Stockwinners Market Radar for September 19, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:09 EDT Cathie Wood's ARK Investment bought 81K shares of 3D Systems

19:50 EDT Wheeler Real Estate Investment Trust trading halted, news pending

18:55 EDT J&J says FDA approves Rybrevant in combination with standard of care chemo - Johnson & Johnson announced that the U.S. Food and Drug Administration approved RYBREVANT in combination with standard of care chemotherapy for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer with epidermal growth factor receptor exon 19 deletions or L858R substitution mutations, whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor. "RYBREVANT plus chemotherapy may address the most common mechanisms of treatment resistance to third generation EGFR TKIs, such as osimertinib, in the first line," said Martin Dietrich, M.D., Ph.D., Oncologist, Cancer Care Centers of Brevard. "This multitargeted combination extended progression-free survival and improved overall response compared to chemotherapy alone, offering an important and effective new second-line option for patients."

17:39 EDT FedEx says Q1 demand environment was weaker than expected - Says weakness in industrial economy pressured deliveries in the U.S. Says continued to execute on structural cost reductions in Q1. Comments taken from Q1 earnings conference call.

17:33 EDT Nauticus Robotics receives extension to regain Nasdaq compliance - Nauticus Robotics announced receipt of a letter from Nasdaq approving an extension of time to regain compliance with all listing standards. The letter received from Nasdaq grants Nauticus an exception until December 31 to demonstrate compliance with the Nasdaq Capital Market listing rules. Nauticus management presented its detailed plan to gain compliance during the Nasdaq Hearings Panel meeting held on September 5. Nauticus will continue to work through its plan with intent to resolve all compliance issues before the deadline of December 31. With the granting of this Nasdaq exception, Nauticus remains listed on the Nasdaq capital market. Once the compliance plan is fully executed, Nauticus will make further disclosures describing the actions taken by the Company to achieve compliance.

17:12 EDT Airbnb CEO Chesky sells 230,769 class A shares - In a regulatory filing, Airbnb CEO and chairman Brian Chesky disclosed the sale of 230,769 class A common shares of the company on September 17 at a price of $120 per share.

17:08 EDT Arcadium Lithium details expansion programs, long-term targets at investor day - Arcadium Lithium provided a number of strategic updates at its inaugural 2024 investor day. During the event, the company reviewed its operating, commercial and growth strategies. The company also discussed its plans for volume expansion and provided a long-term financial view. Arcadium Lithium expects 25% higher combined lithium carbonate and lithium hydroxide volumes in 2024 and 2025 from expansion projects at Fenix and Olaroz that have already been completed, are in operation and have no further capital requirements. Arcadium Lithium outlined two waves of expansions across its large, high-quality and low-cost assets in Argentina and Canada. The first wave of four existing projects at various stages of advancement is expected to be fully completed, in stages, by 2028 and more than double sales volumes. The second wave of projects are at the development and planning stage and this wave offers the company the opportunity to increase production capacity beyond 2028 by a further 125,000 metric tons to 295,000 metric tons total. The size and quality of Arcadium Lithium's portfolio of resources means it is not constrained in its ability to continue to grow organically. Arcadium Lithium outlined a path to an expected $1.3B in Adjusted EBITDA by 2028, subject to certain assumptions, with margins continuing to be supported by low-cost positions and multi-year customer agreements. This growth is underpinned by higher volumes from expansion, and by consensus expectations for pricing to move higher than current levels towards prices that are needed to incentivize industry supply growth. Since the January merger of Allkem and Livent creating Arcadium Lithium, the company has taken actions to drive cost reductions throughout the organization. The company said the benefits of these actions are already being seen, with post-merger cost savings coming in higher and quicker than initial forecasts. Beyond expected cost savings of up to $80M in 2024, the company now expects to deliver close to its initial run-rate savings target of $125M by the end of 2025, roughly two years ahead of plan. These savings are driven primarily by organizational restructuring, operational and supply chain synergies and a reduction in third-party and other services across the two legacy companies. The company also believes the total longer-term savings opportunity to be greater than $125M. Arcadium Lithium announced the recent signing of a memorandum of understanding, or MoU, with its long-time partner Toyota Tsusho, an initial step in providing greater flexibility for Arcadium Lithium to optimize its global integrated operating network and to contribute its production expertise to Naraha. This includes using technical grade lithium carbonate produced at Olaroz to feed the company's existing downstream lithium hydroxide network, thus allowing more battery grade lithium carbonate produced at Fenix to be sold directly to customers. This is expected to have a positive impact on the company's earnings and to be achievable as early as 2026.

17:01 EDT Eupraxia Pharmaceuticals to present at ISDE Congress for Esophageal Diseases - Eupraxia Pharmaceuticals "announced that the Company will be presenting a poster at the upcoming 20th International Symposium on Digestive Endoscopy - ISDE - World Congress for Esophageal Diseases to be held in Edinburgh, Scotland on September 22-24, 2024. Presentation Title: PP02.05 Initial Results from RESOLVE, a Phase 1b Dose-Escalation Study of EP-104GI (Extended-Release Fluticasone Propionate Intra-Esophageal Injection) for Eosinophilic Esophagitis."

16:51 EDT Adobe CFO sells $3.35M in common stock - In a regulatory filing, Adobe disclosed that its CFO Daniel Durn sold 6.5K shares of common stock on September 17th in a total transaction size of $3.35M.

16:46 EDT AngioDynamics initiates clinical trial assessing AlphaVac F18 system - AngioDynamics "announced the launch of the Prospective, Multicenter, Multi-national, Single Arm Trial Evaluating the Efficacy, Safety and long term functional outcomes of percutaneous mechanical aspiration thrombectomy for Treatment of Acute Pulmonary Embolism, or PE, using the AlphaVac Multipurpose Mechanical Aspiration - MMA - F1885 System - RECOVER AV. The RECOVER-AV trial is designed to evaluate the safety and efficacy of AlphaVac for the treatment of acute, intermediate-risk PE to support its adoption in the European market. This study follows the Acute Pulmonary Extraction Trial with AlphaVac study, a single-arm Investigational Device Exemption study that enrolled 122 patients with confirmed acute, intermediate-risk PE across 25 hospital-based sites in the United States to assess the AlphaVac F18 System for the treatment of PE. APEX-AV, which completed enrollment in December 2023, demonstrated that the AlphaVac F1885 System is safe in patients with acute intermediate-risk PE and provides significant improvement in right ventricular function and reduction in clot burden. The RECOVER-AV study is a multi-center, multi-national trial enrolling patients with confirmed acute, intermediate-risk PE across up to 20 hospital sites in Europe. The primary efficacy endpoint is the reduction of the right ventricular/left ventricular ratio from baseline to 48 hours post-procedure. The primary safety endpoint focuses on the incidence of Major Adverse Events, such as device-related death or major bleeding within seven days. Patients will be followed for 12-months, with functional outcomes assessed at 30-days, six-months, and 12-months."

16:38 EDT Biodexa anounces ratio change on its ADR, effective date October24 - Biodexa Pharmaceuticals announces a ratio change on its American Depositary Receipts or ADR from one ADR representing four hundred ordinary shares, to the new ratio of one ADR representing ten thousand ordinary shares . The effective date of the Ratio Change is expected to be October 4. .

16:35 EDT Lennar reports Q3 new orders up 5% to 20,587 homes - Q3: Backlog of 16,944 homes with a dollar value of $7.7B; Deliveries increased 16% to 21,516 homes.

16:34 EDT Lennar sees Q4 new orders 19,000-19,300 - Sees Q4 deliveries 22,500-23,000; average sales price ~$425,000.

16:33 EDT Corporacion America Airport reports August traffic down 1.5% - Corporacion America Airports "reported total passenger traffic declined by 3.8% in August compared to the same month in 2023, or 1.5% when adjusting for the discontinuation of Natal airport. This represents a sequential improvement compared to the YoY decline of 4.2%, or 1.8% excluding Natal, reported in July. Domestic passenger traffic decreased by 12.6% YoY, or 8.9% when excluding Natal, primarily due to weaker YoY performance in Argentina. International traffic increased by 5.8%, mainly driven by growth in Argntina and positive YoY contributions from all countries except Armenia."

16:26 EDT Millicom chair Mauricio Ramos to step down - Millicom announced that Mauricio Ramos is stepping down from his roles of director and chair of Millicom board of directors on September 30. The board, which will be composed of eight directors for the time being, has unanimously appointed Maxime Lombardini to act as interim chair of the board. A nominations committee will be convened and work to submit a proposal for election of a chair of the board to the next annual general meeting of Millicom shareholders. Ramos joined Millicom in 2015 as CEO, became a member of the board in 2020 and was appointed executive chair of the board in September 2023 and non-executive chair in May.

16:21 EDT Viking Holdings' Viking Yi Dun completes Shanghai to Hong Kong voyage - The company states: "Viking is celebrating its historic return to China as the Viking Yi Dun completed her first voyage from Shanghai to Hong Kong (Shenzhen). Viking's new itineraries include a domestic sailing of China's coast that highlights rarely-visited destinations and ports to which only Viking has access-something that has never been offered for international visitors. The itineraries operate from September to November on the 930-guest Viking Yi Dun-formerly the Viking Sun-a sister ship featuring the ame award-winning design and service as all other ocean ships in Viking's fleet. The launch of Viking's new China itineraries was commemorated in Shanghai, where a celebration was held with local officials. Guests were treated to cultural performances, both shoreside and on board the ship, offering an introduction to the country's rich traditions. Given the historic nature of the inaugural voyage, the Viking Yi Dun was welcomed to port with fanfare from local partners and residents in Zhoushan, Dongtou, Pingtan, Xiamen and Shenzhen. And, at the end of the voyage, guests provided enthusiastic feedback about their time in China."

16:18 EDT BEN teams with KangarooHealth to optimixe RPM and CCM with GenAI platform - Brand Engagement Network or BEN and KangarooHealth, a healthcare technology company have entered into a partnership agreement that will enable the companies to work together to broaden access to AI-supported remote patient monitoring - aiming to improve chronic condition patient outcomes in value-based care model with omnichannel support capabilities. ...KangarooHealth offers plug-and-play solutions for remote patient monitoring RPM and chronic condition management, designed to improve patient care while minimizing the burden on healthcare staff. As a comprehensive remote care provider, KangarooHealth supplies everything from devices and platforms to staffing and billing solutions. Founded in 2015, KangarooHealth has earned the trust of hundreds of providers nationwide. With a proven track record, the company boasts an impressive 92% compliance rate among enrolled patients and a 98% customer satisfaction rate. KangarooHealth's solutions effectively help providers reduce readmissions and emergency room visits, enhancing overall healthcare delivery. "BEN is excited to work with KangarooHealth to help them scale their monitoring service by providing 24/7 AI-based human-like technology," said Paul Chang, CEO of BEN. "Through this collaboration, we are aiming to improve outcomes for all patients despite workforce and physician limitations that would otherwise inhibit optimal care."

