Stockwinners Market Radar for November 26, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:15 EST Maximus says it will continue to perform CCO contract - Maximus announced that the U.S. Department of Health and Human Services, Centers for Medicare & Medicaid Services has withdrawn their early re-procurement of the Contact Center Operations 1-800-MEDICARE and Federal Marketplace contract. The early re-procurement of the contract would have otherwise caused Maximus to recompete for the same scope of work it currently performs under its contract today. The current contract retains its available option periods until 2031. "We are pleased with this outcome and appreciate the opportunity to continue supporting HHS and CMS in their vital missions and look forward to delivering innovative, high-quality, and reliable solutions that benefit the American public. Maximus employees have consistently demonstrated their ability to successfully manage this critical program providing essential support to more than 75 million eligible Americans who rely on Medicare and the Federal Marketplace," stated Bruce Caswell, President and CEO, Maximus.

19:50 EST ELEVAI Labs Inc trading halted, news pending

19:48 EST Charles Schwab CRO Murtagh sells 12,739 common shares - In a regulatory filing, Charles Schwab chief risk officer Nigel Murtagh disclosed the sale of 12,739 common shares of the company on November 22 at a price of $81.1659 per share.

19:03 EST TransUnion director Awad sells 12,000 common shares - In a regulatory filing, TransUnion director George Awad disclosed the sale of 12,000 common shares of the company on November 25 at a price of $100 per share.

18:11 EST Venu Holding IPO priced at $10 per share - Venu Holding Corporation announced the pricing of its initial public offering of 1,200,000 shares of the Company's common stock at public offering price of $10.00 per share, for aggregate gross proceeds of $12 million prior to deducting underwriting discounts and other offering expenses. In addition, VENU has granted the underwriters a 45-day option to purchase up to an additional 180,000 shares of common stock to cover over-allotments, if any. The shares of common stock are expected to begin trading on the NYSE American under ticker symbol "VENU" on November 27, 2024. The offering is expected to close on November 29, 2024, subject to customary closing conditions. The Company intends to use the net proceeds from the offering to fund the expansion of its business operations, further development of Company services, business promotion activities, and for working capital and general corporate purposes, including general market expansion and due diligence efforts to explore the opening of new restaurant, entertainment, and music venues.

17:21 EST Boeing awarded $113.14M Army contract modification - Boeing was awarded a $113.14M modification to a contract to remanufacture Block 1 CH-47F aircraft into Block 2. Work locations and funding will be determined with each order, with an estimated completion date of Dec. 31, 2026. U.S. Army Contracting Command is the contracting activity.

17:20 EST Mondee appoints Jesus Portillo as CEO - Mondee Holdings announced that on November 21, Prasad Gundumogula informed the board of directors of the Company that he would be taking a leave of absence as CEO of the Company, effective as of November 25. Gundumogula will continue to serve as a director and chairman of the Company's Board. On November 21 the Board appointed Jesus Portillo as the Company's CEO and a member of the Board, effective as of November 25. Portillo will retain his current duties and responsibilities as CFO of the Company.

17:18 EST RTX awarded $590.8M Navy contract - RTX was awarded a $590.8M fixed-price incentive, cost-plus-fixed-fee contract for low rate initial production of 13 Next Generation Jammer Mid-Band ship sets for the Navy EA-18 Growler and Royal Australian Air Force; nine of which will be allocated for the Navy and four allocated for the Royal Australian Air Force. In addition to the ship sets, this procurement will also include associated spares, support equipment, and non-recurring engineering. Work is expected to be completed in January 2028. FY24 aircraft procurement funds in the amount of $329.62M;FY25 aircraft procurement funds in the amount of $75.22M; and Royal Australian Air Force cooperative funding in the amount of $185.96M will be obligated at the time of award, none of which will expire at the end of the current fiscal year. This contract was not competed. Naval Air Systems Command is the contracting activity.

17:15 EST Nutanix sees Q3 revenue seasonality relative to Q2 similar to that of FY23 - Says 'happy' with Q1 revenue performance. Comments taken from Q1 earnings conference call.

17:03 EST TechTarget announces shareholder approval for Informa deal - TechTarget (TTGT) announced that at its Special Meeting of Stockholders held on November 26, 2024, its shareholders approved the previously announced transaction between TechTarget and Informa PLC (IFPJF), whereby Informa PLC will combine Informa Tech's digital businesses with TechTarget to create a global B2B growth accelerator under a new holding company. The parties anticipate closing the transaction on December 2, 2024. Upon completion of the transaction, New TechTarget's shares of common stock are expected trade on Nasdaq under the stock ticker symbol "TTGT".

16:43 EST YXT.com CEO Teng Zu steps down, chairman of board Xiaoyan Lu to replace - XT.com Group Holding announced changes to its senior management team. Mr. Teng Zu has resigned from his position as the chief executive officer or CEO due to personal reasons ..Mr. Zu's resignation did not result from any disagreement with the Company. In addition, the board of directors of the Company appointed Mr. Zu as the vice chairman of the Board. Mr. Zu will remain with the Company as a director and the vice chairman of the Board. Following this transition, the Board has appointed Mr. Xiaoyan Lu, the Company's director, founder, and chairman of the Board, to serve as the CEO of the Company, effective November 26. Mr. Lu will continue his role as chairman of the Board. Additionally, the Board has appointed Mr. Yazhou Wu, the Company's chief technology officer CTO to the additional role of chief operating officer or COO In this expanded capacity, Mr. Wu will oversee the Company's overall operational management while continuing his technology leadership role. l

16:32 EST Valens Semiconductor approves $10M share repurchase program - Valens Semiconductor announced that its Board of Directors has approved a "distribution", as defined in the Israeli Companies Law, 1999, by way of a share repurchase program, pursuant to which the Company may repurchase an aggregate amount of up to $10M of the Company's ordinary shares, subject to the completion of required Israeli regulatory procedures. According to Section 7C. of the Companies Regulations 2000, the Company's creditors may apply to the Company and object to the Distribution, within 30 days following its publication. Following, and subject to, completion of the required Israeli regulatory procedures, share repurchases under the program will be made from time to time in open market purchases, private transactions or other transactions as permitted by securities laws and other legal requirements.

16:31 EST Knife River names Glenn Pladsen chief excellence officer - Knife River Corporation announced that Glenn R. Pladsen has been named Vice President and Chief Excellence Officer, tasked with leading core elements of the company's "Competitive EDGE" strategy for long-term, profitable growth. The position takes effect Jan. 1, 2025. "EDGE" stands for EBITDA Margin Improvement, Discipline, Growth and Excellence. The "Excellence" pillar of EDGE helps support each of the other key initiatives. In his current role as vice president of support services, Pladsen has been directly involved in launching the company's Process Improvement Teams (PIT Crews), the Knife River Training Center and other strategic programs aimed at building a strong team and delivering profitable results. His role is being expanded to help the company achieve industry-leading safety performance and excellence across its commercial and operational initiatives. "We have seen significant early success with our PIT Crews and our training and development efforts, and we believe there are considerable opportunities to build on this momentum," said Knife River President and CEO Brian Gray. "This is an exciting time at Knife River. We're focused on continued growth and success. Glenn is well-respected across our organization and is highly skilled at developing and standardizing best practices for process improvements. There are multiple paths to achieving our strategic goals, and on each of those paths we are focused on excellence and continuous improvement."

16:30 EST Mannatech names Robert Toth vice chairman of the board - Mannatech announced that on November 20, 2024, the Board of Directors of Mannatech, Incorporated appointed Robert A. Toth to the Board where he will serve as Vice Chairman of the Board of Mannatech, Incorporated effective December 1, 2024. Toth will serve as a Class III director of the Board. Mr. Toth previously served on the Company's Board between March 2008 through May 31, 2023. Toth previously served as the Chairman of the Compensation and Stock Option Plan Committee, served on the Audit Committee, the Nominating/Governance and Compliance Committee, the Science and Marketing Committee, and from August 2014 to March 2019, Vice Chairman of Mannatech's Board.

16:25 EST Akamai receives approval to acquire select assets from Edgio - Akamai Technologies announced that the U.S. Bankruptcy Court for the District of Delaware has approved its bid to acquire select assets from Edgio, including certain customer contracts from Edgio's businesses in content delivery and security, and non-exclusive license rights to patents in Edgio's portfolio. The transaction does not include the acquisition of Edgio personnel, technology, or assets related to the Edgio network. The court approval follows Akamai submitting the winning bid for the select assets during Edgio's 363 bankruptcy auction on November 13 as part of its filing for Chapter 11 bankruptcy relief. For the Q4 Akamai expects this transaction to add approximately $9M-$11M in revenue. As part of its bid, Akamai agreed to pay certain costs for Edgio to operate its network during the transition and wind-down period until such time as Edgio ceases operation of its content delivery network in mid-January 2025. Akamai expects those transition services costs to be approximately $15M-$17M in the Q4. Akamai anticipates the transaction to be dilutive to non-GAAP net income per diluted share by approximately 3c-5c in the Q4, inclusive of the transition service costs. For the FY25, Akamai anticipates this transaction will add approximately $80M-$100M in revenue, approximately $25M-$30M of transition service costs, and be accretive to non-GAAP net income per diluted share by approximately 15c-20c. The transaction is expected to close in early December 2024, subject to customary closing conditions for a transaction of this type. When the transaction closes, several hundred net new Akamai customers will have a clear path and the necessary support to migrate.

