Stockwinners Market Radar for December 08, 2023 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

19:50 EST Aurora Mobile trading halted, news pending

17:34 EST W. R. Berkley declares 50c per share special cash dividend - W. R. Berkley announced that its board of directors has declared a special cash dividend on its common stock of 50c per share to be paid on December 27 to stockholders of record at the close of business on December 18. Together with the 50c per share special dividend that was paid on January 24 and the 50c per share special dividend that was paid on October 4, this will bring special cash dividends paid during 2023 to $1.50 per share, the company noted. In addition, the board has declared a regular quarterly cash dividend on its common stock of 11c per share to be paid on December 27 to stockholders of record at the close of business on December 18. "Including today's announced special and regular quarterly cash dividends and all shares repurchased through September 30, 2023, total capital returned to shareholders during 2023 is approximately $932M," the company stated.

17:16 EST Textron awarded $128.18M Navy contract modification - Textron was awarded a $128.18M modification to a previously awarded firm-fixed-price contract. This modification exercises options to provide for the production and delivery of 10 Multi-Engine Training System, or METS, aircraft, initial spares, peculiar support equipment, and METS aircraft interim contractor logistics support to provide intermediate and advanced training for accession into P-8, EP-3, KC-130, E-6, E-2, CMV-22 and MV-22 aircraft in support of the mission of Chief Naval Air Training for the Navy. Work will be performed in Wichita, Kansas (99%); and Corpus Christi, Texas (1%), and is expected to be completed in June 2024. Fiscal 2024 aircraft procurement (Navy) funds in the amount of $128,180,782 will be obligated at the time if award, none of which will expire at the end of the current fiscal year. Naval Air Systems Command is the contracting activity.

17:08 EST American Electric awarded $315.9M Defense Logistics Agency contract - AEP Energy has been awarded an estimated $315.9M fixed-price utilizing locational marginal price contract under solicitation for electricity. This contract was a competitive acquisition with four responses received. This is a four-year contract with no option periods. Locations of performance are Pennsylvania, New Jersey and Maryland, with a June 30, 2028, performance completion date. Using customers are Army, Air Force, Navy, Defense Intelligence Agency, Institute for Defense Analysis, National Institute of Standards & Technology, Transportation Security Administration, Department of Agriculture and Veterans Affairs Maryland Health Care System. Using customers are solely responsible to fund this contract and vary in appropriation type and fiscal year. The contracting activity is the Defense Logistics Agency Energy.

16:10 EST Near Intelligence Inc trading resumes

16:05 EST Arcellx announces new data from expansion study of CART-ddBCMA - Arcellx announced new clinical data from its Phase 1 expansion study of CART-ddBCMA, now known as anitocabtagene autoleucel, or anito-cel. Anito-cel utilizes a novel D-Domain BCMA binder that is compact and stable, which results in a drug product with a high proportion of CAR+ cells and high surface expression, potentially enhancing antigen binding and more efficient Multiple Myeloma cell killing. The data continue to demonstrate robust long-term responses with median duration of response, progression free survival, or PFS, and overall survival rate not reached. The data are from an October 15 data cut, with median follow-up after anito-cel infusion of 26.5 months. These latest study findings will be presented as an oral presentation during the 65th American Society of Hematology, or ASH. As of October 15, 38 patients were evaluable for efficacy and safety analysis based on a median follow-up of 26.5 months following treatment. These evaluable patients comprised the dose escalation cohorts for the first dose level and the second dose level and a dose expansion cohort at 100 million CAR+ T cells. The median dose administered to patients in the first dose level and dose expansion cohorts was 115M CAR+ T cells. All patients evaluable for this analysis have poor prognostic factors with 38 of 38 patients triple-refractory, 26 of 38 penta-refractory, and 34 of 38 refractory to last line of treatment under International Myeloma Working Group, or IMWG, criteria. Additionally, 9 of 38 patients had high tumor burden with greater than 60% bone marrow plasma, or BMPC, cells, 13 of 38 patients had extra-medullary disease and 11 of 38 patients had high-risk cytogenetics at screening/baseline. Further, 24 of 38 had at least one high-risk clinical feature, defined as presence of EMD, BMPC greater than60%, or Beta 2 microglobulin greater than 5.5 mg/L at screening/baseline. All 38 patients had at least three prior lines of therapy. The interim anito-cel Phase 1 clinical results demonstrate deep and durable responses in patients with poor prognostic factors. Of the 38 evaluable patients with a median follow-up of 26.5 months: 100% overall response rate, or ORR. achieved in all patients per IMWG criteria; 29 of 38 evaluable patients achieved a complete response, or CR, or a stringent complete response; 35 of 38 patients achieved a very good partial response or higher. Of those evaluable for MRD testing to date, 25 were MRD-negative at a minimum of 10-5 sensitivity. Median duration of response, progression free survival and overall survival were not reached at the time of the October 15 data cut. While median PFS is yet to be reached, the estimated Kaplan-Meier median progression free survival for the study population was 28 months at the time of the data cut with 26.5 months of median follow-up. The Kaplan-Meier method estimated PFS rates for 6, 12, 18 and 24 months were 92%, 76%, 64% and 56%, respectively. Durable responses were also observed in patients with high-risk features and high-risk cytogenetics. Anito-cel dosed at RP2D continues to be well-tolerated at the time of the October 15, 2023 data cut: Adverse events with anito-cel, including CRS and ICANS, were manageable. No cases of grade 3 CRS and only one case of grade 3 ICANS event with no additional cases from previously reported. No tissue-targeted toxicities were observed No cases of delayed neurotoxicity events or parkinsonian symptoms were observed.