16:17 EDT Macy's to hire more than 31,500 seasonal positions - Macy's announced plans to hire more than 31,500 full- and part-time seasonal positions this upcoming holiday season at its Macy's, Bloomingdale's and Bluemercury stores, as well as its distribution centers. Macy's, Inc. offers several convenient hiring experiences for candidates including an online application process that takes as little as five minutes, with most job offers made within 48 hours. Additionally, the company is holding four nationwide in-person holiday hiring events at all stores and supply chain locations. Times may vary by location. The dates are September 26, October 24, November 21, and December 4. "At Macy's, Inc., our colleagues play a special role in delivering memorable customer experiences through our Bold New Chapter strategy," said Danielle Kirgan, Macy's, Inc. chief human resources and corporate affairs officer. "We are excited to add more than 31,500 seasonal positions to help us welcome and serve our customers during the holidays. Whether they are looking for extra income for the season or the start of a new career in retail, we offer an unmatched culture, competitive pay and fulfilling career opportunities."

16:16 EDT Nike CEO Donahoe to retire, Elliott Hill named next president and CEO - The Board of Directors of NIKE, Inc. announced that Elliott Hill will become President and Chief Executive Officer of NIKE, Inc., effective October 14, 2024. Hill will also become a Director of the NIKE, Inc. Board of Directors and a member of the Executive Committee. The Board and John Donahoe have decided he will retire from his role as President and Chief Executive Officer and from the NIKE, Inc. Board of Directors effective October 13. He will remain as an advisor to the company to ensure a smooth transition through January 31, 2025. "I am excited to welcome Elliott back to NIKE. Given our needs for the future, the past performance of the business, and after conducting a thoughtful succession process, the Board concluded it was clear Elliott's global expertise, leadership style, and deep understanding of our industry and partners, paired with his passion for sport, our brands, products, consumers, athletes, and employees, make him the right person to lead Nike's next stage of growth," said Mark Parker, Executive Chairman of NIKE, Inc. "Personally, I have worked with Elliott for more than 30 years and I look forward to supporting him and his senior management team as they seize the opportunities ahead."

16:12 EDT Tenon Medical issued three notices of allowance from USPTO - Tenon Medical announced the United States Patent and Trademark Office, or USPTO, issued three notices of allowance for U.S. Patent Application Numbers 17,469,132 and 17/468,811, both entitled "Sacroiliac Joint Stabilization Prostheses", and 18/612,032, entitled "Systems, Apparatus and Methods for Stabilizing Sacroiliac Joints". The U.S. patents based on the applications should thus issue within the next 90 days. U.S. Pat. App. Nos. 17,469,132 and 17/468,811 are directed to SI joint prostheses that include unique drug delivery compositions that aid in bone growth about and within the prostheses when implanted in a SI joint. U.S. Pat. App. No. 18/612,032 is directed to SI joint prostheses with unique configurations to correct failed SI joint stabilization with alternative commercial SI joint implants without requiring removal of the failed implant. The three U.S. patents, when issued, will further enhance the company's growing patent portfolio for its Catamaran SI Joint implant system, which now comprises nine issued U.S. and foreign patents, and 26 pending U.S. and foreign patent applications.

16:08 EDT FedEx drops over 10% to roughly $269 after cutting FY25 guidance

16:06 EDT Synopsys to sell Optical Solutions Group to Keysight Technologies, no terms - Synopsys (SNPS) announced it has entered into a definitive agreement for the sale of its Optical Solutions Group to Keysight Technologies (KEYS), a leading provider of design, emulation and test solutions. The transaction is subject to customary closing conditions, including review by regulatory authorities, and the closing of Synopsys' proposed acquisition of Ansys, which is pending regulatory approvals and expected to close in the first half of 2025. The sale of OSG was determined to be a necessary step towards obtaining regulatory approval of and successfully closing Synopsys' proposed acquisition of Ansys. This transaction is not material to Synopsys' financials, and terms of the agreement were not disclosed. Synopsys is committed to a seamless transition for the OSG team, customers and partners. Until the transaction closes, OSG will operate business-as-usual, as part of Synopsys with a focus on execution, customer service and continued innovation.

16:03 EDT Iridium announces $500M share repurchase program - Iridium announced that its Board of Directors has authorized the repurchase of an additional $500M of Iridium common stock through December 31, 2027. This is the fourth stock repurchase authorization from the Board of Directors in the past four years and brings the total value of the program to $1.5B. This $500M authorization is also the largest ever approved by the Board of Directors, underscoring the strength of Iridium's business.

16:02 EDT Texas Instruments raises quarterly dividend 5% to $1.36 from $1.30 per share - Texas Instruments said it will raise its quarterly cash dividend 5%, from $1.30 per share to $1.36, or $5.44 annualized. The higher dividend will be payable November 12, 2024, to stockholders of record on October 31, 2024, contingent upon formal declaration by the board of directors at its regular meeting in October.

15:15 EDT Village Super Market CEO Robert Sumas to step down, John Sumas to succeed - Village Super Market announced that Robert Sumas has notified the Board of Directors of his decision to step down as CEO and interim Chairman of the Board of Directors effective December 13, 2024. Sumas will remain employed by the company as a Senior Advisor to the executive team to ensure a smooth transition of duties. Sumas also plans to continue to serve the company as a member of its Board of Directors. The company also announced that the Board plans to appoint John Sumas as the new CEO and Nicholas Sumas as President and Chairman of the Board of Directors effective December 13, 2024. John Sumas has served as a Director since 2009, and has been a Co-President since 2018. Sumas has held a diversity of supervisory positions since his employment in 1987, including COO, General Counsel and Vice President. Nicholas Sumas has served as a Director since 2009, and has been a Co-President since 2018. Sumas has held a diversity of supervisory positions since his employment in 1994, including Chief Marketing Officer and Vice President. Sumas is also an executive officer of Wakefern and a member of the Wakefern Board of Directors. Additionally, the company has announced, by resolution of the Board of Directors, the Board will not fill the vacancy resulting from the passing of Board member William Sumas on July 11, 2024, reducing the number of members on the Board of Directors from ten to nine, effective immediately.

15:10 EDT Elanco announces FDA approval of Zenrelia - Elanco Animal Health announced the U.S. FDA has approved Zenrelia, a safe, highly effective, and convenient once-daily oral JAK inhibitor for control of pruritus (itching) associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. Zenrelia launch begins in U.S. with Elanco now taking orders; product expected to ship in coming days.

14:56 EDT New Found Gold down 4% after Iceberg Research short report

14:25 EDT Skechers down 4% as company presents at Wells Fargo conference - Skechers shares are down $2.85, or 4%, to $65.26 near 2:20 PM EDT. The company is presenting this afternoon at the Wells Fargo Consumer Conference.

14:01 EDT UniFirst names Kelly Rooney COO - UniFirst Corporation announced the appointment of Kelly Rooney as Chief Operating Officer, effective September 30, 2024. Rooney has extensive knowledge and experience in large-scale B2B route-based operations. Over her twenty-five plus year career, she has held operational and leadership roles of increasing responsibility. Her most recent position was as the Chief Human Resources Officer at Waste Management, a $20 billion public company. Rooney is returning to her roots and will oversee UniFirst's day-to-day operations, focusing on driving growth, enhancing customer service excellence, and executing operational efficiencies. Her innovative leadership style, systematic approach, and strong customer focus have consistently yielded outstanding results throughout her career. "We are thrilled to welcome Kelly to the team," said Steve Sintros, CEO of UniFirst. "Her partnership and ability to effect positive change will be critical as we continue to evolve. Alongside her deep operational experience, her talent and passion for empowering workforces to succeed fit like a glove with our culture and our promise to always deliver for our customers and our employees." In addition, the company has announced that Michael Croatti, Executive Vice President, will transition from his current role in November of 2024. UniFirst acknowledges the significant contributions of Croatti, who has played an integral role in the company's success over his 35-year career. Croatti, the son of former UniFirst CEO Ron Croatti, has been a leader in maintaining relationships with customers and within the industry. Though stepping down as a full-time executive with the company to spend more time with his family, Croatti expects to remain involved in a consulting capacity for a period of time, collaborating with Sintros on key customer and industry partnerships.

13:05 EDT Knightscope announces contract renewal in Texas, robot upgrade in California - Knightscope announces another security robot contract renewal in Texas and a robot upgrade for a California hospital. One of Houston's top commercial real estate brokerage and property management firms, with dozens of office locations across the U.S., renewed its agreement for one K1 Hemisphere and one K1 Tower that protect a large parking structure at one of its many properties. A California hospital, Knightscope's oldest healthcare client dating back to 2016, received its upgrade to the fifth generation of its K5 Autonomous Security Robot. Machine 'hot-swaps' began following the engineering release of the fully redesigned K5v5.

12:09 EDT Kaspi.kz calls short report 'misleading' and 'inaccurate' - Kaspi.kz issued a statement following the research report published by Culper Research today: "In our view, the report is misleading, inaccurate and misrepresents our business. Being the first company from Kazakhstan to successfully list on Nasdaq has obviously raised our profile amongst short sellers. For those investors who have known us over the years, our reputation speaks for itself."

12:01 EDT Ginkgo Bioworks rises 13.4% - Ginkgo Bioworks is up 13.4%, or 99c to $8.40.

12:01 EDT Daily S&P Biotech Bear 3x Shares falls -7.6% - Daily S&P Biotech Bear 3x Shares is down -7.6%, or -42c to $5.14.

12:00 EDT Direxion Daily Semiconductor Bear 3X Shares falls -13.8% - Direxion Daily Semiconductor Bear 3X Shares is down -13.8%, or -$3.43 to $21.49.

11:52 EDT uniQure treatment of Fabry disease granted orphan designation - The FDA has granted orphan designation to uniQure biopharma's treatment of Fabry disease, according to a post to the agency's website. Reference Link

11:38 EDT Publicis confirms acquisition of Mars United Commerce - Publicis Groupe has announced the acquisition of Mars United Commerce. The company said, "Winning in commerce, by changing shopper behavior to drive business results, is increasingly a core element of marketeers' winning strategies. But activating in commerce has become increasingly complex, as brands must navigate a fragmented array of channels, media, technologies and data. The combination of Mars and Publicis Groupe solves for this complexity by creating the world's leading connected commerce solution, allowing clients to plan and activate through the full marketing funnel and increase sales at the point of purchase." Rob Rivenburgh, Global CEO of Mars United, said that, "Joining Publicis Groupe will help Mars realize our vision of being the preeminent global commerce company faster and more completely. We're excited to have the support of Publicis to bring new opportunities to our existing clients and also to share our connected commerce solution with new clients around the globe. We look forward to writing the next chapter of commerce together."Reference Link

11:27 EDT Associated Capital trading resumes

11:13 EDT Associated Capital announces special dividend of $2 per share - Associated Capital Group announced that its board of directors has declared a special cash dividend of $2.00 per share, payable on November 4, to Class A and Class B shareholders of record as of the close of business on October 21. The aggregate payment will be approximately $42.4M, based on shares outstanding of 21.2M as of the date of this release, the company stated.

