Stockwinners Market Radar for December 16, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:05 EST Cathie Wood's ARK Investment buys 274.9K shares of PacBio today

19:50 EST 22nd Century trading halted, news pending

18:50 EST Tempest Therapeutics' PPARalpha inhibitor receives FDA orphan designation - Tempest Therapeutics' PPARalpha inhibitor, a treatment of hepatocellular carcinoma, received FDA orphan designation, according to a post on the agency's site. Reference Link

17:44 EST JBDI Holdings receives noncompliance letter from Nasdaq - JBDI Holdings announced that it received a delinquency notification letter from Nasdaq indicating that JBDI is not currently in compliance with the $1.00 minimum bid price requirement for continued listing of the company's ordinary shares on Nasdaq, as set forth in Nasdaq Listing Rules. The notice indicated that the company has 180 days, or until June 10, 2025, to regain compliance with the minimum bid price requirement by having the closing bid price of the ordinary shares meet or exceed $1.00 per ordinary share for at least ten consecutive business days.

17:24 EST Google debuts Whisk to visualize and remix ideas using images and AI - Thomas Iljic, Director of Product Management, Google Labs & Nicole Brichtova, Product Manager, Google DeepMind blogged in part: "Today in the US, we're launching our newest experiment in generative AI: Whisk. Instead of generating images with long, detailed text prompts, Whisk lets you prompt with images. Simply drag in images, and start creating. Whisk lets you input images for the subject, one for the scene and another image for the style. Then, you can remix them to create something uniquely your own, from a digital plushie to an enamel pin or sticker.Behind the scenes, the Gemini model automatically writes a detailed caption of your images. It then feeds those descriptions into Google's latest image generation model, Imagen 3. This process captures your subject's essence, not an exact replica. That way, you can easily remix your subjects, scenes and styles in novel ways...In our early testing with artists and creatives, people have been describing Whisk as a new type of creative tool - not a traditional image editor. We built it for rapid visual exploration, not pixel-perfect edits. It's about exploring ideas in new and creative ways, allowing you to work through dozens of options and download the ones you love. If you are based in the US, you can try it out today at labs.google/whisk and tell us what you think." Reference Link

17:03 EST Pentair increases quarterly dividend to 25c per share - Pentair announced that it will pay a regular quarterly cash dividend of 25c per share on February 7 to shareholders of record at the close of business on January 24. The 25c per share quarterly cash dividend, or $1.00 per share on an annualized basis, represents an approximate 9% increase in the company's regular cash dividend rate as compared to 23c per share per quarter in 2024, or 92c per share on an annualized basis. 2025 will mark the 49th consecutive year that Pentair has increased its dividend.

16:59 EST WM raises quarterly dividend 10% to 82.5c from 75c per share - WM announced that its Board of Directors has approved a 10.0% increase in the planned quarterly dividend rate for 2025, from 75c to 82.5c per share. This increase brings the annual dividend rate to $3.30 per share, up from $3.00, and marks the company's twenty-second consecutive year of dividend increases. While the company has remaining authorization from WM's Board of Directors to repurchase $1.24B of the company's common stock, as previously announced, the company has temporarily suspended share repurchases. Pausing share repurchase activity reflects the company's commitment to return to targeted leverage levels within about 18 months after the acquisition of Stericycle. Each individual future quarterly dividend will be declared at the discretion of WM's Board of Directors prior to payment. It is expected that the first increased dividend will be paid in March of 2025.

16:45 EST Novonix offered conditional commitment for $754M DoE loan for new facility - Novonix "announced a conditional commitment to NOVONIX through one if its wholly-owned U.S.-based subsidiaries, from the U.S. Department of Energy, DOE, through the Loan Programs Office for a direct loan of up to $754.8M to be applied towards partially financing a proposed new facility in Chattanooga, Tennessee. The proposed financing is being offered under the DOE LPO's Advanced Technology Vehicles Manufacturing Loan Program. If finalized, the loan would be applied towards partially financing the construction of the New Facility in Chattanooga, Tennessee, to manufacture synthetic graphite primarily for use in electric vehicle batteries. At full capacity, the new facility is expected to produce approximately 31,500 tonnes per annum of synthetic graphite, which can support the production of lithium-ion batteries for approximately 325,000 EVs each year. China currently has over 95% market share for battery grade graphite1. The new facility is expected to reach full production capacity by the end of 2028 and is anticipated to create 450 full-time operational jobs and 500 construction jobs."

16:40 EST eBay announces incremental $3B share repurchase program - In a regulatory filing, eBay stated, "On December 12, 2024, the Board of Directors of the company authorized an incremental $3.0 billion under our stock repurchase program, in addition to the remaining amounts previously authorized. Our stock repurchase program has no expiration from the date of authorization."

16:36 EST Ryder names John Diez as COO, Cristina Gallo-Aquino as CFO - Ryder System "announces the appointment of John J. Diez to president and chief operating officer, effective January 1, 2025. In this new role, Mr. Diez will continue to report to Ryder Chairman and Chief Executive Officer Robert E. Sanchez with responsibility for the general management of all business operations of Ryder's three business segments. In addition, Cristina Gallo-Aquino, most recently senior vice president, controller, and principal accounting officer since August 2020, has been promoted to succeed Mr. Diez as executive vice president and chief financial officer, effective January 1, 2025. In this role, Ms. Gallo-Aquino will oversee all of Ryder's financial management functions, including finance and accounting, treasury, tax, audit, investor relations, and continue to serve as principal accounting officer."

16:35 EST Becton Dickinson discloses resolution with SEC over Alaris System invesigation - Becton Dickinson issued the following statement: "BD has reached an agreement with the U.S. Securities and Exchange Commission (SEC) to resolve the previously disclosed investigation related to prior public disclosures and SEC reporting regarding the BD Alaris System, which was acquired by BD from CareFusion in 2015 and is part of the BD Medication Management Solutions business. The SEC Order, the findings of which BD neither admits nor denies, relate to matters concerning BD Alaris that occurred more than four years ago. As part of the settlement, BD has agreed to pay $175 million to the SEC, an amount that was reserved and disclosed in the company's fiscal year 2024 Form 10-K and was contemplated in BD's fiscal year 2025 cash flow plan. No financial restatements are required as a result of the settlement, and the settlement amount does not impact BD's investments in innovation or its previously disclosed capital allocation strategy. BD is not updating its fiscal 2025 guidance as a result of the settlement. The company believes that settling with the SEC is the right course of action to fully resolve this matter and move forward. The BD Alaris System is safe and effective and is a critical part of health care in the United States. The system has been used for many years to safely deliver IV therapies to patients, including throughout the COVID-19 pandemic. The updated BD Alaris System received 510(k) clearance from the U.S. Food and Drug Administration in July 2023, and the company continues to update its Alaris fleet. BD has implemented a number of improvements to its operational and governance processes and related disclosure practices. BD is committed to operating with integrity and the highest ethical standards to produce high-quality, safe and effective products and serve as a trusted partner for its customers and their patients."

16:33 EST Tenaya Therapeutics to announce initial data from Phase 1b/2 trial of TN-201 - Tenaya Therapeutics will announce initial Cohort 1 data from the MyPEAK-1 Phase 1b/2 clinical trial of TN-201 gene therapy for MYBPC3-associated hypertrophic cardiomyopathy on Tuesday, December 17.

16:30 EST Nano Dimension appoints Ofir Baharav as chairman - Nano Dimension announced changes in the composition of its board of directors. Nano's board currently consists of four members: Ofir Baharav, Robert Pons, Joshua Rosensweig and Kenneth Traub. Baharav has been appointed as chairman of the board. In light of the previously announced results of the company's 2024 annual general meeting of shareholders, dated December 6 and the previously announced ruling of the Israeli central region district court in Lod, dated November 21 regarding Nano's extraordinary general meeting of shareholders held on March 20, 2023, Yoav Nissan-Cohen, Eitan Ben-Eliahu, Oded Gera, Roni Kleinfeld, Chris Moran and Georgette Mosbacher have resigned from the board, effective immediately. Baharav and Pons were elected to the board following the AGM results and replaced the seats formerly occupied by Yoav Stern and Michael X. Garrett. Rosensweig and Traub were elected to the board at the EGM, but since the company had contested the legality of the EGM, they joined the board immediately after the court ruling, which determined, among other matters, that the EGM was duly held and the vote that elected them to the board was consequently valid.

16:25 EST Dow Inc. CEO buys $1.06M in common stock - In a regulatory filing, Dow Inc. disclosed that its CEO James Fitterling bought 25.6K shares of common stock on December 12th in a total transaction size of $1.06M. Dow Inc. shares are up 1% afterhours at $40.54.

16:23 EST Great Elm Capital increases 1uarterly dividend 5.7% to 37c per share - In addition, the company's board of directors has approved a quarterly cash distribution of 37c per share for the first quarter of 2025, equating to a 14.5% annualized yield on the company's closing market price on December 16, 2024 of $10.24. The First Quarter 2025 Distribution will be payable on March 31, 2025 to stockholders of record as of March 17, 2025. "We are very pleased to announce the 5.7% increase to our base quarterly distribution to $0.37 per share from $0.35 per share," said Matt Kaplan, GECC's Chief Executive Officer. "As we look into 2025, we believe our platform is well positioned to continue generating durable long-term income and we are pleased the Board has approved this increase to our base distribution. In addition, we find ourselves in a position to again deliver a special cash distribution to stockholders, attributable to our portfolio's strong income generation throughout the year."

16:21 EST Geo Group announces $70M investment in expanding ICE services - The GEO Group announced a $70 million investment in capital expenditures to strengthen the Company's capabilities to deliver expanded detention capacity, secure transportation, and electronic monitoring services to U.S. Immigration and Customs Enforcement ("ICE"). GEO is currently the largest service provider to ICE, currently providing approximately 21,000 detention beds (with a present census of 14,000) at 16 ICE Processing Centers with the ability to expand to a minimum of 32,000 beds at 23 facilities. GEO also presently provides electronic monitoring and case management services for approximately 185,000 participants under the Intensive Supervision Appearance Program, as well as secure ground transportation and air operations support services. With the objective of offsetting the $70 million investment in capital expenditures and further reducing debt, GEO intends to pursue the possible sale of several underperforming company-owned state correctional facilities.

16:16 EST Fortive recommends rejection by shareholders of TRC's mini-tender offer - Fortive Corporation has been notified of an unsolicited "mini-tender offer" by TRC Capital Investment Corporation for TRC to purchase for cash up to 1,500,000 shares, or approximately 0.44%, of the outstanding common stock of Fortive, at a price of $75.00 per share. TRC's offer price of $75.00 per share represents a 4.93% discount to the closing price per share of Fortive's common stock on December 6, 2024, the last trading day before the commencement of TRC's unsolicited mini-tender offer. Fortive recommends that shareholders reject TRC's unsolicited offer because, among other reasons, the offer price is below the current market price for shares of Fortive common stock. The offer also is subject to numerous conditions. Fortive also recommends that any shareholders who have tendered shares to TRC withdraw those shares by providing the written notice described in the offering documentation before the expiration of the offer, which is currently scheduled for one minute after 11:59 p.m., New York City Time, on January 9, 2025.

16:14 EST Affirm down 3% at $70.67 after announcing convertible debt offering

16:14 EST Mama's Creations CEO Michaels: 'Well positioned for profitable growth' - "To lead us forward and emerge as a dominant player in the prepared foods space, we also completed the build-out of our industry-leading executive team during the quarter. Chris Darling, our new Chief Commercial Officer, brings over 20 years of experience in executive leadership from a storied career in the deli - where he led world class commercial organizations at industry-leading firms such as Boar's Head, HEB, Ahold and Albertsons. Most importantly, Chris knows how to build a national brand, particularly in the prepared meal solutions space. Chris joins Skip Tappan, our Chief Operating Officer, an end-to-end supply chain leader, bringing over 30 years of experience with Gordon Food Service, Walmart, Campbell's and Procter & Gamble. With this world-class leadership team now in place, we are better positioned to fully optimize operations, execute on our Catapult growth plan and identify, acquire and integrate future M&A opportunities. "The fundamentals of our operations are incredibly strong, and with these growing pains behind us - supplemented by our investments in CapEx, senior leadership, and marketing - have enabled our team to sell with confidence and fulfill pent-up demand as we enter the new year. Ultimately, I believe this will support a return to the high end of our historical margin profile. Combined with a reversal of recent commodity highs and strong November results, we believe we are well positioned for profitable growth in the months and years ahead," concluded Michaels.Cash and cash equivalents as of October 31 totaled $9.3 M as compared to $11M as of January 31 . The change in cash and cash equivalents was primarily driven by $5M in capital investments and $2.5M of debt paydown year-to-date, partially offset by working capital improvements as third quarter cash flow from operations increased 23.7% year-over-year. As of October 31 total debt stood at $6.3M.

16:09 EST Bionomics announces Australia Supreme Court approves re-domiciliation - Bionomics announced that the Supreme Court of New South Wales, Australia has made orders approving the scheme of arrangement in relation to the company's proposed re-domiciliation from Australia to the United States, under which Neuphoria Therapeutics, will become the ultimate parent company of Bionomics Limited following the implementation of the scheme. A copy of the court's orders with respect to the Scheme was lodged with the Australian Securities & Investments Commission following the Court hearing, at which time the Scheme became legally effective. Bionomics' ADSs will continue to trade on Nasdaq until the implementation date. Bionomics shareholders who hold shares on the record date for the scheme. The scheme consideration will be paid to scheme shareholders on the implementation date. Shares of Neuphoria are expected to begin trading on Nasdaq under the symbol (NEUP) on December 24 or as soon as possible thereafter.

16:07 EST ChargePoint, Colorado Energy Office complete six EV fast charging corridors - ChargePoint and the Colorado Energy Office announced the completion of six EV fast charging corridors across the state. In total, 33 DC fast charging sites offering more than 80 charging ports are now available to EV drivers along highways across Colorado. The initiative was made possible by $10M in state funding and more than $2M in contributions from private and local government partners. "This project is a testament to the leadership we're seeing across the country at a state level to accelerate the build out of a robust charging network for all EV drivers," said Rick Wilmer, CEO at ChargePoint. "Public-private partnerships such as our relationship with the Colorado Energy Office continue to play a critical role in building out charging infrastructure. Together, we are ensuring drivers across the state are able to charge quickly at convenient locations."

16:06 EST Jazz Pharmaceuticals CEO Bruce Cozadd to retire by end of 2025 - Jazz Pharmaceuticals announced that Bruce Cozadd, Co-Founder, Chairperson and CEO, has informed the Board of Directors of his intent to retire from his role as CEO upon appointment of the company's next leader, expected by the end of 2025. The Board will commence a formal search process to identify a new CEO, which is anticipated to conclude within 12 months. Cozadd will retire as CEO once a successor has been appointed and will continue serving as Chairperson of the Board of Directors, providing ongoing leadership and strategic guidance to the company. Jazz remains on track to meet its full year 2024 total revenue guidance of between $4B-$4.1B.

16:03 EST Merus doses first patient in petosemtamab trial - Merus announced that the first patient has been dosed in the company's phase 2 trial evaluating petosemtamab monotherapy in heavily pretreated metastatic colorectal cancer. Petosemtamab is a Biclonics targeting EGFR and LGR5. The phase 2, open-label trial will evaluate the safety and antitumor activity of petosemtamab monotherapy in 3L+ mCRC, post anti-EGFR therapy. To be eligible for enrollment, patients must lack certain mutations as detected in plasma by ctDNA NGS, including KRAS, NRAS.

15:54 EST Teamsters at Amazon delivery station in Illinois vote to authorize strike - Teamsters at the DIL7 Amazon delivery station in Skokie, Illinois, have voted overwhelmingly to authorize a strike as part of their fight for a union contract that improves wages and benefits and strengthens workplace safety. This follows Amazon Teamsters at two New York City facilities announcing on Friday that they had authorized strikes. DIL7 serves thousands of households throughout Chicagoland. The Teamsters represent hundreds of workers at the facility.