16:22 EST Workday names Rob Enslin President, Chief Commercial Officer - Workday (WDAY) announced the appointment of Rob Enslin to the newly created role of president, chief commercial officer. Enslin will be responsible for driving Workday's revenue growth and leading the company's global sales, partnership and customer experience efforts. Enslin brings more than 30 years of experience in the technology industry, most recently serving as CEO of UiPath (PATH) where he led the company to non-GAAP profitability, advanced the company's AI strategy, and drove expansion into new markets.

16:22 EST MAXIMUS trading resumes

16:19 EST Ziff Davis names Lori Tansley CAO - Ziff Davis announced the appointment of Lori Tansley as Chief Accounting Officer. She will report to Bret Richter, Chief Financial Officer of Ziff Davis, and will be part of Ziff Davis' executive leadership team, leading Ziff Davis' global accounting and public reporting functions. Her first day at Ziff Davis will be December 2, 2024. Most recently, Ms. Tansley was SVP and Chief Accounting Officer of Ankura Consulting Group, LLC. There, she led a global team responsible for business controllership, corporate consolidation, technical accounting, tax compliance, statutory reporting, contract administration, financial systems, finance operations, and shared services. Prior to Ankura, Ms. Tansley worked at Moody's Corporation as Managing Director - Digital Finance Transformation Leader, at Affinion Group, Inc., as SVP and Chief Accounting Officer, and in a variety of finance and accounting roles at General Electric Company for nearly two decades, most recently as its Managing Director - Global Technical Advisor, GE Capital Audit. Prior to GE, Ms. Tansley launched her career at PricewaterhouseCoopers, LLP.

16:17 EST Workday CEO calls Q3 a 'solid performance' - "Workday's solid performance in Q3 reflects the trust our customers place in us across industries, the global momentum around our AI-driven innovations, and the strength of our partner ecosystem," said Carl Eschenbach, CEO, Workday. "Organizations are increasingly consolidating on the Workday platform to reduce total cost of ownership, simplify their operations, and to unlock the power of our best-in-class AI solutions. Workday gives them the ultimate advantage - and that positions our business for long-term success." "In Q3, we once again made good progress across a number of our key growth areas," said Zane Rowe, CFO, Workday. "Looking ahead, we expect fiscal 2025 subscription revenue of $7.703 billion, growth of 17%, and fiscal 2025 non-GAAP operating margin of 25.5%. We are focused on executing in our seasonally strongest quarter, as we lay the foundation for durable, profitable growth at scale."

16:14 EST Acadia announces exclusive license agreement with Saniona for SAN711 - Acadia Pharmaceuticals Inc. announced it has entered into an exclusive worldwide license agreement with Saniona for the development and commercialization of SAN711, a first-in-class, highly selective GABAA-alpha3 positive allosteric modulator. The first indication the Company plans to pursue is development of SAN711 for essential tremor, a neurological condition that includes shaking or trembling movements in one or more parts of the body. Acadia is planning to initiate a Phase 2 study of SAN711 in essential tremor in 2026. Licensing SAN711 to expand our pipeline underscores our unwavering commitment to delivering innovative therapies for patients with central nervous system disorders," said Catherine Owen Adams, Chief Executive Officer. "Essential tremor is a condition that has not seen innovation in treatment for decades, creating a compelling opportunity to address a long-overlooked need. Our work with SAN711 will draw on our deep expertise in developing and commercializing cutting-edge treatments for neurological disorders." Under the terms of the License Agreement, Saniona will receive $28M upfront plus potential milestone payments of up to $582M. In addition, Saniona is eligible to receive tiered royalties of mid-single digits to low double digits on net sales of commercial products that may result from development of SAN711. The potential milestone payments to Saniona consist of up to $147M subject to achievement of development and commercial milestones related to potential first and second indications, and up to $435M subject to achievement of thresholds of annual net sales of SAN711 worldwide. Acadia will lead further clinical development, regulatory submissions, and global commercialization efforts for SAN711 while also providing financial support for Saniona's ongoing Phase 1 study and preparations for Phase 2.

16:13 EST Workday revises FY25 subscription revenue view to $7.703B - Prior view was $7.7B-$7.725B. Sees FY25 non-GAAP operating margin of 25.5% vs. prior view of 25.25%.

16:09 EST Evolv sees $3.9M of ARR possibly impacted by right to cancel - Evolv Technology announced that it has resolved the United States Federal Trade Commission's inquiry into certain aspects of the company's prior marketing claims. "While Evolv disagrees with the FTC's allegations, and has not admitted any wrongdoing, it has chosen to resolve the matter to focus on its core mission of protecting lives through innovation and maintaining the trust of its valued customers," the company stated. Evolv added: "There are no financial penalties or other monetary relief associated with today's announcement. As part of the resolution announced today: Approximately 237 Evolv Express units of certain customers could be impacted by the right to cancel, or approximately 4% of the Company's total installed base of 5,323 Evolv Express units as of June 30, 2024; Approximately $3.9 million of the Company's Annual Recurring Revenue could be impacted by the right to cancel, or approximately 4% of the Company's Annual Recurring Revenue as of June 30, 2024; Approximately $10.5 million of the Company's Remaining Performance Obligation3 could be impacted by the right to cancel, or approximately 4% of the Company's Remaining Performance Obligation as of June 30, 2024. As noted above, the cancellation option will be provided only to a limited group of K-12 customers that comprise approximately 8% of the Company's total customers."

16:04 EST Workday sees Q4 subscription revenue $2.025B, representing growth of 15% - Sees Q4 Non-GAAP operating margin of 25.0%.

16:02 EST Iovance Biotherapeutics promotes Raj Puri to chief regulatory officer - Iovance Biotherapeutics announced that Raj Puri has been promoted to the newly created role of chief regulatory officer. Puri joined Iovance in March 2022 as executive VP, regulatory strategy and translational medicine.

15:37 EST ASP Isotopes says Fuzzy Panda report includes 'speculative conjecture' - ASP Isotopes issued the following statement in response to a short seller report published on November 26 by Fuzzy Panda Research. Fuzzy Panda is a self-proclaimed short seller who stands to realize significant gains if the price of ASP Isotopes's stock declines. Based upon ASP Isotopes's and its legal counsel's preliminary review and evaluation of the report, the company believes the report includes speculative conjecture and claims that are inaccurate or filled with innuendo in an attempt to mislead investors about ASP Isotopes's technology, leadership and future growth. Investors are encouraged to review the company's public filings made with the SEC. ASP Isotopes is in the process of commissioning three isotope enrichment facilities in South Africa and has hosted commercial partners and investors at these facilities. The first facility is scheduled to enrich Carbon-14 for use in healthcare and agrochemicals. The second facility is scheduled to enrich Silicon-28, which the company believes will enable faster, more efficient semiconductors for use in artificial intelligence and quantum computing. The third facility is scheduled to enrich Ytterbium-176, a critically important raw material used in the production of radio-oncology therapies.

14:49 EST Blue Star Foods announces $1.5M stock buyback program - Blue Star Foods announced a stock buyback program to repurchase up to $1.5M of the company's common stock.Under the program, the Company is authorized to repurchase its shares from time to time in the open market. The timing and amount of any repurchases will depend on a variety of factors, including price, trading volume, general market conditions, and other corporate considerations. The repurchase program does not obligate the Company to repurchase any specific number of shares and may be suspended, modified, or discontinued at any time without prior notice. John Keeler, Chairman and CEO of Blue Star Foods, commented, "We are pleased to announce this stock buyback program, which reflects our confidence in the strong and growing business of Blue Star. We believe our stock is significantly undervalued. This buyback program represents an attractive opportunity to return value to our shareholders."

12:31 EST CD Projekt's 'Cyberpunk 2077' sells 30M units - CD Projekt announced that its game "Cyberpunk 2077," which first released in late 2020, has sold 30M total units. Reference Link

12:00 EST Kohl's falls -18.4% - Kohl's is down -18.4%, or -$3.37 to $14.97.

12:00 EST Arcus Biosciences rises 10.5% - Arcus Biosciences is up 10.5%, or $1.53 to $16.09.

12:00 EST Trinseo rises 14.8% - Trinseo is up 14.8%, or 56c to $4.35.

