course. In addition to Stein, Rite Aid has appointed Carrie Teffner and Paul Keglevic to its board of directors, also effective immediately.
HSIC

Hot Stocks

05:37 EDT Henry Schein reports cybersecurity incident - Henry Schein determined that a portion of its manufacturing and distribution businesses experienced a cybersecurity incident. Henry Schein took precautionary action, including taking certain systems offline and other steps intended to contain the incident, which has led to temporary disruption of some of Henry Schein's business operations. The company is working to resolve the situation as soon as possible. Henry Schein has determined that the practice management software used by its clients has not been disrupted. The company has engaged outside cybersecurity and forensic information technology experts to help investigate any data impact and respond to this situation. Henry Schein also has notified relevant law enforcement authorities.
KKR

Hot Stocks

05:35 EDT KKR, Flerie partner to form pharma services platform and invest in companies - KKR announced, in partnership with Flerie, the formation of a new global pharma services platform, Frontier Biosolutions, which will invest in a portfolio of companies focused on specialized pharmaceutical services to advanced therapeutics customers. Frontier will invest in differentiated scientific capabilities and proprietary technology platforms that address critical bottlenecks in the development and manufacturing of advanced therapeutics. Industry veteran and co-investor Thomas Eldered will serve as Frontier's executive chairman, bringing more than 34 years of senior management expertise to the management board and drawing on his experience as co-founder of Recipharm and as a life sciences investor at Flerie. As the platform's foundational investment, funds managed by KKR and Flerie, through Frontier, have invested in Munich-based Coriolis Pharma, a company in formulation research and development, analytical services and non-GMP manufacturing of biologics and cell and gene therapy products. KKR's investment will enable Coriolis' continued expansion, especially into the fast-growing cell and gene therapy segment and will expand its range of services offered to customers globally.
EGY

Hot Stocks

05:31 EDT Vaalco Energy provides Q3 production, sales volume update - Vaalco Energy provided an operational and financial update, including production and sales volumes for the third quarter and its increased cash and cash equivalents balance as of September 30. The company highlighted: strong operational performance in Gabon, Egypt and Canada continued to drive robust production and sales volumes in Q3; produced nearly 19,000 net revenue interest barrels of oil equivalent per day, or boepd, at the upper end of Vaalco's Q3 guidance range of 17,500 to 19,200 NRI boepd; recorded sales volumes of almost 19,900 NRI boepd, also at higher end of its guidance range of 18,400 to 20,600 NRI BOEPD; completed an additional crude sales lifting in Gabon of about 600,000 gross barrels of oil in the first week of October and grew cash and cash equivalents to over $100M at September 30, more than double cash and cash equivalents as of June 30, 2023.
DBVT

Hot Stocks

05:29 EDT DBV Technologies appoints Virginie Boucinha as CFO - DBV Technologies announced the appointment of Virginie Boucinha as its CFO, effective November 6. An experienced financial and operations executive, Virginie will report directly to Daniel Tasse, CEO, and serve as a member of the executive committee. Boucinha will be responsible for DBV's financial management and operations, information technology, strategic planning, and investor relations. Boucinha brings approximately 30 years of experience in the pharmaceutical industry. She most recently served as the group performance director for Pierre Fabre.
PFE BNTX

Hot Stocks

05:26 EDT BioNTech provides update on Pfizer $0.9B Comirnaty write-offs - Pfizer (PFE), a collaboration partner of BioNTech (BNTX), announced a non-cash charge for inventory write-offs and other charges related to Pfizer of $0.9B. The company has been informed by Pfizer that the majority of the write-offs relate to raw materials, mainly formulation-related lipids, purchased during the pandemic, as well as COVID-19 vaccine doses adapted to other, non-XBB.1.5 variants produced at risk. According to Pfizer, the write-offs do not address Pfizer-BioNTech COVID-19 Vaccine doses adapted to the XBB.1.5 variant, which has been approved and is being marketed in key geographies. BioNTech is evaluating the potential impact of Pfizer's write-offs and other charges related to Comirnaty on the company's financial results. BioNTech's current expectation is that the company is likely to recognize the effect of Pfizer's inventory write-offs and other charges related to Comirnaty in the third quarter of 2023 up to EUR 0.9B, which represents BioNTech's half of the gross profit-sharing agreement with Pfizer. Any such write-offs will reduce the revenues the company would report for 2023. BioNTech expects to release its financial report for the third quarter of 2023 on November 6.
LBTYA

Hot Stocks

05:23 EDT Liberty Global acquires Telenet Group following simplified squeeze-out - Liberty Global announced that, during the simplified squeeze-out period of its voluntary public takeover bid for all the shares of Telenet Group by its indirect wholly-owned subsidiary, Liberty Global Belgium, it received acceptances for 1,156,941 Telenet shares. Any shares of Telenet that were not tendered by the end of the Simplified Squeeze-Out Period were automatically transferred to the offeror by operation of law and, as a result, the offeror will own 100% of the shares of Telenet upon settlement of the shares that were tendered during the Simplified Squeeze-Out Period. Payment of the offer price for the Telenet shares tendered during the Simplified Squeeze-Out Period will occur on the payment date, October 19. The funds required to pay the offer price for any non-tendered shares will be deposited with the deposit and consignment office. Shareholders that have not tendered their shares, but which were transferred by operation of law, will need to contact the deposit and consignment office to receive payment for such shares. On October 13, Telenet shares were delisted from Euronext Brussels at close of trade.