15:22 EST Riot Platforms jumps over 10% after disclosing Bitcoin purchase - Shares of Riot Platforms (RIOT) are up approximately 10% on Monday afternoon after a regulatory filing issued earlier by the company, showed that Riot purchased 667 Bitcoin ($BTC) for approximately $67.5M at an average price of $101,135 per Bitcoin, inclusive of fees and expenses. As of December 13, the Company increased its total holdings to 17,429 Bitcoin. Shares of Riot are currently trading at $14.18 per share up $1.19 or 9.12%

15:08 EST Riot Platforms buys 667 bitcoin for $67.5M, total holdings now 17,429 bitcoin - On December 16, Riot Platforms (RIOT) issued a press release announcing the closing of its previously announced offering of $594.4M aggregate principal amount of the 2030 Notes, which included the partial exercise by the initial purchasers of their option to purchase additional 2030 Notes. During the period between December 12 and December 13 the company acquired approximately 667 Bitcoin ($BTC) for approximately $67.5M at an average price of $101,135 per Bitcoin, inclusive of fees and expenses. As of December 13 the company increased its total holdings to 17,429 Bitcoin. The Bitcoin purchases were made using a portion of the net proceeds from the issuance and sale of the 2030 Notes, as well as cash on hand. This information was provided in a company 8k filing. Reference Link

14:40 EST Lincoln Educational signs lease for new campus in Hicksville, New York - Lincoln Educational Services announced that it has signed a lease for a new campus in Hicksville, New York, representing the company's second campus in New York and eleventh in the tri-state area. "The campus demonstrates a commitment to its strategic growth plan, and follows the successful launch of the Company's newest campus in East Point, Georgia earlier this year. The Hicksville campus is expected to commence operations towards the end of 2026 and will focus on preparing students for hands-on careers in high-demand industries. The 65,000 square-foot training center will offer specialized career training in automotive, welding, HVAC and electrical and electronics fields. This new facility will increase Lincoln's presence in the tri-state, complementing its closest flagship automotive campus in Queens, New York which has been operating for nearly 20 years. With demand for approximately 54,000 talented automotive technicians by 2030, the State of New York is certainly a region with abundant employment opportunities to meet strong student demand," the company stated.

14:24 EST YouTube tests voice replies for more 'meaningful relationships' with audiences - Google's YouTube said earlier in a blog post: "We're experimenting with a feature that enables creators to reply to comments with their voice. If you're a creator in the test group, you can click the sound wave icon when responding to a comment greater than record a voice reply greater than then post it as a comment. While we gather feedback in the experiment phase, voice replies can only be left by creators on their own channel via the YouTube app on iOS, but all viewers and creators can engage with these comments. This test is rolling out to a small number of creators in the US. We hope that the voice reply experiment enables more meaningful relationships between creators and their audiences." Reference Link

14:10 EST Capcom announces new 'Onimusha,' 'Okami' games, says leveraging more past IP - Capcom announced on Friday that "Onimusha Way of the Sword," the first new title in the "Onimusha" series in over 20 years, is scheduled to be released, while work on an "Okami" sequel project has also started. In addition to regularly releasing major new titles each year, Capcom is focusing on re-activating dormant IPs that haven't had a new title launch recently. The company is working to further enhance corporate value by leveraging its rich library of content, which includes reviving past IPs like the two titles announced above, in order to continuously produce highly efficient, high-quality titles. Capcom remains firmly committed to satisfying the expectations of all users by leveraging its industry leading game development capabilities in order to create highly entertaining gameplay experiences, the company said. Reference Link

13:58 EST Ray-Ban Meta glasses add live AI, live translation & Shazam support - In a new release on the Meta Quest Blog, the company said in part: "Whether you already own a pair or you're hoping Santa drops a one down the chimney, Ray-Ban Meta glasses are the gift that keeps on giving. Right out of the box, they help you experience the world, share your POV, and capture the moments that matter, completely hands-free. And with regular software updates, they keep getting better over time. Since Connect, we've released several new features including reminders, the ability to use your voice to search and play content on Spotify and Amazon Music, Be My Eyes integration, adaptive volume, and the option to set Meta AI on your glasses to celebrity voices including Awkafina, John Cena, Keegan-Michael Key, and Kristen Bell under the US voice options, and Dame Judi Dench under the UK voice options. Starting today, we'll begin rolling out the v11 software update, which makes your Ray-Ban Meta glasses more capable, useful, and fun than ever before. Make sure your glasses and Meta View app are updated to the latest versions. Let's take a look at what's new." Reference Link

13:43 EST Google DeepMind unveils Veo 2, Imagen 3 - Google DeepMind, Alphabet's flagship AI research lab, introduced a new video generation model, Veo 2, and the latest version of Imagen 3, both of which "achieve state-of-the-art results." "Veo 2 creates incredibly high-quality videos in a wide range of subjects and styles," the company said. "In head-to-head comparisons judged by human raters, Veo 2 achieved state-of-the-art results against leading models. It brings an improved understanding of real-world physics and the nuances of human movement and expression, which helps improve its detail and realism overall. Veo 2 understands the unique language of cinematography: ask it for a genre, specify a lens, suggest cinematic effects and Veo 2 will deliver - at resolutions up to 4K, and extended to minutes in length. Ask for a low-angle tracking shot that glides through the middle of a scene, or a close-up shot on the face of a scientist looking through her microscope, and Veo 2 creates it. Suggest "18mm lens" in your prompt and Veo 2 knows to craft the wide angle shot that this lens is known for, or blur out the background and focus on your subject by putting "shallow depth of field" in your prompt." The company also announced Whisk, its newest lab experiment that lets users input or create images that convey the subject, scene and style you have in mind. Then, you can bring them together and remix them to create something uniquely your own, from a digital plushie to an enamel pin or sticker, the company said. []:[https://blog.google/technology/google-labs/video-image-generation-update-december-2024/]

13:14 EST AeroVironment says GAO denied protest of Army's Switchblade award - In a regulatory filing earlier, AeroVironment reported that the U.S. Government Accountability Office has denied the protest filed on September 6, which challenged the U.S. Department of the Army's award of an indefinite delivery, indefinite quantity contract with a ceiling value of $990M on a sole source basis to AeroVironment related to the company's Switchblade systems. "The company intends to fulfill its obligations under the contract and any delivery orders issued thereunder throughout the term of the contract," AeroVironment stated. AeroVironment shares are up $13.19, or 8%, to $169.69 in early afternoon trading following the disclosure. Reference Link

13:04 EST Wallbridge Mining receives final assay results from Phase 2 drilling at Fenelon - Wallbridge Mining has received the final assay results from its 1,303 metre Phase 2 drilling program completed in September 2024 at its 100% owned Fenelon Gold Project. The Phase 2 program comprised four targeted infill holes drilled within an approximate 150 metre by 250 metre area to provide greater definition of gold resources within the upper levels of the high-grade Tabasco zone. Significant highlights include: 5.68 g/t Au over 1.5 metres in drill hole FA-24-581; 3.93 g/t Au over 2.5 metres, 14.66 g/t Au over 1.5 metres in drill hole FA-24-582; 7.03 g/t Au over 0.5 metres, 2.70 g/t Au over 3.0 metres in drill hole FA-24-583; 5.92 g/t Au over 2.7 metres in drill hole FA-24-584. "We're pleased to announce our final drill results for 2024. The grades returned from these latest four holes provide further confirmation of the position and extent of the principal structures that extend upward from the high-grade core of the Fenelon gold resource," commented Brian Penny, CEO. "We look forward to releasing the results of an updated Preliminary Economic Assessment at Fenelon in the first quarter of 2025 and will continue to provide regular updates to the market on our corporate activities."

12:02 EST Daqo New Energy falls -6.7% - Daqo New Energy is down -6.7%, or -$1.23 to $17.16.

12:00 EST Surf Air Mobility falls -7.5% - Surf Air Mobility is down -7.5%, or -30c to $3.70.

12:00 EST D-Wave Quantum rises 27.0% - D-Wave Quantum is up 27.0%, or $1.35 to $6.35.

11:59 EST Momentus trading resumes

11:54 EST Momentus trading halted, volatility trading pause

11:47 EST Universal Music's Virgin Music to acquire Downtown Music - Virgin Music Group, the global independent music division of Universal Music Group, announced it has entered into a definitive agreement to acquire Downtown Music Holdings for cash consideration of $775M. The acquisition, which is subject to regulatory approvals, is expected to close in the second half of 2025. "Upon completion, this transaction will bring together two industry-leading providers of client services and music technology, enhancing their offerings and capabilities to serve the independent music community," the company stated.

11:36 EST Mars Acquisition Corp trading halted, volatility trading pause

11:14 EST FDA says Boston Scientific Accolade pacemakers may need early replacement - In a safety communication dated December 16 posted to the site of the FDA, the agency stated: "The U.S. Food and Drug Administration is alerting patients, caregivers, and health care providers about the potential need for early device replacement of Boston Scientific Corporation Accolade pacemaker devices, which includes the Accolade, Proponent, Essentio, and Altrua 2 Standard Life and Extended Life pacemakers, and the Visionist and Valitude cardiac resynchronization therapy pacemakers. Boston Scientific announced a recall for a subset of Accolade pacemaker devices with an increased risk to permanently enter Safety Mode, which has limited functionality and has been associated with the pacemaker being unable to properly regulate the heart's rhythm and rate in some patients... While the recall by Boston Scientific identifies a subset of Accolade pacemaker devices with increased risk of entering Safety Mode, the FDA is working with the manufacturer to evaluate the potential risk of this issue in all Accolade pacemaker devices and identify additional mitigation strategies as needed. The FDA is issuing this communication to raise awareness of the manufacturer's recall notice, the FDA's ongoing evaluation with the manufacturer of the issue, and the FDA's current recommendations." Reference Link

11:11 EST Walmart announces five-year, $1.3B investment in Chile - Walmart Chile President and CEO Cristian Barrientos, alongside Walmart International President and CEO Kath McLay, announced a five-year, $1.3B investment in Walmart Chile. The investment includes the opening of 70 new stores across all formats and creation of 4,000 new jobs, "representing Walmart's continued commitment to helping Chileans save money and live better," the company stated. "This is not just an investment in infrastructure and technology; it is an investment in people, in communities. We are building a better future for everyone, for future generations and for our children. We trust in Chile. We trust in its people. We continue exploring together," added Barrientos. Reference Link

10:46 EST Creative Global Technology Holdings Ltd trading resumes

10:10 EST GSK's ViiV Healthcare says the CHMP of EMA issued positive opinion for Vocabria - GSK (GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer (PFE) and Shionogi as shareholders, has announced that the Committee for Medicinal Products for Human Use, CHMP, of the Europe Medicines Agency, EMA, has issued a positive opinion recommending marketing authorisation for Vocabria in combination with Johnson & Johnson Innovative Medicine's (JNJ) Rekambys for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 35 kg who are virologically suppressed.

10:01 EST RTX's Collins reports avionics modernization program for King Air, Hawker - Collins Aerospace, an RTX business, has announced a comprehensive avionics upgrade and modernization program for Beechcraft King Air and Hawker aircraft, spanning Collins' Pro Line Fusion and Pro Line 21 advanced avionics systems. The modernization program advances aircraft performance and safety while also equipping cockpits with technologies that reduce pilot workload, enhance situational awareness and enable efficiency and capacity improvements. "Collins' flight deck modernization program provides pilots the intuitive and responsive flight deck performance needed to operate in ever evolving and complex global airspaces," said Nathan Voight, vice president and general manager of Business and Regional Avionics for Collins Aerospace. "The Pro Line updates were designed with the end user in mind, focusing on advanced functionality to make flight simpler, safer and more connected."

10:00 EST Flagstar Financial falls -6.1% - Flagstar Financial is down -6.1%, or -67c to $10.27.

10:00 EST Grupo Supervielle rises 12.7% - Grupo Supervielle is up 12.7%, or $1.68 to $14.90.

10:00 EST Clipper Realty rises 14.7% - Clipper Realty is up 14.7%, or 64c to $5.00.

09:53 EST Immix Biopharma announces publication of NXC-201 clinical results - Immix Biopharma announced the Journal of Clinical Oncology published NXC-201 clinical results in relapsed/refractory AL Amyloidosis. The data reported on 16 enrolled patients in NEXICART-1 who had received a median 4 prior lines of therapy prior to treatment with NXC-201. Results showed a complete response rate of 75%. Notably, findings demonstrated a favorable safety profile in frail relapsed/refractory AL Amyloidosis patients. Ex-U.S. study NEXICART-1 is the first NXC-201 clinical trial to treat relapsed/refractory AL Amyloidosis. "We are pleased that JCO has recognized the impact of NXC-201's positive clinical results in relapsed/refractory AL Amyloidosis, where no FDA drugs are approved today," said Ilya Rachman, CEO. "Building on these positive ex-U.S. results, our ongoing U.S. study is focused on relapsed/refractory AL Amyloidosis patients with preserved heart function, who we believe will benefit most from NXC-201 treatment."

09:51 EST Collective Mining anounces death of director Paul Murphy - Collective Mining announces that Mr. Paul Murphy, a valued member of Collective's Board of Directors, passed away. Paul Murphy was a Partner of PricewaterhouseCoopers LLP from 1981 to 2010 including serving as National Mining Leader from 2004 to 2010.

09:49 EST MarineMax rises 9.0% - MarineMax is up 9.0%, or $2.76 to $33.45.

09:48 EST Banco BBVA Argentina rises 10.2% - Banco BBVA Argentina is up 10.2%, or $1.75 to $18.97.

09:48 EST Oklo falls -7.4% - Oklo is down -7.4%, or -$1.38 to $17.15.

09:47 EST Dynagas LNG falls -7.7% - Dynagas LNG is down -7.7%, or -35c to $4.22.

09:43 EST Mainz Biomed NV trading resumes

09:36 EST Larimar Therapeutics trading halted, volatility trading pause

09:33 EST enVVeno Medical completes final wave of implants in pre-clinical GLP study - enVVeno Medical announced the completion of the final wave of implants for shorter-term subjects in its six-month pre-clinical GLP study for enVVe, its transcatheter-delivered replacement venous valve. The completion of all planned implants in the GLP study, including both long-term and short-term subjects, completes a critical phase of the study. The follow-up period, which began with the first wave of implants, is ongoing as scheduled. Pending successful completion of the GLP study, the Company anticipates submitting its IDE application to the FDA in mid-2025. The submission, if approved, would allow the Company to initiate the pivotal clinical trial for enVVe. Beginning early next year, the Company will begin to implement its strategy to transition from a development stage to a commercial entity for the VenoValve, while completing the necessary non-clinical and GLP testing for enVVe in preparation for its IDE application.

09:32 EST AYRO secures purchase order from top three automotive manufacturer - AYRO announced that through its partnership with GLV Ventures it has secured its first purchase order from one of the top three automotive manufacturers in the United States.

09:31 EST Ideal Power secures first design win for SSCBs - Ideal Power announced the Company secured its first design win for solid-state circuit breakers, SSCBs, with one of the largest circuit protection equipment manufacturers in Asia serving the industrial and utility markets.

