Stockwinners Market Radar for December 11, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

21:05 EST Bristol Myers announces results of golcadomide studies in Non-Hodgkin Lymphoma - Bristol Myers announced the results of two early studies evaluating combinations of potential first-in-class CELMoD agent golcadomide in non-Hodgkin lymphomas. These data are being presented in separate posters at the 2023 American Society of Hematology Annual Meeting from December 9-12. In the dose expansion phase of this Phase 1b study, patients were randomized 1:1 to golcadomide at one of two recommended Phase 2 dose levels plus R-CHOP-21 for a fixed duration of 6 cycles. A total of 65 (83.3%) patients completed 6 cycles of the combination with 13 discontinuing treatment. There were 71 patients evaluable for efficacy, and results showed: Overall response rate (ORR) at end of treatment rate was 84.5% in patients overall, with 87.9% of patients in the DL1 arm achieving a complete metabolic response (CMR) compared to 63.6% in the DL-1 arm. Minimal residual disease negativity at the end of treatment was achieved in 93% (14/15) of patients treated with 0.4 mg of golcadomide plus R-CHOP compared to 70% (7/10) treated with 0.2 mg of golcadomide plus R-CHOP. At both DL1 and DL-1, steady-state levels of golcadomide reduced Ikaros over 80%, to levels predicted to optimize tumor cell killing and to stimulate T and NK cells. In the safety population (n=78), the majority of patients (98.7%) experienced at least one treatment-emergent adverse event (TEAE). Grade 3/4 TEAEs were primarily hematologic with neutropenia (89.7%), thrombocytopenia (42.3%) and anemia (32.1%) being the most common. Any grade febrile neutropenia was reported in 21.8% of patients. Median relative dose intensity of key R-CHOP components was maintained at greater than90%. A separate poster detailed the efficacy and safety results from the dose expansion segment of a Phase 1/2 open-label study of two doses of golcadomide plus rituximab in relapsed/refractory patients with non-Hodgkin lymphoma. Patients were heavily pre-treated with a median number of 4 prior therapies (range 1-11), including 61% who had prior CAR T. In patients evaluable for efficacy (n=26), the ORR was 42% (11/26) with 19% (5/26) achieving a complete response (CR). The median duration of response was 7.5 months (1.8-14.5). The ORR and CR rate was greater for patients in the 0.4 mg arm compared to the 0.2 arm (55% vs. 33% and 27% vs. 13%, respectively). In the study, neutropenia was the most common TEAE of any grade, occurring in 50% of patients (22/44). Febrile neutropenia was observed in 2 patients, with 1 patient at each dose level. A total of 6 patients had serious adverse events with only pneumonia and pyrexia occurring in more than 1 patient (2 each). There were 4 deaths on treatment during the study with one considered related to the study treatment.

20:37 EST Disc Medicine presents positive updated results from Phase 2 study of Bitopertin - Disc Medicine "presented updated results from the phase 2 open-label BEACON study of bitopertin, an orally administered glycine transporter 1 inhibitor, in patients with erythropoietic protoporphyria as an oral presentation at the 65th ASH Annual Meeting. The updated data are consistent with and confirm the initial positive results presented in June, demonstrating significant decreases in PPIX, robust and consistent improvements in sunlight tolerance across all study measures, including the precedented pivotal endpoint, and improvements in patient quality of life. The BEACON study is a randomized, open-label, parallel-arm study that enrolled 22 adult subjects with EPP or X-linked protoporphyria in Australia, and has been expanded to include adolescents. This trial was designed to assess changes in levels of PPIX, as well as measures of photosensitivity, quality of life, and safety and tolerability. Subjects are randomized to receive either 20 mg or 60 mg of bitopertin once-daily for 24 weeks, after which patients have the option of continuing in an open-label extension of the trial for up to an additional 24 weeks. The updated data presented reflects results from all 22 adults, with a data cutoff of September 18, 2023 for PPIX data and October 20, 2023 for all other endpoints. The data are consistent with and confirm the initial positive results presented in June 2023."

20:23 EST Cathie Wood's ARK Investment bought 1.19M shares of Recursion Pharmaceuticals

19:50 EST Applied UV Inc trading halted, news pending

19:45 EST Gilead announces results supporting use of Tecartus - Kite, a Gilead Company, "announced the results of four new analyses supporting the use of Tecartus in relapsed/refractory mantle cell lymphoma and relapsed/refractory adult B-cell precursor acute lymphoblastic leukemia . These results include four-year overall survival data from the pivotal ZUMA-2 study and primary results from ZUMA-18, an expanded access study, evaluating the CAR T-cell therapy Tecartus in patients with R/R MCL that were presented orally at the 2023 American Society of Hematology Annual Meeting & Exposition. An analysis from ZUMA-2 showing that patients who received early versus late intervention for management of cytokine release syndrome and neurological events experienced improved safety outcomes was also presented in a poster session. In addition, real-world findings on effectiveness and safety outcomes from the Center for International Blood and Marrow Transplant Research (CIBMTR) observational database of U.S. patients who received Tecartus for R/R MCL were highlighted in an oral session; CIBMTR data from adult patients with R/R B-ALL were also presented orally today."

19:34 EST Eli Lilly announced updated clinical data from Phase 1/2 trial of pirtobrutinib - Eli Lilly and Company announced updated clinical data from the international Phase 1/2 BRUIN trial of pirtobrutinib, a non-covalent Bruton's tyrosine kinase inhibitor, in adult patients with a range of B-cell malignancies. These data, which were presented in oral and poster presentations at the 65th American Society of Hematology Annual Meeting and Exposition, continue to support the role of pirtobrutinib in the treatment of chronic lymphocytic leukemia or small lymphocytic lymphoma and mantle cell lymphoma. The labeling for pirtobrutinib contains warnings and precautions for infections, hemorrhage, cytopenias, cardiac arrhythmias, second primary malignancies, and embryo-fetal toxicity. "Following the two FDA accelerated approvals for pirtobrutinib in 2023, we are excited to present these data at ASH, further building the body of evidence for this medicine in CLL, SLL, MCL, and other B-cell malignancies," said David Hyman, M.D., chief medical officer, Lilly. "These data support the potential role that pirtobrutinib, the first and only FDA-approved non-covalent BTK inhibitor, can play in extending the time patients may benefit from BTK inhibition therapy and provide additional efficacy data in patients previously treated with a covalent BTK inhibitor. We look forward to expanding our understanding of the broader potential clinical utility of pirtobrutinib as we continue to progress our series of randomized Phase 3 studies in CLL, SLL, and MCL."

19:10 EST Autodesk director Smith sells 5,000 common shares - In a regulatory filing, Autodesk director Stacy Smith disclosed the sale of 5,000 common shares of the company on December 11 at a price of $228 per share.

19:04 EST NextEra Energy - NextEra Energy Transmission MidAtlantic announced that PJM has selected its transmission proposal, the MidAtlantic Resiliency Link, to address the western cluster of reliability needs for the 2022 Regional Transmission Expansion Plan Window 3. The MidAtlantic Resiliency Link was selected as part of a set of transmission solutions necessary for addressing the regional grid's reliability needs in the coming years.

18:28 EST Gap exec Gruber sells 24,178 common shares - In a regulatory filing, Gap chief legal and compliance officer Julie Gruber disclosed the sale of 24,178 common shares of the company on December 7 at a price of $21.50 per share.

18:07 EST Century Communities announces grand opening in Hanford, CA - Century Communities has introduced two brand-new model homes at its new Hanford community, Live Oak. Bringing 99 new homes to Hanford, Live Oak showcases single- and two-story floor plans with contemporary open-concept layouts and the builder's Century Home Connect smart home package. Convenient main-floor bedrooms, mud rooms, and lavish owner's suites make these standout homes even more desirable, the company said.

18:00 EST Harbor Custom Development Inc trading resumes

17:46 EST Kite announces results from three-year analysis of ZUMA-12 - Kite, a Gilead Company, announced results from a three-year follow-up analysis of ZUMA-12, a Phase 2 study of Yescarta as first-line treatment after two cycles of chemoimmunotherapy in patients with high-risk, large b-cell lymphoma. The analysis, which demonstrated durability of clinical benefit - both high complete response and objective response rates, including in patients with MYC and BCL2 and/or BCL6 rearrangements - was presented during an oral presentation at the 65th American Society of Hematology Annual Meeting & Exposition. "Patients with high-risk, large B-cell lymphoma, have a poor prognosis with currently available therapies," said Julio C. Chavez, MD, lead investigator, Moffitt Cancer Center. "This is particularly true of patients with double- or triple-hit histology, who have a median survival of under a year with standard treatment. The impressive results at a median follow-up of 40 months build on the ZUMA-12 primary analysis, the first prospective Phase 2 study to evaluate CAR T-cell therapy as first-line treatment and reinforce axi-cel's potential to be used safely and effectively in this patient population with high medical need."

17:38 EST AMC Entertainment completes $350M at-the-market offering, reducing debt by $62M - AMC Entertainment "announced that it has completed its previously disclosed $350 million at-the-market equity offering launched on November 9, 2023 and repurchased debt or exchanged debt for equity thereby reducing liabilities by $62.28 million. AMC raised $350 million of new equity capital, before commissions and fees, through the sale of approximately 48.0 million shares, at an average price of approximately $7.29 per share. Using a portion of the proceeds raised through the ATM offering, AMC repurchased $50 million principal amount of its 10% second lien notes due 2026 at an average discount of 19.67%, plus accrued interest. In addition, AMC exchanged $12.275 million principal amount of its 10% second lien notes due 2026 plus accrued interest for approximately 1.6 million shares of Class A common stock with an implied value of $8.19 per share." CEO Adam Aron said, "Successfully raising an additional $350 million of equity capital and reducing debt by more than $62 million in a single month underscores our continued commitment to strengthen our balance sheet by bolstering liquidity and methodically reducing debt levels. Thus far in 2023, AMC has raised $865 million of gross equity capital and lowered liabilities by approximately $440 million by reducing our corporate borrowings by approximately $350 million and repaying more than $90 million of COVID-19 related deferred rent liabilities. Our commitment to strengthening the balance sheet is further evidenced by the more than $1 billion reduction in our corporate borrowings and deferred rent liabilities since December 31, 2020."

17:27 EST Virtus Investment reports November assets under management of $165.5B - Virtus Investment reported preliminary assets under management of $165.5 billion as of November 30, 2023. In addition, the company provided services to $2.6 billion of other fee-earning assets, which are not included in assets under management.

17:15 EST Cohen & Steers reports preliminary AUM of $78.7B as of November 30 - Cohen & Steers reported preliminary assets under management of $78.7B as of November 30, 2023, an increase of $6.5B from assets under management at October 31, 2023. The increase was due to market appreciation of $7B, partially offset by net outflows of $264M and distributions of $155M.

17:06 EST Hasbro confirms to eliminate additional 900 positions beginning in Q4 - In a regulatory 8-K filing, the company states: "In October 2022, following a strategic review, Hasbroannounced an Operational Excellence Program, an ongoing enterprise-wide initiative intended to improve our business through specialized organizational programs that include targeted cost-savings, supply chain transformation and certain other restructuring actions designed to drive growth and enhance shareholder value. As part of this program, in January 2023, the Company announced the intention to eliminate approximately 1,000 positions from its global workforce, or approximately 15% of global full-time employees. On December 11, 2023, following a further review of the Company's cost structure and organizational design, the Company announced additional strategic steps to position the business for future growth, including a revised organizational structure whereby certain corporate functions are anticipated to be supported by a third-party outsourcing provider as well as additional headcount reductions under the Operational Excellence Program. The Company's organizational structure changes will result in the reallocation of people and resources, which will include voluntary early retirement for certain groups of employees and additional involuntary reductions in employees. The Company currently anticipates that approximately 900 incremental positions will be eliminated as part of the Additional Actions, which are expected to be substantially completed over the next 18 to 24 months. In connection with the Initial Actions, the Company accrued approximately $94 million of expenses related to severance, stock compensation and employee benefits, and expects to accrue approximately $40 million of incremental severance related expenses in connection with the Additional Actions. The Company expects that the cash payments related to the Additional Actions will begin in the fourth quarter of 2023 and continue through the next 18 to 24 months. The Additional Actions are expected to deliver gross annual run-rate cost savings of approximately $100 million. As a result, under the Company's Operational Excellence Program, the Company now expects to deliver gross annual run-rate cost savings of approximately $350 million to $400 million by the end of 2025 which is increased from the previous estimate of $250 million to $300 million. The foregoing amounts are estimates. Actual amounts may vary based on a number of factors, including, but not limited to, the number of employees who are impacted through both the voluntary and involuntary workforce reductions."

17:01 EST Sanofi issues statement on FTC plan to block deal with Maze Therapeutics - The company states: "Sanofi is disappointed with the Federal Trade Commission's announcement that it is seeking a preliminary injunction against a proposed licensing agreement between Sanofi and Maze Therapeutics. The agreement, announced on May 1, 2023, is for MZE001, a glycogen synthase 1 inhibitor program that has completed Phase 1 and is in development for Pompe Disease, a rare, inherited and often fatal disorder that disables the heart and skeletal muscles. We respectfully disagree with the action by the FTC which also delays potential advancements that could impact the lives of patients. The Maze partnership was designed to apply Sanofi's resources, knowledge, and expertise to accelerate the development of MZE001, with the hope of addressing unmet medical needs for this devastating condition. The delay associated with a long litigation has led Sanofi to conclude that it would not be in the best interests of patients to contest this litigation and Sanofi will therefore be terminating the agreement with Maze in accordance with its terms. Sanofi remains committed to address the Pompe patient community's unmet needs."

16:50 EST Duckhorn Portfolio CEO buys $45K in common stock - In a regulatory filing, Duckhorn Portfolio disclosed that its CEO Deirdre Mahlan bought 5K shares of common stock on December 11th in a total transaction size of $45K. Shares of Duckhorn Portfolio are up 3% afterhours at $9.39.

16:42 EST Pentair raises quarterly dividend to 23c from 22c per share - The dividend is payable on February 2, 2024 to shareholders of record at the close of business on January 19, 2024.

16:38 EST Rogers Communications sells shares of Cogeco for C$829M in private transaction - Rogers Communications announced the sale of all of its shares of Cogeco to Caisse de depot et placement du Quebec in a private transaction for C$829M. "This sale further demonstrates our commitment to strengthen our investment grade balance sheet and aggressively reduce our debt leverage ratio," said Tony Staffieri, President and CEO, Rogers. "We're tracking six months ahead on our deleveraging priorities and we're committed to reducing our debt leverage ratio even further." With the sale of these Cogeco shares, the company expects to achieve a debt leverage ratio of 4.7x by year end, compared to the expected 4.8x at year end announced on the release of its third quarter results. The company's debt leverage ratio was 4.9x at the end of Q3. The sale proceeds are in addition to the previously announced divestiture of C$1B in non-core assets, predominantly real estate, that is expected to be completed in 2024.

16:35 EST Geron announces IMerge phase 3 data presentations at ASH - Geron announced presentations of data from its IMerge Phase 3 clinical trial evaluating first-in-class investigational telomerase inhibitor imetelstat in patients with lower risk myelodysplastic syndromes, as well as population analysis of claims data in lower risk MDS. The data were presented at the American Society of Hematology Annual Meeting, taking place from December 9-12, 2023, in San Diego, CA and virtually as well as published online in Blood. "These latest analyses from IMerge Phase 3 presented at ASH contribute to a growing body of data from the trial, including a recent publication in The Lancet, which continue to give us confidence in what we believe is a meaningful clinical benefit with imetelstat in these lower risk MDS patients," said Faye Feller, M.D., Executive Vice President, Geron's Chief Medical Officer. "If approved, we believe that the significant improvement in red blood cell transfusion independence possible with imetelstat could provide an important new treatment option for many lower risk MDS patients who suffer from iron overload and low quality of life associated with transfusion dependence."

16:33 EST Installed Building Products acquires Combee Insulation, terms not disclosed - Installed Building Products announced the acquisition of Combee Insulation Company, Inc., Combee Foam Products, Inc. and Air Tight Diagnostics, LLC. Established in 1970, Combee is headquartered in Lakeland, Florida and installs a diverse mix of building products including, fiberglass insulation, spray foam insulation, and garage doors, primarily into new residential construction projects throughout the greater Central Florida area. "With approximately $16.5 million of annual revenue, Combee expands our presence to serve single-family, multifamily, and commercial customers throughout Central Florida," stated Jeff Edwards, Chairman and Chief Executive Officer. "To date in 2023, we have acquired approximately $75 million of annual revenue. Acquisitions remain a key component of our growth strategy and we continue to have a robust pipeline of opportunities across multiple geographies, products, and end markets. On behalf of everyone at Installed Building Products, I want to welcome Combee onto our team."