11:49 EST Valneva submits label extension application for chikungunya vaccine to FDA - Valneva announced that it has submitted a label extension application to the U.S. Food and Drug Administration to potentially extend the use of its chikungunya vaccine IXCHIQ, which is currently approved in adults, to adolescents aged 12 to 17 years. "The application also includes adding the two-year antibody persistence data to the product label, which is a key differentiator for IXCHIQ. This FDA application follows the submission of label extension applications to the European Medicines Agency and Health Canada two months ago," the company noted.

11:03 EST Quantum Corp trading halted, volatility trading pause

10:46 EST Stellantis plans to consolidate UK manufacturing, close Luton van plant - Stellantis announced the start of a consultation with its employees and Trade Union partners on a proposal to consolidate its UK manufacturing of light commercial vehicles to create an all-electric, sustainable vehicle hub at its Ellesmere Port site in Cheshire through a GBP 50M investment. The proposal, made within the context of the UK's ZEV Mandate, will potentially contribute to greater production efficiency, including additional production of the medium-sized K0 battery electric LCVs, and support the Company's ambition to become the No. 1 LCV manufacturer globally. Ellesmere Port is proposed as the new all-electric UK LCV hub to take advantage of UK employees' expertise on the new line, the site's footprint and proximity to the Green Automotive Hub located at the adjacent Queen Elizabeth II Eastham docks and the recently constructed 59,500m Stellantis UK parts distribution centre. Whilst strengthening Ellesmere Port as its sustainable LCV hub in the UK with the transfer of Luton operations, Stellantis remains committed to acting responsibly toward its employees in Luton and, if the Company proposal is approved, will offer relocation support to facilitate employees wishing to transfer to the Ellesmere Port site with an attractive package, where hundreds of permanent jobs will be created. Dedicated comprehensive job support, including opportunities for retraining, for all employees affected will also be implemented in the very active Luton area, just one mile from the international airport. At the same time, Stellantis will work with local government and local employers to identify new employment opportunities within the Luton area for Stellantis employees who might be impacted by this proposal if it goes ahead.

10:30 EST FTC takes action against Evolv Technologies for deceiving users - The Federal Trade Commission is taking action against Evolv Technologies over allegations that the company made false claims about the extent to which its AI-powered security screening system can detect weapons and ignore harmless personal items, including in school settings. In the proposed FTC settlement order, Evolv would be banned from making unsupported claims about its products' ability to detect weapons by using artificial intelligence and would also have to give certain K-12 school customers the option to cancel their contracts, which generally lock customers into multi-year deals. Under the proposed settlement, Evolv will be required to notify certain K-12 school customers that they can opt to cancel contracts signed between April 1, 2022, to June 30, 2023. Reference Link

10:20 EST S&W Seed trading halted, volatility trading pause

10:09 EST Dye & Durham CEO Matthew Proud to step down - Dye & Durham announced that Matthew Proud has decided to step down from his role as CEO of the Company. Mr. Proud will remain in his role for approximately three months or until the Board-led search for his successor is completed.

10:03 EST ZJK Industrial Co Ltd trading resumes

10:00 EST Dana rises 5.9% - Dana is up 5.9%, or 52c to $9.40.

10:00 EST J.M. Smucker rises 8.2% - J.M. Smucker is up 8.2%, or $9.29 to $122.91.

10:00 EST Kohl's falls -19.0% - Kohl's is down -19.0%, or -$3.49 to $14.85.

09:58 EST ZJK Industrial Co Ltd trading halted, volatility trading pause

09:48 EST Source Capital falls -7.5% - Source Capital is down -7.5%, or -$3.32 to $41.00.

09:47 EST Select Medical falls -46.2% - Select Medical is down -46.2%, or -$17.88 to $20.82.

09:47 EST Copel rises 6.1% - Copel is up 6.1%, or 40c to $7.02.

09:43 EST AgEagle Aerial Systems trading resumes

09:41 EST ZenaTech Inc trading resumes

09:40 EST Knightscope says closes contracts in 12 states - Knightscope announced that it has closed new contracts in 12 U.S. states for its K5 Autonomous Security Robots, K1B Emergency Communication Devices and related services. Deployment locations will span the United States across California, Connecticut, Delaware, Florida, Georgia, Maryland, New York, North Carolina, Ohio, South Carolina, Texas and Washington and represent clients across diverse industries such as state and local government, universities, utilities and commercial real estate, the company said in a statement.

09:38 EST AgEagle Aerial Systems trading halted, volatility trading pause

09:34 EST SmartKem Inc trading halted, volatility trading pause

09:33 EST Capri Holdings chairman John Idol to assume Michael Kors CEO role - Capri Holdings announced that Michael Kors is reorganizing its leadership team. John Idol, chairman and CEO of Capri Holdings, will assume the role of CEO of Michael Kors. Effective December 2, Philippa Newman will be promoted to Michael Kors chief product officer. Newman joined Michael Kors over 14 years ago having most recently served as the president of accessories and footwear. In this new role, Newman will report to Idol and oversee merchandising, production, licensing and design across all product categories, in partnership with chief creative officer Michael Kors.

09:31 EST ZenaTech Inc trading halted, volatility trading pause

09:21 EST Kingstone Insurance selects Earnix to enhance pricing capabilities - Kingstone Companies announced that Kingstone Insurance has selected Earnix to enhance its pricing capabilities and support its strategic growth initiatives.This partnership will enable Kingstone Insurance Company to leverage Earnix's modeling and pricing solutions backed by robust data-science, analytical modeling, and artificial intelligence capabilities, allowing Kingstone to deliver more accurate pricing strategies by leveraging predictive modeling as well as improved implementation timelines.

09:16 EST Mullen announces Pape, Emerald refrigerated solution for Class 3 truck - Mullen Automotive announces today that Emerald Transportation Solutions is working with the Pape Group to develop an advanced reefer upfit for the Mullen THREE, a Class 3 all-electric truck. The refrigerated Class 3 EV box truck opens new rapidly expanding categories for home delivery, frozen food, grocery and beverage transportation.

09:09 EST VCI Global regains compliance with Nasdaq minimum bid price rule - VCI Global has received written notice from the Listing Qualifications Staff of The Nasdaq Stock Market informing the Company that it has regained compliance with the minimum bid price requirement under Nasdaq Listing Rule 5550(a)(2) for continued listing. To regain compliance with the Rule, the Company's stock was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive business days, which was achieved during the period between November 6, 2024, to November 20, 2024; on November 21, 2024, Nasdaq informed the Company that it has achieved compliance with such Rule. Therefore, the Nasdaq Listing Qualifications Staff considers the prior bid price deficiency matter now closed.

09:09 EST 180 Degree Capital notes BrightCove to be acquired by Bending Spoons - 180 Degree Capital (TURN) noted that its portfolio company, Brightcove (BCOV), announced that it has entered into a definitive agreement to be acquired by Bending Spoons for approximately $233M, or $4.45 per share. Prior to this announcement, 180 Degree Capital owned approximately 1.35M shares of BCOV. "We would like to congratulate Marc, John, and the entire BCOV team on today's announcement," said Kevin Rendino, CEO. "We began building our position in BCOV when Marc joined as CEO, and we continued to add to it based on our belief that BCOV's strong balance sheet, differentiated platform, and recurring revenue would ultimately be fairly valued by the market or through an acquisition of the company. Today's announcement validates our belief that BCOV was a deeply undervalued company. We have repeatedly stated we own a portfolio of what we believe to be deeply undervalued companies. We also stated that we have been ramping up our constructive activism. We believe this combination has positioned us well for potential additional value-creating events in the future."

09:07 EST Amazon announces Buy with Prime availability on StevenMadden.com - Amazon (AMZN) announced that Buy with Prime, a direct-to-customer offering, is now available on SteveMadden.com (SHOO). With Buy with Prime, Prime members can shop directly from Steve Madden's online store using the shopping benefits they already know including free delivery, returns, 24/7 shopper support, and a checkout experience. Now Prime members can shop on SteveMadden.com using their Prime shopping benefits with Buy with Prime.

09:04 EST Nano Dimension calls for shareholders to vote all of Nano's proposals - Nano Dimension reiterated its calls for its shareholders to protect their investment and vote "FOR" all of the Company's proposals ahead of the 2024 Annual General Meeting .Nano also issued the following statement in response to a report published by Institutional Shareholder Services a leading independent proxy advisory firm: "We are pleased that ISS recognizes the progress we have made in our successful execution of Nano's focused value creation strategy and its recommendation that our shareholders vote for the re-election of General Garrett in the AGM. Over the past year, Nano's recently refreshed Board of Directions and leadership team have delivered on promises made to our shareholders, including transformational M&A agreements, improvements in financial and operational performance, and significant governance enhancements - all with the ultimate goal of driving significant, long-term value for our shareholders." "In compliance with last week's Israeli court ruling, Nano Dimension has welcomed Murchinson prior nominees, Kenneth Traub and Dr. Joshua Rosensweig, as full members to Nano's Board. We disagree with any recommendation supporting the addition of more of Murchinson's nominees to Nano's Board, as well as the recommendations to vote against Nano's compensation proposals and for the elimination of the staggered Board structure. The addition of Traub and Rosensweig provides Murchinson with reasonable and appropriate representation on the Board. If our shareholders do not vote for Nano's proposals, including the election of CEO Yoav Stern and General Garrett to the Board, they risk facilitating Murchinson's path to gain control of the Board, which would prevent the Company from maximizing long-term value for all our shareholders."

