Stockwinners Market Radar for September 10, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:13 EDT Cathie Wood's ARK Investment bought 212K shares of Absci today

19:50 EDT Hyzon Motors trading halted, news pending

19:50 EDT UTime Ltd trading halted, news pending

19:34 EDT AppLovin exec sells $13.5M in common stock - In a regulatory filing, AppLovin disclosed that its Chief Technology Officer Vasily Shikin sold 160K shares of commom stock on September 6-9 in a total transaction size of $13.5M.

19:13 EDT SEC charges Deere with FCPA violations for unit's role in Thai bribery scheme - The Securities and Exchange Commission today announced that Deere & Company, which does business as John Deere, agreed to pay nearly $10M to resolve SEC charges that it violated the Foreign Corrupt Practices Act arising out of bribes paid by its wholly owned subsidiary, Wirtgen Thailand. The company is an Illinois-based global manufacturer of agricultural machinery and heavy equipment. The SEC's order finds that, from at least late 2017 through 2020, Wirtgen Thailand employees bribed Thai government officials with the Royal Thai Air Force, the Department of Highways, and the Department of Rural Roads to win multiple government contracts and also bribed employees of a private company to win sales to that company. The order finds that the bribes included cash payments, massage parlor visits, and international travel for the government officials and private company employees. According to the SEC's order, Wirtgen Thailand made approximately $4.3 million in profits as a result of these bribes. The improper payments were inaccurately recorded as legitimate expenses in Deere's books and records. "After acquiring Wirtgen Thailand in 2017, Deere failed to timely integrate it into its existing compliance and controls environment, resulting in these bribery schemes going unchecked for several years," said Charles E. Cain, Chief of the SEC Enforcement Division's FCPA Unit. "This action is a reminder for corporations to promptly ensure newly acquired subsidiaries have all the necessary internal accounting control processes in place." The SEC's order found that Deere violated the recordkeeping and internal accounting controls provisions of the FCPA. Without admitting or denying the SEC's findings, Deere consented to the entry of the SEC's order requiring it to cease and desist from further violations and to pay disgorgement and prejudgment interest totaling approximately $5.4 million and a civil penalty of $4.5 million.

19:02 EDT Eli Lilly says QWINT-2 trial met primary endpoint of non-inferior A1C reduction - Earlier, Eli Lilly and Company announced detailed results from the QWINT-2 phase 3 trial evaluating once-weekly insulin efsitora alfa compared to once-daily insulin degludec in adults with type 2 diabetes using insulin for the first time. The data were published in The New England Journal of Medicine and simultaneously presented today at the European Association for the Study of Diabetes Annual Meeting 2024. In the trial, efsitora met the primary endpoint of non-inferior A1C reduction. For the efficacy estimand, efsitora reduced A1C by 1.34% compared to 1.26% for insulin degludec resulting in an A1C of 6.87% and 6.95% respectively at 52 weeks. Additionally, participants taking efsitora achieved 45 minutes more time in range per day, a key secondary endpoint, without additional time in hypoglycemia in comparison to insulin degludec for the efficacy estimand. "Traditionally, basal insulins are dosed once a day - a treatment schedule that can make compliance difficult for a significant portion of people living with type 2 diabetes," said Carol Wysham, M.D., clinical professor of medicine at the University of Washington School of Medicine. "Efsitora has the potential to address treatment burden and improve adherence - all while lowering A1C. These results can make a significant impact for people living with type 2 diabetes looking for a once-weekly option that provides similar outcomes as daily insulins." QWINT-2 was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 52 weeks in insulin-naive adults with type 2 diabetes. The trial randomized 928 participants across the U.S., Brazil, Canada, China, Czechia, Germany, Greece, Japan, Korea, Mexico and Puerto Rico to receive efsitora once weekly or insulin degludec once daily administered subcutaneously. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to insulin degludec. The trial was also designed to assess efficacy and safety for patients using and not using GLP-1 receptor agonists.

18:46 EDT Meta Platforms COO sells $215.6K in common stock - In a regulatory filing, Meta Platforms disclosed that its COO Javier Olivan sold 522 shares of common stock on September 6th in a total transaction size of $215.6K.

18:44 EDT Credo Technology CEO sells $3.7M in common stock - In a regulatory filing, Credo Technology disclosed that its CEO Willam Brennan sold 144K shares of common stock on September 6th in a total transaction size of $3.7M.

18:31 EDT Elastic CEO Kulkarni sells 19,649 ordinary shares - In a regulatory filing, Elastic CEO Ashutosh Kulkarni disclosed the sale of 19,649 ordinary shares of the company on September 9 at a price of $70.25 per share.

18:00 EDT Cemex sells its operations in Guatemala for $200M - Cemex announced that it has sold its operations in Guatemala to Holcim Group, for a total consideration of approximately $200M. The transaction was signed and closed. The divested assets mainly consist of one grinding mill, three ready mix plants and five distribution centers. As of December 31, 2023, the grinding mill had an installed capacity of around 0.6M metric tons per year. "In 2024, we have accelerated the execution of our portfolio rebalancing strategy with the announced sale of more than US$2 billion in assets located primarily in emerging markets," said Fernando A. Gonzalez, CEO of Cemex. "We are now primed for the next stage by redeploying most of the divestment proceeds in developed markets, primarily the US. We expect these efforts to drive sustainable growth for our business in the short and medium term." The use of divestment proceeds will prioritize aggregates, urbanization solutions, and cement, with a strong focus on lower-carbon and circular economy initiatives, along with other general corporate purposes. This aligns with its growth strategy, which targets bolt-on acquisitions in developed markets. By concentrating on markets where it already operates and offers the most promising growth opportunities, in businesses that fit seamlessly with its current products and customers, Cemex has successfully driven incremental EBITDA over the past year. Reference Link

17:23 EDT First American increases quarterly dividend 2% to 54c per share - First American announced that its board of directors has declared a quarterly cash dividend of 54c per common share, a 2% increase over the prior level of 53 cents per common share. The cash dividend is payable on September 27 to shareholders of record as of September 20.

17:12 EDT Southwest eliminates Executive Committee structure for board - Southwest announced the next phase of the Board's transformation, including significant ongoing refreshment. The Board presented its plans at a meeting yesterday and invited Elliott Investment Management L.P. to participate in refreshment efforts and other corporate governance changes. Southwest Airlines intends to continue its constructive engagement with Elliott toward a collaborative resolution in the near term. Executive Chairman Gary Kelly has announced his intention to voluntarily retire from the Board and his Executive Chairman position effective immediately after the 2025 Annual Meeting. Six current Directors have informed the Board of their plans to voluntarily step down immediately after the Company's regularly scheduled Board meeting in November: David Biegler (Compensation Committee Chairman), Veronica Biggins (Nominating and Corporate Governance Committee Chair), Senator Roy Blunt, Dr. William Cunningham (Lead Director), Dr. Thomas Gilligan (Audit Committee Chairman), and Jill Soltau. "The Board anticipates appointing four new independent Directors in the near future," the company said. "In addition to considering Elliott's Director candidates, the Nominating and Corporate Governance Committee has engaged a leading independent search firm to identify and review strong candidates who can bring complementary skills and experience to lead the airline forward." Consistent with feedback from Shareholders, the Board has eliminated the Executive Committee structure and created a new Finance Committee with a mandate focused on assisting the Board with oversight of financial, operational, and business plans and strategies, major transactions, capital structure and capital allocation priorities, among other duties. In connection with the planned Director retirements in November and other Board committees being reconstituted at that time, the Finance Committee also will be reconstituted to include both new and incumbent Directors with relevant strategy and financial expertise. The Board will name a new Lead Director and new Committee Chairs for each of the Audit, Compensation, and Nominating and Corporate Governance Committees at that time as well.

17:03 EDT Citi names Robert Walsh as interim Chief Accounting Officer - The company states: "On September 4, 2024, Johnbull Okpara informed Citigroup Inc. that he would resign from his position of Chief Accounting Officer and Controller of Citi to pursue another opportunity, effective September 10, 2024. On September 10, 2024, Robert Walsh, age 54, agreed to become interim Chief Accounting Officer of Citi, effective immediately, while a search for a permanent replacement is conducted. Mr. Walsh has been the Controller for the Services business since November 2023. Since his employment by Citi commenced in 1999, he has been an SEC Reporting Analyst; Assistant Accounting Policy Head - Global Consumer Banking; Head of Accounting Policy - Cards; Controller for Citi's Institutional Clients Group in North America; Controller - Citigroup Global Markets, Inc.; Head of Corporate and Regulatory Reporting; and, immediately prior to assuming his current role, Head of Financial and SEC Reporting."

17:02 EDT Aeries Technology receives Nasdaq deficiency notification - Aeries Technology announced that it received an expected deficiency notification letter from the Listing Qualifications Staff of The Nasdaq Stock Market LLC on September 5, 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 quarter ended June 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 August 15, 2024, and for remaining delinquent in filing its Annual Report on Form 10-K for the year ended March 31, 2024. The Listing Rule requires Nasdaq-listed companies to timely file all required periodic reports with the SEC. In accordance with the Notice, the company has until September 30, 2024 to submit a plan to regain compliance with the Listing Rule. Following receipt of such plan, Nasdaq may grant an extension of up to 180 calendar days from the Fiscal 2024 Form 10-K's due date, or until January 13, 2025, for the company to regain compliance.

16:56 EDT Universal Technical appoints Christine Kline as interim CFO - Universal Technical Institute announced that Troy Anderson has resigned as Executive Vice President CFO, effective October 11, to accept a position at another public company. Christine Kline, Chief Accounting Officer, has been appointed interim CFO while a national search is conducted for a replacement. Recently, Universal Technical Institute announced the second phase of its North Star Strategy to accelerate the company's mission to close the skilled workforce gap in America. The core tenets of the strategy-growth, diversification and optimization-are the foundation for initiatives across the company's two divisions of Universal Technical Institute, which offers transportation, skilled trades, and energy education programs; and Concorde Career Colleges, which specializes in the dental, nursing, and allied health professions.

16:51 EDT APA Corp. to sell non-core producing properties in Permian Basin for $950M - APA Corp. announced entry into an agreement for the sale of non-core producing properties in the Permian Basin to an undisclosed buyer for $950M, prior to customary closing adjustments. The properties are located in the Central Basin Platform, Texas and New Mexico Shelf, and Northwest Shelf and currently represent estimated net production of 21,000 barrels of oil equivalent per day, of which approximately 57% is oil. Proceeds from this sale will be used primarily to reduce debt. The effective date of the transaction is July 1, 2024, and the transaction is expected to close during the fourth-quarter 2024. Pro-forma fourth-quarter U.S. production guidance is 307,000 boe/d which is 34% above the company's fourth-quarter 2023 production.

16:49 EDT BridgeBio reports results from Phase 1/2 open-label trial of BBP-631 - BridgeBio Pharma announced topline results from the Phase 1/2 open-label ADventure study investigating BBP-631, the Company's investigational adeno-associated virus 5 gene therapy, for the treatment of congenital adrenal hyperplasia. The Phase 1/2 open-label ADventure study was designed to evaluate the safety, tolerability and pharmacodynamic activity of BBP-631 in adults with classic CAH. To date, key results from the study include: Increased endogenous cortisol production was achieved in all patients at higher doses. A maximum change from baseline post-ACTH stimulation test of 4.7 undefined/dL and 6.6 undefined/dL was observed at the two highest dose levels, respectively, with cortisol levels as high as 11 undefined/dL achieved. Substantial and durable increases in 11-deoxycortisol, the product of 21-hydroxylase, and reductions in 17-hydroxyprogesterone, the substrate of 21-hydroxylase, provide compelling evidence of durable BBP-631 transgene activity. At the highest dose levels, sustained 11-deoxycortisol averaged a 55-fold increase from baseline with a maximum of 99-fold increase from baseline. These represent an average maximum of 23-fold the upper-limit of normal. Robust reduction in 17-hydroxyprogesterone, with the majority of patients reaching a reduction of greater than or equal to50%, with a max reduction of 95%. BBP-631 has been well tolerated with only mild to moderate treatment-emergent adverse events (TEAEs) and no treatment-related SAEs reported. "While the data to date are not yet transformational, the study showed for the first time that people living with CAH can indeed make their own cortisol, and that gene therapy can be safely administered in this patient population. We remain committed to finding the right partner for those in the CAH community and are grateful to the participants and those who expressed interest in both the pre-screening study and the ADventure study. We also want to thank the ADventure study investigators and staff, the CAH patient advocacy organizations and the broader CAH community," said Neil Kumar, Ph.D., CEO and Founder of BridgeBio. "Given that the results of the trial did not meet the threshold to warrant additional capital investment at this time, BridgeBio will be reducing the gene therapy budget more than $50M, consistent with our capital allocation principles, and reserving gene therapy for priority targets that we cannot treat any other way," said Brian Stephenson, Ph.D., CFA, Chief Financial Officer of BridgeBio. "We believe that gene therapies have the potential to fulfill a significant unmet need and are eager to work closely with the FDA and the Canavan community with the goal of bringing our therapy to families living with Canavan disease as fast as possible." BridgeBio will no longer be pursuing development of BBP-631 for CAH and the company is actively seeking partnership opportunities to support future development of BBP-631 or next-generation gene therapies for the treatment of CAH, a very prevalent genetic disease that still has significant unmet need, with more than 75,000 cases estimated in the United States and European Union.

16:37 EDT Marathon Oil exec Henderson sells 38,000 common shares - In a regulatory filing, Marathon Oil executive VP of operations Michael Henderson disclosed the sale of 38,000 common shares of the company on September 6 at a price of $27.2079 per share.