16:32 EST Pfizer says FDA, EMA accept Marstacimab regulatory submissions - Pfizer announced that the U.S. Food and Drug Administration has accepted the company's Biologics License Application for its anti-tissue factor pathway inhibitor candidate marstacimab for individuals living with hemophilia A or hemophilia B without inhibitors to Factor VIII or Factor IX. The European marketing authorization application for marstacimab also passed validation and is currently under review by the European Medicines Agency. The FDA has set a Prescription Drug User Fee Act action date in the fourth quarter of 2024, and a decision from the European Commission is anticipated by the first quarter of 2025. If approved in the U.S. and EU, marstacimab is expected to become the first once-weekly subcutaneous treatment for people living with hemophilia B and the first treatment administered as a flat dose for people living with hemophilia A or B. "Marstacimab has demonstrated that it may be an efficacious treatment option with once-weekly, subcutaneous flat-dose administration via an auto-injector pen, for appropriate patients, if approved. This is critical as intravenous infusions are typically required for people living with these diseases today," said James Rusnak, M.D., Ph.D., Senior Vice President, Chief Development Officer, Internal Medicine and Infectious Diseases, Research and Development, Pfizer. "We look forward to progressing the review of this novel therapy with the FDA, EMA, and global regulatory authorities to bring this important medicine to patients globally."

16:31 EST Victory Capital reports AUM of $159.6B as of November 30 - Victory Capital reported assets under management of $159.6B as of November 30, 2023, and average assets under management for November of $155.4B.

16:30 EST Aramark CFO Ondrof to retire - Aramark announced that Tom Ondrof, Chief Financial Officer, plans to retire from his current position on January 12, 2024, at which time he will serve as a Strategic Advisor through May 2024. Jim Tarangelo, Aramark's Senior Vice President Finance & Treasurer, has been appointed to succeed Ondrof as Chief Financial Officer, effective January 13. "Tom leaves a strong legacy that's both broad and deep," said John Zillmer, Aramark's Chief Executive Officer. "When I asked him to join Aramark shortly after my return, he left a hard-earned retirement to help us create and drive a successful growth strategy based on our hospitality culture, focused on accelerating net new business, optimizing supply chain economics, containing above unit costs, and instilling a value-creating mindset across the organization. On behalf of the Board and the Company leadership, I want to thank Tom for his immeasurable contributions, and wish him well as he returns to retirement."

16:27 EST UpHealth trading halted, news pending

16:23 EST SAIC to reorganize business to 'accelerate sustainable organic growth' - SAIC announced it will reorganize its business, effective February 3, 2024. The reorganization will seek to accelerate sustainable organic growth, better align with SAIC's four strategic pivots - portfolio, go-to-market, culture and brand - and ensure the company is focused and agile in allocating investments to maximize innovation, differentiation and long-term value creation. The current Defense and Civilian Sector and National Security and Space Sector will be replaced by five new business groups - Army; Navy; Air Force and Combatant Commands; Space and Intelligence; and Civilian. The new Civilian group will encompass the current Civilian, Health and State and Local businesses. This flatter organization is designed to enhance customer intimacy for the executive leadership team, who will work closely with the new business group leaders to advance SAIC's innovation and go-to-market strategy and drive improved cross-collaboration, business development and organic growth. Four of the five new business groups will be led by current SAIC senior vice presidents who will be promoted to executive vice president and report directly to Townes-Whitley beginning on February 3, 2024. Josh Jackson, Barbara Supplee, Vinnie DiFronzo and David Ray, will lead the Army, Navy, Air Force and Combatant Commands and Space and Intelligence business groups, respectively. An external search for the Civilian business group is being conducted to identify a strong best-of-market leader who will drive significant organic growth in this market. Bob Genter, President, Defense and Civilian Sector and Michael LaRouche, President, National Security and Space Sector will depart the company, effective as of February 2, 2024, to pursue opportunities outside of SAIC. "SAIC has an unmatched history of partnering with our nation's most critical mission-driven government customers and offering a best-in-class portfolio of capabilities. As we look ahead, we are becoming a more focused and growth-oriented SAIC that realizes the full potential of our differentiators, fueled by our innovation factory. This builds upon our recent decision to centralize our business development function to prioritize the quality and pace at which we execute our market opportunities," said SAIC Chief Executive Officer Toni Townes-Whitley. "We are confident the company will continue to bring innovative solutions to market, further prioritize growth and deliver significant long-term value for our shareholders, customers and employees."

16:21 EST Sutro announces data on anti-leukemic activity from luvelta compassionate use - Sutro Biopharma announced that its research collaborators presented data on anti-leukemic activity from the compassionate use of luveltamab tazevibulin, or luvelta, a folate receptor-alpha targeting ADC, in pediatric patients with relapsed/refractory CBFA2T3-GLIS2 acute myeloid leukemia, or AML, commonly known as RAM phenotype AML. Data demonstrated that treatment with luvelta produced meaningful clinical responses, including complete remission, or CR; and prolongs overall survival, or OS, enabling some patients to receive potentially curative therapies such as hematopoietic stem cell transplant. These patients were treated under the single patient IND mechanism. These data were featured in a poster presentation at the 65th American Society of Hematology Annual Meeting and Exposition, or ASH 2023, in San Diego, California. Under compassionate use, 25 pediatric patients with relapsed/refractory CBF/GLIS subtype AML were treated with luvelta at doses up to 4.3 or 5.2mg/kg every two to four weeks for a median duration of 15.9 weeks, with the majority of patients receiving at least five doses. Of the 25 treated patients, 19 had greater than or equal to 5% blasts and 8 had less than 5% blasts. Collective results show that treatment with luvelta produced clinically meaningful and durable responses across a broad range of patients in various settings including in patients with or without prior stem cell transplant and in monotherapy or in combination with cytotoxic therapy. These data were generated by the treating physicians and collected and enabled for presentation by Sutro. Overall, anti-leukemic activity was seen with luvelta either as a single agent or in combination. Overall, 19 patients had greater than or equal to 5% blasts and 8 patients had less than5% blasts. A CR/CRh was observed in 8 out of 19 patients with greater than or equal to 5% blasts treated with luvelta, with 5 out of 8 CR/CRh patients reaching a minimal residual disease, or MRD-negative CR. In total, 6 out of 8 patients with less than5% blasts experienced an MRD-negative CR. Patients whose leukemia experienced an MRD-negative CR had an improved outcome over those who did not experience an MRD-negative CR. Treatment with luvelta also enabled some children to bridge to stem cell transplant, which is potentially curative therapy. Luvelta was well-tolerated as a monotherapy agent and in combination with standard of care therapies with minimal hematopoietic toxicity and can be delivered as outpatient therapy. As of September 17, 8 patients remain on treatment, with 5 of the 8 in continued remission and on luvelta maintenance.

16:18 EST Ameresco selected for Hawaiian Electric's clean energy procurement initiative - Ameresco (AMRC) announced that it has been selected in Hawaiian Electric's (HE) clean energy procurement initiative to bring a cleaner and more resilient energy supply to Hawaii. Ameresco was awarded two clean energy facilities located on the island of O'ahu. The Pu'uloa Energy installation is designed to generate 99 megawatts of firm renewable power leveraging clean fuels including biodiesel and biogas fuels. The Pu'uloa Solar project is designed to provide Oahu with an additional 6.4 MW of solar generation combined with 6 MW/30 megawatt hours of energy storage to provide solar after sunset when electricity use remains high.

16:17 EST Invesco reports preliminary AUM $1.54T as of November 30 - Invesco reported preliminary month-end assets under management of $1.54T, an increase of 6.3% versus previous month-end. The firm delivered net long-term inflows of $1.7B in the month. Non-management fee earning net inflows were $2.7B and money market net inflows were $5.8B. AUM was positively impacted by favorable market returns which increased AUM by $75B. FX increased AUM by $6.7B.

16:16 EST Olaplex Holdings names Amanda Baldwin CEO - According to a regulatory filing, on December 11, 2023, Olaplex Holdings announced that Amanda Baldwin has been appointed as Chief Executive Officer of the company, effective immediately, completing the leadership transition that the company previously announced in its Current Report on Form 8-K filed with the Securities and Exchange Commission on October 12, 2023. Baldwin succeeds John P. Bilbrey, who served as interim Chief Executive Officer from October 12, 2023 until Baldwin's appointment and who remains Executive Chair of the company's board of directors. In addition, on December 11, 2023, the Board elected Baldwin to serve as a Class III director of the Board with a term expiring at the company's 2024 Annual Meeting of Stockholders, effective immediately. On December 11, 2023, Ms. Baldwin and the Company entered into an indemnification agreement in substantially similar form as Exhibit 10.2 to the company's Annual Report on Form 10-K filed with the SEC on February 28, 2023. A description of Baldwin's business experience was disclosed in the October 12 Form 8-K and is incorporated by reference herein.

16:14 EST Casey's General Stores sees FY24 adjusted EBITDA growth in line with target - The company states: "As a result of the strong financial performance and unit growth year-to-date, fiscal 2024 EBITDA growth is expected to be in-line with the long-term strategic plan's goal of 8% to 10%. The Company also expects to repurchase at least $100 million in shares throughout the fiscal year. Same-store inside sales are expected to increase 3.5% to 5%. Net interest expense is expected to be approximately $53 million. The tax rate is now expected to be approximately 23% to 25% for the year. As discussed in the first quarter, the Company now expects to add at least 150 stores in fiscal 2024, more than the originally planned 110. As a result of this, total operating expenses are now expected to increase approximately 6% to 8%, though same-store operating expenses excluding credit card fees are expected to only increase approximately 3% for the year. Depreciation and amortization is now expected to be approximately $350 million for the year. The Company is not updating its outlook for the following metrics. We expect inside margin improvement to approximately 40% to 41%. The Company expects same-store fuel gallons sold to be between negative 1% to positive 1%. The purchase of property and equipment is expected to be $500 to $550 million."

16:13 EST Discover names Michael Rhodes as new CEO - Discover Financial Services "announced that the Company's Board of Directors has appointed Michael G. Rhodes Chief Executive Officer and President, effective on or before March 6, 2024, at which time he will be appointed to the Company's Board of Directors. He will also serve as President of Discover Bank and will be appointed to the Discover Bank Board of Directors, effective the same date. John Owen, who has been serving as interim Chief Executive Officer and President of the Company and interim President of Discover Bank since August 14, 2023, will continue in this capacity until Mr. Rhodes officially joins Discover, after which Mr. Owen will continue to serve as a member of the Company's Board of Directors and the Discover Bank Board of Directors."

16:11 EST ICF International awarded $78M digital modernization task order - ICF was recently awarded a new $78M task order by the U.S. Department of Agriculture's U.S. Forest Service to modernize wildfire management applications and services. The task order, which was awarded under ICF's General Services Administration's IT Schedule with ICF as the team lead in conjunction with Xentity Corp through a GSA contractor teaming agreement in the third quarter of 2023, has a term of seven years, including a one-year base and six 12-month option periods.

16:09 EST Lucid Group CFO Sherry House to depart, Gagan Dhingra named interim CFO - Lucid Group announced Sherry House, CFO, informed the company that she is resigning from her position, effective immediately, to pursue other opportunities. House will be available in an advisory role through December 31, 2023, to assist in the transition of her duties. Gagan Dhingra, Lucid's current Vice President of Accounting and Principal Accounting Officer, will additionally serve as interim CFO and Principal Financial Officer, effective immediately, while Lucid's search for a replacement CFO is underway. Having spent two years at Lucid, Dhingra is deeply entrenched in the company's business, and with decades of prior accounting and finance experience, he has the expertise to carry forward the company's focus on achieving its next phases of growth and on controlling costs.

16:07 EST MaxCyte CEO Doug Doerfler to retire, Maher Masoud to succeed - MaxCyte announced that Maher Masoud has been named president and CEO of MaxCyte, succeeding Doug Doerfler, who will retire as president and CEO, effective January 1, 2024. Masoud, currently the company's EVP, head of global business development and chief counsel, will also serve as a director on MaxCyte's board of directors. Doerfler will step down from the board of directors upon his retirement and will remain an advisor to the company. Doerfler founded MaxCyte in 1999 and served as CEO for 24 years, leading the company from initial technology concept through to the commercialization of its flow electroporation technology.

16:06 EST Cedar Fair names Robert White chief commercial officer - Cedar Fair Entertainment Company announced a strategic reorganization to its corporate leadership structure. Robert White, who since 2021 has served as senior vice president of business intelligence, has been promoted to chief commercial officer, a new executive-level position created to better meet the challenges of today's dynamic consumer landscape and enhance the Company's focus on driving guest demand. Additionally, Christian Dieckmann will step into an elevated role as chief strategy officer, focused on identifying growth opportunities and driving strategic initiatives at the Company. Both promotions are effective immediately. As part of this strategic reorganization, Kelley S. Ford will transition out of the executive vice president and chief marketing officer position after serving 11 years in the post. To support the organizational change, she will remain employed in a non-executive role until March 29, 2024. "I want to thank Kelley for her leadership and guidance over the years," said Richard A. Zimmerman, Cedar Fair's president and chief executive officer. "In 2012, Kelley became the company's first dedicated chief marketing officer on Cedar Fair's executive team. Since then, she has helped modernize and develop a comprehensive marketing function that has played a key role in the company's growth. On behalf of all associates, I extend my sincere appreciation and respect for her many contributions to Cedar Fair."

16:01 EST Highway Holdings signs LOI to acquire majority stake in Synova - Highway Holdings announced it has signed a non-binding letter of intent to acquire a majority stake in Synova Metall- und Kunststofftechnik GmbH. Synova has been a comprehensive original equipment manufacturer for the production of electrotechnical and electromechanical components based in Germany for over 60 years. Synova's core competencies lie in plastic injection molding technology and metal technology. The customer base includes well-known companies in the automotive and electrical industries as well as manufacturers of optics and supply technology. The companies entered strategic discussions approximately one year ago. With negotiations around terms and conditions substantially completed, both Highway Holdings and Synova have mutually agreed to a non-binding letter of intent. Under the LOI, Highway Holdings will acquire a 51% interest in Synova. Highway Holdings will also acquire a right, exercisable under certain circumstances, to acquire the remaining 49% interest in Synova. The purchase price will be paid partly in cash, and partly in shares of Highway Holdings common shares. Highway Holdings is currently conducting due diligence, which is expected to be finished over the coming weeks. The companies are targeting to complete the transaction and combine businesses in the first quarter of 2024. The consummation of the transaction is subject to the completion of Highway Holdings' due diligence review, negotiation and execution of a mutually agreeable purchase agreement and other customary conditions. Synova serves as an all-encompassing OEM manufacturer, sharing a comparable technological proficiency and a parallel business approach with Highway Holdings.

15:49 EST FTC seeks to block Sanofi deal for exclusive license for Maze Pompe therapy - The Federal Trade Commission is seeking to block Sanofi's proposed acquisition of an exclusive license to Maze Therapeutics' therapy in development for treatment of Pompe disease. The Commission today issued an administrative complaint and authorized a lawsuit in federal court alleging the deal, valued at up to $755M, would eliminate a nascent competitor poised to challenge Sanofi's monopoly in the Pompe disease therapy market. The complaint, which also names Genzyme Corporation, the Sanofi subsidiary seeking to license the drug from Maze, alleges the transaction would protect Sanofi's monopoly and eliminate competition between Sanofi and Maze to develop new Pompe drugs, denying patients and doctors the benefits of competition, including lower prices and greater innovation. Reference Link

15:31 EST FirstEnergy director Andrew Teno resigns as Icahn holding fell below 1.5% - According to a regulatory filing, on December 8, 2023, Andrew Teno, a member of the Board of Directors of FirstEnergy Corp., tendered his resignation as a director of the company, effective immediately. Teno's resignation was required by the terms of the previously-disclosed Director Appointment and Nomination Agreement, dated as of March 16, 2021, by and among the Company and the individual members of the Icahn Group (as defined therein), which was filed as Exhibit 10.1 to the company's Current Report on Form 8-K dated and filed with the Securities and Exchange Commission on March 16, 2021. Under the terms of the Agreement, Teno was required to submit his resignation once the Icahn Group and certain of its affiliates ceased to collectively beneficially own an aggregate Net Long Position in at least 1.5% of the total outstanding shares of common stock, 10c par value per share, of the company. On December 8, 2023, Teno advised the company that such condition had been met and submitted his resignation in accordance with the Agreement. Teno's resignation is not due to any disagreements with the company's operations, policies or practices.

14:23 EST Walgreens Boots rating cut to Ba2 from Baa3 at Moody's - Moody's Investors Service downgraded the senior unsecured ratings of Walgreens Boots Alliance to Ba2 from Baa3 and its backed senior unsecured commercial paper rating to Not Prime from Prime-3. Moody's also downgraded Walgreens Co.'s senior unsecured rating to Ba1 from Baa3. At the same time, Moody's assigned WBA a Ba2 corporate family rating, a Ba2-PD probability of default rating and an SGL-2 speculative grade liquidity rating, which concludes the review for downgrade that was initiated on October 13. The rating outlook is stable.

