Stockwinners Market Radar for September 09, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

21:02 EDT Workday director sells $1.9M in common stock - In a regulatory filing, Workday disclosed that its director George Still sold 7.5K shares of common stock on September 5th in a total transaction size of $1.9M.

19:54 EDT Mountain & Co Acquisition gets Nasdaq denial of request for continued listing - Mountain & Co. I Acquisition announces that on September 3, 2024, the Company received a letter from the NASDAQ Stock Market notifying the Company that Nasdaq Listing Qualifications Staff have determined to deny the Company's request for continued listing on The Nasdaq Stock Market. On June 5, 2024, Staff notified the Company the Company that it was not in compliance with Nasdaq's Listing Rule 5250(c)(1) due to the delay in the filing of the Company's Form 10-Q for the period ended March 31, 2024. On August 2, 2024, The Company submitted a plan to regain compliance with the Filing Requirement. Subsequently, the Company also failed to timely file its Form 10-Q for the period ended June 30, 2024.

19:01 EDT MediciNova says abstract regarding MN-166 accepted for poster presentation - MediciNova announced that an abstract regarding a clinical trial of MN-166 in the treatment of Amyotrophic Lateral Sclerosis, COMBAT-ALS study has been selected for a poster presentation at the 35th International Symposium on ALS / MND to be held December 6-8, 2024 in Montreal, Canada. The poster presentation will be presented by lead Principal Investigator of this clinical trial, Bjorn Oskarsson, MD, FAAN Associate Professor of Neurology at Jacksonville, FL, Director of ALS, Center of Excellence.

18:40 EDT Agilysys CEO sells $2.1M in common stock - In a regulatory filing, Agilysys disclosed that its CEO Ramesh Srinivasan sold 20K shares of common stock on September 9th in a total transaction size of $2.1M.

18:28 EDT World Kinect announces new $200M buyback - World Kinect Board of Directors approved an additional $200 million share repurchase authorization. The new authorization is in addition to the Company's previous authorization, which had approximately $108 million remaining as of June 30, 2024.

18:21 EDT Deckers Outdoor director sells $3.38M in common stock - In a regulatory filing, Deckers Outdoor disclosed that its director David Powers sold 3.9K shares of common stock on September 6th in a total transaction size of $3.38M.

17:40 EDT Woodward names Ron Charles as Chief Human Resources Officer - Woodward (WWD) announced the appointment of Ron Charles as its Executive Vice President and Chief Human Resources Officer, effective September 9. Charles joins Woodward with over 25 years of experience in Human Resources. His most recent position was CHRO at Chemours (CC), where he spent seven years in progressively senior roles.

17:34 EDT Boot Barn reports August SSS up 6%, preliminary Q2 SSS up 4% - Sees SSS for first two weeks in Sept up 8.2%. Jim Conroy, CEO, commented, "I am pleased with the strong execution from the entire Boot Barn team. We continue to see solid performance from new store openings in multiple markets across the country. From a same store sales perspective, it is encouraging to see sequential improvement from July to August and for the first two weeks of fiscal September. On a quarter-to-date basis, we are now comping positive in both channels, across all four store geographies and in every major merchandise classification. Additionally, the recent strength in same store sales has been driven by year-over-year growth in average store transactions with no meaningful change in our promotional posture. While macro uncertainty continues, we are increasingly confident in the underlying tone of the business as we prepare for the upcoming holiday quarter."

17:19 EDT Under Armour down 4% at $7.15 after providing restructuring update

17:01 EDT Regeneron says Libtayo demonstrates durable survival benefit at five years - Regeneron Pharmaceuticals announced five-year results from the final pre-specified overall survival analysis of the Phase 3 EMPOWER-Lung 1 trial, which evaluated Libtayo monotherapy versus chemotherapy as a first-line treatment for adults with advanced non-small cell lung cancer with greater than or equal to50% PD-L1 expression and no EGFR, ALK or ROS1 aberrations. The late-breaking results will be presented in an oral session at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer. "The five-year results from EMPOWER-Lung 1 showcase the durable survival benefit and impressive efficacy of first-line Libtayo monotherapy compared to chemotherapy in patients with PD-L1 high, advanced NSCLC, including a direct correlation between survival benefits and PD-L1 expression level," says Ana Baramidze, MD, PhD, Head of Clinical Research Department at Todua Clinic, Tbilisi, Georgia. "Furthermore, EMPOWER-Lung 1 continues to offer important new data to help doctors increase their understanding of investigational treatment strategies for patients who progress on PD-1 inhibitor monotherapy. For instance, EMPOWER-Lung 1 was one of the few trials to evaluate survival when adding chemotherapy to a PD-1 inhibitor following progression."

17:01 EDT Tigo Energy files patent infringement suit against Zhejiang Benyi New Energy Co. - Tigo Energy announced that the company's Chinese affiliate, Tigo Energy Equipment Trading (Suzhou) Co., Ltd., has filed a patent infringement lawsuit against Zhejiang Benyi New Energy Co., Ltd. The complaint (Case No. (2024) Hu 73 Zhi Min Chu No. 177) was filed in the Shanghai Intellectual Property Court on August 21, 2024. The complaint alleges that certain Zhejiang Benyi New Energy Co., Ltd. rapid shutdown devices infringe on Tigo IP, specifically China Patent No. 200880114564.0, which relates to rapid shutdown technology. Rapid shutdown is a safety function for photovoltaic systems on buildings, designed to reduce the risk of electrical shock to emergency responders, and is mandated by building codes and regulatory bodies in a rapidly growing number of countries around the world. Tigo is a leader in rapid shutdown technology and module-level power electronics, with more than 150 patents granted or pending. The company actively licenses its patented technology to other solar equipment providers and has prevailed in multiple patent disputes.

16:38 EDT Goldman Sachs CEO says FICC/equities business tracking down 10% in Q3 - At today's Barclays Global Financial Services Conference, Goldman Sachs CEO David Solomon states: "The operating environment has been good. In particular, our client franchise, has been very, very strong. I think with respect to the quarter, I would highlight a few things. First, with respect to trading, I would say that with FICC and equities, we had an extremely strong third quarter in 2023. And given this quarter, given what I'd say is a more challenging macroenvironment, particularly in the month of August, that business is trending down close to 10% largely due to FICC. Second, we continue to reduce the private equity and alternatives on balance sheet investing and we've made very, very good progress. Obviously, as we do that, the revenues from those activities are going to come down and move toward the medium-term targets we set out for that. This quarter, there were a handful of positions that are leading to those line items being significantly more muted."

16:32 EDT Calavo Growers increases quarterly dividend to 20c per share - The board of directors increased the cash dividend by 10c per share to 20c per share to be paid on October 30 to shareholders of record on October 2. The company said, "Our momentum has carried into the fourth quarter, and we look forward to delivering solid financial results for the fourth quarter and fiscal year. We intend to deploy the cash that we generated from the sale of our Fresh Cut business by investing in our core avocado and guacamole businesses and by returning cash to shareholders over time. Given the renewed focus on our core operations, improvements in our financial performance, and our confidence in our operational execution going forward, I am pleased to share that we have doubled the quarterly dividend to $0.20 per share."

16:31 EDT Markforged announces 1-for-10 reverse stock split - Markforged Holding announced that its Board of Directors approved a 1-for-10 reverse stock split of its Common Stock to be effective 12:01 a.m., Eastern Time, on September 19, 2024 and an associated proportional reduction in the number of shares of Common Stock the Company is authorized to issue. The Company expects its Common Stock to begin trading on a split-adjusted basis on the New York Stock Exchange as of the commencement of trading on September 19, 2024.

16:30 EDT NerdWallet announces new $50M share repurchase program - NerdWallet announced that the company's Board of Directors authorized a new share repurchase program. Under the new program, the company may purchase up to $50M of shares of its Class A common stock from time to time, as market conditions warrant. The company's proposed repurchases may be made in the open market, in privately negotiated transactions, or otherwise in accordance with applicable securities laws and other requirements. The amount and timing of any repurchases will be determined at management's discretion and depend on a variety of factors, including business, economic and market conditions, regulatory requirements, prevailing stock prices and other considerations. The share repurchase program has no time limit, does not obligate the company to repurchase any dollar amount or number of shares of Class A common stock, and may be amended, suspended or discontinued at any time. This new $50M program replaces the previous $30M program which had been exhausted.

16:25 EDT Simply Good Foods names Mike Clawson CCO, Jill Short departs - The Simply Good Foods Company announced Mike Clawson as Chief Customer Officer or CCO, effective October 14. Clawson is a distinguished CPG veteran with 25 years of experience leading teams and building capabilities across all the functions and capabilities o Reporting directly to Geoff Tanner, President and Chief Executive Officer...Clawson will succeed Simply Good Foods' current CCO, Jill Short, who has announced her departure...

16:20 EDT Trinity Biotech updates glucose monitor technology evelopment - Trinity Biotech provided an update on the continued development of its glucose biosensor technology. Earlier this year Trinity Biotech was granted a European patent or a novel method that enhances the performance of an indwelling sensor, such as a glucose biosensor. Recent testing of this patented process has confirmed its effectiveness in improving the performance of Trinity Biotech's glucose biosensor. Trinity Biotech intends to use this breakthrough process to stabilise and improve the functionality of the glucose biosensor in its next generation continuous glucose monitor CGM technology. CGMs are small patch-like wearable medical devices that use biosensor wires under the skin to measure glucose in real-time. These devices are increasingly popular in diabetes management and health monitoring. Trinity Biotech's Chief Technology Officer, Dr Gary Keating, said: "The technology covered by this patent represents a major advancement for our CGM platform. The CGM technology we acquired in January already offers strong advantages in terms of affordability and sustainability, thanks to its unique self-inserted biosensor wire. However, in advance of the acquisition, we recognised that the requirement for users to periodically re-calibrate the device using a separate finger-stick blood glucose monitor was not in line with the market leading solutions and was a barrier to broader adoption. We believed that this patented conditioning process would likely play an important role in further enhancing the technology towards a more user-friendly, fully self-calibrating, device. Our post-acquisition testing of this conditioning process has confirmed its effectiveness and - together with other refinements to the biosensor wire design - will be further evaluated in upcoming pre-pivotal trials to create an optimized CGM that can be rapidly introduced into global markets."

16:18 EDT Robinhood reports August assets under custody $143.6B - Robinhood reported select monthly operating data for August. Funded customers at the end of August were 24.3M. Assets under custody at the end of August were $143.6B. Net deposits were $3.3B in August, translating to a 27% annualized growth rate relative to July AUC. Over the last twelve months, net deposits were $37.5B, translating to an annual growth rate of 42% relative to August 2023 AUC. Equity notional trading volumes were $96.2B. Options contracts traded were 146.9M. Crypto notional trading volumes were $5.4B. Margin balances at the end of August were $5.5B. Total cash sweep balances at the end of August were $22.8B. Total securities lending revenue in August was $18M.

16:16 EDT Loews announces favorable resolution of Boardwalk Pipelines litigation - Loews announced that the Delaware Court of Chancery found no liability in connection with Loews's 2018 acquisition of the minority limited partner interests in its Boardwalk Pipelines subsidiary. "We are very pleased that the Delaware Court of Chancery ruled in our favor and continue to believe that the process we undertook in 2018 to purchase the minority units in Boardwalk was appropriate. We are hopeful that this ruling will resolve the litigation," said James Tisch, President and CEO of Loews. As a reminder, in November 2021 the Delaware Court of Chancery awarded the class of former minority unitholders in Boardwalk Pipelines approximately $690M, plus interest, in the litigation. That ruling was reversed by the Delaware Supreme Court in December 2022 and the remaining open claims were remanded back to the Court of Chancery. Those remaining claims were decided on September 9.

16:15 EDT Wolfspeed unveils silicon carbide module to boost clean energy capacity - Wolfspeed "unveiled a silicon carbide module designed to transform the renewable energy, energy storage, and high-capacity fast-charging sectors through improved efficiency, durability, reliability, and scalability. The 2300V baseplate-less silicon carbide power modules for 1500V DC Bus applications were developed and launched utilizing Wolfspeed's state-of-the-art 200mm silicon carbide wafers. Wolfspeed also announced today that it is partnering with EPC Power, a premier North American utility-scale inverter manufacturer. EPC Power will be employing the Wolfspeed(R) modules in utility-grade solar and energy storage systems, which offer a scalable high-power conversion system and high-performance controls and system redudancy."

16:11 EDT Oracle jumps 5% to $147.50 after Q1 results top estimates

16:10 EDT Parsons added to S&P MidCap 400 Index, effective September 23 - Parsons Corporation announced that the company has been named to S&P Dow Jones Indices prestigious S&P MidCap 400 Index, effective prior to the open of trading on September 23 . The company, which celebrated its 80th anniversary earlier this year, is a leading disruptive technology provider in the national security and global infrastructure markets, with capabilities across cyber and intelligence, space and missile defense, transportation, environmental remediation, urban development, and critical infrastructure protection. "We are honored for Parsons to join the S&P MidCap 400 Index. This accomplishment is a testament to the continued success of our talented workforce and their commitment to successfully delivering on our customers' missions around the world," said Carey Smith, Parsons' Chair, President, and Chief Executive Officer. "Together, we have transformed the company into a high-value solutions provider that is capitalizing on strong tailwinds across our six core end markets. Joining this prestigious list of companies is an important milestone in our storied history and reflects our momentum in creating the future of global infrastructure and national security ahead."

16:09 EDT Limoneira raises FY24 fresh lemon volumes view to 4.5M-5M cartons - The company said, "The Company now expects avocado volumes to be in the range of 14.5 million to 15.5 million pounds for fiscal year 2024, compared to previous guidance of 9.0 million to 10.0 million pounds, a more than 50% increase compared to prior guidance. We expect to complete the avocado harvest in the fourth quarter with approximately 4.0 million to 5.0 million pounds remaining. The Company now expects fresh lemon volumes to be in the range of 4.5 million to 5.0 million cartons for fiscal year 2024, compared to previous guidance of 5.0 million to 5.5 million cartons, due to lower fresh utilization from late season rains. The lemon harvest for fiscal year 2024 is approximately 85% complete. The Company continues to expect to receive total future proceeds of $180 million from Harvest, LLCB II, LLC and East Area II spread out over the next seven fiscal years."

16:08 EDT Oracle, Google Cloud announce availability of Oracle Database@Google Cloud - Oracle (ORCL) and Google Cloud (GOOG, GOOGL) announced the general availability of Oracle Database@Google Cloud in four Google Cloud regions across the United States and Europe. Customers will now be able to run Oracle Exadata Database Service, Oracle Autonomous Database, and Oracle Database Zero Data Loss Autonomous Recovery Service on Oracle Cloud Infrastructure in Google Cloud datacenters across U.S. East (Ashburn), U.S. West (Salt Lake City), U.K. South (London), and Germany Central (Frankfurt), expanding to many more regions in the coming months across North America, Europe, the Middle East, Africa, Asia Pacific, and Latin America. With Oracle Database@Google Cloud, customers will for the first time get direct access to Oracle Database services running on OCI and deployed in Google Cloud datacenters. They can now take advantage of Oracle's industry-leading database and Exadata technology to accelerate innovation and develop new applications. In addition, customers can run applications on Oracle Linux, which is now supported by Oracle on Google Cloud. Oracle Linux images can be imported using Google Cloud's virtual disk image import process. Within the next 12 months, customers are also expected to be able to streamline Oracle Linux image provisioning in Google Compute Engine with ready-to-use images. Finally, by combining industry-leading generative AI capabilities from offerings like Google Cloud's Vertex AI, Gemini foundation models, and Oracle Database 23ai, customers can bring enterprise truth to their data and gain faster insights by operating two clouds as one while maintaining feature and pricing parity with OCI.

