Stockwinners Market Radar for January 04, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

22:55 EST American Tower completes strategic review, agrees to sell India operations - American Tower (AMT) has signed a definitive agreement with Data Infrastructure Trust, an Infrastructure Investment Trust sponsored by an affiliate of Brookfield Asset Management (BAM), pursuant to which DIT will acquire 100% of the equity interests in American Tower's operations in India. DIT currently houses Brookfield's telecom tower businesses in India through Summit Digitel and Crest Digitel. Total cash proceeds to American Tower at closing, subject to certain pre-closing terms, would potentially represent up to approximately INR 210 billion, or $2.5 billion at today's exchange rates. The transaction, which reflects the completion of the previously announced strategic review of American Tower's operations in India, is subject to customary closing conditions, including government and regulatory approvals, and is expected to close in the second half of 2024. Total cash proceeds include an enterprise value on the ATC India operations of approximately $2.0 billion, plus a ticking fee that accrues from October 1, 2023, to the date of closing.

19:56 EST Adobe exec sells $3.49M in common stock - In a regulatory filing, Adobe disclosed that its Digital Media President David Wadhwani sold 6.1K shares of common stock on January 3rd in a total transaction size of $3.49M.

19:50 EST SAB Biotherapeutics Inc trading halted, news pending

18:46 EST Constellation Brands's Wine & Spirits head Robert Hanson to step down - Constellation Brands "announced that the Company and Robert Hanson, who has led the transformation of the company's Wine & Spirits business since 2019, have mutually agreed that Mr. Hanson will step down from his role as Executive Vice President and President of the company's Wine & Spirits Division, at the end of Constellation's fiscal year on February 29, 2024. The company has initiated a search to identify a successor. Bill Newlands, President and Chief Executive Officer, will assume responsibilities as interim leader for the company's Wine & Spirits Division, in addition to his existing responsibilities, until a successor is named. Newlands and Hanson will work together over the coming weeks to ensure a smooth transition of leadership."

18:30 EST Definitive Healthcare drops after cutting 154 jobs in restructuring - Definitive Healthcare earlier today said it committed to a restructuring plan intended to reduce operating costs, improve operating margins, and continue advancing its "ongoing commitment to profitable growth." The plan provides for a reduction of the company's current workforce by 154 people. Definitive estimates that in the first half of 2024 it will incur pre-tax cash restructuring and related charges to its GAAP financial results of approximately $6.5M to $7.2M, consisting primarily of severance payments, employee benefits, and related cash expenses, as well as an approximate $1.5M non-cash charge related to the vesting of share-based awards for employees who are terminated. The company expects the plan will be substantially complete by the end of Q2. Shares of Definitive Healthcare dropped 9% to $8.83 at the close of Thursday's trading.

17:26 EST Royalty Pharma director sells $13.2M in common stock as part of option exercise - In a regulatory filing, Royalty Pharma disclosed that its director Rory Riggs sold 470K shares of common stock on January 2nd as part of option exercise in a total transaction size of $13.2M.

17:19 EST Lockheed Martin awarded $1.15B Navy contract modification - Lockheed Martin was awarded a $1.15B cost-plus-incentive-fee, fixed-price-incentive-fee modification against a previously awarded indefinite-delivery/indefinite-quantity contract. This modification exercises options and increases the ceiling to provide site activation and hardware requirements, to include site activation events and training devices, as well as contract management, planning and readiness reviews and associated non-recurring introduction to service activities. Additionally, this effort provides production readiness requirements and production engineering for training device production lines in support of F-35A, F-35B and F-35C aircraft initial sustainment activities for the Air Force, Marine Corps, Navy, non-Department of Defense participants, and Foreign Military Sales customers. Work is expected to be completed in December 2028. No funds will be obligated at the time of award; funds will be obligated on individual orders as they are issued. Naval Air Systems Command.

17:17 EST Dermata Therapeutics issues new patent in Japan for DMT410 program - Dermata Therapeutics "announced the issuance of a new patent in Japan for its DMT410 program for the treatment of hyperhidrosis. The patent, entitled 'Compositions for the treatment of skin conditions,' further strengthens Dermata's intellectual property for DMT410 for the treatment of hyperhidrosis and could lead to further protections for additional indications." CEO Gerry Proehl says: "We believe this patent issuance further validates DMT410's novel concept to easily deliver botulinum toxin topically instead of requiring patients to receive multiple injections. We are excited about the opportunities the DMT410 program can bring to patients, not only for the treatment of axillary hyperhidrosis as we have seen in our proof-of-concept study, but potentially for palmer and plantar hyperhidrosis which has no currently approved products. We also believe there are opportunities to use DMT410 to treat many aesthetic skin conditions like reducing pore number and size, decreasing sebum production, and reducing fine lines and wrinkles, all while improving the look and quality of facial skin," continued Mr. Proehl. "We also believe this new patent could aid us in our partnership discussions with a company that has a botulinum toxin to further develop the DMT410 program for multiple indications."

17:12 EST Lumos Pharma promotes Pisit Pitukcheewanont, MD to CMO, effective January 1 - Lumos Pharma has promoted Pisit "Duke" Pitukcheewanont, MD, known also as Dr. Duke, to the position of Chief Medical Officer CMO , effective January 1. In this role, Dr. Pitukcheewanont will provide his leadership in Lumos Pharma's efforts to hone its clinical and regulatory strategy, and he will continue to oversee medical affairs as the Company prepares to initiate its pivotal Phase 3 trial evaluating the efficacy of oral LUM-201 in treating moderate pediatric growth hormone deficiency PGHD . "Dr. Duke has extensive experience in clinical development and medical affairs related to the advancement of novel therapeutics for growth disorders. In his recent role, he was instrumental in both the expeditious enrollment of Lumos Pharma's Phase 2 trials evaluating LUM-201 for moderate PGHD and the timely analysis and release of topline data from these trials," said Rick Hawkins, Chairman and CEO. "Dr. Duke's impressive academic tenure at the Keck School of Medicine, University of Southern California, Children Hospital Los Angeles and his over 12-year presidency at the Human Growth Foundation underscore his ability to engage with an extensive network of endocrinologists and disseminate advanced approaches for treating growth disorders within this community. In his role as Lumos Pharma's CMO, Dr. Duke is expected to significantly bolster the advancement of our clinical programs."

16:46 EST Eledon Pharmaceuticals announces anticipated 2024 milestones - CEO David-Alexandre C. Gros says: "Eledon made significant progress in 2023 on multiple fronts, highlighted by the presentation of the first clinical evidence of tegoprubart's potential to prevent organ rejection while producing robust improvements in eGFR and maintaining a favorable safety profile. We were also honored to play an important role in the second-ever transplant of a genetically modified heart from a pig to a human with the use of tegoprubart as part of the patient's cornerstone immunosuppressive regimen. In the coming year, we look forward to building upon the promising results from our tegoprubart kidney transplant Phase 1b trial, generating additional long-term data from the Phase 1b extension study, and completing enrollment in our Phase 2 BESTOW trial." In 2024, the company's anticipated 2024 milestones are: "First half of 2024: Report updated interim clinical data from the ongoing Phase 1b trial of tegoprubart in kidney transplantation. First half of 2024: Dose the 12th participant in the Phase 2 BESTOW trial. Upon the dosing of the 12th participant, the Company will have completed both clinical development milestones related to the second financing tranche from the private placement announced on May 1, 2023. End of 2024: Complete enrollment in the Phase 2 BESTOW trial of tegoprubart in kidney transplantation. 2024: Dose the first islet cell transplant participant for the treatment of type 1 diabetes at the University of Chicago Transplantation Institute."

16:35 EST Kura Sushi falls 3% to $72.00 after Q1 earnings miss

16:33 EST Volaris reports December load factor 85.4% - Volaris reported its December 2023 preliminary traffic results. In December 2023, Volaris' ASM capacity decreased by 3.1% year-over-year, while RPMs decreased by 2.3%; the result was a load factor increase of 0.7 pp YoY to 85.4%. Volaris transported 2.8M passengers during the month, a 4.6% decrease compared to December 2022. Mexican domestic RPMs decreased by 11.1%, while international RPMs increased by 18.4%.

16:31 EST Cboe Global Markets reports December trading volume - Cboe Global Markets reported December and full year 2023 trading volume statistics and projected rate per contract/net revenue capture for the fourth quarter of 2023 across its global business lines. Reference Link

16:24 EST Allogene Therapeutics, Foresight Diagnostics enter strategic partnership - Allogene Therapeuticsand Foresight Diagnostics announced a strategic partnership to develop a minimal residual disease, or MRD, in-vitro diagnostic, or IVD, to determine eligibility in ALPHA3, the first pivotal trial for first line, or 1L, consolidation treatment of large B-cell lymphoma, or LBCL. The ALPHA3 trial uses Foresight's investigational PhasED-Seq ctDNA-MRD platform to identify patients with MRD after 1L treatment for LBCL. The study will evaluate whether such patients benefit from consolidation with cemacabtagene ansegedleucel, or cema-cel. If successful, cema-cel could become part of the 1L treatment plan for newly diagnosed LBCL patients who are at a high risk for recurrence. Start-up activities for the ALPHA3 trial have been initiated.

16:22 EST Great Lakes Dredge provides update on Empire Wind contracts - Great Lakes Dredge announced that Empire Offshore Wind has informed Great Lakes in consortium with Van Oord, of the termination of the rock installation contract for Empire Wind II which was set to commence in 2026. In 2022, the Consortium, was contracted by Empire Wind to perform rock installation for the Empire Wind I and II projects with installation windows in 2025 and 2026, respectively. The Article VII for Empire Wind I was approved by the New York State Public Service Commission in December of 2023. Empire Wind I is currently on track for rock installation in 2025. However, Empire Wind has informed the Consortium that they have terminated the Empire Wind II rock installation contract that was set to commence in 2026. Termination of the Empire Wind II project initiates a contractually obligated termination fee payable to the Consortium that is intended to cover lost earnings potential related to Empire Wind II.

16:18 EST Coinbase COO sells $1.39M in common stock - In a regulatory filing, Coinbase disclosed that its COO Emilie Choi sold 8K shares of common stock on January 2nd in a total transaction size of $1.39M.

16:12 EST Fusion Pharmaceuticals provides clinical and manufacturing updates - Fusion Pharmaceuticals announced progress with its FPI-2265 development program, an update on FPI-1434 Phase 1 Cohort 2 data and the production of the first clinical doses at the company's proprietary manufacturing facility. The company has aligned with the FDA on its submitted Phase 2/3 protocol for FPI-2265, a targeted alpha therapy targeting prostate specific membrane antigen for the treatment of patients with metastatic castration-resistant prostate cancer with progressive disease. The updated development plan includes a Phase 2 dose optimization lead-in, expected to complete enrollment by the end of 2024, and a Phase 3 registrational trial expected to begin in 2025. The Phase 2 trial is expected to initiate in Q2 with enrollment completed by year-end. The company will seek to hold an End of Phase 2 meeting with the FDA to determine the recommended Phase 3 dosing regimen based on analysis of the Phase 2 data. The company plans to initiate the Phase 3 trial in 2025. The company is also pursuing the opportunity to potentially move the therapy candidate into earlier lines of treatment with combinations of FPI-2265 and olaparib. Fusion expects to initiate a combination trial in the first half of this year. Fusion announced encouraging early findings from Cohort 2 in the ongoing FPI-1434 Phase 1 clinical trial. No dose limiting toxicities were observed to date in the 25 kBq/kg dose cohort. FPI-1434 was well tolerated, with no DLTs and transient Grade 1 or less thrombocytopenia at the 25 kBq/kg dose level. Fusion plans to share more details on the data and the FPI-1434 development program in mid-2024. Fusion has completed validation of its good manufacturing practice manufacturing facility and produced the first clinical dose of a TAT. Fusion's facility is expected to be capable of producing up to 100,000 doses per year. As of September 30, 2023, Fusion's cash, cash equivalents and investments were approximately $287M. Fusion expects its cash, cash equivalents and investments will now be sufficient to fund operating expenses and capital expenditure requirements into Q4 2025.

16:10 EST NetApp president Cernuda sells 22,000 common shares - In a regulatory filing, NetApp president Cesar Cernuda disclosed the sale of 22,000 common shares of the company on January 2 at a price of $86.6729 per share.

16:08 EST Vaxcyte gives PCV franchise update, advances adult VAX-31 Phase 1/2 study - Vaxcyte announced an update regarding the ongoing progress of the Company's pneumococcal conjugate vaccine or PCV franchise. These updates include the initiation of the Phase 2 portion of the ongoing VAX-31 adult Phase 1/2 study and encouraging input from ongoing discussions with the U.S. Food and Drug Administration FDA about the VAX-24 adult program to further inform the Company's chemistry, manufacturing and controls CMC licensure requirements. Vaxcyte's carrier-sparing PCV franchise candidates, including VAX-24, a 24-valent PCV proceeding to Phase 3, and VAX-31, the Company's next-generation 31-valent PCV, are being studied for the prevention of invasive pneumococcal disease IPD . "Vaxcyte continues to make significant progress across our PCV franchise, and we are pleased with the advancement of the adult VAX-31 Phase 1/2 study, which has begun dosing participants in the Phase 2 portion, and we now expect to announce topline data in the third quarter of this year," said Grant Pickering, Chief Executive Officer and Co-founder of Vaxcyte... "We also received encouraging feedback from the FDA regarding the licensure requirements for VAX-24 in adults. We are fortunate to be afforded these ongoing discussions, given the Breakthrough Therapy designation granted to VAX-24, and expect to seek additional CMC-focused input from regulators as we prepare for and conduct the adult Phase 3 program, which will comprise several studies. With VAX-24 and VAX-31, we are confident in our plans to build a best-in-class PCV franchise that delivers the broadest-spectrum of coverage against invasive pneumococcal disease."

16:07 EST Betterware de Mexico announces senior management changes - Betterware de Mexico announced the following management changes given its expanded geographical presence and in order to support its future growth. Andres Campos, who served as Betterware Commercial Director from 2013 to 2018 and has been the CEO for Betterware Mexico from 2018 to the present, will assume the position of Betterware Group CEO, which includes Betterware and Jafra brands, both in Mexico and abroad. Andres will report directly to Luis Campos, Chairman of the Board. During his eleven years in Betterware, Andres has been a key contributor to the company's different stages of outstanding growth, where his leadership strength and strategic vision added to the company's overall success. Santiago Campos, who has been with the company for six years, and served as Chief Marketing Officer from 2019-2022, and Chief Transformation Officer from 2023 to date, will assume the position of Managing Director of Betterware Mexico, reporting directly to Andres Campos. Santiago's successful track record, and deep knowledge of the business, make him uniquely positioned for this role. Before assuming the CMO role in 2019, he worked rotational periods with the Sales team, and lived in China for 6 months working with our Quality team.