16:34 EDT Telesis Bio to delist shares from Nasdaq - Telesis Bio announced that it has notified the Nasdaq Stock Market of its decision to delist the Company's shares of common stock, par value $0.001 per share and deregister the Common Stock under Section 12(b) of the Securities Exchange Act of 1934, as amended. Telesis intends to file a Form 25 with the Securities and Exchange Commission o remove its Common Stock from listing on the Nasdaq Global Select Market on or about September 20. As a result, Telesis expects that the last trading day of its Common Stock on the Nasdaq Global Select Market will be on or about September 30. Telesis will remain subject to continued reporting obligations under Sections 13 and 15(d) of the Exchange Act. As previously noted in the Company's Current Report on Form 8-K filed with the SEC on April 8 Telesis received a letter on April 3 from the Listing Qualifications Department of Nasdaq notifying Telesis that the Company was not in compliance with the minimum stockholder's equity requirement for continued listing set forth in Nasdaq Listing Rule 5450(b)(1)(A), which requires companies listed on the Nasdaq Global Select Market to maintain a minimum of $10,000,000 in stockholders' equity for continued listing . The Company was granted a 180-day extension to regain compliance with the Stockholders' Equity Requirement, which expires on September 30 .

16:29 EDT Worthington begins modernization project at its Chilton, Wisconsin, facility - Worthington Enterprises has begun a modernization project at its Chilton, Wisconsin, campus where it manufactures Bernzomatic and Mag-Torch( hand torches and fuel cylinders. A new 58,000-square-foot building and equipment will increase automation and production efficiencies, help ensure continued product quality and safety performance and allow for future expansion. Andy Rose, president and chief executive officer, Worthington Enterprises, said, "Ths is an investment in U.S. manufacturing, Chilton, our employees and our Company's future. Consumers and professionals around the world trust the brands made here because of the quality products they represent.

16:21 EDT Cohen & Steers reports preliminary AUM of $88.1B as of August 31 - Cohen & Steers reported preliminary assets under management of $88.1B as of August 31, 2024, an increase of $3.5B from assets under management of $84.6B at July 31, 2024. The increase was due to market appreciation of $3.7B and net inflows of $8M, partially offset by distributions of $152M.

16:17 EDT Construction Partners completes John G. Walton Construction Company acquisition - Construction Partners announced that it has acquired John G. Walton Construction Company, headquartered in Mobile, Alabama. In connection with the transaction, the company added a hot-mix asphalt plant and related crews and equipment serving the greater Mobile and southwestern Alabama market area.

16:16 EDT National Bank CFO Aldis Birkans named president, Nicole Van Denabeele succeeds - National Bank announced that Aldis Birkans, the company's EVP, CFO was promoted to president of the company with Tim Laney continuing to serve as the company's chairman and CEO. Nicole Van Denabeele, the company's EVP, chief accounting officer has been appointed as the company's EVP, CFO. In addition, Emily Gooden has been appointed as the company's SVP, chief accounting officer and will continue to serve as investor relations director. The effective date of these promotions are all as of September 10. Birkans has served as the company's CFO since 2018 and previously served as the treasurer of the company. In his role as president, he will have oversight of the company's lines of business functions.

16:16 EDT Clorox completes divestiture of its Better Health VMS business - The Clorox Company announced the completion of the previously disclosed divestiture of its Better Health Vitamins, Minerals and Supplements business in its entirety to an affiliate of Piping Rock Health Products. The divested business includes the Natural Vitality, NeoCell, Rainbow Light and RenewLife brands, relevant trademarks and licenses, and associated manufacturing and distribution facilities in Sunrise, Florida. This transaction reflects Clorox's commitment to continue evolving its portfolio to reduce volatility and accelerate sales growth, as well as structurally improve its margin, in service of driving more consistent and profitable growth over time.

16:10 EDT Flexsteel Industries raises quarterly dividend over 13% to 17c per share - Flexsteel Industries announced its Board of Directors declared an increased quarterly dividend of 17c per share, payable October 7, 2024, to shareholders of record as of September 25, 2024. The 17c per share quarterly dividend is an increase of over 13% from the previous quarterly dividend. Flexsteel has paid cash dividends on its common stock each year since 1938. This is the 331st consecutive quarterly cash dividend.

16:08 EDT Yext launches social media management solution Yext Social - Yext announced the launch of Yext Social, a cutting-edge AI-powered social media management solution that transforms how brands manage local customer engagement at scale globally. Yext Social empowers brands to connect with customers where it matters most-locally-through personalized, data-driven content, all managed on a single platform. Yext Social represents a major expansion of the Yext platform. Leveraging advanced AI technology, Yext Social simplifies content creation, optimizes engagement strategies, and delivers actionable insights, enabling brands to manage both corporate and local social media with ease from the Yext platform.

16:07 EDT Tyra Biosciences appoints Doug Warner as Chief Medical Officer - Tyra Biosciences announced the appointment of Doug Warner, as Chief Medical Officer. Warner will be responsible for overseeing TYRA's clinical portfolio and will serve as a key member of its executive management team. Warner held roles of increasing responsibility over 18 years at Amgen where he oversaw clinical development for programs across oncology and bone diseases. This included being an Executive Director and Group Product Area Lead, where Dr. Warner led a team responsible for the development of a portfolio of medicines ranging from those in Phase 1 to those with approved indications, including Vectibix, XGEVA, and Prolia. Most recently, Warner was Chief Medical Officer for eFFECTOR Therapeutics where he was responsible for overseeing eFFECTOR's clinical pipeline, including its KICKSTART Phase 2b trial of tomivosertib in non-small cell lung cancer, and its Phase 1/2 study of zotatifin in solid tumors. Dr. Warner is co-author of numerous peer-reviewed articles including those in The Lancet, The Lancet Oncology, and The Journal of Clinical Oncology.

16:06 EDT Velo3D trading halted, news pending

15:55 EDT Assa Abloy acquires Level Lock in U.S., says dilutive to EPS from start - Assa Abloy announced it has acquired Level Lock, a technology solutions business based in Redwood City, California. "Level Lock was founded in 2016 and has some 70 employees. The main office is located in Redwood City, California, USA. Sales for 2023 amounted to about MUSD 16 (approx. MSEK 170). The acquisition will be dilutive to EPS from the start," the company stated. "The acquisition of Level Lock complements ASSA ABLOY's technology portfolio and strengthens our digital offering across multiple businesses in the Americas division," says Lucas Boselli, Executive Vice President of ASSA ABLOY and Head of the Americas Division. "Their innovative platform provides an easy transition from mechanical locking to digital access solutions with minimal effort."

14:21 EDT Boeing delivers 40 planes in August, up 5 from a year ago - Boeing said it has delivered a total of 40 commercial jets in August, up five from August 2023. These included 32 Max jets, 1 767F, 3 777s and 4 787s. In the month of July, Boeing delivered 43 aircraft, including 31 Max jets.

14:13 EDT Bio-Rad COO Last sells $990K in company shares - Bio-Rad Labs' COO Andrew Last disclosed the sale of 3,000 shares of company stock at $329.94 per share on September 6, for a total transaction amount of $989,815.

14:10 EDT Alimera Sciences trading halted, volatility trading pause

13:40 EDT Bank of America can continue stock buybacks, CEO Moynihan says

13:33 EDT BofA sees Q3 sales and trading revenue flat quarter-over-quarter - BofA sees Q3 trading revenue up in the low single digits percentage versus last year, CEO Brian Moynihan said while speaking at the Barclays 22nd Annual Global Financial Services Conference.

13:02 EDT Campbell Soup to change name to The Campbell's Company - Campbell Soup held an Investor Day at the Nasdaq MarketSite in New York City where Campbell's management team "outlined plans for the next era of accelerated growth," the company announced. "The company aims to set the standard for performance in the industry with a new strategy, new mission and new name. As part of its evolution and transformed portfolio, the company intends to change its name to The Campbell's Company, subject to shareholder approval at its annual meeting of shareholders in November," Campbell stated. "This subtle yet important change retains the company's iconic name recognition, reputation and equity built over 155 years while better reflecting the full breadth of the company's portfolio," said Mark Clouse, Campbell's President and CEO.

12:46 EDT New Starbucks CEO vows to focus initially on U.S. turnaround - In an open letter, new Starbucks CEO Brian Niccol said, "Over the past few weeks, I've spent time in our stores, speaking with partners and customers, and talking with teams across operations, store design, marketing and product development. In each conversation, two truths emerged: First, Starbucks is a beloved brand with wonderful people. We are woven into the fabric of people's lives and the communities we serve. Second, there's a shared sense that we have drifted from our core. We have an opportunity to make the store experience better for our partners and, in turn, for our customers...Many of our customers still experience this magic every day, but in some places - especially in the U.S. - we aren't always delivering. It can feel transactional, menus can feel overwhelming, product is inconsistent, the wait too long or the handoff too hectic. These moments are opportunities for us to do better. Today, I'm making a commitment: We're getting back to Starbucks. We're refocusing on what has always set Starbucks apart - a welcoming coffeehouse where people gather, and where we serve the finest coffee, handcrafted by our skilled baristas...To support this vision for our U.S. business, we're making investments in technology that enhance the partner and customer experience, improve our supply chain and evolve our app and mobile ordering platform...This is our plan for the U.S., and where I need to focus my time initially...In China, we need to understand the potential path to capture growth and capitalize on our strengths in this dynamic market. Internationally, we see enormous potential for growth, especially in regions like the Middle East, where we'll work to dispel misconceptions about our brand, and in Asia Pacific, Europe and Latin America, where the love for Starbucks is strong." Reference Link

12:08 EDT Newmont says 'firmly on track' to deliver 2024 commitments - The company said, "Newmont remains firmly on track to deliver on our 2024 commitments. With the expectation that the transaction will close in the fourth quarter of 2024, Newmont has made minor adjustments to its non-core gold and copper production guidance to reflect the Telfer divestiture."

12:01 EDT Bread Financial falls -10.2% - Bread Financial is down -10.2%, or -$5.51 to $48.40.

12:01 EDT Ally Financial falls -15.9% - Ally Financial is down -15.9%, or -$6.30 to $33.35.

12:00 EDT a.k.a. Brands rises 9.8% - a.k.a. Brands is up 9.8%, or $2.23 to $25.00.

11:45 EDT Amazon trialing last-mile deliveries by tram in Frankfurt - Amazon announced that it is working with partners to use a tram to deliver packages to the center of Frankfurt, from where electric cargo bikes complete the delivery, creating a zero-tailpipe emission journey from delivery station to the customer. The pilot project is part of the 'LastMileTram RheinMain V' research project of Frankfurt University of Applied Sciences, together with Verkehrsgesellschaft Frankfurt am Main and Intermodal City Injections, a collaboration between Amazon Transportation Services and Amazon Logistics. Martin Andersen, MEU Country Director, Amazon Logistics said: "The decarbonisation of our logistics network plays a key role in achieving the goal of The Climate Pledge. We are therefore delighted to be working with VGF and UAS on this project." Reference Link

11:20 EDT Eli Lilly: QWING-2 ph3 trial met primary endpoint of non-inferior A1C reduction - Eli Lilly and Company announced detailed results from the QWINT-2 phase 3 trial evaluating once-weekly insulin efsitora alfa compared to once-daily insulin degludec in adults with type 2 diabetes using insulin for the first time. The data were published in The New England Journal of Medicine and simultaneously presented today at the European Association for the Study of Diabetes Annual Meeting 2024. In the trial, efsitora met the primary endpoint of non-inferior A1C reduction. For the efficacy estimand1,2, efsitora reduced A1C by 1.34% compared to 1.26% for insulin degludec resulting in an A1C of 6.87% and 6.95% respectively3 at 52 weeks. Additionally, participants taking efsitora achieved 45 minutes more time in range4 per day, a key secondary endpoint, without additional time in hypoglycemia in comparison to insulin degludec for the efficacy estimand. "Traditionally, basal insulins are dosed once a day - a treatment schedule that can make compliance difficult for a significant portion of people living with type 2 diabetes," said Carol Wysham, M.D., clinical professor of medicine at the University of Washington School of Medicine. "Efsitora has the potential to address treatment burden and improve adherence - all while lowering A1C. These results can make a significant impact for people living with type 2 diabetes looking for a once-weekly option that provides similar outcomes as daily insulins." QWINT-2 was a parallel-design, open-label, treat-to-target, randomized controlled clinical trial comparing the efficacy and safety of efsitora as a once-weekly basal insulin to insulin degludec for 52 weeks in insulin-naive adults with type 2 diabetes. The trial randomized 928 participants across the U.S., Brazil, Canada, China, Czechia, Germany, Greece, Japan, Korea, Mexico and Puerto Rico to receive efsitora once weekly or insulin degludec once daily administered subcutaneously. The primary objective of the trial was to demonstrate non-inferiority in reducing A1C at week 52 with efsitora compared to insulin degludec. The trial was also designed to assess efficacy and safety for patients using and not using GLP-1 receptor agonists.

11:05 EDT Coliseum Acquisition Corp trading halted, volatility trading pause

10:46 EDT CyberArk, Proofpoint expand strategic collaboration - Proofpoint and CyberArk announced an extended strategic collaboration, working together to help organizations around the world secure identities everywhere. Supporting this joint aim, the expanded partnership includes the launch of new integrations and solutions to address critical cyber challenges.

10:21 EDT JPMorgan: No change in guidance for credit card net charge-offs

10:18 EDT JPMorgan's Pinto says 2025 expense estimates too optimistic

10:13 EDT JPMorgan sees Q3 markets revenue flat to up about 2% y/y

10:10 EDT JPMorgan sees "solid" quarter for investment banking - Says investment banking fees could increase 15% in Q3.