09:27 EST Fortune Rise Acquisition terminates business combination with Water On Demand - Fortune Rise Acquisition Corporation did not complete its initial business combination and has mutually terminated its Business Combination Agreement with Water On Demand. Therefore, the Company will dissolve and liquidate. On December 9, 2024, FRLA and WODI-PWT entered into a Mutual Termination Agreement pursuant to Section 7.1(a) of the Business Combination Agreement, dated October 24, 2023, by and among FRLA, WODI-PWT and FRLA Merger Sub, Inc., a Delaware corporation. Capitalized terms not otherwise defined in this paragraph have the meanings ascribed to them in the Business Combination Agreement, and section references in this notice are references to sections of the Business Combination Agreement. FRLA's amended and restated certificate of incorporation requires FRLA to complete its initial business combination by no later than May 5, 2025, provided monthly extension deposits are received in the trust account for the benefit of FRLA's stockholders. As FRLA has terminated the Business Combination Agreement, it did not make the monthly extension deposit due December 5, 2024; therefore, the Existing Company Charter requires FRLA to, and FRLA will: cease all operations except for the purpose of winding up, as promptly as reasonably possible but not more than ten business days thereafter subject to lawfully available funds therefor, redeem 100% of the Offering Shares in consideration of a per-share price, payable in cash, equal to the quotient obtained by dividing the aggregate amount then on deposit in the Trust Account, including interest, by the total number of then outstanding Offering Shares, which redemption will completely extinguish rights of the Public Stockholders, subject to applicable law, and as promptly as reasonably possible following such redemption, subject to the approval of the remaining stockholders and the Board in accordance with applicable law, dissolve and liquidate, subject in each case to the Corporation's obligations under the DGCL to provide for claims of creditors and other requirements of applicable law. All terms in this section not defined herein shall have the meaning under the Existing Company Charter. As of December 11, 2024, after giving effect to the redemption payments required to be made in connection with FRLA's stockholder meeting held November 4, 2024, the per-share redemption price for the Class A common stock of FRLA was approximately $11.94, which will be further adjusted, as described below. In accordance with the terms of the related trust agreement, FRLA expects to retain $50,000 of the interest and dividend income from FRLA's trust account to pay dissolution expenses. The balance of FRLA's trust account, including the reduction for the dissolution expenses, as of December 11, 2024, was approximately $10.0 million. FRLA is calculating taxes due for 2023 and 2024 that will be removed from the trust account prior to any Redemption Amount being paid to the holders of FRLA's public shares upon presentation of their respective share or unit certificates or other delivery of their shares or units to FRLA's transfer agent, VStock Transfer, LLC. The number of remaining public shares of FRLA as of December 11, 2024 was 843,183. Beneficial owners of FRLA's public shares held in "street name," however, will not need to take any action in order to receive the Redemption Amount. There will be no redemption rights or liquidating distributions with respect to FRLA's warrants, which will expire worthless. As of December 6, 2024, FRLA ceased all operations except for those required to wind up its business.

09:24 EST Star Bulk Carriers announces amended dividend policy - Star Bulk Carriers announced that the Company's Board further amended its dividend policy which was in place since 2021. Under the amended dividend policy, as set out herein below, the Company may approve an allocation of up to 60% of cash flow from operations less debt amortization, less maintenance/upgrade CAPEX less any deficit of cash below $2.1 million per owned vessel towards quarterly shareholder dividends. Any remaining Cash Flow to be allocated, at the Company's discretion, to: Share repurchases: Buybacks will be prioritized when the share price is trading at a significant discount to the estimated net liquidation value of the Company's hard assets Growth Opportunities: Cash Flow may be also used for opportunistic vessel acquisitions and investments that will create enhanced returns over time and for general corporate purposes.

09:21 EST HWH International enters collaboration with Asia Business College - HWH International announced a strategic partnership with Asia Business College to launch its Hapi Wealth program in China in the first quarter of 2025. Hapi Wealth is HWH's flagship program dedicated to providing comprehensive knowledge in equity investment and wealth-building strategies. Following a successful soft launch in November 2024, which garnered keen interests from selected potential facilitators, the official launch is scheduled for the first quarter of 2025. Building on the momentum, HWH plans to expand Hapi Wealth globally, with a targeted rollout in North America thereafter. To further support its mission, Hapi Wealth has established its China headquarters as a dedicated hub, providing a collaborative and supportive environment for individuals to engage in in-person tutorials and workshops. This space is designed to foster deeper understanding of equity investment and facilitate the practical application of wealth-building strategies. The strategic partnership with Asia Business College will further amplify HWH's mission by delivering high-quality educational materials on equity investment and wealth-building strategies to a broader audience. The collaboration will initially focus on content delivery in Chinese and English, with plans to expand into additional languages in the near future. HWH also plans to leverage its network of Hapi Cafes as venues for program sessions, promotions, and community-building efforts. By combining in-person engagement with its financial education initiatives, HWH aims to create a stronger connection with participants while driving interest in its broader suite of offerings. These programs will be rolled out at key locations across Asia, including community colleges, Hapi Cafes, and other strategic venues.

09:20 EST Mastech Holdings trading resumes

09:18 EST LQR House announces 19.95% year-over-year revenue growth in November - LQR House announced financial results for November 2024, highlighting a 19.95% increase in revenue year-over-year compared to November 2023, and a significant 61% month-over-month revenue increase from October to November 2024. The Company believes that this growth showcases LQR House's ongoing commitment to innovation and its ability to scale operations successfully in a highly competitive market. In November 2023, the Company generated $320,666.51 in revenue. For November 2024, LQR House reported $384,662.12-an increase of $63,995.61. Additionally, the month-over-month revenue jumped from October 2024 to November 2024, which underscores LQR House's robust performance during the critical holiday season. This achievement is particularly noteworthy, as November 2024's revenue figures do not include Cyber Monday sales, unlike the November 2023 numbers, which benefitted from Cyber Monday. Sean Dollinger, CEO of LQR House, shared his enthusiasm for the results "November kicks off the busiest season for alcohol sales, including Black Friday, making it one of our favorite times of the year. With Cyber Monday falling in December this year, we faced the challenge of surpassing last November's numbers without those additional sales. The LQR House team rose to the occasion, and we delivered. Many investors closely following our journey may have questioned whether we can sustain our growth momentum since acquiring CWSpirits.com in November 2023. We believe that achieving a 19.95% year-over-year revenue increase in November-and a 61% month-over-month jump-confirms our ability to scale the platform and potentially lead in alcohol marketing. It's a significant win for the team, and we are committed to building on this success."

09:16 EST Premium Catering receives non-compliance notice from Nasdaq - Premium Catering received a notice from the Nasdaq Stock Market that the Company is currently not in compliance with the minimum market value of listing securities of $35,000,000 for continued listing of the Company's ordinary shares on the Nasdaq Capital Market, as set forth in Nasdaq Listing Rule 5550(b)(2). Nasdaq calculates the MVLS based upon the most recent total shares outstanding multiplied by the closing bid price. The MVLS Notice indicated that the Company has 180 days, or until June 9, 2025, to regain compliance with the MLVS Requirement by having its MVLS close at $35,000,000 or more for a minimum of ten consecutive business days. If at any time prior to June 9, 2025, the Company's MVLS closes at $35,000,000 or more for a minimum of ten consecutive business days, Nasdaq will provide a written confirmation of compliance and the matter regarding the Company's MLVS will be closed. Receipt of the MVLS Notice does not result in the immediate delisting of the Company's ordinary shares and has no immediate effect on the listing or the trading of the Company's ordinary shares on the The Nasdaq Capital Market under the symbol "PC". On December 11, 2024, the Company received a further notice from Nasdaq indicating that the Company's ordinary shares failed to maintain a minimum bid price of $1.00 over the last 30 consecutive business days as required by Nasdaq Listing Rule 5550(a)(2). Receipt of the Minimum Bid Price Notice does not result in the immediate delisting of the Company's ordinary shares and has no immediate effect on the listing or the trading of the Company's ordinary shares on the The Nasdaq Capital Market under the symbol "PC". Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the Company has a compliance period of 180 calendar days from the date of the Minimum Bid Price Notice, or until June 9, 2025, to regain compliance with the Minimum Bid Requirement. If at any time before June 9, 2025, the closing bid of the Company's ordinary shares is at least $1.00 for a minimum of 10 consecutive business days, the Company will be deemed to have regained compliance with the Minimum Bid Requirement following which Nasdaq will provide a written confirmation of compliance and the matter will be closed. In the event the Company does not regain compliance with the Minimum Bid Price Requirement, the Company may be eligible for additional time. To qualify for the additional time, the Company will be required to meet the continued listing requirements for market value of publicly held shares and all other listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period by effecting a reverse stock split if necessary. The MVLS Notice, however, contained a footnote referencing that the Company currently does not meet the other listing requirements under the Listing Rule 5550(b)(1) and 5550(b)(3), and is not in compliance with the listing standards which are: an equity standard that the Company maintain stockholders' equity of at least $2.5 million; and a net income standard regarding the Company's continuing operations of $500,000 in the most recently completed fiscal year or in two of the three most recently completed fiscal years. Neither the MVLS Notice nor the Minimum Bid Price Notice will have any immediate effect on the listing of the Company's Ordinary Shares, which continue to trade on The Nasdaq Capital Market under the symbol "PC". The Company intends to monitor its MVLS and Minimum Bid Price and may, if appropriate, consider implementing available options, including a reverse stock split, to regain compliance with the MVLS and Minimum Bid Price listing standards. If the Company does not regain compliance by the Compliance Deadlines, the Company will receive further written notification from Nasdaq that its securities are subject to delisting. At that time, the Company may qualify for additional time or appeal the delisting determination to a hearings panel. .

09:13 EST Akari Therapeutics appoints Torsten Hombeck as CFO - Akari Therapeutics announced the appointment of Torsten Hombeck, Ph.D. as CFO. Prior to joining Akari, Dr. Hombeck served as the CFO, Corporate Secretary and SVP at Aspira Women's Health (AWH). Prior to that, Dr. Hombeck served as the CFO of Akari Therapeutics from 2019-June 2023 where he raised over $50 million during his tenure.

09:11 EST LivePerson announces appointment of two new board members - LivePerson announces the appointment of two new board members, Dan Fletcher and Karin-Joyce Tjon. Dan Fletcher currently serves as Chief Financial Officer of SaaS provider Planful. Karin-Joyce Tjon held senior roles such as CFO at Alorica.

09:10 EST Scilex announces early installment payment on senior secured promissory note - Scilex Holding Company has voluntarily made an early installment payment in the aggregate amount of $13.2 million under its senior secured promissory note issued to Oramed Pharmaceuticals in September 2023. Subsequent to this early installment payment, the remaining principal balance under the Oramed Note will be payable in one final payment on March 21, 2025, and the Oramed Note will be retired in its entirety.

09:09 EST Nexstar's NewsNation and reporter Chris Cuomo in multi-year deal - NewsNation announced that anchor and reporter Chris Cuomo has reached a multi-year agreement with the network to continue hosting his top-rated primetime program, CUOMO, weeknights at 8 p.m. ET. "Chris is a one-of-a-kind talent whose unrivaled analysis and commentary have helped grow the audience at NewsNation and strengthen our brand," said Sean Compton, President of Nexstar's Networks Division. "He believes strongly in NewsNation's mission of delivering 'News for All Americans' and we are extremely pleased that he will remain a staple of the network's primetime lineup." Commenting on the announcement, Mr. Cuomo said, "Of course I am staying. Where else but NewsNation can you expose the game instead of being forced to play? Let's get after it!" Throughout his career as a broadcast journalist, Mr. Cuomo has conducted countless news interviews with world leaders, sitting Presidents and First Ladies, politicians, and celebrities, including the President of Ukraine, Since its launch in 2022, ratings for CUOMO have doubled across key measurements, increasing by 54 percent in total viewers and 28 percent among adults 25-54.

09:08 EST Anghami secures significant investment from OSN Group - Anghami announced that it secured a significant new round of funding, from OSN Group of up to USD $55 million with a USD $12 million initial investment in a convertible note program. This investment represents a significant milestone in Anghami Inc.'s journey to redefine digital entertainment in the MENA region, further solidifying its position as the go-to destination for premium audio and video content.

09:07 EST DXC Technology, Blackout Technologies announce new partnership - DXC Technology and UK based Blackout Technologies announced a new partnership to enhance security for enterprises worldwide. Together, DXC and Blackout will help companies better manage compliance for personal smart devices as well as increase productivity by optimizing device functionality.

09:07 EST Tantech Holdings establishes new U.S-based subsidiaries - Tantech announced that Tantech has established two subsidiaries in the United States, Gohomeway Inc and Gohomeway Group Inc. The new companies aim to support the Company's growing demand for overseas business, increase its presence in the green building materials sector, and expand its operations in this field.

09:06 EST Jeld-Wen entered into asset purchase agreement for sale of Towanda for $115M - JELD-WEN announced that, in compliance with the court-ordered divestiture of its Towanda, Pennsylvania business and related assets, JELD-WEN has entered into an asset purchase agreement for the sale of Towanda to Woodgrain for approximately $115M, subject to certain adjustments and closing conditions. "After many years of working through the court-ordered divestiture of Towanda, we have now reached an important inflection point in this process. We continue to evaluate our options in this unprecedented legal proceeding, but following a thorough review, we have concluded that it is in the best interest of the Company and its stakeholders to proceed with closing the transaction at this time. Regardless, JELD-WEN is well positioned to continue to service and supply its door customers at the high level they have come to expect from us," said Chief Executive Officer William Christensen.

09:04 EST Envoy Medical announces four new patents - Envoy Medical announces four new patents. The US Patent & Trademark Office issued Envoy Medical Corporation US Pat. No. 12,151,102 on November 25, 2024. The title of the patent is Combination Hearing Aid and Cochlear Implant System. This patent relates to updating a transfer function associated with an implanted signal processor of a cochlear implant system to compensate for operation of an external auditory aid device, such as a hearing aid, that affects a stimulus received at an input source of the cochlear implant system and input signals representative of the stimulus. The European Patent Office will grant European Patent No. 4255554 to Envoy Medical Corporation on January 1, 2025. The title is Combination Hearing Aid and Cochlear Implant System. This patent relates to cochlear implant systems and receiving a status indicator signal indicative of whether an external auditory aid device is active, and updating a transfer function of a signal processor of the cochlear implant system to compensate for operation of the external auditory aid device if it is active. The European Patent Office will grant European Patent No. 4255555 to Envoy Medical Corporation on January 1, 2025. The title is Cochlear Implant Stimulation Calibration. This patent relates to calibrating current flow in a cochlear implant system. A switching network can be controlled to place a source element of a cochlear implant system in communication with a testing circuit. An amount of electrical current provided to the testing circuit can be determined, and the output of the source element can be adjusted based on the determined amount of electrical current. The European Patent Office will grant European Patent No. 4319866 to Envoy Medical Corporation on January 1, 2025. The title is Cochlear Implant System with Electrode Impedance Diagnostics. This patent relates to electrode impedance diagnostics in cochlear implant systems. A cochlear implant system can determine an impedance associated with a current path from a source element to a return electrode and determine one or more stimulation parameters for the source element based on the impedance. An example stimulation parameter can include a compliance voltage for the source element to provide a prescribed current.

09:00 EST Tharimmune announces Phase 2 study plan for TH104 - Tharimmune announced plans for initiating a Phase 2 study evaluating TH104 in patients suffering from moderate-to-severe pruritus associated with primary biliary cholangitis, a rare and chronic liver disease, and also provided a corporate update. The launch of this clinical trial, expected in 2025, follows favorable results from Tharimmune's Phase 1 study with TH104, recent regulatory feedback from the European Medicines Agency and the U.S. Food and Drug Administration, as well as progress on manufacturing clinical study supply.

08:57 EST Sezzle, Bealls partner to transform holiday shopping - Sezzle announced its partnership with Bealls. With this collaboration, Sezzle flexible payment options are now available to their guests, online and across its more than 650 stores, just in time to ensure a seamless and stress-free holiday shopping experience. Approaching its milestone 110th anniversary next year, Bealls Inc. continues to solidify its legacy as a trusted destination for apparel, home goods, and gifts by embracing forward-thinking solutions that enhance the shopping experience. The introduction of Buy Now, Pay Later with Sezzle highlights the commitment by Bealls Inc. to meeting the evolving needs of its loyal shoppers while maintaining its reputation for providing exceptional value.

08:54 EST Aspira CEO Nicole Sandford to depart, Sandra Milligan named interim - Aspira Women's Health announced that Nicole Sandford, CEO and Board member, will be departing the Company to focus on a family health matter. Aspira's President Dr. Sandra Milligan will step into the role of interim CEO while a nationwide search of internal and external candidates is conducted. Ms. Sandford's departure will be effective immediately. She will remain as a consultant to ensure a seamless transition.