16:05 EST Novocure names Nicolas Leupin CMO - Novocure announced the appointment of Nicolas Leupin, M.D., Ph.D., MBA to the role of Chief Medical Officer. Dr. Leupin brings a proven track record of leadership and accomplishment in the biotechnology and pharmaceutical industries, as well as extensive experience as a medical oncologist and educator. At Novocure, Dr. Leupin will oversee medical affairs, medical safety, and clinical development operations as the company advances its clinical pipeline and prepares to treat an expanded patient population. "It is a pleasure to welcome Dr. Leupin to Novocure as our new Chief Medical Officer," said Asaf Danziger, Novocure's Chief Executive Officer. "Nicolas brings a wealth of knowledge and experience from some of the most innovative oncology companies in the world, as well as a dedication to patients that is core to Novocure's mission. I am confident that his expertise will be instrumental as Novocure enters its next chapter, treating patients with aggressive tumors of the brain, torso and abdomen."

16:03 EST Galapagos enters GMP manufacturing agreement with Thermo Fisher - Galapagos (GLPG) announced that it has entered into a strategic collaboration agreement with Thermo Fisher Scientific (TMO) for the decentralized manufacturing of Galapagos' point-of-care CAR-T product candidate in the San Francisco area. Under the terms of the agreement, Thermo Fisher will provide GMP manufacturing as well as BioServices and Specialty Logistics for Galapagos' CAR-T hemato-oncology clinical program in the San Francisco area, effective January 2024. Galapagos will initiate the technology transfer to enable Thermo Fisher's manufacturing activities. This collaboration follows Galapagos' agreement with Landmark Bio for decentralized CAR-T manufacturing in the Boston area announced in November 2023. Financial terms of the agreement are not disclosed.

16:00 EST Gyrodyne trading resumes

15:18 EST PNM Resources 'disappointed' with NMPRC decision in rate review - The New Mexico Public Regulation Commission, or NMPRC, issued an order in the application for a 2024 change in customer base rates by Public Service Company of New Mexico, a wholly-owned subsidiary of PNM Resources, the company announced. The order modified the recommended decision in the case and equates to an estimated increase in base rates of $15.3M, based on a 9.26% return on equity and a 50% equity capitalization structure on $2.557B of rate base. PNM had requested a $63.8M increase to base rates. PNM's current authorized rates are based on a 9.575% return on equity with a 50% equity capitalization ratio. "We are disappointed with this outcome after holding rates steady for the past six years. The transition to clean energy means our system is changing rapidly, requiring investments to upgrade the grid to maintain reliability while bringing solutions to customers at affordable prices. As we move forward it will require collaboration by stakeholders to achieve the clean energy transition while preserving the financial health of the utility," said Pat Vincent-Collawn, Chairman and CEO of PNM Resources. The order also postpones recovery of $55M of rate base investments that may be requested again in PNM's next filing and $9M of adjustments to forecasted annual costs, the company noted. "PNM will evaluate the final order and consider its next steps, including the potential appeal of certain issues. Additionally, PNM plans to file its next rate case during 2024 with rates requested to be implemented during 2025," the company added.

14:36 EST Dell debuts new 'minimalistic approach' XPS laptops with built-in AI - "With our XPS portfolio, we have a long history of taking risks, being inquisitive and asking big design questions....Now, we are unifying the design across our XPS portfolio, introducing new screen sizes with the XPS 16 and XPS 14 and revamping the XPS 13 Plus to XPS 13. This trio of laptops share elements that eliminate distractions and place the focus on productivity...The striking, unconventional look has key components that amplify the laptop experience... Style Meets Performance..Each new XPS laptop features InfinityEdge panels with OLED touch options, variable refresh rates, high-resolution options, stunning color and Dolby Vision for rich detail. The new portfolio boasts an exceptional audio experience starting with a quad speaker design, support for Dolby Atmos immersive audio and 3D stereo surround from MaxxAudio Pro by Waves...The lineup also brings new AI-enabled features, with AI acceleration built into the device thanks to Intel Core Ultra processors and experiences brought to life by Windows 11. These experiences enhance creativity and productivity while also providing better performance and longer battery life" said the company, in part, earlier.

14:08 EST Pono Capital Three Inc trading resumes

14:03 EST Pono Capital Three Inc trading halted, volatility trading pause

14:00 EST Commercialization through large partner among Anixa goals, CEO tells The Fly

14:00 EST Anixa CEO says breast cancer vaccine data looking 'incredibly promising'

13:23 EST Endeavour Mining announces termination of President and CEO - The Board of Directors of Endeavour Mining plc announces the termination of the President and Chief Executive Officer, Sebastien de Montessus, for serious misconduct with immediate effect. "This follows an investigation by the Board into an irregular payment instruction issued by him in relation to an asset disposal undertaken by the Company. The amount of this irregular payment instruction is US$5.9 million. The Board recently became aware of this in the course of a review of acquisitions and disposals, which is ongoing. Sebastien de Montessus has been removed from the Company's Board of Directors with immediate effect. Separately, in October 2023 allegations were made against Sebastien de Montessus through the Company's confidential whistleblowing channel relating to his personal conduct with colleagues. Following a recent external investigation, the Board had received the findings and, at the point of termination, was considering the appropriate course of action. The Board has appointed Ian Cockerill (currently Deputy Chair of the Board) as Chief Executive Officer and Executive Director with immediate effect," the company stated.

13:01 EST Celularity confirms commercialization agreement with BioCellgraft - Celularity confirmed that it has entered into an exclusive U.S. strategic commercialization agreement with BioCellgraft, Inc. under which Celularity will manufacture advanced biomaterial products for BioCellgraft which BioCellgraft will distribute in the United States for use in multiple dental/oral healthcare applications. Robert J. Hariri, M.D., Ph.D., Chairman, CEO, and founder of Celularity, said, "This commercialization agreement with BioCellgraft opens an important pathway for Celularity-manufactured, BioCellgraft-branded and marketed advanced biomaterial products into dental and oral healthcare applications in the United States that include periodontology, implant dentistry and oral surgery, all of which are large and growing markets."

12:37 EST Restaurant Brands, Starbucks off highs after McDonald's war comments - Shares of Restaurant Brands (QSR) and Starbucks (SBUX) moved lower after McDonald's CEO Chris Kempczinski CEO said in a LinkedIn post that the war in the Middle East and "associated misinformation" are having a "meaningful business impact."

12:27 EST McDonald's CEO says Middle East war causing 'meaningful impact' - In a LinkedIn post, McDonald's president and CEO Chris Kempczinksi said he recognizes that "several markets in the Middle East and some outside the region are experiencing a meaningful business impact due to the war and associated misinformation that is affecting brands like McDonald's." "This is disheartening and ill-founded. In every country where we operate, including in Muslim countries, McDonald's is proudly represented by local owner operators who work tirelessly to serve and support their communities while employing thousands of their fellow citizens," the CEO added. "That local community connection is the genius of the McDonald's System." Shares of McDonald's have erased earlier gains and are now fractionally lower following the comments. Reference Link

12:24 EST McDonald's CEO says Middle East war causing 'meaningful impact'

12:13 EST Jin Medical International Ltd trading resumes

12:08 EST Jin Medical International Ltd trading halted, volatility trading pause

12:02 EST CVS Pharmacy announces two membership tiers for loyalty program - CVS Pharmacy, the retail division of CVS Health, announced the evolution of its loyalty program to include two membership tiers: ExtraCare and ExtraCare Plus. ExtraCare will now include benefits previously found within the ExtraCare Pharmacy & Health Rewards program. The CarePass loyalty and membership program is now known as ExtraCare Plus and "unlocks all the benefits of ExtraCare, plus the new convenience of free same-day delivery of nearly all products in the store in as little as three hours, and so much more."

12:00 EST Avanos falls -13.5% - Avanos is down -13.5%, or -$2.93 to $18.78.

12:00 EST Amprius Technologies rises 13.9% - Amprius Technologies is up 13.9%, or 62c to $5.07.

12:00 EST QuantumScape rises 32.9% - QuantumScape is up 32.9%, or $2.14 to $8.64.

11:06 EST NGM Biopharma confirms The Column Group interested in acquiring company - In a regulatory filing from January 2, NGM Biopharmaceuticals confirmed that it received a non-binding expression of interest dated December 28, 2023 from The Column Group and certain affiliated investment funds and persons, outlining TCG's intent to explore and evaluate a potential acquisition of all of the outstanding shares of common stock of the company not already owned by TCG in a going-private transaction. TCG currently beneficially owns approximately 26.7% of the outstanding shares of NGM Bio's common stock. In response to the EOI, the company's board formed a special committee consisting of disinterested and independent directors to consider the EOI and any other strategic alternatives that may be available to the company, including remaining a standalone publicly-traded company. The special committee has retained Hogan Lovells US as its independent legal advisor, and intends to retain an independent financial advisor, to assist it in considering the EOI. The special committee intends to carefully consider the EOI with the assistance of its independent financial and legal advisors. There can be no assurance that any definitive agreement will be executed, or that the proposed transaction with TCG or any other transaction will be approved or consummated. NGM Bio and the special committee do not intend to comment on or disclose further developments regarding the special committee's consideration of the EOI unless and until it deems further disclosure is appropriate or required. NGM Bio's stockholders are advised to take no action at this time.

10:06 EST Tryp announces first patient dosed in Phase 2a trial in fibromyalgia - Tryp Therapeutics announced that the first patient has been dosed in a Phase 2a clinical trial being conducted by the University of Michigan in a collaboration with Tryp Therapeutics. The clinical trial is evaluating Tryp's TRP-8802 in patients with fibromyalgia. TRP-8802 is the predecessor to Tryp's lead psilocybin-based drug candidate, TRP-8803. TRP-8803 includes a unique formulation and delivery system and is designed to enhance the positive effects of psilocybin and psilocybin-related compounds, while markedly reducing the limitations of psilocybin dosed through other routes of administration. In combination with psychotherapy, TRP-8803 is intended to serve as a treatment for certain neuropsychiatric disorders including fibromyalgia, binge eating disorder and irritable bowel syndrome. Tryp is utilizing TRP-8802 to evaluate the use of psilocybin-related compounds in certain neuropsychiatric disorders in early-stage trials. If initial efficacy is shown, TRP-8803 will be studied in future trials.

10:00 EST Pinstripes falls -5.1% - Pinstripes is down -5.1%, or -42c to $7.78.

10:00 EST Avanos falls -11.6% - Avanos is down -11.6%, or -$2.52 to $19.19.

10:00 EST Miniso rises 13.3% - Miniso is up 13.3%, or $2.65 to $22.57.

09:47 EST Guess falls -4.7% - Guess is down -4.7%, or -$1.09 to $22.15.

09:47 EST Aptiv falls -5.3% - Aptiv is down -5.3%, or -$4.45 to $80.04.

09:47 EST iHuman rises 8.8% - iHuman is up 8.8%, or 25c to $3.09.

09:46 EST Mullen Automotive reports 2023 Class 1, Class 3 invoice totals of $12.56M - Mullen Automotive announced vehicles delivered through Dec. 31, 2023, with the company delivering 100 Class 1 and 141 Class 3 vehicles for a total invoiced amount of $12,559,520 to Randy Marion Automotive Group. The company has an additional 185 Class 1s scheduled for delivery to RMA through Jan. 8, 2024. "2023 closed out strong and we continue to scale our production and deliveries throughout 2024," said David Michery, CEO and chairman of Mullen Automotive.

09:38 EST Pressure BioSciences evaluating AI, ML prospective partnerships - Pressure BioSciences announced they are actively pursuing and evaluating multiple artificial intelligence and machine learning prospective partnerships. The Company expects such collaborations to accelerate the identification and prioritization of exciting commercial product opportunities within key markets for PBIO's patented BaroFold Technology and Ultra Shear Technology platforms. BaroFold employs high pressure for the disaggregation and controlled refolding of proteins to their desired native structures to significantly improve the quality and production costs of protein therapeutics. UltraShear uses intense shear forces from ultra-high pressure valve discharge to turn oil-based supplements, therapeutics, and other water-insoluble active ingredients into stable, effectively water-soluble, highly bioavailable nanoemulsions. A major PBIO goal in 2024 is to employ AI/ML tools to address a critical challenge - understanding protein folding kinetics to predict the optimal chemical environment for high-pressure refolding. This groundbreaking approach will greatly streamline biopharmaceutical R&D, resulting in more efficient, efficacious, and cost-effective processes and products.

09:33 EST Sinclair Broadcast enters network distribution agreements with CBS stations - Sinclair Broadcast Group announced network distribution agreements with CBS Television Stations to add Sinclair's free over-the-air national broadcast TV networks Comet, CHARGE!, TBD. and The Nest to additional CBS affiliates beginning this week. The expanded agreement positions Sinclair's networks Comet and CHARGE! in CBS's key channel slots in several of the country's top-10 markets, adjacent to all five broadcast networks.

09:24 EST LQR House transfers repurchased shares to account held by transfer agent - LQR House announces the repurchase of 576,713 of its shares and subsequent transfer of those shares from its brokerage account to its account with its transfer agent, representing 15% of its total outstanding shares. In a strategic move guided by advice from close advisors, LQR House acknowledges that shares held by its transfer agent would not be available to cover short sales of the LQR's common stock. Employing this approach, the company anticipates that the repurchased shares will remain beyond the reach of short sellers, establishing a more robust defense against bearish speculation on the stock.

09:20 EST Liquidia announces $100M in new financings - Liquidia announced that the Company has entered into agreements for an additional $100 million in capital between two transactions with funds associated with Patient Square Capital and HealthCare Royalty, HCRx, respectively. On January 4, 2024, Liquidia and an affiliate of Patient Square Capital entered into a common stock purchase agreement for the private placement of 7,182,532 shares of common stock at a purchase price of $10.442 per share. The price per share represents an 8% discount to the closing price on January 3, 2024. The private placement is expected to close January 8, 2024, and yield gross proceeds of approximately $75.0 million. On January 3, 2024, HCRx and Liquidia entered a fourth amendment to the Revenue Interest Financing Agreement to fund an additional $25.0 million. HCRx has now invested $67.5 million in non-dilutive capital from the $100 million originally contemplated from four tranches under the RIFA. The fourth amendment moves $25.0 million from the third tranche to the second tranche, such that HCRx has funded a total of $35.0 million under the second tranche. The remaining third tranche of $10.0 million and fourth tranche of $22.5 million can be funded in the future upon the mutual agreement of both HCRx and Liquidia.