11:05 EDT Associated Capital trading halted, news pending

11:02 EDT Caesars launches Caesars Sportsbook Muckleshoot app - Caesars Entertainment launched the Caesars Sportsbook Muckleshoot app, which is now accepting mobile sports bets at Muckleshoot Casino Resort in Auburn, Washington. Guests 21 and older who are interested in wagering on mobile devices can download the Caesars Sportsbook Muckleshoot app and must be physically present on the property at Muckleshoot to verify their registration for an account and place wagers during their visit, in accordance with state law. The Caesars Sportsbook Muckleshoot mobile app extends the sports wagering experience beyond the on-premise Caesars Sportsbook at Muckleshoot, which accepted its first bets in 2022. The app provides an industry-leading sports wagering experience with user-friendly technology like lightning-fast live scoreboards, live streaming games, quick and secure payouts, and daily special odds boosts and promotions from anywhere inside the casino. The app also contains thousands of betting markets across all major sports, with live in-game betting, same-game parlays, and much more.

10:47 EDT Earlyworks, CAICA DIGITAL enter business alliance agreement - Earlyworks has signed a business alliance agreement with CAICA DIGITAL. Together, the Company and CAICA will provide comprehensive support to businesses engaged in Web3 projects. Through this business alliance, Earlyworks aims to enhance the services of GLS, while also supporting the system development of new businesses that adopt "CAICA Web3 for Biz", providing strong support for companies in promoting their Web3 ventures.

10:28 EDT Galaxy Payroll Group Ltd trading halted, volatility trading pause

10:02 EDT IMAC Holdings launches Ignite Proteomics subsidiary - IMAC Holdings announces the launch of an entirely new precision oncology assay for breast cancer treatment decision making utilizing the Reverse Phase Protein Array technology through its newly established subsidiary, Ignite Proteomics. This launch follows IMAC Holdings' strategic acquisition of key assets from Theralink Technologies, Inc., and is underscored by a landmark clinical case study "Proteomics based selection achieves complete response to HER2 therapy in HER2 IHC 0 breast cancer", demonstrating the power of RPPA technology in precision oncology published in npj Precision Oncology, an international, peer-reviewed journal focused on precision oncology. Ignite Proteomics introduces the only commercialy available and clinically validated assay that can measure both the expression and activated protein drug target levels in breast tumors, a superior way to measure the potential effectiveness of targeted cancer therapies. The clinical utility of the Ignite proteomic assay is highlighted by this recent case study involving a 57-year-old woman with metastatic triple-negative breast cancer who exhibited an exceptional response to treatment guided by Ignite's RPPA-based analysis. Despite previous extensive treatments including chemotherapy and targeted therapies, the patient experienced disease progression across multiple sites. A clinical trial at the Inova Schar Cancer Institute allowed for a comparative analysis using both current next-generation sequencing assays and Ignite's novel assay on the same biopsy. After Ignite Proteomics RPPA assay identifed the expression and activation of an important protein called HER2, which was missed by both the NGS analysis and current approaches to measure HER2 the patient was treated with the antibody-drug conjugate trastuzumab deruxtecan, which relies on HER2 expression and activation to work. After 9 cycles no measurable disease was observed, representing a complete response to therapy.

10:00 EDT Direxion Daily Semiconductor Bear 3X Shares falls -10.2% - Direxion Daily Semiconductor Bear 3X Shares is down -10.2%, or -$2.54 to $22.38.

10:00 EDT Miniso rises 8.5% - Miniso is up 8.5%, or $1.29 to $16.43.

10:00 EDT Direxion Daily Semiconductor Bull 3X Shares rises 10.3% - Direxion Daily Semiconductor Bull 3X Shares is up 10.3%, or $3.21 to $34.35.

09:53 EDT Galmed trading resumes

09:48 EDT Coursera rises 10.1% - Coursera is up 10.1%, or 77c to $8.42.

09:48 EDT Direxion Daily Semiconductor Bull 3X Shares rises 11.0% - Direxion Daily Semiconductor Bull 3X Shares is up 11.0%, or $3.43 to $34.57.

09:48 EDT Steelcase falls -10.1% - Steelcase is down -10.1%, or -$1.42 to $12.69.

09:46 EDT FTC study finds 'vast surveillance' of social media users by Meta, TikTok - A new Federal Trade Commission staff report that examines the data collection and use practices of major social media and video streaming services shows they engaged in vast surveillance of consumers in order to monetize their personal information while failing to adequately protect users online, especially children and teens. The staff report is based on responses to 6 orders issued in December 2020 to nine companies including some of the largest social media and video streaming services: Amazon.com, Inc., which owns the gaming platform Twitch (AMZN); Facebook, Inc. (META); YouTube (GOOGL); Twitter, Inc. (TWTR); Snap (SNAP); ByteDance Ltd., which owns the video-sharing platform TikTok; Discord Inc.; Reddit (RDDT); and WhatsApp Inc. The orders asked for information about how the companies collect, track and use personal and demographic information, how they determine which ads and other content are shown to consumers, whether and how they apply algorithms or data analytics to personal and demographic information, and how their practices impact children and teens. "The report lays out how social media and video streaming companies harvest an enormous amount of Americans' personal data and monetize it to the tune of billions of dollars a year," said FTC Chair Lina M. Khan. "While lucrative for the companies, these surveillance practices can endanger people's privacy, threaten their freedoms, and expose them to a host of harms, from identify theft to stalking. Several firms' failure to adequately protect kids and teens online is especially troubling. The Report's findings are timely, particularly as state and federal policymakers consider legislation to protect people from abusive data practices." The report found that the companies collected and could indefinitely retain troves of data, including information from data brokers, and about both users and non-users of their platforms. The staff report further highlights that many companies engaged in broad data sharing that raises serious concerns regarding the adequacy of the companies' data handling controls and oversight. In particular, the staff report noted that the companies' data collection, minimization and retention practices were "woefully inadequate." In addition, the staff report found that some companies did not delete all user data in response to user deletion requests. The staff report also found that the business models of many of the companies incentivized mass collection of user data to monetize, especially through targeted advertising, which accounts for most of their revenue. It further noted that those incentives were in tension with user privacy, and therefore posed risks to users' privacy. Notably, the report found that some companies deployed privacy-invasive tracking technologies, such as pixels, to facilitate advertising to users based on preferences and interests. Furthermore, the staff report concluded that the social media and video streaming services didn't adequately protect children and teens on their sites. The report also noted some of the potential competition implications of the companies' data practices. It noted that companies that amass significant amounts of user data may be in a position to achieve market dominance. Reference Link

09:46 EDT Northwest Bancshares lowers prime lending rate to 8% from 8.5% - Northwest Bank has lowered their prime lending rate to 8% from 8.5%, effective September 19.

09:34 EDT Culper Research short Kaspi.kz, says shares 'headed lower' - In a recently published report, Culper Research says it is short Kaspi.kz as it believes the company "has systematically misled U.S. investors and regulators in its repeated claims - especially ahead of the company's January 2024 NADSAQ listing - that the company has zero exposure to Russia." "We believe that not only do Kaspi's relationships with Russian partners permeate every segment of its business, but that in the wake of Russia's February 2022 invasion of Ukraine and into 2024, Russia has contributed materially to Kaspi's reported growth... We believe Kaspi's premium valuation and U.S. listing are at risk, and shares are headed lower," the report reads. "As the U.S. and other nations continue to broaden sanctions against those found to be aiding Russia's wartime economy, we believe Kaspi now risks secondary sanctions," Culper adds, further arguing that "Notwithstanding these concerns, we think Kaspi is wildly overvalued." Shares of Kaspi.kz have dropped about 4% to $114.80 in morning trading. Reference Link

09:32 EDT FibroBiologics engages Southern Star Research as CRO in Australia - FibroBiologics has engaged with Southern Star Research to provide clinical research organization services for FibroBiologics in Australia. Initial CRO services will include preparatory work for a Phase 1/2 clinical trial utilizing product candidate, CYWC628, to treat diabetic foot ulcers.

09:28 EDT Kaspi.kz down 10% after Culper publishes short report - Shares of Kaspi.kz are down $11.80, or 10%, to $107.21 in pre-market trading after the publication of a short report by Culper Research.

09:22 EDT Agape ATP regains compliance with Nasdaq minimum bid price rule - AGAPE ATP has regained compliance with the $1 minimum bid price requirement under the continued listing requirements of the Nasdaq Stock Market and that the matter is now closed. On September 17, 2024, the Company received a written notification from Nasdaq's Listing Qualifications Department confirming that the closing bid price of the Company's ordinary shares has been $1.00 per share or greater for 10 consecutive trading days, from August 30, 2024 to September 16, 2024. Accordingly, the Company has successfully regained compliance with Nasdaq Listing Rule 5550(a)(2).

09:10 EDT Gryphon Digital names Steve Gutterman CEO, Jimmy Vaipoulos chairman - Gryphon Digital Mining announced that Steve Gutterman has been appointed as CEO and Jimmy Vaipoulos as Chairman of the board of directors. Gutterman becomes CEO after serving as a member of the Gryphon Board and the Chair of its Audit Committee. Prior to his appointment, Gutterman has built, led, acquired and invested in market-changing companies for almost 30 years. Gutterman replaces Rob Chang, who remains on the Board as a Director. Joining the Board as Chairperson is Jimmy Vaipoulos. Mr. Vaiopoulos is a Partner, CFO and Co-Founder of Stack Capital Group.

09:08 EDT Insight Acquisition, Alpha Modus announce registration statement effectiveness - Alpha Modus and Insight Acquisition Corp. announced that the U.S. Securities and Exchange Commission has declared effective the registration statement on Form S-4 filed with the SEC related to the previously announced business combination. Insight has also filed with the SEC the definitive proxy statement for its special meeting of stockholders, to, among other things, approve the Business Combination. Upon closing of the Business Combination, which is subject to stockholder approval, the combined company will operate as "Alpha Modus Holdings, Inc." and its common stock and warrants are expected to commence trading on the Nasdaq Global Market under the tickers "AMOD" and "AMODW", respectively, shortly thereafter.

09:06 EDT Brilliant Earth expands retail reach with new showrooms in Boston market - Brilliant Earth Group announced the expansion of its retail fleet with the opening of two new street-level showrooms in Boston, as well as the renovation of its Newbury Street location. The new Chestnut Hill location is now open at 27 Bolyston Street and is part of the shopping destination "The Street Chestnut Hill". The second new Boston area showroom at the Seaport's newest shopping destination, "The Superette", is located at 254 B Street and is slated to open in November.

09:05 EDT Jewett-Cameron retained Lytham Partners to lead strategic investor relations - Jewett-Cameron Trading announced it has retained one of the industry's leading investor relations firms, Lytham Partners, to lead a strategic investor relations and shareholder communication program. "We have implemented a number of key strategic initiatives over the past two years that we believe will contribute to Jewett-Cameron's long-term success, while at the same time honoring the roots of our long and storied history," commented Chad Summers, CEO of Jewett-Cameron. "Having reached a pivotal stage of this new transformation of Jewett-Cameron, the time is appropriate to expand the visibility of the Company. I look forward to working with Robert and the team at Lytham Partners to execute on this important initiative."