09:04 EST Fat Brands, Buffalo's Express continue expansion in Mexico - FAT Brands Inc., parent company of Fatburger, Buffalo's Express and 16 other restaurant concepts, announces a series of new Fatburger and Buffalo's Express openings in Mexico. Since announcing its aggressive growth strategy for the country in 2021, the co-branded burger and wing concept now operates five Mexico locations. Fatburger & Buffalo's Express have experienced significant growth in Mexico City specifically, opening all five new restaurants in the country's largest urban area. Recently opened locations in Mexico City include Reforma Capital, Polanco, Mundo E Mall and Tepeyac.

09:02 EST Shuttle first patient enrollment, dosing in Phase 2 Ropidoxuridine line - Shuttle Pharmaceuticals announced first patient enrollment and dosing at the UVA Cancer Center in its Phase 2 Clinical Trial of Ropidoxuridine for the treatment of patients with glioblastoma. UVA is one of six cancer centers conducting the clinical trials. Shuttle Pharma previously announced the dosing of patients at Miami Cancer Institute, part of Baptist Health South Florida.The Phase 2 trial will consist initially of 40 patients randomized into two different doses

09:01 EST Safe and Green Development completes 50% of Sugar Phase I Project - Safe and Green Development is pleased to announce a significant milestone in the progress of its Sugar Phase I project in South Texas. The company has successfully completed 50% of the Project, marking a critical step in its construction timeline. The Project, now halfway through its construction, is an integral part of SG Devco's strategy to deliver high-quality single-family homes in rapidly growing communities. The Project is on track for completion before the end of 2024, reinforcing SG Devco's commitment to meeting housing demands and delivering on its development objectives. With this milestone achieved, the company is launching its marketing campaign to sell the homes in the Sugar Phase I Project. SG Devco will leverage its proprietary digital platform and tools to enhance the homebuying process. The platform seeks to simplify the homebuying experience for SG Devco homes by seamlessly incorporating mortgage services and down payment assistance.

08:55 EST White House proposes Medicare and Medicaid cover weight loss drugs - The Biden-Harris Administration proposed a new rule to expand coverage of anti-obesity medications for Americans with Medicare and Medicaid. An estimated 42% of the U.S. population has obesity, which is now widely recognized as a chronic disease, with increased risk of all-cause mortality and multiple related comorbidities such as diabetes, cardiovascular disease, stroke, some cancers, and more, the Administration said in a statement. "Over the past few years, there have been major scientific advancements in the treatment of obesity, with the introduction of new life-saving drugs. These anti-obesity medications can help prevent the development of Type 2 diabetes. Furthermore, these drugs reduce deaths and sickness from heart attack and other cardiovascular outcomes by up to 20%. But for too many Americans, these critical treatments are too expensive and therefore out of reach. Without insurance coverage, these drugs can cost someone as much as $1,000 a month," it added. Currently, Medicare and Medicaid cover the use of anti-obesity medications for certain conditions, like diabetes. The new proposal would expand access to these medications for obesity, the White House says. The drugs covered would include Wegovy from Novo Nordisk (NVO) and Zepbound from Eli Lilly (LLY). Reference Link

08:42 EST LQR House unveils new bottle design for SWOL Tequila - LQR House unveiled a sleek, newly designed bottle for its SWOL Tequila brand. Alongside this launch, LQR House is introducing its first ever Golden Ticket campaign that offers 5 lucky winners the chance to visit Guadalajara and Tequila, Mexico, to experience firsthand the production process and vibrant culture behind SWOL. The redesigned SWOL Tequila bottle, crafted with a unique new glass shape, embodies elegance and premium appeal, making it a standout in the competitive tequila market. The design upgrade reflects LQR House's dedication to delivering products that not only taste exceptional but also offer a visually striking and memorable experience. As part of the latest batch, SWOL Tequila bottles will feature its signature peelable label patch that can be sewn onto clothing or accessories, creating a lasting brand impression. Five of these bottles will include a special golden sticker hidden beneath the patch, granting winners an exclusive, once-in-a-lifetime opportunity to explore the origins of tequila.

08:41 EST Banzai board approves purchase of bitcoin as treasury reserve asset - Banzai International Board of Directors has approved the purchase of Bitcoin as a treasury reserve asset. The Company's Board of Directors has authorized Banzai to use company funds to purchase and hold an amount of Bitcoin comprising up to 10% of the Company's corporate treasury account for the purpose of diversifying its financial holdings and hedging against inflation.

08:40 EST Tomi Environmental says Bonneville School District No. 93 purchases SteraPaks - TOMI Environmental Solutions announced that Bonneville Joint School District No. 93, located in Bonneville County, Idaho, has integrated SteraMist technology into its cleaning protocols. The district has recently purchased and implemented a number of SteraPaks to augment preventative measures. By employing SteraMist, the district will enhance its existing cleaning protocols, ensuring a higher level of disinfection and protection against harmful bacteria and viruses. SteraMist's cutting-edge technology effectively eliminates microorganisms, creating a cleaner, healthier environment and significantly reducing the risk of illness transmission. As a result, SteraMist will help mitigate illness-related absences as winter approaches and cold and flu season commences. The implementation of SteraMist SteraPak technology by Bonneville School District No. 93 showcases the scalability and adaptability of TOMI's products to meet the unique challenges of educational facilities.

08:39 EST Critical Metals discovers 147 PPM of Gallium at Tanbreez project - Critical Metals provided a project update for the Tanbreez Greenland Rare Earth Mine, one of the world's largest rare earth assets located in Southern Greenland. In connection to the drilling, the Company has discovered one of the world's highest concentrations of Gallium, an essential rare earth element for the production of computer chips and defense applications. Based on initial results obtained from Critical Metals Corp's recent drilling program, four high-grade zones have now been identified on the site. These zones are expected to play a significant role in the Company's strategy for optimizing its mining operations and increasing throughput .

08:37 EST CorMedix supports CMS policy updates - CorMedix highlights key policy changes from CMS that benefit hemodialysis patients. Yesterday, the Centers for Medicare & Medicaid Services, CMS, and the Center for Medicare and Medicaid Innovation, CMMI, released important policy updates that will broaden the access of Medicare patients managing End Stage Renal Disease, ESRD, and on dialysis to innovative new therapies. Joe Todisco, CorMedix CEO, commented, "CorMedix applauds CMS for making a patient-centered policy change that will align provider incentives with patient care and broaden access to innovation. I am appreciative of the industry stakeholders, patient advocacy organizations, and CorMedix team members that worked closely with CMS to enact this change for the benefit of patient access. This important change will better allow providers to more easily protocolize a product like DefenCath across clinics and patient payor segments system-wide."

08:36 EST Milestone Scientific announces approval on contract for FSS - Milestone Scientific announced its approval on contract for the Federal Supply Schedule, FSS,, also known as the GSA Schedule, for the CompuFlo Epidural System. This significant milestone follows the Company's earlier registration with the U.S. Government's System for Award Management, SAM, in March 2023.

08:35 EST Netcapital secures FINRA approval for broker-dealer license - Netcapital has received approval from the Financial Industry Regulatory Authority to become a FINRA-member broker-dealer. Key Highlights: Netcapital Securities Inc. is specifically approved to engage in the following types of business: private placements of securities and referral business. The purpose of Netcapital Securities Inc. is to support companies raising equity capital under Regulation A and/or Regulation D, and to partner with other broker-dealers to collaboratively syndicate deals. This approval allows Netcapital to support larger fundraises while potentially offering its investor base a broader range of investment opportunities. Additionally, this approval enables Netcapital Securities Inc. to charge fees on the capital issuers raise under Reg A and Reg D, and to enter into fee sharing agreements with other broker-dealers.

08:33 EST Soleno Therapeutics announces U.S.. FDA to ended review period for NDA - Soleno Therapeutics announced that the U.S. Food and Drug Administration, FDA, has extended the review period for the New Drug Application, NDA, for DCCR extended-release tablets for the treatment of Prader-Willi syndrome, PWS, in individuals four years and older who have hyperphagia. The new Prescription Drug User Fee Act, PDUFA, target action date is March 27, 2025.