12:52 EST Natera says court denies CareDX's motion for summary judgment on patents - Natera (NTRA) announced that the United States District Court for the District of Delaware has issued an order denying CareDx's (CDNA) motion for summary judgment on two Natera patents in the infringement lawsuit filed by Natera against CareDx. The Court has ruled that two of the patents asserted by Natera against CareDx will proceed to trial. The trial will commence on January 22, 2024. The company stated: "We are gratified that the Court has issued a decision that provides a clear path to trial as we work to protect our significant investments in innovation from unlawful infringement." As previously disclosed, Natera successfully invalidated all three of CareDx's patents that were asserted against Natera in a related case.

12:18 EST RTX says interceptor succesfully defeats ballistic missile target - An Exoatmospheric Kill Vehicle, developed by Raytheon, an RTX business, successfully destroyed an Intermediate-Range Ballistic Missile during a recent test of the Ground-based Midcourse Defense System, the company said in a statement. The test was conducted today in the Pacific region by the U.S. Missile Defense Agency and the U.S. Northern Command. This was the 13th intercept for the program, which protects the U.S. by destroying incoming ballistic missiles while they are outside the Earth's atmosphere. "This test demonstrates that the U.S. ballistic missile defense system is operational, reliable and ready to protect the country," said Wes Kremer, president of Raytheon. "Raytheon kill vehicles have now successfully completed nearly 50 space intercepts, which underscores our expertise and ability to design and develop these systems to defeat the evolving threat."

12:03 EST Nurix Therapeutics presents clinical data from NX-5948, NX-2127 programs - Nurix Therapeutics presented clinical data from its orally available degraders of BTK, NX-5948 and NX-2127, which are being evaluated in separate Phase 1a/1b clinical trials in patients with relapsed or refractory B-cell malignancies, including CLL, mantle cell lymphoma, diffuse large B-cell lymphoma, marginal zone lymphoma, follicular lymphoma, primary CNS lymphoma, and Waldenstrom's macroglobulinemia. These data were presented in two posters at the 65th American Society of Hematology Annual Meeting and Exposition, which is being held in San Diego, California. Nurix reported data from the dose escalation stage of its Phase 1a/1b clinical trial evaluating daily oral dosing of BTK degrader NX-5948 in patients with r/r B-cell malignancies. These data were from 26 patients enrolled in cohorts 1-5 who had received a median of four prior therapies and included patients with acquired mutations associated with drug resistance. Dose-dependent pharmacokinetics were observed, resulting in rapid, robust, and sustained BTK degradation in all patients treated once daily with oral NX-5948. In the CLL population that received doses ranging from 50 to 200 mg, six of seven patients demonstrated clinical benefit with three partial responses that were all ongoing as of the October 17, 2023 data cut, including one over nine months and three showing stable disease, with treatment ongoing in two patients. In NHL patients who were treated with doses from 50 to 450 mg, durable responses were seen across indications, with almost half the patients continuing to receive treatment as of the cut-off date. NX-5948 was well-tolerated across all doses tested with no dose limiting toxicities or treatment-related serious adverse events and no treatment emergent adverse events that resulted in drug discontinuation. Importantly, there were no incidences of atrial fibrillation or hypertension. Dose escalation continues across all indications and the study is actively enrolling patients in the United States, the United Kingdom, and the Netherlands. Additional data with higher dose levels and longer treatment duration are expected in 2024.Data from the Phase 1a dose escalation and Phase 1b dose expansion cohorts of Nurix's clinical trial of NX-2127, an orally available degrader of both BTK and cereblon neosubstrates Ikaros and Aiolos were reported in a second poster presentation. The presentation included data from 54 patients with r/r B-cell malignancies treated once daily with NX-2127 at doses that ranged from 100 to 300 mg. The patient population had a median age of 72.5 years and had received a median of four prior lines of therapy. Among the patients with CLL, 36% had acquired BTK mutations associated with BTK inhibitor drug resistance prior to entry in the study. NX-2127 exhibited dose-dependent PK, leading to robust and sustained degradation of BTK and biologically-relevant degradation of Ikaros. Treatment with NX-2127 resulted in encouraging rapid and durable responses in this heavily pre-treated patient population with complete responses reported in two of the 17 evaluable NHL patients. These responses were durable for over one year. Two PRs in other NHL patients were also reported. Among the 27 evaluable patients with CLL, 11 experienced a PR for an overall response rate of 40.7%. This compares favorably to earlier results presented at ASH 2022 showing a preliminary 33% ORR. NX-2127 had a manageable safety profile that was consistent with previous reports for BTK-targeted and immunomodulatory therapies. The most common grade greater than or equal to3 TEAEs were neutropenia, which showed evidence of dose response, hypertension and anemia. Atrial fibrillation was observed in six patients, with three patients having grade greater than or equal to3 events. Twenty-one patients had serious TEAEs, of which eight had serious adverse events considered related to NX-2127 treatment. Two patients experienced DLTs, and 13 patients developed TEAEs that resulted in discontinuation of NX-2127. As of the September 15, 2023 cutoff date, treatment was ongoing in 13 patients.

12:02 EST Editas presents new EDIT-301 safety and efficacy data in 17 patients - Editas Medicine announced new safety and efficacy data in 17 patients treated with EDIT-301, now known as renizgamglogene autogedtemcel, or reni-cel, in the RUBY trial for severe sickle cell disease, or SCD, and in the EdiTHAL trial for transfusion-dependent beta thalassemia, or TDT. The total dataset of 17 treated patients includes 12 additional patients since the data presentation at the European Hematology Association Annual Congress and in a company-sponsored webinar this past June. Reni-cel is being investigated in the RUBY and EdiTHAL clinical trials as a potential one-time, durable gene editing medicine for people living with severe SCD and TDT. Editas Medicine will present the RUBY and EdiTHAL trial data today at 1 p.m. ET in a company-sponsored webinar. The data will also be presented in a poster presentation at the American Society of Hematology Annual Meeting in San Diego, CA, at 9:00 p.m. ET. In both the RUBY and EdiTHAL trials to date, reni-cel was well-tolerated and continues to demonstrate a safety profile consistent with myeloablative conditioning with busulfan and autologous hematopoietic stem cell transplant by all patients in the two trials. Since treatment with reni-cel, all RUBY patients are free of vaso-occlusive events. All RUBY patients with greater than or equal to5 months follow-up have maintained a normal hemoglobin level and a fetal hemoglobin level of greater than40%. All EdiTHAL patients had early and robust increase of total hemoglobin, above the transfusion independence threshold of 9 g/dl. "These new and promising data with a larger patient cohort support our belief that reni-cel can be a clinically differentiated, one-time, durable medicine that can provide life-changing clinical benefits to patients with sickle cell disease and beta thalassemia, specifically driving early and robust correction of anemia and sustained increases in fetal hemoglobin. I would like to thank the clinical trial participants, their families, clinicians, and colleagues at collaborating institutions that contribute to the RUBY and EdiTHAL trials. We look forward to dosing additional patients and sharing further RUBY and EdiTHAL clinical updates in mid-2024," said Baisong Mei, MD, Ph.D., Senior Vice President and Chief Medical Officer, Editas Medicine.

12:00 EST Beachbody Company falls -10.2% - Beachbody Company is down -10.2%, or -$1.15 to $10.10.

12:00 EST Xponential Fitness falls -12.8% - Xponential Fitness is down -12.8%, or -$1.35 to $9.24.

12:00 EST ProShares UltraShort Bloomberg Natural Gas rises 16.6% - ProShares UltraShort Bloomberg Natural Gas is up 16.6%, or $16.11 to $112.95.

11:29 EST Affirm SVP discusses holiday season, transaction costs - During a fireside chat with analysts from Piper, Rob O'Hare, a Senior Vice President at Affirm, stated in part according to a transcript of the event: "So for us, you know, if you at the end of November and then the peak holiday season continues into the first couple of weeks of December. And so what that does to our income statement from a profitability perspective, you know, if you think about the fact that we're capturing a lot of GMV and capturing that GMV in the back half of the December quarter, we'll recognize, obviously, all of that GMV that comes in. But from a revenue and transaction cost perspective, there can be some nuances. And so the first would be for the majority of our loans, you know, they tend to be interest-bearing in nature. And we recognize the revenue that comes from the interest income over the life of that loan, you know, as the interest is collected. And so in a period where you have a lot of volume come in, we do need to wait a quarter or two or three in some cases to recognize all of the interest income against those loans. So when you're looking at revenue as a proportion or percentage of GMV, we will typically see some compression in Q2 in terms of our revenue take rate. So revenue divided by GMV. And we've tried to acknowledge that to reflect that in the outlook for the December quarter that we provided in our November earnings call. But that's -- that's probably the most consistent and obvious compression that we see on the revenue side. When you're thinking about transaction costs in our business. We have adopted CECL for provisioning for an allowance against all of the GMV that we underwrite and bring on to the platform. And so you'll see us book an allowance against all of that GMV in the quarter that it's originated. And so that will compress that will increase the amount of costs we have against that GMV. And like I said, on the revenue side, it will take a quarter or two or three for the interest income to come in against those same loans. So you sort of have this dynamic where revenue is a bit depressed from a timing perspective in quarter and then you're taking all of the provision expense against those same loans in the same quarter. So that does increase transaction costs. And the combination of those two results in compression down at RLTC, which is revenue less transaction costs, particularly when you're looking at it as a percentage of in-quarter GMV."

11:13 EST 7GC & Holdings Co Inc trading halted, volatility trading pause

10:59 EST Eli Lilly: Zepbound achieved additional 6.7% weight loss after lead-in period - Detailed results from SURMOUNT-4, which showed Zepbound injection achieved superior mean percent change in body weight compared to placebo in adults with obesity or overweight with weight-related comorbidities, excluding type 2 diabetes, were published in The Journal of the American Medical Association. Zepbound met the primary endpoint of mean percent change in body weight, and all key secondary endpoints for both estimands, compared to placebo 52 weeks after randomization. SURMOUNT-4, a phase 3 study evaluating the safety and efficacy of Zepbound compared to placebo, had two periods. Lead-in period: 36-week open-label period during which participants took Zepbound at the maximum tolerated dose. Double-blind treatment period: 52-week treatment period during which participants were randomized to either continue on Zepbound or switch to placebo. SURMOUNT-4 utilized a maximum tolerated dose of 10 mg or 15 mg once-weekly. The starting dose of 2.5 mg Zepbound was increased by 2.5 mg every four weeks until maximum tolerated dose was achieved. Participants who tolerated 15 mg continued on 15 mg as their maximum tolerated dose. Participants who tolerated 10 mg but did not tolerate 15 mg continued on 10 mg as their maximum tolerated dose. After 36 weeks of open-label Zepbound, participants, who would then go on to be randomized to Zepbound or placebo in the double-blind period, experienced a mean weight reduction of 20.9% from mean body weight of 236.6 lb. at study entry. Primary and key secondary endpoints assessed efficacy during the double-blind period and over the course of the entire treatment period. For both estimands, Zepbound met the primary endpoint and all key secondary endpoints. Additional secondary endpoints showed that Zepbound was also associated with improvements in BMI, fasting insulin, lipids, blood pressure, and health-related quality of life. The overall safety profile of tirzepatide in SURMOUNT-4 was similar to previously reported SURMOUNT and SURPASS trials. The most commonly reported adverse events in SURMOUNT-4 were gastrointestinal-related and generally mild to moderate in severity. During the Zepbound lead-in treatment period, the most frequent adverse events were nausea, diarrhea, constipation and vomiting. During the double-blind period, the most frequent adverse events for Zepbound and placebo, respectively, were diarrhea, nausea, vomiting, COVID-19 and upper respiratory infection. Treatment discontinuation due to an adverse event occurred in 7.0% of enrolled participants during the 36-week open-label lead-in treatment period, mainly due to gastrointestinal events. After the open-label lead-in period, treatment discontinuation rates due to adverse events were 1.8% and 0.9%.

10:38 EST Intchains Group Ltd (ADR) trading halted, volatility trading pause

10:31 EST Citi leads investment round in Colombian fintech Supra - Citi has led a strategic investment round in Supra. Far Out Ventures and H20 Capital also participated in the financing round. Supra is a Colombian fintech that enables cross-border payments and treasury solutions for small and medium-sized businesses that participate in import and export activities. The new capital will enable the growth of Supra's Colombian operations to fulfill its payment aggregator role in partnership with Foreign Exchange Market Intermediaries and licensed Payment Service Providers. Diego Santoyo, Head of Corporate Sales and Solutions for the Andean region at Citi, said: "Citi's best-in-class cross-border payments and FX technology will help enable Supra's operations and expansion in Colombia."

10:14 EST Maison Solutions Inc trading halted, volatility trading pause

10:04 EST Apache Corporation partners with Borderlands Research Institute - Apache Corporation announced a partnership with the Borderlands Research Institute at Sul Ross State University in Alpine, Texas, to launch a well pad restoration research project. Through this multiyear partnership, researchers at BRI and Texas Native Seeds, a project of the Caesar Kleberg Wildlife Research Institute at Texas A&M Kingsville, will investigate methods to improve habitat restoration efforts in the Permian Basin with the goal of publishing a science-backed, best practices reclamation document to be shared with other Permian operators. The BRI project will help inform oil and gas operators in the Permian about how changes in the industry's collective approach to restoring end-of-service well pads can have broader benefits to local biodiversity and reunite fragmented habitats.

10:00 EST Gildan Activewear falls -10.5% - Gildan Activewear is down -10.5%, or -$3.84 to $32.68.

10:00 EST Xponential Fitness falls -16.5% - Xponential Fitness is down -16.5%, or -$1.75 to $8.85.

10:00 EST Macy's rises 16.6% - Macy's is up 16.6%, or $2.89 to $20.28.

09:57 EST Viracta Therapeutics granted orphan status for carcinoma treatment - The FDA granted Viracta Therapeutics orphan status for its potential treatment of nasopharyngeal carcinoma. Reference Link

09:48 EST SharkNinja appoints Adam Petrick as global CMO - SharkNinja announced that Adam Petrick has been named its Chief Marketing Officer. Petrick most recently served as PUMA's Global Chief Brand Officer.

09:47 EST United States Natural Gas Fund falls -8.8% - United States Natural Gas Fund is down -8.8%, or -44c to $4.58.

09:47 EST Macy's rises 12.7% - Macy's is up 12.7%, or $2.21 to $19.60.

09:47 EST ProShares UltraShort Bloomberg Natural Gas rises 17.6% - ProShares UltraShort Bloomberg Natural Gas is up 17.6%, or $17.06 to $113.90.

09:45 EST EF Hutton Acquisition Corp trading halted, volatility trading pause

09:42 EST Knightscope announces Unico Properties adds Knightscope K5 to security team - Knightscope announces Unico Properties has advanced its security at U.S. Bancorp Tower in downtown Portland by adding a new member to its security team: the Knightscope K5 a 5-foot-5-inch, 420-pound Autonomous Security Robot that began patrolling the perimeter of the building's parking structure in December. Unico's robot is the first autonomous security robot in downtown Portland.

09:39 EST Immix Biopharma reports 100% ORR for CAR-T NXC-201 in r/r AL amyloidosis - Immix Biopharma announced new clinical data from its Phase 1b/2a NEXICART-1 study of novel, autologous, BCMA-targeted chimeric antigen receptor T cell therapy, NXC-201, in patients with relapsed/refractory AL Amyloidosis at an oral presentation by study investigator Moshe E. Gatt, MD at the 65th American Society of Hematology Meeting being held in San Diego, CA. The updated results include follow-up and clinical data from one new patient. All patients were relapsed/refractory to standard-of-care Dara-CyBorD and had experienced a median of 6 prior lines of therapy that failed to stop worsening of disease prior to receiving NXC-201. "There is a rising prevalence of relapsed/refractory AL Amyloidosis patients who have no approved options for treatment," said Polina Stepensky, M.D., Director of the Hadassah Medical Organization's Department of Bone Marrow Transplantation and Immunotherapy for Adults and Children, and principal study investigator. "We continue to be encouraged by NXC-201's 100% overall response rate, including in this 10th relapsed/refractory AL amyloidosis patient." Safety and efficacy data: Overall response rate of 100%; Complete response + very good partial response rate of 90%;Complete response rate of 70%; Organ response rate of 60%; Best responder had a duration of response of 23.7 months as of December 10, 2023, with response ongoing.

09:38 EST Unionized employees at 114 Food Basic stores ratify collective agreement - Food Basics, a subsidiary of METRO, announced that its unionized employees at 114 Food Basics locations in Ontario have ratified a new five-year collective agreement which provides wage increases and benefits improvements for all employees, including part-time employees.