09:18 EST Hub Group announces 2-for-1 stock split - Hub Group announced a 2-for-1 stock split of its Class A Common Stock in the form of a one-time special stock dividend. Each stockholder of record of Hub Group's Class A Common Stock and Class B Common Stock at the close of business on Tuesday, January 16, 2024 will receive one share of Class A Common Stock for each share held on the record date, with the distribution to occur on Friday, January 26, 2024 and trading to begin on a split-adjusted basis on Monday, January 29, 2024. This stock split is part of Hub Group's previously announced growth-focused capital allocation plan and is designed to improve market liquidity.

09:17 EST Crown Fiber Optics selected for Arizona fiber construction project - Crown Electrokinetics has been selected for a project in Chandler, Arizona. Crown's customer is a $5B NYSE-listed infrastructure construction company operating mainly throughout North America. The Company's primary activities include the engineering, building, installation, maintenance and upgrade of communications, energy, utility and a variety of other infrastructure industries.

09:16 EST Capital Product announces successful delivery of LNG Carrier 'Axios II' - Capital Product Partners announced that it successfully took delivery of the LNG Carrier 'Axios II'. Pursuant to the agreement to acquire 11 LNG/Cs provided under the Umbrella Agreement entered into on November 13, 2023, the Partnership took delivery on January 2, 2024 of LNG/C Axios II. The vessel commenced a one-year time charter at a market-linked rate, which will be followed by a seven-year bareboat charter with Bonny Gas Transport Limited, who maintain an option to extend by an additional three years. The vessel acquisition was financed with cash from the balance sheet, a new senior secured loan facility led by ING Bank N.V. for an amount of $190.0 million payable in 28 equal quarterly instalments of $2.5 million, in addition to a balloon payment of $120.0 million payable together with the final quarterly instalment in December 2030, and the deferral of $92.6 million of the purchase price, in accordance with the seller's credit agreement included in the Umbrella Agreement, maturing on June 30, 2027.

09:14 EST Safe and Green announces update on LOI for acquisition of Xene platform - Safe and Green Development announces an update to the previously announced proposed investment in Majestic World Holdings, a real estate technology firm and owner of the Xene AI Software platform. After conducting initial due diligence, the Company has negotiated a complete acquisition of Xene Platform along with its parent company MWH. The company will look to complete the acquisition by the end of the first quarter subject to final approval by the Board of Directors and execution of definitive documents. David Villarreal, President & CEO of Safe and Green Development Corporation, stated, "The successful BETA run earlier in 2023 has given us the confidence to move forward with a complete acquisition of the XENE Platform. This unique platform is expected to save banks and financial institutions time and money on foreclosure listings by leveraging the technology, property preservation, eviction, listing and sales, title, home warranty and homeowners' insurance all in one place. We look forward to adding this line of business and diversifying our business portfolio."

09:12 EST Riot Platforms produces 6,626 bitcoin in FY23 - Riot Platforms announces unaudited production and operations updates for December 2023. FY23 bitcoin produced: 6,626; average bitcoin produced per day 18.2. Bitcoin held: 7,362. Bitcoin sold: 6,185. Deployed hash rate: 12.4 EH/s. Deployed miners: 112,944. Bitcoin sales - net proceeds: $176.2 million

09:11 EST Galaxy Gaming, ODDSworks debut Roulette Up in North America - Galaxy Gaming announced the official online launch of its brand new RNG game, Roulette Up, through its in-house Galaxy Gaming Digital division. Now available to play online with Draft Kings, Golden Nugget, and WynnBET in multiple states and coming soon to Canada, this launch marks the debut of Roulette Up in the iGaming space. This inventive game features an optional side bet and progressive wager where players can wager that the outcome will provide an increasing sequence from each spin. The winning payouts are based on the streak length. This game launch will soon be followed by additional Galaxy Gaming Digital titles including Split To Double Blackjack which will also feature Galaxy's top performing progressive jackpot. Using its BETguard Remote Gaming Server platform, ODDSworks is well suited to handle the high volume of play anticipated for these Galaxy Gaming Digital titles.

09:08 EST AMD introduces Versal AI Edge XA adaptive SoC, Ryzen Embedded V2000A processor - AMD will showcase automotive innovation at CES 2024 and expand its portfolio with the introduction of two new devices, the Versal AI Edge XA adaptive SoC and Ryzen Embedded V2000A Series processor. The devices underscore AMD automotive technology leadership and are designed to serve key automotive focus segments including infotainment, advanced driver safety and autonomous driving. Working alongside a growing automotive partner ecosystem, AMD will demonstrate at CES 2024 the broad range of capabilities and applications for these new devices in automotive solutions available today and in the future. Versal AI Edge XA adaptive SoCs add an advanced AI Engine, enabling the devices to be further optimized for numerous next-generation advanced automotive systems and applications including: forward cameras, in-cabin monitoring, LiDAR, 4D radar, surround-view, automated parking and autonomous driving. Versal AI Edge XA adaptive SoCs are also the first AMD 7nm device to be auto-qualified, bringing hardened IP and added security to automotive applications where safety is paramount. Ryzen Embedded V2000A Series processors power the next-generation automotive digital cockpit, from the infotainment console to the digital cluster and passenger displays. The expansion of the AMD Ryzen Embedded V2000A Series brings the first x86 auto-qualified processor family to offer the same PC-like experience consumers have come to expect from home entertainment which they can now enjoy in-vehicle, on the go.

09:06 EST Edible Garden launches PulpFlavors.com e-commerce site - Edible Garden AG announced the launch of an e-commerce site for the Company's Pulp line of sustainable gourmet, USDA Organic fermented sauces and chili-based products.

09:05 EST Oncternal Therapeutics to effect 1-for-20 reverse stock split - Oncternal Therapeutics board of directors has approved a 1-for-20 reverse stock split of the company's common stock. The reverse stock split will become effective at 12:01 a.m. Eastern time on January 8, 2024. The company's common stock is expected to begin trading on a split-adjusted basis on The Nasdaq Capital Market under the same symbol when the market opens on January 8, 2024 with the new CUSIP number 68236P206. The reverse stock split was approved by the company's stockholders at its 2023 annual meeting, held on June 28, 2023, to be effected at the Board's discretion with a ratio within the range of not less than 1-for-5 and not more than 1-for-30. As a result of the reverse stock split, every 20 shares of the company's common stock issued and outstanding will be automatically converted into one share of common stock, with no change in the $0.001 par value per share or authorized number of shares of common stock. No fractional shares will be issued in connection with the reverse split and stockholders who would otherwise be entitled to a fractional share of common stock will instead be entitled to receive a proportional cash payment. The reverse stock split is primarily intended to bring the company into compliance with Nasdaq's minimum bid price requirement. To regain compliance, the bid price of the company's common stock must close at $1.00 per share or more for a minimum of ten consecutive business days.

09:04 EST Stran & Company appoints Wall as Chief Information Officer - Stran & Company announces that it has appointed Ian Thomas Wall as its Chief Information Officer. Most recently, Wall served as the Senior Vice President of Digital Transformation and Service Delivery at Digital Radius, a consulting firm focused on digital transformation and implementing software-as-a-service solutions for its clients.

09:03 EST California Water Service appoints James Lynch as CFO, treasurer - California Water Service announced that after conducting an extensive, nation-wide search, it has selected James Lynch to join the company as Senior Vice President, CFO and Treasurer, effective January 3, 2024. He succeeds interim Vice President, CFO and Treasurer David Healey. Mr. Healey will serve as Principal Financial Officer on an interim basis, ensuring a smooth transition and supporting the company in its fiscal year 2023 financial reporting. Mr. Lynch has more than 22 years of experience in the water utility industry, including 12 years at SJW Group where he served as Chief Accounting Officer and, prior to that, CFO, and Treasurer.

09:02 EST LegalZoom launches Beneficial Ownership Information Report - LegalZoom announced the release of its Beneficial Ownership Information Report, a new addition to LegalZoom's ecosystem of compliance services. The new service helps customers satisfy the federally mandated beneficial ownership information reporting rule under the Corporate Transparency Act, which went into effect on January 1, 2024. According to the Financial Crimes Enforcement Network, a bureau of the United States Department of Treasury, 89% of all business entities must file identifying information with FinCEN about the individuals who own or control a business.

08:58 EST Zevra Therapeutics appoints Adrian Quartel as CMO - Zevra Therapeutics announced the appointment of Adrian Quartel, M.D., FFPM, as Chief Medical Officer. Dr. Quartel was previously the Chief Medical Officer of Acer Therapeutics - Recently acquired by Zevra -, where he played a key role in guiding clinical development, medical affairs and regulatory compliance.

08:54 EST Harte Hanks extends line of credit with Texas Capital Bank - Harte Hanks has extended its $25 million secured revolving line of credit with Texas Capital Bank for an additional six month term, beyond its original maturity date in December, 2024. The revised loan agreement, which now matures at the end of June, 2025, will enhance the Company's financial flexibility and provide the Company with operational stability over this extended term. The Company intends to use the credit facility for working capital and to create growth opportunities by investing in and enhancing client offerings.

08:52 EST American Resources' ReElement appoints Mark Gilbert to board - American Resources Corporation's ReElement Technologies announced the appointment of former U.S. Ambassador Mark Gilbert and former Vice Chairman of UBS Private Wealth Management to its Board of Directors.

08:50 EST Signing Day Sports CEO provides letter to stockholders - Signing Day Sports provided the following letter to stockholders from the Company's Chairman and CEO, Daniel Nelson: "We are pleased to share with you a recap of the significant milestones and exciting developments that Signing Day Sports achieved in 2023, as well as our positive outlook for 2024. First and foremost, the Company's recent initial public offering and commencement of trading on the NYSE American exchange marked a pivotal moment in the Company's evolution... Among our recent milestones, the collaboration with the U.S. Army Bowl National Combine and high school all-star game stands out, an event celebrated as America's Biggest Week in Football. This December, we had the opportunity to demonstrate the capabilities of the Signing Day Sports app at the global headquarters of the Dallas Cowboys. The app played a crucial role for athletes participating in the U.S. Army Bowl, serving as both a marketing and branding tool in their recruitment journey... Furthermore, our recently-announced appointment of Kevin Grogan as Senior Soccer Advisor, marks a significant event for Signing Day Sports in the realm of soccer recruitment. Kevin's distinguished background as a former professional soccer player, a seasoned coach, and a knowledgeable sports business consultant adds considerable depth and expertise to our team... As we look ahead to 2024, we could not be more excited about the outlook for the business. In particular, we look forward to leveraging key strategic alliances to rapidly scale the business. As an example, we are collaborating with Elite Development Program, a premier youth soccer organization providing us access to more than 150,000 athletes from more than 1,050 clubs playing on more than 7,700 league teams and more than 5,500 tournament teams. As recently announced, on January 1, 2024, we commenced our collaboration with EDP Soccer on the joint marketing and promotion of EDP Soccer events and the Signing Day Sports platform, led by Kevin Grogan. Not only does this collaboration provide us a solid foothold within soccer, but it illustrates the adaptability of our app to new sports, as well as the scalability of our business model. We look forward to announcing further developments regarding our collaboration with EDP in the near future... Overall, we believe that the Signing Day Sports app is positioned well to address major inefficiencies in the collegiate athletic recruitment process. By addressing key challenges within the industry, our product serves a vast market with a compelling need for access to college-athlete recruitment services. "

08:49 EST BriaCell releases images from Phase 2 study of Bria-IMT - BriaCell Therapeutics releases transformational images of the recently reported remarkable responder in the Phase 2 study of BriaCell's Bria-IMT combination regimen. The patient had metastatic breast cancer behind her eye, causing proptosis and significant pain that were both markedly reduced with BriaCell's treatment. "We are extremely excited to report significant tumor reduction in this very difficult to treat patient who had failed 7 prior regimens including treatment with Enhertu(R), an antibody-drug conjugate, highlighting the robust anti-tumor activity of the Bria-IMT regimen in difficult to reach tumors such as those in the eye orbit. We observed significant tumor reduction along with significant eye pain reduction after only 3 cycles of treatment with the Bria-IMT combination regimen. The Bria-IMT regimen has been very well tolerated and the patient remains on treatment," stated Dr. William Williams, BriaCell's President and CEO. "We look forward to sharing additional data in the coming months."

08:47 EST Foremost Lithium receives third $300,000 grant from MMDF - Foremost Lithium Resource & Technology has received a $300,000 grant from the Manitoba Mineral Development Fund to help support and advance the Company's recently announced 7,500-meter diamond drill program at its Zoro Lithium Project located in the Snow Lake area of the Province of Manitoba. On January 4, 2023 and September 21, 2021 Foremost Lithium announced the MMDF's approval of its previous two grant applications of $300,000 each in support of the Company's continued exploration and drilling program on its Lithium Lane properties. The Company wishes to acknowledge MMDF's continued contributions and recognizes that the grant's financial injections assist and accelerate Foremost's exploration objectives in the Province of Manitoba.

08:46 EST ICE: December ADV up 39% y/y, +10% y/y in 2023, Energy OI up 21% y/y - Reports: Total open interest OI up 18% y/y, including record OI of 86.5M lots on December 14; average daily volume ADV up 39% y/y in December, up 26% y/y in 4Q23 and up 10% y/y in 2023 Energy OI up 21% y/y, including record OI of 53.7M lots on December 22; ADV up 38% y/y in December, up 35% y/y in 4Q23 and record ADV in 2023 up 18% y/y ...Total Oil OI up 28% y/y; ADV up 31% y/y in December, up 32% y/y in 4Q23 and record ADV in 2023 up 19% y/y ..Brent OI up 13% y/y; ADV up 20% y/y in December, up 27% y/y in 4Q23 and record ADV in 2023 up 16% y/y...WTI OI up 53% y/y; ADV up 49% y/y in December, up 55% y/y in 4Q23 and record ADV in 2023 up 27% y/y ..Gasoil OI up 38% y/y; ADV up 33% y/y in December, up 30% y/y in 4Q23 and up 20% y/y in 2023...Other crude and refined products OI up 35% y/y; ADV up 51% y/y in December, up 46% y/y in 4Q23 and up 35% y/y in 2023...