08:51 EST Telos expands enrollment, renewal options by opening fifteen locations - Telos Corporation continues to expand locations to enroll consumers in the TSA PreCheck program by opening 15 new locations in Arizona, California, Colorado, Florida, Georgia, Illinois, Kansas, Ohio, Tennessee, Texas and Washington. These locations began offering enrollment services today, December 16, 2024. Telos now has 188 TSA PreCheck enrollment centers open in 29 states across the U.S. The launch of these new enrollment centers represents the ongoing expansion of Telos' national TSA PreCheck enrollment footprint. Throughout 2024 and 2025, Telos will continue delivering convenience to consumers by launching additional locations and extended hours of operation for enrollment and renewals.

08:50 EST Menarini announces topline data from Phase 3 BROADAY, TANDEM trials - Menarini Group announces positive topline data from the Phase 3 BROADWAY and the Phase 3 TANDEM clinical trials sponsored by NewAmsterdam Pharma Company, a late-stage, clinical biopharmaceutical company developing oral, non-statin medicines for patients at risk of cardiovascular disease, CVD, with elevated low-density lipoprotein cholesterol, for whom existing therapies are not sufficiently effective or well tolerated. Both pivotal studies achieved primary endpoints of LS mean reduction in LDL-C on top of maximally tolerated lipid-modifying therapies with high statistical significance. Approximately 50% of patients in BROADWAY and over 70% of patients in TANDEM achieved LDL-C target below 55 mg/dL. In BROADWAY a 21% reduction in major adverse cardiovascular events favoring Obicetrapib was observed at one year. In both studies, Obicetrapib monotherapy and the fixed dose combination with Ezetimibe were shown to be well tolerated.

08:48 EST Ascendis Pharma announces results from New InsiGHTS tril of TransCon hGH - Ascendis Pharma announced Week 26 topline results from New InsiGHTS, its Phase 2 randomized, open-label, active-controlled trial in the U.S. to investigate the safety, tolerability, and efficacy of once-weekly TransCon hGH compared to daily somatropin in prepubertal children with Turner syndrome. New InsiGHTS randomized and dosed 49 children with Turner syndrome aged 1 to 10 years old into one of four treatment groups 1:1:1:1 - one of three starting doses of TransCon hGH or an active comparator of daily somatropin with a starting dose of 0.35 mg/kg/week. Doses were individualized based on IGF-1. On the primary endpoint of annualized height velocity and secondary endpoint of change from baseline in height SDS, children treated with TransCon hGH demonstrated improved growth similar to daily somatropin at Week 26, independent of starting dose. In the trial, TransCon hGH was generally safe and well tolerated, with no discontinuations related to study drug and with comparable safety and tolerability to daily somatropin. Ascendis expects Week 52 results for lonapegsomatropin-treated children compared to daily somatropin-treated children in 2025.

08:45 EST Treace announces first surgical cases utilizing SpeedPlate MicroQuad Implant - Treace Medical Concepts announced the completion of the first cases utilizing SpeedPlate MicroQuad implants. The MicroQuad implant expands upon the broad utility of the SpeedPlate platform, which is designed for fast titanium compression fixation. The MicroQuad implant has a unique anatomic design with multiple points of fixation on each side of the joint to deliver dynamic compression with rotational stability through a one-inch incision for compatibility with minimally invasive techniques.

08:42 EST Turbo Energy provides update on impact of flash flooding disaster in Spain - Mariano Soria, CEO, issued a formal update to shareholders on the financial and operational impact of the historical flash flooding disaster that left much of Valencia and surrounding regions in southeastern Spain in ruins in late October 2024. Soria stated: "Torrential rains that fell on October 29 caused flash floods that tragically claimed the lives of more than 200 people, swept away cars and wrecked many homes and businesses. Thankfully, all Turbo Energy employees and their families affected by the storm are safe and accounted for and our production systems and supply chain resources largely escaped harm and remained fully functional. However, while our corporate headquarters suffered no material damage, Turbo Energy's warehousing was directly impacted by high flood waters and a portion of our legacy product inventory, valued at approximately $2.3 million, was compromised. In collaboration with our business insurance carrier, we have completed an assessment of the impact of the storm on our warehousing operations and have confirmed that 100% of the losses are fully covered, with reimbursement funds expected within the next 60-90 days. There are no words to adequately express our deepest gratitude to the Turbo Energy team for their help with the clean-up and restoration of our facility, not to mention the time and energy that our employees personally committed to aiding our local community in the recovery effort. As our families come together to celebrate the holidays, our thoughts and prayers remain with those who suffered losses of loved ones in this natural disaster. Today, Turbo Energy is stronger than ever and looking forward to what we believe will be a pivotal year of growth and geographic expansion for our Company in 2025. Moreover, as we continue to execute our plan to perpetuate our reputation as a globally respected pioneer of leading edge solar energy storage technologies and solutions for the residential, commercial and industrial markets worldwide, we believe the future outlook for Turbo Energy remains incredibly bright and promising."

08:41 EST HeartBeam announces FDA clearance for high-fidelity ECG system - HeartBeam announced that the US Food and Drug Administration FDA has granted 510(k) clearance of the HeartBeam system for comprehensive arrhythmia assessment. With its patented design, the HeartBeam device is the first-of-its-kind to receive FDA clearance. As a high-fidelity electrocardiogram ECG system with a credit card-sized form factor and cable-free design, it captures heart signals from three distinct directions for actionable heart health information. When a patient feels symptoms, the HeartBeam patient app guides them through the process of placing the device on their chest and capturing a 30-second recording. Once a recording is taken, the signals are sent to the cloud, processed and sent to a physician for review. The physician reviews the ECG recording in the context of the patient's symptoms and medical history, then follows up with the patient on next steps. The Company plans to initiate an Early Access Program and is creating a waitlist of interested patients and physicians.

08:41 EST Chubb appoints Latter for Chubb Overseas General - Chubb has announced the appointment of John Latter to lead Claims for Chubb Overseas General, COG, effective immediately. In his new role as Head of Claims, COG, Latter will oversee Chubb's claims organization in Europe, the Middle East, Asia Pacific, Latin America and the Far East, leading a team of 3,000 professionals.

08:40 EST Inspira delivers systems to leading distributor for U.S. deployment - Inspira Technologies announced the delivery of INSPIRA ART100 systems to its U.S. distributor, Glo-Med Networks. The systems were shipped in fulfilment of a purchase order issued by Glo-Med to Inspira.

08:39 EST Brookline to merge with Berkshire in all-stock transaction valued at $1.1B - Berkshire Hills Bancorp (BHLB), the parent company of Berkshire Bank, and Brookline Bancorp (BRKL), the parent company of Brookline Bank, Bank Rhode Island, and PCSB Bank, announced they have entered into a definitive agreement pursuant to which Brookline will merge with and into Berkshire in an all-stock transaction valued at approximately $1.1 billion, or $12.68 per share of Brookline common stock, based on the $30.20 closing price of Berkshire common stock on December 13, 2024.

08:38 EST Cardio Diagnostics:Precision, Epi+Gen CHD tests get CMS pricing determinations - Cardio Diagnostics Holdings announced that the Company's PrecisionCHD and Epi+Gen CHD tests have received final pricing determinations from the Centers for Medicare & Medicaid Services or CMS. Following the preliminary pricing determination made by CMS in August 2024, CMS finalized the 'gapfill' pricing determination for both PrecisionCHD and Epi+Gen CHD. This decision will be effective for claims with dates of service on or after January 1, and will allow Medicare contractors to determine pricing for PrecisionCHD and Epi+Gen CHD based on actual cost data from Cardio Diagnostics. The Medicare contractors will report to CMS preliminary gapfill pricing for calendar year 2025 by April 1 . "Receiving this final determination is a crucial step for our innovative solutions to help improve the risk assessment, diagnosis, management and monitoring of coronary heart diseas CHD for Medicare patients," said Meesha Dogan, Ph.D., CEO and Co-Founder of Cardio Diagnostics. "This milestone brings us closer to addressing the significant unmet needs in cardiovascular care for the Medicare population, enabling clinicians to better personalize treatment strategies and ultimately improve patient outcomes."

08:37 EST Sabre announces new agreement with Gardua Indonesia - Sabre announced a new agreement with Garuda Indonesia. The airline will use fare management solutions from Sabre to enhance its pricing management capabilities, streamline operations, and reinforce its competitive positioning. By adopting Sabre's advanced solutions, Garuda Indonesia aims to support its broader transformation strategy and address critical challenges in fare management.

08:36 EST FibroGen appoints David DeLucia as CFO - FibroGen announced the appointment of David DeLucia to CFO, effective December 16, 2024. The company previously announced that Juan Graham would step down on December 15, 2024. Reporting to CEO, Thane Wettig, DeLucia will lead and oversee FibroGen's global finance organization. He has most recently served as FibroGen's Vice President, Head of Corporate Financial Planning and Analysis, Investor Relations, and Treasury.

08:35 EST FlexShopper enters partnership with Tire Agent - FlexShopper announced a new partnership with Tire Agent. Tire Agent currently originates over $100M in lease-to-own transactions annually. This new collaboration integrates FlexShopper's payment solutions directly onto Tire Agent's website and establishes Tire Agent as the preferred online tire retailer on the FlexShopper marketplace. The partnership also launches flexshopper.tireagent.com as the combination of Tire Agent's top-tier tire and wheel inventory with FlexShopper's flexible payment options.This partnership is tailored to support near-prime credit consumers-individuals who may not qualify for traditional prime financing but still need access to flexible payment solutions for essential purchases. Tire Agent's dedication to making tire purchases more accessible aligns perfectly with FlexShopper's mission to offer affordable payment alternatives.

08:34 EST Upstream Bio to be added to Russell 2000 Index - Upstream Bio announced that the Company will be added to the Russell 2000 index as part of the planned fourth quarter initial public offering additions effective at the open of the U.S. equity markets on December 23, 2024.

08:34 EST Rio2 Limited reports on Fenix Gold Mine progrss - Rio2, after completing the Company's debt and equity financing announced on October 21, 2024, provides an update on the progress made by its Chilean subsidiary, Fenix Gold, which is currently constructing the Fenix Gold Mine located in the Maricunga Gold Belt of the Atacama Region, in Chile. Advancements include the commencement of hiring of our Chilean workforce, mobilization of civil construction and plant construction contractors, completion of civil works for the processing plant site and commencement of construction of the heap leach pad and adjoining PLS pond. The Company has also entered a fixed price contract totaling $49M with its plant construction contractor, HLC Chile SPA, for the construction of the Fenix Gold Mine adsorption, desorption, and gold recovery plant, associated infrastructure and site electrical distribution lines. Long lead items such as gensets, principal pumps, and electrical switchgear facilities have been purchased directly by Fenix Gold. Rio2 will provide guidance in January 2025 for the construction schedule and associated budget, along with a projection of when the first gold production is expected to be achieved. Andrew Cox, President & CEO, commented, "Since closing our debt and equity financing in October, we have made excellent progress on all fronts related to the construction of our Fenix Gold Mine. The execution of the mine built on our proven alliance approach with our civil contractor and plant contractor is progressing as planned and the negotiation of a fixed price contract for the plant construction is a positive bonus to managing and controlling our construction budget. We are extremely happy to see the positive impact that we are making to employment in the Atacama Region and look forward to providing regular quarterly updates through construction in 2025."

08:30 EST Dare Bioscience announces Phase 3 plans for sildenafil cream in FSAD - Dare Bioscience announced plans for a Phase 3 study of Sildenafil Cream, 3.6%, an investigational topical cream formulation of sildenafil being developed as an on-demand treatment for female sexual arousal disorder, reflecting U.S. Food and Drug Administration feedback for safety and efficacy evaluations to support the indication of treatment of FSAD in premenopausal women. As an immediate next step, Dare will submit the protocol and statistical analysis plan for an adequate and well-controlled Phase 3 clinical study, reflecting the FDA's recommendations, to the FDA in the first quarter of 2025, and is targeting mid-2025 for commencement of the Phase 3 study A second confirmatory Phase 3 study will be required to support the New Drug Application submission.

08:28 EST Soluna Cloud and Gynger team on AI computing accessibility and affordability - Soluna Holdings announced a strategic partnership between its subsidiary Soluna Cloud and Gynger, the leading embedded payments platform for technology. "Gynger is excited to partner with Soluna Cloud to help make renewables-powered data management more accessible across all sectors of industry."The Soluna Cloud and Gynger partnership aims to make renewable-powered high-performance computing solutions more accessible to customers. Through this partnership, Soluna's clients will benefit from flexible payment options provided by Gynger, enabling them to adopt Soluna's cutting-edge AI Cloud without the burden of upfront costs. "Our partnership with Gynger reflects our commitment to not only providing high-performance and environmentally sustainable computing solutions but also to ensuring our clients have flexible financial options to support their growth," said John Belizaire, CEO of Soluna. "Together, we're removing financial barriers, allowing customers to access the technology they need to stay competitive."

08:27 EST Jana reiterates wanting leadership change or sale in letter to Lamb Weston board - Jana Partners, which together with its strategic and operating partners owns more than 5% of Lamb Weston, and is one of the company's largest shareholders, sent a letter to the company's board of directors reiterating its belief that significant board and leadership change is needed at Lamb Weston, and that in its absence the company should pursue a formal review of strategic alternatives, including a sale, in order to maximize value for shareholders. The full text of the letter is as follows: JANA Partners together with our strategic and operating partners beneficially own more than 5% of the outstanding shares of Lamb Weston Holdings, Inc., making us one of the Company's largest shareholders. Having received no response from the Board to our months-long involvement and engagement, we are hopeful that the Company will use the upcoming fiscal second quarter earnings announcement to address our previously expressed view that significant Board and leadership change is needed at Lamb Weston, and that in its absence the Company should pursue a formal review of strategic alternatives, including a sale. We believe Lamb Weston's Board and management have wasted the chance to sustain and grow shareholder value in a high-quality business. It is indisputable that Lamb Weston's track record for shareholders prior to the disclosure of our investment has been poor, not only in a disastrous 2024, but also over the long-term with total returns in the last five years dramatically trailing the S&P 500 and performing in the bottom quartile when compared to proxy peers. Regrettably, we believe this dismal performance record significantly understates the magnitude of lost opportunity at the Company. Relative to its publicly traded packaged food peers, we believe Lamb Weston enjoys the benefits of an attractive end market, a strong industry position and key competitive advantages. When coupled with Lamb Weston's long-time reputation as a premier foodservice supplier - which took prior management many years to build - we think these attributes should have positioned the Company as an attractive 'compounder' stock and best-in-class performer for investors. Instead, the current Board and management have overseen a multi-year period of uncorrelated failures across many major elements of operating the business, in the process damaging the Company's reputation and leading market position. This has impaired performance, dissolved confidence among customers, investors and other stakeholders and caused Lamb Weston to veer off its path as a world-class business. The disclosure of our involvement on October 18th led to an approximately $1 billion increase in Lamb Weston's market cap and an overwhelmingly positive reception from investors and Wall Street analysts,4 which we believe demonstrates the intense appetite from shareholders for a change in direction. The extensive investor feedback we have received since emerging publicly in the Company, including proprietary survey work that has included dozens of investors and other stakeholders, has further confirmed what was clear from our initial due diligence: that there is urgent need - and strong desire - for significant Board and leadership change at Lamb Weston..."