09:31 EST Nitches, Inc. unveils flavor profiles for 2024 - As the year comes to a close, Nitches announced the upcoming flavor profiles for 2024 under its Tover Spirits brand. Introducing "The Republic" portfolio, Tover Spirits is set to make a splash in the Ready to Serve alcohol beverage segment. This collection will feature a meticulously crafted range of Whiskey, Tequila, and Vodka based on Tover's signature cocktails, aptly named "Future of the Past."

09:30 EST LQR House enters marketing partnership with Brody's Crafted Cocktails - LQR House announces its strategic marketing collaboration with Brody's Crafted Cocktails. The company expects that this partnership will propel sales for Brody's Craft Cocktails on CWSpirits.com.

09:28 EST Movistar begins selling Turbo Energy's "Do It Yourself" GoSolar - Turbo Energy announced that Movistar has launched Turbo Energy's GoSolar offering for sale this week through Movistar's energy branch, Solar360.

09:25 EST Napo says majority of subjects in Phase 3 OnTarget trial continue to Stage II - Napo Pharmaceuticals announced that a majority of subjects in the company's placebo-controlled pivotal Phase 3 OnTarget trial for prophylaxis of diarrhea in adult cancer patients receiving targeted therapy with or without standard chemotherapy chose to continue on to Stage II of the two-stage trial. After completing the Stage I double-blind, placebo-controlled primary prophylactic treatment phase of OnTarget, subjects had the option to remain on their blinded assigned treatment arm and reconsent to enter into the Stage II extension phase. Stage II of the trial has concluded. Inclusion of Stage I data and Stage II data, with success, is required in the supplemental NDA filing of crofelemer to add the indication for prophylaxis of diarrhea in cancer patients receiving targeted therapy with or without standard chemotherapy. OnTarget is a first-of-its-kind, 24-week clinical trial with a primary endpoint based on patient-reported outcomes that address the highly neglected and unmet burden of cancer therapy-related diarrhea, an indication Napo also refers to as preventive treatment of chemotherapy-induced overactive bowel - which includes symptoms such as chronic and/or episodic debilitating diarrhea urgency, bowel incontinence and abdominal pain and discomfort. Diarrhea is a common side effect of targeted therapies and new treatments are needed. Up to 95% of patients on tyrosine kinase inhibitors r from diarrhea, depending on the TKI used.1 The OnTarget study is testing whether the company's plant-based prescription drug crofelemer can prevent diarrhea and other symptoms of CIOB when any one of the selected 24 different targeted therapies is initiated.

09:20 EST Hollysys to be acquired by Ascendent Capital for $26.50 per share in cash - Hollysys Automation Technologies announced that it has reached an agreement to be acquired by Ascendent Capital Partners, an international private investment firm headquartered in Hong Kong. The acquisition, which concludes a months-long sale process, will be completed through an all-cash transaction valued at approximately US$1.66B. According to the terms of the agreement, Ascendent will acquire all outstanding shares of Hollysys that it does not currently own for US$26.50 per share in cash. This price represents a premium of 42% to the unaffected price of US$18.66 as of August 23, 2023. The Board of Directors of Hollysys, upon the unanimous recommendation of the Special Committee of independent directors, has given its unanimous approval for the transaction.

09:19 EST Microsoft, AFL-CIO announce new tech-labor partnership - The American Federation of Labor and Congress of Industrial Organizations, AFL-CIO, and Microsoft on Monday announced the formation of a new partnership to create an open dialogue to discuss how artificial intelligence must anticipate the needs of workers and include their voices in its development and implementation. This partnership is the first of its kind between a labor organization and a technology company to focus on AI and will deliver on three goals: sharing in-depth information with labor leaders and workers on AI technology trends; incorporating worker perspectives and expertise in the development of AI technology; an helping shape public policy that supports the technology skills and needs of frontline workers.

09:12 EST CareCloud launches redesigned Therapy Solution Suite - CareCloud announced the launch of its redesigned and enhanced Therapy Solution Suite, an all-in-one web-based solution poised to transform therapy and rehabilitation practice management by offering an unparalleled combination of financial, operational, and clinical efficiency. "Drawing upon our extensive expertise in rehabilitation and therapy practices, which spans from small independent practices to an enterprise-level company with more than 2,500 clinicians, our Therapy Solution Suite is a meticulously designed, all-in-one solution that bridges the gaps left by other providers in the rehabilitation industry," stated Hadi Chaudhry, president and chief executive officer of CareCloud. "With our unparalleled hands-on familiarity with all six components in our offering, we are a trusted partner within the industry, and our solution has already been embraced and lauded by a larger player in this field."

09:10 EST Fortinet announces generative AI assistant Fortinet Advisor - Fortinet added Fortinet Advisor, a generative AI assistant, to its portfolio of more than 40 AI-powered offerings. AI has served as the backbone of the Fortinet Security Fabric and FortiGuard Labs threat intelligence and security services for more than a decade, and the implementation of GenAI is Fortinet's latest innovation designed to protect customers and keep business operations online. The initial release of Fortinet Advisor will help support and guide security operations teams so they can investigate and remediate threats faster than ever before.

09:09 EST Inpixon receives shareholder approval of proposals to merge with XTI Aircraft - Inpixon announced that it has received shareholder approval of the proposals related to the previously announced merger agreement with XTI Aircraft Company, an aviation company developing the TriFan 600, a fixed-wing, vertical takeoff and landing aircraft. The merger is expected to be completed at or around year end and remains subject to certain closing conditions including Nasdaq approval of an initial listing application of the combined company. The combined company is expected to operate under the name XTI Aerospace and to trade on the Nasdaq Capital market under the symbol "XTIA" if approved for listing. "With the support of our shareholders, we are thrilled to announce the approval of this business combination," said Nadir Ali, CEO of Inpixon. "This strategic transaction will not only deliver XTI stockholders securities of a publicly traded company but it also ensures that Inpixon shareholders can continue to hold a significant stake in a company that we believe is creating a revolutionary solution for point-to-point air travel. With this combination, we're looking to capture the vast opportunities in the alternative aircraft market, a sector we believe is ripe with innovation and expansion potential. The TriFan 600 airplane combines the comfort, speed, and range of similar conventional business aircraft with the flexibility, convenience, and pinpoint transportation of a helicopter. The feedback from the market has been overwhelmingly positive as illustrated by the conditional pre-orders2 for more than 700 TriFan 600s, which would equate to potential gross revenues of more than $7 billion3 upon delivery."

09:07 EST Verb Technology enters new collaboration with CardCash - Verb Technology Company announces a new collaboration with consumer brand discount gift card exchange, CardCash. Adding the CardCash store to MARKET.live provides shoppers with unmatched savings on some of the most sought-after brands this holiday season, including Apple, Macy's, Nike, Callaway, Build-A-Bear, and Top Golf.

09:07 EST SharkNinja names Adam Petrick as chief marketing officer - SharkNinja announced that Adam Petrick has been named its chief marketing officer. Petrick is a brand and marketing strategist with 24 years of global experience, most recently serving as Puma's global chief brand officer

09:06 EST Shuttle Pharmaceuticals submits IND application to U.S. FDA for Ropidoxuridine - Shuttle Pharmaceuticals announced submission of an Investigational New Drug, IND, application with the U.S. Food and Drug Administration, FDA, to support the next phase of development of Ropidoxuridine. Ropidoxuridine is Shuttle Pharma's lead radiation sensitizer candidate for use in combination with radiation therapy to treat brain tumors, a deadly malignancy of the brain with no known cure. "Today's announcement is an important milestone for Shuttle Pharma and the thousands of patients with brain tumors who currently lack effective therapies," stated Shuttle Pharma's Chairman and CEO, Anatoly Dritschilo, M.D. "The IND submission is the culmination of many years of clinical development by the Shuttle Pharma team, as well as support from the broader cancer community, including the National Institutes of Health's National Cancer Institute and Small Business Innovation Research program, who have provided guidance and grant funding to bring this potentially important new radiation sensitizing therapy to market."

09:05 EST Inspira Technologies announces appointment of Gorfil to medical advisory board - Inspira Technologies announces the appointment of Dr. Dan Gorfil to its medical advisory board. Dr. Gorfil is a distinguished specialist in cardiac surgery and intensive care medicine. Dr. Gorfil is both the head of the Cardiothoracic Surgery Intensive Care Unit and the Extracorporeal Membrane Oxygenation program at the Department of Cardiothoracic Surgery at Rabin Medical Center, Israel.

09:05 EST Uber Technologies announces partnership with Torchy's Tacos - Uber Technologies announced that Austin-based Torchy's Tacos is now available for delivery with Uber Eats. This month over 100 Torchy's Tacos locations will be added to the Uber Eats app across Arizona, Arkansas, Colorado, Florida, Indiana, Kansas, Louisiana, Missouri, North Carolina, Ohio, Oklahoma, Tennessee, Texas, and Virginia. "Joining forces with Torchy's Tacos is a game-changer for hungry Uber Eats users in their home state of Texas and beyond," said Sarfraz Maredia, VP and Head of the Americas for Uber Eats. "We're thrilled to bring this beloved brand onto the app and deepen the creative ways we can work together. And as a Texan myself, I feel incredibly fortunate to have such strong local partners who pride themselves on high standards-both for the quality of their food and how they treat their customers."

09:04 EST Bit Origin secures $6.74M investment to build mining data center in U.S. - Bit Origin has entered into a securities purchase agreement to sell up to $24.74 million of convertible notes and warrants to U.S. based institutional investor ATW Digital Asset Opportunities. The initial commitment of $6.74 million will fund the construction of a brand-new 25MW cryptocurrency mining data center, named as Auspice. This facility is situated in Cheyenne, Wyoming, USA. Management anticipates that the project will commence producing substantial revenue and cash flow for the company starting in the second half of 2024. The Project Auspice is a 25 MW crypto mining data center located in Cheyenne Wyoming, where electricity supply is abundant as well as stable and the weather condition is favourable to crypto mining. The Company owns 55% interests of the Project Auspice with the remaining interests owned by ATW and certain other investor. The Project adopts advanced immersion cooling technology, which has low noise, low energy consumption and strong heat dissipation capacity. The Project Auspice will also have a professional team to provide operation and maintenance technical services to ensure the stable operation of the data center. The Company has finalized the budget preparation, project plans, and design drawings of the project. The Company expects to complete it in early Q2 2024. Upon completion, the project can host around 4,480 to 8,400 bitcoin miners depending on the types of the miners.

09:03 EST Emerson Electric chosen as automation partner by SungEel HiTech - Emerson has been selected by Korea's SungEel HiTech, a specialist in lithium-ion battery recycling, to provide advanced automation solutions in support of sustainable production and operational efficiency goals at the newest of three lithium-ion recycling plants located at SungEel's Hydro Center complex in Gunsan, Jeollabuk-do. Through the combination of Emerson's process automation technology and SungEel HiTech's unique battery recycling methods, the collaboration aims to establish a robust resource cycle that will help enable a more stable supply of battery materials for electric vehicles in pursuit of bolstering the world's overall production capacity. "Our automation portfolio and expertise are empowering our customers to optimize and scale the circular economy for critical battery components, a key step toward meeting global net-zero targets head-on," said Mike Train, Emerson's chief sustainability officer.

09:01 EST Moleculin Biotech presents interim data from Phase 1B/2 trial in AML - Moleculin Biotech announced the presentation of preliminary efficacy findings from the Company's ongoing European Phase 1B/2 clinical trial evaluating Annamycin for the treatment of acute myeloid leukemia or AML to key opinion leaders and current investigators at a meeting held in conjunction with the 65th American Society of Hematology Meeting and Exposition (ASH) in San Diego on December 10, 2023. Additionally, the Company will have a paper published on its MB-106 clinical trial as part of ASH. A link will be provided on the Company's website once this publication is available online. The KOL presentation included an update to the positive preliminary efficacy findings previously reported on MB-106. To date, among patients who had an evaluable post treatment bone marrow biopsy, or who dropped out due to an adverse event, there have been 4 complete responses or 36% of the intent to treat subjects and 44% of the subjects treated. Two subjects experienced adverse events and were not dosed with one being an allergic reaction to Annamycin, the first the Company has seen in over 70 subjects dosed in the Company's multiple Annamycin clinical trials; the second dropout was due to an allergic reaction to cytarabine. There continues to be no evidence of cardiotoxicity as measured by ejection fraction, strain analyses, ECGs, and cardiac biomarkers including Troponin-I and T in MB-106

09:00 EST Tharimmune announces topline phase 1 data with TH104 - Tharimmune announces phase 1 data with TH104, a proprietary transmucosal buccal film which easily adheres to the inside of the mouth. The Phase 1 trial was a single-dose, single-center, open-label, randomized, study of TH104 transmucosal buccal film conducted in India in two different cohorts. The primary outcome measure was to determine the safety and tolerability of a buccal dose of TH104 in chronic liver disease patients, while a secondary objective included establishing its' response for clinical efficacy studies for pruritus or "debilitating itching" using a validated endpoint, the Worst Itch-Numerical Rating Scale. This study enrolled 2 types of chronic liver disease patients including subjects with cholestatic liver disease categorized as Child-Pugh A and cholestatic liver disease categorized as Child-Pugh B. The Child-Pugh score is a system for assessing the prognosis and necessity of transplant in chronic liver disease. It provides a forecast of the increasing severity of a patient's liver disease and expected survival rate. The score is determined by scoring clinical measures of liver disease and the possibility of eventual liver failure. Class A refers to the least severe liver disease with a one to five-year survival rate of 95% and Class B refers to moderately severe liver disease with a one to five-year survival rate of 75%. There were no patients in this study enrolled with a very severe Child-Pugh C classification. Pruritus is a common clinical feature seen in most liver diseases but particularly frequently in cholestatic liver disease. The WI-NRS is a validated numerical rating scale with 11 numbers anchored at 0 representing "no itch" to 10 representing "worst imaginable itch" which are displayed, and patients are asked to pick the number corresponding to the intensity of their pruritus. Results from multiple large studies support the usefulness and validity of WI-NRS for evaluating change over time in the clinical trial setting. This study incorporated this relevant clinical outcome assessment for pruritus in chronic liver disease patients administered one 2 mg dose of TH104 applied as a transmucosal buccal film and assessed patient itch intensity over a 24-hour period. A total of 12 cholestatic liver disease patients with a known history of persistent chronic pruritus for at least 4 weeks prior to screening were randomized in this study with 6 subjects each in Cohorts A and B. The mean baseline WI-NRS scores in Groups A and B were 4.33 and 6.17, respectively, translating to moderate-to-severe chronic pruritus at the start of the study. The mean baseline itch score for all 12 subjects was 5.25. At 1-hour post dosing with TH104, Group A and Group B had a mean decline in WI-NRS scores by 26.8% and 19.0% and continuing to decline 2-hours post-dose by 42.3% and 21.7%, respectively. All 12 subjects had a mean decline of 30.1% in WI-NRS scores at 1-hour and 2-hours post-dose. Both Cohorts continued to improve in mean itch scores at the 4-hour and 8-hour time points including the combined total subjects. At 24-hours post dosing, Group A and Group B achieved a mean decline of 30.7% and 35.2%, respectively in pruritus scores. All 12 subjects had a mean decline of 33.3% in itch scores after a single dose at 24-hours post dosing of TH104. There were no deaths, other serious adverse events, or other significant adverse events reported during the entire study. There were no new adverse events during the entire study with events correlated with previous studies and a safety profile consistent in the literature with nalmefene, the active ingredient in TH104. Further analysis including bioanalytical, pharmacokinetic, biomarker, safety and tolerability are currently ongoing, and the Company plans to announce the full data set in 1Q24. The Company intends to provide topline data in 2024 for a phase 1 pharmacokinetic bridging study in the United States designed as a single-dose, single-center, open-label, randomized 2-way crossover study of TH104 transmucosal buccal film and an intravenous dose of drug administered under fasting conditions, with a 7-day washout period between doses. Sixteen normal healthy volunteers will participate in the study. The primary objective is to evaluate the absolute bioavailability of TH104 as well as assess safety and tolerability of the formulation. The Company plans to engage the US and EU Regulatory Authorities and expects to launch a 28-day Phase 2a trial in the coming months which is currently planned as a multiple ascending dose trial to assess the safety and tolerability of TH104 which will also assess the change from baseline in WI-NRS to evaluate chronic pruritus in PBC patients, with a topline data readout expected in 4Q24.

08:59 EST Uber announces Uber Eats delivery partnership with Torchy's Tacos - Uber announced that Austin-based Torchy's Tacos is now available for delivery with Uber Eats. This month over 100 Torchy's Tacos locations will be added to the Uber Eats app across Arizona, Arkansas, Colorado, Florida, Indiana, Kansas, Louisiana, Missouri, North Carolina, Ohio, Oklahoma, Tennessee, Texas, and Virginia.