09:04 EDT Nano Nuclear Energy announces addition of two engineers to its team - NANO Nuclear Energy announced the addition of two engineers, Major Daniel Lamb, MPhil, and Rui Guo, Ph.D., to its Nuclear Technology and Engineering Team. Major Lamb serves as a Major in the US Air Force Reserves. Dr. Rui Guo specializes in nuclear materials in the waste and fuel cycle area and has extensive experience in novel experimental characterization and simulation methods for studying nuclear materials.

09:03 EDT SmartRent appoints Natalie Cariola as chief revenue officer - SmartRent announced Natalie Cariola is joining the company as its chief revenue officer, or CRO, effective September 30. Cariola will be a member of the recently formed management committee, which reports to SmartRent's chairman of the board, John Dorman.

09:02 EDT LPL Financial: Bury Financial joins broker-dealer, RIA, custodial platforms - LPL Financial announced that the advisors with Bury Financial Group have joined LPL Financial's broker-dealer, RIA and custodial platforms. They reported having served approximately $655 million in advisory, brokerage and retirement plan assets and join LPL from Osaic. President and Managing Partner Todd Bury founded the Youngstown, Ohio-based practice in 1992 while he was a sophomore in college. He earned his financial planning license by age 20 and steadily grew his client base, operating as a one-man shop for more than a decade. In 2006, Bury partnered with Vice President/ Managing Partner Brian Laraway, who shared his values and belief that clients are better served in a collaborative environment where each advisor brings a different skillset and background to the team.

09:00 EDT Tang's Concentra Biosciences offers to buy Singular Genomics for $12 per share - In a regulatory filing, Kevin Tang reported a 14.9% stake in Singular Genomics Systems and disclosed a letter dated September 18 that states in part: "On behalf of Concentra Biosciences, LLC, I am pleased to present this non-binding proposal to acquire all of the outstanding shares of common stock of Singular Genomics Systems, Inc. not already owned by Tang Capital Partners, LP. Tang Capital, Concentra's controlling shareholder, beneficially owns approximately 14.9% of the Common Shares of the Company. The transaction detailed in this Proposal would offer the Company's stockholders an opportunity to (1) obtain immediate liquidity at a significant premium to the unaffected stock price or, in the alternative, (2) continue to participate in any future value realized from the ongoing Singular Genomics Systems business through a contingent value right, or "CVR". The key terms of the Proposal are as follows: 1. Purchase Price: We are prepared to offer $12.00 per share in cash to acquire 100% of the Common Shares. This per share price is a 112% premium to the closing stock price of $5.65 on September 12, 2024. The Company announced that it had received a non-binding acquisition proposal from another party after market close on September 12, 2024. 2. Alternative Consideration: Provided there is sufficient interest from existing stockholders, including management holders, we contemplate inviting all interested stockholders (regardless of how many or how few shares they own) to elect to continue to participate in any future value realized from the ongoing Singular Genomics Systems business through a CVR in lieu of receiving $12.00 per share in cash. In this scenario, following the Transaction, the Company would continue as a privately held entity, and its management team would be able to operate the business without the expenses, disclosure obligations and other burdens associated with being a publicly traded company. 3. Financing: The Transaction would be fully financed by Tang Capital and not be subject to any financing condition. 4. Timing: We are prepared to efficiently complete all due diligence required to enter into a definitive agreement. We would expect to consummate the Transaction as quickly as possible through a two-step merger, subject to entry into a definitive merger agreement and satisfaction of customary closing conditions. An acquisition through a two-step merger is typically significantly faster than an acquisition through a one-step merger." Reference Link

08:49 EDT Wearable Devices announces upgrade to Mudra Band for Apple Watch - Wearable Devices unveiled the newest upgrade to its flagship product, the Mudra Band for the Apple Watch. The company said, "Imagine hands-free control with just a gesture! The enhanced functionality of the Mudra Band enables seamless, same-hand, touchless watch operation, providing unmatched convenience and accessibility for all Apple Watch users. With this powerful new update, users can easily manage everyday tasks like answering calls, checking notifications, and controlling music-all without ever touching the screen. By leveraging intuitive gestures to navigate and interact with their watch, it becomes the perfect solution for moments when hands are full or multi-tasking. This update delivers a new level of convenience and freedom for users on the go."

08:47 EDT Crown Electrokinetics' Element 82 secures $10M contract - Crown Electrokinetics announced that its Element 82 division has secured a contract valued at $10 million for lead pipe inspection. The work is scheduled to begin in late October.

08:44 EDT Sonoma Pharmaceuticals regains compliance with Nasdaq requirement - Sonoma Pharmaceuticals received a formal determination letter from Nasdaq notifying Sonoma that it has regained compliance with the minimum bid price requirement for continued listing on the Nasdaq Capital Market and the matter is now closed. As previously reported, On September 22, 2023, Sonoma received a letter from Nasdaq indicating that it did not comply with the $1.00 minimum closing bid price requirement for its common stock for continued listing on the Nasdaq Capital Market. On March 21, 2024, Nasdaq granted us an additional 180 calendar days, or until September 16, 2024, to regain compliance with the listing rule. Effective with the opening of the market on August 30, 2024, the company implemented a 1-for-20 reverse stock split. The closing bid price of Sonoma's common stock exceeded the required $1.00 per share minimum over the subsequent 10 business days. Accordingly, Sonoma has regained compliance and is no longer subject to delisting at this time.

08:43 EDT Twin Vee PowerCats CEO showcases 280 GFX2 in YouTube video - Twin Vee PowerCats announced the launch of its all-new 280 GFX2. Twin Vee's next-generation 28-foot boat was released in a YouTube video where CEO Joseph Visconti showcased and demonstrated the many new upgrades and additions Twin Vee designed and engineered into this offshore PowerCat fishing machine. The 280 GFX2 marks a significant leap forward in boating technology. As Visconti mentions during the video, the 280 GFX2 "is an all-digital product." A 24-inch, fully integrated touchscreen helm offers an intuitive user interface, allowing owners to easily navigate and control the boat like a smartphone. The Company also introduced an all-digital switching system, which replaces the traditional mechanical switches and circuit breakers used in years past. This upgrade increases the reliability of the boat's power distribution system and is more convenient and flexible for boat owners.

08:41 EDT AmpliTech Group receives over $700,000 in cash from single products sale - AmpliTech Group announced receipt of the single cash payment, in excess of $700K, for the reported end of August single sale transaction by its Spectrum Semiconductor Materials Division, this, while AmpliTech Group also surpassing bookings in excess of $1M in the timeframe of September to date, once again as result of increased quoting activity experienced since the start of Q3 2024.

08:40 EDT Byrna Technologies expands presence in Argentina - Byrna Technologies announced a 1,000 launcher order from Argentina's Policia de Seguridad Aeroportuaria, PSA, the federal agency responsible for airport security across the country. The PSA initially purchased Byrna's less-lethal pistols and rifles in April. Since then, the agency has been training officers to use the launchers and has recently begun deploying them in airports across the nation.

08:39 EDT Neuronetics announces additional payors have updates their TMS coverage - Neuronetics announced that additional payors have updated their TMS, transcranial magnetic stimulation, coverage to reduce access barriers for patients with major depressive disorder, MDD. This expanded access allows people to receive treatment such as the Company's NeuroStar TMS Therapy earlier in their treatment regimen. Effective immediately, BlueCross BlueShield of North Carolina has expanded its TMS policy to cover adolescents 15 years and older, based on recent clearance from the United States Food and Drug Administration for NeuroStar as the first and only TMS treatment authorized for this population. BCBC of North Carolina policies affect more than 2.2 million covered lives. Additionally, Louisiana Medicaid has started covering TMS for adults 18 and older, effective immediately.

08:38 EDT EU starts proceedings to specify Apple's interoperability obligations under DMA - The European Commission has started two specification proceedings to assist Apple in complying with its interoperability obligations under the Digital Markets Act. Under the DMA, Apple must provide free and effective interoperability to third party developers and businesses with hardware and software features controlled by Apple's operating systems iOS and iPadOS, designated under the DMA. The specification proceedings formalize the Commission's regulatory dialogue with Apple on certain specific areas of Apple's compliance with Article 6(7) DMA. The first proceeding focuses on several iOS connectivity features and functionalities, predominantly used for and by connected devices. The second proceeding focuses on the process Apple has set up to address interoperability requests submitted by developers and third parties for iOS and IPadOS. The Commission will conclude the proceedings within 6 months from their opening. In the course of these proceedings, the Commission will communicate its preliminary findings to Apple, where it will explain the measures the gatekeeper should take to effectively comply with the interoperability obligation of the DMA. A non-confidential summary of the preliminary findings and envisaged measures will be published to enable third parties to provide comments. These proceedings are without prejudice to the powers of the Commission to adopt a decision establishing non-compliance with any of the obligations laid down in the DMA by a gatekeeper, including the possibility to impose fines or periodic penalty payments. "Today is the first time we use specification proceedings under the DMA to guide Apple towards effective compliance with its interoperability obligations through constructive dialogue. We are focused on ensuring fair and open digital markets. Effective interoperability, for example with smartphones and their operating systems, plays an important role in this. This process will provide clarity for developers, third parties and Apple. We will continue our dialogue with Apple and consult third parties to ensure that the proposed measures work in practice and meet the needs of businesses," said Margrethe Vestager, Executive Vice-President in charge of competition policy. Reference Link

08:38 EDT ReShape Lifesciences announces 1-for-58 reverse stock split - ReShape Lifesciences announced that its Board of Directors has declared a 1-for-58 reverse stock split of the company's common stock, which will be effective for trading purposes upon the commencement of trading on September 23, 2024. At that time, each 58 shares of issued and outstanding common stock and equivalents will be converted into one share of common stock. As a result of the reverse stock split, proportional adjustments will be made to the number of shares of common stock issuable upon exercise or conversion, and the per share exercise or conversion price of the company's outstanding warrants, stock options and convertible preferred stock, in each case in accordance with their terms.

08:36 EDT Sidus Space signs agreement with Neuraspace - Sidus Space announced at the World Space Business Week, or WSBW, conference in Paris, the signing of an agreement with Neuraspace. Under the agreement, Neuraspace will provide Space Traffic Management and LEOP support services to Sidus Space, thereby enhancing the company's constellation operation capabilities. Neuraspace will provide Sidus with high-precision tracking and real-time conjunction screening, using a global network of ground-based sensors, including optical, radar, and laser systems. Neuraspace will also deliver accurate and timely two-line element data and deliver refined orbit determination, to ensure positive satellite identification and safety during separation.

08:36 EDT Disc Medicine appoints Caffe as CRO - Disc Medicine (IRON) announced the appointment of Steve Caffe, MD as the company's Chief Regulatory Officer, CRO. Dr. Caffe is an experienced biotech executive with significant expertise in global regulatory leadership across a wide range of therapeutic areas, including hematology, oncology, and rare diseases. Most recently, Caffe served as Head of Regulatory Affairs at CRISPR Therapeutics (CRSP) where he was involved in the development and approval of Casgevy for sickle cell disease and beta thalassemia.