16:06 EDT Oracle reports Q1 Total Remaining Performance Obligations up 53% to $99B - Reports: Q1 Cloud Revenue (IaaS plus SaaS) $5.6 billion, up 21% in USD and up 22% in constant currency; Q1 Cloud Infrastructure (IaaS) Revenue $2.2 billion, up 45% in USD and up 46% in constant currency; Q1 Cloud Application (SaaS) Revenue $3.5 billion, up 10% in both USD and constant currency; Q1 Fusion Cloud ERP (SaaS) Revenue $0.9 billion, up 16% in USD and up 17% in constant currency; Q1 NetSuite Cloud ERP (SaaS) Revenue $0.9 billion, up 20% in both USD and constant currency.

16:04 EDT Environmental Tectonics awarded $9.7M in contracts from three customers - Environmental Tectonics announced it has been awarded $9.7M in contracts from three international customers in the Aeromedical Training Solutions, or ATS, business unit for mid-life upgrades of various Aerospace products as well as a contract for an Airfield Driver Training Simulator System at a large International Airport located in the United States by its Simulation business unit, or ADMS. In addition, ETC's Commercial/Industrial Systems Segment was awarded $3.7M in contracts from two domestic customers. The contracts include four steam sterilizer system chambers from the Sterilization Systems Group as well as the design, supply and installation of a 300kW air to water heat pump Psychometric Test Room by ETC's Environmental Testing and Simulation Systems, or ETSS, unit.

16:02 EDT Oracle, Amazon Web Services announce partnership - Oracle (ORCL) and Amazon Web Services (AMZN) announced the launch of Oracle Database@AWS, a new offering that allows customers to access Oracle Autonomous Database on dedicated infrastructure and Oracle Exadata Database Service within AWS. "Oracle Database@AWS will provide customers with a unified experience between Oracle Cloud Infrastructure and AWS, offering simplified database administration, billing, and unified customer support. In addition, customers will have the ability to seamlessly connect enterprise data in their Oracle Database to applications running on Amazon Elastic Compute Cloud, AWS Analytics services, or AWS's advanced artificial intelligence and machine learning services, including Amazon Bedrock," the companies stated.

15:40 EDT Sony announces PlayStation 'Technical Presentation' hosted by Mark Cerny - "Join us for a streamed presentation hosted by Mark Cerny, Lead Architect of the PS5 console.The 9-minute Technical Presentation will focus on PS5 and innovations in gaming technology. How to watchThe stream will be broadcast in English on the PlayStation YouTube channel September 10 at 8:00am PT / 11:00am ET / 4:00pm BST," the company announced earlier, in a blog posting... Reference Link

15:17 EDT News Corp. says 'dual-class capital structure promotes stability' - News Corp confirmed that a stockholder has submitted a non-binding proposal for presentation at News Corp's 2024 Annual Meeting of Stockholders to request that the Board of Directors adopt a recapitalization plan that would eliminate News Corp's dual-class capital structure. "The Board believes that the company's dual-class capital structure promotes stability and has facilitated the successful implementation of News Corp's transformational strategy and long-term outperformance for all News Corp stockholders. The company has thrived under the current structure and guidance of the Board and senior leadership despite major changes in consumer behavior amidst the digital revolution of the last decade. During this time, the company has transformed its revenue and earnings base due to organic digital reinvestment, strategic acquisitions and divestments and on-going cost management initiatives that have delivered record profitability and significant value creation for stockholders. With the Board's long-term vision and support, News Corp has struck landmark, multi-year content licensing deals with major technology platforms, creating new revenue streams and additional growth levers including a significant step to prepare the company to prosper in the AI age. And over the last five years, News Corp's stock price has materially outperformed both the S&P 500 and its peer group."

15:16 EDT MNC says no 'substantive response or engagement' by Vista since revised bid - MNC Capital Partners is providing background on its $43 per share revised offer for Vista Outdoor, stating in a press release: Vista Outdoor Inc. announced on July 30 that it was going to re-engage with MNC. Immediately after that, MNC informed Vista that it required a fully negotiated Merger Agreement before it could consider revising its offer. Despite this, for almost three weeks Vista did not engage on negotiating a Merger Agreement or provide any of the related Schedules. During the past two weeks, Vista engaged and provided comments on the draft Merger Agreement that had been sent on March 25. After extensive negotiations of the Merger Agreement (and review of the Schedules) MNC submitted its revised offer of $43 per share this past Friday, which included a full financing package alongside of proof of funds for all equity sources. MNC had informed Vista ahead of last Friday that MNC intended to submit a revised offer for review by the Vista Board of Directors over this past weekend. Since the revised offer was submitted last Friday, there has not been any substantive response or engagement by Vista other than their short press release acknowledging our offer. Since MNC's $42 offer in June, comparables for Revelyst, many of which Vista lists in its filings as direct competitors, have continued to perform poorly-for example, shares of Helen of Troy are down 42%, TopGolf shares are down 33%, Solo Brands are down 35% and Fox Factory shares are down 20%... We believe it is clear that if Revelyst were to become a public company it would face significant headwinds, and any CSG transaction that included Revelyst shares would provide a value substantially below MNC's prior offer of $42 a share. Vista shareholders have already let Vista know that they would not support such a transaction. Vista has been exploring strategic alternatives since May of 2022, and MNC does not believe that any of the alternatives that the Vista Board says it is considering could provide a value that is superior to MNC's prior offer of $42 a share. Vista has so far not shown any indication that there are any other all-cash acquisition alternatives for all of Vista. Even if such an alternative were available, it would not close until well after a transaction with MNC would close if Vista agreed now to an MNC transaction. Notwithstanding the recent negative trends, MNC increased its offer from $42 per share to $43 per share. MNC's offers have always accounted for Vista's cash flow generation and debt paydown."

14:51 EDT J&J Rybrevant/Lazcluze study shows superiority over lazertinib for NSCLC - Johnson & Johnson (JNJ) announced longer follow-up data from the landmark Phase 3 MARIPOSA study which showed first-line treatment with RYBREVANT or amivantamab-vmjw combined with LAZCLUZE or lazertinib provided consistent benefit across long-term outcomes compared to osimertinib monotherapy in adult patients with advanced non-small cell lung cancer NSCLC with epidermal growth factor receptor EGFR exon 19 deletions or L858R substitution mutations. The data show a strong and improving overall survival OS trend favoring RYBREVANT plus LAZCLUZE at approximately three years of follow-up. These results were presented in a late-breaking oral presentation at the International Association for the Study of Lung Cancer IASLC 2024 World Conference on Lung Cancer WCLC..."By combining the multi-targeted mechanism of RYBREVANT with LAZCLUZE, a central nervous system-penetrant third-generation tyrosine kinase inhibitor, we are advancing a chemotherapy-free regimen for the first-line treatment of patients with EGFR-mutant NSCLC. This approach blocks EGFR and MET pathways and leverages the immune system, offering patients an opportunity for prolonged benefits," said Shirish M. Gadgeel, M.D., Chief of Division of Hematology and Oncology, Associate Director at Henry Ford Cancer Institute and presenting author. "Even more encouraging is the marked improvement in the hazard ratio and the ongoing separation of survival curves, showing an eight percent improvement at three years for RYBREVANT plus LAZCLUZE compared to osimertinib (AZN). This supports the long-term benefit of the combination as a first-line treatment option in this setting."

14:41 EDT Apple introduces iPhone 16 Pro and Pro Max featuring Apple Intelligence - Apple introduced iPhone 16 Pro and iPhone 16 Pro Max, featuring Apple Intelligence, larger display sizes, new creative capabilities with pro camera features, and more - all powered by the A18 Pro chip. "With Apple Intelligence, powerful Apple-built generative models come to iPhone in the easy-to-use personal intelligence system that understands personal context to deliver intelligence that is helpful and relevant while protecting user privacy. Camera Control unlocks a fast, intuitive way to tap into visual intelligence and easily interact with the advanced camera system. Featuring a new 48MP Fusion camera with a faster quad-pixel sensor that enables 4K120 fps video recording in Dolby Vision, these new Pro models achieve the highest resolution and frame-rate combination ever available on iPhone. Additional advancements include a new 48MP Ultra Wide camera for higher-resolution photography, including macro; a 5x Telephoto camera on both Pro models; and studio-quality mics to record more true-to-life audio. The durable titanium design is strong yet lightweight, with larger display sizes, the thinnest borders on any Apple product, and a huge leap in battery life - with iPhone 16 Pro Max offering the best battery life on iPhone ever. iPhone 16 Pro and iPhone 16 Pro Max will be available in four stunning finishes: black titanium, natural titanium, white titanium, and desert titanium. Pre-orders begin Friday, September 13, with availability beginning Friday, September 20," stated Apple. iPhone 16 Pro and iPhone 16 Pro Max will be available in black titanium, natural titanium, white titanium, and desert titanium, in 128GB, 256GB, 512GB, and 1TB storage capacities. iPhone 16 Pro starts at $999 or $41.62 per month, and iPhone 16 Pro Max starts at $1,199 or $49.95 per month in the U.S.

14:39 EDT Apple announces iPhone 16 and 16 Plus, 'built for Apple Intelligence' - Apple announced iPhone 16 and iPhone 16 Plus, which it says are "built for Apple Intelligence, the easy-to-use personal intelligence system that understands personal context to deliver intelligence that is helpful and relevant while protecting user privacy." Apple stated: "The iPhone 16 lineup also introduces Camera Control, which brings new ways to capture memories, and will help users quickly access visual intelligence to learn about objects or places around them faster than ever before. The powerful camera system features a 48MP Fusion camera with a 2x Telephoto option, giving users two cameras in one, while a new Ultra Wide camera enables macro photography. Next-generation Photographic Styles help users personalize their images, and spatial photo and video capture allows users to relive life's precious memories with remarkable depth on Apple Vision Pro. The new A18 chip delivers a huge leap in performance and efficiency, enabling demanding AAA games, as well as a big boost in battery life. iPhone 16 and iPhone 16 Plus will be available in five bold colors: black, white, pink, teal, and ultramarine." Pre-orders begin Friday, September 13, with availability beginning Friday, September 20. iPhone 16 and iPhone 16 Plus will be available in ultramarine, teal, pink, white, and black in 128GB, 256GB, and 512GB storage capacities. iPhone 16 starts at $799 or $33.29 per month, and iPhone 16 Plus starts at $899 or $37.45 per month in the U.S.

14:37 EDT Apple introduces Apple Watch Series 10, starts at $399 - Apple unveiled Apple Watch Series 10, featuring a refined design and bringing new capabilities to the world's most popular watch that make it even more powerful, intelligent, and sophisticated. Apple Watch Series 10 is the thinnest Apple Watch yet - making it more comfortable than ever - and offers the biggest, most advanced display of any Apple Watch. It also features new sleep apnea notifications; faster charging; water depth and temperature sensing; plus new health and fitness insights and intelligence in watchOS 11. Apple Watch Series 10 is available in both aluminum and titanium, in an array of stunning colors and finishes. Jet black is a new polished aluminum finish that is distinctively reflective and sleek, while new titanium cases - available in natural, gold, and slate - have a spectacular jewelry-like shine. The new Apple Watch lineup can be pre-ordered today, with availability beginning Friday, September 20. Customers in Australia, Canada, France, Germany, India, Japan, the UAE, the U.K., the U.S., and more than 49 other countries and regions can pre-order Apple Watch Series 10 today, with availability in stores beginning Friday, September 20. Apple Watch Series 10 starts at $399 (U.S.). Apple Watch SE is available starting at $249 (U.S.).

14:18 EDT Espey Mfg. boosts quarterly dividend to 25c from 20c per share - Espey Mfg. & Electronics declared a regular quarterly dividend of 25c per share, a 25% increase over the prior dividend. The dividend will be payable on September 27, to all shareholders of record on September 20.

14:16 EDT Apple says iPhone 16 Pro has best iPhone battery life ever - Says 16 Pro built from the ground up with Apple Intelligence.

14:12 EDT Apple says iPhone 16 starts at $799, 16 Plus starts at $899

14:00 EDT Flex seeing some 'general weakening in volume outlooks' in auto - Executives from Flex, while presenting at the Goldman Sachs 2024 Communacopia + Technology Conference, stated in part, according to a transcript of the event, when asked about end-market momentum: "There's been a little bit of change. When we talked about power and cloud - So that's our our data center portfolio - We talked about we've been very strong. That continues its - it's very strong. No changes there. No change to the health solutions and consumer markets they're performing as expected. Non-cloud networking and comms, so nothing touching the cloud. We said that would remain weak. No change there. We're - I know there's been some discussions. We're not really seeing any bounce yet, but we didn't expect it for the year, where we might be seeing a little bit of change is in auto. We are seeing some general weakening in volume outlooks really even starting in Q3. This is more than just the EV changes that people have seen sentiment get a little sour and EV particularly in North America and some in Europe. I think this is more cyclical driven. I think interest rates are catching up with spending and you're the expert in here. I think they haven't cut prices the way they normally do and all those sorts of things. So some inventories backing up. So, no, just change in volumes wise and then in industrial, so core industrial, that includes renewables, maybe just a little softer than we had expected 30 or 40 days ago or whatever. And again, this is looking towards the back half of the year. So there could be some volume pressure there. But I think the important point is, is that given our improving mix and our continued strong cost management that you've seen us do for multiple quarters now, don't expect any pressure on profitability or EPS with that. If that scenario plays out.''

13:53 EDT AstraZeneca says Dato-DXd showed clinically meaningful trend toward improving OS - Detailed results from the TROPION-Lung01 Phase 3 trial showed a clinically meaningful trend toward improving overall survival, or OS, with datopotamab deruxtecan, or Dato-DXd, compared to docetaxel, the current standard of care chemotherapy, in adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer, or NSCLC, treated with at least one prior line of therapy, AstraZeneca (AZN) announced. These results will be presented during an oral presentation at the IASLC 2024 World Conference on Lung Cancer, or WCLC, hosted by the International Association for the Study of Lung Cancer. Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate discovered by Daiichi Sankyo and being jointly developed by AstraZeneca and Daiichi Sankyo (DSNKY). In the overall trial population, OS results numerically favored datopotamab deruxtecan compared to docetaxel, but did not reach statistical significance, the company stated. In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a 2.3-month improvement in OS compared to docetaxel. In patients with nonsquamous NSCLC, OS improvement was observed regardless of the presence of actionable genomic alterations. In patients with squamous NSCLC, consistent with the previous analysis, datopotamab deruxtecan did not show an OS improvement. Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "TROPION-Lung01 showed a clinically meaningful trend towards improving the survival of patients with advanced or metastatic nonsquamous non-small cell lung cancer, building on the previously reported progression-free survival data. Together with the data we have presented for the potential TROP2-QCS biomarker and from NeoCOAST-2 in early-stage disease, these results underscore our confidence in the important role datopotamab deruxtecan can play across segments and settings of non-small cell lung cancer."

13:48 EDT Apple says iPhone 16 has five-core 'desktop class' GPU

13:42 EDT Apple unveils iPhone 16, says it 'raises the bar' for iPhones

13:39 EDT Apple says AirPods Pro to soon have OTC hearing aid feature - Says all newly announced updates coming to AirPods Pro 2. Sees clearance from FDA and other regulators soon. Says features should be coming to AirPods Pro 2 and iOS 18 in software update.

13:33 EDT Apple unveils new AirPods Max, starts at $549 - Says available September 20.

13:32 EDT Apple says AirPods 4 come with Conversation Awareness - Says AirPods 4 also get wireless charges.

13:29 EDT Apple says AirPods 4 come with improved audio quality - Says AirPods 4 come with richer bass and personalized spatial audio.