15:41 EST Near Intelligence files for Chapter 11 bankruptcy protection - Near Intelligence announced that it and certain of its subsidiaries have voluntarily initiated a Chapter 11 proceeding in the United States Bankruptcy Court for the District of Delaware and will seek to sell their assets through a court supervised sales process. The company has also entered into a DIP financing agreement with its existing secured lenders, affiliates of Blue Torch Finance, to provide up to $16M of operating capital. In addition, the company intends to file a motion on or shortly after the petition date seeking, among other things, approval of sale procedures with respect to the sale of substantially all of its assets that provides for the company's existing secured lenders to serve as a "stalking horse" bidder. The Debtors have filed various "first day" motions with the Bankruptcy Court requesting customary relief that will enable them to transition into Chapter 11 while continuing to operate their business in the ordinary course without material disruption, including seeking authority to obtain debtor-in-possession financing and pay employee wages and benefits without interruption. The Debtors' existing secured lenders are supportive of the Chapter 11 proceeding and court supervised sale process.

15:25 EST Near Intelligence Inc trading halted, news pending

13:44 EST Bluebird Bio down 35%, halted again for volatility - Bluebird Bio shares, which had been halted earlier ahead of the company announcing that the U.S. Food and Drug Administration has approved Lyfgenia, also known as lovo-cel, for the treatment of sickle cell disease in patients ages 12 and older who have a history of vaso-occlusive events, have resumed trading and subsequently halted several times for volatility. Shares were down $1.66, or 35%, to $3.15 at the last halt after the company announced a $3.1M wholesale acquisition cost of Lyfgenia and noted that the safety information for Lyfgenia included a boxed warning for hematologic malignancy.

13:22 EST Jazz Pharmaceuticals presents updated data from Phase 2a trial of zanidatamab - Jazz Pharmaceuticals announced that it presented updated data from the Phase 2a trial of investigational zanidatamab, a HER2-targeted bispecific antibody, in combination with palbociclib, a CDK4/6 inhibitor, and fulvestrant, a selective estrogen receptor antagonist, in patients with HER2-positive/HR-positive metastatic breast cancer, or mBC, as part of a late-breaking oral presentation at the 2023 San Antonio Breast Cancer Symposium, or SABCS. Data from 51 patients with heavily pretreated HER2+/HR+ mBC who were treated with zanidatamab plus palbociclib and fulvestrant demonstrated a progression-free survival at six months of 67%. Secondary endpoint findings included a median progression-free survival, or mPFS, of 12 months and a confirmed objective response rate, or cORR, of 35% with a median duration of response, or DOR, of 15 months. The combination regimen was well tolerated with a manageable safety profile. "The late-breaking data presented at SABCS for zanidatamab in combination with palbociclib and fulvestrant in HER2+/HR+ metastatic breast cancer as a chemotherapy-free treatment option in heavily pretreated patients provide yet another example of the promise this HER2-targeted bispecific antibody holds in the treatment of HER2-expressing cancers where significant unmet needs exist. We are encouraged by the meaningful clinical benefit seen in this trial, and we look forward to continuing to advance our broader clinical development program for zanidatamab in breast cancer and other HER2-expressing solid tumors, with the goal of addressing some of the greatest unmet needs in cancer with HER2 expression," said Rob Iannone, M.D., M.S.C.E., executive vice president, global head of research and development of Jazz Pharmaceuticals.

13:13 EST Bluebird Bio in advanced discussions with large commercial payers - Bluebird Bio said it is in advanced discussions with the nation's largest commercial payers and more than 15 Medicaid agencies representing 80% of individuals with sickle cell disease in the U.S. The company added it has designed outcomes-based contract options unique to Lyfgenia that offer payers "meaningful risk sharing tied to vaso-occlusive events -related hospitalizations-a claims-based metric that is directly correlated with clinical benefit and aligned with study endpoints in the Lyfgenia clinical development program-with patients followed for three years." A second contracting option is available specifically for state Medicaid agencies, based on direct input from these payers that predictability and operational ease are essential for states that are grappling with resource constraints.