08:32 EST Femasys announces peer-reviewed data from FemaSeed ITI in JGRM - Femasys announces the peer-reviewed publication of positive data from its pivotal trial of FemaSeed intratubal insemination, ITI, in the Journal of Gynecology & Reproductive Medicine, JGRM, a leading peer-reviewed journal covering gynecology and reproductive medicine. "We are grateful for the renowned investigators from leading academic medical centers and private practices that participated in this landmark trial," stated Kathy Lee-Sepsick, CEO of Femasys. "Our impressive pivotal data for FemaSeed, showed significantly improved pregnancy rates, over double that of intrauterine insemination for low male sperm count, a primary or contributing cause of infertility for approximately 50% of couples. FemaSeed offers a highly effective, first-line solution for women and couples seeking a less invasive and more affordable option than in vitro fertilization."

08:20 EST Ensysce Biosciences doses first subjects in PF614-MPAR trial - Ensysce Biosciences has treated its first group of subjects in the PF614-MPAR-102 study. PF614-MPAR received Breakthrough Therapy designation from the U.S. Food and Drug Administration and had its development bolstered by the recent $14M multi-year award from the National Institute on Drug Abuse. The trial 'A Single and Multiple Dose Study to Evaluate the Pharmacokinetics of Oxycodone and PF614 when PF614 capsule is Co-Administered with Nafamostat as a combination Immediate Release solution and Extended-Release Capsule Formulation in Healthy Subjects', is designed to evaluate the full dosage range of PF614-MPAR, study food effects and to conduct a multi-ascending dose study.

08:17 EST SteelPhalt unveils new brand identity - SteelPhalt unveiled a new brand identity that reflects its continuous commitment to sustainability through providing low-carbon products. SteelPhalt has been a pioneer in recycling and high-performance asphalt production since the 1960s and continues its legacy as a leader in sustainable asphalt solutions. This aligns with Harsco Environmental's and Enviri's focus on innovative customer solutions

08:15 EST LeddarTech provides financing update - LeddarTech provides an update with respect to the previously disclosed bridge financing offer entered into with the initial bridge lenders and certain members of management and the board of directors dated as of August 16, 2024 which Bridge Financing Offer, as well as the amended and restated financing offer entered into with Federation des caisses Desjardins du Quebec dated as of April 5, 2023, required LeddarTech to secure certain equity investments by November 15, 2024, Although LeddarTech did not complete the required financing by the Maturity Date, LeddarTech continues to progress towards completing such financing and remains actively engaged in discussions with its lenders. LeddarTech has not received any notice of repayment from Desjardins or the other Bridge Lenders to date. Further updates will be provided by LeddarTech in due course

08:15 EST Dr. Reddy's and Senores launch Ivermectin tablets USP, 3 mg in U.S. - Dr. Reddy's Laboratories and Senores Pharmaceuticals announced the launch of Ivermectin Tablets USP, 3 mg, which is bioequivalent and therapeutically equivalent to STROMECTOL Tablets of Merck Sharp and Dohme in the U.S. market. The product will be marketed by Dr. Reddy's. "We are pleased to advance our growth with the launch of a limited-competition product. With our continuous focus on niche opportunities, we are proud to be the second generic to receive approval for this product," stated Swapnil Shah, Managing Director, Senores Pharmaceuticals Limited. Ivermectin Tablets, 3 mg brand and generic products, had U.S. sales of approximately $20M MAT for the twelve months ending in September 2024 according to IQVIA.

08:13 EST Tevogen announces additional responsibilities for key leaders - Tevogen Bio announced addition responsibilities for key leaders to further expand company capabilities. As part of this leadership evolution: Tapan V Shah, Head of Investor Relations and Corporate Development, will take on added responsibility for US Government Affairs and Policy. William Keane, Vice President of Strategic Initiatives, will assume additional responsibilities for New Business Development. Wojtek Stobinski, Corporate Identity Lead, will oversee the business integration of any potential future acquisitions.

08:12 EST Sonder receives notification of deficiency from Nasdaq due to delayed filing - Sonder Holdings announced that it received an expected deficiency notification letter from the Listing Qualifications Staff of The Nasdaq Stock Market on November 20, 2024. The Notice indicated that the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1) as a result of its failure to timely file its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2024, as described more fully in the Company's Form 12b-25 Notification of Late Filing filed with the Securities and Exchange Commission on November 14, 2024. The Listing Rule requires Nasdaq-listed companies to timely file all required periodic reports with the SEC.

08:10 EST PharmaTher initiates activities to address 'minor deficiencies' in ketamine NDA - PharmaTher announced that the FDA provided preliminary responses to questions contained in the post-complete response letter clarification meeting scheduled for December 2, 2024. PharmaTher has decided to cancel the Meeting as the Responses were satisfactory and do not require further discussion. The Company expects to resubmit information to address the deficiencies classified as MINOR in the complete response letter by January 2025. Fabio Chianelli, CEO commented: "We are very pleased with the responses by the FDA to the clarification questions in our post-CRL meeting request. The FDA has addressed our questions, paving the way for our Ketamine product's new drug approval. As such, we decided to cancel the meeting, and our team has already begun compiling the responses. We have also initiated additional tests to address the MINOR deficiencies in the CRL, and we expect to submit the MINOR AMENDMENT by January 2025." As previously announced, the Company requested the Meeting in response to the FDA issuing a CRL, dated October 22, 2024, for the Company's Ketamine product's Abbreviated New Drug Application, which was assigned a Generic Drug User Fee Amendments of 2022 goal date of October 29, 2024. As noted by the FDA in the CRL, the resubmission to this CRL will be considered to represent a MINOR AMENDMENT, given that the deficiencies have been classified as MINOR. The FDA requested new and updated information and clarifications related to drug substance, drug product, manufacturing, and microbiology. The FDA did not express concern about the stability of the ketamine submission batches, which achieved 18 months of stability without issue, and no new preclinical and clinical studies were requested.

08:08 EST Teledyne launches Z-Trak 3D Apps Studio - Teledyne DALSA introduced Z-Trak 3D Apps Studio, a suite of software tools developed for in-line 3D machine vision applications. Designed to work with Teledyne DALSA's Z-Trak family of laser profilers, it simplifies 3D dimensional measurement and inspection tasks on production lines. Capable of handling 3D scans of objects with varied surface types, sizes and geometric features, Z-Trak 3D Apps Studio is ideal for factory automation applications across a wide range of industries including electric vehicles, automotive, electronics, semiconductors, packaging, logistics, metal fabrication, lumber, and many more. Z-Trak 3D Apps Studio features streamlined tools for measuring object thickness, inspecting glue-beads, weld seams, and identifying defects on flat, inclined, and curved surfaces on machined, assembled, or extruded parts. It also includes anchoring and data enhancement features like reflection elimination to ensure reliable and repeatable results under diverse operating conditions.

08:07 EST ASP Isotopes completes construction, starts commissioning Silicon-28 facility - ASP Isotopes announced that it has completed the construction of a Silicon-28 enrichment facility in Pretoria, South Africa. The completion of the facility is broadly in line with previously communicated timelines. Today the Company started the commissioning phase of the facility's construction and start-up, in preparation for supplying commercial quantities of Silicon-28 during 1H 2025.

08:06 EST UroGen Pharma publishes long-term Jelmyto follow-up study results - UroGen Pharma highlighted results from a long-term follow-up study with Jelmyto for pyelocalyceal solution, which is FDA approved for the treatment of low-grade, upper tract urothelial cancer in adult patients. Among patients from the OLYMPUS trial who achieved a complete response after primary chemoablation with Jelmyto, the median duration of response was 47.8 months. The study results are published online in the Journal of Urology. Of the 71 patients enrolled in OLYMPUS, 41 achieved a complete response after treatment with Jelmyto and had a median duration of response of 47.8 months, with median follow-up of 28.1 months. The analysis has certain limitations, including its post-hoc nature and the inherent selection bias of the 20 patients enrolled in the long-term follow-up study. To further explore the potential of Jelmyto in treating patients with UTUC, investigators are currently enrolling participants in the Jelmyto uTRACT Registry to gather longitudinal real-world usage data. As of July 10, 19 sites have been activated with 191 patients enrolled.

08:04 EST Asset acquires 50% ownership of media rights to Blue's Linkin Park story - Asset Entities announced it has signed an agreement with its Head of Entertainment, Jeff Blue, and has acquired a fifty percent ownership interest in all film, TV, streaming and media rights to Blue's story, One Step Closer: From Xero to #1: Becoming Linkin Park. Per the agreement, Asset Entities has also engaged with Blue to write the screenplay, with an anticipated completion date by the end of February 2025. Published by Simon & Schuster/Posthill Press in 2020, One Step Closer: From Xero to #1: Becoming Linkin Park has been translated into seven different languages. Most recently, the band announced a massive 2025 worldwide tour in support of its new album, "From Zero," released on November 15, 2024.