08:24 EST BioAtla presents data on mecbotamab vedotin in advanced NSCLC - BioAtla presented a poster entitled "Characterization of Mutated KRAS Genotype and Clinical Outcomes in Patients With Advanced NSCLC Treated With Mecbotamab Vedotin, a CAB-AXL-ADC" at the IASLC 2024 Hot Topic in Basic & Translational Science Meeting on December 14, 2024. Data highlights: Phase 2 trial of Mec-V, CAB-AXL-ADC in NSCLC; 78 patients were enrolled and received either Mec-V monotherapy or Mec-V + nivolumab; Patients received a median of 3 prior lines of therapy. Among the 78 treated patients, 24 had mKRAS NSCLC. Overall survival analyses: Landmark OS at one year: 58% for patients with mKRAS NSCLC vs. 23% for patients with wtKRAS NSCLC. Median OS was not yet reached for patients with mKRAS NSCLC vs. 8.7 months for patients with wtKRAS NSCLC. Among 21 efficacy-evaluable patients with mKRAS NSCLC: 6 responses. Antitumor activity observed across 9 different mutated KRAS variants; 1 patient treated with Mec-V + nivolumab Q2W continues in Complete Response after greater than2 years of follow-up. Treatment with Mec-V was well tolerated with a manageable safety profile. No new safety signals were observed. AXL is highly expressed in mKRAS NSCLC; 113 screening tissue samples were evaluated for KRAS mutation status and AXL expression by immunohistochemistry assay. Among 27 NSCLC samples harboring any KRAS mutation, AXL was highly expressed. 19 of 27. 9 of 11, among the mKRAS G12C variant subset of the 27 total.

08:20 EST Crinetics appoints Isabel Kalofonos as CCO - Crinetics announced the appointment of Isabel Kalofonos as Chief Commercial Officer. Ms. Kalofonos will lead the company's commercial strategy and operations for the potential launch of paltusotine, a once-daily, oral, selective somatostatin receptor type 2 nonpeptide agonist for adults living with acromegaly and will lead pre-commercialization activities for the company's deep, innovative pipeline of candidates. She previously served as Senior Vice President and Chief Commercial Officer at ImmunoGen. On January 10, 2025, the Company expects to grant Ms. Kalofonos a stock option to purchase 100,000 shares of common stock under the Crinetics Pharmaceuticals, Inc. 2021 Employment Inducement Incentive Award Plan 25 percent of which will vest on December 16, 2025, and the remainder will vest in 36 equal monthly installments thereafter. The stock option will have an exercise price equal to the closing price of the Company's common stock on the Nasdaq Global Select Market on January 10, 2025. The stock option will be subject to the terms and conditions of the 2021 Inducement Plan and the terms and conditions of a stock option agreement covering the respective grant. The stock option will be granted as an inducement material to Ms. Kalofonos entering into employment with Crinetics in accordance with Nasdaq Listing Rule 5635(c)(4).

08:18 EST VSee Health teams with Tele911 to create 1st virtual emergency department - VSee Health announces its partnership with Tele911, the nation's foremost ER diversion solution provider. This collaboration will harness the power of VSee Health's versatile telehealth building blocks platform to expand Tele911's impact in tackling two of the most critical challenges in emergency medical servicesEMS: emergency room overcrowding and the ongoing 911 and EMS staffing crisis..."This partnership is a game-changer for the EMS industry," said Dr. Milton Chen, Co-CEO of VSee Health. "By combining Tele911's innovative care model with our robust telehealth platform, we are providing a scalable secure solution that allows Tele911 to deliver care on average in just 40 seconds, ensuring a robust 911 system for our nation. Together, we can ensure that emergency care is available when and where it's truly needed."

08:17 EST Emergent BioSolutions receives $50M contract option from BARDA - Emergent BioSolutions announced that the Biomedical Advanced Research and Development Authority within the Administration for Strategic Preparedness and Response at the U.S. Department of Health and Human Services has awarded a $50 million option to Emergent's existing contract for the acquisition of CYFENDUS. Deliveries are expected to begin this calendar year and be complete by April 2025. This award follows a previously announced contract modification of $30.0 million to supply CYFENDUS this year. CYFENDUS vaccine was approved by the U.S. Food & Drug Administration in July 2023 as a two-dose anthrax vaccine for post-exposure prophylaxis use in individuals 18 through 65 years of age. Anthrax is a Tier 1 biological select agent due to its potential to be used for a bioterrorist incident and threat to public health and national security.

08:16 EST Windtree Therapeutics announces presentation highlighting istaroxime - Windtree Therapeutics announced that Alexandre Mebazaa, MD, one of the world's recognized leaders in cardiogenic shock, gave a presentation highlighting the data on istaroxime from the recently completed Phase 2b SEISMiC B study in early cardiogenic shock due to heart failure. The presentation was given at the Cardiovascular Clinical Trials Conference in Washington, DC. Dr. Alexandre Mebazaa is Professor of Medicine at Universite Paris Cite, Chair of Department of Anesthesia & Critical Care and an expert in heart failure and cardiogenic shock. He is part of the task force that wrote the 2021 ESC/HFA Guidelines of Heart Failure and the 2023 addendum. Early cardiogenic shock is characterized by low blood pressure, leaving the patient at risk of developing inadequate blood flow to vital organs leading to high morbidity and mortality. Istaroxime is a novel first-in-class investigational therapy that is intended to improve cardiac function and increase blood pressure to reverse the condition. Istaroxime maintains renal function and has a generally favorable safety profile. Istaroxime has been studied in four positive Phase 2 trials enrolling patients with acute heart failure and early cardiogenic shock due to heart failure.

08:13 EST Forian, Databricks partner to expand access to healthcare analytics - Forian announced a partnership with Databricks to deliver access to its Chartis product, which maps physician and organization affiliations, through Databricks Marketplace. This collaboration will empower healthcare organizations with enhanced visibility into Forian's robust information products, driving innovative solutions in healthcare research, drug development and patient care.

08:11 EST 4D Molecular announces publication of 4D-150 preclinical data - 4D Molecular Therapeutics announced the publication of landmark preclinical data demonstrating the potential of the Company's proprietary Therapeutic Vector Evolution platform, intravitreal R100 vector and the R100-based genetic medicine 4D-150. Pioneering efficacy and safety results in a difficult-to-treat nonhuman primate model of wet age-related macular degeneration demonstrated the potential of 4D-150 to substantially reduce the treatment burden and improve long-term vision outcomes for patients with wet AMD, diabetic macular edema and diabetic retinopathy. The data were published in Investigative Ophthalmology & Visual Science; December 2024 issue. IOVS is the journal of the Association for Research in Vision and Ophthalmology, a leading basic and translational research association in ophthalmology. The publication entitled, "Design and Characterization of a Novel Intravitreal Dual-Transgene Genetic Medicine for Neovascular Retinopathies," reports the results of preclinical discovery, engineering and characterization studies evaluating the safety, retinal cell transduction, transgene expression and clinical activity of proprietary evolved intravitreal vector R100 and 4D-150, an R100-based genetic medicine carrying 2 therapeutic transgenes: a codon-optimized sequence encoding aflibercept, a recombinant protein that inhibits VEGF-A, VEGF-B and PlGF, and a microRNA sequence that inhibits expression of VEGF-C. The data showed that R100 demonstrated significantly superior human retinal cell transduction compared to AAV2, and intravitreal administration of 4D-150 to nonhuman primates was well tolerated and led to robust panretinal expression of both transgenes, especially within the macula region; AAV2 was unable to transduce deep retinal cell layers in the same model. In a difficult-to-treat primate laser-induced choroidal neovascularization model of wet AMD, 4D-150 completely prevented grade IV angiogenic lesions at all tested doses.

08:10 EST Arcutis Biotherapeutics submits sNDA for ZORYVE cream to FDA - Arcutis Biotherapeutics announced the submission of a supplemental New Drug Application to the U.S. Food and Drug Administration for ZORYVE cream 0.05%, a once-daily, next generation phosphodiesterase 4 inhibitor, for the topical treatment of mild to moderate AD in children 2 to 5 years old. The sNDA is supported by positive results from one pivotal Phase 3 trial, one pivotal long-term extension study, as well as a Phase 1 pharmacokinetic study. The INTEGUMENT-PED vehicle-controlled, pivotal Phase 3 trial enrolled 652 children 2 to 5 years of age, with a mean AD Body Surface Area of 22% overall, and ranging from 3% to 82%. In the study, at Week 4, 25.4% of children treated with roflumilast cream 0.05% achieved vIGA-AD Success, defined as a validated Investigator Global Assessment - Atopic Dermatitis score of 'Clear' or 'Almost Clear' plus a 2-grade improvement from baseline, compared to 10.7% of children treated with vehicle, with significant improvements seen as early as Week 1. All secondary endpoints were also met, with significant improvements seen across all time points, including vIGA-AD success and vIGA-AD of 'Clear' and 'Almost Clear' at Week 1. In addition, 35.3% of children treated with roflumilast cream who had a baseline Worst Itch Numeric Scale score greater than or equal to4 achieved a four-point reduction in WI-NRS at Week 4. Roflumilast cream 0.05% was well-tolerated. Overall, the safety profile observed in 2- to 5-year-old pediatric subjects treated with ZORYVE cream 0.05% during the trial was consistent with the favorable safety profile established in adults and older pediatric subjects treated with ZORYVE cream 0.15% with mild to moderate AD. The most frequent adverse events occurring in the roflumilast arm greater than vehicle included upper respiratory tract infection, diarrhea, and vomiting. The submission is also supported by data from the INTEGUMENT-OLE open-label extension study in which patients ages 2 to 5 were treated for up to 52 weeks.

08:08 EST Reviva announces topline data for OLE portion of Phase 3 RECOVER study - Reviva Pharmaceuticals announced preliminary topline data for the open-label extension portion of the Company's ongoing Phase 3 RECOVER study evaluating the long-term safety and tolerability of brilaroxazine in patients with schizophrenia. Administration of brilaroxazine once daily led to robust broad-spectrum efficacy that was sustained over 1 year. Brilaroxazine was generally well tolerated with no single side effect greater than5% and favorable compliance, with a discontinuation rate of 35% in the OLE part of this study. All three doses of brilaroxazine tested were efficacious and generally well-tolerated. Key safety, efficacy and compliance findings for pooled analysis of brilaroxazine at 15, 30, and 50 mg include: A total number of 435 patients were enrolled in the OLE across three dose groups: 139 in brilaroxazine 15 mg, 155 in brilaroxazine 30mg and 141 in brilaroxazine 50mg; 156 rollover participants from the double-blind portion of the Phase 3 trial, while 279 de novo participants enrolled in the OLE; Preliminary efficacy results are presented for 113 patients who completed 52 weeks of treatment; preliminary safety results are presented for all 435 patients who enrolled in the OLE, including patients that are still participating in the trial. Brilaroxazine across doses improved major symptom domains of schizophrenia after 1-year of treatment: Dose dependent efficacy at the 15, 30, and 50 mg doses was observed, with decreases in PANSS total scores of -15.2, -18.6 and -20.8 points, respectively, from baseline to end-of-treatment at 52 weeks; Pooled data of brilaroxazine at the 15, 30, and 50 mg doses demonstrated clinically meaningful and sustained long-term efficacy for schizophrenia with a significant decrease in PANSS total scores, PANSS positive symptoms, and PANSS negative symptoms compared to baseline; PANSS Total scores: 18.6-point decrease, p less than or equal to 0.0001; PANSS Positive Symptoms: 5.2-point decrease, p less than or equal to 0.0001; PANSS Negative Symptoms: 4.5-point decrease, p less than or equal to 0.0001; Brilaroxazine demonstrated strong sustained efficacy from acute through maintenance treatment over 1 year with a decrease in PANSS Total score in rollover patients from the double-blind portion of the trial; 30-point decrease of PANSS total in 86.76% of patients; 40-point decrease of PANSS total in 64.70% of patients; 50-point decrease of PANSS total in 33.82% of patients. Long-term clinical safety, tolerability and adherence findings of brilaroxazine administered for up to one year support a well-tolerated safety profile: 15.2% of participants reported at least one treatment-related adverse event, which were mostly mild or moderate in severity and transient in nature; Most common TRAEs 1% were weight increase, insomnia and somnolence; Brilaroxazine was not associated with any clinically meaningful changes in movement disorder scales over 1 year treatment; No drug-related serious adverse events observed or major safety concerns reported for brilaroxazine after up to 1 year of treatment; 3 serious adverse events were reported and none were related to brilaroxazine treatment; Treatment discontinuation rate of 35% reported in this OLE, primarily due to withdrawal of consent participant lost to follow up, and treatment-related adverse events. Collectively, the findings from the OLE portion of the Phase 3 RECOVER study further strengthen the safety, efficacy and treatment adherence findings from the double-blind portion of RECOVER. The OLE portion of the RECOVER Study is being conducted globally at multiple centers to assess the safety, and efficacy of brilaroxazine at flexible doses of 15, 30 or 50 mg, administered once daily for 52 weeks in patients with stable schizophrenia. The OLE included both rollover participants from the double-blind portion of RECOVER study and de novo participants with stable schizophrenia. Long-term safety data from a minimum of 100 patients who have completed 1 year of treatment is a requirement for brilaroxazine's NDA submission to the FDA.

08:06 EST Local Bounti announces multi-year award from multinational retailer - Local Bounti announced that it has received a two-year award from a large multinational retailer to supply Local Bounti's living butter lettuce product to 13 of the Retailer's distribution centers from Local Bounti's California and new Texas facilities. This award underscores Local Bounti's commitment to providing high-quality, fresh produce to consumers nationwide.

08:06 EST Clarivate announces new $500M share repurchase authorization - Clarivate announced that its Board of Directors authorized a new share repurchase program of up to $500 million of the Company's outstanding ordinary shares through open-market purchases for a period of two years, from January 1, 2025 through December 31, 2026.

08:05 EST Curtiss-Wright announces $100M share repurchase program expansion - Curtiss-Wright announced a $100M expansion of its 2024 share repurchase program, which it expects to complete via a 10b5-1 program by the end of the year. This program will be conducted in concurrence with the existing $50m share repurchase program being executed this year, and follows the recent completion of a $100M opportunistic program that was executed in the third quarter. As a result, the company now expects annual share repurchases of $250M in 2024. Beginning in January 2025, the company also expects to repurchase $60M in shares via a 10b5-1 program, an increase from the prior $50M annual plan, which is expected to offset potential dilution from compensation plans.

08:04 EST NV5 Global awarded $10M in critical mineral geospatial projects - NV5 has been awarded $10M in contracts by the U.S. Geological Survey to provide high-precision geospatial services to support essential geological research across multiple regions. These contracts will provide USGS with the critical data needed to advance the Earth Mapping Resources Initiative program, supporting the identification and management of critical minerals in the United States. Demand for critical minerals is growing to support the energy independence transition, and identification of domestic sources reduces dependence on international suppliers.

08:03 EST authID, TurboCheck partner to combat fake job candidates - TurboCheck and authID announced a partnership to tackle the escalating challenges of hiring fraud in the digital age. To date, TurboCheck has identified over 200,000 fake candidates, demonstrating the scale of the problem and the critical need for advanced fraud detection solutions. This collaboration combines TurboCheck's advanced fraud detection platform with authID's biometric technology, providing employers and staffing firms with unparalleled confidence in candidate authenticity.

08:01 EST AFEELA introduces Stingray Karaoke as in-car entertainment services - Sony Honda Mobility partnered with Stingray Group to expand its in-car entertainment services. Through this partnership, AFEELA customers will be able to use Stingray Karaoke and enjoy in-car karaoke services. With the introduction of Stingray Karaoke, customers will have access to a massive international song library of over 100,000 licensed tracks. This collection browsable by title, artist, lyrics, or genre, features today's top charting artists and yesterday's legends. It spans a wide range of genres, including Pop, Rock, Country, Rap, R&B, K-Pop, Holiday Classics and Kids & Family, providing AFEELA customers with an enhanced entertainment experience for every taste and occasion.