13:11 EST Bluebird Bio announces $3.1M wholesale acquisition cost of Lyfgenia - Bluebird Bio said data from clinical studies support Lyfgenia as a "potentially curative gene therapy for sickle cell disease through durable production of anti-sickling adult hemoglobin and resolution of vaso-occlusive events." Bluebird has set the wholesale acquisition cost of Lyfgenia in the U.S. at $3.1M "in recognition of the value the therapy may deliver through robust and sustained clinical benefits and the estimated lifetime impact that reducing or eliminating VOEs may have on patients' healthcare utilization, future earnings, and life opportunities."

13:04 EST Bluebird Bio announces $3.1B wholesale acquisition cost of Lyfgenia - Bluebird Bio said data from clinical studies support Lyfgenia as a "potentially curative gene therapy for sickle cell disease through durable production of anti-sickling adult hemoglobin and resolution of vaso-occlusive events." Bluebird has set the wholesale acquisition cost of Lyfgenia in the U.S. at $3.1M "in recognition of the value the therapy may deliver through robust and sustained clinical benefits and the estimated lifetime impact that reducing or eliminating VOEs may have on patients' healthcare utilization, future earnings, and life opportunities."

13:02 EST Baker Hughes reports U.S. rig count up 1 to 626 rigs - Baker Hughes reports that the U.S. rig count is up 1 from last week to 626 with oil rigs down 2 to 503, gas rigs up 3 to 119 and miscellaneous rigs unchanged at 4. The U.S. Rig Count is down 154 rigs from last year's count of 780 with oil rigs down 122, gas rigs down 34 and miscellaneous up 2. The U.S. Offshore Rig Count is unchanged at 21, up 3 year-over-year. The Canada Rig Count is up 2 from last week to 194, with oil rigs down 2 to 120, and gas rigs up 4 to 74. The Canada Rig Count is down 8 from last year's count of 202, with oil rigs down 11, and gas rigs up 3.

12:58 EST Vertex and Crispr announce FDA approval of Casgevy for sickle cell disease - Vertex Pharmaceuticals (VRTX) and CRISPR Therapeutics (CRSP) announced that the U.S. Food and Drug Administration has approved Casgevy, a CRISPR/Cas9 genome-edited cell therapy, for the treatment of sickle cell disease, or SCD, in patients 12 years and older with recurrent vaso-occlusive crises, or VOCs. "This approval means that for the first time, approximately 16,000 patients with SCD may be eligible for a durable one-time therapy that offers the potential of a functional cure for their disease by eliminating severe VOCs and hospitalizations caused by severe VOCs," the companies stated. The administration of Casgevy requires specialized experience in stem cell transplantation; therefore, Vertex is engaging with experienced hospitals to establish a network of independently operated, authorized treatment centers, or ATCs, throughout the U.S. to offer Casgevy to patients. Additional ATCs will be activated in the coming weeks, the company noted. The use of Casgevy for the treatment of transfusion-dependent beta thalassemia, or TDT, in the U.S. remains investigational. Vertex has submitted a BLA to the U.S. FDA for the potential use of Casgevy for patients 12 years and older with TDT and has been assigned a Prescription Drug User Fee Act, or PDUFA, target action date of March 30, 2024. The press release contains no mention of a boxed warning for Casgevy; Bluebird Bio (BLUE), which also today received FDA approval for a gene therapy for SCD, says the safety information for Lyfgenia included a boxed warning for hematologic malignancy.

12:42 EST Bluebird Bio says Lyfgenia label includes boxed warning - Bluebird Bio says the safety information for Lyfgenia included a boxed warning for hematologic malignancy. The most common adverse reactions greater than or equal to Grade 3 were stomatitis, thrombocytopenia, neutropenia, febrile neutropenia, anemia, and leukopenia. As previously reported, three patients died during Lyfgenia clinical trials; one from sudden cardiac death due to underlying disease and two from acute myeloid leukemia who were treated with an earlier version of Lyfgenia using a different manufacturing process and transplant procedure, the company said in a statement. Hematologic malignancy has occurred in patients treated with LLyfgenia, it added. The label says to monitor patients "closely for evidence of malignancy through complete blood counts at least every 6 months and through integration site analysis at Months 6, 12, and as warranted." Shares of Bluebird Bio are up 7% to $5.17 following the approval.