13:25 EDT Apple Watch Ultra 2 starts at $799, out September 20 - Says pre-orders start today.

13:20 EDT Apple Watch Series 10 starts at $399, out September 20 - Says pre-orders start today.

13:17 EDT Apple says sleep apnea detection available in 150+ regions - Says sleep apnea detection to soon be on Series 9 and Ultra 2 watches. Says expects approval from FDA and other countries soon.

13:08 EDT Apple unveils Apple Watch Series 10 - Says Series 10 has biggest display of any Apple Watch. Says larger screen allows users to increase font size and makes it easier to type messages. Says Series 10 "softer and sleeker," and more power efficient. Comments taken from the company's "It's Glowtime" event.

12:27 EDT Supermicro extends rally, shares up 6% after GlassHouse goes long - Shares of Supermicro extended their rally, up 6% to $409.98 in midday trading, after GlassHouse Research announced a long position via X.

12:12 EDT PNC Financial sees Q3 NII at high end of prior 1%-2% view - Comments taken from Barclays 22nd Annual Global Financial Services Conference.

12:10 EDT State Street sees FY24 NII in line with prior guidance - The company previously forecast FY NII would be up slightly y/y. The company sees FY24 fees tracking toward the middle of the prior range. Comments taken from Barclays 22nd Annual Global Financial Services Conference.

12:02 EDT Trupanion launches medical insurance product in Germany, Switzerland - Trupanion announce the official launch of its Trupanion product in Germany and Switzerland. The launch follows the Company's expansion to Continental Europe in 2022 with the acquisition of two rapidly growing pet insurance companies with strong expertise in the region.

12:02 EDT Finance of America rises 19.2% - Finance of America is up 19.2%, or $1.98 to $12.29.

12:01 EDT Healthcare Services names Vikas Singh CFO - Healthcare Services Group announced the appointment of Vikas Singh as EVP & Chief Financial Officer, effective September 3, 2024. He will oversee HCSG's accounting and finance operations, and play a key role in corporate development, investor relations, and the success of its long-term growth strategy. Singh brings over two decades of diverse experience in finance, strategy and operations to the Company. Most recently, he served as Managing Director of Leveraged Finance & Capital Markets at Bank of America Securities. Prior to that he worked in the Financial Sponsors Group at Credit Suisse and in the Asia-Pacific Credit Card Group at Citibank. Mr. Singh began his career with GSK's Consumer Healthcare Division and held roles in Sales Management and as National Brand Manager within the marketing organization. "Vikas is a highly accomplished finance executive with a proven track record of success," said Ted Wahl, Chief Executive Officer. "His extensive experience and deep expertise in finance will be invaluable as we continue to grow and expand our business. We are thrilled to welcome him to our leadership team." The company also announced the promotion of Andrew Brophy, CPA to the position of SVP, Controller & Chief Accounting Officer. Brophy joined the Company in 2018 and has held roles of increasing responsibility in the accounting and finance department, most recently as VP & Controller.

12:00 EDT Trinseo falls -5.6% - Trinseo is down -5.6%, or -21c to $3.55.

11:39 EDT Xencor jumps after announcing four new XmAb programs - Xencor earlier today announced four new XmAb programs in development for the treatment of patients with autoimmune diseases and provided updates from dose-escalation studies evaluating its oncology programs, including XmAb819 in patients with advanced clear cell renal cell carcinoma and XmAb808 in patients with advanced solid tumors. XmAb819 is designed to engage the immune system, activating T cells for highly potent and targeted killing of tumor cells expressing ENPP3, an antigen highly expressed on kidney cancers, the company said in a statement. It added that initial evidence of anti-tumor activity has been observed in recent dose-escalation cohorts in the ongoing Phase 1 study. Xencor continues to anticipate reaching target dose levels by year end and plans to provide a clinical update around initiation of the first dose expansion cohort during the first half of 2025. On XmAb808, the company said the majority of patients enrolled into the ongoing Phase 1 dose-escalation study are men with metastatic castration-resistant prostate cancer. In this group of patients, prostate specific antigen declines have been observed during the four-week monotherapy safety run-in period. It continues to anticipate reaching target dose levels by year end and plans to provide a clinical update around initiation of dose expansion cohorts during the first half of 2025. Shares of Xencor are up 18%, or $2.93, to $19.11 in late morning trading.

11:04 EDT Zealand Pharma announces topline results from Phase 1b trial of dapiglutide - Zealand Pharma announces topline clinical results from a Phase 1b multiple ascending dose trial, investigating safety, tolerability, and clinical effects of 13 weeks of dosing with dapiglutide, a long-acting GLP-1/GLP-2 receptor dual agonist in development for weight management. In Part 1 of the Phase 1b trial, a total of 54 participants with a median age of 46 years and a median baseline BMI of 30.0 kg/m2 were randomized to receive 13 weekly doses of either dapiglutide or placebo within three dose cohorts. At week 13, the estimated mean body weight had decreased by up to 8.3% on a placebo-corrected basis among participants on dapiglutide treatment. No lifestyle modifications, such as diet or exercise, were included in the trial. Dapiglutide was assessed to be safe and well-tolerated in Part 1 of the trial, with no severe treatment-emergent adverse events and one serious AE, which was deemed not related to the drug. The most common TEAEs were gastrointestinal including nausea and vomiting. Only two participants discontinued treatment due to AEs, which were related to the GI system. Overall, the number of GI events observed were consistent with clinical trials of other incretin-based therapies with a similar, rapid dose escalation scheme. A low number of participants reported injection site reactions, all of which were mild. Anti-drug antibodies were observed in 14.3% of participants. Part 2 of this Phase 1b trial is evaluating higher doses of dapiglutide up to 26 mg over a 28-week treatment period with up-titration every fourth week. Zealand expects to report topline results from Part 2 in the first half of 2025 and present further details from Part 1 and Part 2 of this Phase 1b trial at a future scientific congress. The company plans to progress the clinical development of dapiglutide into a Phase 2b trial in people living with overweight and obesity, with initiation expected in the first half of 2025. Also, the company expects to evaluate the potential of dapiglutide in select obesity-related comorbidities.

10:58 EDT Citi wants to be 'smart' about any share buyback plans, says CFO

10:53 EDT Citi CFO sees $2.7B cost of credit in Q3

10:47 EDT Citi sees Q3 markets revenue down 4% y/y

10:46 EDT Citi sees Q3 investment banking fees up 'somewhere around 20%' y/y

10:44 EDT Citi CFO sees soft landing as interest rates expected to fall - CFO Mark Mason says has seen good pick up in M&A. Says credit card customers switching to staples from discretionary purchases.

10:17 EDT Expensify pays down all debt, announces share repurchase - Expensify announced that the company paid down the balance of its revolving line of credit, paid off the mortgage on its headquarters in downtown Portland, OR, and repurchased 645,938 shares of its Class A common stock from its founder. The company still retains access to $24M in a revolving line of credit if needed, but has otherwise cleared the debt from its balance sheets. Additionally, rather than refinance its mortgage which was scheduled to come due in the third quarter of 2024, the company has paid it off. The 645,938 Class A common stock shares were purchased at an average price of $2.34, reflecting the weighted average price over a three-day period ending August 27, 2024. The shares will be retired. The Company's share repurchases are designed to offset dilution from stock issuances and reduce share count over time. Expensify CFO, Ryan Schaffer, said, "We are happy with the continued progress our business has made since this time last year. The cost cutting efforts we initiated have had a great impact on the health of our business. The end of our multi-year product revamp journey is within sight, we returned to positive cash flows for the past two quarters, we've eliminated our debt, and continued to repurchase shares. We are excited for the future of the company and the product we're bringing to market."

10:01 EDT Inspire Medical rises 12.9% - Inspire Medical is up 12.9%, or $25.40 to $222.28.

10:00 EDT Emerald Holding rises 15.1% - Emerald Holding is up 15.1%, or 81c to $6.17.

10:00 EDT Lumen falls -6.0% - Lumen is down -6.0%, or -35c to $5.49.

09:50 EDT Ryde Group Ltd trading resumes

09:48 EDT Havertys falls -6.3% - Havertys is down -6.3%, or -$1.62 to $23.96.

09:47 EDT Zurn Elkay Water rises 9.1% - Zurn Elkay Water is up 9.1%, or $2.69 to $32.40.

09:47 EDT Inspire Medical rises 9.6% - Inspire Medical is up 9.6%, or $18.97 to $215.85.

09:45 EDT Ryde Group Ltd trading halted, volatility trading pause

09:38 EDT GSK presents full results from SWIFT-1 and SWIFT-2 Phase 3 trials - GSK presented the full results from the SWIFT-1 and SWIFT-2 phase III clinical trials which assessed the efficacy and safety of depemokimab versus placebo in adults and adolescents with severe asthma with type 2 inflammation characterised by raised blood eosinophil count. The data were presented at the European Respiratory Society International Conference in Vienna, Austria and simultaneously published in the New England Journal of Medicine. SWIFT-1 and SWIFT-2 are duplicate studies with the same primary and secondary endpoints. Both trials met their primary endpoints with statistically significant reductions in the annualized rate of clinically significant exacerbations over 52 weeks versus placebo, with the pre-specified pooled analysis showing a significant 54% reduction in exacerbations. In the pooled analysis of SWIFT-1 and SWIFT-2, there was a 72% reduction in the secondary endpoint of clinically significant exacerbations requiring hospitalisation or emergency department visit compared to placebo. As the pooled analysis of SWIFT-1 and SWIFT-2 did not control for multiple comparisons, results with a significant p-value are termed nominally significant. In the individual trials, the secondary endpoints assessing quality-of-life or the symptoms-based measure, showed improvements but did not reach statistical significance versus placebo. "These data are part of GSK's aspirations to advance treatment goals for those with severe asthma. Preventing exacerbations, a known risk for hospitalisation, and cause of cumulative lung damage and disease progression, has been a longstanding goal of asthma treatment and care. Sustained suppression of type 2 inflammation, an underlying driver of exacerbations, could help change the course of disease.3 Extended dosing intervals could also help tackle other barriers to optimal outcomes such as adherence or frequent healthcare appointments," the company stated. Kaivan Khavandi, SVP, Global Head of Respiratory/Immunology R&D, said: "With a dosing schedule of just two injections per year, depemokimab has the potential to be the first approved ultra-long-acting biologic with six-month dosing. This could offer physicians and millions of patients with severe asthma an option that provides reassurance of sustained suppression of a key marker of type 2 inflammation and a reduction in the rate of exacerbations and hospitalisation - the fundamental treatment goal in asthma."

09:35 EDT Edgio files for chapter 11, enters stalking horse pact with Lynrock - Edgio announced that it has voluntarily filed for chapter 11 relief in the United States Bankruptcy Court for the District of Delaware to effectuate one or more sale transactions that should allow for the continued operation of the company's business under new ownership. The company enters this process with the support of its primary lender, Lynrock Lake, to facilitate a completion of the Chapter 11 cases. To anchor the sale process, Edgio has entered into a stalking horse asset purchase agreement with Lynrock, which has agreed to acquire assets of the company through a credit bid in the amount of $110M of the existing secured debt held by Lynrock. Prior to the commencement of Chapter 11 Cases, the company engaged in discussions with a number of interested parties with respect to a potential sale of all or part of the company's businesses and assets. In response to such interest, the company intends to use a court-supervised sale process to seek the highest or otherwise best bid for its assets, including its valuable individual business product offerings. The company is targeting the sale process to be completed in approximately 80 days, if not sooner. Edgio has also entered into an agreement to receive approximately $15.6M in principal amount of funded debtor-in-possession financing from Lynrock that, following approval by the court, is expected to ensure continuity of delivering its products to customers in the ordinary course throughout the sale process and Chapter 11 cases. To avoid any disruption to its operations, Edgio has also filed standard "first day" motions in the Chapter 11 cases, seeking court approval to continue supporting its operations throughout the sale process. These motions, upon approval, will help facilitate the continued payment of employee wages and benefits, enable payments to critical vendors and other relief measures customary in these circumstances.

09:32 EDT Synovus names Chad Parramore as head of product commercialization - Synovus Bank has promoted Chad Parramore to executive director and head of product commercialization for the bank's treasury and payment solutions team. In this newly created role, Parramore will develop a comprehensive product strategy and lead product commercialization initiatives for treasury and payment solutions. Parramore joined Synovus in 2019 as senior director of treasury management sales.

09:30 EDT SmartKem Inc trading halted, volatility trading pause

09:25 EDT Moderna's Canadian manufacturing facility receives DEL - Moderna announced that its manufacturing facility in Laval, Quebec, has been granted a Drug Establishment License from Health Canada. This certification affirms the facility's compliance with rigorous safety and quality standards, authorizing it to produce drug substance. This key milestone enables Moderna's Canadian manufacturing site to become fully operational, bringing the company closer to ensuring a reliable and onshore supply of mRNA vaccines within Canada. With the DEL in place, the facility will proceed with the final qualification process, positioning it to domestically manufacture a portfolio of mRNA vaccines against respiratory viruses beginning in 2025, including COVID-19 and, contingent on approval by Health Canada, respiratory syncytial virus, and seasonal influenza.

09:23 EDT Newmont enters two-year extension on option agreement with Gold Terra - Gold Terra Resource extended its four year definitive option agreement with Newmont Canada FN Holdings and Miramar Northern Mining, both wholly owned subsidiaries of Newmont Corporation, to a six year agreement which grants Gold Terra the option, upon meeting certain minimum requirements, to purchase MNML from Newmont FN, which includes 100% of all the assets, mineral leases, Crown mineral claims, and surface rights comprising the Con Mine, as well as the areas immediately adjacent to the Con Mine. The extended Option Agreement to six years provides the Company more time to complete its evaluation before exercising its option to purchase 100% of MNML, the owner of the past-producing Con Mine, which produced more than 6.1 Moz along the Campbell and Con Shear structures. Completion of the Option Agreement will consolidate the Company's strategic land position in the prolific Yellowknife Gold Belt and provide potential future development optionality. The former Con Mine is a world-class gold deposit and part of the prolific Yellowknife mining camp. Option Agreement Highlights: Execution of the 2021 Option Agreement to include all of MNML and the Con Mine Property. The Option Agreement has now been extended whereby in order to retain the Earn-In Right and earn the Purchase Option, Gold Terra must, within six years following the Effective Date complete the Earn-In specifications. Gold Terra has agreed to incur a minimum of C$8.0 million in exploration expenditures over a period of six years, which will include all exploration expenditures incurred to date under the initial Exploration Agreement. Gold Terra has also agreed to: Complete a Pre-Feasibility Study of a mineral resource and a minimum of 1.5 Moz in all categories, Obtain all necessary regulatory approvals for the purchase and transfer of MNML's assets and liabilities to Gold Terra, Post a cash bond to reflect the status of the Con Mine reclamation plan at the time of closing. The closing of the Transaction will then be completed with Gold Terra making a final cash payment of C$8,000,000. Newmont will retain a 2% net smelter returns royalty on minerals produced from the Con Mine Property. The NSR may be reduced by 50% by the Company paying Newmont the sum of C$10,000,000, for a period of two years following the annoucement of commercial production. After Gold Terra exercises its option, Newmont will have a period of two years to exercise its one time back-in right of a 51% participating interest in MNML and the Con Mine Property, which can be triggered by Gold Terra delineating a minimum of five million ounces of gold in the measured and indicated mineral resource categories supported by a National Instrument NI 43-101 technical report. If Newmont exercise its one time only back-in right, it will have to reimburse Gold Terra 3 times its exploration expenditure to that date, and also pay US$ 30 per once on 51% of all the ounces delineated in the latest 43-101 report

09:18 EDT CureVac to present CVGBM glioblastoma cancer vaccine data at ESMO - CureVac announced that the first clinical data from CureVac's ongoing Phase 1 CVGBM cancer vaccine study in patients with resected glioblastoma will be presented at the European Society for Medical Oncology Congress. Clinical data will be presented as an oral presentation on Friday, September 13, along with a poster presentation of preclinical data supporting the program's development. The Phase 1 study includes a dose-escalation part and dose-expansion part. Results for Part A will be covered in the oral presentation, with safety and tolerability as well as initial immunogenicity data provided for all evaluable patients at dose levels of 12-100 microgram. A summary of treatment-emergent adverse events, which were mostly Grade 1-2 and yielded no dose-limiting toxicities as confirmed by a Data Safety Monitoring Board, will also be provided. The Phase 1 study is evaluating the safety and tolerability of CVGBM in patients with newly diagnosed and surgically resected MGMT-promoter unmethylated glioblastoma or astrocytoma with a molecular signature of glioblastoma. CVGBM features a single unmodified mRNA encoding eight epitopes derived from known tumor-associated antigens, with demonstrated immunogenicity in glioblastoma. Enrollment began earlier this year for Part B of the study, which is expected to include up to an additional 20 patients at the recommended 100 microgram dose.