08:35 EDT Heramba Electric's Kiepe Electric receives order for SmartHybrid battery drive - Heramba Electric announced that its wholly owned subsidiary, Kiepe Electric, KIEPE, has received a framework order from Vossloh Rolling Stock to equip eleven class DE 18 diesel-electric shunting locomotives with KIEPE's SmartHybrid battery drive instead of an additional diesel tank. The low-emission and low-noise operation of KIEPE's SmartHybrid battery drive brings operators various benefits, such as higher availability, decarbonization, and energy efficiency. KIEPE will present the SmartHybrid solution at Booth 430, Hall 9 at InnoTrans in Berlin from September 24-27, 2024.

08:33 EDT Adial Pharmaceuticals announces database lock in PK study of AD04 - Adial Pharmaceuticals announced database lock for the pharmacokinetics, PK, study of AD04, the Company's lead investigational genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder, AUD, in heavy drinking patients. Topline results are expected to be announced during the fourth quarter of 2024. Cary Claiborne, President and Chief Executive Officer of Adial, said, "We are pleased to announce database lock for our pharmacokinetics study. The data has now been transferred to independent statisticians, who will begin the data analysis process for our next FDA interaction. As we prepare for the release of topline results in the fourth quarter, our attention turns to the next critical steps, including planning for re-engagement with the FDA. The insights gained from this study will be crucial in shaping our clinical strategy for the Phase 3 study. In addition, we believe the topline results, will strengthen our position for potential strategic collaborations as we finalize planning efforts for the future clinical development of AD04."

08:32 EDT Sabre signs distribution agreement with Iceland's Play airlines - Sabre and Play airlines, an Icelandic low-cost carrier, announced a multi-year distribution agreement. Through this partnership, Sabre-connected travel agencies will have access to Play airlines' network of flights across North America and Europe. The carrier offers transatlantic travel options, with Iceland serving as a hub for both North American and European travelers. The airline currently operates an all-Airbus fleet, connecting passengers up to 40 destinations in 2024.

08:28 EDT Rezolve AI applauds Microsoft, BlackRock investment in AI infrastructure - Rezolve AI (RZLV) applauds the recent announcement by Microsoft (MSFT) and BlackRock (BLK) to invest $30B into AI infrastructure. This strategic move signals a watershed moment for the artificial intelligence sector and highlights the growing importance of scalable AI platforms to transform industries globally. Daniel M. Wagner, CEO of Rezolve AI, remarked, "The substantial investment by Microsoft and BlackRock into AI infrastructure reflects the accelerating pace of AI adoption across every industry. For companies like Rezolve AI, this investment marks a pivotal shift in the landscape, providing the technological foundation that will allow AI innovators to scale more rapidly and deliver increasingly sophisticated solutions. As a company committed to revolutionizing commerce through our suite of AI products, including Brain Commerce and Brain Checkout, we view this as a tremendous opportunity to leverage the evolving infrastructure and collaborate with major players in AI. The creation of robust, scalable AI platforms will enable Rezolve AI to continue pushing the boundaries of how AI powers the global digital economy, helping businesses connect more deeply with consumers and creating seamless, intelligent experiences across the commerce ecosystem."

08:19 EDT Cidara Therapeutics announces new appointment to its Scientific Advisory Board - Cidara Therapeutics announced the appointment of Rick Bright, Ph.D., Philip Krause, M.D., Mario Barro, Ph.D., and Frederick G. Hayden, M.D., FACP to its Scientific Advisory Board. Bright was most recently CEO of the Pandemic Prevention Institute at The Rockefeller Foundation. Krause has 30 years of experience at the FDA. Barro is a Venture Partner and Head of the Infectious Disease Team at RA Capital Management. Hayden is a Stuart S. Richardson Professor Emeritus of Clinical Virology and Professor Emeritus of Medicine at the University of Virginia School of Medicine in Charlottesville, Virginia, USA.

08:18 EDT Biotricity launches cardiac monitoring pilot program wih hospital system - Biotricity announces the launch of a new cardiac monitoring pilot program with a top hospital system.

08:15 EDT Worksport initiates Alpha launch of Solis Solar Array, COR mobile battery - Worksport announces a major update on its innovative nano-grid system, known as "SOLIS & COR." This system includes the SOLIS solar tonneau cover and the COR portable energy system. The plan to bring this system to market is strategically arranged in three phases: Alpha release, Beta release, and full-scale market launch. The Alpha release phase has been initiated, with approximately 100 systems set for rigorous testing and public exposure during this initial market release.

08:14 EDT Evaxion Biotech launches improved AI-Immunology platform - Evaxion Biotech launches an enhanced version of its clinically validated AI-Immunology platform with an update of its EDEN AI prediction model. Among other improvements, the model can now predict toxin antigens, allowing for the development of improved bacterial vaccines. "Today's launch of the improved EDEN AI prediction model marks an important milestone for Evaxion, further strengthening our AI-Immunology platform. As one of the few truly AI-first TechBio companies, our AI-Immunology platform is at the forefront of innovation. We will continue to invest in its development and refinement to further improve our ability to discover novel targets and develop advanced vaccines," says Christian Kanstrup, CEO of Evaxion.

08:12 EDT Ontrak announces 1-for-15 reverse split effective September 23 - Ontrak y announced that it will implement a 1-for-15 reverse split of the issued shares of its common stock, effective at 12:01 a.m. Eastern Time on September 23, 2024. The Company's common stock is expected to begin trading on a split-adjusted basis when the market opens on September 23 and will continue to trade on The Nasdaq Capital Market under the symbol "OTRK." The new CUSIP number for the common stock will be 683373 401. The reverse stock split is intended to increase the bid price of the common stock to enable the Company to regain compliance with the $1.00 minimum bid price requirement for continued listing on The Nasdaq Capital Market. The Company's stockholders authorized the reverse stock split at the Company's annual meeting of stockholders held on September 10.

08:12 EDT Corning shares 'Springboard' operating-margin target of 20% by end of 2026 - Corning announced it will host a meeting today at its optical fiber facility in Concord, North Carolina, with investors and industry analysts to provide significant updates to its "Springboard" plan to add more than $3B in annualized sales with strong incremental profit and cash flow in the next three years. Wendell Weeks, chairman and Chief Executive Officer, said, "I'm very pleased with the progress we have made on our 'Springboard' plan to add more than $3B in annualized sales by 2026. The plan leads to an improving return profile, with profits growing significantly faster than sales. Today, we are sharing our Springboard operating-margin target of 20% by the end of 2026. We are implementing price increases in Display Technologies and expect to deliver segment net income of $900M to $950M in 2025, and to maintain net income margin of 25%. Additionally, our positive momentum in Optical Communications continues - Enterprise sales are expected to grow by more than 40% year over year in the third quarter, driven by the continued strong adoption of our generative AI products."

08:10 EDT BODi and Truemed team to provide pre-tax reimbursement for health products - The Beachbody Company announced a strategic partnership with Truemed, a leading healthcare payment provider that helps qualified customers spend their HSA/FSA funds on supplements, exercise and other lifestyle interventions that can help treat or prevent chronic disease. The partnership enables qualifying BODi customers to use their pre-tax HSA or FSA money to pay for supplement purchases from BODi's best-in-class product portfolio, including its Shakeology superfood nutrition shakes. By using pre-tax income for purchases, BODi customers can access their supplements at a significant discount... "Since our inception more than 25 years ago, BODi's mission has always been to help people feel their best through our industry-leading fitness and nutrition solutions," said Carl Daikeler, BODi's Co-Founder and Chief Executive Officer. "We believe that health and wellness should be accessible to everyone, and that health savings should be available for the products consumers use to improve their wellness. We are so thrilled to partner with Truemed to make our line of world class supplements and fitness offerings more affordable to the more than 40% of Americans with HSA/FSA accounts."

08:07 EDT Fox Factory debuts first team in Rebelle Rally 2024 - Fox Factory Holding is fielding its first team to compete in the Rebelle Rally, the longest competitive off-road navigation rally in the United States and the first women's endurance off-road rally in America. Kristen Matlock, professional driver and FOX-supported athlete, along with Ashleigh Ballas, one of Fox Factory's test engineers, will debut in the 4x4 class, driving a Fox Factory-designed and developed King of the Hammers Edition Ford Bronco. Additionally, Fox is returning for a second consecutive year as a Rebelle Rally official partner through Trail Trust, Fox Factory's social impact initiative. Since launching Trail Trust in 2021, Fox Factory has focused on championing sustainable adventure for all, including expanding access to outdoor adventuring so everyone can experience the thrill of the ride.

08:06 EDT Aethlon Medical Hemopurifier cancer trial in India approved by ethics committee - Aethlon Medical announced that, on September 9, the Medanta Institutional Ethics Committee - MIEC - granted full ethics approval for Aethlon's safety, feasibility and dose-finding clinical trial of the Hemopurifier in cancer patients with solid tumors who have stable or progressive disease during anti-PD-1 monotherapy treatment, such as Keytruda or Opdivo. The approval is valid for one year, followed by annual reviews. This trial has previously been reviewed by the Institutional Review Board at Medanta. Additionally, the company previously received a No Objection Certificate from DCGI for the proposed oncology trial. The primary endpoint of the approximately nine to 18-patient, safety, feasibility and dose-finding trial is safety. In addition to monitoring safety, the study is designed to examine the number of Hemopurifier treatments needed to decrease the concentration of EVs. These exploratory central laboratory analyses are expected to inform the design of a subsequent efficacy and safety, Premarket Approval, study required by regulatory agencies.

08:06 EDT Microchip announces Microchip Graphics Suite solution - Microchip announces Microchip Graphics Suite, an easy-to-learn, comprehensive solution that simplifies the process of incorporating GUIs, animations and images into a touchscreen display. Developing a GUI can be a complex and lengthy process, requiring significant time and resources to debug and integrate code from various tools. MGS is designed to easily integrate with Microchip's 32-bit microcontrollers and microprocessors and supports multiple development platforms, including MPLAB Harmony v3 and Linux environments. This comprehensive solution to build a GUI interface aims to help designers improve reusability across projects and simplify design complexities. MGS offers compositional tools, including a simulator for hardware-free prototyping. By leveraging the MPLAB Code Configurator, the simulator builds the MCC-generated C code in either web or native mode. In web mode, the tool creates an HTML file that can run on most web browsers with simulated touch interactivity. In native mode, the simulator enables debugging of the GUI on Windows desktop computers. These features enable accurate display and functionality demonstrations that are independent of hardware availability.

08:05 EDT Stingray launches Stingray Naturescape, ZenLIFE on Amazon Fire TV Channels - Stingray announces the launch of two new free ad-supported TV channels, Stingray Naturescape and ZenLIFE, on Amazon Fire TV Channels. These channels are designed to bring tranquility and wellness into the homes of viewers worldwide, with additional videos also available on ad-supported video on demand on the platform. Looking ahead, Stingray is set to expand its offerings on Amazon Fire TV Channels with the future addition of Qello Concerts, Stingray Classica, and Stingray Djazz. These upcoming channels will further diversify Stingray's portfolio of streaming content, providing even more options for entertainment and enrichment.