12:37 EST Bluebird Bio announces FDA approval of LYFGENIA - Bluebird Bio announced the U.S. Food and Drug Administration has approved LYFGENIA, also known as lovo-cel, for the treatment of sickle cell disease in patients ages 12 and older who have a history of vaso-occlusive events. LYFGENIA is a one-time gene therapy that has the potential to resolve vaso-occlusive events and is custom-designed to treat the underlying cause of sickle cell disease. "Bringing LYFGENIA to people living with sickle cell disease is a milestone that bluebird has been working toward for almost a decade-and one that members of the sickle cell disease community have been waiting on for much longer," said Andrew Obenshain, chief executive officer, bluebird bio. "LYFGENIA has the potential to have a transformational impact for patients who currently live under the shadow of unpredictable and debilitating vaso-occlusive events. This approval also marks bluebird's third ex vivo gene therapy approved by the FDA for a rare genetic disease and second FDA approval for an inherited hemoglobin disorder, cementing our position as a gene therapy leader."

12:21 EST EF Hutton Acquisition Corp trading halted, volatility trading pause

12:05 EST Sunnova falls after House Committee questions $3B DOE loan - House Energy Committee Chair Cathy McMorris Rodgers sent a letter, dated December 7, to Jigar Shah, Director of the Department of Energy's Loan Programs Office, which stated, in part, "We write to you regarding disturbing reports about Sunnova Energy Corporation, a residential solar company, to which the Department of Energy's Loan Programs Office recently awarded a $3 billion partial loan guarantee...We are alarmed about recent, credible reports that Sunnova has racked up numerous consumer complaints, including those alleging troubling sales practices, such as Sunnova pressing elderly homeowners in poor health to sign long-term contracts costing tens of thousands of dollars." Shares of Sunnova Energy are down 12% to $10.95 in midday trading. Reference Link

12:00 EST RH falls -14.7% - RH is down -14.7%, or -$41.27 to $240.13.

12:00 EST Axos Financial rises 10.7% - Axos Financial is up 10.7%, or $4.79 to $49.42.

12:00 EST MBIA rises 73.7% - MBIA is up 73.7%, or $5.44 to $12.82.

11:48 EST Roche reports 'positive' results from Phase III INAVO120 study - Genentech, a member of the Roche Group, presented "positive" results from the Phase III INAVO120 study evaluating inavolisib in combination with palbociclib and fulvestrant as a first-line treatment for people with PIK3CA-mutated, hormone receptor-positive, HER2-negative, endocrine-resistant, locally advanced or metastatic breast cancer. The inavolisib combination reduced the risk of disease worsening or death by 57% compared to palbociclib and fulvestrant alone. The benefit was consistent across subgroups. Overall survival, or OS, data were immature at this time, but "a clear positive trend has been observed," the company said. Follow-up for OS will continue to the next analysis. Data available for other secondary endpoints at this analysis showed clinically meaningful increases in objective response rate, duration of response and clinical benefit rate. "The importance of the PI3K pathway has long been recognized across many cancers, and inavolisib could transform the way breast cancer is treated in patients whose tumors harbor PIK3CA mutations," said Levi Garraway, M.D., Ph.D., Genentech's chief medical officer and head of Global Product Development. "The clinically meaningful benefit observed with the inavolisib combination speaks to its potential to become a new standard of care in this patient population and builds on our commitment to improve outcomes across all types of breast cancer. We look forward to bringing inavolisib to patients as soon as possible." Data from the INAVO120 study will be submitted to health authorities with the view of bringing this potential treatment option to patients as soon as possible, the company stated.

11:26 EST Eli Lilly reports 15% dividend increase, declares Q1 dividend of $1.30 per share - The board of directors of Eli Lilly and Company has announced a 15% increase in its quarterly dividend and declared a dividend for the first quarter of 2024 of $1.30 per share on outstanding common stock. The dividend is payable on March 8, 2024 to shareholders of record at the close of business on Feb. 15, 2024.

11:17 EST FDA approves Bluebird Bio, Vertex sickle cell disease gene therapies - The U.S. Food and Drug Administration approved two "milestone treatments," Casgevy and Lyfgenia, representing the first cell-based gene therapies for the treatment of sickle cell disease, or SCD, in patients 12 years and older, the agency announced. Additionally, one of these therapies, Casgevy, is "the first FDA-approved treatment to utilize a type of novel genome editing technology, signaling an innovative advancement in the field of gene therapy," the FDA stated. Both the Casgevy and Lyfgenia applications received Priority Review, Orphan Drug, Fast Track and Regenerative Medicine Advanced Therapy designations. The FDA granted approval of Casgevy to Vertex Pharmaceuticals (VRTX) and approval of Lyfgenia to Bluebird Bio (BLUE). Vertex Pharmaceuticals and Crispr Therapeutics (CRSP) are partners on Casgevy. Reference Link