08:45 EST Global Mofy Metaverse announces registration of subsidiary in California, U.S. - Global Mofy Metaverse announced the registration of its subsidiary, Global Mofy Technology, in California, the United States, aiming to expand its virtual content production business overseas, and to delve into the overseas short drama markets. This strategic decision aligns with the Company's global business strategy. Yang Haogang, CEO of the Company commented, "We are delighted to announce the establishment of our first overseas subsidiary in the United States. This is a vital step in our strategic development, enabling us to serve global clients better and enhance our competitiveness in overseas markets. We will rely on Global Mofy Metaverse's advanced virtual technology solutions to subsequently provide comprehensive virtual technology services for clients in Hollywood and, indeed, worldwide, ushering in immersive audiovisual experiences for our global audience."

08:43 EST Portage Biotech to evaluate range of strategic options - After a review of Portage's funding requirements, the Board of Directors has made the decision to pause further drug development in the PORT-2 iNKT program. "This was a difficult decision considering the promising phase 1 safety and translational data from the non-small cell lung and melanoma trial," said Dr Ian B. Walters, chairman and CEO, "As a result, the company will evaluate a range of potential strategic options which may include among other things, finding a partner for our iNKT program or other corporate transactions."

08:42 EST Portage Biotech implements cost savings plan including reduction in force - In connection with these developments and to extend its cash runway, Portage is implementing a cost-savings plan that includes a reduction in internal and contracted workforce, with remaining employees focusing primarily on pursuing the adenosine clinical programs.

08:41 EST Portage Biotech to pause further development in PORT-2 iNKT program - Portage Biotech announced the outcome from the company's comprehensive review of its pipeline in the context of the current capital raising market conditions. The ADPORT-201 adaptive Phase 1a/1b clinical trial of PORT-6 and PORT-7 has been progressing well with strong interest from our eight academic centers in the US. The phase 1a dose escalation portion of the trial is enrolling quickly and there have been no safety signals of concern at the doses evaluated to date. The company looks forward to presenting data from this portion of the trial at a conference later this year. We are also excited about future development with these candidates including combining our potential best-in-class adenosine 2A and adenosine 2B inhibitors at the optimum biologic doses in a biomarker enriched population and collaborating with Merck to study combinations with KEYTRUDA, Merck's anti-PD-1 therapy. After a review of Portage's funding requirements, the Board of Directors has made the difficult decision to pause further drug development in the PORT-2 iNKT program. "This was a difficult decision considering the promising phase 1 safety and translational data from the non-small cell lung and melanoma trial," said Dr Ian B. Walters, chairman and CEO, "As a result, the company will evaluate a range of potential strategic options which may include among other things, finding a partner for our iNKT program or other corporate transactions." Portage does not intend to disclose developments with respect to this evaluation unless and until it determines that further disclosure is appropriate or necessary.

08:39 EST Middlefield Banking Company appoints Noblit as CCO, Cheravitch as CBO - The Middlefield Banking Company announced enhancements to its leadership team to support the Company's growth across its Central, Western, and Northeast Ohio markets. Rebecca Noblit has been promoted to Chief Credit Officer, succeeding Alfred F. Thompson Jr. who will retire from the Company on February 1, 2024. In addition, Michael Cheravitch has joined The Middlefield Banking Company as Chief Banking Officer. As Chief Credit Officer, Noblit will be responsible for leading the Company's credit administration and loan administration programs. Noblit joined Middlefield as part of the December 2022 Liberty National Bank acquisition, and most recently served as Middlefield's Credit Administration, Senior Vice President. As Chief Banking Officer, Cheravitch will oversee all Commercial, Business, and Consumer banking channels, including digital banking, the retail branch network and call center, along with consumer lending, and residential mortgage. Cheravitch joins Middlefield from F.N.B. Corporation where he spent four years as SVP Regional Banking Executive.

08:37 EST NewAmsterdam Pharma announces upcoming milestones - "NewAmsterdam is entering 2024 on the precipice of a major transformation, with the potential to deliver significant benefit to patients globally and create value for our shareholders," said Michael Davidson, M.D., Chief Executive Officer of NewAmsterdam. "In the year ahead, we are on track to report topline results from our first two pivotal Phase 3 trials of obicetrapib, BROOKLYN and BROADWAY. We are optimistic that these data will build on our prior Phase 2 trials, where we observed a robust impact on lipid and lipoprotein parameters believed to be predictive of CVD risk. We continue to believe that our oral small molecule, low-dose, once-daily CETP inhibitor, if approved, has the potential to become the preferred LDL-C lowering therapy for the millions of dyslipidemia patients who are underserved by existing therapies. In addition, in the first quarter, we expect to complete enrollment in PREVAIL, our cardiovascular outcomes trial, and initiate a fourth pivotal Phase 3 trial evaluating a fixed-dose combination of obicetrapib and ezetimibe, which was observed in our Phase 2 trial to reduce LDL-C by 63%. Taken together, we believe our comprehensive Phase 3 program will showcase obicetrapib's potential to help many more patients reach guideline-mandated LDL-C goals and, as a result, reduce suffering from major adverse cardiac events, while also providing physicians with multiple treatment options to optimize the care of each patient. We look forward to advancing our clinical program, while investing in our commercial organization and laying the groundwork for a successful global launch if obicetrapib receives the necessary marketing approvals." Program Updates and Upcoming Milestones: NewAmsterdam is developing obicetrapib, an oral, low-dose and once-daily cholesteryl ester transfer protein inhibitor, as the preferred LDL-C lowering therapy to be used as an adjunct to maximally tolerated statin therapy for high-risk CVD patients. In 2023, NewAmsterdam reported positive, statistically significant and clinically meaningful data from two Phase 2 clinical trials of obicetrapib: the Phase 2 ROSE2 trial, which evaluated obicetrapib in combination with ezetimibe, and a Phase 2b dose-finding trial, which evaluated obicetrapib in Japanese patients. In total, the Company has completed six Phase 1 or 2 clinical trials and tested obicetrapib in over 800 patients. Statistically significant LDL-lowering was observed in each of the Company's completed Phase 2 clinical trials, combined with generally moderate side effects and no drug-related, treatment-emergent serious adverse events. The Company is currently conducting three pivotal Phase 3 clinical trials of obicetrapib: BROOKLYN, BROADWAY and PREVAIL. In addition, the Company plans to initiate a fourth Phase 3 trial, TANDEM, evaluating a fixed-dose combination of obicetrapib and ezetimibe. BROOKLYN is evaluating obicetrapib in patients with heterozygous familial hypercholesterolemia, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The primary objective is to evaluate the effect of obicetrapib on LDL-C levels. Secondary objectives include evaluating the effect of obicetrapib on non-high-density lipoprotein cholesterol, apolipoprotein B, and lipoprotein. The trial is also evaluating the safety and tolerability profile of obicetrapib. NewAmsterdam completed enrollment of approximately 350 patients in April 2023 and expects to report topline data in the third quarter of 2024. BROADWAY is evaluating obicetrapib in adult patients with HeFH and/or established atherosclerotic cardiovascular disease, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The primary objective is to evaluate the effect of obicetrapib on LDL-C levels at day 84. Secondary objectives include evaluating the effect of obicetrapib on ApoB, Lp, HDL-C, and non-HDL-C, at day 84, and on LDL-C levels at days 180 and 365. The trial is also evaluating the safety and tolerability of obicetrapib. NewAmsterdam completed enrollment of over 2,500 patients in July 2023 and expects to report topline data in the fourth quarter of 2024. PREVAIL is a cardiovascular outcomes trial evaluating obicetrapib in patients with a history of ASCVD, whose LDL-C is not adequately controlled, despite being on maximally tolerated lipid-lowering therapy. The primarily objective is to evaluate the effect of obicetrapib on the risk of major adverse cardiovascular events, including cardiovascular death, non-fatal myocardial infraction, non-fatal stroke, or non-elective coronary revascularization. Secondary objectives include evaluating the effect of obicetrapib on all-cause mortality, total cardiovascular events, new-onset diabetes mellitus, and change in LDL-C, non-HDL-C, and ApoB levels. NewAmsterdam expects to complete patient enrollment in PREVAIL in the first quarter of 2024 and to report topline data in 2026. TANDEM is designed as a pivotal Phase 3 clinical trial to evaluate obicetrapib as part of a FDC tablet with ezetimibe, a non-statin oral LDL-lowering therapy. The Company expects to initiate TANDEM in the first quarter of 2024 and to report topline data in the first quarter of 2025. Also in 2023, NewAmsterdam reported positive initial data from a Phase 2a clinical trial evaluating obicetrapib in patients with early Alzheimer's disease who carry at least one copy of the apolipoprotein E4 mutation. NewAmsterdam anticipates sharing the full results from this Phase 2a clinical trial in a forthcoming publication or in a presentation at a medical meeting.

08:36 EST CytomX Therapeutics announces 2024 anticipated milestones, cash runway - CytomX Therapeutics announced its 2024 company priorities and anticipated milestones for its wholly-owned and partnered pipeline: CX-904: Continued enrollment into Phase 1a dose escalation. Phase 1a initial dose escalation data are expected in the second half of 2024. These data are expected to inform a potential decision, to be taken with Amgen, to initiate Phase 1b expansion cohorts in specific EGFR positive tumor types in 2024. CX-2051: Initiation of Phase 1 dose escalation in solid tumors with known EpCAM expression including metastatic colorectal cancer as one priority indication is expected in the first half of 2024. CX-801: Initiation of Phase 1 dose escalation in solid tumors including melanoma, renal, and head and neck squamous cell carcinoma is expected in the first half of 2024. Next-Generation CTLA-4 Program: Continued clinical progress for BMS-986288 including proof-of-concept studies in MSS CRC and NSCLC. Bristol Myers Squibb anticipates data from the study will be available in 2024. Financial: CytomX ended the third quarter of 2023 with $194 million of cash and cash equivalents. Cash runway is projected to the second half of 2025, excluding any potential milestones from existing collaborations or new business development.

08:35 EST OSI Systems receives $5M order for healthcare division - OSI Systems announced that its healthcare division, Spacelabs Healthcare, has received an order valued at approximately $5M to provide patient monitoring solutions and related supplies and accessories to a U.S. based hospital. The company expects to install a range of patient monitoring tools including the Rothman Index, an AI-enabled predictive analytics solution; SafeNSound, a clinical workflow solution; and Xhibit Central Stations with XTR Telemetry and Qube bedside patient monitors.

08:33 EST Avenue Therapeutics reaches final agreement with FDA for Phase 3 safety study - Avenue Therapeutics has reached final agreement with the U.S. Food and Drug Administration on the Phase 3 safety study protocol and statistical analysis approach, including the primary endpoint, for intravenous tramadol, which is in development for the treatment of acute post-operative pain in a medically supervised setting. The final non-inferiority study is designed to assess the theoretical risk of opioid-induced respiratory depression related to opioid stacking on IV tramadol compared to IV morphine. The study will randomize approximately 300 post bunionectomy patients to IV tramadol or IV morphine for pain relief administered during a 48-hour post-operative period. Of note, IV tramadol demonstrated safety and efficacy in this same surgical model in two Phase 3 efficacy trials. Patients will have access to IV hydromorphone, a Schedule II opioid, for rescue of breakthrough pain. The primary endpoint is a composite of elements indicative of respiratory depression. Avenue believes the study can be completed within 12 months and submitted to the FDA to address the CRL and potentially lead to approval of IV tramadol.

08:32 EST Indaptus Therapeutics to receive European patent for platform technology - Indaptus Therapeutics announces that the European Patent Office has informed the company that it will grant a European patent related to the company's platform technology, covering a composition that can be used in the prevention or treatment of viral infections. The patent, titled "Methods of Treatment of Infections Using Bacteria," provides protections for the application of the Company's Decoy technology platform alone or in combination with standards of care for the prevention or treatment of any viral infection. The EPO patent will be the second patent granted to Indaptus outside the United States for this application.

08:29 EST Casa Systems appoints Dasgupta as Chief Technology OfficerAlphabet - Casa Systems (CASA) announced the appointment of telecom industry leader Santanu Dasgupta as Chief Technology Officer, CTO. Previously at Google (GOOG;GOOGL), he served as Head of Product, Telco Network Modernization, where he led its Telecom Access business including product engineering, solutions, partnerships, acquisition of several lighthouse customers, and innovations that set new cross-organization standards.

08:27 EST authID signs new contracts with gross bARR preliminarily valued at $1.7M - authID announced that it signed new customer contracts with gross Booked Annual Recurring Revenue or bARR preliminarily valued at $1.7 million during the fourth quarter of 2023. This achievement continues the momentum seen throughout the entirety of 2023, with Q4 bookings representing a 64% increase over the Company's third quarter. The authID sales team secured various customers in Q4, including an international digital wallet provider leveraging authID to deliver frictionless biometric identity assurance for their network of banks, merchants and customers while securing international payments; and a leading entertainment business software provider partnering with authID to stop fraud and eliminate account takeover with strong identity assurance for transferring money in the entertainment industry. The Company also signed contracts with a mobile application provider committed to advancing responsible firearm instruction, training, and ownership; and with a service provider of verified identities to ensure safe online interactions and prevent fake profiles, catfishing, and potential cyber-predator risks. "I am extremely pleased to continue our strong sales momentum through the fourth quarter," said Rhon Daguro, CEO of authID. "It's not enough to have powerful products - you must also be able to convey value to customers. authID is fortunate to have great people developing our technology, and equally great people selling it. Together, we provide best-in-class solutions and cutting-edge thought leadership to the market."

08:26 EST Dirtt Environmental, SourceBlue enter strategic alliance - DIRTT and SourceBlue announced a strategic alliance. Known for creating flexible and agile procurement methods, SourceBlue has a vision to transform the supply chain management process in response to construction projects becoming increasingly complex and demanding. Through its established relationships with leading international manufacturers, SourceBlue will offer DIRTT clients and Construction Partners a single point of contact for all of their supply chain planning and procurement requirements. Through this alliance, both DIRTT and SourceBlue, alongside Parent Company Turner Construction, will gain access to new markets while offering a more comprehensive solution to clients.