08:03 EDT Humacyte announces allowance of U.S. patent covering BioVascular Pancreas - Humacyte announced the allowance of a U.S. Patent covering its BioVascular Pancreas product candidate for the treatment of type 1 diabetes. The BVP is designed to enable the delivery and survival of insulin-producing islets inside the body, using Humacyte's investigational acellular tissue engineered vessel as a carrier for the islets. The new U.S. Patent, titled "Bioartificial Vascular Pancreas," covers the design and composition of the BVP. The patent is owned by Yale University and is exclusively licensed to Humacyte. The BVP is designed to enable the delivery and survival of insulin-producing islets inside the body. Such technology could overcome many of the hurdles currently associated with implantation of islets into diabetic patients. In June 2024, Humacyte reported positive results from two sets of ongoing preclinical studies, supporting the potential of the BVP product candidate to deliver insulin-producing islets as a treatment for type 1 diabetes. At a presentation at the Breakthrough T1D Beta Cell Consortium Meeting, Humacyte's scientists presented data in which stem cell-derived islets restored normal blood sugar in diabetic mice. Islets manufactured from human stem cells may provide the basis for the islets that are ultimately delivered using the BVP product candidate. At the American Diabetes Association annual meeting, Humacyte reported successful implantation of BVPs into non-human primate recipients. In the study, primate BVP implants showed islet survival and continued insulin production throughout the three-month duration of the study. Islets also developed capillaries to support survival of the insulin-producing cells.

08:02 EDT Arcutis Biotherapeutics annonnces publication of ZORYVE in JAMA Dermatology - Arcutis Biotherapeutics announced that the Journal of American Medical Association Dermatology, JAMA Dermatology, published the positive results from two pivotal Phase 3 studies evaluating the efficacy and safety of ZORYVE cream 0.15% as a once-daily, steroid-free treatment for mild to moderate AD. ZORYVE cream, 0.15%, was approved in July 2024 by the U.S. Food and Drug Administration, FDA, for the topical treatment of mild to moderate AD in adult and pediatric patients 6 years of age and older and is available in pharmacies nationwide. The article reported that treatment with ZORYVE cream resulted in significant improvements across multiple efficacy endpoints, including achieving a statistically significant improvement in the primary efficacy endpoint of IGA Success, as well as statistically significant improvements in key secondary endpoints, including itch and a reduction in Eczema Area and Severity Index score.

07:59 EDT Allstate reports August estimated catastrophe losses of $272M vs. $542M in July - The Allstate Corporation "announced estimated catastrophe losses for the month of August of $272 million or $215 million, after-tax, including favorable reserve reestimates for prior period events. Catastrophe losses for August include 15 events estimated at $306 million, with approximately $75 million related to a hail event in Calgary, Canada. The Calgary hail event estimate includes reinsurance reinstatement premiums and is net of anticipated reinsurance recoveries of $225 million. Total catastrophe losses for July and August were $814 million or $643 million, after-tax, and total catastrophe losses for August year-to-date were $3.67 billion or $2.90 billion, after-tax."

07:39 EDT DocGo expands care gap closure program for CA medicaid recipients - DocGo announced the expansion of a program to enhance healthcare access for California Medi-Cal enrollees/patients/members. The program aims to re-engage patients with the healthcare system, delivering essential care to underserved communities in Sacramento, San Diego, Riverside, Los Angeles, San Bernadino, and Orange County through a partnership with a top 10 national insurance provider. "This expansion reinforces DocGo's leadership in facilitating the delivery of high-quality, highly-accessible healthcare," said Lee Bienstock, CEO of DocGo. "By leveraging technology and mobile clinicians to broaden services in California, we're removing barriers to care and helping drive the transition to a value-based care system. This program is part of a larger movement toward proactive, preventative care-helping individuals stay healthy, reduce unnecessary hospitalizations, and improve health outcomes across the board."

07:33 EDT Psyence Biomedical to acquire 11.13% stake in PsyLabs - Psyence Biomedical has entered into a conditional share sale agreement with Psyence Group for the acquisition of an 11.13% stake in privately-held PsyLabs, a company focused on the production of psychedelic active pharmaceutical ingredients and extracts for use in research, clinical trials and drug development. Per the terms of the Proposed Acquisition, Psyence Biomed will issue to Psyence Group shares of its common stock valued at $1.1M, at a price of $0.55 per share, in exchange for Psyence Group's 11.13% stake in PsyLabs. Psyence Biomed previously announced a worldwide, exclusive, royalty-bearing IP licensing agreement with PsyLabs to supply pharmaceutical-grade, EU GMP nature-derived psilocybin to be evaluated in future clinical trials as a potential treatment for Alcohol Use Disorder and other Substance Use Disorders and for commercialization of the licensed product. Psyence Biomed plans to lead with a clinical trial in AUD, Psyence Biomed's second development indication. The licensed product will require further development work by PsyLabs, which will be conducted during the remainder of 2024 and into 2025. PsyLabs is also commercially licensed for the production and export of additional pharmaceutical grade psychoactive compounds, including ibogaine and mescaline. The completion of the Proposed Acquisition is subject to the fulfilment, or waiver, of certain conditions, including board approvals, regulatory approvals, a satisfactory due diligence process, and the achievement of a pre-defined product development milestone by PsyLabs by no later than October 31, 2024.

07:24 EDT Ensysce Biosciences submits Phase 3 protocol to FDA - Ensysce Biosciences has submitted to the FDA its PF614-301 protocol of the study, "A Multicenter, Randomized, Double-Blind, Placebo-and Active-Controlled Study to Evaluate the Efficacy and Safety of PF614 for the Treatment of Moderate to Severe Pain after Abdominoplasty". Included in the Phase 3 study is the Company's statistical analysis plan for review and input by the FDA. The study, once finalized with the FDA, will be conducted through four to six clinical sites in the United States, and is designed to assess the analgesic efficacy of PF614 compared to placebo in subjects with moderate-to-severe pain following abdominoplasty. Additionally, Ensysce will evaluate PF614 versus an active comparator, the use of rescue medication and the safety and tolerability of PF614.

07:22 EDT Genmab launches partnership with OpenAI for 'AI Everywhere' - Genmab (GMAB) announced that it is pioneering next-generation antibody therapies to treat cancer and other serious diseases. Their mission is ambitious: to revolutionize patient care with transformative "knock-your-socks-off" antibody treatments. "Genmab's ambition is to integrate AI into everything we do," said Tahi Ahmadi, Executive Vice President and Chief Medical Officer, Head of Experimental Medicines. "We anticipated AI to contribute significantly to the quality of our science, decision making, and efficiency in bringing medicines to patients." As a company that has recently tripled in size, Genmab wanted to use AI to address operational challenges-and develop new ways of working with vast amounts of complex scientific data, the company said. Just one month after ChatGPT Enterprise launched, Genmab rolled it out to 1,000 employees. Now, less than a year later, the company announced that it has launched "AI Everywhere" to give ChatGPT access to almost everyone at the company-more than 2,000 licenses. Genmab said it now has more than 100 custom GPTs that help with everything from drafting documents, summarizing scientific literature to simple and advanced analytics of data. "Our partnership with OpenAI not only highlights Genmab's commitment to innovation, but also aims to unleash every colleague's inner algorithmic leader to truly unlock large language model's potential and discover increasingly novel and progressive ways of leveraging AI to improve, and at times, re-imagine their tasks," said Hisham Hamadeh, SVP and Global Head of Data Sciences and AI at Genmab. TheFly notes that previous reports have said that Nvidia (NVDA), Apple (AAPL) and Microsoft (MSFT) have discussed joining a funding round for OpenAI. Reference Link

07:19 EDT PyroGenesis congratulates EarthGrid on JV with EnerTech - PyroGenesis Canada congratulated its client EarthGrid, which announced yesterday that it has signed a joint venture agreement with EnerTech to deploy infrastructure projects in four phases across the United States, Europe and the Middle East. The first two phases of the projects consist of an estimated $18 billion in US infrastructure projects. PyroGenesis is pleased to confirm that in its press release dated January 16, 2024, wherein it was announced that PyroGenesis "received a $667,000 non-refundable down payment under a master agreement for multi-year multi-plasma torch purchases" from an undisclosed client, that the undisclosed client is EarthGrid and is related to this project. PyroGenesis and EarthGrid are parties to a Master Agreement according to which they have agreed to work collaboratively with the goal of finalizing and executing an initial statement of work, which would outline the terms that PyroGenesis would design, build, and deliver five high power 2MW air plasma torch systems for an aggregate price of approximately $13 million. The Master Agreement contemplates additional SOWs being entered into for the purchase of torches, related equipment, and services. As part of the Master Agreement, EarthGrid provided PyroGenesis with a $500,000 non-refundable down payment. At the time of this earlier announcement, EarthGrid's name was withheld for competitive and confidentiality reasons.

07:18 EDT Nayax to sponsor Five Star's 2024 Feeding the Future Golf Classic - Nayax will sponsor Five Star's 2024 Feeding the Future Golf Classic in Chattanooga, Tennessee on September 23, 2024. Founded in 2017 by Chattanooga-based Five Star Breaktime Solutions, a provider of on-site food and beverage services for workplaces nationwide, Feeding the Future is a 501(c)(3) nonprofit dedicated to providing meals to children in need. The annual Golf Classic combines fun, philanthropy, and community to raise funds for Feeding the Future, and has raised over $1 million for food banks and other charitable organizations.

07:17 EDT Atha Energy completes staking of additional claims at Angilak Project - ATHA Energy announced the completion of the staking of additional claims at the Company's 100%-owned Angilak Project in Nunavut. The Angilak Project area is now 158,447 hectares in size. The claims were staked as a follow-up to the Company's highly successful maiden drill program that was completed in late August 2024. With the additional property, the Company now controls the entire prospective Lac 50 structural corridor as well as an additional parallel corridor, both related to the Snowbird Tectonic Zone. These claims represent prospective continuations of known mineralized trends related to the Snowbird Tectonic Zone and the margins surrounding the Angikuni Basin, which is prospective to host unconformity style mineralization. The Angilak Project is situated within the Angikuni Basin , approximately 225 km southwest of Baker Lake in the Kivalliq Region of Nunavut. The Angilak Project is host to the Lac 50 Uranium Deposit, which has a historical mineral resource estimate of 43.3M lbs at an average grade of 0.69% U3O8. The 2024 Angilak exploration program consisted of diamond drilling, airborne geophysical surveys, and surficial sampling and mapping programs. Exploration activities prioritized areas proximal to known zones of uranium mineralization for expansion and discovery. During Phase I: diamond drilling, which began in early June and continued through to late August, the Company completed twenty-five diamond drill holes for a total of ~10,051 m. Drilling targeted expansion along the Lac 50 Trend while also expanding mineralization along several regional targets identified as the Lac 48, 52, and 54 Trends. All samples have been sent to SRC laboratories in Saskatoon, SK for assay analysis.