09:16 EDT Conor McGregor increases ownership in Alta Global - Alta Global Group announced a partnership with Conor McGregor, the iconic UFC champion and global superstar. This new deal envisions McGregor eventually becoming a significant stakeholder in the company, further solidifying Alta's influence in the MMA community. McGregor will leverage his extensive 63+ million fan base to promote Alta's innovative platform and products. As a former UFC Featherweight and Lightweight World Champion, the first to hold titles in two weight classes simultaneously, and a former Cage Warriors Featherweight and Lightweight Champion, McGregor's achievements have cemented his status as the biggest pay-per-view draw in MMA history. His fights have consistently broken records, with his bout at UFC 229 drawing 2.4 million buys and his boxing debut against Floyd Mayweather Jr. garnering over 5.3 million buys. Performance share rights issued to McGregor will vest once the 30-day volume-weighted average price achieves the following trigger; 150,000 on execution of the Ambassador Agreement; 100,000 when the share price reaches $7.50; 150,000 when the share price reaches $10.00; 150,000 when the share price reaches $15.00 and 150,000 when the share price reaches $20.00. Aligned with the three year term of the ambassador agreement, McGregor is restricted from selling shares within three years of issuance unless specific conditions are met, such as the company's written consent, a sale or liquidation of the company, or if the company breaches the agreement.

09:14 EDT Chubb renews as official insurance sponsor of the U.S. Open - The USTA and Chubb have signed a multi-year partnership renewal, extending Chubb's designation as the Official Insurance Sponsor of the US Open. The extended agreement begins in 2025. Chubb and the USTA first partnered in 2020 and renewed during a record-setting 2024 US Open that for the first time surpassed one million attendees.

09:12 EDT First Mining Gold expands, advances gold discovery ay BUGB Exploration Project - First Mining Gold announced new assay results for the Challenger high-grade gold discovery at the Company's Birch-Uchi Greenstone Belt Exploration Project located in northwestern Ontario, Canada. The Challenger target area is located 12 km southwest of the First Mining's flagship Springpole Gold Project and has become one of several high priority exploration targets for the Company. The 2024 follow-up field mapping program has yielded four new gold occurrences, including visible gold in grab and channel samples, that are proximal to the original 2023 discovery area. The new results also include detailed channel sampling across the discovery area with assay highlights of 6.53 g/t Au over 3 m and grab sample assays at the new outcrop sites of up to 26.6 g/t Au, 20.3 g/t Au, and 7.73 g/t Au. First Mining has now established a series of significant high-grade samples within additional outcrops that expand the mineralization footprint of the original discovery area. "We are extremely excited to be returning additional high-grade results and visible gold from our major discovery at the Challenger target hosted in the Red Lake Mining District and in very close proximity to our flagship Springpole Gold Project," stated Dan Wilton, CEO of First Mining Gold. "We fully believe that the endowment within our extensive Birch-Uchi Greenstone Exploration Project is at a stage where immense value in discovery can be realized through our value driven exploration efforts. While our Springpole Gold Project is well advanced in the environmental assessment process, these exploration efforts will continue to demonstrate district-scale potential around Springpole."

09:10 EDT T2 Biosystems provides update on product development pipeline progress - T2 Biosystems provided an update on its new product development pipeline progress. The Company's product pipeline is focused on direct-from-blood diagnostic tests for antimicrobial resistance, pediatric Candida infections, Lyme disease, and Candida auris. Pipeline Progress Highlights: Finalizing a 510(k) premarket notification application for the T2Resistance Panel planned to be filed with the U.S. Food and Drug Administration during the fourth quarter of 2024. The previously submitted 510(k) premarket notification to expand use of the T2Candida Panel to detect pediatric Candida infections is pending clearance with the FDA. Advanced internal validation and plans to submit a 510(k) premarket notification to the FDA to expand the use of its FDA-cleared T2Bacteria Panel to detect pediatric bacterial infections. The Company maintains its plan to launch the T2Lyme Panel as a Laboratory Developed Test; however, it now plans to build or buy its own laboratory rather than launch through a partnership. Pursuing non-dilutive funding to complete the development, validation, and clinical studies for a diagnostic test to detect Candida auris, following the completion of feasibility and early development in collaboration with the U.S. Centers for Disease Control and Prevention/ "Our team is making excellent progress developing novel diagnostics to rapidly detect pathogens directly-from-blood, including antimicrobial resistance, pediatric Candida infections, Lyme disease, and Candida auris, and we expect to launch multiple new products in 2024 and 2025," stated John Sperzel, Chairman and CEO of T2 Biosystems. "Three of our pipeline products have received FDA Breakthrough Device designation, including the T2Resistance Panel, the T2Lyme Panel, and the Candida auris test, and we believe all four of our pipeline products will allow clinicians to achieve faster targeted treatment, reduce cost, and improve patient outcomes."

09:10 EDT Kennametal presents first look at new HARVI II TE End Mill - Kennametal announced a new HARVI solid end mill today at the International Manufacturing Technology Show 2024, IMTS, at McCormick Place, in Chicago. New, HARVI II TE is a 5-flute end mill designed for aggressive applications in general engineering, aerospace and defense, and medical where high metal removal rates and increased versatility and flexibility are a must. This addition further expands the company's bestselling end mill platform.

09:09 EDT Vroom announces appointment of Kharche as SVP of Business Transformation - Verra Mobility announced the appointment of Harshad Kharche as Senior Vice President, SVP, of Business Transformation. He will report to David Roberts, president and CEO, Verra Mobility.

09:08 EDT Toro Corp. announces results of 2024 AGM - Toro Corp.announces that the Company's 2024 Annual General Meeting of Shareholders was duly held on September 6, 2024, at 5:00 p.m., local time, at 223 Christodoulou Chatzipavlou Street, Hawaii Royal Gardens, 3036 Limassol, Cyprus. At the Meeting, the following proposals were approved and adopted:The re-election of Mr. Petros Zavakopoulos to serve as the Company's Class A Director until the 2027 Annual General Meeting of Shareholders; The appointment of Deloitte Certified Public Accountants S.A., as the Company's independent auditors for the fiscal year of 2024.

09:08 EDT American Rebel Light completes initial production run of 12oz, 16oz cans - American Rebel Holdings announced the completion of its initial full production run of American Rebel Light 12oz and "Tall Boy" 16oz cans for distribution. American Rebel Light Beer is a premium domestic light lager. The Company is processing initial stocking orders from distributors Best Brands in Tennessee, Missouri Eagle in Missouri and Dichello in Connecticut. Reorders are being aggregated for Ohio's Bonbright and Kansas's Standard Beverage. Shipments are scheduled to begin September 9, 2024.

09:06 EDT Greenidge: 55 bitcoin produced in August, 17 made byGreenidge-owned miners - Greenidge Generation Holdings provided a bitcoin production update for August of 2024. The Company also highlighted CEO Jordan Kovler's presentation at the H.C. Wainwright Annual Global Investment Conference, taking place today, September 9 at 10:30AM ET. Greenidge will be filing an updated investor presentation in conjunction with the event. Greenidge produced approximately 55 bitcoin in August, of which 17 bitcoin were produced by Greenidge-owned miners and 38 were produced through our datacenter hosting. Greenidge's hash rate in August was approximately 2.50 EH/s, with 0.8 EH/s from Greenidge-owned miners and 1.7 EH/s from our datacenter hosting. The Company held 51 Bitcoin as of September 6 . Greenidge anticipates continuing to upgrade its fleet with newer generation miners over the remainder of 2024 and 2025 and securing additional sites for future development.

09:05 EDT Myers Industries CEO Mike McGaugh steps down, Dave Basque succeeds - Myers Industries announced a leadership transition to support the continued transformation of the company. The board of directors has appointed Dave Basque, Myers Industries' VP, special projects, to the additional role of interim president and CEO, replacing Mike McGaugh, effective immediately. Dave Basque will serve in that role until a new CEO is appointed. Until September 1, Basque served as the company's VP, integration and VP, material handling segment - injection molding. The board has engaged an executive search firm to help identify a new CEO.

09:05 EDT GlobalFoundries, Silicon Catalyst partner for differentiated tech solutions - GlobalFoundries and Silicon Catalyst announced that GF has joined the incubator's semiconductor startup ecosystem as a Strategic Partner and an In-Kind Partner. The partnership will provide innovative startups with access to GF's differentiated platforms to speed the development and commercialization of next generation IoT, automotive and generative AI applications while anticipating future growth markets such as medical and quantum compute. As a Strategic Partner, GF will work closely with Silicon Catalyst to recruit, evaluate and select early-stage startups seeking to participate in their program. As a member of the IKP ecosystem, GF will provide access to PDKs, MPWs, Foundation IP, and Reference Designs to accelerate time to market for approved, early-stage companies on GF's 22FDX, Silicon Photonics, and Gallium Nitride platforms.

09:02 EDT Data Storage secures six-figure contract with educational music publisher - Data Storage Corporation has secured a six-figure contract with one of the world's largest educational music publishers, which further solidifies the Company's reputation as a trusted provider of specialized cloud hosting services.

08:56 EDT LPL Financial: Northern Plains joins broker-dealer, RIA, custodial platforms - LPL Financial LLC, announced that financial advisors with Northern Plains Financial have joined LPL Financial's broker-dealer, RIA and custodial platforms. They reported serving approximately $225 million in advisory, brokerage and retirement plan assets and join LPL from Cetera. Based in Grand Forks, N.D., the firm was founded in 2014 and is led by Michael Elsberry, CFP, CRPC, who has nearly 20 years of experience in financial services. In 2021, he was joined by his lifelong friend and fellow advisor Eric Carlson, who worked in commercial banking for 13 years before transitioning to financial advising. Together, they offer a full spectrum of financial planning and investment management services, with a niche serving those in the farming and ranching community, as well as business owners who love to hunt and fish.

08:53 EDT Starboard issues letter to News Corp.'s holders on dual-class share structure - Starboard Value's letter to News Corp shareholders said, in part: Starboard Value ..."we believe News Corp has an opportunity for significant shareholder value creation. Since that time, we have enjoyed discussions with our fellow shareholders, who share our concerns that the Company is significantly undervalued and is burdened by its dual-class share structure that provides outsized influence to the Murdoch family. To be clear, we believe dual-class share structures are NOT in the best interests of shareholders and are NOT reflective of best-in-class corporate governance practices......Shareholders do have a choice and will have an opportunity to make their voices heard - there is a path to achieve majority support for this proposal. We believe majority support for this proposal will send a clear and direct message to the Board to eliminate the dual-class share structure. If the Board refuses to listen, we can then take further action. We will be filing a proxy statement in the coming weeks with more details on the proposal. We look forward to continuing to engage with our fellow shareholders..."

08:50 EDT NRSInsights reports August same-store sales increased 5.1% year-over-year - NRSInsights announced comparative same-store sales results for August 2024. As of August 31, 2024, the NRS retail network comprised approximately 32,300 active terminals nationwide, scanning purchases at independent retailers including bodegas, convenience stores, liquor stores, grocers, tobacco, and sundries sellers nationwide, predominantly serving urban consumers. Same-store sales increased 5.1% year-over-year. In the previous month, same-store sales had increased 1.2% year-over-year. Same-store sales increased 1.7% compared to the previous month. Same-store sales in July 2024 had decreased (1.9)% compared to the previous month. For the three months ended August 31, 2024, same-store sales increased 3.2% compared to the same three months a year ago.

08:48 EDT Banzai appoints Kent Schofield to board of directors - Banzai International announced the appointment of Kent Schofield to its Board of Directors effective immediately. Mr. Schofield's appointment as an independent director increases the total number of board members to six, with five independent directors. He currently serves as the Chief Financial Officer of Welcome Tech, a leading provider of immigrant and hourly employee subscription services.

08:45 EDT Trust Stamp issued new patent covering invention of PII encoder - Trust Stamp announced the issuance by the US Patent of Trademark Office of Patent No. 17/719,975 entitled, "Personal Identifiable Information Encoder." Gareth N. Genner, Trust Stamp's Chief Executive Officer, said, "Data protection and privacy should be non-negotiable for any enterprise or governmental agency that stores or processes personal identifiable information. Despite frequent assurances as to secure storage and processing, we continue to see data losses across a wide range of organizations. This technology provides the means to maintain the essential utility of PII without storing highly sensitive data. Anyone processing or storing PII should embrace this technology to fulfill their data protection obligations and mitigate damage and losses in the event of a data breach."

08:43 EDT Quoin Pharmaceuticals announces insider share purchases - Quoin Pharmaceuticals announced that its Chief Executive Officer, Michael Myers, and Chief Operating Officer, Denise Carter, have recently made significant purchases of the company's American Depositary Shares, signaling their confidence in the company's growth and direction. On September 3 and 4, 2024, Michael Myers, CEO of Quoin Pharmaceuticals, acquired a total of 37,894 ADSs at prices ranging from $0.619 to $0.7974 per ADS. Similarly, COO Denise Carter acquired a total of 37,735 ADSs between September 3 and 4, 2024, at prices between $0.6253 and $0.7965 per ADS. These insider purchases reflect the leadership's strong confidence in Quoin's growth trajectory and commitment to delivering long-term value to shareholders as the company advances its mission to address unmet needs in underserved patient populations globally.

08:42 EDT Mama's Creations appoints Skip Tappan as COO - Mama's Creations announced the appointment of Moore "Skip" Tappan to the role of Chief Operating Officer. Prior to joining Mama's Creations, Tappan was Chief Supply Chain Officer at Gordon Food Service, the largest privately owned Food Distributor in North America, where he implemented end-to-end supply chain strategies for all business units, planning for the "Supply Chain of the Future." Adam L. Michaels, Chairman and CEO of Mama's Creations, said: "We are privileged to welcome Skip to our senior leadership team, positioning us to better develop our employees and deliver on our vision of becoming the leading 'one-stop-shop' solution for high quality fresh, clean and easy to prepare foods."

08:41 EDT Lightwave Logic appoints Connelly as newest board member - Lightwave Logic (LWLG) announced that its Board of Directors has appointed former DuPont (DD) executive and CEO of the American Chemical Society, ACS, Thomas Connelly, Jr., as its newest Board member, effective September 4, 2024.