08:24 EST Viracta Therapeutics provides anticipated 2024 milestones - Viracta Therapeutics provided a clinical update, including its roadmap for advancing Nana-val's clinical development in 2024. Nana-val, is the company's all-oral investigational therapy targeting Epstein-Barr virus-associated cancers. Anticipated Key 2024 Milestones: Pivotal NAVAL-1 study of Nana-val in patients with relapsed or refractory Epstein-Barr virus-positive lymphomas: Complete enrollment of Stage 2 in the R/R EBV+ peripheral T-cell lymphoma cohort of patients treated with Nana-val in the first quarter of 2024. Report Stage 1 data from both arms of the R/R EBV+ PTCL cohort in the first half of 2024. Meet with the U.S. Food and Drug Administration to discuss additional requirements for accelerated approval by mid-2024. Enroll patients with R/R EBV+ PTCL into the post-Phase 2 expansion cohort to support potential accelerated approval. Present Stage 2 data from patients with R/R EBV+ PTCL in the second half of 2024. Report Stage 1 data from patients with R/R EBV+ diffuse large B-cell lymphoma and R/R EBV+ post-transplant lymphoproliferative disorder by year-end 2024. Phase 1b/2 study of Nana-val in patients with advanced EBV+ solid tumors: Determine the recommended Phase 2 dose by investigating the novel split daily dosing regimen at higher dose levels of Nana-val in the second half of 2024. Initiate a dose-optimization cohort to confirm the RP2D as part of the study's Phase 2 expansion by year-end 2024. "Our primary focus in 2024 is the speed to market strategy for Nana-val in patients with relapsed or refractory EBV-positive PTCL, supported by its accelerating pace of enrollment into Stage 2 and plans to engage with the FDA to discuss Nana-val's potential accelerated approval pathway in mid-2024," said Mark Rothera, President and Chief Executive Officer of Viracta. "Additionally, we are encouraged by the progress of the Phase 1b/2 trial of Nana-val in patients with advanced EBV-positive solid tumors, which is now enrolling and treating patients with the novel split daily dosing regimen, and we remain on track to expand the study into Phase 2 in 2024. The growing clinical data together with the recent orphan drug designation granted by FDA for the treatment of nasopharyngeal carcinoma further positions Nana-val as a tumor-agnostic approach to address the high unmet medical need for patients with EBV-associated cancers, including both lymphomas and solid tumors. With an anticipated cash runway into 2025, we are well-positioned for a successful 2024."

08:23 EST SAIC awarded $63M contract from Navy - SAIC has been awarded a $63M contract from the U.S. Navy to support hypersonics advanced concepts and strategic mission solutions for the Navy's Strategic Systems Programs, or SSP, and the Naval Surface Warfare Center, or NSWC, Crane, Ind., Strategic Systems Hardware Division, or GXW. Under the new contract, SAIC will enhance hypersonics advanced concepts and strategic missions focused on next-generation systems, subsystems, components, features and technologies to include Hardware-in-the-Loop, or HWIL, and Software-in-the-Loop, or SWIL, simulations, manufacturing techniques and other strategic mission areas.

08:23 EST Reviva Pharmaceuticals provides program updates, upcoming milestones - Reviva Pharmaceuticals Holdings provided program updates and announced upcoming key milestones. "In 2023, we made significant progress across our late-stage brilaroxazine clinical program in schizophrenia, including positive topline Phase 3 data demonstrating statistically significant reductions across all major symptom domains, successful ongoing enrollment in our one-year OLE trial, and positive clinical drug-drug interaction data supporting a competitive profile for once-daily brilaroxazine," said Laxminarayan Bhat, Ph.D., Founder, President, and CEO of Reviva. Anticipated Milestones and Events: Topline data from 1-year OLE trial expected Q4 2024; Initiation of registrational Phase 3 RECOVER-2 trial expected Q1 2024; Initiation of investigational new drug application enabling studies for liposomal-gel formulation of brilaroxazine in psoriasis expected in 2024; May initiate Phase 2 studies in bipolar disorder, major depressive disorder, and attention deficit hyperactive disorder in 2024; Pursue partnership opportunities for the development of our pipeline.

08:21 EST Third Harmonic appoints Christopher Murphy as chief financial, business officer - Third Harmonic Bio announced the appointment of Christopher Murphy as Chief Financial and Business Officer. In his role, Chris will be responsible for strategic leadership and direction of the company's finance, corporate strategy, and business development functions. Chris Murphy most recently served as a member of the leadership team that transformed Horizon Therapeutics PLC

08:20 EST Bruker acquires Tornado Spectral Systems, terms undisclosed - Bruker announced the acquisition of Tornado Spectral Systems, a Canadian company specializing in process Raman instruments, primarily used in pharma and biotech quality control applications. The company said Tornado, with over a decade of experience in Raman solutions, will enhance Bruker's biopharma PAT portfolio with its well-established products. Financial details were not disclosed.

08:18 EST Alimera Sciences completes recruitment for the Synchronicity Study - Alimera Sciences announces that it has completed enrollment for the company's Synchronicity Study, a prospective, open-label clinical study evaluating the safety and efficacy of YUTIQ in the treatment of chronic non-infectious uveitis and related intraocular inflammation. "We are pleased to reach the enrollment target for this Phase 4 open-label study only a few short months after our acquisition of YUTIQ," said Rick Eiswirth, Alimera's President and Chief Executive Officer. "We look forward to the initial readout from this study in the second half of next year to provide retina specialists with a broader sense of the utility of fluocinolone acetonide in a durable intravitreal implant across a variety of patients with chronic non-infectious uveitis affecting the posterior segment. This could potentially benefit both YUTIQ in the United States and ILUVIEN in Europe and the Middle East, where it is approved to treat chronic NIU-PS."

08:17 EST 4D Molecular appoints Kasahara as Chief Scientific Officer of 4DMT - Noriyuki Kasahara was appointed as Chief Scientific Officer of 4DMT, effective January 2, 2024, and previously served as a member of 4DMT's Board of Directors and chaired the Board's Science & Technology Committee from September 2022 to December 2023.

08:15 EST Peloton jumps 10% in premarket trading after announcing TikTok partnership

08:13 EST Peloton partnering with TikTok for new fitness hub - Peloton and TikTok, a platform for short-form mobile video, announced an exclusive partnership to bring Peloton's workout content to the TikTok community. This will result in a new fitness hub on TikTok - #TikTokFitness - on which Peloton will have a dedicated, co-branded hub that houses custom Peloton content: #TikTokFitness Powered by Peloton.

08:12 EST iCoreConnect announces the acquisition of Teamworx Dental - iCoreConnect announced today its strategic acquisition of Teamworx Dental. This acquisition continues to expand iCoreConnect's portfolio of SaaS software that serves the healthcare market. Robert McDermott, President and CEO of iCoreConnect, commented, "The integration of Teamworx into iCoreConnect's Platform represents the continued execution of our strategic mission to provide comprehensive, integrated technology solutions. We are excited about the possibilities this acquisition brings to our company and our customers. iCoreAcademy adds to our extensive portfolio of software solutions we bring to our customers to help them optimize operations and increase the profitability of their practices. We plan to leverage our current subscriber base to introduce this new offering." McDermott continued, "We have a strategic vision to bring all our SaaS solutions under one enterprise platform with single sign-on capabilities. We are planning to launch the iCoreEnterprise platform in the second quarter of 2024."

08:11 EST ZeroFox awarded $289M from U.S. OPM for digital identity protection services - ZeroFox has received $289M in awards from the U.S. Office of Personnel Management, OPM, for the continued provision of digital identity protection services to the 22.1 million individuals impacted by previous security incidents. ZeroFox received a $41.3M extension to its current service through June 2024, along with a new award for $247.9M to prolong the company's eight-year partnership with the agency through September 30, 2028. "We're grateful to continue our work alongside OPM, providing millions of Americans with critical digital identity theft protection services to protect and restore their right to privacy," said James C. Foster, Chairman and CEO at ZeroFox. "This renewed commitment signifies the joint dedication between the U.S. Government and ZeroFox in helping individuals, agencies and enterprises affected by devastating external cyberattacks - something that is all too common these days. Our goal is to minimize the impact with proactive protection and give people peace of mind."

08:10 EST Element Solutions unit acquires All-Star Chemical's metal finishing solutions - MacDermid Enthone Industrial Solutions, an Element Solutions company, announced the acquisition of All-Star Chemical Company's surface finishing and cleaning chemical solutions. Going forward, All-Star's proprietary chemical solutions will be integrated into the MacDermid Enthone Industrial Solutions portfolio. Established in 1983, All-Star Chemical Company, a family owned and operated business, has a rich history of supplying high quality products and service to their customers. The business is headquartered in Westerville, Ohio and serves customers across the mid-western United States.

08:10 EST Rigel Pharmaceuticals collaborating with Connect network in Phase 2 glioma trial - Rigel Pharmaceuticals announced a collaboration with CONNECT, an international collaborative network of pediatric cancer centers, to conduct a Phase 2 clinical trial to evaluate Rezlidhia - olutasidenib - in combination with temozolomide as maintenance therapy in newly diagnosed pediatric and young adult patients with high-grade glioma harboring an isocitrate dehydrogenase-1 mutation. Under the collaboration, CONNECT will include olutasidenib in CONNECT's TarGeT-D, a molecularly guided Phase 2 umbrella clinical trial for HGG. The Rigel-sponsored arm will study post-radiotherapy administration of olutasidenib in combination with temozolomide followed by olutasidenib monotherapy as maintenance treatment in newly diagnosed pediatric and young adult patients with IDH1 mutation positive HGG, including diffuse intrinsic pontine glioma, an aggressive brain tumor with limited treatment options. Rigel will provide funding up to $3M and study material over the four-year collaboration. The primary objective of the olutasidenib arm of the trial is to estimate progression-free survival. The study is estimated to begin enrolling patients in the first half of 2024 and will fulfill Rigel's post-marketing pediatric study requirement related to the FDA approval of Rezlidhia in relapsed or refractory AML.

08:09 EST Sprinklr appoints Trac Pham as interim COO - Sprinklr (CXM) announced the appointment of Trac Pham as interim COO. Pham will report directly to Sprinklr Founder and CEO Ragy Thomas and join the executive leadership team to help drive cross-functional alignment on all business operations and planning decisions. Pham retired as CFO at Synopsys (SNPS) in 2022.

08:08 EST TransUnion enhances TruAudience marketing solutions line - TransUnion announced the enhancement of its TruAudience marketing solutions line with the newly improved TransUnion identity graph that delivers more accurate identity resolution and robust demographic enrichment. This marks a significant step forward in the integration of the Neustar and TransUnion marketing businesses, as clients using products across our portfolio benefit. TransUnion's identity graph serves as the single backbone for an interoperable suite of identity-driven marketing products. TransUnion's unique approach to graph building incorporates advanced artificial intelligence (AI) to cluster identifiers into individuals and households and then score the strength of those identities. This methodology helps drive greater scale and more accuracy from the combined data assets of TransUnion and Neustar, leading to superior recommendations.

08:08 EST ProPhase Labs appoints Latkin as COO - ProPhase Labs reported that Jed Latkin, a long-time operations and finance expert, has accepted the role as COO of the parent company. Latkin, a Columbia MBA, represented the seller in the Company's acquisition of the BE-SMART Esophageal Cancer Test. He immediately became a consultant to ProPhase to help develop its biotech assets including the BE-Smart test as the Company works toward its commercialization, as well as work on the Company's other subsidiaries.

08:07 EST Elevance Health to acquire Paragon Healthcare, terms undisclosed - Elevance Health announced that it has entered into an agreement to acquire Paragon Healthcare, a company specializing in life-saving and life-giving infusible and injectable therapies. The company, headquartered in Plano, Texas, provides care to patients with a broad range of chronic and acute conditions. Paragon Healthcare serves more than 35,000 patients at over 40 ambulatory infusion centers across eight states as well as patients' homes. The company helps treat more than 300 health conditions with 24/7 on-call support. Following the acquisition, Elevance Health will look to expand Paragon Healthcare's geographical footprint and operations while bolstering its therapeutic coverage. Elevance Health will also remain committed to the company's leading customer service approach. Once integrated, Paragon Healthcare patients who receive both medical and pharmacy benefits from Elevance Health's subsidiaries will benefit from the company's ability to leverage medical and pharmacy data to deliver proactive, whole health insights. After the acquisition closes, Paragon Healthcare will operate as part of CarelonRx, the pharmacy services segment within Carelon, Elevance Health's health services division. The acquisition is subject to customary closing conditions and is expected to close in the first half of 2024; it is not expected to have a material impact on adjusted earnings per share in 2024.

08:07 EST Vislink appoints DeSalvo as CFO, Vice President of Operations - Vislink Technologies (VISL) announced the appointment of Christopher DeSalvo as its Chief Financial Officer, CFO, and Vice President of Operations, effective immediately. In his most recent role as Shared Services and Operations Executive at Paychex (PAYX), DeSalvo led initiatives resulting in substantial annual savings, operational excellence, and robust client engagement. Paul Norridge will transition from his role as Chief Financial Officer of the Company to the position of Vice President of Finance. He will serve in this capacity until March 31, 2024, at which point he will become an advisor to the Company as needed. This transition is part of a mutually agreed plan and reflects a shared commitment to ensure a smooth and effective transition.

08:06 EST Kratos Defense, Rancher Government Solutions partner for OpenSpace platform - Kratos Defense & Security Solutions and Rancher Government Solutions announced a strategic partnership to enable customers to seamlessly deploy and scale virtual ground systems using Kratos' software-based OpenSpace Platform.

08:04 EST Eiger BioPharmaceuticals announces 1-for-30 reverse stock split - Eiger BioPharmaceuticals announced that it will conduct a reverse stock split of its outstanding shares of common stock at a ratio of 1-for-30. The Reverse Stock Split will become effective at 11:59 p.m. Eastern Time, on January 5, 2024. The company's common stock will begin trading on a post-split basis at the market open on January 8, 2024. The Reverse Stock Split is part of the company's plan to regain compliance with the minimum bid price requirement of $1.00 per share required to maintain continued listing on The Nasdaq Global Market, among other benefits.

08:04 EST Gorilla's AI solution assists London's police to secure successful convictions - Gorilla Technology announces the successful application of its Smart Policing Solution, in assisting the London's Metropolitan Police Service in the recent murder case of Susan Hawkey in Neasden. Gorilla's Post Event based Smart Policing Solution played a crucial role in expediting the comprehensive analysis of diverse and extensive video footage collected during the investigation. The system facilitated a rapid examination of thousands of hours of evidence, having successfully identified, categorized, and reconstructed events captured from various locations, pinpointing people of interest with precision. "Our team is thrilled with this result and we extend our heartfelt congratulations to the Metropolitan Police Service on this conviction. Video footage often plays an important, or even pivotal, role in these types of investigations. I am delighted that Post Event aided in bringing justice in this complex case and delivered meaningful efficiencies to the Met's resources. Artificial intelligence tools are working as they should - empowering users to deliver remarkable results," said Will Addison, VP of Innovation & Growth EMEA, of Gorilla Technology.