10:06 EDT Barr says 'material changes' warranted to bank capital requirement proposals - Vice Chair for Supervision Michael Barr stated in a speech to be presented at the Brookings Institution on "The Next Steps on Capital," according to summary posted on the Federal Reserve website: "Since I joined the Federal Reserve Board as Vice Chair for Supervision, I have spoken many times about the importance of bank capital to the safety and soundness of banks and the stability of the financial system. It is critical that banks have the capacity to continue lending to households and businesses through times of stress. Bank capital is a key component of this resilience. And bank capital rules help to ensure that banks are holding capital commensurate with the risks of their activities and the risks that they pose to the U.S. financial system. But capital has costs too. As compared to debt, capital is a more expensive source of funding to the bank. Thus, higher capital requirements can raise the cost of funding to a bank, and the bank can pass higher costs on to households, businesses, and clients engaged in a range of financial activities. These activities are critical to a well-functioning economy that works for everyone. That's why it is important to get the balance between resiliency and efficiency right. Today, I'll return to these themes in the context of two rules of great public interest: The Basel III endgame proposal and the proposal to adjust the capital surcharge for global systemically important banks - G-SIB. A little over a year ago, the Board sought comment on those two proposed rules, which would modify risk-based capital requirements for large banks. We received a great number of comments on the provisions in the proposal, as well as on the justifications and analysis that underlie those provisions. Since that time, we have been hard at work analyzing the comments and the data we collected to evaluate the combined impact of these proposals. We have spoken with a wide range of stakeholders, including banks, academics, public interest groups, consumers, businesses, other regulators, Congress, and others. As you would expect in a project as technical and consequential as this one, I have had many productive meetings with Board colleagues and our fellow federal bank regulatory agencies, the Federal Deposit Insurance Corporation and the Office of the Comptroller of the Currency. This process has led us to conclude that broad and material changes to the proposals are warranted. As I said, there are benefits and costs to increasing capital requirements. The changes we intend to make will bring these two important objectives into better balance, in light of the feedback we have received. The changes to the endgame proposal have been a joint effort with my counterparts at the FDIC and the OCC. I intend to recommend that the Board re-propose the Basel endgame and G-SIB surcharge rules. This will provide the public the opportunity to fully review a number of key broad and material changes to the original proposals and provide comment. We will accept public comments on any aspect of the Basel endgame and G-SIB surcharge proposals." Publicly traded large banks include Bank of America (BAC), Citi (C), Goldman Sachs (GS), JPMorgan (JPM), Morgan Stanley (MS), U.S. Bancorp (USB) and Wells Fargo (WFC). Reference Link

10:04 EDT JPMorgan's Pinto a 'strong believer' that trading wallet will consolidate

10:03 EDT IZEA forms Strategy & Capital Allocation Committee - A Strategy & Capital Allocation Committee is being formed to evaluate strategic options, sources and uses of capital, capital structure, and cash management.The company is committing resources to M&A to capitalize on opportunities as they arise in the marketplace. The company reaffirms the previously stated commitment to pursue profitable growth.

10:03 EDT IZEA expands share buyback program to $10M - IZEA's share buyback program is expanding from $5 million to $10 million as a demonstration of the Board's confidence in the company's ability to create more value.

10:02 EDT IZEA, GP Investments partner on value creation plan - IZEA Worldwide announced a partnership with GP Investments, Ltd. and a series of value creation actions. Antonio Bonchristiano and Rodrigo Boscolo of GP Investments, a global investment firm with flexible, long-term capital, are joining IZEA's Board of Directors. These appointments reflect GP's substantial IZEA shareholding and its track record in creating value across a range of enterprises. Bonchristiano is the CEO and a board member of GP Investments, which he joined in 1993. Previously, he worked in London and New York for Solomon Brothers and Johnston Associates. Over the last three decades, he has served as a director on several boards, including AMBEV, Rimini Street, G2D Investments, BR Properties, among others. Boscolo is a Managing Director and the CFO at GP Investments since 2018. Before, he was a consultant at The Boston Consulting Group. Boscolo has also served on numerous boards of both private and public companies across geographies, including G2D Investments, Spice Private Equity, LEON Restaurants, Magnesita, Sascar, and Allis.

10:01 EDT Fluent names Ryan Perfit as CFO - Fluent has announced Ryan Perfit's appointment as CFO. Perfit has served as interim CFO since February 1, 2023, and his appointment as CFO reflects his valuable contributions as the company has evolved its business and financial strategies. This appointment is a homecoming for Perfit, who, from 2012 to 2019, demonstrated exceptional leadership at Fluent by spearheading company-wide strategic planning initiatives, cash flow planning, and capital structure design as Senior Vice President. His proficiency in financial controls, investor relations, SEC reporting, and audit compliance was pivotal in preparing Fluent for its 2015 merger and the 2018 spin-off that put Fluent's management team in charge of the public company.

10:00 EDT Skillsoft falls -11.4% - Skillsoft is down -11.4%, or -$1.71 to $13.29.

10:00 EDT Yatsen rises 7.2% - Yatsen is up 7.2%, or 24c to $3.56.

10:00 EDT Oracle rises 14.3% - Oracle is up 14.3%, or $20.06 to $159.95.

09:56 EDT JPMorgan's Pinto says U.S. consumer still in relatively good shape

09:50 EDT Elliott 'hopes to engage' with remaining Southwest directors

09:49 EDT Kodiak Gas Services rises 5.4% - Kodiak Gas Services is up 5.4%, or $1.36 to $26.59.

09:48 EDT Boot Barn rises 11.6% - Boot Barn is up 11.6%, or $16.25 to $155.80.

09:47 EDT Elliott: Nominees the right people to steady Southwest board

09:47 EDT Elliott: Need for 'thoughtful' change at Southwest 'remains urgent' - Elliott Investment Management L.P. released a statement on behalf of Partner John Pike and Portfolio Manager Bobby Xu regarding Southwest Airlines Co. and the actions announced, including the resignation of seven directors: "We learned yesterday, which was made public today, that nearly half of Southwest's Board of Directors had decided to resign based on shareholder feedback. In our experience, this is unprecedented. We are pleased that the Board is beginning to recognize the degree of change that will be required at Southwest, and we hope to engage with the remaining directors to align on the further necessary changes. The need for thoughtful, deliberate change at Southwest remains urgent, and we believe the highly qualified nominees we have put forward are the right people to steady the Board and chart a new course for the airline."

09:46 EDT Xiao-I regains compliance with Nasdaq listing rules - Xiao-I Corporation announced that on September 9, 2024 it received a written notice from The Nasdaq Listing Qualifications Staff of the Nasdaq Stock Market LLC stating that the company regained compliance with the minimum bid price requirement, as set forth in Nasdaq Listing Rule 5450(a)(1) for continued listing on the Nasdaq Global Market. As previously disclosed, on July 11, 2024, Xiao-I was notified by Nasdaq that its American Depositary Share had failed to meet the $1.00 minimum closing bid price over a consecutive 30-business-day period, as required by Nasdaq Listing Rule 5450(a)(1). The company was given a compliance period to meet the requirement by maintaining a closing bid price of at least $1.00 for a minimum of 10 consecutive business days. As of September 9, 2024, Nasdaq has confirmed that Xiao-I's ADS has maintained a closing bid price of $1.00 or more for 10 consecutive business days, from August 23, 2024 to September 8, 2024.

09:40 EDT Borealis Foods Inc trading resumes

09:35 EDT Thunderbird acquires global medi, consumer product rights to BeddyByes - Thunderbird Entertainment Group announced that Thunderbird Distribution has acquired global media and consumer products rights to new preschool series BeddyByes. The CG-animated series is produced by Ireland's JAM Media and is an original production for BBC Children's and Education that will debut on CBeebies and BBC iPlayer in spring 2025. Additionally, Ireland's RTE is on-board as a co-producer and Nordic pubcasters DR, YLE and SVT have prebought the series.Thunderbird Distribution will be previewing BeddyByes to buyers at MIPCOM, taking place October 21 - 24 in Cannes, France.

09:31 EDT Campbell Soup: Impact of GLP-1s on business 'still somewhat to be seen'

09:30 EDT Campbell Soup says long-term algorithm requires soup to remain stable

09:29 EDT Sunrise New Energy regains compliance with Nasdaq minimum bid price rule - Sunrise New Energy has received a formal notification from the Nasdaq Capital Market, dated September 9, 2024, notifying the Company that it has regained compliance with the minimum bid price requirement as set forth under NASDAQ Listing Rule 5550(a)(2) for continued listing on Nasdaq. The Nasdaq staff made this determination of compliance after the closing bid price of the Company's common stock has been at $1.00 per share or greater for the last 10 consecutive business days from August 22, 2024 to September 6, 2024. Accordingly, the Company has regained compliance with Nasdaq Listing Rule 5550(a)(2) and the bid price deficiency matter is now closed.

09:25 EDT Lucid Group says midsize platform scheduled to start production in late 2026 - Lucid Group showcased the forthcoming Lucid Gravity SUV, its enabling technologies, and presented an independent third party analysis of the cost effectiveness of manufacturing these innovations at its Technology & Manufacturing Day, held today at the company's Arizona factory, the company announced. Additionally, Lucid announced that through August 31, 2024, the company has already delivered more cars in 2024 than in all of 2023. "Today demonstrates how the Lucid Gravity is set to be the best SUV ever, showcasing its revolutionary package and attributes only made possible with the technologies Lucid has pioneered. Our drive unit is one of several important enabling technologies, delivering next-level performance, collectively enabling a lower cost for our powertrain system than our competitors. Simply put, our vehicles go farther with less, unlocking significant cost and mass savings as we scale," said Peter Rawlinson, CEO and CTO at Lucid. The company added: "Lucid also announced today that the Lucid Gravity will be equipped with a NACS charging connector in 2025, allowing access to 15,000+ Superchargers. The Lucid Gravity is scheduled for start of production later this year. The technologies, innovations and learnings of Lucid Air have been incorporated into the upcoming Lucid Gravity, designed to be the world's most advanced electric SUV. Powered by the company's ultra-compact powertrain technology, Lucid Gravity is expected to deliver exhilarating performance while also offering an expansive, sophisticated interior with space for up to seven adults and their belongings. Today's event also offered a glimpse at one of the company's upcoming midsize vehicles. The new crossover will use the efficiency and cost advantages enabled by Lucid technology to deliver the same range as competitors while using a smaller battery. The midsize platform is scheduled to start production in late 2026 with a starting price under $50,000." Reference Link

09:24 EDT JFrog expands collaboration with GitHub - JFrog and GitHub unveiled new integrations at JFrog's annual user conference. This deepening collaboration provides developers with a consolidated view of project status and security posture to help address potential vulnerabilities discovered by the companies' respective Advanced Security offerings. Additionally, the companies announced a Copilot chat extension to quickly select software packages.

09:19 EDT Thumzup welcomes Helms Flowers to Adtech platform - Thumzup Media welcomes Helms Flowers as one of its newest advertising partners on its proprietary social media AdTech platform. Helms Flowers, a family-owned business deeply rooted in West Los Angeles, is dedicated to creating personal connections with every customer. Across their two locations, they offer a curated selection of flowers from around the globe, along with vibrant plants to brighten any space. Thumzup is excited to support Helms Flowers in expanding its reach and growing its customer base through our app. Now, Thumzup users have the unique opportunity to earn money by sharing their experiences and showcasing Helms Flowers' floral arrangements on the app.

09:18 EDT Vislink to debut DragonFly V, INCAM-GV transmitters at IBC 2024 - Vislink Technologies is set to showcase its solutions at IBC 2024, offering an exciting glimpse into the future of live production. Broadcast professionals can visit Vislink at Hall 1, Stand C52, to experience immersive product displays, live presentations, and real-time video demos designed to help them succeed in the rapidly evolving live broadcast landscape. Under the theme "Taking Live Video Content Further," IBC attendees will discover how Vislink's trailblazing solutions - spanning COFDM, 5G, AI, and cloud production - are pushing the boundaries of video capture and transmission. These technologies are poised to redefine live event production with industry-leading reliability, efficiency, and creative possibilities. Featured innovations will include: Miniaturized transmitters for PoV, drone, and body-worn applications; Hybrid IP/COFDM transmission solutions for robust, flexible workflows; Cloud-based remote production platforms for global collaboration; AI-powered systems for automated live sports and studio productions; Airborne downlink solutions for ENG and live event coverage. One of the most anticipated highlights at IBC 2024 is the European debut of Vislink's latest wireless transmitters - the DragonFly V and INCAM-GV. The DragonFly V, Vislink's smallest miniature HEVC HDR COFDM transmitter, is designed to deliver real-time, high-quality video from Point-of-View cameras, UAVs, and body-worn devices. This product offers broadcasters unprecedented flexibility in capturing dynamic, first-person perspectives for live events, while maintaining robust, high-definition video transmission.

09:14 EDT Tetra Tech awarded $39M USAID contract for gender equality - Tetra Tech announced that the U.S. Agency for International Development USAID has awarded the Company a $39.3M million, single-award contract to increase gender equality and women's economic empowerment opportunities in industries such as water, power, infrastructure, transportation, and information and communications technology worldwide. Through the USAID Engendering Industries program, our experts will use data-driven change management approaches to support companies and institutions to improve equality and strengthen business operations. Tetra Tech has supported USAID's Engendering Industries program since 2018, providing technical support to more than 68 organizations in 39 countries. "Tetra Tech has partnered with USAID to strengthen organizations to increase gender equality and enhance economic opportunities for women around the world for more than 40 years," said Dan Batrack, Tetra Tech Chairman and CEO.