08:40 EDT Horizon Aircraft begins full-scale development of eVTOL aircraft - New Horizon Aircraft announced several key business and technical updates as the Company is steadily progressing in the development of key technological components of its novel, hybrid-powered eVTOL aircraft. Brandon Robinson, CEO of Horizon Aircraft, commented, "I am extremely proud of the pace of our full-scale aircraft systems development program, the world-class team we're building, and the game-changing technology that we're bringing to Advanced Air Mobility. Our unique, customer-first approach prioritizes building a tough eVTOL aircraft that can operate in bad weather, icing conditions, and other challenging operational environments. This strategy is gaining strong traction with operators, driving substantial demand."

08:39 EDT Eaton launches collaboration with Tesla - Eaton (ETN) announced a planned collaboration with Tesla (TSLA) designed to boost the functionality and adoption of home energy storage and solar installations in North America. Targeting early 2025, Tesla's Powerwall would support Eaton's new AbleEdge smart breakers and make it easier and faster for installers and homeowners to achieve intelligent load management functionality that helps optimize energy use and extend backup duration during a grid outage.

08:37 EDT iCoreConnect expands partnership with Mississippi Dental Association - iCoreConnect has announced an expanded partnership with the Mississippi Dental Association. The MDA now endorses seven of iCoreConnect's products, broadening its initial endorsement of the company's cloud-based electronic prescribing software.

08:36 EDT Volato announces acceptance of complianceplan by NYSE American - Volato Group announced that the NYSE American has accepted the Company's plan of compliance for continued listing on the exchange. As previously reported, on June 18 the Company received a notice rom the NYSE American advising the Company that it is not in compliance with the NYSE American continued listing standards set forth in Section 1003(a)(i) of the NYSE American Company Guide equiring a company to have stockholders' equity of at least $2.0 million if it has reported losses from continuing operations and/or net losses in two of its three most recent fiscal years and Section 1003(a)(ii) of the Company Guide requiring a company to have stockholders' equity of at least $4.0 million if it has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. The Company was required to submit a plan to the NYSE American by July 18, o the NYSE American outlining actions it has taken or will take to regain compliance with the continued listing standards by December 18, 2025

08:35 EDT Color Star Technology enters strategic cooperation agreement with Zero2one - Color Star Technology has signed a non-binding framework strategic cooperation agreement with Zero2one Consultancy. This agreement creates a framework of planned operations and marks the commencement of the cooperation between the two parties in jointly promoting the innovative development of education, culture and sports undertakings in the United Kingdom. Zero2one Consultancy Ltd., is an investment company located in the heart of London's business district, providing investment consulting and management services with a deep insight into the education investment sector. Zero2one stands at the forefront of the industry, accurately grasping the market dynamics, to provide investors with efficient and professional services. The planned cooperation with Color Planet is expected to further leverage Zero2one's strengths in the field of education investment, and jointly explore the business opportunities hidden within the UK education market. Both parties plan to invest in cutting-edge areas such as youth football training camps and artist incubation programs, aiming to cultivate more young talents with potential and provide solid support for their growth and success. Looking ahead, the two parties plan to set up training bases in various locations in the UK to provide the youth with richer and more diversified learning opportunities through the introduction of advanced teaching concepts and methods, combined with localized practical exploration. The establishment of these training bases will not only promote the prosperous development of the UK education market, but also inject new vitality into the development of global youth education and sports and culture.

08:34 EDT Femasys gets FDA clearance to market FemChec - Femasys "announced it has received 510(k) clearance from the FDA for FemChec(R), an innovative diagnostic solution for checking the fallopian tubes, designed for controlled delivery of contrast for confirmation of tubal status." CEO Kathy-Lee Sepsick, commented, "FemChec is an essential part of our suite of women's health products, as it fortifies our position to provide safe and technologically-advanced diagnostic and therapeutic solutions addressing women's healthcare needs. In particular, FemChec is a key element of our FemBloc(R) non-surgical permanent birth control solution as it allows for confirmation of procedure success by the same practitioner using natural contrast and ultrasound. This is opposed to the traditional methodology, which requires a referral to radiology, utilizes x-ray dye, and unnecessarily exposes the woman to radiation. We look forward to continuing to work with FDA as we progress our FemBloc solution through the FINALE pivotal trial, which is currently enrolling."

08:34 EDT Hyliion Holdings awarded $15M + contract by Office of Naval Research - Hyliion Holding has been awarded a $15+ million contract by the Office of Naval Research or ONR, to develop its groundbreaking KARNOTM generator for Navy ships and stationary power applications. Upon successful validation and demonstration, the Hyliion KARNO generator could be used as a power system in future platforms, providing US Naval operations with scalability and flexibility while significantly reducing maintenance, emissions, and fuel consumption. "At Hyliion, we are dedicated to delivering innovative power generation solutions that prioritize our customers' need for efficiency and reliability," said Thomas Healy, Founder and CEO of Hyliion. "This new partnership with the ONR is a testament to the performance and potential of our KARNO generator technology. We're incredibly proud to contribute to the future of the US military and help them achieve their power generation goals."

08:33 EDT 3D Systems announces milestone in commercializing O1ton Manufacturing OS - 3D Systems has achieved a significant milestone in commercializing Oqton Manufacturing OS. This solution is designed to enable on-demand additive manufacturing in regulated markets by providing full factory-floor workflow integration thus transforming how products are brought to market. Baker Hughes now in full production with Oqton Manufacturing OS in its central manufacturing facilities in Houston, Texas. This marks a significant milestone in the commercial software agreement Baker Hughes entered with Oqton, a wholly owned, independently operated subsidiary of 3D Systems, in March 2023 and reinforces the companies' shared vision to support decentralized manufacturing. The successful implementation of this solution by Baker Hughes demonstrates the Oqton Manufacturing OS' ability to accelerate the design and production of additively manufactured parts across the entire manufacturing workflow to increase efficiency and facilitate regulatory compliance.

08:29 EDT Sacks Parente Golf appoints Doug Samuelson as CFO - NEWTON GOLF announces the appointment of Doug Samuelson as its CFO, effective as of September 9, 2024. He served in various financial reporting and audit roles, including as CFO for Response Genetics, Medacta USA, Smack Sportswear, Solis Tek, AdvaVet, Wellness Center USA, Genelux, and, most recently, Kairos Pharma, a position he held since 2019. Samuelson replaces former CFO Steve Handy, who resigned to pursue other options and whose departure is not the result of any disagreement with management concerning the Company's operations or management.

08:26 EDT Pasithea Therapeutics completes PAS-004 chronic toxicity studies - Pasithea Therapeutics announced the completion of long-term chronic toxicity studies in both rats and dogs with its lead candidate PAS-004, currently being investigated in a Phase 1 clinical trial in advanced cancer patients. Results show that once daily treatment with PAS-004 for 6-months in rats and 9-months in dogs at different dose levels confirms the observations of prior 28-day toxicity studies and indicates a similar safety profile following long-term dosing in both species. Further, the 9-month study in dogs established 0.5 mg/kg as the no adverse effect level in dogs, the most sensitive species. PAS-004 demonstrated a consistent safety profile at doses that correlate with significant pathway engagement and will likely produce significant pERK reduction when dosed below the NOAEL. Completion of this milestone is planned to support chronic patient dosing. For the chronic toxicity studies, PAS-004 was administered in crystalline form and demonstrated a similar adverse event profile and equivalent NOAEL in dogs as compared to the original amorphous formulation. The Company is using a crystalline form of PAS-004 in its human clinical trials.

08:23 EDT Lotus Technology starts delivery of Lotus Eletre SUV in North Asia - Lotus Technology announces the commencement of deliveries of its Eletre model, the intelligent hyper SUV, in Korea and Japan. This milestone marks a significant step forward as Lotus continues to expand its footprint in key geographies, following the brand's successful re-entry into these regions last year. Korea and Japan are established markets for luxury consumption and are also recognized for their welcoming embrace of advanced technologies. As a brand with 76 years of racing heritage, Lotus enjoys a strong and loyal following in these markets and sees a well-established community of drivers who appreciate the brand's leading performance and craftsmanship. To enhance customer experience, Lotus has upgraded its sales network, offering customers the opportunity to test-drive and fully immerse themselves in the exceptional driving dynamics and luxury customer service. For instance, the Lotus Brand Center in Seoul, situated in the prestigious Gangnam district - home to many modern luxury stores - features an official one-stop Lotus service center, ensuring that Lotus owners receive high level of care and convenience.

08:23 EDT Power Engineers shareholders approve acquisition by WSP Global - WSP Global announced that the shareholders of POWER Engineers voted at their special meeting of shareholders in favour of the proposal to approve the previously announced acquisition of POWER by WSP pursuant to an agreement and plan of merger dated as of August 12, 2024 between WSP and POWER, among others. The Acquisition received overwhelming support from POWER shareholders and was approved by over 99% of POWER shares voted at the special meeting, representing approximately 99% of the total issued and outstanding shares of POWER voted in favour of the Acquisition. This step marks an important milestone towards welcoming the POWER team to WSP. Closing of the Acquisition remains subject to certain customary closing conditions, including receipt of regulatory approval in the U.S. The Acquisition is expected to be completed early in the fourth quarter of 2024.

08:22 EDT Protara Therapeutics announce results from THRIVE-1 study - Protara Therapeutics announced the results of THRIVE-1, a prospective, observational study evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support. Results from the study were featured during a poster session at the 46th European Society for Clinical Nutrition and Metabolism Congress, from September 7, 2024, to September 10, 2024, in Milan. The study found that 78% of patients who are dependent on PS were choline deficient, and that 63% of choline deficient participants had liver dysfunction, including steatosis, cholestasis, and hepatobiliary injury, underscoring the need for intravenous choline supplementation in this patient population. Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement therapy, as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated. THRIVE-1 was a multi-center, cross-sectional prospective, observational study involving 78 patients to assess the prevalence of choline deficiency and liver injury in adolescents and adult patients with intestinal failure who are dependent on PS. 78% were choline deficient, with 63% of these patients demonstrating liver dysfunction including steatosis, cholestasis, and signs of hepatobiliary injury. IV choline is recommended for patients receiving PS by the American Society for Parenteral and Enteral Nutrition Recommendations for Changes in Commercially Available Parenteral Multivitamin and Multi-Trace Element Products, as well as by ESPEN in its Guideline on Home Parenteral Nutrition. Based on feedback from the U.S. Food and Drug Administration, Protara intends to assess the safety and efficacy of IV Choline Chloride in THRIVE-3, a seamless registrational Phase 2b/3 trial with dose confirmation followed by a double-blinded, randomized, placebo-controlled trial in adolescents and adults receiving parenteral support.

08:20 EDT Replimune completes pre-BLA meeting with FDA for RP1 - Replimune Group completed a pre-Biologics License Application meeting with the U.S. Food and Drug Administration that supports the Company's plans to submit a BLA for RP1 for the treatment of anti-PD1 failed melanoma via the accelerated approval pathway in 2H 2024. Topline results from the primary analysis of the IGNYTE clinical trial of RP1 plus nivolumab shared earlier this year showed an overall response rate of 33%. Independently reviewed data from the IGNYTE clinical trial, including key secondary endpoints and subgroup analyses will be presented as a late-breaking abstract during an oral session at the European Society for Medical Oncology Annual Congress 2024 in Barcelona on Sunday, September 15, 2024, at 3:45pm CEST.

08:19 EDT Metals Company, PAMCO achieve breakthrough in polymetallic nodule processing - TMC the metals company had produced high temperature material during the first phase of a commercial-scale campaign to process a 2,000 tonne sample of deep-seafloor polymetallic nodules at its partner PAMCO's Hachinohe Rotary Kiln Electric-Arc Furnace facility in Hachinohe, Japan. Undertaken on PAMCO's 131-meter-long #6 commercial kiln, engineers fed approximately 1200 tonnes of nodules into the kiln via conveyor at up to 60 tonnes per hour, and produced roughly 500 tonnes of calcine which will cool slowly before being transferred to PAMCO's demonstration smelting facility [see video]. With sufficient quantities of calcine material now produced to proceed to the next phase of the trial, PAMCO intends to commence commercial-scale smelting of the calcine into a high-grade nickel-copper-cobalt alloy and manganese silicate in the coming months. TMC's Head of Onshore Development, Dr Jeffrey Donald, commented: "After years of carefully-planned development, bench-scale tests, engineering studies and pilot demonstrations it's very exciting to see the world's first commercial-scale processing of our nodules. With decades of experience in processing nickel laterite at industrial scale in its Hachinohe facility, and with dozens of highly capable and disciplined technical and operating personnel on our project, PAMCO is the perfect partner to help optimize our near-zero-solid-waste flowsheet in preparation for commercial production. We appreciate PAMCO's professional efforts and technical contributions to the development of this process."

08:18 EDT Cinemark achieves all-time best September domestic box office weekend - Cinemark announced that the company achieved its all-time best September domestic box office weekend driven by "Beetlejuice Beetlejuice," which also was the company's biggest domestic opening weekend box office for a September title. The company also set September weekend records within food and beverage offerings and premium formats. In addition, the company experienced its best September weekend concession results.

08:16 EDT Rubicon Organics appoints Jesse McConnell to the board - Rubicon Organics announced that Jesse McConnell has been appointed to the Company's Board of Directors after receipt of security clearance from Health Canada. Mr. McConnell was elected to the Board by the shareholders at the Annual General Meeting on July 31, 2024, but his appointment to the Board was subject to being granted security clearance by Health Canada. Jesse McConnell was the Co-Founder of Rubicon Organics in 2015 and served as its Chief Executive Officer from May 20, 2015, to December 31, 2022. The Company has awarded a total of 140,459 Deferred Share Units under its Omnibus Equity Incentive Plan to a director as compensation for their upcoming service. These DSUs will vest after twelve months from the grant date and can only be redeemed if the holder ceases to be a director of the Company or in accordance with the provisions of the Omnibus Equity Incentive Plan.

08:13 EDT Biora Therapeutics achieves ISO 13485 certification - Biora Therapeutics announced it has been awarded ISO 13485:2016 certification by TundefinedV SundefinedD America, demonstrating the company's commitment to compliance with the most rigorous global regulatory and quality standards.

08:10 EDT Ocean Power completes WAM-V for immediate delivery - Ocean Power Technologies has achieved a major contractual milestone and completed the build of a new unmanned surface vehicle for delivery to a survey customer in Latin America. This delivery is part of the Company's previously announced expansion into the region, working with end customers and resellers. This milestone triggers revenue recognition of the fully integrated system, including survey equipment.

08:10 EDT Agilent unveils Biopharma CDx Services Lab to accelerate precision medicine - Agilent Technologies announced the launch of its Biopharma CDx Services Lab BCSL in Carpinteria, California, following receipt of California State clinical laboratory license and Clinical Laboratory Improvement Amendments CLIA ertificate of compliance. These credentials signify that the lab operates in accordance with CLIA regulations, which are federal standards applicable to all U.S. facilities testing human specimens for health assessment, diagnosis, prevention, or treatment of diseases. The CLIA certificate of compliance ensures high standards for accuracy and reliability in laboratory testing, confirms regulatory adherence, boosts market credibility, and improves operational efficiency. The BCSL and Agilent's assay development model will support drug development from early clinical studies through regulatory approval with efficient, flexible, and streamlined companion diagnostic development. The BCSL will also provide access to innovative technologies for biomarker assessment with novel precision therapeutics in clinical trials, as well as high-quality assays that deliver robust data. The continuous development model from feasibility through FDA approval of companion diagnostics offers significant cost and time advantages to biopharma seeking to maximize the value of their investment in companion diagnostics and precision therapeutics.