08:03 EST Maxeon Solar restructuring business portfolio - Maxeon Solar announced a broad strategic restructuring of the company's business portfolio and geographic market focus. Going forward, the company intends to focus exclusively on the U.S. market. As a part of this strategy, Maxeon has executed a five-year lease of an existing building in Albuquerque, New Mexico and plans to begin solar panel manufacturing in this 2 GW capacity facility in early 2026. In rest-of-world markets, Maxeon and TCL Technology Group, the parent company of its majority shareholder have reached agreement-in-principle for the sale of Maxeon's EMEA, APAC and LATAM sales and marketing organization to TCL Group which will be incorporated into a newly formed solar solutions business unit, TCL SunPower International. The two companies have also agreed in principle for TCL Group to acquire Maxeon's Philippines manufacturing operations. Maxeon and TCL Group anticipate signing definitive agreements by the end of 2024. Following the completion of these transactions, Maxeon will continue to operate as an independent, publicly traded NASDAQ listed company solely focused on the U.S. residential, commercial, and utility-scale markets.

07:59 EST ParaZero partners with Drone Nerds to expand SafeAir Systems - ParaZero Technologies is partnering with Drone Nerds. This collaboration marks a significant step forward in making ParaZero's SafeAir Parachute Recovery System accessible to enterprise customers across industries as the company expands its reach across in North America. The ParaZero SafeAir System is designed to autonomously detect and mitigate flight risks in real-time. By integrating flight pattern monitoring and autonomous response mechanisms, including parachute deployment and audible alerts, the SafeAir system safeguards people, property and valuable drone assets. Through this partnership, Drone Nerds will introduce SafeAir to a broader customer base, enhancing operational safety and compliance for enterprise users.

07:48 EST LeddarTech awarded ISO/IEC 270001 certification - LeddarTech announced that the International Organization for Standardization and the International Electrotechnical Commission have awarded LeddarTech ISO/IEC 27001 certification on September 18, 2024. "This certification provides unparalleled data integrity and security assurance for our customers," stated Tal Alber, Senior Director of IT, Quality, Functional Safety and company security officer at LeddarTech. "Achieving ISO/IEC 27001 certification underscores our dedication to high cybersecurity standards. Our customers can be confident that their information assets are protected, preserving their trust in LeddarTech."

07:45 EST Electra calls special meeting of shareholders to vote on reverse stock split - Following receipt of notice, received September 17, 2024, from The Nasdaq Stock Market of noncompliance with the minimum bid price requirement of $1.00 per share under Nasdaq Listing Rule 5550(a)(2), the Company submitted an appeal of Nasdaq's determination. A hearing on the appeal was held on November 5, 2024, and the Company was notified it has been granted until January 15, 2025, to regain compliance with the Minimum Bid Requirement, subject to certain conditions. The Company has called a special meeting of shareholders on December 20, 2024. At the meeting, the Company will seek shareholder approval for a reverse stock split of the issued and outstanding common shares of the Company at a ratio of one post-Reverse Split common share for between three to five pre-Reverse Split common shares, as determined by the Board of Directors of the Company, and to approve the revised employee share purchase plan for the Company. Additional information and details of voting are available in the Management Information Circular distributed to shareholders in connection with the meeting.

07:41 EST Abercrombie & Fitch appoints Robert Ball as CFO - Abercrombie & Fitch Co. announced the promotion of Robert Ball to CFO, effective November 20, 2024. In his new role, Ball will serve on the company's executive leadership team and continue to report to Scott Lipesky, EVP and COO. Ball, previously the company's SVP of Corporate Finance, Investor Relations, and Treasury, brings nearly 22 years of experience leading key Abercrombie & Fitch Co. Finance and Strategy functions to the role. Lipesky, who served as the company's CFO since 2017, was promoted to COO in May 2023, and will remain in that role, leading the company's global operations and growth strategies, while driving financial discipline, capital allocation and efficiency.

07:37 EST Lifeway Foods expands on reasons for rejection of Danone's acquisition proposal - Lifeway Foods (LWAY) provided additional information regarding the reasons that its board of directors rejected the revised unsolicited proposal made on November 15 by Danone (DANOY) North America to acquire all the shares of Lifeway that it does not already own for $27.00 per share. The board determined that Danone's $27.00 per share proposal substantially undervalues the company. The board is not, however, opposed to the sale of the company at any price. Lifeway Foods is experiencing double-digit growth and believes it has sustained momentum with runway for significant long-term growth and margin expansion. This growth is being driven by an increasing recognition among consumers of the importance of the gut microbiome to overall health and the benefits of the naturally available high-quality protein and probiotics contained in kefir. Lifeway has achieved 20 consecutive fiscal quarters of year-over-year topline growth. Over the past five years, Lifeway achieved a total shareholder return of 788% as measured through September 23, 2024. From 2019 to 2023, annual revenue has grown from $94M to $160M, a 71% increase. ver that same five-year period, gross profit increased 92%. Lifeway forecasts annual Adjusted EBITDA to grow from $22M in 2023 to $45M$-50M in 2027. Based on the expected 2027 EBITDA range, the Danone proposal of $27 per share implies a very low multiple of ~7.5x - 8.5x EBITDA.

07:37 EST Beyond Air's NeuroNOS appoints Kornberg to SAB - NeuroNOS, a subsidiary of Beyond Air, announces the appointment of Professor Roger Kornberg, to its Scientific Advisory Board, SAB. This appointment marks a key milestone in NeuroNOS's commitment to advancing scientific innovation and improving the lives of individuals affected by neurological disorders

07:36 EST Cognition announces all participants completed final visit in SHIMMER study - Cognition Therapeutics announced that the last patient has completed their final clinic visit in the Phase 2 SHIMMER study of CT1812 in patients with mild-to-moderate dementia with Lewy bodies, DLB. The Company anticipates that topline results will be available in December 2024. Lisa Ricciardi, Cognition's president and CEO, concluded, "We look forward to reviewing the results of this study to enhance our understanding of CT1812's tolerability profile and identify signals of efficacy across measures of cognition and function."

07:33 EST Theratechnologies submits updated tesamorelin F8 forumlation for FDA review - Theratechnologies announced the resubmission of its supplemental Biologics License Application, sBLA, to the U.S. Food and Drug Administration, FDA, for the F8 formulation of tesamorelin, the only medication approved in the U.S. for the reduction of excess abdominal fat in adults with HIV who have lipodystrophy. Theratechnologies has filed the resubmission to address concerns raised in the FDA's Complete Response Letter, CRL, to the initial F8 formulation sBLA filing. In the CRL, which was issued in January 2024, the FDA requested clarifications largely related to chemistry, manufacturing and controls, as well as further information on immunogenicity risk.

07:32 EST Anavex announces submission of blarcamesine MAA to EMA - Anavex Life Sciences announced the submission of the blarcamesine Marketing Authorization Application, MAA, to the European Medicines Agency, EMA. The MAA submission is for the treatment of Alzheimer's Disease. Overall, blarcamesine, a small molecule administered orally once daily, demonstrated clinically meaningful improvement over 48 weeks with primary endpoint ADAS-Cog13 score being larger than 2 points. This suggests superior numerical clinical efficacy compared to approved therapies while also slowing neurodegeneration in early AD patients. Blarcamesine's safety profile indicates not requiring routine MRI monitoring, and the advantage of blarcamesine is that it is a small oral molecule that exerts clinical benefits on cognition and neurodegeneration and could be appealing because of its easy and convenient route of administration and good comparative safety profile.

07:21 EST ARway.ai integrates Toggle's FOTOgpt.ai Studio into Map Dynamics - Toggle3D.ai announced its strategic integration with ARway.ai's Map Dynamics platform. This partnership brings FOTOgpt.ai's AI photography tools to MapD's extensive network of over 400 enterprise clients, creating new revenue opportunities and expanding the capabilities of both platforms.

07:19 EST Arrowhead to get $825M in Sarepta licensing pact, appoints Sarepta CEO to board - Arrowhead (ARWR) announced a global licensing and collaboration agreement with Sarepta (SRPT). Upon closing, Arrowhead will receive $825M, consisting of $500M cash and $325M as an equity investment priced at a 35% premium. Arrowhead also receives $250M to be paid in equal installments over five years and is eligible to receive an additional $300M in near-term payments, which Arrowhead is on track to achieve during the next 12 months. Additionally, Arrowhead is eligible to receive royalties on commercial sales and up to approximately $10B in future potential milestone payments. The agreement covers multiple clinical and preclinical programs in rare, genetic diseases of the muscle, central nervous system and the lungs, as well as allows Sarepta to select up to six new targets for Arrowhead to conduct discovery and preclinical development activities in areas complementary to Sarepta's leadership in precision genetic medicine for rare diseases, which can utilize Arrowhead's Targeted RNAi Molecule platform. At the close of the agreement, Doug Ingram, president and CEO of Sarepta, will be appointed to the Arrowhead board of directors. Upon closing, Arrowhead will receive a $500M upfront payment and $325M through the purchase by Sarepta of Arrowhead common stock priced at a 35% premium to the 30-day volume weighted average price. Arrowhead will also receive $250 million to be paid in annual installments of $50M over five years. Arrowhead also has the potential to receive $300M in near-term payments associated with the continued enrollment of certain cohorts of a Phase 1/2 study, which Arrowhead is on track to achieve during the next 12 months. Arrowhead is eligible to receive development milestone payments of between $110M and $410M per program and sales milestone payments of between $500M and $700M per program. Arrowhead is also eligible to receive tiered royalties on commercial sales up to the low double digits. Under the agreement, Arrowhead will manufacture clinical drug supply for all programs arising out of the license and collaboration, and commercial drug product for the four programs currently in clinical trials. The transaction is expected to close in early 2025, subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.