08:02 EST Dare Bioscience achieves technological proof of concept for DARE-LARC1 - Dare Bioscience has achieved technological proof of concept for DARE-LARC1 and the underlying innovative drug delivery platform designed to store and precisely deliver therapeutic doses over months or years through a single device. This milestone reflects the drug delivery platform's potential to address the treatment burden for various conditions where treatment requires frequent dosing or regular injections. The technology behind this drug delivery platform was originally developed at the Massachusetts Institute of Technology by renowned researchers Robert Langer, Ph.D. and Michael J. Cima, Ph.D. and was previously validated in a first-in-human study in osteoporosis patients using an earlier prototype. Dare has since made significant technological enhancements to the design and integration of custom electronics, hardware, and software to achieve drug delivery targets while incorporating user feedback to optimize form and function. Dare's progress has resulted in a highly versatile platform technology with potential to address meaningful unmet needs in reproductive health as well as other therapeutic areas including diabetes, obesity, and other conditions requiring precise and prolonged treatment. To support development opportunities outside of the reproductive health category, including diabetes, obesity, and other conditions requiring precise and prolonged treatment, Dare plans to begin strategic discussions with potential industry partners.

08:01 EST Ocuphire Pharma receives FDA agreement under SPA for LYNX-2 Phase 3 trial - Ocuphire Pharma announced it has received agreement from the U.S. Food and Drug Administration, FDA, under a Special Protocol Assessment, SPA, for the clinical trial protocol and planned statistical analysis of the LYNX-2 Phase 3 trial to evaluate phentolamine ophthalmic solution for the proposed indication for the treatment of decreased visual acuity under dim light conditions. "The SPA agreement with the FDA provides a clear regulatory path for phentolamine ophthalmic solution in patients with poor night vision after keratorefractive surgery," said George Magrath, M.D., M.B.A, M.S, CEO of Ocuphire. "Preparations for the LYNX-2 Phase 3 trial have begun, and we anticipate patient enrollment to begin in the first quarter of 2024." Ocuphire received written agreement from the FDA that the clinical trial protocol and planned statistical analysis of the LYNX-2 Phase 3 trial of phentolamine ophthalmic solution could adequately address objectives supporting regulatory submission and a potential future marketing application in this indication.

07:54 EST Relmada Therapeutics provides corporate update - Relmada Therapeutics provided a corporate update and outlined its anticipated 2024 clinical development milestones. CEO Sergio Traversa said, "In our ongoing Phase 3 program for REL-1017 as an adjunctive treatment for major depressive disorder, we completed a thorough analysis of the study 301 and study 303 results...Importantly, study 302 is now approximately 50% enrolled. We have also completed all of the necessary pre-clinical, manufacturing and Phase 1 studies required for a potential REL-1017 NDA filing, and are currently conducting various pre-commercial readiness activities...Looking ahead, we have multiple clinical development milestones expected in 2024, for both REL-1017 and our non-psychedelic/modified-release psilocybin program, and we expect our cash runway to extend beyond all of these anticipated catalysts." Upcoming anticipated milestones include: complete enrollment in REL-1017 study 302 in the first half of 2024; complete enrollment in REL 1017 study 304 by year-end 2024; commencing Phase 1 trial in obese patients with steatotic liver disease in the first half of 2024 to define the pharmacokinetic, safety and tolerability profile of the company's modified-release psilocybin formulation, followed by a Phase 2a trial to establish clinical proof-of-concept with data expected in the first half of 2025.

07:48 EST Rekor Systems announces $2.1M contract expansion with TxDOT - Rekor Systems announced that its Transportation Management division has expanded collaboration with the Texas Department of Transportation. This contract leverages Rekor's cutting-edge AI-powered traffic management platform, Rekor Command, to enhance traffic management and safety in the TxDOT Austin District, including Austin and the surrounding areas. TxDOT first awarded Rekor a contract in August 2022. This renewal and expansion, worth $2.1 million over a 5-year term, will significantly enhance the features and services Rekor Command provides to ensure smarter, safer, and more efficient transportation for the Austin District.

07:46 EST Medigus says Revoltz opens for pre-orders for PORTO EV - Medigus announced the launching of the pre-order of the PORTO, an innovative electric vehicle from its subsidiary, Revoltz Ltd. The pre-order launch is led by Revoltz, which is 19.9% held by Charging Robotics Ltd., a wholly owned subsidiary of Fuel Doctor Holdings. Revoltz specializes in high-end, mini electric vehicles, bringing innovation and elevating single-rider transportation. Revoltz will enable customers to secure their specifically designed PORTO during the launch period.

07:42 EST Kiniksa expects cash to fund operating plan into at least 2027 - Kiniksa's year-end 2023 cash, cash equivalents, and short-term investments of $206.3 million (unaudited) are expected to fund its current operating plan into at least 2027.

07:39 EST SHF Holdings originates $9M loan for major cultivation facility in Colorado - SHF Holdings announced that it originated a $9M loan to fund the refinancing of a major Colorado cultivation facility in Denver, Colorado. The $9 million loan, which will refinance existing debt, is being funded by Safe Harbor and its partner financial institutions at market-competitive rates and terms for permanent financing. Dan Roda, Executive Vice President & Chief Operating Officer at Safe Harbor, stated, "This new, sizable loan speaks directly to Safe Harbor's increasing loan placement activity and the role the Company continues to play in supporting the growth of leading cannabis MSOs around the country. As we further build our loan book by originating and participating in today's market-leading deals and opportunities, this growing revenue channel, composed of origination fees and interest income, continues to drive a new level of financial growth for Safe Harbor."

07:38 EST Kiniksa sees 2024 ARCALYST net product revenue $360M-$380M - Portfolio Execution: ARCALYST: ARCALYST net product revenue was $71.2 million and $233.1 million for the fourth quarter and full year 2023, respectively. Since launch in April 2021, more than 1,700 prescribers have written ARCALYST prescriptions for recurrent pericarditis. As of the end of the fourth quarter of 2023, average total duration of ARCALYST therapy in recurrent pericarditis increased to approximately 23 months. As of the end of the fourth quarter of 2023, approximately 9% of the target 14,000 multiple-recurrence patients were actively on ARCALYST treatment. Kiniksa increased the size of its salesforce to approximately 85 representatives by the end of 2023 to help drive further physician adoption and patient enrollments in 2024. Kiniksa expects 2024 ARCALYST net product revenue of between $360 million and $380 million. Abiprubart: Kiniksa announced that the Phase 2 clinical trial of abiprubart in rheumatoid arthritis met its primary efficacy endpoint, change from baseline in Disease Activity Score of 28 Joints Using C-reactive Protein versus placebo. In Cohorts 1 and 2 multiple doses of abiprubart were well-tolerated and enabled the proof-of-concept portion of the study. Although these cohorts were not powered for DAS28-CRP, the following results were observed: In Cohort 1, in the abiprubart 2 mg/kg subcutaneous biweekly dosing group the mean change from baseline in DAS28-CRP at Week 12 was -3.16 points compared to -1.09 points in pooled placebo recipients. In Cohort 2, in the abiprubart 5 mg/kg SC biweekly dosing group, the mean change from baseline in DAS28-CRP at Week 12 was -3.44 points compared to pooled placebo recipients. In Cohort 3, in the abiprubart 5 mg/kg SC weekly dosing group, the Least Squares mean change from baseline in DAS28-CRP at Week 12 was -2.21 points compared to -1.65 points in placebo recipients. In Cohort 3, in the abiprubart 5 mg/kg SC biweekly dosing group, the LS mean change from baseline in DAS28-CRP at Week 12 was -2.00 points compared to -1.65 points in placebo recipients. Abiprubart significantly reduced Rheumatoid Factor by over 40% in both Cohort 3 dose levels. Abiprubart was well-tolerated, with no dose-related adverse experiences observed. Kiniksa has now completed enrollment in a fourth cohort of the Phase 2 clinical trial of abiprubart in rheumatoid arthritis. Cohort 4 will evaluate a fixed dose level administered as a single subcutaneous injection once monthly. The company expects data from Cohort 4 in the second quarter of 2024. Mavrilimumab: Kiniksa is now evaluating potential partnership opportunities to advance development of mavrilimumab, which has generated positive data in mid-stage clinical trials across multiple indications.

07:38 EST Eli Lilly launches end-to-end digital healthcare experience through LillyDirect - Eli Lilly announced LillyDirect, a new digital healthcare experience for patients in the U.S. living with obesity, migraine and diabetes. LillyDirect offers disease management resources, including access to independent healthcare providers, tailored support, and direct home delivery of select Lilly medicines through third-party pharmacy dispensing services. For patients living with obesity, migraine and diabetes, LillyDirect offers: LillyDirect Pharmacy Solutions, a digital pharmacy for select Lilly medicines powered by third party online pharmacy fulfillment services; disease state and healthcare educational information to help empower and support patients on their care journeys; access to independent telehealth providers; an independent search tool that allows a patient to find healthcare professionals near them if they prefer in-person care. LillyDirect will continue to be updated and expanded to improve the customer experience. Future updates may include new products, partners and services, such as programs designed to help patients with adherence to their medicines.

07:37 EST Cognition Therapeutics CEO issues letter to shareholders - Cognition Therapeutics announced that CEO Lisa Ricciardi has issued a Letter to Shareholders to provide an update on recent pipeline developments and a preview of the company's strategy in 2024. "The year ahead holds great promise for Cognition Therapeutics. We are anticipating proof-of-concept data from two Phase 2 neurodegenerative disease studies of our lead clinical oral product candidate, CT1812: the SHINE trial in mild-to-moderate Alzheimer's disease and the SHIMMER trial in mild-to-moderate dementia with Lewy bodies. As we work towards these important milestones, we take stock of the achievements that give rise to optimism at Cognition Therapeutics and in the broader medical community. With the landmark approval of the first disease-modifying anti-amyloid drugs, patients and their families can access treatments to slow the progression of Alzheimer's disease... Advances are continuing not only in disease treatment but in the development of tools for diagnosis and monitoring. Results from our studies with fluid biomarkers and instruments like quantitative EEG, as well as those of other innovating companies using these tools, are providing insights into noninvasive ways to diagnose, stage and monitor treatments... Key Clinical Milestones Expected in 2024. Our first catalyst in 2024 is expected to occur at mid-year when we unblind topline safety and efficacy data from our Phase 2 SHINE trial of oral CT1812 in adults with mild-to-moderate Alzheimer's disease... Also in 2024, we anticipate reaching full enrollment for our SHIMMER trial, which is evaluating oral CT1812 in adults diagnosed with mild-to-moderate DLB, the second most common form of dementia. More than half of DLB patients are estimated to have both Abeta and alpha-synuclein oligomers in the brain.. Our 540-patient START trial in adults with early Alzheimer's disease is actively recruiting participants from a number of Alzheimer's Clinical Trials Consortium centers of excellence. We and our collaborators on this study made the important decision to allow participants on stable background therapy with lecanemab to enroll in START, which we expect will provide real-world evidence of CT1812's potential as a monotherapy and in combination with monoclonal antibody treatments. In addition, our early proteomics analyses and subsequent preclinical work provided compelling evidence that the sigma-2 receptor has an important role in the function of retinal pigment epithelial cells,"

07:35 EST Conagra Brands cites 'ongoing challenging macro environment' in Q2 - Sean Connolly, president and CEO of Conagra Brands, commented, "Despite an ongoing challenging macro environment, we saw several positive signs in Q2. In particular, volume trends in our domestic retail business improved substantially, as inflation-driven volume declines were cut in half compared to Q1. Most importantly, our targeted investments in our frozen business generated strong lifts and market share gains. These developments reinforced our confidence in investing to build momentum in the second half and set up a strong FY25."

07:34 EST Kiniksa reports Q4 ARCALYST net product revenue $71.2M - "Strong execution to date has laid the foundation for the continued advancement of Kiniksa's portfolio in 2024. ARCALYST 2023 net product revenue grew ~90% year-over-year to $233.1M, underscoring our robust commercial performance. We believe there is substantial opportunity with ARCALYST in recurrent pericarditis and expect to drive continued revenue growth and collaboration profitability by reaching an increasing number of patients. In fact, at the end of 2023 Kiniksa penetrated approximately 9% into the multiple-recurrence population, compared to approximately 5% at the end of 2022," said Sanj K. Patel, Chairman and Chief Executive Officer of Kiniksa. "Additionally, abiprubart showed clinical effect in the first three cohorts of the Phase 2 trial in rheumatoid arthritis. Despite a high placebo response rate, the 5 mg/kg weekly dose level in Cohort 3 achieved statistical significance, but the 5 mg/kg biweekly dose level did not. We look forward to evaluating results from Cohort 4, and we will use the totality of the data to determine next steps for the program. Importantly, our strong financial position provides optionality to continue to invest across our business, including ARCALYST commercialization as well as both pipeline and business development."

07:33 EST Soligenix reports top-line results of Phase 2a study of SGX302 in psoriasis - Soligenix announced preliminary top-line results of its ongoing Phase 2a trial of SGX302 - synthetic hypericin - for the treatment of mild-to-moderate psoriasis. In the expanded portion of the trial, an additional five patients were enrolled. The Cohort 2 patients were treated more aggressively than the patients enrolled in Cohort 1 during an 18-week treatment period. SGX302 therapy was well tolerated by all patients with no drug related adverse events identified. In the four evaluable patients from Cohort 2, two reached a disease status of "Almost Clear". In addition, the Psoriasis Activity and Severity Index score for patients in Cohort 2 had a mean drop of approximately 50% over the 18-week treatment. The company anticipates continuing to pursue SGX302 in psoriasis as it completes discussions with the FDA and the European Medicines Agency regarding a feasible confirmatory trial design for HyBryte in the treatment of early-stage CTCL.

07:25 EST Clearmind Medicine, SciSparc reflect on collaboration in 2023 - Clearmind Medicine (CMND) reflects on the collaboration with SciSparc (SPRC) in 2023. Early in 2023, Clearmind filed six provisional patent applications with the United States Patent and Trademark Office for unique combinations of future psychedelic-based compounds. The patent applications were filed as part of Clearmind's ongoing collaboration with SciSparc, a specialty clinical-stage pharmaceutical company focusing on the development of therapies to treat disorders of the central nervous system. The patent applications, refer to novel proprietary combinations of lysergic acid diethylamide, psilocybin, and N,N-dimethyltryptamine, 3,4-Methylenedioxymethamphetamine, Ibogaine, and Ketamine, each with Palmitoylethanolamide, the active ingredient of SciSparc's proprietary CannAmide. The companies said,"The patent applications are part of the company's commitment to offer patients safer and more effective treatments than those available today partly by strengthening its IP portfolio to broaden the therapeutic psychedelic toolbox for patients with mental health disorders that require transformative medicines, and developing treatments that offer synergy, efficacy and safety while reducing cost." Clearmind has a broad IP footprint in the psychedelic space, with 51 patents in 15 utility patent families, of which twenty-six are granted patents in major jurisdictions like the US, Europe, China, and India and twenty-five patent pending applications internationally. As part of the collaboration agreement between Clearmind and SciSparc, originally announced on March 8,2022, any assets generated from the collaboration shall be jointly owned by Clearmind and SciSparc .