07:59 EST LeMaitre announces proposed convertible senior notes offering - LeMaitre Vascular announced its intention to offer, subject to market and other conditions, $150,000,000 aggregate principal amount of Convertible Senior Notes due 2030 in a private offering to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. LeMaitre also expects to grant the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional $22,500,000 aggregate principal amount of notes. The notes will be senior, unsecured obligations of LeMaitre, will accrue interest payable semi-annually in arrears, and will mature on February 1, 2030, unless earlier repurchased, redeemed or converted. Noteholders will have the right to convert their notes in certain circumstances and during specified periods into cash, shares of LeMaitre's common stock, or a combination of cash and shares of LeMaitre's common stock, at LeMaitre's election. The notes will be redeemable, in whole or in part, for cash at LeMaitre's option at any time, and from time to time, on or after February 5, 2028 and on or before the 40th scheduled trading day immediately before the maturity date, but only if the last reported sale price per share of LeMaitre's common stock exceeds 130% of the conversion price for a specified period of time and certain other conditions are satisfied. The redemption price will be equal to the principal amount of the notes to be redeemed, plus accrued and unpaid interest, if any, to, but excluding, the redemption date. If certain corporate events that constitute a "fundamental change" occur, then noteholders may require LeMaitre to repurchase their notes for cash. The repurchase price will be equal to the principal amount of the notes to be repurchased, plus accrued and unpaid interest, if any, to, but excluding, the applicable repurchase date. The final terms of the notes, including the initial conversion price, interest rate and certain other terms of the notes, will be determined at the time of pricing. LeMaitre intends to use the net proceeds from the offering, including the purchase of additional notes, for working capital and other general purposes, which may include acquisitions of or investments in complementary companies, product lines, products or technologies.

07:49 EST Healwell AI to acquire Orion Health for C$165M - HEALWELL AI has entered into an agreement to acquire 100% of the shares of Auckland, New Zealand based Orion Health Holdings Limited, a subscription license and services revenue business serving marquee public sector clients globally with data interoperability and healthcare navigation products and services after the concurrent divestiture of Orion Health's divisions that are non-strategic to HEALWELL, for total consideration of NZD$200m or C$165m. The acquisition of Orion Health and concurrent divestment of non-strategic divisions will represent a transformative milestone in HEALWELL's journey to become a global leader in healthcare technology and artificial intelligence. Orion Health is expected to generate revenue of more than C$100M with EBITDA of over C$20m in calendar 2025. Orion Health is a leader in global healthcare technology, with over 70 worldwide customers in 11 countries. This acquisition will provide HEALWELL with a significant muti-jurisdictional platform to deliver its best-in-class AI-driven solutions by integrating them with Orion Health's advanced healthcare data infrastructure capabilities. Orion Health's software solutions currently serve a population approaching 150 million lives globally; which will materially expand HEALWELL's footprint to execute against its mission of early disease detection. Orion Health is a global leader in the development and deployment of data management platforms at scale, delivering healthcare information intelligence through their advanced Virtuoso Digital Front Door and Amadeus Digital Care Record platforms. Their ability to aggregate data from multiple sources and knit it together for healthcare practitioners to have seamless data flow across multiple complex health systems benefits patients but also delivers population scale data. These platforms have won Orion Health long-term contracts in some of the largest countries and regions globally. Australia and New Zealand, the NHS in the UK and North America are their strongest markets with Canada being their largest regional market. The Province of Ontario is implementing both the DCR and DFD solutions while the Province of Alberta has been a DCR customer for more than 20 years. The acquisition of Orion Health will provide opportunities for global health systems to access HEALWELL's AI technology to deliver actionable insights and drive better healthcare outcomes. It also significantly scales HEALWELL's platform by deepening its penetration into the public sector, supported by Orion Health's long-standing government relationships and broader customer base. Moreover, the acquisition will unlock substantial revenue synergy potential, as well as improved operational efficiencies and cost savings through shared services with WELL Health Technologies Corp., HEALWELL's largest investor and strategic partner. Collectively, these advantages will strengthen HEALWELL's financial profile, creating a larger, scalable business with substantial growth and value-creation potential. HEALWELL will acquire 100% of the shares of Orion Health, following the concurrent divestiture of Orion Health's non-strategic assets, for an aggregate purchase price of $175M NZD plus a performance based earnout of up to a further $25M NZD. On closing, HEALWELL will satisfy the purchase price of C$144M with a combination of C$86M in cash and C$57.4M in HEALWELL Class A Subordinate Voting shares priced with reference to the related financing. The Transaction is expected to close on or before April 1st, 2025 subject to regulatory approval, approval from the Toronto Stock Exchange, divestment of the non-strategic assets, and exercise of a call option to consolidate minority share positions in Orion Health with the major shareholder. The purchase price is expected to be financed through a combination of up to C$50M in senior bank debt provided by a Canadian Schedule I bank and the net proceeds of the Offering. The C$57.4M of equity issued as part of the purchase price will be issued at a deemed price of $1.61 per share. The Offering will be completed on a "bought deal" private placement basis and will be co-lead by Eight Capital and Scotiabank, on behalf of a syndicate of underwriters. The Offering will consist of: 10,000,000 subscription receipts of the Company at a price of $2.00 per Subscription Receipt; and 31,250 convertible debentures of the Company by way of private placement on a "bought deal" basis at a price per Convertible Debenture of $960, for total gross proceeds of $50,000,000. The Convertible Debentures will be issued with a 4% original issue discount and will be convertible into Shares at a price of $2.40 per Share. The Company may force the conversion of all of the principal amount of the then outstanding Convertible Debentures at a price of $2.40 per Share on not less than 30 days' notice should, at any time following the date that is 4 months and 1 day following the issue date, the daily volume weighted average trading price of the Shares be greater than $3.85 for any 10 consecutive trading days. The Convertible Debentures will bear interest at the rate of 10% per annum, payable semi-annually in arrears on June 30 and December 31 of each year, beginning on June 30, 2025. The Convertible Debentures will mature on December 31, 2029, unless earlier repurchased, redeemed, or converted in accordance with their terms. The Convertible Debentures will not be redeemable at the Company's option prior to December 31, 2027. On or after January 1, 2028, the Convertible Debentures will be redeemable at the Company's option, in whole or in part, at a price equal to 110% of the principal amount of the Convertible Debentures to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. Each Subscription Receipt will entitle the holder thereof to receive, upon satisfaction of the Release Conditions, for no additional consideration, one unit of the Company consisting of one Share and one-half of one Share purchase warrant, with each whole warrant exercisable at a price of $2.50 for a period of 36 months following the closing of the Offering. The gross proceeds of the Subscription Receipt portion of the Offering, less 50% of the Underwriters' cash commission and certain expenses of the Underwriters, will be deposited in escrow on closing of the Offering until the satisfaction of certain release conditions, including that all conditions precedent to the Transaction have been met. In the event that the Release Conditions have not been satisfied prior to 5:00 p.m. on June 30, 2025, or the Company advises the Underwriters or announces to the public that it does not intend to satisfy the Release Conditions or that the Transaction has been terminated, the aggregate issue price of the Subscription Receipts shall be returned to the applicable holders of the Subscription Receipts, and such Subscription Receipts shall be automatically cancelled and be of no further force and effect. The Company has granted the Underwriters an option to offer for sale up to an additional 15% of the Subscription Receipts, exercisable in whole or in part at any time for a period of up to 48 hours prior to the closing date. Completion of the Offering will be subject to various conditions, including the approval of the Exchange. As the Transaction and Offering will exceed 25% of the number of HEALWELL's current issued and outstanding shares, HEALWELL is required to obtain shareholder approval from shareholders holding at least a majority of the voting power of the Company.

07:42 EST Biohaven reports clinical, regulatory milestones across MoDE platform - Biohaven highlighted the achievement of several clinical and regulatory milestones across its proprietary Molecular Degrader of Extracellular Proteins, MoDE, platform as well as its glutamate modulation and ion channel programs. Subcutaneously administered BHV-1300 achieved deep lowering of targeted IgG, with reductions greater than 60% in the lowest subcutaneous dose tested in the ongoing multiple ascending dose study. Subcutaneous BHV-1300 achieved progressive reduction in IgG within hours of each weekly dose administration in the MAD, and pharmacodynamic effects were sustained relative to baseline over the four-week study period. BHV-1300 has been safe and well-tolerated across the Phase 1 study. There were no clinically significant effects on albumin or liver function, and no increases in cholesterol were noted. In addition to the new Phase 1 data with BHV-1300, Biohaven also announced regulatory acceptance of three INDs and/or CTAs for its next-generation MoDE molecules to target other immune mediated diseases. Two of these novel MoDEs, BHV-1400 and BHV-1600, represent the platform's first autoantibody specific degraders, sparing the body's healthy antibodies to function normally while clearing disease-causing antibodies. Dosing in humans has been initiated for BHV-1400, a novel IgA nephropathy investigational therapy designed to selectively degrade galactose deficient IgA1 without immunosuppression. Biohaven also initiated dosing in humans with BHV-1600 in 4Q 2024.

07:38 EST Nut Tree Capital, Caspian urge Martin Midstream shareholders vote against sale - Nut Tree Capital Management and Caspian Capital, which together with their affiliates have combined exposure in Martin Midstream Partners of approximately 13.6% of the outstanding common units, sent a letter to MMLP's common unitholders urging them to vote "AGAINST" the sale of MMLP to Martin Midstream Resource Corporation for $4.02 per common unit at the Company's upcoming meeting of unitholders scheduled for Monday, December 30, 2024.

07:36 EST FDA approves Organon's VTAMA cream, 1% for the treatment for AD - Organon announced that the U.S. Food and Drug Administration or FDA has approved VTAMA or tapinarof cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis AD in adults and pediatric patients 2 years of age and older.Organon received the FDA approval prior to its extended target action date PDUFA of March 12. "With the FDA's approval of VTAMA cream in atopic dermatitis for adults and children as young as 2 years old, there is now a therapy that offers the potential for powerful skin clearance with no label warnings or precautions, contraindications, and no restrictions on duration of use or percentage of body surface area affected," said Kevin Ali, Organon's Chief Executive Officer. "Introducing this new first-in-class therapy for AD patients reaffirms Organon's commitment to addressing areas of high unmet need." ... "Moreover, because the prevalence of itch makes this condition extremely burdensome to patients and their families, the itch data from the ADORING program demonstrates reduction of one of the condition's most prevalent symptoms with use of VTAMA cream."

07:35 EST FDA approves Organon's VTAMA cream, 1% for the treatment for AD treatment - Organon announced that the U.S. Food and Drug Administration or FDA has approved VTAMA or tapinarof cream, 1%, an aryl hydrocarbon receptor agonist, for an additional indication of the topical treatment of atopic dermatitis AD in adults and pediatric patients 2 years of age and older.Organon received the FDA approval prior to its extended target action date PDUFA of March 12. "With the FDA's approval of VTAMA cream in atopic dermatitis for adults and children as young as 2 years old, there is now a therapy that offers the potential for powerful skin clearance with no label warnings or precautions, contraindications, and no restrictions on duration of use or percentage of body surface area affected," said Kevin Ali, Organon's Chief Executive Officer. "Introducing this new first-in-class therapy for AD patients reaffirms Organon's commitment to addressing areas of high unmet need." ... "Moreover, because the prevalence of itch makes this condition extremely burdensome to patients and their families, the itch data from the ADORING program demonstrates reduction of one of the condition's most prevalent symptoms with use of VTAMA cream."

07:34 EST Soligenix initiates confirmatory Phase 3 trial of HyBryte - Soligenix announced that it has opened patient enrollment for its confirmatory Phase 3 study evaluating HyBryte in the treatment of cutaneous T-cell lymphoma, CTCL. The confirmatory Phase 3 study builds on the previous statistically significant Phase 3 study, as well as a recent successful comparative study and an ongoing investigator-initiated study, each further supporting the design of the FLASH2 clinical trial.

07:32 EST Xilio Therapeutics appoints Caroline Hensley as CLO - Xilio Therapeutics (XLO) announced the appointment of Caroline Hensley as chief legal officer. Hensley most recently served as senior vice president, assistant general counsel and chief compliance officer at Seres Therapeutics (MCRB).

07:31 EST Cemtrex's Vicon Industries secures $10.4M Valerus expansion order - Cemtrex's Vicon Industries subsidiary has received a record breaking $10.4M order for a state government corrections facility in the mid-Atlantic region. This significant order will expand the customer's Valerus surveillance security system with additional hardware, including enhanced storage infrastructure. The order is expected to be fulfilled in the Company's second fiscal quarter of 2025, fully within Cemtrex's fiscal year. Specific details about the customer remain confidential in accordance with non-disclosure agreements.

07:29 EST GSK announces FDA granted BTD for Jemperli - GSK announced that the US Food and Drug Administration, FDA, has granted Breakthrough Therapy Designation, BTD, for Jemperli for the treatment of patients with locally advanced mismatch repair deficient/microsatellite instability-high, MSI-H, rectal cancer. The Breakthrough Therapy Designation aims to expedite the development and review of drugs with the potential to treat a serious condition and where preliminary clinical evidence may indicate substantial improvement over currently available therapy. This is the second regulatory designation for dostarlimab in locally advanced dMMR/MSI-H rectal cancer, following Fast Track designation for the same patient population in January 2023.

07:28 EST StorageVault Canada appoints Deborah Robinson to board of directors - STORAGEVAULT CANADA announced that Deborah Robinson, ICD.D, has been appointed as a director of StorageVault as Jay Lynne Fleming has decided to step down from the Board for personal reasons. Effective December 16, 2024, the Board of Directors of StorageVault will be Benjamin Harris, Iqbal Khan, Deborah Robinson, Steven Scott, Alan Simpson and Mary Vitug. Upon joining the Board, Ms. Robinson will serve as Chair of the Governance, Nominating and Compensation Committee. Robinson is the founder and President of Bay Street HR, an outsourced human resources service provider to small and mid-sized financial and professional service firms

07:26 EST Ecopetrol announces changes in senior management - Ecopetrol announces that German Gonzalez Reyes, who has been serving as Secretary General since September 29, 2023 and Acting Director of Institutional Relations and Communications since June 28, 2024, will perform his duties until January 17, 2025. Ecopetrol thanks German Gonzalez for his seven years of service, his valuable management, and the contributions made to Ecopetrol, and wishes him much success in his new professional endeavors. Consequently, the Board of Directors made the following appointments on December 13, 2024: Cristina Toro Restrepo, current Corporate Legal Vice President, as Acting Secretary General, effective as of January 18, 2025, until the position is permanently filled; Rodolfo Garcia Paredes, current Hydrocarbons Legal Manager, as Acting Corporate Legal Vice President, effective as of January 18, 2025, until the position of Secretary General is permanently filled; Diana Marcela Jimenez, current Regulatory Strategy Manager, as Acting Director of Institutional Relations and Communications, effective as of January 18, 2025, until the position is permanently filled.

07:25 EST Domino's Pizza teams up with wide receiver Stefon Diggs - Domino's is teaming up with All-Pro wide receiver Stefon Diggs, who was injured earlier this season, to give away $1 million worth of free Emergency Pizzas to fans who had him on their fantasy football roster. "Domino's promised we'd bring back Emergency Pizza in more fun and unexpected ways than ever before, so we're here to continue delivering on that promise," said Kate Trumbull, Domino's executive vice president - chief marketing officer.

07:24 EST Innoviva enters distribution, license agreement with Basilea for Zevtera - Innoviva announced it has entered into an exclusive distribution and license agreement with Basilea Pharmaceutica for the commercialization of Zevtera, an advanced-generation cephalosporin antibiotic, in the United States. In April, the FDA approved Zevtera for three specific treatment indications, and it is the only FDA-approved methicillin-resistant Staphylococcus aureus, or MRSA, cephalosporin antibiotic for treating adult patients with Staphylococcus aureus bloodstream infections and endocarditis. Zevtera is indicated for the treatment of adult patients with SAB, including right-sided infective endocarditis, and adult patients with acute bacterial skin and skin structure infections and for adult and pediatric patients with community-acquired bacterial pneumonia.