08:09 EDT Casella Waste to acquire Royal Carting and Welsh Sanitation; terms not disclosed - Casella Waste Systems announced that it has entered into a definitive agreement to acquire Royal Carting and Welsh Sanitation and related real estate assets. The acquisition is expected to close in the fourth quarter, subject to customary closing conditions, including regulatory approvals. The pending acquisition includes two solid waste collection operations and two transfer stations in New York's Middle and Lower Hudson Valley regions and western Connecticut, which will extend the company's service territory into new adjacent markets. The pending acquisition is expected to generate over $90M in annualized revenues with a high concentration of commercial collection service and waste volumes that can be internalized into Casella's landfills over time. "Royal is a well-known and respected waste and recycling service provider, and we are excited to enter these new markets with such a strong platform. We have worked closely with Royal for over 30 years and we have the utmost respect for the Panichi family and their team," said John W. Casella, Chairman and CEO of Casella Waste Systems.

08:08 EDT Vestis receives preliminary inquiry from Elis regarding potential transaction - Vestis confirmed that it received a preliminary inquiry from Elis SA regarding a potential transaction involving the company. The board of directors takes seriously and evaluates any inquiries regarding the company and all alternatives available to the company. There can be no assurance that any transaction or other alternative will result from this inquiry. The company does not undertake to make any further announcements with respect to this or any other inquiries or any strategic alternatives.

08:07 EDT Sintx Technologies receives notice of allowance for U.S. patent - SINTX Technologies has received a Notice of Allowance from the United States Patent and Trademark Office for patent application no. 17/634,141 entitled "Methods of Surface Functionalization of Zirconia-Toughed Alumina with Silicon Nitride Ceramic." This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed. This patent allowance underscores the Company's commitment to advancing the development of advanced ceramic for biomaterial applications, protecting its intellectual property, and delivering innovative solutions to its customers. The patent covers novel methods of bonding bioactive silicon nitride or mixtures of silicon nitride and bioactive glass to zirconia-toughened alumina and similar material surfaces. This invention is designed to impart silicon nitride's beneficial biomedical properties, namely improved osseointegration and resistance to bacterial colonization, to relatively biologically inert ZTA substrates, positioning SINTX at the forefront of medical device biomaterial manufacturing.

08:07 EDT SM Energy appoints McDonald as EVP, COO - SM Energy Company announced that it has appointed Beth McDonald as its Executive Vice President, EVP, and Chief Operating Officer, COO, effective as of September 9, 2024.

08:05 EDT Soluna Holdings secures $25M growth capital line - Soluna Holdings announced that it has entered into a $25M standby equity purchase agreement, or SEPA, with a fund managed by Yorkville Advisors Global. The financing will enable Soluna to: Fund critical Soluna Cloud AI operations and data center development activities. Deploy additional capital into projects to significantly improve equity cash flows. Retire its existing Convertible Notes. Strengthen its balance sheet. This new capital and simplification of the capital structure will enable Soluna to advance its AI data center designs, prepare for the build-out of a 2 MW AI data center adjacent to its flagship Project Dorothy, accelerate the development of the 166 MW Project Kati - which includes AI - and complete the acquisition of new sites for up to 20 MW of additional AI data center development. The secured convertible notes will be replaced with more flexible unsecured financing.

08:04 EDT Harmonic, TOD announces strategic partnership - Harmonic and TOD announces a strategic partnership that elevates live sports streaming. By leveraging Harmonic's cloud-native VOS360 Media SaaS, TOD aims to enhance the viewer experience for live sports fans across the region through unmatched agility, reliability, security and scalability.

08:03 EDT FOREWARN partners with Howard County Association of Realtors - FOREWARN announced that Howard County Association of REALTORS will offer FOREWARN services to its 2,000+ members it serves throughout Columbia, Maryland and the surrounding Howard County area to promote proactive real estate agent safety.

08:02 EDT PodcastOne appoints Steve Lehman as vice chairman - PodcastOne announced the appointment of Steve Lehman as its Vice Chairman, focusing on helping PodcastOne drive both organic and inorganic growth opportunities, as well as advising PodcastOne's senior management with regard to PodcastOne's mergers and acquisitions efforts and overall strategy and increasing its shareholder value. Lehman will leverage his extensive background in business and finance having headed both Nasdaq and NYSE companies, as well as start-up businesses in the media, entertainment, and tech industries.

08:01 EDT Oryzon Genomics announces first patient dosed in Phase Ib study of iadademstat - Oryzon Genomics announced that the first patient has been dosed in an investigator-initiated Phase Ib dose-finding trial of iadademstat, Oryzon's potent and selective LSD1 inhibitor, in combination with venetoclax and azacitidine in newly diagnosed acute myeloid leukemia, sponsored by the Oregon Health & Science University Knight Cancer Institute. Under the direction of Dr. Curtis Lachowiez at OHSU Knight Cancer Institute, the study aims to test the safety, tolerability, and best dose of iadademstat when administered together with the standard-of-care venetoclax and azacitidine in treating patients with newly diagnosed AML. The trial also aims to assess the preliminary efficacy of the triple combination.

07:53 EDT Medicenna presents preclinical results at Promise of Interleukin-2 Conference - Medicenna Therapeutics announced that, as planned and previously announced, new data from two of its preclinical programs were presented orally at the Promise of Interleukin-2 Conference held in Paris, France from September 4-7, 2024. MDNA209 and MDNA113 are preclinical assets based on the MDNA109 platform also used to develop MDNA11, a long-acting IL-2 Super-agonist, currently being evaluated in the Phase 1/2 ABILITY-1 clinical trial for the treatment of solid tumors. The first presentation outlined the potential of MDNA209 to treat autoimmune diseases, including high grade GvHD which has a 1-year survival rate of only 40%. Transplant patients with GvHD experience significant morbidity and mortality with limited therapeutic options to prolong survival. The initial preclinical data presented on the MDNA209 platform highlight the potential of the Company's long-acting, high-affinity IL-2beta biased IL-2/IL-15 Super-antagonists to downregulate the immune system, with therapeutic potential for GvHD and autoimmune diseases. The second presentation focused on MDNA113, which is being developed as a novel, targeted and bifunctional version of a class of blockbuster anti-PD1 therapies, with current annual sales of over $30 billion but lose patent protection from 2028 onwards. Although Anti-PD-1 checkpoint blockade has improved survival outcomes in many types of solid tumors, approximately 70% of cancer patients do not benefit. To further improve patient outcomes, Medicenna has designed an anti-PD1-IL-2SK BiSKIT that uses an IL-13 Superkine to simultaneously target and localize the BiSKIT to the TME while masking the IL-2 domain during peripheral circulation and reducing its toxicity. At the TME, tumor specific proteases cleave the IL-13 component, releasing the BiSKIT to engage with T-cells thereby stimulating T-cell activity via the IL-2 domain and preventing T-cell exhaustion via the anti-PD1 domain. Key highlights from the presentations are: MDNA209, a High Affinity IL-2beta Biased IL-2/IL-15 Super-antagonist, for the Treatment of Autoimmune Diseases: MDNA209 is an IL-2 Super-antagonist with enhanced affinity for IL-2Rbeta but does not engage with the gammac subunit, therefore acting as a receptor clamp to exclude native IL-2 as well as native IL-15. MDNA209 is fused to an Fc scaffold to extend its in vivo half-life, reducing the need for frequent dosing. MDNA209-Fc inhibits both, IL-2 and IL-15 induced p-STAT5 signaling, reduces IFNgamma release and slows immune cell proliferation without reducing Treg population. In an aggressive animal model of acute GvHD, MDNA209 was able to extend overall survival by 400 percent, reduce weight loss and improve clinical scores. MDNA113, an IL-13Ralpha2 Tumor Targeting and Conditionally Activatable anti-PD1-IL-2SK BiSKIT Shows. Enhanced Safety and Potent Therapeutic Efficacy: MDNA113 showed reduced capacity to induce IL-2R mediated pSTAT5 signaling compared to anti-PD1-IL-2SK in cell-based assay and human CD8+ T cells without impacting PD1/PDL1 blockade. Proteolytic cleavage of MDNA113 releases anti-PD1-IL-2SK and fully restores its capacity to activate IL-2R signaling. Mice treated with MDNA113 showed reduced peripheral lymphocyte expansion compared to anti-PD1-IL-2SK due to masking by the IL-13 Superkine. MDNA113 showed greater tolerability than anti-PD1-IL-2SK following repeat dose administration in mice. MDNA113, but not a non-cleavable version, demonstrated similar efficacy as anti-PD1-IL-2SK in MC38 colon tumor model despite these tumors lacking IL-13Ralpha2 expression. Efficacy of MDNA113 is substantially enhanced when tested in mice harboring MC38 tumors that have been engineered to overexpress IL-13Ralpha2, resulting in complete tumor regression in most animals. Variants of MDNA113 have also been designed with tunable masking of the IL-2 Superkine underscoring the versatility of the platform.

07:51 EDT TC Energy announces record date for South Bow spinoff - TC Energy announced the setting of the distribution record date of Sept. 25, 2024 for the previously announced spinoff of TC Energy's Liquids Pipelines business into South Bow Corporation by way of a plan of arrangement. Pursuant to the Arrangement, TC Energy shareholders will retain their interest in TC Energy and receive a pro rata interest in South Bow, as further described in the management information circular of TC Energy dated April 10, 2024. The spinoff has received the requisite tax rulings in Canada and the U.S., as well as required shareholder and court approvals. Subject to the satisfaction or waiver of the remaining closing conditions to the Arrangement, it is expected that the Arrangement will become effective on Oct. 1, 2024. The Toronto Stock Exchange and New York Stock Exchange will both implement "due bill" trading markets for common shares of TC Energy commencing Sept. 25, 2024 and ending at the close of business on Oct. 1, 2024. The TC Energy Common Shares are expected to trade in the "due bill" markets under the designation TRP on both the TSX and NYSE

07:48 EDT Revival Gold reports metallurgical test results at Mercur - Revival Gold reports results from the Company's column leach metallurgical test program on representative samples from the Mercur Gold Project in Utah, U.S.A. Five composite samples were developed from seven HQ core holes for testing. The composites were developed to be geologically and grade representative of the primary gold-bearing heap leachable host rocks at Mercur. The composites were crushed to 100% passing 12.5 mm and actively leached for seven weeks. The test program was undertaken by Kappes Cassiday & Associates at KCA's laboratory in Reno, Nevada. Results of were as follows: Overall extraction rates for gold for the five column leach tests were 85%, 85%, 74%, 92%, and 82%. Average sodium cyanide consumption for the column leach tests was 0.57 kg/T (1.14 lbs/t) and lime addition was 1.0 kg/T. The column leach kinetics were rapid on all composites with 90% of the gold leached reporting to solution after only five days.

07:46 EDT Progress Software to acquire ShareFile for $875M - Progress (Nasdaq: PRGS), the trusted provider of AI-powered infrastructure software, today announced it has entered into a definitive agreement to acquire ShareFile, a business unit of Cloud Software Group, Inc., providing SaaS-native, AI-powered, document-centric collaboration, focusing on industry segments including business and professional services, financial services, healthcare and construction. Progress products help organizations to develop, deploy and manage responsible AI-powered applications and experiences. Upon closing of the transaction, ShareFile will add to these capabilities with SaaS-native, AI-powered document-centric collaboration and workflows, client portal, secure file sync and share and eSignature. The proposed acquisition of ShareFile is another example of the continued execution of Progress' Total Growth Strategy. Progress continues to maintain financial discipline while seeking to acquire strong businesses with products that complement its existing software portfolio, include a robust customer base with strong retention rates and solid recurring revenue, and align with its company culture. ShareFile is expected to add more than $240M in annual revenue and more than 86,000 customers to Progress. Subject to the satisfaction of the terms and conditions set forth in the definitive agreement, Progress is expected to acquire ShareFile for $875 million, paid for with a combination of cash and Progress' existing revolving credit facility. The acquisition is currently expected to close within Progress' fiscal year, ending November 30, 2024, subject to obtaining regulatory approvals and satisfaction of other customary closing conditions set forth in the definitive agreement.

07:45 EDT G Mining Ventures to acquire CentroGold project from BHP Group - G Mining Ventures (GMNIF) announces that it has entered into a purchase and sale agreement to acquire tenements in the Gurupi Gold Belt from wholly-owned subsidiaries of BHP Group Limited (BHP). This includes the CentroGold Project. In consideration for the acquisition, GMIN will grant BHP a 1.0% NSR royalty on the first 1 million ounces of gold produced at the tenements and a 1.5% NSR royalty on gold production thereafter.

07:43 EDT Palatin provides update on its clinical programs - Palatin Technologies provided an update on its clinical programs, strategic priorities, and anticipated milestones. Program Updates and Anticipated Milestones: Dry Eye Disease: MELODY-2 & MELODY-3 Phase 3 Pivotal Clinical Studies; FDA Confirms Protocols and Endpoints; Targeting Enrollment Start in 4Q Calendar Year 2024; Topline Results Anticipated 4Q Calendar Year 2025; Potential Collaboration/Funding Discussions Ongoing. Obesity: Phase 2 Clinical Study with Melanocortin-4 Receptor (MC4R) Agonist + Glucagon Like Peptide-1: Patient Dosing Commenced 3Q Calendar Year 2024; Topline Results Expected 1Q Calendar Year 2025. Male Sexual Dysfunction: Development and Clinical Program with Bremelanotide Co-Formulated with a PDE5i for the Treatment of Erectile Dysfunction (ED) in Patients That Do Not Respond to PDE5i Monotherapy; Pharmacokinetics Study Expected to Start 1Q Calendar Year 2025; Patient Recruitment in Phase 3 Study Anticipated in 2H Calendar Year 2025. Ulcerative Colitis (UC): Oral PL8177 Phase 2 Clinical Study in Active UC Patients; Interim Analysis Readout Expected in 4Q Calendar Year 2024; Topline Results Anticipated 1Q Calendar Year 2025; Potential Collaboration Discussions Ongoing

07:41 EDT Mobileye to end internal lidar development - Mobileye has chosen to end the internal development of next-generation frequency modulated continuous wave, or FMCW, lidars for use in autonomous and highly automated driving systems. The company now believes that the availability of next-generation FMCW lidar is less essential to its roadmap for eyes-off systems. The company said, "This decision was based on a variety of factors, including substantial progress on our EyeQ6-based computer vision perception, increased clarity on the performance of our internally developed imaging radar, and continued better-than-expected cost reductions in third-party time-of-flight lidar units. This action does not impact any of our customer product programs or product development in general. It also has no bearing on Mobileye's commitment to development of our in-house imaging radar, which is meeting performance specifications based on B-samples and is expected to enter production next year, on schedule. In terms of Mobileye's internal sensor development, imaging radar is a strategic priority. This is a core building-block technology that we expect to drive competitive advantage for Mobileye-based eyes-off systems in cost/performance optimization and scalability. The lidar R&D unit will be wound down by the end of 2024, affecting about 100 employees. Operating expenses for the lidar R&D unit are expected to total approximately $60M in 2024. While this action is not expected to have a material impact on Mobileye's results in 2024, it will result in the avoidance of lidar development spending in the future."

07:39 EDT NIP Group establishes game publishing division - NIP Group announced that it has established a dedicated game publishing division. This strategic move marks a significant expansion of NIP Group's digital entertainment ecosystem and leverages the Company's esports expertise to tap into the booming youth-driven gaming market. NIP Group's game publishing strategy will be multifaceted, focusing on esports-oriented titles, as well as exploring opportunities in various game categories. This approach includes developing mini-games for social media platforms, mobile games, and PC games, enabling the Company to cater to a wide range of player preferences and capitalize on emerging market trends. By diversifying its game offerings, NIP Group aims to strengthen its position in the competitive gaming landscape. The new game publishing division will be led by Hang "Allen" Sui, Chief Operating Officer of NIP Group

07:37 EDT Marimaca Copper appoints Oscar Valenzuela as VP, project - Marimaca Copper announced the appointment of Oscar Valenzuela as Vice President, Project and Alexis Munoz as Vice President, Project Execution. Prior to joining Marimaca, Mr. Valenzuela was the Director of Projects for Capstone Copper. Before joining Marimaca, Mr. Munoz was the Construction and Commissioning Manager for Capstone's recently completed Mantoverde Development Project.