08:57 EST Popular CFO Carlos Vazquez to retire, Jorge Garcia to succeed - Popular announced that Carlos Vazquez will retire effective March 31 after serving as CFO since 2013, and in other senior leadership positions since joining Popular in 1997. He will be succeeded by Jorge Garcia, currently corporate comptroller and chief accounting officer.

08:55 EST Collective Audience appoints Peter Bordes as CEO - Collective Audience has appointed Peter Bordes as CEO, succeeding Brent Suen who will continue to serve on the board of directors. Bordes is the founder and managing partner of Trajectory Ventures, a venture capital platform comprised of operators, founders, and entrepreneurs focused on advancing technology and industry innovation with investments in over 100 tech innovators. He is also founder and managing partner of Trajectory Capital, a later-stage investing platform and private equity fund.

08:51 EST Coherus Biosciences announces updated NCCN practice guidelines for LOQTORZI - Coherus BioSciences announced that the National Comprehensive Cancer Network has updated the clinical practice guidelines for nasopharyngeal carcinoma to include LOQTORZI as a preferred, category 1 first-line treatment option for adults with metastatic or recurrent locally advanced NPC when used in combination with cisplatin and gemcitabine. The guidelines also recommend LOQTORZI monotherapy as the only preferred treatment in subsequent lines of therapy if disease progression on or after a platinum-containing therapy. The NCCN recommendations are based on results of the JUPITER-02 Phase 3 study and the POLARIS-02 Phase 2 study. In the JUPITER-02 Phase 3 study, LOQTORZI combined with chemotherapy significantly improved progression-free survival, reducing the risk of disease progression or death by 48% compared to chemotherapy alone. LOQTORZI also demonstrated a statistically significant and clinically meaningful improvement in overall survival, with treatment resulting in a 37% reduction in the risk of death versus chemotherapy alone. In the POLARIS-02 clinical study, LOQTORZI demonstrated durable anti-tumor activity in patients with recurrent or metastatic NPC who failed previous chemotherapy, with an objective response rate of 20.5%, a disease control rate of 40.0%, and a median OS of 17.4 months with an acceptable safety profile.

08:49 EST Kustom Entertainment appoints Erik Dahl as CFO - Kustom Entertainment has tapped Erik Dahl as its new CFO. The appointment, effective November 20, 2023, puts Mr. Dahl at the helm of Kustom Entertainment's financial operations, including FP&A, strategy, accounting, procurement, tax, and human resources. Dahl joins Kustom Entertainment from AVI Systems, Inc., where he served as Financial Reporting Manager.

08:45 EST Gorilla collaborates with Red Hat for cloud infrastructure - Gorilla Technology announced its collaboration with Red Hat. Gorilla aims to revolutionize Smart Government Security Convergence solutions leveraging Red Hat OpenShift Virtualization, a feature of Red Hat OpenShift and Red Hat Enterprise Linux for cloud infrastructure deployment, operation, and management.

08:43 EST Puma Biotechnology announces design of alisertib trial - Puma Biotechnology announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer. Based on the company's interactions with the FDA, the company will be initiating a Phase II trial of alisertib in combination with endocrine treatment in patients with chemotherapy-naive HER2-negative, hormone receptor-positive metastatic breast cancer. Patients must have been previously treated with CDK 4/6 inhibitors and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting to be eligible for the trial. The company has updated the presentation on its website to include a slide that describes the PUMA-ALI-1201 trial. The company plans to initiate this trial in the second half of 2024. Patients will be dosed with alisertib given at either 30 mg, 40 mg or 50 mg twice daily, or BID, on days 1-3, 8-10 and 15-17 on a 28-day cycle in combination with the endocrine therapy of the investigator's choice. Patients must not have been previously treated with the endocrine treatment that will be given in combination with alisertib in the trial. Each dose level will enroll up to 50 patients. Patients must provide blood samples and tissue-based biopsies so that biomarkers can be evaluated. The primary efficacy end points will include objective response rate, duration of response, disease control rate and progression-free survival. As a secondary objective, the Company will be evaluating each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with better efficacy as has been seen in preclinical and clinical studies in other cancers including breast cancer and small cell lung cancer. The company will then look to focus the future clinical development of alisertib in combination with endocrine therapy for patients with HER2-negative hormone receptor-positive breast cancer in patients with these biomarkers. Based on its interactions with the FDA, the company believes that this trial design will satisfy the FDA's Project Optimus intended to find the optimal dose of alisertib in combination with endocrine therapy in patients with HER2-negative, hormone receptor-positive metastatic breast cancer to move into a pivotal Phase III trial. Once the optimal alisertib dose is identified, the company plans to engage with global regulatory agencies regarding the design of a pivotal Phase III trial, which it anticipates will be a randomized trial of alisertib plus investigator's choice endocrine therapy versus placebo plus investigator's choice endocrine therapy in patients with chemotherapy naive HER2-negative, hormone receptor-positive metastatic breast cancer.

08:42 EST Imunon appoints Sebastien Hazard as CMO - IMUNON announces the appointment of Sebastien Hazard, M.D. as Chief Medical Officer, effective December 11, 2023. Dr. Hazard brings to IMUNON a strong background in building and leading clinical development organizations, most recently at Bicycle Therapeutics. He will report to IMUNON's President and CEO Corinne Le Goff. The Company also announced today that on December 7, 2023, in connection with Dr. Hazard's appointment as CMO, the Compensation Committee of the Board of Directors of the Company approved an inducement option to purchase 80,000 shares of common stock and a restricted inducement stock grant of 20,000 shares of common stock to Dr. Hazard. The Inducement Option has an exercise price of $0.88 per share, which is equal to the closing price of the Company's common stock on the Nasdaq Capital Market on December 7, 2023, will vest over four years, subject to Dr. Hazard's continued service with the Company on each applicable vesting date, with 25% of the underlying shares vesting on the one-year anniversary of the vesting commencement date, and 75% of the underlying shares vesting in equal installments over the next twelve calendar quarters. The Restricted Inducement Grant will vest on the one-year anniversary of Dr. Hazard's first day of employment, subject to Dr. Hazard's continued service with the Company on such date. Each of the Inducement Option and the Restricted Inducement Grant is an inducement material to Dr. Hazard entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

08:39 EST Ascendis Pharma announces FDA acceptance of resubmitted TransCon PTH NDA - Ascendis Pharma A/S announced that the U.S. Food & Drug Administration has accepted for review the Company's resubmitted New Drug Application for TransCon PTH for the treatment of adult patients with hypoparathyroidism. The agency considered the resubmission a complete, class 2 response and set a Prescription Drug User Fee Act goal date of May 14, 2024. In the United States, TransCon PTH for adult patients with hypoparathyroidism.

08:37 EST Brilliant Earth announces $20M share repurchase program - Brilliant Earth Group announced that its Board of Directors has approved a share repurchase program with authorization to repurchase up to $20M in shares of its Class A common stock.

08:36 EST Duck Creek Technologies appoints Barbara Bufkin, Diane Fanelli to board - Duck Creek Technologies announced the appointments of Barbara Bufkin and Diane Fanelli to the company's board of directors. Bufkin joins Duck Creek's board with an extensive background in global insurance, distribution, underwriting, and technology, advising companies in originating and fostering strategic partnerships. Fanelli is a global customer-centric operations leader known for her expertise in guiding global enterprise software teams and company growth. Most recently, Bufkin served as a senior advisor to Amwins and was a founding member of the Amwins Group Diversity & Inclusion Council. Fanelli currently serves as COO at iCIMS.

08:34 EST Jeffs' Brands signs exclusive distribution agreement with Bolly Jon - Jeffs' Brands announces its latest market expansion through an exclusive distribution agreement with Bolly Jon, a biotech-beauty hair care product brand. This partnership introduces the distribution of a line of hair products based on stem cell technology via the Amazon Marketplace by Jeffs' Brands. Pursuant to the distribution agreement, Jeffs' Brants will have exclusive rights to sell and distribute on the Amazon Marketplace the hair products offered by Bolly Jon, for a period of approximately five years.

08:33 EST RBB Bancorp appoints Lynn Hopkins as CFO - RBB Bancorp (RBB) announced the appointment of Lynn Hopkins as interim executive VP and CFO of Royal Business Bank and RBB Bancorp effective December 7. Prior to joining the company, Hopkins held the position of executive VP and CFO, at Banc of California (BANC).

08:33 EST Commvault appoints Borst as Area VP for Asia, Dea as Area VP for APAC - Commvault expanded its Asia Pacific leadership team with two key senior appointments. Michel Borst has joined as Area Vice President, VP, for Asia. Based out of Singapore, Borst will lead the region and work directly with customers and partners who are looking for industry-leading cyber resilience solutions that secure, protect, and rapidly recover data in the event of a cyber event. Joanne Dea has joined as Area Vice President for Channels and Alliances, Asia Pacific, APAC.

08:31 EST Freehold Royalties to acquire Permian Basin royalty assets for C$112M - Freehold Royalties has entered into definitive agreements with two private sellers to acquire high quality Permian mineral title and royalty assets located in the Midland basin in Texas and the Delaware basin in New Mexico and Texas for approximately $112 million, net of estimates for exchange rates and customary closing adjustments. All references in this news release to dollar amounts are in Canadian dollars unless otherwise indicated. The Acquired Assets are located primarily in Martin County Texas within the Midland Basin capturing some of the thickest stacked pay reservoir quality in North America, with up to ten benches available for development under current practices. Additionally, the Acquired Assets have a significant weighting to undeveloped lands, which is expected to maximize development and recoveries. Future development will be led by a strong portfolio of well capitalized operators with this core inventory ranking as some of the best within their portfolio. Acquired Asset highlights include: Approximately 123,000 gross acres concentrated in the core of the Permian basin, comprised of 2,670 net royalty acres; 76% Midland, 24% Delaware. Upon closing the Acquisitions, Freehold's total Permian land position will increase by 40% to greater than 0.5 million gross acres and will represent approximately 57% of Freehold's US gross land base. Over 40% of the Acquired Assets net royalty acres are undeveloped, providing significant future activity potential. 2024 forecast average production of 600 boe/d, generating funds from operations of approximately $15 million, increasing Freehold's Permian production by approximately 30% and the Company's US production by 12%. 85% liquids weighted based on production, versus Freehold's Q3-2023 average US liquids weighting of 78% and the Company's total liquids weighting of 63%, providing meaningful uplift to Freehold's average realized price and sustainability of returns. Strong well performance with average 365-day initial gross production rates of approximately 600 boe/d per Permian well. Multiple years of future upside, with greater than 2,000 gross development locations identified. Upon closing the Acquisitions, Freehold's total US inventory is expected to increase by 25%, bringing the Company's total proforma US inventory to greater than 10,000 gross locations. This implies approximately 17-years of drilling inventory based on 2022 drilling levels. Future development is underpinned by some of North America's top operators with the combined Exxon Mobil and Pioneer Natural Resources expected to move into Freehold's top five payors and represent greater than 25% of future gross locations within the Company's US inventory. Additional payors from the Acquired Assets include other large well capitalized producers such as Marathon Oil, Endeavor Energy Resources LP and Diamondback Energy. The Acquisitions are expected to double Freehold's Midland basin activity and on a proforma basis, with one in every seven wells drilled in 2023 year to date in the Midland basin of the Permian will have occurred on Freehold's lands. The Acquisitions will be funded through the utilization of Freehold's existing credit facility and are expected to close in January 2024. Freehold will provide an update on its 2024 guidance as part of its 2023 year-end operating and financial results, which are expected to be released after market close on February 28, 2024.

08:30 EST Playa Hotels & Resorts announces new $200M share repurchase program - Playa Hotels & Resorts announced that the Company's Board of Directors has authorized a new $200.0 million share repurchase program, replacing the prior $200.0 million authorization announced in February 2023, of which there was approximately $30 million remaining

08:27 EST Silicon Motion announces new organizational structure to support global business - Silicon Motion Technology Corporation announced a new organizational structure and leadership team appointments to support the Company's continued global business growth. These changes will take effect immediately. Core to this announcement is the establishment of two business units designed to create a more focused and specialized structure that should enable faster innovation and stronger growth and support the Company's commitment to delivering the best-in-class solutions for its customers. The Client & Automotive Storage Business Unit will house the Company's client SSD controllers, mobile controllers, Ferri products and expandable controllers. The Enterprise Storage & Display Interface Solution Business Unit will encompass the Company's enterprise SSD controllers and display interface products. As part of the new organizational structure, Silicon Motion has created the following leadership roles: Nelson S. Duann, currently Silicon Motion's Senior Vice President of Marketing and R&D, has been appointed as a Senior Vice President of the CAS business unit. In this capacity, he will oversee product planning, major OEM business development and OEM project management for the Company's client SSD controllers, mobile controllers, Ferri products and expandable controllers. Alex Chou joins Silicon Motion as a Senior Vice President to lead the ESDI business unit. In this role, he will be responsible for leading Silicon Motion's enterprise storage group, to expand the business into data center and enterprise storage as well as expand the Company's display interface business into the PC docking market. Robert Fan, currently the Company's President of Silicon Motion, has been promoted to Senior Vice President of Global Sales and President of SMI USA. In this capacity, he will lead the Company's worldwide sales, field application engineers, and corporate marketing communications and public relations efforts. Alex Chou joined Silicon Motion on Dec. 1st, 2023. Prior to joining the Company, he was Senior Vice President at Synaptics.

08:25 EST Altamira says 'substantially' lowered spending levels in 2023 - In 2023, the Company realigned its cost structure with the strategic shift towards the RNA delivery business. Following the conclusion of its clinical trials within the legacy business, which were the key spending drivers over the past 3 years, Altamira has substantially lowered spending levels and is operating with a significantly reduced 'burn rate'. The streamlining included a reduction in headcount by approximately 25%, a reduction in office space and lower expenditures on legacy assets. Altamira expects to realize the full impact of these reductions in 2024. Further, Altamira strengthened its balance sheet in 2023 despite challenging capital market conditions in the biotech sector. In July 2023, the Company raised $5 million in equity through a public offering with the last pre-funded warrants from the transaction getting exercised in mid-November 2023. In addition, shareholders' equity was reinforced through the financial gain of about $5.2 million related to the partial spin-off of the Bentrio business. Additionally, the Company repaid the convertible loan of about $2.7 million from FiveT Investment Management ahead of schedule through a combination of conversion into shares and cash amortizations. Thanks to the early repayment, Altamira today is free of financial debt.

08:23 EST Altamira Therapeutics proides update following partial Bentrio spin-off - Altamira Therapeutics provided an investor and business update highlighting recent activities and milestones achieved following the Company's partial spin-off of its Bentrio business and pivot towards becoming a pure-play RNA delivery business. The partial Bentrio spin-off closed on November 21, 2023, resulting in the sale of a 51% stake in the Company's subsidiary Altamira Medica AG to a Swiss private equity investor for a cash consideration of approximately $2.3 million. Apart from the raise of non-dilutive cash, the transaction generated a financial gain of about USD $5.2 million in accordance with International Financial Reporting Standards. Altamira will be entitled to receive 25% of the future licensing income of Medica and of Medica's value appreciation in case of a sale, which, together with the 49% stake, captures 62% of the business upside potential. Bentrio is a drug free, preservative free nasal spray for the treatment of allergic rhinitis and is the key asset of Medica. The product is marketed primarily through distributors. Medica expects sales to grow significantly from 2024 and onward, driven by the launch of Bentrio in a growing number of countries. In the coming year, Nuance Pharma will aim for market approval in Mainland China and South Korea. Medica will initially supply Bentrio to Nuance and may receive development and commercial milestones of up to $3 million and up to $19.5 million, respectively. Once Nuance assumes local production of Bentrio, it will pay to Medica a staggered royalty on net sales at a high-single to low-double-digit percentage. In Scandinavia, Pharma Nordic will launch the product in Q1 2024. In addition, discussions and negotiations for distribution in the US, Europe and other key markets are ongoing. Meanwhile, Altamira is also pursuing the partnering of its other legacy assets, which include several development programs in inner ear therapeutics. Discussions are most advanced regarding AM-125, a nasal spray for the treatment of acute vestibular syndrome, a very frequent type of dizziness. Altamira invested more than $18 million to date and demonstrated proof of concept in a Phase 2 trial. There is no comparable product in the US. The Company expects significant partnering progress during the first half of 2024. The inner ear legacy assets further comprise early and late stage development programs in tinnitus and hearing loss. Any proceeds derived from the partnering of the remaining legacy assets will have a direct and positive impact on the Company's bottom line.