07:23 EST SciSparc, Clearmind Medicine reflect on collaboration in 2023 - SciSparc (SPRC) reflects on the collaboration in 2023 with Clearmind Medicine Inc. (CMND). Early in 2023, Clearmind filed six provisional patent applications with the United States Patent and Trademark Office for unique combinations of future psychedelic-based compounds, as part of its ongoing collaboration with SciSparc. The patent applications are for novel proprietary combinations of lysergic acid diethylamide, psilocybin, N,N-dimethyltryptamine and Palmitoylethanolamide and novel proprietary combinations of 3,4-Methylenedioxymethamphetamine, Ibogaine, Ketamine, and PEA. PEA is the active ingredient of SciSparc's proprietary CannAmide. The companies said, "The patent applications represent a commitment by SciSparc and Clearmind to offer patients safer and more effective treatments than those available today partly by strengthening their IP portfolios to broaden the therapeutic psychedelic toolbox for patients with mental health disorders that require transformative medicines and by developing treatments that offer synergy, efficacy and safety, while reducing the total cost." As part of the collaboration agreement between SciSparc and Clearmind, originally announced on March 8,2022, any assets generated from the collaboration shall be jointly owned by SciSparc and Clearmind.

07:21 EST Wearable Devices releases Mudra Developer Kit - Wearable Devices announced the launch of the Mudra Developer Kit, a technology in wristband neural gesture control, set to redefine how we interact with our devices. With the capability of interpreting neural signals intended for the fingers, the Mudra Developer Kit signifies a leap forward in the human-device interaction domain.

07:20 EST Kymera Therapeutics highlights immunology strategy at R&D Day - Kymera Therapeutics will share an overview of its strategy to build the industry leading immunology pipeline of oral degrader medicines that target validated pathways and demonstrate efficacy comparable to biologic therapies. As part of its strategy, Kymera is unveiling two new programs that each have the potential to address multiple immune-mediated diseases, each with considerable market potential. The new programs target STAT6, the obligate and specific transcription factor of the IL-4/13 pathway, and TYK2, the key scaffolding kinase of the IL-23/IFN pathways. These represent two essential signaling nodes in genetically and clinically validated pathways driving inflammation in autoimmune diseases that are undrugged or inadequately drugged with other technologies. Kymera will share its immunology strategy, including market insights, program updates, new preclinical data and development timelines, at its virtual R&D Day this morning. The R&D Day presentation will focus on three first-in-class oral degrader immunology programs, including Kymera's new, wholly-owned STAT6 and TYK2 degraders and its IRAK4 degrader: KT-621: STAT6 is an essential transcription factor specific to the IL-4/IL-13 signaling pathway and the central driver of Type 2 inflammation in allergic diseases. STAT6 is a genetically validated target and the pathway has been clinically validated by approved IL-4/IL-13-targeting biologics, including dupilumab. In preclinical studies, KT-621, Kymera's first-in-class oral STAT6 degrader, demonstrated full inhibition of the IL-4/IL-13 pathway in all relevant human cell contexts with picomolar potency that was superior to dupilumab, and equivalent or superior efficacy to dupilumab in multiple preclinical efficacy studies. In addition, at low oral doses, KT-621 demonstrated near full in vivo STAT6 degradation and was well-tolerated in multiple preclinical toxicity studies. KT-621, a once daily oral small molecule degrader with a preclinical biologics-like efficacy profile, has the potential to have broad activity across multiple diseases, including atopic dermatitis, asthma, chronic obstructive pulmonary disorder, eosinophilic esophagitis and chronic rhinosinusitis with nasal polyps, among others. The Company expects to initiate a Phase 1 clinical trial in the second half of 2024 and report the Phase 1 results in 2025. KT-294: TYK2 is a member of the Janus Kinase family required for Type I interferon, IL-12 and IL-23 signaling with both genetic and clinical validation in autoimmune and inflammatory diseases. TYK2 has a well-established scaffolding function that plays a key role in cytokine receptor surface expression and activation. In preclinical studies, KT-294, Kymera's first-in-class oral TYK2 degrader, demonstrated picomolar to nanomolar potencies across all relevant human cell contexts evaluated, representing what Kymera believes is the only approach to TYK2 targeting that has the potential to recapitulate the human loss-of-function biology of near full pathway inhibition of Type I IFN, IL-12 and IL-23, while also sparing IL-10. Degradation of TYK2 has the potential to overcome the challenges of small molecule inhibitors, which have limitations due to lack of selectivity, limited target engagement, and/or lack of potent activity against Type I IFN. KT-294, a once daily oral small molecule degrader with a potential biologics-like efficacy profile, has the opportunity to address conditions such as inflammatory bowel disease, psoriasis, psoriatic arthritis and lupus, among others. Kymera intends to initiate a Phase 1 clinical trial in the first half of 2025 and report the Phase 1 results in 2025. KT-474/SAR444656: KT-474 is a first-in-class IRAK4 degrader in Phase 2 clinical trials for the treatment of hidradenitis suppurativa and atopic dermatitis. IRAK4 is a key scaffolding protein of the myddosome complex that mediates signaling through IL-1 receptors and toll-like receptors, which play a crucial role in inflammation across multiple autoimmune diseases. In a Phase 1 trial published last November in Nature Medicine, KT-474 demonstrated robust degradation of IRAK4 in the blood and skin of healthy volunteers and patients with HS and AD, which was associated with a systemic anti-inflammatory effect and preliminary evidence of clinical activity. Enrollment in both Phase 2 trials is ongoing and anticipated to be completed in the fourth quarter of 2024, with topline data expected in the first half of 2025. Kymera is collaborating with Sanofi on the development of KT-474.

07:16 EST ADC Therapeutics regains compliance with NYSE continued listing standards - ADC Therapeutics announced that it received a notice from the New York Stock Exchange on January 2, 2024 that the Company has regained compliance with the continued listing minimum price criteria set forth in Section 802.01C of the NYSE Listed Company Manual and, as a result, will be removed from the NYSE's noncompliant issuers list. The Company previously received a notice from the NYSE that it was not in compliance with the continued listing minimum price criteria, as the average closing price of its common shares was below $1.00 over a consecutive 30 trading-day period. As closing price of the common shares on December 29, 2023 and the average closing price of the common shares over the 30 trading-day period ending on December 29, 2023 were both above $1.00, the deficiency was cured.

07:15 EST Atai Life Sciences announces strategic investment in Beckley Psytech - atai Life Sciences announced a strategic investment in Beckley Psytech Limited, a private clinical-stage biotechnology company dedicated to transforming short-duration psychedelics into effective and rapid-acting medicines for neuropsychiatric conditions. This strategic investment and collaboration aims to accelerate the development of Beckley Psytech's two clinical-stage, patent-protected, short-duration psychedelic candidates, BPL-003 and ELE-101, by adding them to atai's mental health innovation platform. BPL-003 is a novel, short-duration, intranasal formulation of 5-methoxy-N,N-dimethyltryptamine, and ELE-101 is a novel intravenous formulation of psilocin, the primary moiety of psilocybin. BPL-003 is currently in development for two indications: Treatment Resistant Depression and Alcohol Use Disorder, with three clinical trials underway. In addition to the Phase 2b study in TRD that is anticipated to read out in the second half of 2024, BPL-003 is also being investigated in two small Phase 2a open-label studies in TRD and AUD, with data expected in the first half of 2024 and mid 2024 respectively. Under the terms of the investment Beckley Psytech will remain an independent, privately-owned company and atai will own 35.5% of Beckley Psytech. This is based on a $50m total investment, with a $40m direct investment into the company to fund ongoing research programs, and an additional $10m in secondary share purchases from existing shareholders. Upon closing, atai will receive 1:1 warrant coverage at a 30% premium on the primary issuances. atai will also have the right to appoint and hold 3 of the 9 seats in Beckley Psytech's Board of Directors, and will hold a time-limited right of first refusal on a future sale of the company, asset sales or other transfer of commercial rights, as well as an indefinite right of first negotiation for BPL-003 and ELE-101.

07:12 EST OraSure secures strategic distribution rights, invests in Sapphiros - OraSure Technologies announced it is leading the Series B financing and has entered wide-ranging strategic distribution agreements with Sapphiros, a privately held consumer diagnostics portfolio company based in Boston, and certain of its related entities. Sapphiros was conceived in 2020 by experienced healthcare executive Namal Nawana and launched along with leading global investment firm KKR in 2021. Through this strategic relationship, OraSure expects to be able to offer a more comprehensive range of low-cost diagnostic tests and sample management solutions to its customers globally. OraSure has secured exclusive distribution rights to key products in Sapphiros' development pipeline that align with and enhance OraSure's existing areas of expertise, including self-collected blood samples and diagnostic tests for sexually transmitted infections, respiratory conditions, and other diseases. "Our partnership and investment in Sapphiros significantly expands and accelerates our product and innovation pipeline. It also advances our vision to improve the access, quality, and affordability of healthcare, including addressing unmet needs in the growing consumer diagnostic market," said Carrie Eglinton Manner, President and CEO of OraSure. "We are excited to collaborate with the Sapphiros team to fully unlock the value and benefits of this relationship."

07:11 EST Rapid Micro announces Samsung Biologics selected its Growth Direct platform - Rapid Micro Biosystems announced that Samsung Biologics has selected the Growth Direct platform to automate its microbial quality control processes to deliver increased efficiency, more robust data integrity and scalable quality control operations. "Samsung Biologics is a leading global contract development and manufacturing organization and has demonstrated an unwavering commitment to automation and quality management in biopharmaceutical manufacturing," said Robert Spignesi, President and CEO of Rapid Micro Biosystems. "The Growth Direct(R) improves operational efficiency and data integrity in the quality control microbiology lab, and we are proud to partner with Samsung Biologics."

07:10 EST Aldeyra announces advancement of RASP modulator platform - Aldeyra Therapeutics announced advancement of its RASP modulator platform, including the expected submission to the FDA of a proposed expansion of the Phase 2 clinical trial of the investigational RASP modulator ADX-629 in Sjogren-Larsson Syndrome to include pediatric patients, initiation of a Phase 2 clinical trial of ADX-629 in moderate alcoholic hepatitis, submission of an IND application of the investigational RASP modulator ADX-246 for a Phase 1 clinical trial that is expected to be expanded to include atopic dermatitis patients, anticipated submission of an IND application of the investigational RASP modulator ADX-248 for a Phase 1/2 clinical trial in patients with the dry form of age-related macular degeneration AMD and dark adaptation deficit, and initiation of a preclinical program of RASP modulators in metabolic disease..."With an unparalleled RASP modulator discovery and development platform, Aldeyra remains a leader in the development of RASP modulators for the treatment of immune-mediated disease," stated Todd C. Brady, M.D., Ph.D., President and Chief Executive Officer of Aldeyra.

07:10 EST Southland Holdings awarded $470M in new awards in Q4 - Southland Holdings announced that it has been awarded approximately $470M of the following new awards which will be included in fourth quarter 2023 backlog. Robert F. Kennedy Bridge rehab design-build project in New York, New York for the Metropolitan Transportation Authority. A Southland subsidiary, American Bridge Company, has approximately an 80% share in the joint venture awarded this contract. The scope of work includes rehabilitation of the East River suspended spans and anchorages, main cable dehumidification, replacement of the shared use path, replacement of the median barrier, miscellaneous deck repairs, and painting. American Bridge constructed the original bridge, formerly known as the Triborough Bridge, in 1936. In San Francisco the Oakland Bay Bridge main cable and suspender ropes rehab project in San Francisco, California for the California Department of Transportation through subsidiary, American Bridge Company. An American Bridge led joint venture completed construction of the Bay Bridge in 2014. Cedar Crest Tunnel project in Dallas, Texas for the City of Dallas through subsidiary, Southland Contracting. The scope of work consists of installation of up to 84" of steel water pipe by tunnel. Various water resource awards through subsidiary, Oscar Renda Contracting.

07:08 EST Oncolytics sees cash balance sufficient for over 12 month runway - Oncolytics CFO Kirk Look commented, "Our $40M cash balance as of September 30, 2023, and the grant funding from The Pancreatic Cancer Action Network provides us with over 12 months of runway to support our operations, including the initiation of our first Phase 3 study and the BRACELET-1 survival data. We continue to have active conversations with potential partners and work diligently with clinical collaborators, including Roche and Pfizer. We believe the positive, extended dataset, including continued and durable responses, survival results, and translational observations, will provide potential partners with a well-defined and unique target product profile that will add to our discussions." CEO Matt Coffey stated, "Looking ahead to 2024, we expect to initiate the first Phase 3 study for pelareorep in pancreatic cancer. The transition to a late-stage biopharmaceutical company will mark an important inflection point for investors, clinical collaborators and potential partners by providing a line of sight towards the path to regulatory approval and achieving our mission of developing pelareorep as an immunotherapeutic agent for cancer. We are excited to launch a new Phase 1/2 pancreatic cancer study investigating, for the first time, pelareorep in combination with modified FOLFIRINOX. Finally, our discussions with regulators on a pivotal Phase 3 trial have been productive to date, and we expect to provide guidance on the registration path for metastatic breast cancer in the first half of 2024..."

07:06 EST Axsome Therapeutics provides 2024 development pipeline anticipated milestones - Axsome is advancing an industry-leading neuroscience portfolio encompassing five innovative late-stage product candidates for 10 serious conditions, which affect more than 150 million people in the U.S. alone. 2024 anticipated milestones for key pipeline programs are summarized below. Regulatory Milestones: AXS-07 for migraine, NDA resubmission 1H 2024; AXS-14 for fibromyalgia, NDA submission 1Q 2024. Clinical Trial Topline Results: Phase 3 SYMPHONY trial of AXS-12 in narcolepsy 1Q 2024; Phase 3 ADVANCE-2 trial of AXS-05 for Alzheimer's disease agitation 1H 2024; Phase 3 FOCUS trial of solriamfetol in attention deficit hyperactivity disorder in adults 2H 2024. Clinical Trial Initiations: Phase 3 trial of solriamfetol in major depressive disorder 1Q 2024; Phase 3 trial of solriamfetol for binge eating disorder 1Q 2024; Phase 3 trial of solriamfetol in shift work disorder 1Q 2024; Pivotal Phase 2/3 trial of AXS-05 for smoking cessation 2024.