07:15 EDT Genmab launches partnership with OpenAI for 'AI Everywhere' - Genmab announced that it is pioneering next-generation antibody therapies to treat cancer and other serious diseases. Their mission is ambitious: to revolutionize patient care with transformative "knock-your-socks-off" antibody treatments. "Genmab's ambition is to integrate AI into everything we do," said Tahi Ahmadi, Executive Vice President and Chief Medical Officer, Head of Experimental Medicines. "We anticipated AI to contribute significantly to the quality of our science, decision making, and efficiency in bringing medicines to patients." As a company that has recently tripled in size, Genmab wanted to use AI to address operational challenges-and develop new ways of working with vast amounts of complex scientific data, the company said. Just one month after ChatGPT Enterprise launched, Genmab rolled it out to 1,000 employees. Now, less than a year later, the company announced that it has launched "AI Everywhere" to give ChatGPT access to almost everyone at the company-more than 2,000 licenses. Genmab said it now has more than 100 custom GPTs that help with everything from drafting documents, summarizing scientific literature to simple and advanced analytics of data. "Our partnership with OpenAI not only highlights Genmab's commitment to innovation, but also aims to unleash every colleague's inner algorithmic leader to truly unlock large language model's potential and discover increasingly novel and progressive ways of leveraging AI to improve, and at times, re-imagine their tasks," said Hisham Hamadeh, SVP and Global Head of Data Sciences and AI at Genmab. TheFly notes that previous reports have said that Nvidia (NVDA), Apple (AAPL) and Microsoft (MSFT) have discussed joining a funding round for OpenAI. Reference Link

07:15 EDT Siyata Mobile announces new order for private security firm - Siyata Mobile's SD7 handsets and VK7 vehicle kits were purchased and deployed by a new customer, Trans-West Security Systems. Trans-West Security Systems is the largest physical private security company in the county in which it operates. It has been providing security services for more than 50 years. Trans-West is deploying hundreds of the company's devices in an initiative to replace its aging two-way radios.

07:13 EDT Gain Therapeutics to present preclinical data on GT-02287 at Neuroscience 2024 - Gain Therapeutics announced presentations, including two late-breakers, at Neuroscience 2024 featuring preclinical data supporting development of GT-02287, the Company's clinical stage lead drug candidate, in Parkinson's disease with or without a GBA1 mutation. Neuroscience 2024, the Society for Neuroscience's premier event, will be held at McCormick Place Convention Center in Chicago, IL from October 5-9, 2024.

07:13 EDT Canoo's Oklahoma City manufacturing facility achieves final activation - Canoo announced that the U.S. Customs and Border Protection, CBP, has officially approved final activation of Canoo's Oklahoma City operations as a Foreign-Trade Zone, FTZ, becoming one of the largest FTZs in the State of Oklahoma. This activation status qualifies Canoo to take advantage of FTZ benefits, effective immediately. This final designation will allow Canoo to significantly streamline its operations, offering financial and logistical benefits as the company scales production of its modular electric commercial vehicles for customers in the U.S., the United Kingdom, Europe, and the Middle East.

07:11 EDT Adicet Bio announces clinical biomarker data from GLEAN trial - Adicet Bio announced ADI-001 clinical biomarker data from the Phase 1 GLEAN trial which further reinforces the potential of ADI-001 as a best-in-class allogeneic cell therapy for autoimmune diseases. Notably, ADI-001 demonstrated robust tissue trafficking resulting in high levels of ADI-001, significant chimeric antigen receptor, or CAR, T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue. These data will be presented at the 9th Annual CAR-TCR Summit on Thursday, September 19 in Boston. ADI-001 demonstrated significant levels of CAR T cell activation and tissue exposure in lymph node biopsies in the GLEAN trial, with a mean exposure of 236,701 CAR T cells per million across all dose levels, representing a range of 27-64% of total cellular material detected by ddPCR in evaluable biopsies at the 1E9 dose, and exceeding levels previously reported for patients who received autologous alpha-beta CAR T therapies. CAR T cells detected in tissues also demonstrated a robust activation profile, based on in situ detection of granzyme B. Recently published studies have demonstrated depletion of CD19+ plasmablasts, memory B cells and naive B cells in peripheral blood using anti-CD20 targeted antibodies, however, these CD20-targeted antibody modalities failed to deplete B cells within secondary lymphoid tissues. Concurrent with ADI-001 tissue trafficking and activation, complete depletion of CD19+ B cells within analyzed secondary lymphoid tissue was also observed. These results support ADI-001's potential for achieving complete B-cell depletion in peripheral blood and within tissues. Adicet is advancing the ADI-001 clinical program in lupus nephritis, systemic lupus erythematosus, systemic sclerosis and anti-neutrophil cytoplasmic autoantibody associated vasculitis (AAV) and expects to report initial clinical data in the first half of 2025.

07:11 EDT Tonix Pharmaceuticals announces issuance of U.S. patent on Tosymra - Tonix Pharmaceuticals announced that the United States Patent and Trademark Office issued U.S. Patent No. 12,090,139 to the Company on September, 17, 2024. The patent, entitled "Formulations Comprising Triptan Compounds", claims a pharmaceutical composition, a method of treating migraine via intranasal administration, and an intranasal delivery system for Tosymra(R). This patent, excluding possible patent term extensions, is expected to expire in 2030. "We believe this patent further solidifies Tosymra(R) in the market as a differentiated drug with a differentiated administration method," said Seth Lederman, M.D., Chief Executive Officer of Tonix Pharmaceuticals. "This new patent targets specific delivery and composition. We are thrilled to have these additional issued patent claims, which add to the intellectual property protection existing for Tosymra"

07:09 EDT Edgewise Therapeutics announces top-line data of EDG-7500 - Edgewise Therapeutics announced top-line data of EDG-7500 from the Phase 1 trial in healthy subjects and the single-dose arm of the Phase 2 CIRRUS-HCM trial in patients with obstructive HCM. EDG-7500 is a novel oral, selective, cardiac sarcomere modulator, specifically designed to slow early contraction velocity and address impaired cardiac relaxation associated with HCM. In the placebo-controlled Phase 1 single ascending dose, or SAD, trial, healthy subjects received single doses of EDG-7500, ranging from 5 to 300 mg. In the multiple ascending dose, or MAD, portion of the trial, healthy subjects received 25 to 100 mg once daily for 14 days. EDG-7500 was well tolerated in both the SAD and MAD; there were no clinically meaningful changes or trends in vital signs, clinical chemistry, hematology, or electrocardiograms. There were no meaningful changes in LVEF for all SAD and MAD subjects across a broad range of EDG-7500 exposures. In the MAD, a half-life of approximately 30 hours was observed, and steady state was achieved in approximately 4 days after the start of once-daily dosing. Generally, dose proportional increases in exposure were observed in both SAD and MAD. In CIRRUS-HCM Part A, patients with obstructive HCM received a single dose of 50, 100 or 200 mg of EDG-7500. A 67% mean reduction in resting LVOT pressure gradient and a 55% mean reduction in provokable LVOT-G were observed in patients receiving the 100 and 200 mg single doses. LVOT gradients less than 30 mmHg at rest and less than 50 mmHg with Valsalva were observed in 60% of patients receiving 100 or 200 mg of EDG-7500. Importantly, gradient reduction was achieved without a meaningful change in LVEF. Treatment with a single dose of EDG-7500 also led to a 64% mean reduction in NT-proBNP, a key biomarker of heart failure, in the 200 mg cohort. This reduction highlights the potential of our mechanism in the treatment of diseases of diastolic dysfunction, including non-obstructive HCM. Across the Phase 1 and CIRRUS-HCM trials, no subjects had a LVEF reduction to below 50% across a broad range of EDG-7500 exposures.

07:09 EDT European Wax Center announces commercial, operational updates - European Wax Center announced several strategic Commercial and Operational updates as the Company continues to focus on its key initiatives of attracting new guests, retaining first-time guests and winning back lapsed guests. These updates include a new partnership with dolabra digital, a leader in data-driven strategy, and a realignment of its Commercial and Field Operations teams. Dolabra will focus on enhancing guest acquisition, engagement and loyalty with the goal of driving sustained growth and operational efficiency for the Company.

07:08 EDT Laser Photonics releases shareholder letter on growth and strategic plans - Laser Photonics Corporation has released a shareholder letter.... "we have served clients operating in defense, nuclear power, oil and gas, nondestructive testing, robotics, and more. Along with this interest from industry professionals in our products, we have seen our stock rise significantly over the past months...Further, LPC has enhanced its defense and military-oriented product line as we offer DefenseTech laser systems in collaboration with Fonon Technologies, our promotion sibling for defense and military applications. With new partnerships and increased sales in this division, this venture has proven its success and achieved a new level of monetization lately. Expansion of Team and Facilities We have been actively attracting new talents to expand our capabilities and accelerate efforts in sales and engineering. Among top management, LPC has welcomed a new Vice President of Sales, as well as new Directors for Semiconductor, Additive Manufacturing, and Outside Sales...To expand our visibility and awareness in various industrial sectors and capital markets, we have actively participated in several key conferences this year, including NCMS technology showcases for government contractors, MegaRust 2024 in San Diego, focusing on corrosion solutions for the Navy, and many others..."

07:07 EDT Plug Power launches equipment lease financing platform - Plug Power has announced the establishment of an equipment leasing platform and is targeting over $150 million in the near to mid-term. This platform is intended to enable Plug to access capital by leveraging its equipment asset base and to provide equipment financing solutions to Plug's customers to support equipment sales growth. As a first step in this platform, Plug signed three separate sale and leaseback transactions equivalent to ~$44 million with GTL Leasing, a portfolio company of Antin Infrastructure Partners. The sale and leaseback transactions include various gaseous and cryogenic assets such as trailers and storage tanks for the transport and storage of hydrogen molecules.

07:07 EDT SLB, Nvidia collaborate to develop generative AI solutions - SLB (SLB) is building on its long-standing collaboration with Nvidia (NVDA) to develop generative AI solutions for the energy industry. The collaboration accelerates the development and deployment of industry-specific generative AI foundation models across SLB's global platforms, including its Delfi digital platform and Lumi data and AI platform, by leveraging Nvidia NeMo, part of the Nvidia AI Enterprise software platform, to develop custom generative AI that can be run in the data center, in any cloud or at the edge. Working together with Nvidia, SLB will build and optimize models to the specific needs and requirements of the data-intensive energy industry, including subsurface exploration, production operations and data management.

07:06 EDT Darden, Uber partner to introduce on-demand delivery - Darden Restaurants (DRI) and Uber Technologies (UBER) have entered into an exclusive multi-year delivery partnership, set to begin with Olive Garden in late 2024. The agreement will enable restaurant guests to order on-demand delivery via Darden restaurant channels, with delivery handled by Uber Direct, through Uber's national delivery network. An initial pilot of first-party delivery from a limited number of Olive Garden locations will begin in late 2024. Upon the completion of a successful pilot, national expansion at Olive Garden is expected to be complete by May 2025. Once live, guests will be able to order delivery through Olive Garden's website and app at more than 900 company-owned locations across the U.S., giving Olive Garden fans access to stress-free delivery while guest data and insights will remain with Olive Garden. Uber Direct, which enables merchants to tap into Uber's delivery technology and logistics network, will power deliveries enabling couriers to bring guests their Olive Garden favorites at home.