07:22 EST Phillips 66 to sell DCP GCX Pipeline to ArcLight for proceeds of $865M - Phillips 66 announced that it has entered into a definitive agreement to sell DCP GCX Pipeline which owns a 25% non-operated equity interest in Gulf Coast Express Pipeline to an affiliate of ArcLight Capital Partners, for pre-tax total cash proceeds of $865M, subject to purchase price adjustments. "With this transaction, we have exceeded our $3 Basset divestiture target established in our strategic priorities. We intend to continue to optimize the portfolio and rationalize non-core assets going forward," said Mark Lashier, chairman and CEO of Phillips 66. "The evolution of our portfolio underscores our position as a leading integrated downstream energy provider, enhancing shareholder value and positioning the company for the future." Gulf Coast Express Pipeline is an approximately 500-mile pipeline system that transports about 2 billion cubic feet per day of natural gas from the Permian Basin to the Agua Dulce, Texas area. Following the transaction, Gulf Coast Express Pipeline will be jointly owned by subsidiaries of Kinder Morgan( KMI) and affiliates of ArcLight Capital Partners The sales price represents an implied Enterprise Value/EBITDA multiple of 10.6x based on expected 2025 EBITDA. Proceeds from the sale will support the strategic priorities of Phillips 66, including returns to shareholders and debt reduction. The sale is expected to close in January 2025.

07:21 EST Vitesse Energy to acquire Lucero Energy for $222M - Vitesse Energy and Lucero Energy announced they have entered into a definitive agreement under which Vitesse will acquire Lucero in an all-stock transaction with a fully diluted equity value of $222M. Under the terms of the agreement, Lucero shareholders will receive 0.01239 of a share of Vitesse common stock for each common share of Lucero. The addition of Lucero's operations will provide additional scale to Vitesse's assets across the Bakken, where Lucero had approximately 6.4 Mboe per day of two-stream net production during the third quarter of 2024. Lucero had no outstanding debt and $56M of cash as of September 30 and Vitesse expects to use a portion of the cash held by Lucero at closing to reduce outstanding borrowings under Vitesse's revolving credit facility. Vitesse is targeting about $3M of general and administrative synergies annually. In this all-stock transaction, each outstanding common share of Lucero will be exchanged for 0.01239 of a share of Vitesse common stock, with approximately 8,175,000 shares of common stock expected to be issued at closing. After closing, existing Vitesse stockholders are expected to own approximately 80% and existing Lucero shareholders are expected to own approximately 20% of the company on a fully diluted basis. The transaction will be structured as a plan of arrangement under the Business Corporations Act and is subject to the approval of at least two-thirds of the votes cast by holders of Lucero common shares at a meeting to be called to consider the transaction and if required under applicable Canadian securities laws, a majority of the votes cast by Lucero shareholders at such meeting. The issuance of shares of Vitesse common stock as consideration in the transaction is subject to the approval of the majority of votes cast at a meeting by holders of shares of Vitesse common stock in connection with the transaction, pursuant to the rules of the New York Stock Exchange, or NYSE. Following the closing of the transaction, the board of directors of Vitesse will increase to nine members and will comprise the seven current members of Vitesse's board and two nominees currently serving on Lucero's board, namely Messrs. Reaves and Chernoff. Vitesse's leadership team will continue to serve in their respective capacities in the company. Vitesse expects to promptly hedge a significant portion of the commodity risk associated with this transaction through 2026 and has hedged a meaningful portion of its own production into 2026. Vitesse historically hedges a portion of its expected oil production volumes to increase the predictability and certainty of its cash flow. Vitesse does not currently have hedges in place on its expected natural gas production volumes. The transaction has been unanimously approved by the boards of directors of both companies. The transaction is expected to close by the second quarter of 2025. The transaction is subject to customary closing conditions in the United States and Canada, as well as the approvals by Vitesse's and Lucero's shareholders described above, the approval of the Court of King's Bench of Alberta, the listing of shares of Vitesse's stock to be issued in the transaction on NYSE and certain other approvals. Further information regarding the transaction will be contained in a management information circular that Lucero will prepare, file and mail to Lucero shareholders in advance of its shareholder meeting and a proxy statement that Vitesse will file with the Securities and Exchange Commission and mail to Vitesse stockholders in advance of its stockholders meeting. Copies of the arrangement agreement and management information circular will be available on Lucero's profile on SEDAR+ at www.sedarplus.ca and the arrangement agreement and proxy statement will be available on the SEC's website at www.sec.gov under Vitesse's profile. The board of directors of Lucero has unanimously determined that the arrangement and the other transactions contemplated by the arrangement agreement are in the best interests of Lucero and fair to holders of the shares of Lucero, authorized and approved the entering into of the arrangement agreement and the performance by Lucero of its obligations under such agreement, and recommend that holders of Lucero shares vote in favor of a special resolution to approve the arrangement. FR XIII PetroShale Holdings L.P, and each of the directors and executive officers of Lucero who hold shares of Lucero, representing in aggregate approximately 63% of the outstanding shares of Lucero (on a non-diluted basis), have entered into support agreements with Vitesse and have agreed, among other things, to support and vote in favor of the transaction, subject to the provisions of such agreements.

07:18 EST Larimar Therapeutics announces initial data from OLE study of nomlabofusp - Larimar Therapeutics announced initial data from the ongoing long-term OLE study evaluating daily subcutaneous injections of 25 mg of nomlabofusp self-administered or administered by a caregiver in participants with FA. The Company also provided a nomlabofusp development program update. The OLE study is evaluating the safety and tolerability, PK, and FXN levels in buccal and skin cells, along with exploratory pharmacodynamic markers and clinical outcomes following long-term subcutaneous administration of nomlabofusp. The participants who completed treatment in Phase 1 studies and the Phase 2 dose exploration study evaluating nomlabofusp are potentially eligible to screen for the OLE study. At the time of data cut off for the OLE study, 14 adults with FA were included with up to 260 days of long-term daily treatment of 25 mg of nomlabofusp. Among these patients, more than 50% were non-ambulatory. Key Safety Findings for Long-term 25 mg Daily Nomlabofusp: Generally well tolerated with two participants that had serious adverse events that resolved within 24 hours and withdrew from the study. Most common adverse events were injection site reactions, with most being mild, brief in duration, and self-limited. Key FXN Data for Long-term 25 mg Daily Nomlabofusp: Tissue FXN levels showed mean change from baseline of 1.32 pg/undefined in buccal cells and 9.28 pg/undefined in skin cells at Day 90. 25 mg of nomlabofusp increased and maintained tissue FXN levels over time, increasing from a mean level of 15% of HV at baseline to 30% in buccal cells and from 16% to 72% in skin cells at Day 90. Tissue FXN levels appear to reach steady-state levels by Day 30 in buccal cells. Early Trends Towards Improvement Observed Across a Number of Clinical Outcomes for Long-term 25 mg Daily Nomlabofusp: Decreased values indicating early trends towards improvement were observed in modified Friedreich Ataxia Rating Scale, FARS-Activities of Daily Living, Modified Fatigue Impact Scale, and 9 Hole Peg Test at Day 90 relative to baseline. Supports potential that nomlabofusp administration may result in a clinical benefit across a broad spectrum of patients with FA. Key Pharmacokinetic Data for Long-term 25 mg Daily Nomlabofusp: Rapid absorption after subcutaneous administration. Exposure appeared to reach steady state in plasma by Day 30 with no further accumulation Pharmacokinetic profile consistent with Phase 1 and Phase 2 studies. Additional Updates on Nomlabofusp Development Program: Dose increased to 50 mg in OLE study in 6 study participants with plan to increase dose in all other study participants Screening adolescents for pediatric PK run-in study with dosing to initiate early next year at weight-based dose equivalent of 50 mg adult dose; plan to transition adolescents who complete study participation into OLE after analysis of PK and safety data. Evaluating global clinical sites for planned registration/confirmatory study. Advancing discussions with FDA on data package required to support accelerated approval, including supplementary nonclinical pharmacology investigations, and FXN, supportive PD, and safety and clinical outcomes data from the OLE study.

07:12 EST Performance Food COO Craig Hoskins to switch roles, Scott McPherson to succeed - Performance Food Group announced its board of directors has approved two changes to PFG's leadership team. Effective January 1, 2025, Scott McPherson has been promoted to president and COO, while Craig Hoskins will transition into the newly established position of executive VP and chief development officer. In his new role, McPherson will continue overseeing PFG's three business segments: Foodservice, Convenience and Vistar. He will focus on the company's growth and will be responsible for all aspects of these businesses. McPherson will report to George Holm, PFG's chairman and CEO. For the past three years, Hoskins has served as president and COO of PFG.

07:10 EST Foghorn to discontinue independent development of FHD-286 with decitabine in AML - Foghorn Therapeutics (FHTX) has made the decision to discontinue the independent development of FHD-286 in combination with decitabine in patients with relapsed and/or refractory acute myeloid leukemia. Foghorn is evaluating partnerships and ISTs to advance FHD-286. The Company will prioritize its proprietary pipeline and Lilly (LLY) collaboration programs, including the clinical-stage selective SMARCA2 inhibitor FHD-909. As of September 30, 2024, the Company had $267.4M in cash, cash equivalents and marketable securities. Its cash runway supports the Company into 2027. In the Phase 1 dose escalation trial of FHD-286 in combination with decitabine in relapsed and/or refractory AML, objective clinical responses were observed by standard response criteria. However, the observed response rate did not meet the Company's threshold to continue development by Foghorn alone. Foghorn expects to report the results at a medical conference in 2025. "While clinical responses were observed for FHD-286, we will prioritize investment into our proprietary pipeline, including our Selective CBP program, Selective EP300 program, and ARID1B program, as well as our Lilly collaboration, including the clinical development of FHD-909." said Adrian Gottschalk, CEO. "Our pipeline of potential medicines represents significant opportunities in oncology with the potential for therapeutic expansion. We want to thank the clinical investigators, the patients, and their families for their participation in the FHD-286 clinical trial."

07:08 EST Mind Med: First patient dosed in Voyage study of LSD in treatment of GAD - Mind Medicine or MindMed announced that the first patient has been dosed in its Phase 3 Voyage study of MM120 ODT, a pharmaceutically optimized form of lysergide D-tartrate LSD or the treatment of GAD. Voyage is the first of two Phase 3 studies in GAD evaluating the efficacy and safety of MM120 ODT versus placebo and is expected to enroll approximately 200 participants in the United States. The Panorama study, the second Phase 3 trial, will be conducted in the U.S. and Europe and is on track to initiate in the first half of 2025."It is critical to continue to develop new and effective treatment options for patients with GAD, a debilitating condition where there is an urgent need for transformational innovation" "Today marks a pivotal moment in our journey towards advancing a novel treatment option for the 20 million people1 in the U.S. living with GAD. Building on our scientifically rigorous Phase 2b study, which demonstrated efficacy that far exceeds today's standard of care and a favorable tolerability profile, our Phase 3 studies are designed to adhere to the highest clinical and ethical standards and are in alignment with guidance from the U.S. Food and Drug Administration," said Daniel R. Karlin, M.D., M.A., Chief Medical Officer of MindMed...The primary endpoint of Voyage will measure the change from baseline in HAM-A at Week 12, which is consistent with the durable clinical effect observed in the Phase 2b study.

07:06 EST V2X opens new corporate headquarters in Reston, Virginia - V2X announces the opening of its new corporate headquarters in Reston, Virginia. "Our new headquarters represents the next chapter of V2X's growth and evolution," said Jeremy Wensinger, President and Chief Executive Officer of V2X. "We are in a position to attract top talent and strengthen our ability to deliver solutions to our clients and partners worldwide."

07:05 EST Agrify closes on acquisition of Senorita - Agrify has closed on its previously announced acquisition of certain assets from Double or Nothing LLC, the owner and creator of the Senorita brand of hemp-derived THC drinks. Senorita was designed and formulated by world-class winemakers Charles Bieler and Joel Gott. Recognizing a growing generational demand for adult beverage alternatives, Bieler and Gott gave the classic margarita a modern twist-replacing alcohol with THC to create a delightful, hangover-free beverage alternative. Through the use of all-natural, premium ingredients like organic Mexican agave, fresh lime juice and sweet, tangy mango, Senorita quickly gained acclaim, taking home the top spot in The High Times Cannabis Cup just one year after inception. Gott and Bieler continue to collaborate on the brand with Kovler and the Agrify team. Senorita currently offers two flavors - classic Lime Jalapeno Margarita and Mango Margarita. The brand's third flavor, Paloma, will launch in January and will bring together Ruby Red grapefruit, lime, and pomelo, offering consumers another refreshing flavor profile with the same vacation vibe and fresh taste consumers love. A fourth flavor, low-calorie Ranch Water, will debut in 2025. Senorita's HD9 products are currently available at top retailers including Total Wine, ABC Fine Wine & Spirits, and Binny's in nine U.S. states and Canada. Products are also available for direct-to-consumer purchase where permissible under state law at senoritadrinks.com. This acquisition of certain Canadian and U.S. hemp-derived assets from Double or Nothing LLC, the owner and creator of the Senorita HD9 beverages, as previously disclosed, was done in exchange for 530,000 shares of Agrify common stock or common stock equivalents. Following the transaction, Agrify has approximately 2.0M common shares outstanding and 7.6M warrants.

07:03 EST KalVista appoints Jeb Ledell as COO - KalVista announced that Jeb Ledell has joined the company as COO. Ledell has more than 20 years of leadership and operational experience in the biotechnology industry. He joins KalVista from Aveo Oncology, an LG Chem company, where he held the same role and oversaw Aveo's operational strategy.

06:59 EST Coca-Cola director Helene Gayle retires - The Coca-Cola Company announced that Helene Gayle has retired from her duties as a director. Gayle had been a director of the company since 2013. She served as a member and former chair of the talent and compensation committee, and she was a member of the corporate governance and sustainability committee.

06:55 EST Funko appoints Jason Harinstein to board of directors - Funko announced that its Board of Directors appointed Jason Harinstein as an independent director to the Board, effective immediately. In connection with the appointment, the Board increased its size to nine members, further strengthening the independent voices guiding the company's strategic vision. Mr. Harinstein will also join the Company's Audit Committee. Jason Harinstein currently serves as CFO of Collectors Holdings, a provider of authentication, grading and marketplaces for the collectibles industry.

06:49 EST Northern Dynasty appoints Josie Hickel to board of directors - Northern Dynasty Minerals advises that Josie Hickel has become a member of Northern Dynasty's Board of Directors and has joined the Compensation and Sustainability Committees. Currently, Josie is the Owner, CEO and President of Sustainable Alaska Consulting Services - an Alaska Native woman-owned small business - providing consulting services related to development opportunities that benefit small communities and Alaska Native people throughout Alaska.

06:47 EST Zedge CEO anticipates 'significant improvements' in Q2 - "We anticipate significant improvements in our second quarter driven by traditional holiday seasonal strength and the resolution of key challenges from the first quarter. For the remainder of fiscal 2025, we are focused on leveraging our solid foundation to drive growth and scalability across all business units. A critical part of this strategy is the ongoing integration of generative AI into our product portfolio, enriching the user experience with cutting-edge features. Our recent beta launch of the AI Emoji Generator on Cyber Monday exemplifies this approach, enabling Emojipedia users to design custom emojis and break free from standard device keyboards. Our top priority for the Zedge Marketplace this year is to transform users from content consumers into content creators, aligning ourselves more deeply within the Creator Economy. The continued rollout of pAInt 2.0 and the planned imminent addition of AI audio capabilities underscore our commitment to innovation. Audio, in particular, represents an exciting opportunity to attract new users and deepen engagement with existing ones, further solidifying our position in this dynamic space. Beyond product advancements, our marketing team remains a critical revenue growth driver. After weathering the first quarter's challenges, we are confident in the team's ability to accelerate ROAS-attractive user acquisition, particularly in well-developed economies, while also building on our strong momentum with iOS users. This alignment of innovative products and strategic marketing positions us for continued success. Emojipedia continues to thrive, with the expansion of the 'Emoji Playground' in early December which now includes the AI-driven emoji creator. Our next priority will be redesigning and upgrading Emojipedia's website to improve engagement and reinforce its reputation as the premier destination for emoji enthusiasts worldwide. For GuruShots, our primary focus is returning to growth. To achieve this, we are allocating resources to new feature introductions and enhancements designed to better attract and engage new users, versus previously relying mainly on legacy players to fuel the game's growth. While this transition may continue negatively impacting short-term revenue, we believe we are seeing the bottom of that curve. The changes we've implemented-including an enhanced onboarding process, a coin-based in-game economy, and the launch of Missions-are already showing promising early results. Looking ahead, the imminent release of Duels during the holiday season will add an exciting competitive PvP layer to the game, driving further engagement and retention. Lastly, we remain committed to introducing new products to drive long-term growth. Projects like Wishcraft and AI Art Master, currently in beta, highlight our ability to foster innovation and agility. By centralizing our development platform, we can iterate quickly, prioritize initiatives that show promise and scale successful concepts while promptly cutting offerings that show less promise. This approach positions us to create incremental wins and breakthrough successes that will hopefully fuel Zedge's sustained growth in the years ahead and make $ZDGE a growth stock once again. In the meantime, we will continue to innovate in our offerings and take advantage of our value stock status with the $5 million share repurchase program that the board authorized," concluded CEO Jonathan Reich.