08:21 EST SRIVARU announces Mohanraj Ramasamy assumes role as CEO - SRIVARU Holding provided a business update following the consummation of its recent business combination with Mobiv Acquisition Corp. In connection with the business combination, former Tesla executive and founder of SRIVARU, Mohanraj Ramasamy, has assumed the role as CEO of the Company. In connection with the transaction, SRIVARU's ordinary shares and warrants are expected to begin trading on Nasdaq under the new ticker symbols "SVMH" and "SVMHW" as of today, December 11, 2023. Mohanraj Ramasamy, CEO of SRIVARU, stated, "We look forward to the next phase of our journey within the U.S. capital markets. We believe our unique business model will drive significant value for our shareholders in the years ahead, given the sheer size of the Indian market, coupled with our global expansion plans. The Indian market alone is forecast to exceed $36 billion by 2027. Moreover, the EV segment is projected to reach 45-50% of the overall market by 2030. Having developed India's fastest mass production electric motorcycle on the road, featuring state-of-the-art technologies, we are well positioned to capture a significant share of the overall EV market. Moreover, we have developed a lean and capital-efficient business model, including highly scalable, low-cost manufacturing, assembly and distribution, to support high product margins. We plan to provide more detailed business updates in the weeks ahead, including an investor webinar, in which we plan to discuss our plans for accelerated commercialization."

08:19 EST PetVivo achieves national distribution of Spryng to over 600 vet clinics - PetVivo Holdings achieved a significant milestone - the sale of its signature product Spryng with OsteoCushion Technology to more than 600 veterinary clinics in 49 states.

08:17 EST Actinium announces Iomab-B achieved primary endpoint in SIERRA trial - Actinium Pharmaceuticals announced that results from the Phase 3 SIERRA trial of Iomab-B were presented in an oral presentation at the 65th Annual American Society of Hematology Meeting & Exposition, ASH. The oral presentation highlighted significantly improved survival in patients with a TP53 mutation receiving Iomab-B. Iomab-B achieved the primary endpoint in the SIERRA trial of durable Complete Remission of at least 6 months with high statistical significance, with 22% of patients randomized to the Iomab-B arm achieving dCR and 0% of patients in the control arm achieving dCR, irrespective of TP53 mutational status. In addition, Iomab-B significantly improved event-free survival, a secondary endpoint, with a hazard ratio of 0.22 and median overall survival was doubled. Dr. Avinash Desai, Actinium's Chief Medical Officer, said, "The SIERRA trial data support that regardless of advanced age, prior therapy, or high-risk cytogenetics including a TP53 mutation, Iomab-B provides unprecedented access to a potentially curative BMT. The results also show that on a population basis and across subgroups, an Iomab-B led BMT may result in improved survival. We are incredibly excited for the potential of Iomab-B and what it represents for patients with relapsed or refractory AML. "

08:15 EST NeoGames' PariPlay signs deal with Tipico US - NeoGames S.A. announced that its subsidiary Pariplay is set for further expansion in the North American market after signing an agreement with Tipico's US business. The deal will enable Tipico's players in New Jersey to enjoy Pariplay's Wizard Games titles, as well as a selection of aggregated content from its Fusion offering. Pariplay's content is set for integration in Q1 of 2024. The deal marks the extension of an existing partnership, with Tipico already an established Pariplay customer in the European market.

08:14 EST Valens Semiconductor appoints Nathanzon as Chief Financial Officer - Valens Semiconductor announced that after completing an executive search, it has appointed Guy Nathanzon as the Company's new Chief Financial Officer effective March 10, 2024. Nathanzon is currently the Chief Financial Officer of Scopio Labs, a medical imaging and deep learning AI company, a position he has held since 2020.

08:14 EST Scinai announces study published in scientific journal Antiviral Research - Scinai Immunotherapeutics announces the publication following peer-review of an article titled "Nanobodies to multiple spike variants and inhalation of nanobody-containing aerosols neutralize SARS-CoV-2 in cell culture and hamsters" in the prestigious scientific journal Antiviral Research. The article discusses a new generation of anti-SARS-CoV-2 NanoAbs, also known as nanobodies or VHH antibodies, developed in a research collaboration between the Max Planck Institute for Multidisciplinary Sciences, the University Medical Center Gottingen, and Scinai Immunotherapeutics, and exclusively licensed to Scinai. These NanoAbs are alpaca-derived recombinant variable domain of heavy-chain-only antibodies. Amir Reichman, CEO of Scinai, added "The publication of this prestigious journal article comes at an auspicious time for our company. Scinai continues to make great strides forward, consistent with our previously announced plans. The publication validates the high level of innovative science being conducted both by our partners and in-house, as well as our decision to work with Max Planck and UMG to generate a pipeline of these versatile relatively small molecule biologics. In addition, Scinai Bioservices, our boutique CDMO business unit, now has several customers, strong interest from other potential clients, and financial support of the Israeli Innovation Authority via a competitive grant as we announced last month."

08:13 EST Gildan Activewear CEO Chamandy announces board terminating employment - Glenn Chamandy, President and CEO and co-founder of Gildan Activewear, issued the following statement following four decades of service to the Company, including nearly 20 years as President and CEO: "Yesterday, I received notice from the Chairman of Gildan Activewear's Board of Directors that the Company was terminating my employment agreement without cause. It is unfortunate that my vision of the path forward has differed from that of other Board members. This comes after 40 years of service in the impressively successful company founded by my family. I am immensely proud of the robust and highly competitive organization we built over more than four decades of unwavering efforts to be the best in every market where we compete. The value created by our great team is impressive by any standard."

08:12 EST Whitestone REIT announces court dismisses all claims by former CEO - Whitestone REIT announced that on Friday, December 8, 2023, the District Court in Harris County, Texas dismissed all claims made by former Whitestone CEO, James C. Mastandrea, against the Company and members of the Board of Trustees and management related to the termination of his employment. The lawsuit was filed by Mr. Mastandrea following his removal from the Company by the Board of Trustees in January 2022 claiming breach of his employment contract, negligence, tortious interference with contract, and civil conspiracy. Mr. Mastandrea was seeking a maximum of $25 million in damages and equitable relief.

08:11 EST Synchronoss completes cloud-only transformation, reaffirms 2023, 2024 projection - Synchronoss Technologies provided the following updates enabled by the completion of its cloud-only transformation. In November, the Company announced the divestiture of its Messaging and NetworkX operations in conjunction with its Cloud-only business transformation. Post-transaction, management shared its initial expectation to improve the Company cost profile by eliminating approximately $10 million to $15 million of stranded and other costs from the standalone Cloud operations. In line with its prior communications, management expects to achieve positive cash flow on an unadjusted basis for 2023, and it still expects 2023 adjusted EBITDA to range between $27 million and $30 million. This projection includes restructuring-related expenses and certain stranded costs, which the Company is actively removing from its standalone Cloud business. Looking to 2024, the Company is also reiterating its expectation to achieve between 5% and 8% revenue growth, gross margins of greater than 75%, and adjusted EBITDA margins surpassing 25%. These projections position Synchronoss within the recognized 'Rule of 30' and on the path to 'Rule of 40' in the coming years. Additionally, after factoring in anticipated revenue growth and the expiration of certain existing payment obligations and other general costs, management expects a significant improvement in cash flow generation for 2024, building upon its expectations of unadjusted positive free cash flow in 2023. This anticipated increase in free cash flow results from the combination of: the return to growth of the overall business.higher corporate gross margins following the divestiture of non-core assets. the removal of approximately $15 million of annualized operating expenses by year-end, enabled by that sale.

08:09 EST HireRight receives non-binding acquisition proposal for $12.75 in cash per share - HireRight announced that it has received a non-binding proposal from General Atlantic and Stone Point Capital and their respective affiliated funds to acquire all of the company's outstanding shares of common stock that are not already owned by the sponsors for $12.75 in cash per share. The board of directors of the company previously formed a special committee of independent directors to evaluate and consider any potential or actual transaction proposal from the sponsors and any other alternative proposals or other strategic alternatives that may be available to the company. There can be no assurance that any definitive agreement will result from the proposal submitted by the Sponsors or that any transaction will be consummated. The company and the special committee do not intend to comment further about this proposal unless and until they deem further disclosure is appropriate.

08:09 EST Nasdaq announces annual changes to Nasdaq-100 Index - On Friday evening, Nasdaq (NDAQ) announced the results of the annual reconstitution of the Nasdaq-100 Index, which will become effective prior to market open on Monday, December 18, 2023. The following six companies will be added to the Index: CDW Corporation (CDW), Coca-Cola Europacific Partners plc (CCEP), DoorDash, Inc. (DASH), MongoDB, Inc. (MDB), Roper Technologies, Inc. (ROP), and Splunk Inc. (SPLK). As a result of the reconstitution, the following six companies will be removed from the Index: Align Technology, Inc. (ALGN), eBay Inc. (EBAY), Enphase Energy, Inc. (ENPH), JD.com, Inc. (JD), Lucid Group, Inc. (LCID), and Zoom Video Communications, Inc. (ZM).

08:08 EST 4Front Ventures debuts cannabis flower brand The Hunt - 4Front Ventures announced the launch of cannabis flower brand, The Hunt, expanding the Company's brand portfolio in Massachusetts and adding to its growing offering of high quality, affordable flower. The Hunt's product lineup, which features exclusive offerings of rare, limited and small-batch phenotypes, is now available for purchase at 4Front's Mission Dispensaries in Georgetown, Worcester, and Brookline, MA, and at partner dispensaries across the Bay State.

08:07 EST Erasca receives FDA Fast Track Designation for naporafenib - Erasca announced that the United States Food and Drug Administration has granted Fast Track Designation to naporafenib in combination with trametinib for the treatment of adult patients with unresectable or metastatic melanoma who have progressed on, or are intolerant to, an anti-programmed death-1-based regimen, and whose tumors contain an NRAS mutation. Naporafenib is an orally available, Phase 3-ready pan-RAF inhibitor with a potential first-in-class and best-in-class profile in NRASm melanoma and other RAS/MAPK pathway-altered solid tumors.

08:05 EST BlackBerry appoints Giamatteo as CEO, to separate IoT, cybersecurity businesses - BlackBerry announced the appointment of John Giamatteo as its new Chief Executive Officer and as a member of its Board of Directors, effective immediately. Richard Lynch, who has served as interim Chief Executive Officer since November 4, 2023, will continue as Board Chair. The Company also announced that it will separate the IoT and Cybersecurity businesses, and that they will operate as fully standalone divisions. BlackBerry will no longer pursue a subsidiary IPO of the IoT business. Giamatteo has served as the President of BlackBerry's Cybersecurity business unit since October 2021. "The Board, with input from its advisors, believes that a full separation of BlackBerry's IoT and Cybersecurity businesses will open up a number of strategic alternatives that can unlock shareholder value," said Dick Lynch, Board Chair, BlackBerry. "Management is focused on moving quickly to complete this reorganization that will further enhance the focus of both businesses on their respective markets as well as their capacity for fast, flexible decision-making."

08:03 EST Equinix to accelerate, simplify liquid cooling deployments - Equinix announced plans to expand support for advanced liquid cooling technologies-like direct-to-chip-to more than 100 of its International Business Exchange data centers in more than 45 metros around the world. This builds on Equinix's existing offering that supports liquid-to-air cooling, through in-rack heat exchangers, at nearly every IBX today. "Liquid cooling is revolutionizing how data centers cool powerful, high-density hardware that supports emerging technologies, and Equinix is at the heart of that innovation," said Tiffany Osias, Vice President of Global Colocation, Equinix. "We have been helping businesses with significant liquid-cooled deployments across a range of deployment sizes and densities for years. Equinix has the experience and expertise to help organizations innovate data center capacity to support the complex, modern IT deployments that applications like AI require."

08:02 EST Yoshitsu to directly operate Hong Kong stores - Yoshitsu announced that it will take over direct operating control of its stores in Hong Kong from the current management agency, Excellent Wellbeing International, an international brand management company. Pursuant to the termination of a business cooperation agreement entered into by and between the Company and EWI dated November 30, 2023, on December 31, 2023, the Company will take over the operating management of all of its stores in Hong Kong from EWI. By changing the operating model of its Hong Kong stores, the Company aims to enhance the its customer experience, profitability, and business performance.

07:58 EST Cogent Biosciences announces data from ongoing Phase 2 APEX trial - Cogent Biosciences reported data from Part 1 of the Company's ongoing Phase 2 APEX clinical trial evaluating bezuclastinib in patients with advanced systemic mastocytosis at the 65th American Society of Hematology Annual Meeting & Exposition taking place December 9-12, 2023 in San Diego, CA. APEX is a global, open-label, multi-center, two-part Phase 2 clinical trial in patients with AdvSM evaluating the safety, efficacy, pharmacokinetic, and pharmacodynamic profiles of bezuclastinib. As of the data cutoff date of September 25, 2023, 32 patients were treated in Part 1 at one of four dose levels. The median age of patients at study entry was 68 years. Patients were enrolled with the following sub-types: seven patients with aggressive systemic mastocytosis, 23 patients with systemic mastocytosis with associated hematologic neoplasm, and two patients with mast cell leukemia. Five patients had received prior avapritinib and 10 patients had received prior midostaurin treatment. As of the data cutoff date of September 25, 2023, bezuclastinib continues to demonstrate a differentiated safety and tolerability profile across doses. The majority of adverse events were low grade and reversible and there were no related cognitive impairment or bleeding events reported. Related serious adverse events were reported in four patients including Grade 4 thrombocytopenia, Grade 3 hypersensitivity, Grade 3 leishmaniasis, and Grade 3 drug induced liver injury in a patient who was subsequently found to have biliary tract outflow obstruction. Nine patients required dose reduction due to adverse events, six of whom were at the 400mg dose, and three patients discontinued due to adverse events. As of the data cutoff date of September 25, 2023, 32 patients enrolled were evaluated for signs of clinical activity, 27 of whom were mIWG-MRT-ECNM evaluable. Patients without post baseline biomarker data were excluded from relevant analyses. 52% ORR per mIWG-MRT-ECNM criteria, including 56% ORR for TKI-treatment-naive patients; 100% of patients treated with 100 mg BID achieved PR or better and all remain on study; 150 mg QD optimized formulation dose selected for APEX Part 2 is expected to deliver patient exposures consistent with this cohort; 75% ORR per pure pathological response criteria, including 86% ORR for TKI-treatment-naive patients; Nearly all patients demonstrated a significant improvement in biomarkers associated with disease burden; 94% of patients achieved greater than or equal to50% reduction in serum tryptase levels; 100% of patients receiving greater than or equal to2 cycles achieved greater than or equal to50% reduction; 53% of patients achieved reduction of serum tryptase below 20 ng/mL; 93% of KITD816V-positive patients achieved greater than or equal to50% reduction in KIT D816V variant allele fraction; 97% of patients achieved a greater than or equal to50% reduction in bone marrow mast cell burden; 79% achieved complete clearance of mast cell aggregates by central review. Bezuclastinib Clinical Development : Cogent continues to actively enroll Part 2 of the APEX trial which is expected to include approximately 65 AdvSM patients and is on track to complete enrollment by the end of 2024. Cogent reported positive initial Part 1a data on December 9, 2023 from SUMMIT, a Phase 2 clinical trial of bezuclastinib in patients with nonadvanced systemic mastocytosis, showing rapid improvement in patient symptoms and improvement across all biomarkers with a safety and tolerability profile that supports the potential for chronic dosing. Cogent completed enrollment in SUMMIT Part 1 and plans to initiate SUMMIT Part 2 in the first half of 2024. In addition, Cogent plans to present data from the completed SUMMIT Part 1 trial in the first quarter of 2024. In Gastrointestinal Stromal Tumors, Cogent is actively enrolling patients in Part 2 of the Phase 3 registration-enabling PEAK trial and remains on track to complete enrollment by the end of 2024, with over 100 active sites globally.

07:48 EST Fairfax Financial announces acquisition of additional Orla shares - Fairfax Financial Holdings has acquired, through its insurance company subsidiaries, 2,500,000 common shares of Orla Mining at a price of $3.82 per Common Share for an aggregate purchase price of approximately $9,550,000 through the facilities of the Toronto Stock Exchange. The Share Purchase represents approximately 0.8% of the issued and outstanding Common Shares of Orla and brings Fairfax's total holdings, through its insurance subsidiaries, of such securities to 33,608,650 Common Shares. Immediately prior to the closing of the Share Purchase, Fairfax, through its insurance company subsidiaries, beneficially owned and controlled 31,108,650 Common Shares, representing approximately 9.9% of the issued and outstanding Common Shares of Orla.