11:08 EST Esports Entertainment temporarily suspends Series A Preferred Stock dividend - Esports Entertainment Group announced that its board of directors has suspended payment of the monthly cash dividend on the company's outstanding 10% Series A Cumulative Redeemable Convertible Preferred Stock, commencing with the monthly dividend that would otherwise be payable in December 2023. The company has paid the monthly dividend for November 2023, as previously announced on November 3. In accordance with the terms of the Series A Preferred Stock, unpaid dividends will continue to be accrued. Alex Igelman, CEO of Esports Entertainment, stated, "We are temporarily suspending the dividend on our 10% Series A Cumulative Redeemable Convertible Preferred Stock, as we believe we can effectively reinvest the capital in the business in order to drive the greatest return on capital for shareholders. This is an exciting time for Esports Entertainment, as we execute on our turnaround strategy and position the company for long-term success. Management and the board of directors will continue to monitor the financial performance of the company to determine the appropriate time to reinstate the dividend."

10:00 EST Miniso falls -8.0% - Miniso is down -8.0%, or -$1.67 to $19.33.

10:00 EST Adecoagro falls -13.8% - Adecoagro is down -13.8%, or -$1.66 to $10.34.

10:00 EST Torrid rises 32.0% - Torrid is up 32.0%, or $1.33 to $5.48.

09:56 EST Corbus Pharmaceuticals trading resumes

09:51 EST Dynex Capital appoints CEO Byron Boston as chairman - Dynex Capital announced that its Board of Directors has appointed Chief Executive Officer Byron L. Boston as Chairman of the Board and current Board member Dr. Julia L. Coronado as Lead Independent Director, effective immediately. In line with Dynex's succession plan, Boston succeeds Michael R. Hughes, who has served on the Board of Directors since November 2010 and as Chairman since March 2017. President and Chief Investment Officer Smriti L. Popenoe and CFO Robert S. Colligan will continue to work closely with Boston and Dr. Coronado in their new roles on the Board. Boston has served as CEO of the Company since January 2014.

09:47 EST RH falls -10.6% - RH is down -10.6%, or -$29.90 to $251.50.

09:47 EST Cano Health falls -10.9% - Cano Health is down -10.9%, or -$1.18 to $9.62.

09:47 EST Torrid rises 27.7% - Torrid is up 27.7%, or $1.15 to $5.30.

09:35 EST Xos Inc trading resumes

09:18 EST Novartis announces results from updated analysis of Phase 3 NATALEE trial - Novartis announced results from an updated invasive disease-free survival, or iDFS, analysis of the pivotal Phase 3 NATALEE trial, with a median follow-up of 33.3 months and following Kisqali treatment completion by 78.3% of patients. "Results reinforce the benefit seen at the earlier interim analysis," with a 25.1% reduction in risk of disease recurrence in patients with stage II and III hormone receptor-positive/human epidermal growth factor receptor 2-negative early breast cancer treated with adjuvant Kisqali plus a non-steroidal aromatase inhibitor as standard endocrine therapy compared to ET alone, the company stated. Late-breaking data from this analysis will be presented today at the 2023 San Antonio Breast Cancer Symposium, or SABCS, Annual Meeting. "The final iDFS analysis of NATALEE represents a significant milestone, building upon the robust evidence supporting Kisqali as a potential new adjuvant treatment for a broad, clinically common and identifiable population of patients with stage II and III HR+/HER2- early breast cancer," said Jeff Legos, Executive Vice President, Global Head of Oncology Development at Novartis. "We are seeking approval for Kisqali in early breast cancer from health authorities worldwide, aspiring to more than double the number of at-risk patients who could potentially benefit from CDK4/6 inhibitor treatment in this setting." Novartis submitted NATALEE data to the European Medicines Agency and plans to finalize submission to the U.S. Food and Drug Administration by end of year, the company noted.

08:51 EST Veradigm CEO Richard Poulton, CFO Leah Jones resign at request of board - Veradigm announced that the company's board of directors appointed current chairman, Greg Garrison, as executive chairman, and current director, Shih-Yin Ho, as interim CEO. In addition, Lee Westerfield, who brings more than 25 years of experience as a senior financial executive, most recently serving as CFO at Clearsense, will be serving as interim CFO. CEO Richard Poulton has resigned at the request of the board from his role as CEO and has stepped down from the board. Also at the request of the board, Leah Jones has resigned as CFO and has agreed to serve in a consulting role to provide business-development related services to the company. Following Garrison's appointment as executive chairman, Carol Zierhoffer was appointed as lead independent director. These changes result from the audit committee's previously disclosed, ongoing independent investigation, which is being conducted by legal counsel and relates to the company's financial reporting and internal controls over financial reporting and disclosure controls. The potential impact, if any, to the financial statements for previously reported periods as a result of the independent investigation is under review by the new leadership team. The board of directors has initiated a search process for a permanent CEO and CFO. The company intends to retain a leading executive search firm to support the process, which will include both internal and external candidates. The new leadership team is reviewing the fiscal year 2023 guidance previously issued on September 18.