06:41 EST Meridian Mining UK provides drilling update for Santa Helena deposit - Meridian Mining UK provided a drilling update for the Santa Helena Cu-Au-Ag & Zn deposit. CD-612 has drilled another lateral extension, assaying 58.9m @ 3.6g/t AuEq , including a higher-grade zone of 26.8m @ 4.1g/t AuEq, in the western gold domain of the Santa Helena deposit. This result extends the localized across strike thickness of CD-605's 1 75.6m @ 4.6g/t AuEq. Drilling is continuing with further assays pending. Meridian is also announcing the securing of new licence applications, expanding the Company's footprint in the Cabacal, Jauru and Araputanga Belts. Highlights Reported: Meridian extends the western gold mineralization at Santa Helena, drilling 58.9m @ 3.6g/t AuEq ; Santa Helena assays further gold rich VMS mineralization with CD-612's 58.9m @ 2.8g/t Au, 0.7% Cu, 19.0g/t Ag & 1.7% Zn from 29.1m, widening the western gold extension; Shallowest high-grade zone assays 26.8m @ 4.1g/t AuEq from 29.1m; Ongoing lateral drill results to the west of Santa Helena extend the potential for future open pit development; CD-612 returns a down-hole 212.0 AuEq gram-metre interval within open pitable depths; Western gold domain of Santa Helena deposit remains open; and Meridian expands land position within the Cabacal, Jauru and Araputanga greenstone belts. Gilbert Clark, CEO, comments: "CD-612's 58.9m @ 3.6g/t AuEq is part of the ongoing success we are having in defining this shallow, gold-dominant western extension to the Santa Helena VMS system. These western expansion results have necessitated a revision to Santa Helena's resource estimation parameters, particularly in the localized gold rich zone, and consequently the Santa Helena Mineral Resource Estimate is now expected to be published in early January. We have recently secured potentially significant additional exploration ground to the southeast of the Cabacal belt's current limits, where we believe that the belt is covered by a younger sedimentary unit. We look forward to expanding our systematic belt-scale exploration program in the Cabacal belt in 2025."

06:37 EST Hyperscale Data sells St. Petersburg development property for $13M - Hyperscale Data announced that its wholly owned indirect subsidiary, Third Avenue Apartments, has completed the sale of its St. Petersburg development property for $13M. This sale reflects the company's ongoing commitment to reorganizing its holdings and becoming a pureplay data center business to support the growing demands of high-performance computing services powering Artificial Intelligence solutions. Approximately $11M of the funds received from the sale of the Property will be held in a segregated account bringing the balance of the segregated account to approximately $18.3M. The segregated account was established in December 2023 because of the Company's guarantee obligations. The Company is currently in discussions with the principal lender to allow for a cash dividend for the amount of the proceeds held in the segregated account to our holders of common stock and Series C convertible preferred stock on an as-converted basis.

06:33 EST nVent Electric raises quarterly dividend 5% to 20c per share - nVent Electric Board of Directors declared a regular quarterly cash dividend of 20c per ordinary share for the first quarter of 2025, which represents an increase of 5% over the prior quarterly dividend of 19c per ordinary share. The dividend is payable on February 7, 2025, to shareholders of record at the close of business on January 17, 2025.

06:32 EST Air Lease closes $966.5M unsecured term loan facility - Air Lease Corporation announced the closing of a new $966.5M unsecured term loan facility that matures in December 2027. The proceeds of the loan will be used to finance the working capital needs of Air Lease Corporation and its subsidiaries and for general corporate purposes. Sumitomo Mitsui Trust Bank, Limited, New York Branch and Oversea-Chinese Banking Corporation Limited acted as Joint Global Coordinators. In addition to Sumitomo Mitsui Trust Bank, Limited, New York Branch and Oversea-Chinese Banking Corporation Limited, Bank of China Limited, London Branch, Bank of East Asia Limited, and Cathay United Bank, Singapore Branch acted as Mandated Lead Arrangers and Bookrunners on the transaction.

06:28 EST Parsons conducts threat environment demonstration - Parsons, in collaboration with the University of Southern Mississippi, the Mississippi Air National Guard, and SeaTrac Systems, has integrated the company's Threat Representative Environment emulator onto a remotely operated SeaTrac Unmanned Surface Vehicle during maritime operations. This demonstration was conducted off the U.S. Gulf of Mexico in November and establishes a new benchmark for realistic training environments for Air Force pilots and operators. Parsons' TReX threat emulator is designed to simulate threats that military personnel may encounter during real-world missions. Utilizing advanced algorithms and real-time data, TReX creates dynamic and realistic scenarios that enable operators to develop critical skills in threat assessment, decision-making, and operational response. During the exercise, Parsons combined this high-fidelity simulation with SeaTrac's SP-48 USV, while targeting airborne systems and communicating with the command-and-control center via commercial and non-commercial communication mediums. Because SeaTrac's SP-48 is solar-powered and remotely commanded, the USV can execute missions at sea 24/7 with no harm to humans or the environment and reduces operational costs when compared to manned vessels. This novel milestone helps the U.S. Air Force train as they fight. "Employing the TReX threat emulator aboard an uncrewed maritime platform optimizes training efficacy and is a cost-effective approach for executing comprehensive training exercises," said Mike Kushin, President of Defense and Intelligence for Parsons. "This innovative solution reduces logistical, and personnel costs associated with manned missions while facilitating a high-fidelity simulation environment-ultimately elevating the United States Air Force's operational readiness."

06:16 EST Check Point appoints Gil Shwed as executive chairman, Nadav Zafrir as CEO - Check Point announces the transition of Gil Shwed into the role of Executive Chairman of the Board of Directors, and the appointment of Nadav Zafrir as the company's new CEO, starting December 16th. Most recently, Mr. Zafrir was the co-founder and managing partner at Team8, a company-building venture group focused on cyber security, data & AI, fintech, and digital health.

06:14 EST Elliott issues statement on ongoing Honeywell review - Elliott Investment Management released the following statement attributed to Partner Marc Steinberg and Managing Partner Jesse Cohn regarding Honeywell. "Elliott welcomes Honeywell's announcement today of its ongoing review of strategic alternatives, including the separation of its Aerospace business. We believe the portfolio transformation Vimal and his team are leading represents the right course for Honeywell, and we look forward to the upcoming completion of the review and to supporting Honeywell as it implements the necessary steps to realize its full value."

06:13 EST MannKind reports six-month results from Phase 3 INHALE-1 trial - MannKind announced six-month results from its Phase 3 INHALE-1 study of Afrezza Inhalation Powder in children and adolescents. MannKind expects to submit a request for a supplemental new drug application meeting with the U.S. Food and Drug Administration in 1H 2025 to discuss the data and filing timeline. The INHALE-1 study is a 26-week, open-label clinical trial that randomized 230 subjects to one of two groups: Afrezza or multiple daily injections of rapid acting insulin analog in combination with basal insulin. The primary endpoint was a non-inferior change in HbA1c levels after 26 weeks. A 26-week extension phase in which all remaining MDI patients switched to Afrezza is still ongoing. An analysis of the full intent-to-treat population found that the between-group difference in mean HbA1c change over 26 weeks exceeded the prespecified non-inferiority margin of 0.4%, largely driven by the variability of a single patient who did not adhere to the study protocol. A modified ITT analysis, which excluded this subject, did not exceed the predetermined threshold of 0.4%, thereby establishing the non-inferiority of Afrezza to MDI, which was the primary endpoint of the study. Over 26 weeks of treatment, no difference in lung function parameters were seen between the treatment groups. The Afrezza-treated patients had a mean FEV1 of 2.901 liters at baseline and 2.934 liters at 26 weeks. MDI-treated patients had corresponding mean FEV1 values of 2.948 liters and 2.957 liters, respectively. Additional safety findings, including for hypoglycemia, did not show any significant concerns or differences between the treatment groups.

06:06 EST Marti Technologies says ride-hailing service reaches 1.61M riders - Marti Technologies announced that as of December 15, 2024, Marti's ride-hailing service has reached 1.61 million riders and 255 thousand registered drivers, exceeding the December 31, 2024 targets of 1.60 million riders and 245 thousand registered drivers. Marti's number of ride-hailing riders grew 15% from September 30, 2024 to December 15, 2024. The number of registered drivers grew 14% during the same time period. The fast growth in both the rider and driver sides of Marti's ride-hailing marketplace demonstrates the strong need for the service across Turkiye. The service intends to provide readily available, safe, and affordable rides for riders, while providing economic opportunities for drivers across the income spectrum.Encouraged by the growth in the rider and driver bases of its ride-hailing business, Marti has set targets for 1.90 million riders and 290 thousand registered drivers by March 31, 2025. Of Marti's 255 thousand registered drivers, 203 thousand are in Turkiye's largest city, Istanbul. This is in contrast to 20 thousand taxis serving the city. With 10 times as many registered drivers as taxis serving the city of Istanbul, Marti is able to offer widespread availability across the city. Furthermore, Marti's drivers undergo formal background checks before acceptance onto the service, thereby contributing to rider safety. The average rating of Marti's ride-hailing drivers by riders is 4.8 out of 5 stars.

06:04 EST Edgewise reports CANYON Phase 2 trial of sevasemten meets primary endpoint - Edgewise Therapeutics announced topline results from the Phase 2 CANYON trial of sevasemten in individuals with Becker muscular dystrophy. Sevasemten is an orally administered first-in-class fast skeletal myosin inhibitor designed to protect muscle against contraction-induced damage in muscular dystrophies. The trial met its primary endpoint of change from baseline in CK. CANYON is the largest interventional trial to date in Becker and the first to achieve its primary endpoint. NSAA, the key secondary endpoint of function, showed a trend towards improvement over time in the sevasemten-treated group. Plasma fast skeletal muscle troponin I, a target-specific biomarker of fast skeletal muscle damage, showed a significant reduction, compared to placebo. Additional functional measures, including the 10-meter walk/run, 4-stair climb and 100-meter timed test, showed trends towards improvement compared to placebo. Notably, the treatment population had more advanced disease than placebo. Sevasemten was well-tolerated, and no new safety concerns were observed in either the adult or adolescent patient populations. Ninety-nine percent of eligible participants from CANYON and other sevasemten trials in Becker have enrolled in MESA, the ongoing open label extension trial. The Company is on track to complete recruitment in the GRAND CANYON cohort by the first quarter of 2025. Based on these positive Phase 2 results, the Company plans to engage the U.S. Food and Drug Administration and European Medicines Agency about marketing authorization filing strategies for sevasemten in Becker. The Company intends to submit the complete results of the CANYON study for publication at a future medical congress. CANYON, the largest interventional Becker trial, is a Phase 2, double-blind, randomized, placebo-controlled study to investigate the effect of sevasemten on the safety, pharmacokinetics, biomarkers, and functional measures of participants. The trial was not powered for the functional endpoints. Forty adults and 29 adolescents with Becker muscular dystrophy were enrolled. This study had a 4-week screening period, a 12-month treatment period, followed by a 4-week follow-up period. The adult participants were randomized to sevasemten or placebo in a 3:1 ratio. The adolescent participants were randomized in a 2:1 ratio to sevasemten or placebo and were assessed for safety and tolerability. The data analysis included the complete adult safety population of 40 individuals. There was a notable imbalance between adult participants in the sevasemten and placebo groups with the sevasemten group having more advanced disease at baseline based on all functional measures and MRI. Primary Endpoint: The primary endpoint to assess the efficacy of sevasemten compared to placebo was change from baseline in CK over the treatment period for adults. The results demonstrated a significant change from baseline in CK in the sevasemten-treated group. Key Secondary Endpoint: The key secondary endpoint was the change from baseline in NSAA total score in adults at month 12. NSAA is a scale commonly used to rate motor function. The between-group difference was 1.1 points, favoring sevasemten; p=0.16 across all adult participants. NSAA remained stable over time in the sevasemten treatment group, similar to the observations in the ARCH study. Further, while the placebo group was small in number, NSAA declined similarly to that observed in previous natural history studies. Other Secondary Endpoints: Plasma TNNI2 decreased 77% from baseline in the sevasemten-treated group compared to placebo, averaged over months 6 through 12 in adults; pless than0.001. The 10-meter walk/run, 4-stair climb and 100-meter timed test showed trends towards improvement, compared to placebo. The Company continues to evaluate additional secondary and exploratory endpoints. Safety and Tolerability: Sevasemten was well-tolerated, and no new safety concerns were identified.

05:32 EST Sinovac Biotech initiates clinical trial on a HFMD vaccine candidate - Sinovac Biotech kicked off the enrollment for a Phase III clinical trial on a vaccine candidate to prevent HFMD caused by both Enterovirus 71 and Coxsackievirus 16. Notably, no multivalent vaccines against HFMD have yet been approved for marketing worldwide. The Phase III clinical trial is designed to be a multicenter, randomized, double-blind, controlled trial to evaluate the efficacy, safety and immunogenicity of this vaccine candidate in infants and young children aged 6 to 71 months. Sinovac has initiated a phase I/II clinical trial on its bivalent vaccine in China since September 2023. The results from Phase I/II clinical trial demonstrated that the vaccine candidate has favorable safety and immunogenicity.

05:25 EST Akoustis to pursue sale through chapter 11 process - Akoustis (AKTS) announced that it has voluntarily filed for chapter 11 relief in the United States Bankruptcy Court for the District of Delaware to provide the company with the flexibility to complete its ongoing marketing and sale process while continuing to deliver for its valued customers around the world. The voluntary chapter 11 filing follows the company's recent legal case with Qorvo (QRVO), in which Akoustis was ordered to pay a total judgement of approximately $59M in damages, fees, and interest related to allegations of trade secret misappropriation and patent infringement. To anchor the sale process, Akoustis has entered into a stalking horse asset purchase agreement with Gordon Brothers Commercial & Industrial for the purchase of certain of the company's assets. Prior to the commencement of its chapter 11 cases, the company engaged in discussions with interested parties regarding the company's continued operations through a potential sale of all or part of the company's businesses and assets. In response to such interest, the company intends to use the court-supervised sale process to seek the highest or otherwise best bid for its assets. The company seeks to execute an organized sale process with sufficient time to obtain going concern qualified bids. Importantly, Akoustis continues to manage its operations with sufficient liquidity to continue to operate in the ordinary course of business during the court-supervised sale process. To ensure the continued operation of its business without interruption, Akoustis has filed customary "first day" motions in its chapter 11 cases. These motions, upon approval, will help facilitate the continued payment of employee wages and benefits, enable payments to critical vendors and other relief measures standard in these circumstances.

05:12 EST Nokia signs four-year deal with EOLO - Nokia announced it has signed a four-year deal with EOLO, the first B Corp in the Italian telecommunications sector to deploy the first 5G standalone mmWave Radio Access Network in Europe. Nokia will supply equipment from its 5G AirScale portfolio including Nokia's AirScale baseband solutions, Massive MIMO radios, and Remote Radio Head products.

05:07 EST ParaZero receives noncompliance notification from Nasdaq - ParaZero announced that it has received a written notice from Nasdaq informing the company that it has regained compliance with the minimum bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550. ParaZero is now in compliance with all applicable listing standards and its ordinary shares will continue to be listed and traded on the Nasdaq Capital Market.