07:38 EST Novartis announce Phase III APPPEAR-C3G study of iptacopan met primary endpoint - Novartis announced positive topline results from the six-month, double-blind period of the Phase III APPEAR-C3G study of iptacopan for the treatment of patients with C3 glomerulopathy. The study met its primary endpoint, with iptacopan demonstrating superiority compared to placebo in providing clinically meaningful and statistically significant proteinuria reduction on top of background therapy at six months. The safety profile of iptacopan was consistent with previously reported data. The data will be submitted for presentation at an upcoming medical meeting and discussed with global health authorities anticipating potential regulatory submissions in 2024. The APPEAR-C3G study continues for a six-month, open-label period, in which all patients receive iptacopan, including those previously receiving placebo. In addition, enrollment is ongoing in a separate cohort of adolescent patients with C3G. "People living with C3 glomerulopathy have no approved treatment options indicated for this progressive disease, posing many challenges and uncertainty for these mostly young patients," said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. "These positive results demonstrate the potential of iptacopan to provide clinically meaningful benefit in C3G and add to our growing body of evidence that supports its use across multiple complement-mediated diseases."

07:36 EST GlobalFoundries appoints John Hollister as CFO - GlobalFoundries (GFS) announced that John Hollister will join the company as CFO, effective February 5, 2024. Hollister will be responsible for GF's financial strategy and will lead the company's global finance organization. Hollister joins GF from Silicon Labs (SLAB). where he has served as Senior Vice President and CFO for more than 10 years. Hollister succeeds David Reeder who announced his intentions to leave GF earlier this year. Both John and David will transition to their new roles in early February 2024.

07:34 EST Aveanna appoints Matt Buckhalter as CFO - Aveanna Healthcare Holdings announced the appointment of Matt Buckhalter to serve as CFO and continuing in the role of Principal Financial Officer, effective January 1, 2024. Mr. Buckhalter was appointed to serve as Interim CFO and Principal Financial Officer in July, 2023.

07:33 EST CalciMedica collaborator SJCRH presents data of Phase 1/2 CRSPA study of Auxora - CalciMedica announced that its collaborator, St. Jude Children's Research Hospital, SJCRH, presented data from the initial cohort of the Phase 1/2 CRSPA study of Auxora in asparaginase-induced pancreatic toxicity, AIPT, at the 65th Annual American Society of Hematology, ASH, Meeting & Exposition on Sunday, December 10, 2023, in San Diego, CA. Investigators at SJCRH presented results from the first cohort of the CRSPA study, consisting of nine children with acute lymphoblastic leukemia experiencing asparaginase-associated pancreatitis, also known as AIPT and referred to as AAP in the abstract. Treatment with Auxora, as compared to the historical matched control group, was shown to have the potential to reduce the severity of AIPT in pediatric patients with ALL. Study results showed that Auxora reduced the average number of days patients spent in the hospital from 13.4 to 6.3 days. The need for intensive care unit care was also reduced, with three control patients requiring ICU care compared to one treated patient, and the average number of days in the ICU was reduced from 5 to 3 days. Additionally, no patients in the CRSPA study required TPN, compared to 68.8% in the historical matched control group, who required 27 days of nutritional support on average. Finally, blinded central reading of pancreatic imaging showed a reduction in the development of significant pancreatic necrosis and the severity of acute pancreatitis by CT severity index scoring in patients treated with Auxora compared to the historical matched cohort. Based on these results, investigators have established dose level 1 as the recommended Phase 2 dose of Auxora for children with ALL experiencing AIPT.

07:30 EST GSK reports emperli plus chemotherapy approved in EU for endometrial cancer - GSK plc announced the European Commission has granted marketing authorisation for Jemperli in combination with carboplatin-paclitaxel chemotherapy for the treatment of adult patients with mismatch repair deficient/microsatellite instability-high primary advanced or recurrent endometrial cancer and who are candidates for systemic therapy. Additionally, with the authorisation in this indication, the EC's conditional approval for Jemperli as a monotherapy for treating adult patients with dMMR/MSI-H recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen is now converted to full approval. Hesham Abdullah, Senior Vice President, Global Head Oncology, R&D, GSK, said: "People living with this type of endometrial cancer typically experience disease progression and poor long-term outcomes with current standard of care. With this approval, we can expand the number of patients who can potentially benefit from treatment with Jemperli in Europe, including patients who are earlier in their journey. We are proud of the recent approvals for Jemperli as we believe that it continues to transform the frontline endometrial cancer treatment landscape and shows promise as a foundational immuno-oncology therapy."

07:29 EST Dundee Precious Metals announces maiden MRE of Coka Rakita project - Dundee Precious Metals announced a maiden Mineral Resource Estimate of 1.78 million ounces for its 100% owned oka Rakita gold project in eastern Serbia, where DPM announced a high-grade discovery in January 2023. Highlights: Strong maiden Mineral Resource estimate: Inferred Mineral Resource estimate of 9.79 million tonnes at a grade of 5.67 grams per tonne for 1.78 million ounces of gold. The maiden MRE was completed after only one full year of drilling on the project and is based on approximately 80,723 metres of drilling in 173 holes. Higher-grade core of mineralization: The MRE contains a significant portion of gold ounces within a continuous high-grade core of mineralization that amounts to 2.81 Mt at a grade of 10.12 g/t Au for 0.914 million ounces of gold. Once sufficient drilling has been completed to upgrade the Mineral Resource confidence, this higher-grade core has the potential to drive strong economics by accessing higher than average grades during the early years of a mine plan. Upside exploration potential: DPM is continuing its drilling program focused on extending the limits of oka Rakita, which remains open to the northeast and to southwest, and is also aggressively pursuing additional skarn targets on the oka Rakita licence as well as on three additional licences to the north and the south. Advancing to a preliminary economic assessment: Based on the favourable size and quality of the MRE, DPM will continue to accelerate the project and expects to complete a PEA on the project in the second quarter of 2024, targeting a throughput rate of 850,000 tonnes per annum. Attractive organic growth opportunity: oka Rakita benefits from good infrastructure, including nearby existing roads and power lines. The project is located in close regional proximity to DPM's existing operations in Bulgaria and is a strong fit with the Company's underground mining and processing expertise, with metallurgical test work demonstrating gold recoveries of approximately 90% by gravity concentration and conventional flotation.

07:25 EST Orchard Therapeutics receives Swissmedic approval for Libmeldy - Orchard Therapeutics announced the Swiss Agency for Therapeutic Products has approved Libmeldy a hematopoietic stem cell gene therapy, for the treatment of early-onset metachromatic leukodystrophy.

07:22 EST Barrick Gold says Goldrush mine gets go-ahead - Barrick Gold Corporation said The US Bureau of Land Management has issued a Record of Decision approving Nevada Gold Mines' plan of operations for its new Goldrush underground mine at the Cortez Complex near Beowawe, Nevada. The long-life mine is expected to start ramping up production in 2024 after the commissioning of the initial project infrastructure and is forecast to produce 130,000 ounces in 2024 and grow to approximately 400,000 ounces per annum by 2028. Barrick and NGM have invested more than $370 million in the project to date and the company anticipates spending a total of approximately $1 billion to get to planned production. Recruitment is being ramped up and the delivery of production equipment is on track. The issuance of the ROD follows a multi-year consultation and independent impacts analysis process pursuant to the National Environmental Policy Act, which included specialist environmental studies. In the course of the analyses, all stakeholders were given the opportunity to engage with NGM and contribute to the outcome. It is anticipated that Goldrush will create a total of approximately 500 jobs during construction and 570 new jobs during operations. Additionally, Goldrush will generate hundreds of millions of dollars in net proceeds tax and gold and silver excise taxes, the latter of which are earmarked for education in Nevada.

07:19 EST Brad Jacobs to enter building products distribution industry - Brad Jacobs has announced his intention to create a market leader in building products distribution. The company will be called QXO, Inc. Jacobs will become chairman and CEO of QXO upon closing a previously announced $1B cash investment into SilverSun Technologies, Inc. After spinning off the existing SilverSun business, the remaining company, QXO, will be a standalone platform for significant acquisitions. Distributors of building products offer materials, finished goods, value-added solutions and expertise to a broad range of customers across residential, nonresidential, industrial and infrastructure end-markets. Their products are used in new construction and in repair and remodeling. Key categories include access control, construction supplies, doors and windows, electrical components, fencing and decking, HVAC, infrastructure, landscaping, lumber, plumbing, pools, roofing, siding and water, among others. "We expect to achieve a revenue run-rate of at least $1 billion by the end of year one, at least $5 billion within three years, and tens of billions of dollars over the next decade," Jacobs said. "QXO's scale should elevate the customer experience, increase sales force effectiveness and enable margin expansion."

07:15 EST Marker announces sustained complete response in patient treated with MT-601 - Marker Therapeutics reported a clinical update on the APOLLO study. The Phase 1 APOLLO study is investigating MT-601, a multi-tumor associated antigen-specific T cell product, for the treatment of patients with lymphoma who have failed or are ineligible to receive anti-CD19 CAR T cell therapy. The Company previously reported first enrollment in the dose escalation stage of the Phase 1 trial. The patient had diffuse large B cell lymphoma and failed four prior lines of therapy, including anti-CD19 CAR T cell therapy. Marker reported in September that the study participant tolerated the treatment well without treatment-related adverse events and achieved a complete metabolic response eight weeks after the second infusion of MT-601. Marker reports today that six months following the initial treatment with MT-601 the study participant has maintained complete response to treatment. These clinical results are reinforced by non-clinical proof-of-concept data demonstrating that MT-601 has the potential to eradicate lymphoma cells resistant to anti-CD19 CAR T cells, highlighting the therapeutic potential of MT-601 in vitro/ Although CD19-targeting CAR T cell therapies have gained acceptance as treatment for patients with lymphoma, up to 60% of patients treated with CAR T therapies relapse within one year. This APOLLO study participant relapsed within 90 days after CAR T cell therapy, yet maintained a complete response for at least six months after treatment with MT-601, suggesting that MT-601 is more durable compared to CAR T cells in this study participant. CAR T cell therapies, which have known severe side effects such as neurotoxicity, are also currently being investigated by the FDA for the risk of potential induction of secondary cancers adding another layer of concern for patients and clinicians. Notably, multiTAA-specific T cell therapies have been well-tolerated in clinical trials, and Marker believes that multiTAA-specific T cells are a safe alternative to CAR T cells due to their non-genetically engineered approach that selectively expands tumor-specific T cells from a patient's/donor's blood without the risk of mutagenesis.

07:13 EST Commercial Vehicle Group appoints James Ray as president, CEO - Commercial Vehicle Group announced that its Board of Directors has appointed James Ray as the Company's next President and CEO. On December 20, 2023, he will replace Interim CEO Robert Griffin, who will continue in his role as Chairman of the Board of Directors for CVG. Ray has served as an Independent Director on CVG's Board since March 2020 and will remain on the Board as a non-independent director following his appointment as President and CEO. Prior to joining CVG's Board, Mr. Ray served as President, Engineered Fastening at Stanley Black & Decker.

07:11 EST Mercury Systems introduces ARES-SAR radar flight testing simulator - Mercury Systems introduced the first commercially available flight testing simulator for air-to-ground synthetic aperture radar systems. The ARES-SAR product builds on more than 25 years of test and train technology from the Mercury Processing Platform to enable government and commercial organizations to save time and costs by reducing the need for actual flight testing through the simulation of realistic SAR scenarios on the ground.

07:09 EST Boeing appoints Stephanie Pope as Chief Operating Officer - Boeing announced Stephanie Pope as executive vice president and chief operating officer of The Boeing Company. In this newly created position, effective January 1, 2024, Pope will report to Boeing President and Chief Executive Officer Dave Calhoun. As Boeing COO, Pope will oversee the performance of the company's three business units with responsibility for driving supply chain, quality, manufacturing and engineering excellence across the company. The business unit Chief Executive Officers, the Boeing Chief Engineer and the President of Boeing Global will report directly to Pope. Stephanie Pope has been serving as president and chief executive officer of Boeing Global Services since April 2022.

07:08 EST Silicon Labs announces CFO Hollister to step down - Silicon Labs (SLAB) announced that John Hollister will step down as chief financial officer, CFO, to join partner GlobalFoundries (GFS) as its CFO. Mark Mauldin, Silicon Labs' chief accounting officer, will work closely with Hollister to transition responsibilities and will be named interim chief financial officer when the handover is completed by February 2, 2024. Silicon Labs is conducting a search for a new CFO to continue to scale the company as a leader in embedded wireless solutions for the Internet of Things. Silicon Labs is poised to continue to scale and grow as the semiconductor market recovers from a cyclical downturn. In its search for a new CFO, Silicon Labs will evaluate candidates for strengths in scaling companies and defining and managing financial strategies for rapid growth.

07:06 EST Occidental to reduce debt principal by at least $4.5B within 12 months - Occidental said that increased cash flow, along with proceeds from a new $4.5B-$6B divestiture program, will enable Occidental to reduce its debt principal by at least $4.5B within 12 months and expect to retain its investment grade credit ratings.

07:05 EST Tellurian names Martin Houston chairman, Meredith Mouer general counsel and CCO - Tellurian announced that following the appointment of Martin Houston as chairman of the board, the board of directors has named former general counsel Daniel Belhumeur as president of Tellurian, and former Deputy general counsel Meredith Mouer as general counsel and chief compliance officer, or CCO, of Tellurian.

07:04 EST Occidental intends to increase quarterly dividend by 4c to 22c per share - Occidental announced its intention to increase the quarterly common stock dividend per share by 4c to 22c, beginning with the February 2024 declaration, consistent with the company's shareholder return priorities.

07:03 EST Occidental to acquire CrownRock in deal valued at $12B in cash and stock - Occidental announced it entered into a purchase agreement to acquire Midland-based oil and gas producer CrownRock L.P., a joint venture of CrownQuest Operating LLC and Lime Rock Partners, for cash and stock in a transaction valued at approximately $12B, including the assumption of CrownRock's debt. Occidental intends to finance the purchase with the incurrence of $9.1B of new debt, the issuance of approximately $1.7B of common equity and the assumption of CrownRock's $1.2 billion of existing debt. The transaction is expected to close in the first quarter of 2024, subject to customary closing conditions and the receipt of regulatory approvals. "We believe the acquisition of CrownRock's assets adds to the strongest and most differentiated portfolio that Occidental has ever had. We found CrownRock to be a strategic fit, giving us the opportunity to build scale in the Midland Basin and positioning us to drive value creation for our shareholders with immediate free cash flow accretion," said Occidental President and Chief Executive Officer Vicki Hollub. "We are excited about combining CrownRock's high-performing team into our organization and expect to continue Occidental's exceptional operational and financial results for years to come."

07:02 EST Occidental to acquire CrownRock in deal valued at $12B in cash and stock

06:58 EST Descartes Systems says AYBL implements ecommerce warehouse management system - Descartes Systems Group announced that U.K.-based ecommerce brand AYBL has transformed its warehouse and fulfillment capabilities by replacing paper-based picking and manual fulfillment practices with Descartes' ecommerce warehouse management system . Using the solution to improve picking efficiency and accuracy, AYBL has doubled its fulfillment capacity with existing staff and can eamlessly scale to fulfill over 70,000 orders a day during peak season.

06:54 EST Northern Dynasty announces $15M convertible notes offering - Northern Dynasty Minerals entered into a definitive agreement with an Investor for US$15,000,000 aggregate principal amount convertible notes of the Company and plans to complete a non-brokered private placement for aggregate proceeds of up to CAD$3,400,000. Per the terms of the Agreement, Kopernik Global Investors, LLC on behalf of its clients will purchase convertible notes having an aggregate principal amount of US$15,000,000. The Notes will have a term of 10 years from the date of issuance and will bear interest at a rate of 2.0% per annum, payable semi-annually in arrears on December 31 and June 30 of each year, commencing on June 30, 2024. The principal amount of the Notes will be convertible at any time at the option of the Investor at a per share conversion price of US$0.3557, which is equal to a 10% premium to the 5-day volume weighted average price on the NYSE American, subject to adjustment in certain circumstances. The terms of the Notes will require that the Company redeem the note at 150% of the principal amount of the Notes, plus accrued but unpaid interest, at the election of the Investor, in the event that the Company proceeds with an equity financing in the future, subject to customary exclusions for non-financing issuances of its equity securities. In addition, the Notes will include change of control provisions under which the Investor may elect to convert the Notes concurrent with a change of control transaction at the lower of the fixed conversion price and the price per common share implied by the change of control transaction, and the Company will be required to offer to repurchase the Notes at 101% of the principal amount, plus accrued but unpaid interest, if the Investor does not elect to convert. Timing of closing is subject to both parties satisfying certain closing conditions. The Company also proposes to issue and sell by non-brokered private placement up to 8,500,000 units of the Company, at a price of CAD$0.40 per Unit, for aggregate gross proceeds of up to CAD$3,400,000. Each Unit shall consist of one common share of the Company and one transferable share purchase warrant. Each Warrant will entitle the holder thereof to purchase one additional common share of the Company for a period of two years from the date of issue at a price of CAD$0.45 per Warrant Share. The Warrants will be subject to accelerated expiry upon 30 calendar days' notice from the Company in the event the Company's common shares trade for 20 consecutive trading days any time after four months from Closing at a volume weighted average price of at least CAD$0.90 on either the Toronto Stock Exchange or the NYSE American. The Units are proposed to be sold and issued under the Unit Offering pursuant to exemptions from prospectus requirements and other similar requirements under applicable securities laws. The Units will be subject to resale restrictions under applicable securities laws in Canada and the United States. The closing of the Convertible Notes Offering and the Unit Offering are subject to a number of conditions, including receipt of all necessary corporate and regulatory approvals including, without limitation, the approval of the TSX and the NYSE American. Closing of the Convertible Notes Offering is not conditional upon the closing of the Unit Offering and closing of the Unit Offering is not conditional on the closing of the Convertible Notes Offering. The net proceeds of the Convertible Notes Offering and the Unit Offering are expected to be used by the Company to fund the ongoing permitting process of the Pebble Project and for general corporate purposes including working capital.