08:46 EST Chevron, Hess received Second Request for info from FTC on deal - In a regulatory filing, Chevron (CVX) noted that as previously disclosed, on October 22, Chevron entered into an agreement and plan of merger with Hess Corporation (HES). The merger is conditioned on, among other things, the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended. Pursuant to the HSR Act, Hess and Chevron filed notification and report forms with the Department of Justice and the Federal Trade Commission. On December 7, Chevron and Hess each received a request for additional information and documentary materials, or the "Second Request," from the FTC in connection with the FTC's review of the merger. "Issuance of the Second Request extends the waiting period imposed by the HSR Act until 30 days after Chevron and Hess have substantially complied with the Second Request, unless that period is extended voluntarily by Chevron and Hess or terminated sooner by the FTC. Both Chevron and Hess expect to promptly respond to the Second Request and to continue to work cooperatively with the FTC in its review of the Merger," the filing stated.

08:33 EST Intensity Therapeutics reports results from Phase 2 INVINCIBLE trial of INT230-6 - Intensity Therapeutics announced that safety, tolerability, efficacy and immune activation data from the company's Phase 2 INVINCIBLE trial of INT230-6 in patients with early-stage breast cancer without chemotherapy was presented at a Podium Poster Spotlight discussion session today during the 2023 San Antonio Breast Cancer Symposium. INT230-6 demonstrated a systemic increase in the median diversity of T-cell repertoire in patients' blood compared to baseline that was also much larger than a control saline injection. A single injection of INT230-6 can induce up to greater than95% necrosis of a tumor. INT230-6 demonstrated an increase in CD4 T-cells and NK cells within tumors. Gene expression profiling revealed treatment effect of up-regulation of immune pathways expressed by T-cell activation, lymphocyte activation and inflammatory responses. INT230-6 demonstrated a favorable safety profile and was well tolerated. Patient interest in the new treatment was high.

08:31 EST Janover to ring NASDAQ closing bell - Janover announced it will celebrate the Company's progress and its recent listing on the Nasdaq Stock Market by ringing the Nasdaq Closing Bell in Times Square, New York City. Janover commenced trading on the Nasdaq under the ticker symbol "JNVR" on July 25, 2023. Blake Janover, CEO of Janover, stated, "We're honored and proud to celebrate the tremendous progress of our business, as well as of our recent listing on Nasdaq. Our mission is to make commercial lending frictionless for both borrowers and lenders. We have developed an AI-enabled platform that is highly scalable, positioning ourselves as the go-to digital marketplace for commercial loans. Our commitment to innovation, particularly our AI-powered tools in the commercial real estate space, sets us up strategically for an exciting future. We are more encouraged than ever by the outlook for the business and look forward to driving significant shareholder value in the years ahead."

08:17 EST Sight Sciences announces acceptance for publication of GEMINI 2 trial - Sight Sciences announced the acceptance for publication in Clinical Ophthalmology of the prospective, multi-center, three-year GEMINI 2 trial with long-term clinical outcomes for patients treated with the OMNI Surgical System technology. Publication is currently expected by December 31, 2023. GEMINI 2, a prospective, multi-center, medication washout trial designed to obtain 36-month follow-up for patients treated in the original 12-month GEMINI trial, has been completed. Favorable results demonstrate sustained and clinically significant intraocular pressur reduction of greater than 20% and clinically significant IOP lowering medication reduction at 36 months. The prospective 3-year clinical outcomes in the GEMINI 2 trial confirm and extend the previously published 12-month data from the original GEMINI trial. GEMINI 2 included 66 patients across eleven participating sites, and all patients underwent medication wash-out at the two-year and three-year endpoints so that the IOP-lowering effect of the OMNI procedure could be better isolated and assessed. GEMINI 2 Clinical Outcomes: Through three years, data from the GEMINI trial and GEMINI 2 study extension reported a 20% or more reduction of IOP in patients on the same or reduced medication at 24 months and at 36 months. Sustained medication reductions at 24 and 36 months were also reported, with 77% of study patients medication-free at two years and 74% of study patients medication-free at three years post-procedure. The published 36-month long-term follow-up data from the GEMINI 2 multi-center trial, along with the published 2-year long-term follow-up data from the ROMEO 2 multi-center study, demonstrate that the beneficial reductions in IOP and medication use observed at the 12-month timepoint with the OMNI procedure were sustained for two and three years post-operatively. The low rate of secondary surgical interventions observed over the study period suggests that patients treated with the OMNI procedure are unlikely to require more aggressive and invasive glaucoma surgery for a meaningful period of time.