07:04 EST Mobileye drops 27% to $28.70 after issuing weak guidance

07:03 EST Mobileye cites 'excess inventory at our customers' for Q1 guidance - The company stated, "As a result of our standard planning process for the upcoming year, including discussions with our Tier 1 customers to determine potential orders for 2024, we have become aware of excess inventory at our customers, which we believe to be 6-7 million units of EyeQ SoCs. Based on our discussions, we understand that much of this excess inventory reflects decisions by Tier 1 customers to build inventory in the Basic ADAS category due to supply chain constraints in 2021 and 2022 and a desire to avoid part shortages, as well as lower than-expected production at certain OEM's during 2023. As supply chain concerns have eased, we expect that our customers will use the vast majority of this excess inventory in the first quarter of the year. As a result, we expect that first quarter 2024 revenue will be significantly below first quarter 2023 revenues and that we will see revenue normalized during the remainder of 2024. In FY2024 we expect total revenue in the range of $1,830 - $1,960 million. This is underpinned by expected EyeQ shipments of 31 - 33 million units (as compared to approximately 37m units in 2023) and SuperVision shipments of 175k - 195k units (as compared to approximately 100k units in 2023). We currently expect Q1 revenue to be down approximately 50%, as compared to the $458 million revenue generated in the first quarter of 2023. We also currently believe that revenue over the balance of the year will be impacted by inventory drawdowns to a much lesser extent. As a result, we expect revenue for Q2 through Q4 2024 on a combined basis to be roughly flat to up mid single-digits as compared to the same period in 2023, and we expect inventory at our customers to be at normal levels by the end of 2024. We anticipate that the lower-than-expected volumes in the EyeQ SoC business will have a temporary impact on our profitability. Similar to revenue, we expect Q1 profit levels to be significantly below the subsequent quarters. We expect Q1 2024 Operating Loss to be in the range of $257 to $242 million. Excluding amortization of intangible assets and stock-based compensation, we expect Adjusted Operating Loss in the range of $80 to $65 million in the first quarter of 2023. We expect FY2024 Operating Loss to be in the range of $468 to $378 million. We expect Adjusted Operating Income in the range of $270 - $360 million."

07:01 EST V2X wins $190M U.S. Army contract in Middle East - V2X was awarded a $190M contract from the U.S. Army as part of the United States Army Central Command Training and Range Operations Maintenance Services Contract. The competitively bid firm-fixed-price contract will span five-years, continuing V2X's support to USARCENT's mission in Kuwait as well as other locations. V2X will provide training support services as well as instruction, operation, and maintenance of Training Aids, Devices, Simulators and Simulations.

06:52 EST The Buckle reports December SSS down 5.8% y/y - The Buckle announced that comparable store net sales, for stores open at least one year, for the 5-week period ended December 30, 2023 decreased 5.8% from comparable store net sales for the 5-week period ended December 31, 2022. Net sales for the 5-week fiscal month ended December 30, 2023 decreased 5% to $203.8M from net sales of $214.5M for the prior year 5-week fiscal month ended December 31, 2022. Comparable store net sales year-to-date for the 48-week period ended December 30, 2023 decreased 7.4% from comparable store net sales for the 48-week period ended December 31, 2022. Net sales for the 48-week fiscal period ended December 30, 2023 decreased 6.8% to $1.189B compared to net sales of $1.276B for the prior year 48-week fiscal period ended December 31, 2022.

06:50 EST New Era Helium Corp. to list on Nasdaq via merger with Roth CH Acquisition V Co. - New Era Helium Corp., an exploration and production company that sources helium produced in association with the production of natural gas reserves in North America, and Roth CH Acquisition V Co., announced the signing of a definitive agreement for a business combination at a pre-money valuation of $90M, that is expected to result in NEH becoming a public company. Upon the closing of the transaction, subject to approval by ROCL's stockholders and other customary closing conditions, the combined company will be named "New Era Helium Corp." and is expected to list on NASDAQ. Current NEH Chairman, Joel Solis, and CEO, E. Will Gray II, will continue to lead the combined company, and existing NEH shareholders will roll 100% of their equity into the combined company. The transaction is expected to close in the first half of 2024.

06:44 EST CGI Inc. selected to partner with NATS for air traffic operations in the UK - CGI has been selected to partner with NATS, a UK provider of air traffic control services, to help transform and modernize the company's digital infrastructure and evolve its services for air traffic operations in the UK. The seven-year agreement is the culmination of a year of working together and will deliver data center and hosting services to further increase the resilience, flexibility, and scalability of NATS' critical digital infrastructure. CGI's support will include transitioning NATS to a hybrid cloud model using an agile delivery approach. In addition, CGI will provide NATS with consulting services, frameworks, and practices for transforming and managing its complex IT portfolio. NATS provides air traffic services at 14 UK airports and manages all UK airspace from two air traffic control centres located at Swanwick in Hampshire, and Prestwick in Ayrshire.

06:35 EST New Found Gold increases Queensway drill program to 650,000 meters - New Found Gold announced an expansion of the exploration program at its 100% owned Queensway Project on the Trans-Canada Highway, Newfoundland. To date the company has completed 516,263 m of drilling at Queensway. New Found is now planning to drill a total of 650,000m as part of its ongoing drilling program at Queensway, an increase of 150,000m over the company's initially planned 500,000m. In 2023, the company contracted HiSeis to complete a 3D seismic program covering the Appleton North Corridor at Queensway North to a depth of 3,000m. The company expects to receive an initial interpretation of this data in the coming weeks.

06:25 EST Zymeworks sees cash runway sufficient into 2H 2027 - Zymeworks (ZYME) provided an update on key strategic priorities for 2024 and 2025. Zymeworks partner Jazz Pharmaceuticals (JAZZ) presented positive pivotal Phase 2b trial data evaluating zanidatamab in HER2-amplified BTC and initiated rolling Biologics License Application submission for accelerated approval in second-line BTC with completion expected in the first half of 2024. As of December 31, 2023, Zymeworks had cash resources on hand of approximately $455M. Collaboration agreements with Jazz Pharmaceuticals and BeiGene represent important components of the commercialization strategy for zanidatamab and the strategy is to continue to expand future product pipeline. Under the company's amended agreement with Jazz, it has received an aggregate of $375M in proceeds to date, and remains eligible to receive up to $525M upon the achievement of certain regulatory milestones and up to $862.5M in potential commercial milestone payments, and tiered royalties between 10% and 20% on future zanidatamab sales, pending regulatory approval of zanidatamab. The company's collaboration agreement with BeiGene in certain Asia Pacific regions remains important given the high prevalence of BTC and GEA in the APAC region. Through the collaboration with BeiGene on zanidatamab, the company remains eligible to receive up to $195M in additional development and commercial milestones together with tiered royalties ranging from the high single digit percentages up to 19.5% on net sales of zanidatamab, pending regulatory approval. Expects to submit INDs for ZW171 and ZW191 in 2024, and INDs for ZW220 and ZW251 in 2025. During 2024, expects to nominate the final '5 by 5' product candidate for preclinical development with an expected IND filing in 2026. Believes that zanidatamab zovodotin has the potential to become a novel treatment option for advanced HER2+ cancers, supporting further but limited clinical development. It will be evaluated in a planned Phase 2 study in HER2 over-expressing NSCLC patients in combination with a checkpoint inhibitor.

06:16 EST Tutor Perini subsidiary awarded $80.7M New Residence Hall at Mississippi State - Tutor Perini subsidiary Roy Anderson has been awarded a project valued at approximately $80.7M for the New Residence Hall at Mississippi State University in Starkville, MS. The project scope of work entails construction of a 155,000 square-foot, five-story residence hall on the Mississippi State University campus. Work is expected to begin in February 2024 with substantial completion anticipated in the spring of 2025. The contract value will be included in the company's backlog beginning in 4Q23.

06:11 EST Callon Petroleum jumps 6% to $35.69 after APA Corp. buyout proposal

06:07 EST APA Corp. acquiring Callon Petroleum in all-stock transaction for $4.5B - APA Corporation (APA) and Callon Petroleum (CPE) have entered into a definitive agreement under which APA will acquire Callon in an all-stock transaction valued at approximately $4.5B, inclusive of Callon's net debt. On a pro forma basis, total company production exceeds 500K BOE per day and enterprise value increases to more than $21B. APA's oil-prone acreage in the Midland and Delaware Basin combined will increase by more than 50% following the transaction; the operation is expected to be accretive on key financial and value metrics; estimated overhead, operational and cost-of-capital synergies are expected to exceed $150M annually; pro forma balance sheet with leverage at 1.1x net debt / adjusted EBITDAX. Pro forma average daily Permian Basin production was 311 Mboe/d in 3Q 2023, which represents a 48% increase from APA's Permian Basin production on a standalone basis. APA's oil production as a percentage of BOE's in the Permian increases from approximately 37% to 43% in 3Q 2023, on a pro forma basis. Each outstanding share of Callon common stock will be exchanged for 1.0425 shares of APA common stock, representing an implied value to each Callon share of $38.31 per share. APA is expected to issue approximately 70 million shares of common stock in the transaction. After closing, existing APA shareholders are expected to own approximately 81% of the combined company and existing Callon shareholders are expected to own approximately 19% of the combined company. APA expects to retire the existing debt at Callon and replace it with APA term loan facilities totaling $2.0B. JPMorgan Chase Bank, Citigroup Global Markets and Wells Fargo Bank, National Association, have jointly provided $2.0B of committed financing for the deal. The transaction has been unanimously approved by the Boards of Directors of both APA and Callon and is expected to close during Q2. Upon the closing of the transaction, a representative from Callon will join the APA board. APA's executive management team will lead the combined company with the headquarters remaining in Houston, Texas. Following the closing, the company's worldwide pro forma production mix will be approximately 64% U.S. / 36% international.

06:04 EST Zymeworks names Dr. Jeffrey Smith as Chief Medical Officer - Dr. Jeffrey Smith has been promoted to Executive Vice President and Chief Medical Officer, where he will play a key role in leading the clinical development of our early-stage programs and overseeing our integrated global early-stage development group. Dr. John Fann has been promoted to Senior Vice President, Process Sciences, where he will continue to play a key role in supporting the advancement of our new product candidates from preclinical studies into clinical trials.

06:03 EST Novo Nordisk enters research pacts with Omega Therapeutics, Cellarity - Novo Nordisk (NVO), Omega Therapeutics (OMGA) and Cellarity announced that Novo Nordisk has entered into separate research collaborations with each company. The Omega collaboration will leverage its proprietary platform technology to develop an epigenomic controller designed to enhance metabolic activity as a part of a potential new treatment approach for obesity management. The Cellarity collaboration aims to unravel novel biological drivers of MASH and will leverage Cellarity's platform to develop a small molecule therapy against this disease. These are the first two programs signed under the framework collaboration between Flagship Pioneering and Novo Nordisk to leverage Flagship's bioplatform companies to develop novel treatment approaches for cardiometabolic diseases.

05:34 EST Teck Resources provides update on QB, Q4 steelmaking coal sales volume - Teck Resources provided unaudited 2023 production volumes for Quebrada Blanca, or QB, operations, an update on the QB2 project, and unaudited fourth quarter steelmaking coal sales volumes and realized prices. 2023 unaudited contained copper production volumes from QB, excluding copper cathode, totaled 56,200 tons, below the bottom end of our guidance range of 80,000 tons for 2023 due to reliability and consistency issues in the fourth quarter. Fourth quarter production was 35,000 tons. During the second half of 2023, each of the operations at QB, including mine operations, crushing, grinding, flotation, tailings, desalination and concentrate handling, all operated at or above design capacity. Our focus in the fourth quarter was on achieving reliable and consistent operations. This took longer than expected to achieve and, as a result, production did not meet forecast. However, by the end of December, QB was operating near design throughput capacity, and this has continued into 2024. Recoveries have generally been in line with expectations and head grades remain within expected levels. The construction of the molybdenum plant was substantially completed in December, and commissioning has commenced. Ramp-up of the molybdenum plant is expected to be completed by the end of the second quarter of 2024. Construction of the port offshore facilities is progressing to plan and is expected to be completed by the end of the first quarter of 2024. The last jetty pile was completed in December, representing a major milestone in the port construction. Our previously disclosed QB2 project capital cost guidance is unchanged at $8.6B-$8.8B. Our fourth quarter steelmaking coal sales were 6.1M tons, near the top end of our previously disclosed guidance of 5.8M - 6.2M tons. The realized steelmaking coal price in the fourth quarter averaged $270 per ton. The company expects to report positive steelmaking coal provisional pricing adjustments of $89M in the fourth quarter. Teck is expecting to provide full 2023 production results and 2024 guidance in a separate news release on January 16. Our fourth quarter and annual 2023 financial results are scheduled for release on February 21.

05:24 EST Innate Pharma announces FDA lifts clinical hold on lacutamab IND - Innate Pharma announced that the FDA has lifted the partial clinical hold placed on the lacutamab IND. On October 5, Innate announced that the lacutamab IND has been placed on partial clinical hold by FDA following a recent patient death in the TELLOMAK study. The death of a patient affected by Sezary syndrome was initially considered due to hemophagocytic lymphohistiocytosis, a rare hematologic disorder. The FDA decision to lift the partial clinical hold is based on the FDA review of the fatal case which Innate, together with a steering committee of independent experts, determined to be related to aggressive disease progression and lacutamab unrelated.

05:12 EST Tango Therapeutics doses first patient in TNG348 trial - Medivir AB announced that Medivir's licensee, Tango Therapeutics has dosed the first patient with TNG348, a novel USP1 inhibitor. Tango received FDA clearance on its Investigational New Drug application for TNG348 in September 2023.TNG348 is a novel USP1 inhibitor for the treatment of BRCA1/2-mutant and other homologous recombination deficiency, or HRD+ cancers. HRD+ cancers, including BRCA1/2 mutations, represent up to 50% of ovarian cancers, 25% of breast cancers, 10% of prostate cancers and 5% of pancreatic cancers. Tango is developing TNG348 from the preclinical USP1 program licensed from Medivir in 2020. In the study, TNG348 will be evaluated both as single agent and in combination with olaparib in patients with BRCA1/2-mutant and other HRD+ cancers. Preclinical data has shown synergistic effect with PARP inhibitors in PARP naive models, including models with resistance to PARP inhibitors.