09:13 EDT Sharecare, Georgia's SHBP announce collaboration, launch new OnMed CareStation - Georgia's State Health Benefit Plan, SHBP, in collaboration with digital health company Sharecare announced the launch of a new OnMed CareStation in the Sloppy Floyd Building across from the state Capitol. The OnMed CareStation is a tech-enabled hybrid-care delivery solution now available at no additional cost to all active state employees - including legislative employees and elected officials, and active state employees not covered under SHBP - as well as school system employees covered under an SHBP plan.

09:12 EDT IS&S gains FAA approval for digital engine-indicating & EICAS for FPDS - Innovative Solutions & Support or IS&S now offers a FAA certified digital Engine-Indicating and Crew-Alerting System, EICAS, Display System as an enhancement for its B757/B767 Flat Panel Display System, FPDS . This IS&S EICAS Upgrade simplifies the flight deck, resolves ongoing CRT obsolescence issues, reduces weight by an additional 40 pounds, improving fuel savings and power consumption, and is easily installed with minimum downtime due to its design approach. Installations have begun with launch customers.

09:11 EDT Apple expects one-time income tax charge of up to about $10B in Q4 - In a regulatory filing, Apple noted that on August 30, 2016, the European Commission announced its decision that Ireland granted state aid to Apple Inc. by providing tax opinions in 1991 and 2007 concerning the tax allocation of profits of the Irish branches of two subsidiaries of the company. The State Aid Decision ordered Ireland to calculate and recover additional taxes from the company for the period June 2003 through December 2014. Irish legislative changes, effective as of January 2015, eliminated the application of the tax opinions from that date forward. The company and Ireland appealed the State Aid Decision to the General Court of the Court of Justice of the European Union. On July 15, 2020, the General Court annulled the State Aid Decision. On September 25, 2020, the Commission appealed the General Court's decision to the European Court of Justice, or the "ECJ," and a hearing was held on May 23, 2023. On September 10, 2024, the ECJ announced that it had set aside the 2020 judgment of the General Court and confirmed the Commission's 2016 State Aid Decision. As a result, the company expects to record a one-time income tax charge in its fourth fiscal quarter ending September 28, 2024, of up to approximately $10B, which will increase the company's effective tax rate for the quarter. Reference Link

09:10 EDT WW appoints Honken as CCO, Picardi as CIO - WeightWatchers announced the appointments of Scott Honken as Chief Commercial Officer, CCO, and Phillip Picardi as Chief Impact Officer, CIO. The two will collaborate, alongside the existing leadership team to redefine community engagement across all stakeholders, including a continued focus on B2B constituents of employers, payers, and health plans and expanding access through WeightWatchers for Business. Honken joins the team from Calibrate, where he served as Chief Commercial Officer. Prior to joining WeightWatchers, Picardi served as Chief Strategy Officer at the Los Angeles LGBT Center.

09:08 EDT Arteris interconnected IP selected by VeriSilicon - Arteris announced that VeriSilicon, a one-stop custom silicon service and semiconductor IP licensing service provider, has licensed Arteris FlexNoC 5 interconnect IP. This physically aware interconnect IP offers enhanced cost and design efficiency, scalability and reliability for VeriSilicon's high-performance data center SoC solutions.

09:08 EDT Intapp partners with Gain.pro to empower mutual clients - Intapp announced that it has partnered with private market intelligence provider Gain.pro to enhance the dealmaking process. The new partnership allows Intapp DealCloud clients with a Gain.pro subscription to access Gain.pro's private market intelligence directly from the DealCloud platform. Enabling professionals to view DealCloud's centralized, proprietary intelligence alongside Gain.pro's global company intelligence creates a single source of truth for all relevant acquisition opportunities.

09:07 EDT Genasys announces multi-year contract with State of Oregon's OREM - Genasys announced a multi-year contract with the State of Oregon's Office of Resilience and Emergency Management, OREM, for Genasys EVAC, EVAC, emergency response planning and evacuation management software. The new contract provides EVAC advanced evacuation software to all of Oregon's 36 counties and nine Tribes to manage emergency evacuations more effectively across the state.

09:06 EDT Firefly Neuroscience enters partnership with Zeto - Firefly Neuroscience announced a strategic partnership with Zeto. Under the agreement, Firefly will act as a non-exclusive distributor of Zeto's FDA-cleared EEG headset devices, cloud platform and services, expanding Firefly's accessibility to healthcare providers and institutions. This collaboration will also integrate Firefly's proprietary Brain Network Analytics technology with Zeto's advanced EEG platform, which is currently being used in more than 200 hospitals and neurology offices across the country.

09:05 EDT Fluence Energy initiates U.S. manufacturing of battery modules - Fluence Energy announced the start of domestic production of its battery modules at a facility in Utah. These battery modules will incorporate battery cells manufactured in Tennessee. This marks a key step in Fluence's strategy to scale module production with domestically sourced components to meet increasing domestic demand for utility-scale energy storage.

09:04 EDT NeuroOne Medical announces case completed with OneRF Ablation System - NeuroOne Medical Technologies announced that the OneRF Ablation System was recently used in a breakthrough patient procedure at the University Hospitals in Cleveland to successfully complete forty four ablations in one patient. In mid-July, led by Dr. Michael Staudt, Neurosurgeon, a patient benefitted from forty-four ablations through six different implanted OneRF electrodes over a two-day period. These ablations were performed based on guidance provided by the sEEG recordings that confirmed the focal epileptic zone in the patient.

09:03 EDT Jakks Pacific's Disguise, Innersloth announce multi-year agreement - Disguise, a division of JAKKS Pacific, announced a new agreement with Innersloth, for global costume rights for Among Us, via Dual Wield Studio, the indie merchandising company contracted to manage Innersloth's consumer products program. Commencing in 2024, with first product planned to launch Fall 2025, Disguise takes on worldwide rights to design, market, manufacture, and distribute costumes and costume accessories. Disguise looks forward to working with Innersloth to bring this game to life with costumes and accessories reflective of the game's unique characters and designs.

09:02 EDT Philips, WSO publish policy paper on stroke care - Royal Philips and the World Stroke Organization, WSO, published a policy paper calling for a revolution in stroke care to make a real difference to the lives of millions and bring significant economic benefits worldwide. The joint WSO-Philips policy paper, which is accompanied by an editorial in The Lancet Neurology and aligned with recent World Health Organization guidance, proposes six policy interventions to improve outcomes, and reduce direct costs with substantial potential savings, releasing essential resources for other priorities across struggling healthcare systems.

09:02 EDT Scholastic names Stacey Jaffe as Chief Digital Officer - Scholastic announced that Stacey Jaffe has been named Scholastic's Chief Digital Officer, effective immediately. Jaffe will drive Scholastic's data initiatives and digital practice with the core approach of bringing customer insights to life as strategies and digital solutions that directly serve customers' needs. A new role for the company and based in New York, the Chief Digital Officer will elevate the organization's digital expression, enhance customer experiences, and leverage data to inform and optimize all aspects of the business. Jaffe joined Scholastic in 2018 and her proven track record has earned her expanded responsibilities, having most recently served as Senior Vice President of Data & Digital Strategy, overseeing Data & Analytics and Digital Marketing, in addition to eCommerce, Product, and UX/UI.

08:56 EDT BrookBridge Private Wealth joins LPL Private Wealth Management - LPL Financial announced that private client advisor John Duane and portfolio manager Gregory Giantsos have joined LPL Financial's high-net-worth-focused employee affiliation model, LPL Private Wealth Management, to launch BrookBridge Private Wealth based in Long Island, New York. The team reported having served approximately $700 million in advisory, brokerage and retirement plan assets and joins LPL from Bank of America Private Bank.

08:52 EDT Vision Marine Technologies partners with ePropulsion - Vision Marine Technologies announces its strategic alliance with ePropulsion to empower the Phantom Boat, crafted from innovative plastic rotomolding technology. Following its debut at the Miami International Boat Show, the Phantom is set to showcase a customized electric ePropulsion system. In this partnership, the Phantom will be available through select ePropulsion dealers, both on request and by recommendation across its dealer network.

08:49 EDT Zapp completes homologation in Thailand for sales of i300 - Zapp Electric Vehicles Group announced its operating subsidiaries have completed homologation with the Department of Land Transportation in Thailand to sell its i300 electric urban motorcycle in the country. First customer deliveries are expected in the months ahead.

08:47 EDT Brightline Interactive enters CRADA with U.S. Army DEVCOM - Brightline Interactive announced the signing of a Cooperative Research and Development Agreement with the United States Army Combat Capabilities Development Command, Command, Control, Communication, Computers, Cyber, Intelligence, Surveillance and Reconnaissance Center. The CRADA is for Brightline to develop, assess and improve workflows to create and augment synthetic imagery for use in training and assessing artificial intelligence and machine learning algorithms. Brightline provides synthetic data generation toolsets and workflows that deliver high-quality data for the creation, refinement, and evaluation of AI/ML algorithms. These solutions are designed to augment traditional training datasets to accelerate and enhance the training of AI / ML algorithms for various use cases across industries, including applications in spatial computing.

08:40 EDT Maxeon Solar solar panels selected by Cypress Creek for power plant installation - Maxeon Solar confirmed that Cypress Creek Renewables, a solar and storage developer and independent power producer, has chosen Maxeon solar panels for installation at key power plant projects in the U.S. Commercial operation for Cypress Creek's largest hybrid facility, Zier, in Brackettville, Texas, commenced in May. The Zier Hybrid Solar Site can generate enough energy to power over 41,000 homes in Texas each year. The site is designed to set a new standard for renewable, utility-scale power projects in the U.S., and is indicative of Cypress Creek's leadership in developing transformational energy infrastructure. The collaboration between Maxeon and Cypress Creek Renewables has resulted in Maxeon providing modules for additional Cypress Creek projects across the country including in New York and Washington states.

08:38 EDT Nano Nuclear Energy joins Russell 3000 Index - NANO Nuclear Energy announced that, effective September 23, 2024, it has been selected as one of only 12 companies for inclusion into the broad-market Russell 3000 Index based on the Index's quarterly review and subsequent addition of companies which have recently undertaken initial public offerings.

08:37 EDT VERSES names Michael Blum as chair, Jay Samit as head, global partnerships - VERSES AI announces that Jay Samit is relinquishing his position as Chairman of the Board in order to take a position with the Company while concurrently appointing Michael Blum into the vacated Chairman position. Mr. Samit's new role at VERSES will be Head of Global Partnerships, focusing on deploying Genius to systems integrators, channel partners, and business process outsource firms and strategic investors. Michael Blum is a co-founder and president of Hedgeye Risk Management, a premier independent investment research house whose customer base advises more than $10 trillion in assets and spans close to 100 countries.

08:37 EDT Repay and Otelier DigiPay integration 'revolutionizes; hotel vendor payment - Repay Holdings announced an embedded integration with Otelier, a hospitality software and performance optimization platform, to create a one-stop shop for their clients to more efficiently execute vendor payments from the same platform they process and manage invoices, DigiPay. REPAY's vendor payment automation expands Otelier's DigiPay capabilities to further optimize accounts payable AP for hotels by digitizing the outbound payment process. Otelier DigiPay automates back-office AP operations, eliminating time spent processing invoices and cutting checks to pay vendors while improving financial management. "Hoteliers are spending too much time and utilizing too many resources each week paying vendors managing the payment process and physically cutting checks," said Otelier CEO Vic Chynoweth. "We are thrilled to integrate with REPAY to digitize the vendor payment process within DigiPay for faster and more secure payments, allowing our clients to get back to providing exceptional hospitality."

08:36 EDT Kopin receives additional $2M follow-on production order - Kopin (KOPN) announced that it has been awarded a $2M follow-on production order for its high-brightness active-matrix liquid crystal display, or AMLCD. This will come from Collins Aerospace, an RTX (RTX) business, in support of the F-35 Lightning II Helmet Mounted Display System.

08:36 EDT NetSol Technologies signs expansion agreement with automaker - NETSOL Technologies has signed a new agreement with a major automaker and longstanding customer to support their operations throughout China. This agreement brings the total value of the contract to over $30 million over five years and is expected to contribute to consistent revenue growth in fiscal 2025 and beyond. Najeeb Ghauri, Founder and Chief Executive Officer of NETSOL Technologies, Inc., commented, "We're pleased to expand our agreement with a longstanding client and major automaker to support their operations in China. This agreement represents a new stage of growth for our business as we begin to broaden our scope in the Asia Pacific market, where we already have a very strong and established presence." Mr. Ghauri added, "We anticipate this new contract will contribute to double digit revenue growth in fiscal 2025."

08:35 EDT Ally Financial committed to 15% ROTC target

08:34 EDT ClearSign receives burner order from Exotherm Corporation of Houston - ClearSign Technologies announces that it has received a burner order from Exotherm Corporation of Houston, Texas for installation in a heater in Oklahoma for use by a power generation company. This order is for a burner to be installed into a bath heater to heat natural gas for dewpoint control. The burner will be installed in a process heater in Oklahoma for a customer in the power generation industry and is expected to be shipped by the end of the fourth quarter of 2024.

08:34 EDT Granite awarded $65M contract by Utah Department of Transportation - Granite has been awarded an approximately $65M contract by the Utah Department of Transportation, UDOT, to commence Phase 2 of the SR-30 Improvement Project in Logan, Utah. Project funding will come from UDOT and Federal funds and was included in Granite's second-quarter CAP. "This project is a strategic win for Granite as it strengthens our ongoing relationship with UDOT," said Jason Klaumann, Granite Vice President of Regional Operations. "The successful completion of Phase 1 in 2023 positioned us as the low bidder for Phase 2, ensuring our structures, pipe, and earthwork crews will remain engaged through late 2024 and most of the 2025 season. Our team is excited to continue working with UDOT Region 1 and deliver these critical improvements for the Logan community." The SR-30 corridor accommodates a diverse traffic mix, including the traveling public, farm equipment, horses, cyclists, and runners. The improvements will include a 12-foot-wide multi-use path with a cast-in-place concrete box underpass, wider shoulders, turning lanes, and advanced warning signs for railroad crossings. Also, the project will feature two new precast box culverts and widening one concrete girder bridge to accommodate the Logan River / Cutler Marsh area. .