08:03 EST IntercontinentalExchange announces approval for CargoDocs - IntercontinentalExchange announced that its ICE CargoDocs Local Law electronic bill of lading solution has received approval by global shipping insurance body, the International Group of Protection & Indemnity Clubs, helping accelerate ICE's work to replace paper-based trade delivery documentation with electronic documents. IG P&I represents the 12 Clubs providing marine liability cover for 90% of the world's ocean-shipped tonnage. The approval coincides with the U.K. and Singapore, two critical shipping jurisdictions, recently changing their laws to recognize electronic bills of lading as the legal equivalent of paper, giving commodity trade participants certainty that electronic bills of lading governed by U.K. and Singapore law are now recognized in those jurisdictions.

08:01 EST VerifyMe announces $500,000 share repurchase plan - The Board has approved a plan to repurchase shares of the company's common stock for up to $500,000. The repurchase program authorization will expire on December 31, 2024.

07:51 EST CMA seekign views on Microsoft's partnership with OpenAI - The U.K.'s Competition and Markets Authority is providing an early opportunity for the parties and interested third parties to comment on whether the partnership between Microsoft and OpenAI, including recent developments, has resulted in a relevant merger situation and, if so, the impact that the merger could have on competition in the U.K. The Invitation to Comment is the first part of the CMA's information gathering process and comes in advance of any launch of a formal phase 1 investigation. "There have recently been a number of developments in the governance of OpenAI, some of which involved Microsoft. In light of these developments, the CMA is now issuing an ITC to determine whether the Microsoft / OpenAI partnership, including recent developments, has resulted in a relevant merger situation and, if so, the potential impact on competition. The CMA will review whether the partnership has resulted in an acquisition of control - that is, where it results in one party having material influence, de facto control or more than 50% of the voting rights over another entity - or change in the nature of control by one entity over another." Reference Link

07:33 EST ProQR completes divestment of late stage ophthalmic assets to Laboratoires Thea - ProQR Therapeutics announced it has completed a transaction divesting late stage ophthalmic assets, sepofarsen and ultevursen, to Laboratoires Thea. "Following previous announcements related to this transaction, we are pleased to share that we have now completed the divestment of the sepofarsen and ultevursen programs to Thea, who will continue the development of these potentially transformational therapies for patients with LCA10 and Usher Syndrome," said Daniel A. de Boer, Founder and Chief Executive Officer of ProQR. "We look forward to continuing to advance our Axiomer RNA editing platform, with an initial focus on targets for cholestatic and cardiovascular diseases, as we seek to develop a new class of therapies for patients with high unmet need." Under the terms of the agreement, ProQR has received an initial payment of EUR 8M and may be eligible for up to EUR 165M in further development, regulatory, and commercial earn-out payments upon related achieved milestones, as well as double-digit royalties based on commercial sales in the US and EU.

07:06 EST uniQure announces inducement grants under Nasdaq listing rule - uniQure announced the grant of inducement equity awards to newly hired employees. The company granted equity awards to 28 employees as a material inducement to commencing their employment. In the aggregate, those employees received 142,300 restricted share units and options to purchase 52,500 ordinary shares of the company. Each option has an exercise price of $7.30 per share, the closing price per ordinary share as reported by Nasdaq on the grant date. Each option has a ten-year term and will vest over four years, with 25% of the original number of shares vesting on the first anniversary of the grant date and an additional 6.25% of the shares vesting in approximately equal quarterly installments over the twelve successive quarters thereafter. The restricted share units vest in three approximately equal annual installments beginning on December 7, 2024.

07:03 EST Virco board authorizes $5M share repurchase program - The Board has authorized an open-market share repurchase program of up to $5,000,000.

07:03 EST American Lithium announces results of drill holes at Tonopah Lithium Project - American Lithium announces results from 14 step out drill holes expanding the measured resource footprint at the Tonopah Lithium Project, located near the town of Tonopah, in Nevada. A total of 26 diamond core holes and 16 Reverse Circulation holes drilled in 2022 and 2023 will be added to the updated mineral resource block model and incorporated into an updated Mineral Resource Estimate on TLC. Simon Clarke, CEO of American Lithium, states, "We continue to make excellent progress at TLC. Drill results from the remainder of our 2022 program and our expansion drilling in 2023 should add significantly to the very large existing Measured & Indicated Resource. In addition, the thick, shallow higher-grade sections added should further enhance robust project economics and will be reflected in an updated TLC mine plan in the PFS. Our confidence in the Project continues to grow and we have now launched work with SRK and Nexus which will feed into and help us fast-track the mine permitting process following completion of the PFS is in 2024."