07:15 EST Sarepta to pay Arrowhead $500M + in licensing deal for siRNA-based treatments - Sarepta Therapeutics (SRPT), the leader in precision genetic medicine for rare diseases announced an exclusive global licensing and collaboration agreement with Arrowhead Pharmaceuticals ( ARWR). Sarepta will obtain exclusive global rights to multiple clinical, preclinical, and discovery-stage programs for rare, genetic diseases of the muscle, central nervous system CNS , and the lungs. The agreement will add meaningfully to Sarepta's mid- and early-stage pipeline, complementing the Company's existing leadership in Duchenne muscular dystrophy and limb-girdle muscular dystrophies and gene therapy, while adding new indications and expanding into adjacent therapeutic areas. In addition, Doug Ingram, president and chief executive officer, Sarepta, will be appointed to Arrowhead's Board of Directors... "With the launch of Elevidys going exceedingly well, this broad siRNA collaboration with Arrowhead provides a synergistic platform to complement Sarepta's gene therapy and gene editing engine....Given the strength of our performance and ability to generate substantial cash to invest in our business over the next several years, Sarepta's Board of Directors has approved a $500M share repurchase program as part of our overall capital allocation strategy," said Mr. Ingram. Over the course of the next 12-18 months, we expect to share multiple data readouts from across our pipeline."...Under the terms of the agreement, Sarepta will pay Arrowhead an upfront payment of $500M and an equity investment of $325 million in Arrowhead common stock, priced at a 35% premium to the 30-day volume weighted average price prior to the announcement of the agreement. Arrowhead will also receive $250M to be paid in annual installments of $50 M over five years, in addition to being eligible for future milestone payments and royalties. Arrowhead will be responsible for Phase 1/2 trials currently underway, and clinical stage programs will transition to Sarepta no later than the completion of current trials. Preclinical assets will transition to Sarepta upon completion of IND-enabling activities by Arrowhead. The deal will be funded with cash on hand and Sarepta does not plan to raise additional capital via the debt or equity capital markets. The transaction is expected to close early 2025, subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and other customary conditions.

07:10 EST Amgen's MariTide shows up to 20% average weight loss in Phase 2 study - Amgen announced positive data at 52 weeks in a double-blind, dose-ranging Phase 2 study with MariTide - maridebart cafraglutide, formerly AMG 133 -, an investigational antibody peptide conjugate subcutaneously administered monthly or less frequently. In people living with obesity or overweight without Type 2 diabetes, MariTide demonstrated up to ~20% average weight loss at week 52 without a weight loss plateau, indicating the potential for further weight loss beyond 52 weeks. People living with obesity or overweight and Type 2 diabetes, who typically lose less weight on GLP-1 therapies, achieved up to ~17% average weight loss, also without a weight loss plateau, and lowered their average hemoglobin A1C by up to 2.2% at week 52.A weight loss plateau was not observed, again indicating the potential for further weight loss beyond 52 weeks. MariTide also demonstrated robust and clinically meaningful improvements in cardiometabolic parameters. There were no significant increases in free fatty acids. There was no association between the administration of MariTide and bone mineral density changes. The most common adverse events in the Phase 2 study were gastrointestinal related, including nausea, vomiting and constipation. The incidence of nausea and vomiting was substantially reduced with dose escalation. Data from this Phase 2 study will be presented at a future medical congress and submitted for publication. The ongoing Part 2 of the Phase 2 study is investigating MariTide beyond 52 weeks to evaluate further weight loss with continued treatment, weight maintenance through less frequent or lower dosing and durability of weight loss after discontinuation of MariTide. MariTide is produced in Amgen's manufacturing network.

07:08 EST Tilray's Broken Coast introduces premium strain 'Platinum Pave' - Tilray Brands announced the latest small batch indica strain by premium craft cannabis brand, Broken Coast: The company said, "Platinum Pave. This exceptional new cultivar is one of the first from Broken Coast's state-of-the-art Vancouver Island, BC facility. Platinum Pave is meticulously grown under optimized conditions in single-strain, laboratory-grade rooms. Each batch is precisely pruned, slowly cold cured, and rigorously inspected for purity, ensuring an exquisite BC bud experience that is sure to impress even the most discerning cannabis connoisseur. Platinum Pave details: Lineage: Spritzer x Pave. Aromas: Sweet, earthy with a potent hint of diesel.Rich terpene profile featuring: Limonene, Caryophyllene, Linalool. THC range: Potent and ideal for winding down after a long day or enjoying socially."

07:07 EST Enovix appoints Yan as Chief Technology Officer - Enovix announced the appointment of Dr. Hongwei Yan as Chief Technology Officer, CTO, reporting directly to CEO Dr. Raj Talluri. In this role, Dr. Yan will work in concert with the CEO and the leadership team to drive technology development, customer qualification and the 2025 scale up of the company's Malaysia high-volume manufacturing plant.

07:06 EST PyroGenesis receives $2M payment under Drosrite contract with Saudi client - PyroGenesis announces the receipt of a $2M payment representing a portion of an outstanding receivable under PyroGenesis' existing C$25+M Drosrite contract with Radian Oil and Gas Services Company. As previously announced, PyroGenesis contracted with PyroGenesis International, which was in turn contracted by Radian Oil and Gas Services Company for an order of seven Drosrite aluminum dross recovery systems. The first three systems were manufactured and delivered by the Company and are in full commercial operation for the Ma'aden aluminum plant in Ras Al-Khair Saudi Arabia, a joint venture corporation with Alcoa. The facility at Ras Al-Khair is known to be the largest and most efficient vertically integrated aluminum complex in the world and boasts one of the world's largest smelters. The remaining four Drosrite systems under the contract have already been manufactured and are expected to be delivered to the end client's operations in Saudi Arabia.

07:04 EST Axsome Therapeutics announces AXS-12 achieves primary endpoint in ENCORE - Axsome Therapeutics announced that AXS-12 achieved the primary endpoint in the ENCORE Phase 3 trial, demonstrating a statistically significant improvement in the frequency of cataplexy attacks compared to placebo. AXS-12 was also well tolerated with long-term dosing with a safety profile consistent with that observed in previously completed trials. ENCORE was a multi-center, two-period Phase 3 trial evaluating the long-term efficacy and safety of AXS-12 in patients with narcolepsy with cataplexy, consisting of a 6-month open-label AXS-12 treatment period, followed by a 3-week double-blind, placebo-controlled, randomized withdrawal period. AXS-12 met the primary endpoint of the change from randomization in the frequency of cataplexy attacks as compared to placebo at week 3 of the double-blind period. Patients randomized to switch to placebo experienced a statistically significant worsening in the average weekly number of cataplexy attacks compared with patients randomized to continue AXS-12 treatment, with an increase of 10.29 attacks per week with placebo versus 1.32 with AXS-12, at 3 weeks .

07:04 EST Aterian launches hOmeLabs, PurSteam, Mueller Living Brands on Target+ - Aterian (ATER) has begun selling products from its popular hOmeLabs, PurSteam, and Mueller Living brands on Target+, the online marketplace of Target Corporation (TGT). The Company expanded its product offerings from Squatty Potty on Target+ as well. This strategic expansion provides Aterian with a premium platform to reach millions of new online shoppers and underscores the Company's strategy to grow its omni-channel presence while maintaining flexibility and scalability in its operations.

06:52 EST Wipro extends relationship with Marelli - Wipro has announced the extension of its work with Marelli, a company in automotive solutions, for an additional four years. As part of this engagement, Wipro FullStride Cloud will migrate Marelli's Milan Data Centre and all their local server rooms to the Cloud to centralize their operations and provide a more agile and stable ecosystem. This transition to a more flexible and advanced cloud environment will empower Marelli to respond quickly to market changes, enable continuous innovation across their business, and strengthen their competitive edge. Ultimately, the project will help reduce the time-to-market for Marelli's products and services, creating long-term value for all stakeholders, continuing to advance Marelli's journey towards modernization and growth.

06:37 EST American Woodmark announces $125M share repurchase plan - On November 20, the Board of Directors authorized an additional stock repurchase program of up to $125M of the company's outstanding common shares. This authorization is in addition to the stock repurchase program authorized on November 29, 2023.