08:34 EDT Sabre enters strategic partnership with Air Serbia - Sabre announced a strategic partnership with Air Serbia, Serbia's national carrier. This agreement establishes Sabre as Air Serbia's NDC - New Distribution Capability - IT provider, empowering the airline to deliver a more personalized travel experience and unlock new revenue opportunities. This enables Air Serbia to not only create and manage their NDC content but also make it seamlessly available through third-party channels. Sabre's NDC airline IT solutions are a building block of SabreMosaic, an intelligent, modular and open technology platform powered by Google's AI capabilities. Air Serbia already utilizes SabreSonic, a comprehensive passenger service system. In addition, the airline has deployed Sabre's Pricing and Revenue Optimization suite. Sabre Air Price IQ, a solution powered by AI, helps Air Serbia to optimize the pricing of offers in real time.

08:33 EDT Ally Financial: Credit challenges have intensified over the course of quarter - Comments taken from the Barclays Global Financial Services Conference.

08:32 EDT Lithia & Driveway expands retail network in Florida - Lithia & Driveway announced it has continued to expand its footprint in the highly profitable U.S. Southeast Region with the purchase of three stores from the Duval Motor Company in Jacksonville and Gainesville, Florida. Combined, these newly acquired Acura, Honda, and Subaru stores are projected to generate over $200M in annualized revenue.

08:32 EDT Atossa Therapeutics announces support of final rule from FDA - Atossa Therapeutics announced its support of the U.S. Food and Drug Administration, FDA, for issuing a final rule to update the mammography regulations issued under the Mammography Quality Standards Act of 1992, MQSA, which becomes effective today. Among the updates, the final rule requires mammography facilities to provide patients with an assessment of breast density in patient friendly terms. Atossa is a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer.

08:28 EDT GameSquare announces over $14M of new contracts in August - GameSquare Holdings closed over $14 million of new contracts in August 2024, representing a record month of new business development for GameSquare. Contract wins were to new and existing customers and are expected to contribute to revenue in 2024 and 2025. New contracts in August were across GameSquare's operating segments and reflect the Company's strategic focus on developing multi-year and higher-margin revenue opportunities. "After growing pro-forma revenue by 22% in the 2024 second quarter, momentum across our business has remained strong and we ended August 2024 with record new monthly contract wins. I believe these positive trends reflect the growing success of the next-generation media platform we have created, strong execution across our global teams, and expanding demand for our services," stated Justin Kenna, GameSquare's CEO. "The amount of multi-year revenue is especially encouraging as more brands are pursuing long-term relationships. This reflects strategies underway to develop a more predictable backlog of revenue. The mix of contracts in August was primarily focused on higher-margin areas of our business, including our Agency, IP and Teams segments. As a result, we believe we are well positioned for gross margin to expand on a sequential and year-over-year basis in the second half of 2024."

08:27 EDT ResMed presents studies on increase COPD health, economic burden by 2050 - ResMed presented 18 supported studies at ERS 2024, including research that projects vaping, smoking, and air pollution will substantially increase the economic and public health burden of COPD in Western Europe. Annual direct and indirect costs are projected to reach over EUR 170 billion by 2050, costing Western European economies over EUR 4.9 trillion cumulatively by 2050. Vaping alone is forecast to require an additional EUR 3.78 billion annually to support its impact on medical care and societal costs.

08:24 EDT Brainsway announces Israel Ministry of Defense cleared Deep TMS - BrainsWay announced that the Israel Ministry of Defense's Rehabilitation Department has granted approval for the reimbursement of Deep Transcranial Magnetic Stimulation system therapy for qualifying patients with post-traumatic stress disorder, PTSD, at Israeli public hospitals. BrainsWay will continue its work toward expanding the available reimbursement for PTSD within the country, with the goal of potentially including more Israeli medical centers, as well as adding private clinic settings.

08:23 EDT Incannex announces strategic financing up to $60M - Incannex Healthcare has entered into an agreement to issue up to $10 million in secured convertible notes to Arena Investors, and its affiliates. Under the terms of the agreements, Incannex will also secure a $50 million equity line of credit with Arena affiliate, Arena Business Solutions, which the Company does not anticipate drawing upon at closing. Incannex intends to use the proceeds from the strategic financing to support the ongoing clinical trials of the Company's proprietary drug candidates, and for working capital and other general corporate purposes. Incannex will determine allocation of funds according to the company's strategic needs. The initial funding tranche of $3.33 million will be received by Incannex upon closing. The Company may elect to access to two subsequent tranches up to a total of $6.67 million. All three tranches will include a 10% original issue discount and are subject to customary closing conditions. Incannex has also entered an ELOC with Arena with ABS. Under the terms of the agreement the Company will have the right, but not the obligation, to issue and sell to Arena up to $50 million of shares of common stock over a period of 36 months, subject to customary conditions.

08:22 EDT Belite Bio announces first patient dosed in Phase 2/3 DRAGON II trial - Belite Bio announced that the first patient has been dosed at the Tokyo Medical Center in the Phase 2/3 portion of its DRAGON II clinical trial evaluating Tinlarebant for the treatment of STGD1. Tinlarebant is a novel oral therapy designed to reduce the accumulation of vitamin A based toxins that cause retinal disease, and this Phase 2/3 study will evaluate the efficacy, safety, and tolerability of Tinlarebant in approximately 60 adolescent STGD1 subjects across the U.S., U.K., and Japan.

08:21 EDT LifeVantage announces in vitro results for new GLP-1 system - LifeVantage announces the results of an in vitro study that investigated the combined effects of its upcoming two-product system on activating GLP-1 production. The study, which began in May and concluded at the end of June 2024, was conducted on specialized L-cells found in the colon, where the body naturally produces GLP-1, a critical hormone in weight management and glucose regulation. Key genes involved in the production and regulation of GLP-1 were thoroughly examined, including: GCG;PCSK1; GLP1R; DPP-4. Results from the in vitro study revealed not only a significant increase in GLP-1 production but also a synergistic activation of the key genes responsible for its synthesis and regulation. Notably, there was a downregulation of DPP-4 gene expression, which allows for more GLP-1 to be available to work within the body.

08:19 EDT Pliant Therapeutics presents data from its Bexotegrast program - Pliant Therapeutics announced its presentations at the European Respiratory Society, ERS, International Congress 2024 taking place in Vienna, Austria September 7 - 11, 2024. In a late-breaker oral presentation, Sydney B. Montesi presented results from the first interventional Phase 2, single-center, randomized, double-blind, placebo-controlled trial evaluating type 1 collagen deposition by positron emission tomography imaging in the lungs of participants with IPF. Following 12 weeks of treatment, bexotegrast demonstrated a reduction in type 1 collagen in contrast to an increase on placebo, supporting bexotegrast's antifibrotic effects and suggesting favorable lung remodeling. In an oral presentation, Gregory Cosgrove, M.D. FCCP, Vice President of Clinical Development at Pliant Therapeutics presented an integrated safety summary of bexotegrast from the INTEGRIS Phase 2a trials in IPF and primary sclerosing cholangitis. In a late-breaker oral presentation, Johanna Schaub, Ph.D., Principal Scientist II, Translational Sciences at Pliant Therapeutics, presented a study assessing the antifibrotic effects of bexotegrast, a dual alphavbeta6/alphavbeta1 integrin inhibitor, in precision cut-lung slices from patients with progressive fibrosing interstitial lung diseases other than IPF. In a poster presentation, Martin Decaris, Ph.D., Senior Director, Translational Sciences at Pliant Therapeutics, presented results from a post-hoc proteomic analysis of plasma samples from the INTEGRIS-IPF Phase 2a clinical trial of bexotegrast in patients with IPF. Results showed that plasma levels of several previously identified biomarkers of ILD progression, including integrin beta-6, were reduced in participants receiving bexotegrast at the 320 mg dose versus placebo.

08:18 EDT Kornit Digital board authorizes $100M share repurchase program - Kornit Digital announced that its Board of Directors has authorized a program to repurchase up to $100 million of the Company's ordinary shares as part of its capital allocation strategy. This repurchase program, in addition to the $65 million of aggregate share repurchases executed by the Company since 2023, reflects the Board's confidence in the Company's strategy and long-term potential, while demonstrating ongoing commitment to driving value creation for its shareholders.

08:16 EDT Kornit Digital partners with Custom Ink for custom apparel production - Kornit Digital announced that Custom Ink has chosen Kornit technology to bolster its production capabilities. By transitioning a significant share of its printing from screen to digital direct-to-garment production, Custom Ink is supporting the growth of its business while accelerating its digital transition through a sustainable printing technology and providing customers with the highest-quality custom apparel, gear, and swag.

08:14 EDT Oxford Lane estimates NAV per share $4.76-$4.86 as of August 31 - Management's unaudited estimate of the range of the NAV per share of our common stock as of August 31, 2024, is between $4.76 and $4.86. This estimate is not a comprehensive statement of our financial condition or results for the month ended August 31, 2024. This estimate did not undergo the Company's typical quarter-end financial closing procedures and was not approved by the Company's board of directors. We advise you that our NAV per share for the quarter ending September 30, 2024 may differ materially from this estimate, which is given only as of August 31, 2024. As of August 31, 2024, the Company had approximately 320.4 million shares of common stock issued and outstanding.

08:13 EDT Lexicon announces data from STOA-INS CGM Phase 3 trial - Lexicon Pharmaceuticals announced that data from the SOTA-INS CGM Phase 3 randomized clinical trial demonstrated that once-daily dosing of sotagliflozin 400 mg improved time-in-range, TIR, and several continuous glucose monitoring, CGM, parameters, including glucose variability, in insulin-treated type 2 diabetes, T2D, patients. Researchers also observed positive trends with the once-daily dose of 200 mg. Study findings will be presented September 12th at the 60th Annual Meeting of the European Association for the Study of Diabetes, EASD, in Madrid, Spain and online. The objective of the SOTA-INS CGM study was to evaluate the effect of sotagliflozin on TIR as assessed by CGM in people with T2D. The primary sub-study endpoint was mean change in percentage of time spent within TIR over 24 hours for sotagliflozin 400 mg versus placebo.

08:10 EDT electroCore announces the AFRL presented new results on TAC-STIM - electroCore announced that the Air Force Research Laboratories, AFRL, presented new results supporting the ability of electroCore's TAC-STIM, nVNS, to accelerate pilot training. The presentation titled "Accelerating Sensorimotor Learning in A Flight Training Simulation Using Transcutaneous Vagus Nerve Stimulation" was presented on Tuesday, August 26th at the 2024 Medical Health System Research Symposium in Orlando, FL. by Dr. Justin Estepp of the Human Effectiveness Directorate of the United States Air Force Research Laboratories. The presentation was based on a study conducted at AFRL's facilities at Wright-Patterson Air Force Base in Dayton, Ohio. The study was funded by the Department of the Air Force through AFRL.

08:08 EDT CareCloud obtained 99% of the minimum required 'FOR' votes - CareCloud announced that while proxy vote solicitation continues, it has already obtained approximately 99% of the minimum required "FOR" votes by proxy in support of the amendment to the Company's Certificate of Designations, Preferences and Rights of its Series A Preferred Stock. If the Preferred Stock Proposal is ultimately approved, holders of Series A Preferred Stock would receive similar change of control protections to those afforded to holders of the Company's Series B 8.75% Cumulative Redeemable Perpetual Preferred Stock. Also, the dividend of Series A Preferred Stock would mirror that of the Series B Preferred Stock, and the Company would, going forward, have the right to exchange the shares of Series A Preferred Stock for common stock at the liquidation preference value of $25/share, plus accrued and unpaid dividends.

08:08 EDT Genesis to get $35M in collaboration with Gilead to develop novel therapies - Gilead Sciences and Genesis Therapeutics announced that the companies have entered into a strategic collaboration to discover and develop novel, small molecule therapies across multiple targets. Genesis is pioneering generative and predictive artificial intelligence AI technologies to help create therapeutics for challenging targets. This collaboration will deploy Genesis' field-leading AI platform, GEMS or Genesis Exploration of Molecular Space,, to assist in generating and optimizing molecules for targets selected by Gilead. The companies will collaborate closely on preclinical research activities and Gilead will have exclusive rights for potential clinical development and commercialization of collaboration compounds...Under the terms of the agreement, Genesis will receive an upfront cash payment of $35M across three targets and Gilead will have an option to nominate additional targets for a predetermined per-target fee. Across programs, Genesis is eligible to receive additional preclinical, development, regulatory, and commercial milestone payments. Genesis is also eligible to receive tiered royalties on net sales should Gilead successfully commercialize products from the collaboration. Gilead does not exclude acquired IPR&D expenses from its non-GAAP financial measures. This transaction with Genesis is expected to reduce Gilead's GAAP and non-GAAP 2024 EPS by approximately 2c.

08:07 EDT Enphase Energy announces initial shipments of IQ8HC Microinverters - Enphase Energy announced initial shipments of IQ8HC Microinverters supplied from manufacturing facilities in the United States with higher domestic content than previous models. The microinverters have SKUs with a "DOM" suffix, indicating the increased amount of domestic content.