07:01 EST IM Cannabis announces 3-month delay of medical cannabis reform - IM Cannabis is announcing a 3-month delay of the anticipated medical cannabis reform announced by the Israeli ministry of health on August 7. Due to the Israel-Hamas war, the anticipated implementation of the medical cannabis regulatory reform, originally scheduled for December 29, has been postponed by three months. The new regulations were designed to alleviate many of the stringent restrictions in the sector, thereby enhancing access to medical cannabis for patients. In addition to the regulatory reform, the Medical Cannabis Unit of the Ministry of Health released new report that shows, among other statistics, data on the number of patients obtaining medical cannabis licenses. There was a notable surge in the number of new medical cannabis patients in November 2023, with 3,254 new patients receiving licenses, the largest increase in new patients per month since 2021.

06:48 EST Invitation Homes raises quarterly dividend 7.7% to 28c from 26c per share - The dividend will be paid on or before January 19, 2024, to stockholders of record of the company's common stock as of the close of business on December 27, 2023.

06:47 EST Merck, Eisai provide update on Phase 3 LEAP-001 trial - Merck (MRK) and Eisai (ESAIY) announced that the Phase 3 LEAP-001 trial evaluating KEYTRUDA, Merck's anti-PD-1 therapy, plus LENVIMA, the orally available multiple receptor tyrosine kinase inhibitor discovered by Eisai, did not meet its dual primary endpoints of overall survival and progression-free survival for the first-line treatment of patients with advanced or recurrent endometrial carcinoma whose disease is mismatch repair proficient (pMMR)/not microsatellite instability-high or mismatch repair deficient (dMMR)/MSI-H. At the final analysis, KEYTRUDA plus LENVIMA did not improve OS or PFS sufficiently to meet the study's prespecified statistical criteria in the first-line treatment of certain patients with advanced or recurrent endometrial carcinoma versus a standard of care, platinum-based chemotherapy doublet (carboplatin plus paclitaxel). The safety profile of KEYTRUDA plus LENVIMA was consistent with that observed in previously reported studies evaluating the combination. A full evaluation of the data from this study is ongoing. The companies will work with investigators to share the results with the scientific community.

06:33 EST LyondellBasell to sell EO&D business, facility to Ineos Oxide for $700M - LyondellBasell announced it has entered into an agreement to sell its Ethylene Oxide & Derivatives, or EO&D, business along with the production facility located in Bayport, Texas to Ineos Oxide. The Ethylene Oxide & Derivatives business in Bayport produces ethylene oxide and various derivatives. The fully integrated platform with access to cost-advantaged feedstocks and logistics networks has excellent performance and reputation in the market. The purchase price for the transaction is $700M. The transaction is expected to close in the second quarter of 2024 following completion of the planned maintenance at the facility and is subject to regulatory and other customary closing conditions. J.P. Morgan acted as financial advisor and King & Spalding acted as legal counsel to LyondellBasell.

06:04 EST Intchains Group acquires Goldshell Brand-related assets - Intchains Group announced it has entered into an asset acquisition agreement, or the Agreement, with a Singapore-based company, GOLDSHELL PTE. LTD., or the Seller, to purchase certain assets used in the Seller's operation of its Goldshell WEB3 infrastructure brand, or the Goldshell brand. Pursuant to the Agreement, Intchains intends to purchase from the Seller all the intellectual property, information and technical materials used in operating the Goldshell brand, which primarily include (i) all trademarks and related materials (including application documents) used in operating the Goldshell brand; (ii) all websites, applications, and lawful rights and control over the above-referenced websites and applications; and (iii) ownership and management rights of all accounts used in operating the Goldshell brand. Intchains will pay the Seller $550,000 in cash as consideration for such acquisition. The acquisition is expected to be completed by the end of the first quarter of 2024, subject to the satisfaction of customary closing conditions.

05:16 EST Joby Aviation partners with ANA Holdings, NRE for vertiports in Japan - Joby Aviation announced it has partnered with ANA Holdings and Nomura Real Estate Development, or NRE, one of Japan's largest real estate developers, on the development of take-off and landing infrastructure, known as vertiports, to support the commercialization of its electric air taxi service across Japan. The three companies plan to jointly explore the design, location, operation, and financing of vertiport locations that will serve as the backbone of future commercial air taxi services in Japan. The partners will primarily focus on locations in the metropolitan areas such as Tokyo, expanding over time to include numerous urban areas across greater Japan.