06:50 EST Merck, Moderna initiat INTerpath-002 phase 3 study of V940 - Merck (MRK) and Moderna, Inc. (MRNA), announced the initiation of INTerpath-002, a pivotal Phase 3 randomized clinical trial evaluating V940, an investigational individualized neoantigen therapy, in combination with KEYTRUDA, Merck's anti-PD-1 therapy, as adjuvant treatment in patients with completely resected Stage II, IIIA or IIIB non-small cell lung cancer. Global recruitment of the INTerpath-002 has begun, and the first patients enrolled in Australia.

06:48 EST Merck Animal Health receives positive CVMP opinion for injectable BRAVECTO - Merck Animal Health announced that the European Medicines Agency's Committee for Veterinary Medicinal Products issued a positive opinion for BRAVECTO 150 mg/ml powder and solvent for suspension for injection for dogs. The CVMP recommends the product for approval for the treatment and persistent killing of fleas and ticks for 12 months. If the European Commission adopts the recommendation, this injectable formulation of BRAVECTO can be used by or under the supervision of a veterinarian and for administration to dogs and puppies six months of age and older. Based on the CVMP's recommendation, the EC is expected to issue a decision for marketing authorization in the European Union during the first quarter of 2024.

06:43 EST Rupert Resources appoints Bill Washington as independent non-executive director - Rupert Resources has appointed Bill Washington as an Independent Non-Executive Director, effective immediately. In his role as an independent non-executive director Mr Washington will also sit on the Audit and Remuneration committees. The Company expects to make further changes to the Board in the New Year. Concurrent to his appointment, the Company furthermore announces that pursuant to the Company's Amended and Restated Equity Incentive Plan dated November 9, 2022 a total of 200,000 options were awarded to Mr. Washington. The Options were granted with an effective date of December 7, 2023 with an exercise price of $4.12 per share, being the closing price of the Company's shares on the TSX on December 6, 2023. The Options are exercisable for a five-year period from the date of grant, with 1/3rd of the Options vesting on each calendar anniversary. Following the award of the Options, there are 5,093,481 options outstanding under the Plan, representing 2.5% of the issued and outstanding shares of the Company. Washington was the Head of Global Mining & Metals at National Bank Financial Markets from July 2011 until his retirement from the firm at the end of 2015.

06:39 EST Kraken Robotics awarded seabed contract in Australia - Kraken Robotics provides more detail on a recent contract announcement. Kraken will supply high-resolution seabed mapping sonar service to Precision Hydrographic Services, a customer supporting the Australian Department of Defence. The Australian Department of Defence has awarded PHS a program to collect Hydrographic High Resolution Route Surveys for a number of Australian ports. The purpose of the RS is to enable the collection of Maritime Geospatial Information to support maritime domain awareness through the acquisition of high-resolution seabed foundation data and associated oceanographic data. Under the scope of Kraken's contract, a KATFISH high-speed survey/detection solution will be used to acquire high-resolution route surveys of Australian ports. The survey campaign will take place between January and May 2024. This contract follows the results of a successful in-country demonstration of KATFISH for the customer in Q1 of this year and the purchase of a KATFISH system by the RAN in Q2.

06:36 EST Trane appoints Riaz Raihan as CDO - Trane Technologies announced the appointment of Riaz Raihan as Chief Digital Officer, effective December 11. Raihan will report to Chair and CEO Dave Regnery as part of the executive leadership team and will lead the digital strategy for Trane Technologies globally. As CDO, Raihan will advance the digital strategy and vision for Trane Technologies and deepen the company's digital capabilities, technology and offerings. His appointment supports Trane Technologies' continued leadership in creating advanced digital services and solutions that help customers reduce greenhouse gas emissions, manage energy and asset performance, and unlock operational cost savings. Most recently, Raihan served as advisor to the CEO and ELT at Alight.

06:34 EST Fisker appoints Wolfgang Hoffmann as country manager, Canada - Fisker confirmed two new hires for its executive team. Wolfgang Hoffmann has joined the company as Country Manager for Canada, and Amira Aly has joined as VP, Sales, for the United States. Hoffmann comes to Fisker after seven years as President of Jaguar Land Rover in Canada and before that, many years with Audi in both Canada and the U.S. He has already assembled a team and will oversee the commencement of Canada deliveries of the Fisker Ocean SUV in December. Aly joins Fisker after serving as the Senior Director and Head of Sales in North America for Lucid Motors. Hoffmann and Aly will report to Dawn Ahmed, Sr. VP, Global Marketing, Sales & Service.

06:32 EST Eaton Cummins JV announces availability of Endurant XD series - Eaton Cummins Automated Transmission Technologies has announced its Endurant X series automated transmission is now available in select vocational Western Star and Freightliner models, both of which are subsidiaries of Daimler Truck North America. As part of the Cummins integrated powertrain, Endurant XD and Endurant XD Pro, paired with the Cummins X12 or X15 engine, are available in the Western Star 47X and 49X and the Freightliner 114SD PLUS.

06:19 EST Affimed discontinues enrollment in AFM24-102 into gastric cancer, basket cohorts - Affimed announced that it has discontinued enrollment in AFM24-102 into the gastric cancer cohort and the basket cohort evaluating pancreatic cancer, biliary tract cancer and hepatocellular carcinoma. While clinical activity was observed in both cohorts, neither cohort is likely to achieve response rates that would meet the Company's efficacy hurdle and the Company's strategic focus is to advance the NSCLC program as fast as possible.

06:16 EST Gildan Activewear president, CEO Glenn Chamandy departs, Vince Tyra to succeed - Gildan Activewear announced that Glenn Chamandy has left his position as President and CEO and director of the Company. Vince Tyra has been appointed President and CEO effective February 12, 2024. Craig Leavitt, a director of the Company since 2018, will serve as Interim President and CEO until Mr. Tyra assumes his new position. Tyra led alphabroder where he spearheaded the transformation of the business through a merger and during his six years as CEO, he tripled alphabroder's revenue. Most recently, he served at Houchens Industries as Senior Vice President of Corporate Strategy and Mergers and Acquisitions.

06:11 EST Keros Therapeutics says KER-050 treatment reduced iron overload - KER-050 Treatment Reduced Iron Overload and Increased Bone Specific Alkaline Phosphatase in Participants with Lower-risk MDS Supporting Potential to Restore Balance to the Osteohematopoietic Niche: Exploratory analysis of biomarkers that may indicate MDS disease modification were evaluated as of the data cut-off date in the ongoing Phase 2 clinical trial of KER-050 in patients with MDS. Observations from these biomarkers included improvements in: Iron metabolism: 48.3% of patients with baseline ferritin greater than or equal to 1,000 ng/ml had a decreased ferritin to less than 1000 ng/ml and 69.0% of patients decreased ferritin by greater than or equal to20%. Two patients, including one who was NT, discontinued iron chelator therapy due to observed decreases in ferritin. These data support potential of KER-050 to ameliorate iron overload. Hematopoiesis: Sustained increases in hemoglobin for 24 weeks coincided with observed increases in soluble transferrin receptor and concomitant decreases in serum ferritin, suggesting KER-050 resulted in durable restoration of erythropoiesis and improved iron metabolism. Bone turnover: Increases in bone-specific alkaline phosphatase, a marker of osteoblast activity, were observed with KER-050 treatment regardless of hematological response, baseline transfusion burden or RS status, suggesting KER-050 can potentially restore a bone marrow microenvironment conducive to functional hematopoiesis. Cardiac stress: Levels of N-terminal prohormone of brain natriuretic protein, a biomarker of myocardial stress, decreased in both HI-E and/or TI responders and non-responders, suggesting that KER-050 may ameliorate cardiac strain directly via inhibition of activin A and indirectly by improving anemia and reducing transfusion burden. Collectively, these exploratory data suggest that KER-050 has the potential to provide benefit to patients with MDS beyond treatment of anemia, such as reestablishing hematopoiesis across multiple cell lineages, restoring homeostasis within the osteohematopoietic niche and ameliorating myocardial strain.

06:07 EST Affimed anounces updated Phase 1/2 data from acimtamig with allogeneic NK - Affimed announced updated data on its lead innate cell engager acimtamig. Data from the investigator-initiated trial is being presented today at the American Society of Hematology 2023 Annual Meeting by Yago Nieto, M.D., Ph.D., Professor of Stem Cell Transplantation and Cellular Therapy at The University of Texas MD Anderson Cancer Center and principal investigator of the study. Affimed will host a webcast following the presentation to review the data and provide a strategic update on acimtamig's future development. A total of 42 patients were enrolled in the study with 36 patients treated at the RP2D. 32 of the 36 patients treated at the RP2D were HL patients. All 32 HL patients were heavily pretreated with multiple lines of chemotherapy, all had previously received CPIs and BV, and were refractory to their most recent line of therapy with active progressive disease at the time of enrollment. Across all dose levels, the treatment regimen achieved an ORR of 93% with a CR rate of 67%; among the 32 HL patients treated at the RP2D the treatment regimen achieved an ORR of 97% and a CR rate of 78%. In addition, the treatment regimen demonstrated a good safety and tolerability profile with no cases of CRS, ICANS or GvHD of any grade. Mild to moderate infusion related reactions were seen in 7.7% of the acimtamig infusions. Across all dose levels, median event free survival was 8.8 months and median overall survival was not reached. For the HL patients treated at the RP2D, median EFS was 9.8 months - with 84% patients alive at 12 months. The median DoR was 8.8 months and 72% CR assessed at 6 months for HL patients treated at the RP2D; 30% of patients with complete response remained in CR beyond 12 months.

06:02 EST Sprouts Farmers Market, Uber partner for on-demand delivery - Sprouts Farmers Market (SFM) is now available on Uber Eats (UBER) for on-demand grocery delivery, starting in Florida. Customers will be able to order thousands of fresh, natural and organic products from Sprouts by simply visiting the Uber Eats mobile app or website, where they can choose to have their groceries delivered on-demand or schedule a delivery for later in the day or week. Sprouts will roll out delivery through Uber Eats to its markets in phases this month, beginning with more than 40 locations currently available in Florida and expanding to all Sprouts locations by the end of the year.

05:37 EST Bristol Myers discloses results from second-line cohort of TRANSCEND FL study - Bristol Myers announced the first disclosure of primary analysis results from the high-risk, second-line cohort of TRANSCEND FL, an open-label, global, multicenter, Phase 2, single-arm study evaluating Breyanzi in patients with relapsed or refractory follicular lymphoma, or FL. TRANSCEND FL is the largest clinical trial to date to evaluate a CAR T cell therapy in patients with relapsed or refractory indolent non-Hodgkin lymphoma, including FL. Additionally, the company presented long-term data from the TRANSCEND CLL 004 study evaluating Breyanzi in patients with relapsed or refractory chronic lymphocytic leukemia, or CLL, or small lymphocytic leukemia, or SLL, with 24-month follow-up. These data are being featured in oral presentations at the 2023 American Society of Hematology, or ASH, Annual Meeting, from December 9-12, with the TRANSCEND FL 2L oral presentation selected as part of the 2024 Highlights of ASH for lymphoma. Results from TRANSCEND FL will be discussed with health authorities. A supplemental biologics license application for Breyanzi in relapsed or refractory CLL based on results from TRANSCEND CLL 004 is currently under review by the FDA with a target action date of March 14, 2024. Bristol Myers has the broadest ongoing cell therapy development program in CD19-positive malignancies with Breyanzi, which also includes trials investigating its use in patients with relapsed/refractory mantle cell lymphoma, or MCL. Results from the primary analysis of the MCL cohort of TRANSCEND NHL 001 were simultaneously published in Journal of Clinical Oncology. In the TRANSCEND FL clinical trial, 130 patients with relapsed or refractory follicular lymphoma, or FL, were enrolled and treated with Breyanzi in the second-line and third-line plus settings. Patients received treatment with Breyanzi at a target dose of 100 x 106 CAR-positive viable T cells. TRANSCEND FL is the largest clinical trial evaluating a CAR T cell therapy in relapsed or refractory FL, and the first trial to report outcomes for a CAR T in second-line, high-risk FL, with results generally consistent with the efficacy and safety results observed in third-line FL. In patients with high-risk relapsed or refractory FL treated with Breyanzi in the second-line setting who were evaluable for efficacy with a median on-study follow-up of 18.1 months, Breyanzi elicited significant responses in nearly all patients, with all responders achieving a complete response, or CR. The overall response rate, or ORR, the study's primary endpoint, and CR rate were 95.7%. With a median follow-up of 16.8 months, median duration of response, or DOR, was not reached. The probability of patients remaining in response at 12 months was 89.8%. Median progression-free survival, or PFS, was also not reached, with a PFS rate of 91.3% at 12 months. Breyanzi continued to exhibit a manageable and predictable safety profile with no new safety signals observed and low rates of severe cytokine release syndrome, or CRS, and neurologic events, or NE. Any-grade CRS occurred in 52.2% of patients, with no grade greater than CRS reported. Any-grade NEs were reported in 17.4% of patients, with Grade 3 NEs occurring in 4.3% of patients and no Grade 4/5 NEs reported. All cases of CRS and NEs were managed to resolution. Patient-reported outcomes, or PROs, from TRANSCEND FL are also being presented, representing the first disclosure of PRO data for a CAR T cell therapy in relapsed or refractory FL. Based on an exploratory analysis, the majority of patients with second- or third-line relapsed or refractory FL reported clinically significant improvements in quality of life, disease symptoms, and functioning after being treated with Breyanzi. Those receiving Breyanzi in the second-line setting generally demonstrated greater and faster meaningful improvements in most primary domains, compared to those who received Breyanzi in the third-line setting, including role and cognitive functioning, fatigue, pain, and Functional Assessment of Cancer Therapy Lymphoma scores. Results from the third-line-plus treatment cohort of TRANSCEND FL were previously presented at the 2023 International Conference on Malignant Lymphoma in June.

05:21 EST Nokia, BT Group announce agreement for new 5G network monetization opportunities - Nokia and BT Group announced an agreement to develop new 5G network monetization opportunities through Nokia's Network as Code platform with developer portal and BT Group's cloud-native network. BT Group, which operates EE is, like other communications service providers, looking to Nokia's growing ecosystem of developer partners to gain access to simplified network capabilities in the form of software code that can be built into applications for enterprise, industrial, and consumer use cases. The Nokia platform helps operators monetize their 5G network assets beyond pure connectivity. It provides application developers with tools such as Software Development Kits, or SDK, and open Application Programming Interfaces, or APIs, which give developers access to deep network functionality and data that enables them to build new use cases for their customers. Through their agreement, Nokia and BT Group will make those tools available to developers so they can utilize BT Group's network features, write new use cases, and create new value for EE customers. Nokia has announced a similar agreement with DISH Wireless. The platform was launched in September following many months of close collaboration with developers and operators. It is based on a revenue share model between developers, operators, and Nokia as the platform provider.

05:15 EST Nyxoah announces data from Genio hypoglossal nerve stimulation system study - Nyxoah announced data from a real-world case series evaluating treatment of three complete concentric collapse, or CCC, patients with the Genio hypoglossal nerve stimulation system. The investigator-sponsored case series was presented by Christian Plettenberg from the Universitatsklinikum Dusseldorf on December 8. Results showed an average apnea-hypopnea index, or AHI, decrease of 73% and Epworth Sleepiness Scale, or ESS, decrease of 58%. There were no implant related adverse events. The AHI in Patient 1 decreased from 44/h to 5.6/h, in Patient 2 from 24/h to 11.2/h and in Patient 3 from 36/h to 11.2/h. This resulted in an average reduction of 73%. The ESS in Patient 1 decreased from 15 to 2, in Patient 2 from 12 to 9 and in Patient 3 from 11 to 5. This resulted in an average reduction of 58%.