08:06 EDT Satellogic selected for NASA Commercial SmallSat Data Acquisition Program - Satellogic announced its selection as one of eight recipients of NASA's Commercial SmallSat Data Acquisition Program, or CSDA, On-Ramp1 Multiple Award contract, with a maximum cumulative value of $476M for all award winners. This award, announced on September 6, highlights Satellogic's commitment to delivering high-quality Earth observation data to advance scientific research and enhance life on Earth. Under the CSDA On-Ramp1, Satellogic will provide NASA with high-resolution multispectral imagery under a multiple-award contract in effect until November 15, 2028. The program aims to offer NASA a cost-effective solution for augmenting or complementing the Earth observation data gathered by the agency, other U.S. government entities, and international agencies. This data will be pivotal in efforts to understand and mitigate the effects of climate change, monitor environmental trends, and improve various applications that benefit humanity.

08:04 EDT Wells Fargo sees more stock buybacks in 2H, but at slower pace than 1H

08:03 EDT Hess Midstream LP signs accretive $100M sponsor unit repurchase - Hess Midstream LP announced the execution of a definitive agreement providing for the repurchase of approximately $100M of Class B units by its subsidiary, Hess Midstream Operations LP, from affiliates of Hess Corporation and Global Infrastructure Partners, Hess Midstream's sponsors. The terms of the proposed unit repurchase transaction were unanimously approved by the board of directors of Hess Midstream's general partner, based on the unanimous approval and recommendation of its conflicts committee composed solely of independent directors. Pursuant to the terms of the repurchase agreement, the repurchased units will be cancelled upon the closing of the unit repurchase transaction, which is expected to result in increased distributable cash flow per Class A share providing capacity for incremental distribution growth above Hess Midstream's annual distribution target of at least 5% through 2026, consistent with Hess Midstream's return of capital framework.

08:02 EDT VCI Global provides updates on AI business, capital raising - VCI Global announced its planning related to the reorganization of its AI business, capital raising, and the forthcoming share repurchase program. AI Business: VCIG has initiated a strategic reorganization of its AI operations under the newly formed subsidiary, VC AI Limited. The AI business has been restructured into four pivotal business segments: GPU servers - VCIG will launch its proprietary brand of GPU servers for the AI industry and commence operation in October 2024. GPU cloud computing - The Company will debut its AI data center business by launching AI Computing Center in Malaysia, with GPU cloud computing services scheduled to commence in the second quarter of 2025, as previously announced. AI and large language model solutions - VCIG has also made notable advancements in its AI and LLM solutions capabilities, which are now actively offered to clients. Cybersecurity - The Company continues to enhance its cybersecurity solutions, focusing on wider and more sophisticated offerings within the AI space. Capital Raising: The capital-raising round for the AI business has been successfully concluded, and the initial funding needed for this business has been secured. The Company is now poised to implement its growth strategy.

07:57 EDT Wells Fargo CFO expects card charge-off rate to come down in Q3

07:56 EDT Passage Bio appoints Tom Kassberg to board of directors - Passage Bio, Inc. (PASG) announced the appointment of Tom Kassberg to the Board of Directors and his appointment to the Audit Committee. Mr. Kassberg is currently Chief Business Officer and Executive Vice President at Ultragenyx (RARE).

07:55 EDT BriaCell announces feedback from pre-IND meeting with FDA for Bria-PROS+ - BriaCell Therapeutics has received feedback from its Pre-IND meeting with the U.S. Food and Drug Administration, which is a step forward to opening an IND to conduct a Phase 1/2 study of its personalized off-the-shelf immunotherapy, Bria-PROS+, in advanced prostate cancer. As a result of the Pre-IND meeting, FDA waived the animal toxicology and animal pharmacokinetic studies requirement for opening the IND, greatly simplifying the development pathway for Bria-PROS+. Other areas of discussion included BriaCell's plan to initiate the Phase 1/2 study pending completion of standard manufacturing and testing requirements. These interactions also inform the further development of the proprietary Bria-OTS+ platform as the company pursues the development of Bria-BRES+, Bria-LUNG+ and Bria-MEL+, for breast cancer, lung cancer and melanoma, respectively. BriaCell is currently evaluating its personalized immunotherapy Bria-BRES in a phase 1/2a study in metastatic breast cancer.

07:47 EDT Wells Fargo CFO says overall deposits performing well

07:47 EDT Altimmune presents results of Phase 2 MRI-based body composition sub-study - Altimmune presented data from its Phase 2, MRI-based body composition sub-study of pemvidutide in subjects with overweight and obesity at the 60th Annual Meeting of the European Association for the Study of Diabetes in Madrid, Spain. Pemvidutide is a novel, investigational, peptide-based GLP-1/glucagon dual receptor agonist in development for the treatment of obesity and metabolic dysfunction-associated steatohepatitis. In an MRI sub-study of 67 subjects from the Phase 2 MOMENTUM obesity trial, 50 of whom were treated with pemvidutide for 48 weeks, the lean loss ratio, defined as the change in lean mass compared to the change in total mass, was 21.9%. Lean mass preservation was greater in subjects aged 60 years and older, in whom the lean loss ratio was only 19.9%. In addition to lean mass preservation, there was a preferential reduction of VAT, the adipose tissue associated with cardiovascular risk. At the 2.4mg dose of pemvidutide, VAT was reduced by 25.6% at Week 48 compared to a 20.1% loss in subcutaneous adipose tissue. "Preservation of lean mass may reduce risk of falls and fractures, development of co-morbidities, and rates of all-cause mortality, particularly in individuals over the age of 60," said Scott Harris, M.D., Chief Medical Officer of Altimmune. "Given the breadth and diversity of the obesity patient population, there has been growing attention given to the quality of weight loss. Our data demonstrates pemvidutide's class-leading lean mass preservation, superior to that reported historically with diet and exercise. The robust reductions in VAT would also be expected to be associated with a lower risk of cardiovascular disease."

07:43 EDT Wells Fargo CFO on wealth adviser attrition: 'The tide has turned'

07:42 EDT Opthea to have presence at 24th EURETINA Congress - Opthea announced scientific presentations and a non-CME educational lunch symposium highlighting sozinibercept's potential to become the first therapy in 20 years to improve visual outcomes in wet AMD patients at the European Society of Retina Specialists Annual Conference -- EURETINA Innovation Spotlight, September 18, 2024, and the 24th EURETINA Congress, September 19-22, 2024, being held at the CCIB in Barcelona, Spain. "We are excited to connect with retina experts from around the world at EURETINA," said Frederic Guerard, PharmD, Chief Executive Officer of Opthea. "Presentations by retina thought leaders featuring sozinibercept's mechanism of action, the design of our ongoing Phase 3 trials, as well as further insights into our previously presented data on superior visual gains in wet AMD patients provide an opportunity to highlight sozinibercept's potential to deliver superior efficacy beyond current standard-of-care anti-VEGF-A treatments." With the completion of patient enrollment in Opthea's Phase 3 pivotal program evaluating the superiority of sozinibercept combination therapy in wet AMD, the Company is planning to announce topline data for COAST in early Q2 CY2025 and for ShORe in mid-year CY 2025.

07:40 EDT Saputo names Frank Guido as COO, Leanne Cutts as CCO - Saputo announced several leadership appointments that will support Carl Colizza who assumed the role of President and CEO on August 9, 2024. These appointments are effective immediately. Frank Guido has been appointed to the role of COO, Saputo Inc. In his new position, he will be overseeing North America, Europe and International operations and will play a key role in the Company's continuous efforts to drive growth and operational results within the organization. All divisional President and COOs will report to Mr. Guido. Mr. Guido most recently served as President and COO, Dairy Division. He will continue to report to Mr. Colizza. Leanne Cutts assumes the newly created position of Chief Commercial Officer, Saputo Inc. Ms. Cutts will be responsible for driving commercial strategy, sales development in global markets and channels, and overseeing marketing, brand management, and market insights functions for all divisions. She joined Saputo in 2021 and since then has served as President and COO. Dominick Bombino has been appointed to the role of President and COO, Dairy Division. He has been with Saputo for more than 25 years and has held diverse roles of increasing responsibility in both operational and commercial leadership in the US and Canada. Most recently, Mr. Bombino served as Senior Vice President, Sales, Dairy Division. Steve Douglas has been appointed to the role of President and COO, Dairy Division. He has been with Saputo for more than 30 years and most recently served as Senior Vice President, Operations and Supply Chain, Dairy Division, where he was responsible for all manufacturing, converting, and optimization efforts and has played an instrumental role in streamlining the Company's supply chain and improving efficiencies. Tom Atherton has announced his intention to leave Saputo to pursue other opportunities. He will remain with Saputo until the end of the calendar year to support Mr. Douglas during the transition. Mr. Atherton has been President and COO, Dairy Division.

07:38 EDT Wells Fargo has 'a couple more' card products 'in the hopper,' says CFO

07:36 EDT Marimed's Bubby's Baked introduces limited-edition Pumpkin Bread Bites - Bubby's Baked has officially launched a new limited-edition batch of mini muffins for autumn: Pumpkin Bread Bites. Bubby's Baked is a brand developed and distributed by multi-state cannabis operator, MariMed. All Bubby's Baked mini muffins are baked fresh with real, simple ingredients and no artificial ingredients or preservatives. Infused with a precise, full-spectrum dose of high-quality cannabis, they are now available for both adult-use and medical cannabis customers at MariMed dispensaries and other select cannabis retailers in Massachusetts. They will be available in Maryland, Illinois, and Delaware soon.

07:35 EDT TC Energy announces equity interest purchase agreement update - TC Energy is providing an update on its previously announced equity interest purchase transaction with an Indigenous-owned investment partnership, which was formed to acquire a minority equity interest in the NGTL System and the Foothills Pipeline assets. The previously announced equity interest purchase transaction with the Purchaser has been delayed due to an identified transaction structuring issue within the NGTL partnership. The Company is focused on developing a transaction that delivers meaningful distributions to Indigenous Communities while upholding the fundamental value of the NGTL System and the Foothills Pipeline assets. The Company acknowledges the effort its many partners have given to this transaction to date and will provide material updates as they become available.

07:34 EDT Electra Battery Materials provides update on granting of DSUs - The Company announces that in accordance with its Long-Term Incentive Plan approved by shareholders at its August 13, 2024 annual general meeting, it has granted an aggregate of C$96,250 in deferred share units in connection with Directors remuneration, which is issued in lieu of cash compensation otherwise payable. DSUs vest after twelve months but may not be exercised until a Director ceases to serve the Company. DSU grants ensure alignment of interests with the Company's shareholders.

07:33 EDT Electra Battery Materials announces $20M strategic investment proposal - Electra Battery Materials provided an update on its financing strategy for North America's first battery grade cobalt refinery, announcing that it has received a non-binding term sheet for a $20 million prepayment facility from an arms-length strategic player in the battery materials sector. Several other financing discussions have been advancing alongside this proposal to raise the $60 million for project completion plus amounts for working capital and operations during the construction and commissioning phases. The strategic investment announced today is equal to the $20 million award Electra received from the U.S. Department of Defense pursuant to Title III of the Defense Production Act last month. More than 90% of battery grade cobalt is produced by Chinese companies today, and none in North America. Electra owns a low carbon, permitted hydrometallurgical refining complex north of Toronto that historically produced nickel and cobalt. The facility is being expanded and modified to provide North America battery makers with a domestic source of cobalt sulfate for lithium-ion batteries. The refining complex was also the location of a year-long battery recycling demonstration plant in 2023. The Company estimates that an additional $60 million in capital costs are required to complete the $250 million cobalt facility. If consummated, the investment would be comprised of an immediate investment of $10 million and a follow-on investment of $10 million during the refinery's commissioning phase. As partial compensation, Electra would provide marketing rights for a portion of future production until the facility is repaid. This investment is intended to provide working capital and general and administrative coverage over and above the remaining construction costs. The transaction is subject to conditions precedent, including developments in parallel financing discussions that are well advanced. Electra continues to make steady progress in securing other non-dilutive sources of financing, including government programs, to complete the construction and commissioning of the refinery. Once fully commissioned, Electra's facility could produce up to 6,500 tonnes of cobalt per year, which could support the production of over 1 million EVs annually. LG Energy Solution intends to purchase up to 80% of capacity over the first five years of operation. At this time, the strategic investment term sheet is a non-binding proposal, and a confirmation of the proposal was received on September 3, 2024. The progression to binding documentation is subject to finalization of diligence and negotiation of customary closing materials and is progressing in line with all parties' agreed timeline. Discussions with other strategic partners are expected to continue until today's proposal becomes binding. Electra's near-term priority is to recommission and expand its low carbon Canadian cobalt refinery, which has already been derisked through the delivery of long lead equipment and the operation of a black mass demonstration plant in the legacy refinery. The Company's longer-term vision includes nickel production and battery recycling, thereby onshoring additional critical mineral refining processes needed for the North American electric vehicle battery supply chain.

07:33 EDT Arrowhead granted breakthrough therapy designation for plozasiran by FDA - Arrowhead announced that the FDA has granted breakthrough therapy designation to investigational plozasiran as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome, or FCS, a severe and rare genetic disease characterized by extremely high triglyceride levels which can cause acute and potentially fatal pancreatitis. There are currently no approved treatments in the U.S. for FCS.

07:28 EDT Avis Budget announces intention to offer $500M of senior notes - Avis Budget Group announced that its wholly-owned subsidiaries, Avis Budget Car Rental and Avis Budget Finance, intend, subject to market and other customary conditions, to offer $500 million aggregate principal amount of senior notes due 2030 in a private offering. The Notes will be guaranteed on a senior unsecured basis by Avis Budget Group, Inc. and certain of its U.S. subsidiaries. The Company intends to use the net proceeds from the offering of the Notes for general corporate purposes, which may include repayment of indebtedness, including, without limitation, repayment of its floating rate term loan C maturing in 2029 and its outstanding fleet debt, and to pay fees and expenses in connection with the foregoing.