07:35 EDT FDA lifts partial clinical holds on Rezolute's RZ358 - Rezolute announced that the U.S. Food and Drug Administration has removed the partial clinical holds on RZ358, a potential treatment for hypoglycemia caused by congenital HI. Ersodetug is currently being studied in sunRIZE, a global Phase 3, multi-center, double-blind, randomized, placebo-controlled, safety and efficacy registrational study in participants with congenital HI. The Company will now commence study start-up activities in the U.S. with the goal of including U.S. participants in the global sunRIZE study. The Company anticipates potential U.S. enrollment to begin in early 2025, which will enable announcement of topline data from the study in the second half of 2025.

07:32 EDT Phillips Edison upgraded by Moody's - Phillips Edison & Company announced that Moody's Ratings upgraded its issuer credit rating for PECO and the Company's operating partnership, Phillips Edison Grocery Center Operating Partnership I L.P., to 'Baa2' from 'Baa3', with a stable outlook.

07:29 EDT Euro Manganese announces offtake term sheet with FeMoCat - Euro Manganese has entered into an offtake term sheet dated September 6, 2024 with FeMoCat, for the sale of high-purity manganese sulphate and a process by-product, magnesium carbonate, from the Company's Chvaletice Manganese Project in the Czech Republic. Highlights: FeMoCat is an established industrial catalyst manufacturer, with a plant at Pardubice in the Czech Republic, less than 1 hour's drive from the Chvaletice Manganese Project. Offtake tonnages represent a portion of the Project's planned high-purity manganese sulphate monohydrate production and a significant tonnage of the magnesium carbonate produced as a by-product. FeMoCat will use these products for its catalysts and Synthetic Hydrotalcites production in Pardubice. Pricing in the Term Sheet is designed to meet the Project's debt finance banking covenants. The Company and FeMoCat intend to enter an offtake agreement, in which the pricing mechanism and tonnages will become binding. The Term Sheet demonstrates the value of producing high purity manganese sulphate with market leading ESG credentials at Chvaletice and the ability to meet the needs of a larger and more diverse customer base. Headquartered in Dublin, Ireland, and with plants in the Czech Republic and China, FeMoCat is a global provider of catalysts for the manufacturing of commodity organic chemicals, including Formaldehyde, Aniline and Volatile Organic Compounds. In addition to manufacturing catalysts, FeMoCat also undertakes recycling of used catalysts and provides tolling services for other catalyst companies and is an advocate for Green Chemistry, seeking to reduce, eliminate, or prevent the generation of hazardous substances in the design, manufacture and application of its catalysts. Offtake tonnages represent a portion of the Project's planned high-purity manganese sulphate monohydrate production. Magnesium carbonate is a by-product produced at Chvaletice from the purification of HPMSM, and a significant tonnage of magnesium carbonate offtake is included in the Term Sheet. Deliveries are to commence from first production, ramping up with the Project's production capacity, for an initial term of seven years with potential for renewals. The commencement of the initial term will be subject to successful qualification of the Company's HPMSM and magnesium carbonate by FeMoCat. The qualification process shall commence with samples from the Project's Demonstration Plant. Pricing for the HPMSM will be on a take or pay basis, based on an index-adjusted western benchmark price. The western benchmark price represents HPMSM with the following attributes: high quality, secure, traceable, western supply source, and market leading ESG credentials, including a low CO2 footprint. Pricing for the magnesium carbonate by-product will reflect current market prices, European origin and the same leading ESG credentials and will be linked to an appropriate magnesium index.

07:26 EDT Autonomix reports pain reduction in pancreatic cancer patient treatment - Autonomix Medical announced 4-6 week preliminary positive results from the first five "lead-in" patients in the Company's ongoing proof-of-concept human clinical trial evaluating the safety and effectiveness of delivering transvascular energy to ablate relevant problematic nerves and mitigate pain in patients with pancreatic cancer pain. Three patients were treated with femoral access and two were treated with brachial access. All patients treated with femoral access positively responded to treatment and patients treated with brachial access showed no improvement in their pain scores. 60% of patients responded with a mean of 6.67, or 83%, reduction of pain on the VAS pain scale (from baseline of 8.0 to 1.33) at 4-6 weeks post-procedure. 66% of responders reported a VAS pain score of 0 or 1 with a greater than 7-point reduction in pain score at 4-6 weeks post-procedure. 100% of the responder group had clinically meaningful pain relief at 4-6 weeks post-procedure. "We are encouraged by the significant, sustained pain reduction demonstrated from the lead-in patients in our ongoing first-in-human trial. These are very sick individuals, who up until this point primarily relied on opioids to help mitigate their pain, which our baseline data shows were not effective. Following our treatment, all the responders had a clinically meaningful mean reduction in pain from 8 to 1.33 on the VAS pain scale at 4-6 weeks post-procedure," commented Brad Hauser, CEO. "While these data are preliminary, we are excited about our precision nerve-targeted technology and the potential it has to revolutionize electrophysiology therapies."

07:25 EDT Evaxion Biotech obtains preclinical PoC for EVX-B2 vaccine candidate - Evaxion Biotech announces new pre-clinical data demonstrating the ability of its novel EVX-B2 mRNA Gonorrhea vaccine candidate in eliminating gonorrhea bacteria by triggering a targeted immune response. This new data, which will be presented today at the 18th Vaccine Congress taking place in Lisbon, Portugal, provides strong Proof-of-Concept for the mRNA-based version of EVX-B2 in a pre-clinical setting. EVX-B2 was initially designed as a protein-based prophylactic vaccine candidate for which pre-clinical PoC has already been obtained. The novel pre-clinical data for the mRNA-version of the vaccine substantiates that AI-Immunology identified vaccine antigens are delivery modality agnostic and can be applied across different vaccine modalities. The new data has been generated in collaboration with Afrigen Biologics. "We are pleased to announce the pre-clinical PoC for EVX-B2, thereby reaching another of our milestones for 2024 according to plan as we continue to execute on our strategy. It is exciting to see yet another validation of our AI-Immunology(TM) platform and its potential to help develop new and better treatments also for bacterial diseases. In the case of Gonorrhea, no vaccine exists today, so we have an opportunity here to develop a potentially groundbreaking treatment. Further, the data confirms that our platform is delivery modality agnostic, which is a very strong value proposition towards existing and new partners," says Christian Kanstrup, CEO of Evaxion.

07:24 EDT Akero Therapeutics announces first patient dosed in Phase 3 SYNCHRONY study - Akero Therapeutics reported the first patient was dosed in the Phase 3 SYNCHRONY Outcomes trial. The study will evaluate the efficacy and safety of EFX for the treatment of compensated cirrhosis, fibrosis stage 4, due to metabolic dysfunction-associated steatohepatitis. Outcomes is part of Akero's broader SYNCHRONY Phase 3 program, which includes two other ongoing, randomized, placebo-controlled trials that began enrolling patients in the fourth quarter of 2023. SYNCHRONY Histology is evaluating the efficacy and safety of EFX in patients with biopsy-confirmed pre-cirrhotic MASH, while SYNCHRONY Real-World, is assessing the safety and tolerability of EFX in patients with non-invasively diagnosed MASH or metabolic dysfunction-associated steatotic liver disease. The SYNCHRONY program is evaluating extent of improvement in fibrosis and resolution of MASH, as well as liver-related long-term clinical outcomes and all cause mortality, with the potential to support marketing applications for treatment of both pre-cirrhotic liver fibrosis and compensated cirrhosis due to MASH. In all Phase 3 studies, patients are self-administering EFX using the LyoJect 3S dual chamber syringe, a pre-filled device intended for commercial use in the event EFX is approved for marketing. Week 96 results from the ongoing Phase 2b SYMMETRY study, evaluating the efficacy and safety of EFX in patients with compensated cirrhosis due to MASH, are anticipated in the first quarter of 2025.

07:21 EDT Squarespace, Permira amend agreement, increase offer price to $46.50 per share - Squarespace and Permira announced that they have agreed to amend their previously announced definitive agreement. Under the terms of the amended agreement, Squarespace stockholders will receive $46.50 per share in cash and an aggregate transaction value of approximately $7.2 billion. The revised offer price represents an increase of 5.7% over the previously agreed offer price of $44.00 per share, a premium of 36.4% over Squarespace's 90-day volume weighted average trading price of $34.09 and a premium of 21.8% over Squarespace's 52-week high share price of $38.19 as of May 10, 2024. The transaction also represents over 20x enterprise value / 2025 unlevered free cash flow1, representing a significant premium to peers.

07:19 EDT Apogee Therapeutics names Jeff Hartness as Chief Commercial Officer - Apogee Therapeutic announced the appointment of Jeff S. Hartness as Chief Commercial Officer. Mr. Hartness joins Apogee from Bausch Health, where he held roles of increasing responsibility over eight years, most recently serving as Executive Vice President on the Global Executive Leadership Team, leading the company's market access, commercial operations, policy and government affairs teams, as well as General Manager of the Neurology portfolio and the Generics businesses.

07:17 EDT Tonix Pharmaceuticals presents data on TNX-801 at Immunology Symposium - Tonix Pharmaceuticals announced data presented at a symposium hosted by the Department of Medical Microbiology & Immunology and the Li Ka Shing Institute of Virology to celebrate the career and honor the retirement of Tonix's collaborator, David Evans, Ph.D., FCAHS, Emeritus Professor, Department of Cell Biology, University of Alberta. The presentation titled, "Using Synthetic Biology to Battle Mpox", detailed the Company's vaccine platform, led by TNX-801 for preventing mpox. TNX-801 is an attenuated live-virus vaccine based on synthesized horsepox that has been shown to provide single-dose immune protection against a monkeypox challenge with better tolerability than 20th century vaccinia live-virus vaccines in animals. TNX-801 is structurally closer to 19th century live-virus vaccinia vaccines than 20th century versions. Genomic sequencing of archaic smallpox vaccines has shown that vaccines used prior to 1900 would be called 'horsepox' today. While effective against smallpox as single-dose vaccines, 20th century vaccines have diverged from horsepox-like progenitors to have greater virulence and toxicity than TNX-801 in animals. The U.S. Food and Drug Administration recently approved ACAM2000 from Emergent Technologies for preventing mpox.4 ACAM200 is a live-virus vaccine derived from a 20th Century vaccinia vaccine. ACAM2000 carries a Black Box warning on its package insert labeling warning of tolerability issues, including myocarditis and pericarditis, encephalitis, encephalomyelitis, encephalopathy, progressive vaccinia, generalized vaccinia, severe vaccinial skin infections, erythema multiforme major, eczema vaccinatum resulting in permanent sequelae or death, and risks in certain individuals that may result in severe disability, permanent neurological sequelae and/or death.5 The Jynneos vaccine from Bavarian Nordic is a non-replicating vaccinia vaccine that is FDA-approved for mpox with a two-dose regimen requiring sterile injection.6 Single-dose TNX-801 has advantages over non-replicating vaccinia vaccines which require two doses. Percutaneous TNX-801 has advantages over vaccines which require sterile injection. The durability of protection from 19th century live-virus vaccinia vaccines was believed to last decades or even be live-long. Consequently, single-dose TNX-801 is believed to stimulate long-lived T cell immunity. Consequently, TNX-801 will not require multiple repeated doses at six-month intervals like mRNA vaccines.7 Also, the stability of live-virus vaccines, particularly in lyophilized form, eliminates the need for ultra-cold storage which complicates the widespread use of mRNA vaccines in Africa, where they are needed most right now. Tonix's focus on single-dose vaccines adheres to recommendations by the Bipartisan Commission on Biodefense8, and the U.S. National Academies of Science. For example, the NAS report highlights the difficulty of a case-contact or "ring" vaccination strategy with even a two-dose regimen. In the presentation, Tonix highlighted positive preclinical efficacy data, demonstrating that TNX-801 protected animals against lethal challenge with intratracheal clade I monkeypox virus.10 An outbreak of Clade I mpox has recently been declared a Public Health Emergency of International Concern by the World Health Organization.11,12 Starting from an outbreak in the Democratic Republic of the Congo, clade I mpox has spread to several Central African Countries and cases have been reported in Sweden, Thailand and Singapore. According to the U.S. Centers for Disease Control and Prevention and other experts, there is a significant risk that clade I strain may appear in the U.S.13 Clade I mpox is typically associated with higher case fatality rates than clade II mpox. After a single dose vaccination, TNX-801 prevented clinical disease and lesions and also decreased shedding in the mouth and lungs of animals challenged with clade I monkeypox.10 These findings are consistent with TNX-801 inducing mucosal immunity and suggest TNX-801 has the ability to block forward transmission, similar to Dr. Edward Jenner's vaccinia vaccine, descendants of which eradicated smallpox and kept mpox out of the human population. The presentation at University of Alberta included results from Tonix scientists at the Research and Development Center (RDC) in Frederick, Md. Data from a manuscript showed that TNX-801 is highly attenuated relative to 20th century vaccinia vaccines in in immunocompromised animals.14 New data showed TNX-801 is unable to spread in blood or tissues in these animals, even at an approximately 100-Fold higher dose than 20th century vaccinia vaccines. In addition to characterizing TNX-801's activity and tolerability, Tonix scientists have explored the characteristics of the monkeypox virus. The prior 2022 global clade IIb mpox outbreak, affected over 90,000 persons in countries where mpox previously had not been endemic, including Europe and the US. The spread of clade IIb strain mpox in 2022 underscores the pandemic potential of mpox. Data presented show that monkeypox clade IIb from a 2022 isolate in Massachusetts is 10,000- to 100,000-fold more attenuated than clade IIa isolates from 2003. The attenuation of clade II monkeypox in the recent 2022 outbreak may have contributed to its greater dissemination. The new and more lethal clade I monkeypox has not yet been analyzed.

07:14 EDT RedHill Biopharma's Talicia listed as first-line choise for H. pylori by ACG - RedHill Biopharma announced the placement of low-dose rifabutin-triple therapy, Talicia, as an empirically-prescribed first-line option for the treatment of Helicobacter pylori infection in the newly published American College of Gastroenterology, ACG, Clinical Guideline: Treatment of H. pylori Infection, previously updated in 2017.

07:13 EDT Cartesian receives FDA Rare Pediatric Disease Designation for Descartes-08 - Cartesian Therapeutics announced that the U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation to Descartes-08 for the treatment of juvenile dermatomyositis. Descartes-08, Cartesian's lead mRNA cell therapy candidate, is an autologous mRNA-engineered chimeric antigen receptor T-cell therapy product candidate targeting B-cell maturation antigen. Descartes-08 is designed to be administered without preconditioning chemotherapy and does not use integrating vectors.

07:12 EDT Telesat selects Calian Group to develop, deploy Element Management System - Telesat (TSAT) has selected Calian Group (CLNFF) to design, develop, deliver and deploy the Element Management System within the Telesat Lightspeed Low Earth Orbit satellite network as well as to provide lifecycle maintenance and support for the system. The EMS will be instrumental in connecting and maintaining operations for various components within the Telesat Lightspeed network, identifying and addressing issues to ensure optimal performance. With the EMS, Telesat will be able to manage the configuration and capabilities of Telesat Lightspeed Landing Stations, User Terminals, and the satellite onboard processors as needed. In addition, Telesat will leverage the EMS to collect and share Telesat Lightspeed system data with the company's Operations Support Systems and Network Operations Centers to gain full visibility into the state of the entire constellation.