06:18 EST AMMO receives listing deficiency notifice from Nasdaq - AMMO received an expected deficiency notification letter from Nasdaq on November 20 indicating that the company was not in compliance with Nasdaq Listing Rules as a result of the company's failure to timely file its Quarterly Report on Form 10-Q for the quarter ended September 30, 2024. The Form 10-Q cannot be filed within the prescribed time period without unreasonable effort or expense as a result of the ongoing independent investigation conducted by a law firm retained by a Special Committee of the Board of Directors of the company. The company has until January 21, 2025, to submit a plan to regain compliance with the Listing Rule. The company intends to timely submit the plan, if necessary. If Nasdaq accepts the plan, Nasdaq has the discretion to grant the company an exception until May 19, 2025, to regain compliance. The company intends to file the Form 10-Q as soon as practicable to regain compliance with the Listing Rule within the compliance period.The notice has no immediate effect on the listing of the company's common stock or preferred stock on Nasdaq.

06:03 EST Beneficient regains Nasdaq compliance - Beneficient announced that it has received notice from The Nasdaq Stock Market that it has regained compliance with the Stockholders' Equity Requirement under Nasdaq Listing Rule 5550(b)(1) and the Audit Committee Requirement under Nasdaq Listing Rule 5605(c)(2). As a result, the company's securities will continue to be listed and traded on Nasdaq.

06:02 EST Radware expands security services relationship with large airport in India - Radware signed an agreement with a top 10 airport in India. The airport plans to leverage Radware's Cloud DDoS Protection and Cloud Application Protection Services and work with Radware's Emergency Response Team in response to a rise in cyber attacks. The cyber investment marks an expansion in the airport's existing relationship with Radware. The airport previously deployed Radware's Alteon application delivery controller. The airport ranks among the busiest in India. It has an infrastructure that connects to more than 30 countries and 20 airlines, and serves more than 10 million travelers annually.

05:48 EST CAF 'applauds' Brazil's investigation into Apple's App Store practices - The Coalition for App Fairness released a statement after Brazil's Administrative Council for Economic Defense issued a decision to investigate Apple's App Store practices and announced comprehensive preventative measures that Apple must comply with in under a month: "We commend CADE for its commitment to creating a competitive digital economy. The measures ordered by CADE require Apple to eliminate several restrictive clauses from its developer agreements and App Store guidelines. Specifically, it allows developers to inform iOS users about alternative payment options and include external links within their apps to make purchases outside the App Store. It also empowers consumers to choose how they get their mobile apps, including from competing mobile app stores or directly downloading apps from the internet. This is a pivotal moment in the global effort to create a more competitive mobile app ecosystem. Brazil joins a long list of brave jurisdictions eager to reform app store practices to the benefit of consumers and developers. CADE's decision reflects a growing global consensus that essential government intervention can create fair and competitive digital marketplaces." Reference Link

05:39 EST Blackstone to buy interests in $1B infrastructure loan portfolio from Santander - Blackstone (BX) and Santander Corporate & Investment Banking (SAN) announced an agreement under which funds managed by Blackstone Credit & Insurance, or BXCI, will acquire interests in a $1B portfolio of infrastructure loans from Santander. The portfolio comprises loans that finance assets located largely in Western Europe and the US across the digital infrastructure, utility scale renewable, energy efficiency and transportation sectors.

05:33 EST Rivian Automotive receives $6.6B conditional commitment from DoE ATVM - Rivian Automotive announced it has received conditional commitment from the U.S. Department of Energy's, or DOE, Advanced Technology Vehicle Manufacturing, or ATVM, Loan Program for a loan of up to $6.6B to accelerate its growth and leadership of electric vehicle design, development and manufacturing in the United States. If finalized, the loan would support the construction of Rivian's next facility in Stanton Springs North, near the city of Social Circle, Georgia, substantially expanding the company's domestic production capacity to support demand from the United States and international markets. This loan from DOE would provide significant funding for production of the company's midsize platform, which underpins the R2, a midsize SUV, and the R3/R3X, a midsize crossover. Rivian intends to build the facility in two phases, each resulting in 200,000 units of annual production capacity, for a total of 400,000 units of annual capacity-supporting the sale of American EVs in international markets. Phase 1 of the project is expected to start production in 2028. Rivian is expected to create approximately 7,500 operations jobs through 2030 at the company's future manufacturing facility in Georgia. This is in addition to 2,000 expected full-time construction jobs that will utilize the region's significant talent and workforce to further strengthen the domestic EV ecosystem. These jobs complement the thousands Rivian has already created and plans to maintain at its current plant in Normal, Illinois, which have bolstered the local and regional economy. Rivian plans to design and build a fully modern manufacturing facility at the Stanton Springs Site, less than one hour's drive from downtown Atlanta, employing modern construction techniques and advanced environmental management while preserving natural spaces and investing actively in the surrounding communities.

05:27 EST Roche reports SKYSCRAPER-01 study misses primary endpoint - Genentech, a member of the Roche, reported an update on the Phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer, or NSCLC. SKYSCRAPER-01 is a global Phase III, randomized, double-blinded study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 534 patients with PD-L1-high previously untreated, locally advanced unresectable or metastatic NSCLC. Patients were randomized 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit, or unacceptable toxicity. The study did not reach the primary endpoint of overall survival at the final analysis. The overall safety profile observed remained consistent with longer follow-up, and no new safety signals were identified. The detailed data will be presented at a medical meeting in 2025.

05:15 EST ArcelorMittal provides update on Europe decarbonization plans - ArcelorMittal provided an update on its decarbonization plans in Europe: "The Company has previously announced the intention to invest in lower carbon emissions "hydrogen ready" DRI-EAF facilities to replace several blast furnaces across our European business, as a key strategic first step towards reducing emissions. In all cases, the host countries offered funding support for these projects, with the approval of the European Commission. These projects were premised on a favourable combination of policy, technology and market developments that would facilitate decarbonization investment by helping offset the significantly higher capital and operating costs that this transition strategy would involve. This included being able to use natural gas until green hydrogen became competitive. However European policy, energy and market environments have not moved in a favourable direction. Green hydrogen is evolving very slowly towards being a viable fuel source and natural gas based DRI production in Europe is not yet competitive as an interim solution. Furthermore, there are significant weaknesses in the carbon border adjustment mechanism (CBAM), trade protection measures need strengthening in response to increasing imports due to overcapacity in China, and there is limited willingness among customers to pay premiums for low-carbon emissions steel. Before taking final investment decisions it is necessary to have full visibility on the policy environment that will ensure higher cost steelmaking can be competitive in Europe without a global carbon price. We expect several important developments in 2025, including the scheduled review of the CBAM, an anticipated review of the steel safeguards, and the publication of the Steel and Metals Action Plan. When complete, these initiatives will provide the parameters needed to shape the business case for decarbonization investments in Europe. In the meantime, we are continuing with engineering work, as well as analysing a phased approach that would first start with constructing electric arc furnaces, which can also be fed with scrap steel to significantly reduce emissions. ArcelorMittal remains committed to decarbonizing and achieving net-zero by 2050. Activity undertaken in Europe to date includes: In May we commenced construction on a 1.1 million tonne capacity EAF at our long products plant in Gijon, Spain. This will ultimately lead to a reduction of 1 million tonnes of CO2e a year. Good progress is being made with our efforts to increase production to 1.6 million tonnes a year by 2026 at our flat products plant in Sestao, Spain, where we have two EAFs. Once complete, much of this production will be our XCarb(R) recycled and renewably produced low-carbon emissions steel. We continue to lead the market with sales of our XCarb(R) low-carbon emissions steel, which have a carbon footprint of as low as 300kg per tonne of steel produced, and are on track to double sales to c. 400,000 tonnes this year. The longer timeline required for final investment decisions will not impact the Company's ability to meet customer demand for low-carbon emissions steel as the Sestao revamp project will materially increase the Company's ability to produce low-carbon emissions flat products. Any revision to the current 2030 intensity targets will be set out in the forthcoming Climate Action Report 3. From an absolute emissions perspective, the absolute emissions of the Company's operations in Europe have reduced by 28.2% since 2018, largely due to lower production due to weak demand. Longer term, the Company remains committed to all technologies that offer the potential to take steelmaking to near-zero. This includes carbon capture utilisation and storage (CCUS), although like green hydrogen, this technology is likely to only make a meaningful difference after 2030. It already has one industrial scale CCU facility operational at its plant in Gent, Belgium, and a further two pilot projects underway in Gent."

05:05 EST Intel, Biden-Harris Administration finalize $7.86B CHIPS Act funding award - Intel and the Biden-Harris Administration announced that the U.S. Department of Commerce and Intel have reached agreement on terms to award the company up to $7.86B in direct funding for its commercial semiconductor manufacturing projects under the U.S. CHIPS and Science Act. The award will support Intel's previously announced plans to advance semiconductor manufacturing and advanced packaging projects at its sites in Arizona, New Mexico, Ohio and Oregon. Intel also plans to claim the U.S. Treasury Department's Investment Tax Credit, which is expected to be up to 25% of qualified investments of more than $100B.