07:26 EDT Datametrex implements AI technology at Imagine Health Centres - Datametrex AI announced the implementation of advanced Artificial Intelligence technology at its Imagine Health Centres clinics in Calgary and Edmonton, Alberta. This initiative underscores the Company's commitment to harnessing AI to enhance healthcare services and accessibility across Canada. This technology is able to dictate and automatically generate encounter notes based on conversations between physicians and patients, seamlessly integrating this information into the Electronic Medical Record system. The Company expects this new implementation to not only reduces the time spent on manual note-taking but also allows doctors to focus more on patient care.

07:24 EDT Vista Outdoor provides update on review of strategic alternatives - Vista Outdoor announced that, as part of the board of directors' ongoing review of strategic alternatives, the company and its board, and their respective financial and legal advisors, are continuing to engage with MNC Capital and its private equity partner and advisors with respect to MNC's revised proposal to acquire Vista Outdoor for $43.00 per share in cash, which was submitted on September 6. The company has not made any determination with respect to MNC's revised proposal. In a letter sent by MNC to the Vista Outdoor Board on September 9, MNC acknowledged the board's engagement, thanking the board for its "time, effort and responsiveness." The board intends to continue to constructively engage with MNC. In light of the company's ongoing discussions and review of strategic alternatives, Vista Outdoor will adjourn the special meeting of stockholders which is scheduled to be held at 9:00 am on September 13 to 9:00 am on September 27. The board continues to recommend Vista Outdoor stockholders vote in favor of the proposal to adopt the merger agreement with CSG at the special meeting.

07:21 EDT G2 Goldfields to distribute 'non-core' assets to shareholders in late 2024 - Further to the Company's press release dated October 24, 2023, G2 intends to distribute its "non-core" assets to shareholders, by way of a plan of arrangement, in late 2024. The new company, "G3", will own assets in both the Puruni and OKO-AREMU districts including three historical past producers and exploration rights to an area extending over 60,000 acres. G2 intends to add additional assets to the G3 portfolio and, subject to shareholder and regulatory approval, distribute the G3 shares to G2 shareholders on a ratio of one share of G3 for each two shares of G2 held. Further details of the transaction will be provided in the coming weeks.

07:20 EDT Draganfly announces launch of APEX Drone - Draganfly announces the launch of its newest product, the APEX Drone, designed specifically to meet the demanding needs of military and law enforcement surveillance operations.

07:18 EDT Lifecore appoints Thompson as SVP of Human Resources - Lifecore Biomedical announced the appointment of Brikkelle Thompson as senior vice president, SVP, of human resources. Thompson brings nearly 25 years of visionary human resources leadership, global experience, and deep talent management to Lifecore, including 14 years in the medical technology, medical device, and healthcare industries.

07:17 EDT Rocket Pharmaceuticals appoints Mikael Dolsten, M.D to Board of Directors - Rocket Pharmaceuticals, announced the appointment of Mikael Dolsten, M.D., Ph.D., as an independent director to its Board of Directors. Dr. Dolsten is an accomplished industry executive with extensive global pharmaceutical management experience. "As an industry-leading pharmaceutical executive, I am very pleased to welcome Mikael to our Board of Directors," said Gaurav Shah, M.D., Chief Executive Officer of Rocket Pharma. "His research and development experience will help advance our leading scientific capabilities and contribute to our mission of developing and delivering potentially transformative treatments for patients."

07:16 EDT Mural Oncology to host first virtual Investor Day on September 26 - Mural Oncology will host a virtual Investor Day on Thursday, September 26, 2024, beginning at 10 a.m. ET. Mural leadership, including Caroline Loew, Ph.D., CEO, and Vicki Goodman, MD, Chief Medical Officer, will provide new clinical insight into the trial design and assumptions of the company's late-stage and potentially registrational trials of nemvaleukin, an engineered IL-2. Those trials are on track to deliver topline results in 1H 2025. Mural will also provide an overview and data presentation of its IL-18 program. The Investor Day will also feature clinician discussion as follows: Clinical proof of concept of Mural's lead program, nemvaleukin: Ulka Viashampayan, MD, Professor, Internal Medicine, Division of Hematology/Oncology, University of Michigan; Unmet need in platinum-resistant ovarian cancer: John Hays, MD, PhD, an associate professor in the Divisions of Medical Oncology and Gynecologic Oncology, and member of the Translational Therapeutics Program at The Ohio State University Comprehensive Cancer Center; Mucosal melanoma and need for dedicated treatments: Rich Carvajal, MD, Deputy Physician-in-Chief and Director of Medical Oncology at the Northwell Health Cancer Institute.

07:16 EDT Viridian Therapeutics announces topline data from THRIVE trial of VRDN-001 - Viridian Therapeutics announced topline data from the THRIVE phase 3 clinical trial of VRDN-001, now known as veligrotug, an intravenously delivered anti-insulin-like growth factor-1 receptor antibody, in patients with active thyroid eye disease, or TED. TED is an autoimmune condition characterized by inflammation, growth, and damage to tissues around and behind the eyes. THRIVE met the primary and all secondary endpoints at 15 weeks after five infusions of veligrotug, showing highly statistically significant improvements on all of the measured signs and symptoms of TED. Veligrotug additionally showed a rapid onset of action, with the majority of veligrotug-treated patients achieving a proptosis response after just 1 infusion, or 3 weeks after start of therapy. THRIVE enrolled 113 patients, randomized to veligrotug and placebo. Patients receiving veligrotug had statistically significant and clinically meaningful improvements across the following key disease endpoints at the primary efficacy analysis timepoint of 15 weeks: 70% proptosis responder rate, or PRR, in patients receiving veligrotug, compared with 5% of patients receiving placebo. PRR is defined as at least a 2-millimeter reduction in proptosis from baseline in the study eye without worsening in the fellow eye, as measured by exophthalmometry. 2.9 mm mean reduction in proptosis from baseline in patients receiving veligrotug, compared with 0.5mm reduction in patients receiving placebo, as measured by exophthalmometry. 54% complete resolution of diplopia in patients receiving veligrotug, compared with 12% of patients receiving placebo. Diplopia resolution is defined by patients achieving a score of 0 on the Gorman subjective diplopia scale at week 15, among patients with diplopia at baseline. 63% achieved a diplopia response in patients receiving veligrotug, compared with 20% of patients receiving placebo. Diplopia response is defined by patients achieving a reduction of at least 1 on the Gorman subjective diplopia scale at week 15, among patients with diplopia at baseline. 64% of patients receiving veligrotug achieved maximal or near-maximal therapeutic effect on CAS, compared with 18% of patients receiving placebo, defined as reaching a CAS of 0 or 1. CAS measures inflammatory signs and symptoms of TED, providing a composite score of pain, as well as redness and swelling of the eyelids and conjunctiva, on a scale from 0 to 7. 3.4-point mean reduction in CAS from baseline for patients receiving veligrotug, compared with 1.7-point reduction in patients receiving placebo. 67% of patients receiving veligrotug achieved an overall response, compared with 5% of patients receiving placebo. Overall Responder Rate is defined as achieving a proptosis response and a 2-point reduction in CAS from baseline without worsening in the fellow eye in either proptosis or CAS. Veligrotug was generally well-tolerated with a safety profile consistent with previous veligrotug studies. The majority of adverse events were mild, and there was a low rate of discontinuations in the veligrotug arm. There were no treatment-related serious AEs. There was a 5.5% placebo-adjusted rate of hearing impairment AEs in THRIVE. The second phase 3 clinical trial of veligrotug, THRIVE-2, in patients with chronic TED is ongoing. Viridian completed enrollment of THRIVE-2 in July, and topline data readout is on track for year-end 2024. Viridian anticipates submitting a BLA for veligrotug for the treatment of TED in 2H 2025, as planned. VRDN-003 is an IGF-1R antibody with the same binding domain as veligrotug and is believed to be the only anti-IGF-1R in development with an extended half-life. Viridian believes these topline results from THRIVE provide strong support for a potential best-in-class profile of VRDN-003, with the potential to deliver clinical efficacy and safety consistent with veligrotug in a low-volume, infrequent, self-administered, subcutaneous injection that patients take at home. Viridian initiated two global phase 3 clinical trials for VRDN-003 in August as planned: REVEAL-1 and REVEAL-2 in active and chronic TED, respectively. Both trials will evaluate VRDN-003 subcutaneously administered every Q4W or Q8W and will assess outcomes versus placebo. Viridian anticipates topline data from both trials in the first half of 2026, with a BLA submission for VRDN-003 for the treatment of TED by year-end 2026.

07:14 EDT Beamr Imaging to demonstrate video optimization workflow - Beamr Imaging announced that it will demonstrate an innovative, high-quality video optimization workflow for live streaming in 4K resolution. The demonstration will run on NVIDIA Holoscan for Media, a software-defined platform that enables live media pipelines to run on the same infrastructure as AI. The demonstration will be presented at IBC 2024, a top global content and technology event, held in Amsterdam, the Netherlands, from September 13-16, 2024.

07:13 EDT Terex announces expiration of waiting period for acquisition of ESG from Dover - Terex (TEX) announced the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, in connection with its previously announced acquisition of Environmental Solutions Group - ESG - from Dover (DOV). On July 22, Terex and Dover announced a definitive agreement for Terex to acquire ESG. Terex expects the agreement to close later this year, subject to the satisfaction of customary non-regulatory closing conditions.

07:12 EDT C4 Therapeutics announces delivery of second development candidate to Biogen - C4 Therapeutics (CCCC) announced it has successfully delivered a second development candidate to Biogen (BIIB) and earned an $8 million milestone payment. This marks the final development candidate under this strategic collaboration.

07:11 EDT Johnson & Johnson says medtech brands now called 'Johnson & Johnson MedTech' - Johnson & Johnson shared that its medical technology businesses - Ethicon, DePuy Synthes, Biosense Webster, Abiomed and CERENOVUS - will now go by the name Johnson & Johnson MedTech. "This is the next step of Johnson & Johnson's updated brand and visual identity announced in September 2023. This move underscores Johnson & Johnson's leadership in medical technology with a focus on cardiovascular, orthopaedic, surgery and vision solutions. Today's announcement has no impact on the medical technology products and solutions currently offer to customers... Partners, customers and consumers will begin to see the change come to life on social media channels and marketing materials over the coming weeks. The updated brand and visual identity will have no impact on the Johnson & Johnson MedTech portfolio," the company stated. Reference Link

07:10 EDT Okyo Pharma announces acquisition of shares by chairman - OKYO Pharma has been notified that Panetta Partners Limited, an entity in which Gabriele Cerrone, the Executive Chairman, has a beneficial interest, purchased 50,000 of the Company's ordinary shares on NASDAQ at a price of US$1.03 per share. This brings the total shareholding of Mr Cerrone to 9,851,570 shares which is 29.12% of issued share capital.

07:09 EDT I-Mab's uliledlimab shows positive pharmacokinetics data in lung cancer - I-Mab announced a poster presentation of PK/PD modeling data for uliledlimab at the International Association for the Study of Lung Disease's 2024 World Conference on Lung Cancer September 7-10 in San Diego. Uliledlimab is an antibody designed to target CD73, the rate-limiting enzyme critical for adenosine-driven immunosuppression in the tumor microenvironment. The WCLC 2024 presentation includes data from uliledlimab PK/PD analyses from three Phase 1 studies including patients with treatment naive metastatic non-small cell lung cancer, or mNSCLC. Key findings include: most of the simulated population - 95% - could achieve the target threshold with 30 mg/kg of uliledlimab; integrated PK/PD modeling and pharmacometrics analyses indicate there is a positive relationship between the probability of overall response and uliledlimab trough concentration in NSCLC patients; CD73 receptor occupancy in peripheral B cells achieved 90% or above and maintained at high levels until the end of treatment; the 30 mg/kg dose with a single boost dose on C1D8 provided uliledlimab concentrations that achieved the target concentration of 80 undefined/mL immediately after the first dose and maintained this threshold afterward.

07:09 EDT Rocket Lab appoints Frank Klein as COO - Rocket Lab announced the appointment of Frank Klein as its new COO, effective September 16. Klein joins Rocket Lab with more than 30 years of international manufacturing experience and leadership in the automotive industry. At Rocket Lab, Klein will lead the company's efforts to scale manufacturing of spacecraft, launch vehicles, and spacecraft components to meet growing customer demand of more than a billion dollars of backlog orders. Prior to joining the Rocket Lab team, Klein served Daimler AG for 27 years where he led various business divisions.

07:07 EDT Tonix Pharmaceuticals appoints Englese as EVP of Commercial Operations - Tonix Pharmaceuticals announced the appointment of Thomas Englese as Executive Vice President, EVP, of Commercial Operations, effective immediately. Englese brings significant leadership across several functions, including commercial operations, sales and marketing, and launching and managing major brands through all stages of commercialization.