07:06 EDT Intel says not currently planning to divest majority interest in Mobileye - Intel (INTC) said in a statement: "As the majority shareholder in Mobileye (MBLY), Intel has an unwavering focus on value creation and are excited about the future of its business. We currently do not have any plans to divest a majority interest in the company. By providing Mobileye with separation and autonomy, we have enhanced its ability to capitalize on growth opportunities and accelerate its path to creating even greater value. We believe in the future of autonomous driving technology and in Mobileye's unique role as a leader in the development and deployment of advanced driver assistance systems." Reference Link

07:05 EDT Builders FirstSource CEO Dave Rush to retire, Peter Jackson to succeed - Builders FirstSource announced that as part of a planned succession, its board of directors has named Peter Jackson, CFO, as the company's next president and CEO and member of its board of directors, effective November 6. Jackson will succeed Dave Rush, who has served as CEO since November 2022 and is retiring after 25 years of dedicated service to the company. Rush will remain on the Builders FirstSource board of directors and continue as a special advisor to ensure a transition. Pete Beckmann, senior VP, financial planning & analysis, will succeed Jackson as CFO.

07:04 EDT Vanda Pharmaceuticals' NDA for tradipitant in gastroparesis rejected by FDA - Vanda Pharmaceuticals provided an update on its tradipitant development program. On September 18, the FDA declined to approve Vanda's New Drug Application - NDA - of tradipitant for the treatment of symptoms in gastroparesis. There has been no effective treatment for gastroparesis approved by the FDA in over 40 years. Vanda's tradipitant application included evidence from two placebo-controlled studies, the results of which were published in peer review journals. The CRL was conclusory in nature, generally disregarded the evidence provided and instead suggested that Vanda conduct additional studies with a design and duration inconsistent with the advice of key experts in the field and not appropriate based on the scientific understanding and natural course of the disorder. Vanda believes that the tradipitant application has met the substantial evidence of efficacy standard with a favorable benefit risk profile for the treatment of patients with gastroparesis. A number of patients currently treated with tradipitant have filed a Citizen Petition urging FDA to approve tradipitant for the treatment of gastroparesis. Vanda will continue to pursue the marketing authorization for tradipitant and will continue to support the expanded access program. Vanda plans to submit a separate NDA for tradipitant for the prevention of vomiting in motion sickness later this year.

07:04 EDT EVgo appoints Paul Dobson Chief Financial Officer - EVgo announced the appointment of Paul Dobson as Chief Financial Officer CFO, effective October 1. Dobson has more than 30 years of professional experience in finance and operations roles - including in the energy sector, most recently serving as CFO of Ballard Power Solutions, a global provider of innovative clean energy solutions. In his role as CFO, Dobson will help EVgo solidify its path to profitability as it continues to expand its nationwide network. Badar Khan, CEO of EVgo, said, "Today's announcement is the conclusion of a rigorous search and selection process to identify the ideal leader to join our executive team and oversee our finance function, and we are thrilled to welcome Paul to EVgo. With his decades of financial, operational and leadership experience in the energy industry, the Board and I are confident that Paul is the right executive at the right time to take on this role. The electric revolution is well underway, and we look forward to benefitting from Paul's expertise as we build on our momentum and further cement EVgo as the charging network of choice for investors, drivers and business partners."

07:04 EDT Autolus Therapeutics appoints WIll as Chief Development Officer - Autolus Therapeutics announced the appointment of Matthias Will, M.D., as Chief Development Officer. Dr. Will is joining Autolus' executive team and will lead the company's development organization effective September 30, 2024. Will joins Autolus from Dren Bio, where he served as Chief Medical Officer

07:03 EDT Darden reports Q1 blended same-restaurant sales decrease of 1.1% - Q1 same-restaurant sales by segment: Olive Garden (2.9%); LongHorn Steakhouse 3.7%; Fine Dining (6.0%); Other Business (1.8%).

06:37 EDT Signing Day Sports to acquire majority equity interest in Swifty Global - Signing Day Sports announced the signing of a binding term sheet to acquire 95-99% of the issued and outstanding shares of Dear Cashmere Group, doing business as Swifty Global, a global sports and casino technologies company, and that this acquisition is expected to be the first transaction of its newly initiated growth strategy to buy and build companies in the sports and casino technology industry and other synergistic companies. The transaction is structured as an all equity deal meaning that Signing Day Sports will acquire such percentage of Swifty through the issuance of its securities to the controlling stockholders of Swifty. Signing Day Sports is not required to make any cash payment to Swifty in connection with the acquisition of the Swifty equity securities. Swifty's technology is scalable and GLI-certified and it holds gaming licenses in the UK, Ireland, South Africa, Curacao, and is expected to obtain a gaming license in Malta in the near future. Swifty's in-house development team has developed GLI-certified software for the sports gaming sector. Swifty also serves its own licensed clients in online sports betting and casino gaming in a limited number of jurisdictions. Swifty, which is debt free, achieved revenue of over $128M and net profit of approximately $2.44M in FY23, despite investments of nearly $3.1M in software development and licensing. Swifty's common stock trades on the Pink market tier of OTC Markets Group under the ticker DRCR. The acquisition of Swifty by Signing Day Sports is intended to result in the combined company being traded on NYSE American. Swifty will continue to operate under the Swifty management team led by James Gibbons, while Signing Day Sports will become a subsidiary of the publicly listed company. At the closing of the expected acquisition, Signing Day Sports will acquire from James Gibbons and Nicolas Link the common stock and preferred stock of Swifty held by them constituting at least 95% of the voting power of Swifty and at least 95% of the economic value of Swifty. The sellers will receive a number of shares of Signing Day Sports common stock that is equal to 19.99% of the issued and outstanding common stock of Signing Day Sports. The preferred stock will convert into common stock following shareholder approval and the clearance of a new initial listing application with NYSE American, ensuring compliance with NYSE American regulations. Signing Day Sports legacy shareholders are expected to retain 8.24% of the post-transaction company's shares, with the remaining 91.76% being issued to the sellers and the other stockholders of DRCR. The transaction is based on an assumed equity value of $14M for Signing Day Sports and $156M for Swifty. To support the transaction, both companies will collectively seek to raise at least $2M in financing, with the proceeds split equally. At the closing, James Gibbons will become CEO of Signing Day Sports and remain CEO of Swifty. Signing Day Sports management will remain the management of the Signing Day Sports subsidiary that will be established in connection with the acquisition. The post-Closing board of Signing Day Sports will consist of five members, two Signing Day Sports board members will resign, and Swifty will appoint two directors to fill the vacancies. After the transaction, Signing Day Sports will consolidate Swifty's financial statements and operate Swifty as a subsidiary. The closing is anticipated by October 31.

06:18 EDT EU new car registrations down 18.3% in August - In August, new EU car registrations saw a sharp decrease of 18.3%, with negative results across the region's four major markets as double-digit losses were witnessed in Germany, France, and Italy, and the Spanish market declining by 6.5%, according to the ACEA. Publicly traded companies in the auto space include Ford (F), General Motors (GM), Honda (HMC), Mercedes-Benz (MBGYY), Nissan (NSANY), Stellantis (STLA), Tesla (TSLA), Toyota (TM) and Volkswagen (VWAGY). Reference Link

06:03 EDT Comstock Inc. provides revenue, operational and financial update - Comstock Inc. announced new revenue contracts for its solar panel recycling business, an international equity partnership with revenue and royalty generating agreements for its low carbon, lignocellulosic fuels business, certain asset sales and an indicative term sheet for $325M in gross funding through SBC Commerce, a U.S. based, globally positioned, private equity group. The company announced an additional convertible debt financing of $3.5M, with an option for an additional $1.5M, to provide the liquidity and capacity to continue the fast pace of commercial transaction execution in the fuels and metals segments. The remainder of Comstock's convertible debt has been either converted, redeemed or extinguished. The SBCC transactions are progressing and subject to final structuring, documentation, due diligence and applicable regulatory approvals. This term sheet represents a combination of direct investments and certain asset sales that recognizes valuations, nearly $500M in management's estimates, for the company's three businesses and positions growth capital to accelerate the commercialization of its fuels, metals and mining businesses.

05:36 EDT BNY Mellon decreases prime lending rate to 8% - BNY Mellon will decrease the prime lending rate by 0.50%, from 8.50% to 8%, effective Thursday, September 19.

05:30 EDT Argenx publishes ADHERE Study in Lancet Neurology - Argenx announced publication in The Lancet Neurology of the ADHERE Study, the largest clinical trial to date in chronic inflammatory demyelinating polyneuropathy, or CIDP. CIDP is a rare, debilitating, often progressive, immune-mediated neuromuscular disorder of the peripheral nervous system. This is the first time the ADHERE Study has been published in a peer-reviewed medical journal. ADHERE met its primary endpoint demonstrating a 61% reduction in the risk of relapse versus placebo; 69% of patients treated with Vyvgart Hytrulo, regardless of prior treatment, demonstrated evidence of clinical improvement, including improvements in mobility, function and strength and 99% of trial participants elected to participate in the ADHERE open-label extension. Vyvgart Hytrulo was well-tolerated and safety results were consistent with the known safety profile of Vyvgart in previous clinical studies and real-world use. Vyvgart Hytrulo reduced the risk of relapse by 61% as assessed by aINCAT deterioration versus placebo. Vyvgart Hytrulo reduced the risk of CIDP disease progression based on time-to-first 4-point decrease in I-RODS score compared with Stage B baseline. In Stage A, time to first improvement on aINCAT, I-RODS, or grip strength scores among the 25th percentile of patients was 9.0 days after the first dose of Vyvgart Hytrulo; the median estimate was 22 days. In June, the FDA approved Vyvgart Hytrulo for the treatment of adult patients with CIDP. Vyvgart Hytrulo is also approved for the treatment of generalized myasthenia gravis in adult patients who are anti-acetylcholine receptor antibody positive.

05:20 EDT BlackSky awarded seven-figure data services contract from HEO - BlackSky was awarded a seven-figure data services contract from HEO to bring automated low-latency capabilities to non-Earth imaging, or NEI, services for defense, intelligence and commercial use. Under the agreement, the companies will partner to bring BlackSky's current constellation into HEO's NEI sensor network. The contract is now moving into its second phase with a focus on automating the entire tasking-to-delivery process, following an initial proof of concept phase. BlackSky will provide proprietary mid-inclination orbit, high-resolution imagery to HEO. BlackSky's high-cadence imaging capabilities are expected to increase the feasibility of capturing NEI data over the middle latitudes of Earth. Activating NEI capabilities gives BlackSky the ability to leverage unused capacity typically associated with satellites passing over the ocean or satellites in eclipse, traveling across the dark side of Earth.

05:15 EDT Sportradar to introduce micro markets for ATP tennis matches in October - Sportradar is set to launch micro markets, the next generation of in-play betting products, across sports, opening fresh revenue streams for operators. In a strategic move, Sportradar, in collaboration with Tennis Data Innovations, or TDI, is introducing micro markets for ATP tennis matches this October. Sportradar currently offers micro markets across other sports including soccer and table tennis. By leveraging advanced artificial intelligence and deep tennis data from TDI, Sportradar will offer operators a solution that processes hundreds of thousands of data points per match. The result is eight distinct micro markets expected to generate approximately 1,500 new betting opportunities per match.