07:07 EDT Stoke Therapeutics presents Zorevunersen data at EEC - Stoke Therapeutics announced highlights from presentations at the 15th European Epilepsy Congress, or EEC, related to the company's work to develop the first disease-modifying medicine for Dravet syndrome. Zorevunersen data showing substantial and sustained reductions in seizures and meaningful improvements in multiple measures of cognition and behavior were presented for the first time in a scientific forum. New data from an analysis of patients treated in the Phase 1/2a ADMIRAL study showed improvements in cognition and behavior during the first year of treatment with additional increases demonstrated as treatment continued. In addition, data from a two-year natural history study presented at the meeting showed that despite treatment with standard-of-care antiseizure medications, patients with Dravet syndrome continued to have high seizure rates and plateaued in their neurodevelopment, resulting in a widening gap in development compared to their neurotypical peers. MONARCH and ADMIRAL Phase 1/2a studies: Single and multiple doses of zorevunersen up to 70mg were generally well tolerated. Patients treated with 2 or 3 doses of 70mg of zorevunersen experienced median seizure reductions of 85% at 3 months and 74% at 6 months after the last dose, compared to baseline. Multiple doses of zorevunersen led to meaningful improvements in multiple measures of cognition and behavior within the first year of treatment, including receptive communication, interpersonal relationships and gross motor skills. SWALLOWTAIL and LONGWING open label extension studies: Safety findings among patients who continued treatment were consistent with the findings from the Phase 1/2a studies, except for a greater incidence of cerebrospinal fluid protein elevation. Durable reductions in convulsive seizure frequency were observed throughout the course of treatment. In addition, data indicated meaningful improvements in multiple measures of cognition and behavior over the first year of continued dosing of zorevunersen. BUTTERFLY: Compared to their neurotypical peers, adaptive functioning and neurodevelopment in patients with Dravet syndrome generally plateaued, resulting in a widening developmental gap over time. Seizure rates remained high over 24 months despite treatment with standard-of-care antiseizure medications.

07:06 EDT Solaris provides update on results from Celestina target - Solaris Resources provides an update on recent results from the Celestina target area as part of its continuing district exploration program. Additional prospecting in an overburden-covered area outside of these anomalies has identified three parallel vein exposures in creek beds within 100m either side of the original breccia outcrop. Follow-up rock chip sampling has returned high values of 16,019 g/t silver and 25.3 g/t gold, with other samples supporting the presence of an underlying silver-gold-base metals vein system.

07:04 EDT InMode announces 7.68M share repurchase program - InMode announced that its Board of Directors has approved a share repurchase program of up to 7.68M ordinary shares.

07:04 EDT Transcode Therapeutics announces publication of study on TTX-MC138 - TransCode Therapeutics, in collaboration with Michigan State University, published an article in the journal Oncotarget titled, Inhibition of miR-10b treats metastatic breast cancer by targeting stem cell-like properties. The article was published on August 26, 2024. The study was led by Dr. Anna Moore, Professor, Director of the Precision Health Program, and Associate Dean of the School of Medicine at Michigan State University and scientific co-founder of TransCode. In this study, the authors show that stem-like breast cancer cells increase expression of miR-10b, the molecule targeted by TTX-MC138. The study also demonstrates that treatment of breast cancer cells with TTX-MC138 reduces their stemness, confirming that these properties make metastatic cells susceptible to the therapeutic candidate's actions.

07:03 EDT Montrose Environmental acquires Origins Laboratory, terms not disclosed - Montrose Environmental Group announced the acquisition of Origins Laboratory, an environmental laboratory. Origins, including owners Noelle and David Mathis, will be integrated into the company's Measurement and Analysis Segment and operate as part of Enthalpy Analytical, a subsidiary of Montrose. Terms of the transaction were not disclosed. Founded in Denver, Colorado in 2006, Origins is a NELAP-certified environmental testing laboratory that specializes in measuring the contamination of water, soil and air for oil and gas clients in the Rocky Mountain region. In addition to servicing the traditional measurement needs of their clients, Origins also offers advanced services for emerging market demands, such as specialized air analysis for volatile organic compounds and measurement of per- and polyfluoroalkyl substances.

07:02 EDT Acelyrin announces PoC data from Phase 1/2 trial of lonigutamab - ACELYRIN announced that data from its Phase 1/2 clinical trial of lonigutamab in thyroid eye disease will be shared in a rapid-fire oral presentation at the 42nd Annual Meeting of the European Society of Ophthalmic Plastic and Reconstructive Surgery taking place from September 12-14, 2024 in Rotterdam, Netherlands. "The rapid suppression of IGF-1 receptor signaling observed with lonigutamab could potentially improve clinical outcomes for patients by achieving robust clinical responses with low drug exposures," said Shephard Mpofu, M.D., Chief Medical Officer of ACELYRIN. "Importantly, we believe these data are supportive of the potential for subcutaneously-delivered lonigutamab to provide deep and durable responses with convenient, self-administered dosing."

06:58 EDT Aclarion completes first Nociscan exams in LIFEHAB Trial - Aclarion announced the completion of the first Nociscan exams for patients enrolled in the LIFEHAB Trial in Norway. The randomized controlled trial studying 202 patients with low back pain greater than 1 year in duration will compare treatment outcomes between lumbar interbody fusion surgery and multidisciplinary rehabilitation. Nociscan was selected for use in the study to help evaluate how magnetic resonance spectroscopy biomarkers can identify patient improvement following treatment. Patient enrollment in LIFEHAB began in the second quarter of 2024. The initial enrolled patients began completing Nociscan exams in the last week of August. Thus far six patients have completed their Nociscan exams.

06:49 EDT Owens & Minor using Google Cloud to enhance Vertex AI platform health system - Owens & Minor announced a new partnership with Google Cloud that combines Owens & Minor's expertise in optimizing the healthcare supply chain with Google Cloud's Vertex AI platform to help drive enhancements for QSight, a cloud-based clinical inventory management system from Owens & Minor. The partnership between Owens & Minor and Google Cloud will focus on enhancing QSight's ability to help hospitals and health systems optimize how they manage medical-grade supplies, surgical implants and human tissue products required for patient care. For providers, the implications of inefficient inventory management can reach beyond the stockroom and into the operating room, including a risk that expired products are used in patient care and inventory loss if products expire before they can be used.

06:37 EDT Roivant Sciences' mosliciguat shows efficacy in pulmonary hypertension trial - Roivant's Pulmovant company announced the presentation of data from the proof-of-concept Phase 1b ATMOS study during the ERS Congress in Vienna, Austria. ATMOS evaluated mosliciguat, a potential first-in-class, inhaled sGC activator with targeted delivery to the lungs and once-daily administration, in pulmonary hypertension, or PH, patients. ATMOS was a proof-of-concept Phase 1b trial that assessed the efficacy, safety, tolerability, and pharmacokinetics of mosliciguat following single dose inhaled administration in participants aged between 18 and 80 years. In the per-protocol set of patients, mosliciguat 1.0, 2.0 and 4.0 mg doses led to mean peak percentage reductions in PVR from baseline of -25.9%, -38.1% and -36.3%, respectively, consistently exceeding the predefined greater than or equal to -20% threshold for the primary outcome. Single dose administration via dry powder inhaler was well tolerated, with low rates of TEAEs observed. Overall, in its Phase 1 development program in 170 healthy volunteers and PH patients, mosliciguat has shown a favorable safety profile, dose-dependent increases in cGMP, and a 40-hour half-life supporting convenient once-daily dosing. Pulmovant will advance the clinical program to assess mosliciguat in its global Phase 2 PHocus study in patients with PH-ILD, a subgroup of Group 3 PH. Approximately 120 patients will be enrolled in the study, which will start imminently.

06:34 EDT KalVista names Brian Piekos as CFO - KalVista Pharmaceuticals (KALV) announced that Brian Piekos has joined the company as CFO. Piekos has more than 25 years of financial and strategic planning experience in the biopharmaceutical industry. He joins KalVista from Elicio Therapeutics (ELTX) where he served as CFO and was responsible for launching Elicio as a public company.

06:31 EDT DexCom's CGM system worn in outer space as part of Polaris dawn mission - DexCom announced the Dexcom G6 Continuous Glucose Monitoring - CGM - System is being worn by astronauts in space as part of the Polaris Dawn mission, which launched this morning and aims to better understand the effects of spaceflight on human health. While in orbit, the Polaris Dawn crew will conduct scientific research designed to advance both human health on Earth and understanding of human health during long-duration spaceflights. Dexcom CGM systems consist of a small, wearable sensor that continually measures and sends glucose data wirelessly to a smart device or receiver, giving users real-time glucose data without the need to scan or prick their finger. Labfront, a platform assisting health researchers in collecting and analyzing physiological data, is collaborating with Dexcom to provide advanced analytics for the data collected using Dexcom CGM.

06:17 EDT Bionano Genomics lays off 45% of staff, or 84 employees - Bionano Genomics yesterday morning said that on September 4, it committed to a reorganization plan, including a reduction in force intended to decrease expenses and maintain a streamlined organization that is expected to conserve cash. The plan will refocus the company's efforts on the current installed base of optical genome mapping systems with less emphasis on new placements of OGM systems and more emphasis on ensuring customers are able to maximize their utilization of the OGM systems. As part of the reduction, the Company expects to reduce its overall headcount by 84 employees, which represents approximately 45% of its full-time employees as of September 3. These cost-saving measures from the plan are incremental to the cost saving initiatives previously announced in May 2023, October 2023, and March 2024 and are expected to reduce annual operating expenses by approximately an additional $25M to $30M, beginning in Q4. The company estimates that it will incur total restructuring charges of approximately $500,000 to $1.0M.

06:08 EDT Inception Growth Acquisition extends business combination period - Inception Growth Acquisition deposited $50K into the company's trust account in order to extend the period of time the company has to complete a business combination for an additional one month period, from September 13 to October 13. The purpose of the extension is to provide additional time for the company to complete a business combination.

06:06 EDT High Tide enters joint venture with Positive Intent Events - High Tide announced that it has entered into a joint-venture with Positive Intent Events, or PIE, to establish a position in Canada's nascent cannabis hospitality sector. The announcement follows Alberta's decision to allow licensed cannabis pop-up stores at adults-only festivals and events.

06:05 EDT KBR awarded contract to deliver technical design services at HMAS Stirling - KBR announced that it has been awarded a contract to continue to deliver technical design services at HMAS Stirling by the Security and Estate Group and the Australian Submarine Agency. This work will support the sovereign nuclear-powered submarines facilities and infrastructure program, enabling the Submarine Rotational Force - West, and accelerating Australia's ability to safely own, operate, maintain and sustain its own future nuclear powered submarine fleet.

06:03 EDT Comstock Inc. announces multiple new revenue contracts - Comstock and its subsidiary, Comstock Metals Corporation announced additional revenues from two commercial companies that have engaged Comstock Metals for the decommissioning and disposal of end-of-life solar panels. Comstock Metals has now received materials from new, nationally recognizable customers where it coordinated and enabled the decommissioning of the end-of-life panels from their facilities and coordinated the transportation of these panels to the facility in Silver Springs, where the materials will be processed and recycled.

05:56 EDT Bank of America raises U.S. minimum hourly wage to $24 - Bank of America announced that it has raised its U.S. minimum hourly wage to $24 per hour, the latest step in the company's commitment to $25 by 2025. With the increase, the minimum annualized salary for full-time employees in the U.S. will rise to nearly $50,000. The increase applies to all full-time and part-time hourly positions in the U.S.

05:30 EDT Infosys, Proximus Group announce strategic collaboration - Infosys and Proximus Group, Belgium's digital services and communication solutions provider, announced a strategic collaboration. The new strategic collaboration will focus on a joint go-to-market approach that will use products of Proximus' International affiliates, including Route Mobile's Communications Platform as a Service, or CPaaS, and Telesign's Digital Identity solutions. This combined with Infosys digital services will drive innovation in omnichannel customer engagement and AI-driven digital assistants for their customers. The collaboration will enhance digital security by providing DI and fraud protection solutions, ensuring trusted communication online.

05:23 EDT ASE Technology reports August revenue $1.63B - Reports August ATM revenue $897M.

05:18 EDT Amazon announces new, exclusive discounts for Prime members at Amazon Fresh - Amazon announced new, exclusive discounts for Prime members shopping in-store and online at Amazon Fresh; a new private-label brand; and enhancements to the online experience that make it easier for customers to shop for groceries from Amazon Fresh. Amazon is rolling out a significant expansion of its exclusive Prime savings program at Amazon Fresh, both in-store and online, offering greater savings on more than 3,000 grocery items for Prime members. This new offer of exclusive Prime savings on 3,000 or more items includes: Up to 50% off eight to 15 grocery favorites that rotate each week, including fresh produce, protein, and pantry staples. More than 1,200 rotating Prime-exclusive grocery items and household favorites from top brands 25% off. Over 1,700 products from Amazon private-label brands always 10% off-including Aplenty, Amazon Fresh, Amazon Kitchen, 365 by Whole Foods Market, Happy Belly, and the company's newest offering, Amazon Saver.

05:13 EDT EU's Court of Justice rules against Apple in EUR 13B Ireland tax case - The European Union's Court of Justice set aside the judgment of the General Court concerning tax rulings issued by Ireland in favor of Apple. In 2016, the European Commission decided that companies belonging to Apple had, from 1991 to 2014, received tax advantages that constituted State aid granted by Ireland. That aid related to the tax treatment of profits generated by Apple's activities outside the United States. In 2020, the General Court annulled the Commission's decision, holding that the Commission had not sufficiently established that those companies enjoyed a selective advantage. On appeal, the Court of Justice "sets aside the judgment of the General Court and gives final judgment in the matter, conversely confirming the Commission's decision." The Commission therefore ordered Ireland to recover the aid. According to Commission estimates, Ireland had given illegal tax benefits worth EUR 13B to Apple.

05:09 EDT MongoDB enters new pact with AICTE Ministry of Education, Government of India - MongoDB announced the expansion of MongoDB for Academia in India, including a new partnership with All India Council for Technical Education, or AICTE, Ministry of Education, Government of India. The AICTE partnership will be supported by SmartBridge's SmartInternz learning platform to give more than 150,000 Indian students access to virtual internships and to gain the skills required to use MongoDB Atlas-the leading multi-cloud developer data platform.