07:11 EDT Acrivon Therapeutics to host investor event on Phase 2 data of ACR-368 - Acrivon Therapeutics announced that the company will host a virtual investor event to review ACR-368 clinical data that will be presented at a poster presentation at the European Society for Medical Oncology congress on September 14, 2024 in Barcelona, Spain, as well as other R&D updates. The poster presentation will contain updated data from the cohort of patients with endometrial cancer in the ongoing, registrational intent Phase 2b study of ACR-368. "At our April 2024 R&D event we shared encouraging initial clinical data showing a confirmed response rate of 50% across ovarian and endometrial cancer patients, as well as initial validation of our response-predictive ACR-368 OncoSignature test," said Peter Blume-Jensen, M.D., Ph.D., chief executive officer, president, and founder of Acrivon. "Enrollment is progressing ahead of schedule for patients with endometrial cancer, a new tumor type that we predicted to be particularly sensitive to ACR-368 with our AP3 platform, and hence we are accelerating this additional interim data disclosure at ESMO. We believe this ongoing registrational intent study for endometrial cancer represents the first potential approval opportunity for ACR-368. We continue enrollment in ovarian and bladder cancer cohorts, and are also enthusiastic about the potential of ACR-368 in other tumor types where it has shown activity, such as squamous cell cancer, and look forward to providing an update on those programs at a future date. In addition to ACR-368, we are also excited to share updates on our clinical candidate, ACR-2316, and the AP3 platform at the webcast on September 14.

07:09 EDT Solaris submits EIA for construction of Warintza - Solaris Resources reports that it has submitted an Environmental Impact Assessment to the Ministry of Environment, Water and Ecological Transition for the construction of the Warintza Project in southeastern Ecuador. The EIA spans over 3,000 pages and represents the culmination of more than three and a half years of dialogue, traditional learning, baseline environmental monitoring, data collection and studies. It is compliant with Ecuadorean regulations, leading international practices, and aligns with the globally recognized Equator Principles framework and Performance Standards on Environmental and Social Sustainability promulgated by the International Finance Corporation. This report builds on prior permitting, including an EIA and community consultations resulting in the granting of an environmental license for advanced exploration in 2023 which facilitated significant site infrastructure and Project development. To date, over US$170 million has been invested in the Project, with nearly 100% procurement through Ecuadorean supply chains and 55% from local cantons. The Project employs over 500 people and is the only significant source of formal employment available locally and one of the largest job creators in the region. The EIA was prepared by ESSAM. With the successful completion of this milestone, the Company has confirmed with its lender that the second tranche of US$15 million will be drawn on its previously announced Offtake Credit Facility in the coming days and remains well-funded with available liquidity of US$84 million. The next update on permitting is expected with the technical approval of the EIA in H1/25. Solaris is also pleased to announce initial steps towards aligning the Company and its management with stakeholders and regulators in Ecuador as Warintza enters the permitting stage. The Company is transitioning its head office to Quito, Ecuador, where certain of Solaris' senior management team will work from. Solaris is continuing to evaluate further steps to complete a greater transition to Ecuador. The Company does not currently anticipate that any such further steps will pose adverse tax consequences for the Company or require a change of stock exchange listings.

07:07 EDT Teekay Corp. board authorizes $40M share repurchase program - Teekay announced that the Company has nearly completed the previously-announced $25 million share repurchase program, repurchasing 3.25 million common shares at an average price of $7.49 per share. Since August 2022, Teekay has repurchased a total of 14.97 million common shares, or 14.7% of the outstanding common shares immediately prior to commencement of the initial share repurchase plan announced in August 2022, for a total cost of $84.4 million, representing an average repurchase price of $5.64 per share. In addition, the Company's Board of Directors has authorized a new share repurchase program for the repurchase of up to $40 million of the Company's outstanding common shares.

07:06 EDT Pembina Pipeline joint venture to acquire midstream assets from Veren for C$400M - Pembina Pipeline (PBA) announced that Pembina Gas Infrastructure, or PGI, a Western Canadian focused gas processing entity jointly owned by Pembina and KKR (KKR), has entered into agreements with Veren Inc. and certain affiliates thereof that include the acquisition of Veren's Gold Creek and Karr area oil batteries and support for future infrastructure development. The net purchase price related to the acquisition of the batteries is C$400M. PGI will acquire four batteries in the Gold Creek and Karr areas, which include natural gas handling capacity of 320M cubic feet per day and liquids handling capacity of 53,000 barrels per day. Natural gas from the batteries is processed at PGI's Patterson Creek Gas Plant and both the batteries and the Patterson Creek Gas Plant are connected to Pembina's Peace Pipeline system. Veren will retain operatorship of the acquired assets, with operating costs and maintenance capital flowing through to Veren. Veren will also assume operatorship of the existing PGI-owned batteries in the area. Additionally, PGI will fund up to C$300 million, of which approximately one-third has already been committed, for Veren's future battery and gathering infrastructure in the area. Veren will construct and operate the batteries, and PGI will construct and operate high pressure gathering pipelines. Veren will enter into a 15 year take-or-pay agreement for capacity at the acquired batteries, which also includes an area-of-dedication to PGI for gathering and processing services for all volumes Veren produces out of the Gold Creek and Karr areas. Anticipated annual adjusted EBITDA associated with the acquisition of the batteries is initially expected to be approximately C$50M. Further capital deployment in support of commitments will generate incremental contracted EBITDA from corresponding fees and increased plant utilization. The transaction will initially be funded using PGI's existing credit facility. Closing is expected to occur in the fourth quarter of 2024 and is subject to the satisfaction or waiver of customary closing conditions, including all required regulatory approvals.

07:05 EDT Relay Therapeutics announces anticipated RLY-2608 next steps - Doublet - Breast Cancer: Initiate 2L pivotal study of RLY-2608 + fulvestrant in 2025, pending regulatory discussions; Triplets - Breast Cancer: Report initial safety data for RLY-2608 + ribociclib + fulvestrant in the fourth quarter of 2024; Initiate RLY-2608 + ribociclib + fulvestrant triplet dose expansion cohort in the first half of 2025; Initiate RLY-2608 + atirmociclib (CDK4) + fulvestrant triplet by the end of 2024; Monotherapy - Solid Tumors: Initiate RLY-2608 monotherapy solid tumor dose expansion cohort by the end of 2024. Monotherapy - Vascular Malformations: Initiate vascular malformations study in the first quarter of 2025

07:04 EDT Bristol Myers to present data at ESMO on immuno-oncology, progression of assets - Bristol Myers Squibb announced the presentation of nearly 60 abstracts of company-sponsored studies, investigator-sponsored studies, and collaborations from across its oncology portfolio and pipeline at the European Society for Medical Oncology Congress 2024 to be held from September 13-17 in Barcelona, Spain. Key data being presented by Bristol Myers Squibb at ESMO Congress 2024 include: Data supporting our innovative oncology portfolio: Ten-year follow-up data from the Phase 3 CheckMate -067 trial showed the continued durable, long-term survival benefit of Opdivo plus Yervoy in patients with advanced or metastatic melanoma. These data represent the longest reported median overall survival from a Phase 3 advanced melanoma trial. An update of clinical outcomes from the Phase 3 CheckMate -77T trial evaluating an Opdivo-based perioperative regimen in patients with resectable non-small cell lung cancer. Expanded analyses from the CheckMate -9DW trial evaluating Opdivo plus Yervoy vs lenvatinib or sorafenib as first-line treatment for unresectable hepatocellular carcinoma. Subgroup efficacy and expanded safety data from the Phase 3 CheckMate -8HW trial evaluating Opdivo plus Yervoy as first-line treatment for microsatellite instability-high/mismatch repair-deficient metastatic colorectal cancer. Updated efficacy and safety results at approximately 15-months of follow up from the Phase 3 CheckMate -67T trial evaluating subcutaneous nivolumab in patients with previously treated advanced or metastatic clear cell renal cell carcinoma. Efficacy and safety data from the randomized Phase 3 KRYSTAL-12 trial evaluating KRAZATI versus docetaxel in patients with pretreated locally advanced or metastatic NSCLC harboring a KRASG12C mutation and baseline brain metastases. Studies supporting our advancing pipeline: Data from the proof-of-concept, randomized, Phase 2 RELATIVITY-104 trial evaluating the combination of nivolumab and relatlimab plus platinum-doublet chemotherapy as first-line treatment for stage IV or recurrent NSCLC. BMS is initiating the Phase 3 RELATIVITY-1093 trial evaluating the fixed-dose combination of nivolumab and relatlimab plus chemotherapy versus pembrolizumab plus chemotherapy as a first-line treatment for patients with stage IV or recurrent non-squamous NSCLC with tumor cell PD-L1 expression of 1 to 49%, supported by findings from the RELATIVITY-104 trial. First data from the randomized, Phase 2 CA001-050 trial evaluating BMS-986012, an anti-fucosyl-GM1 monoclonal antibody, in combination with carboplatin, etoposide, and nivolumab as a first-line therapy in newly diagnosed patients with extensive-stage small cell lung cancer: interim analysis. Updated safety and clinical activity from first-in-human Phase 1 trial evaluating the targeted protein degrader BMS-986365, the company's potential best-in-class oral dual androgen receptor ligand-directed degrader and antagonist, in heavily pre-treated patients with metastatic castration-resistant prostate cancer. Three presentations of data evaluating BL-B01D1, a bispecific antibody-drug conjugate targeting both EGFR and HER3 being developed in collaboration with SystImmune, Inc., in locally advanced or metastatic biliary tract cancer, locally advanced or metastatic urothelial carcinoma, and locally advanced or metastatic esophageal squamous cell carcinoma.

07:02 EDT MagnaChip expands automotive power product lineup - Magnachip Semiconductor Corporation announced the release of four new 40V 1)MXT MV MOSFETs designed in Power Dual Flat No-Lead 33 packages for automotive applications. Magnachip's newly launched 40V MXT MV MOSFETs come in PDFN33, reducing the area by more than 60% and the weight by approximately 75% as compared to 40V MOSFET products packaged in PDFN56. This makes them even more suitable for automotive motors and low-power control systems, where performance, fuel efficiency, and space flexibility are crucial.

07:00 EDT Relay Therapeutics announces interim data for RLY-2608 - Relay Therapeutics announced interim data for RLY-2608, the first known investigational allosteric, pan-mutant and isoform-selective inhibitor of PI3Kalpha. The data showed that despite heavy pre-treatment, patients with PI3Kalpha-mutated, HR+, HER2- locally advanced or metastatic breast cancer who received RLY-2608 600mg BID + fulvestrant demonstrated clinically meaningful progression free survival. ReDiscover - RLY-2608 First-in-Human Study: RLY-2608 is currently being evaluated in ReDiscover, an ongoing first-in-human study, which was designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of RLY-2608 alone, in combination with fulvestrant, and in combination with fulvestrant and ribociclib or atirmociclib. As of the August 12, 2024 interim data cut-off, the RLY-2608 + fulvestrant arm of the study had enrolled 118 patients with PI3Kalpha-mutated, HR+, HER2- locally advanced or metastatic breast cancer across all doses in both the dose escalation and dose expansion portions of the study, including 64 patients at the company's recommended Phase 2 dose of 600mg BID. Among these 64 patients, 31 had a kinase mutation and 33 had a non-kinase mutation. Twelve patients also had a PTEN or AKT co-mutation and were therefore excluded from the efficacy analysis, consistent with the currently proposed pivotal population. An abstract has been submitted for presentation at the San Antonio Breast Cancer Symposium, taking place December 10-13, 2024. Patients were Heavily Pre-Treated: All patients across doses had received a significant level of prior therapy in the advanced setting, including at least one prior endocrine therapy and at least one prior CDK4/6 inhibitor. Among the 64 patients who received the RP2D: 45% of patients had received two or more prior lines of therapy; 52% of patients had received a prior selective estrogen-receptor degrader, such as fulvestrant or a novel SERD; 25% of patients had received chemotherapy or an ADC; 59% percent of patients had visceral metastases; 34% of patients had a BMI of at least 30 and/or HbA1c of at least 5.7%. Promising Efficacy Data in Proposed Pivotal Population: Among the 52 patients who received the RP2D and did not have a PTEN or AKT co-mutation: Median PFS was 9.2 months across all mutations and 10.3 months among patients with kinase mutations; Clinical benefit rate was 57% across all patients; Among the 30 patients with measurable disease, one third achieved a partial response; Nearly three quarters of patients experienced tumor reductions; Among the 15 patients with measurable disease who had a kinase mutation, more than half achieved a PR; Median follow-up was 7.5 months. Maintained Meaningfully Differentiated Tolerability Profile: RLY-2608 + fulvestrant was generally well tolerated in the 118 patients treated across all doses as of the data cut-off date. The overall tolerability profile consisted of mostly low-grade treatment-related adverse events that were manageable and reversible. Safety outcomes were generally as expected across dose levels based on exposure and consistent with mutant-selective PI3Kalpha inhibition. Among the 64 patients who received the RP2D: The low rate of TRAE-related dose modifications allowed for 95% median dose intensity; Only two patients discontinued treatment due to TRAEs; The majority of hyperglycemia was Grade 1; only one patient experienced Grade 3 hyperglycemia; no Grade 4-5 hyperglycemia; Only 25% of patients experienced a Grade 3 TRAE; no Grade 4-5 TRAEs; Continued Progression of Front-Line Breast Cancer Regimens" Two front-line triplet regimens are being progressed - one with the existing CDK4/6 standard-of-care ribociclib and one with Pfizer's investigative selective-CDK4 inhibitor atirmociclib. RLY-2608 + ribociclib + fulvestrant dose escalation portion of the ReDiscover study is currently testing biologically active doses of RLY-2608; On track to identify a dose of RLY-2608 that is combinable with full-dose ribociclib; Initial safety data expected in the fourth quarter of 2024' Expect to initiate dose expansion cohort in first half of 2025; RLY-2608 + atirmociclib + fulvestrant triplet on track for initiation by the end of 2024.

06:50 EDT UniFirst opens latest uniform service and processing facility in Ontario - UniFirst announced the opening of its latest uniform service and processing facility in London, Ontario. The facility, located in London, Ontario, marks an investment in the region. The 56,000 square-foot-facility is equipped with advanced processing technology designed to optimize the quality and efficiency of uniform cleaning, maintenance, and delivery. The new facility will serve nearly 2000 customers across Southwestern Ontario, providing a range of services, including uniform and workwear rental, laundering, and maintenance, as well as facility products and services for industries spanning healthcare, hospitality, food processing, manufacturing, and more. The plant employs approximately 80 residents, contributing to the economic growth of the London community.

06:48 EDT Eli Lilly appoints Lucas Montarce as CFO - Eli Lilly announced the appointment of Lucas Montarce as executive vice president and CFO and member of the company's executive committee, effective immediately. Since joining Lilly in 2001, Montarce has held a range of finance leadership roles. He most recently served in the role of Lilly president and general manager for the Spain, Portugal and Greece hub.

06:38 EDT Azimut Exploration provides update on exploration activities in Quebec - Azimut Exploration provided an update on its 2024 summer exploration activities in the Eeyou Istchee James Bay region of Quebec. This field season stands out as one of the most productive ever for the Company. Work programs over seventeen properties will be completed by the end of October, with a collective minimum budget of $10M, including $6M provided by our partners. The results, which will be regularly disclosed as they become available, will be used to guide follow-up work. Azimut is a Quebec-focused explorer with the province's largest mineral portfolio. The Company uses an advanced targeting methodology and a multicommodity strategy focused on gold, copper, nickel and lithium. This approach is applied to enhance the probability of success while mitigating the exploration and commodity market risks. Nine of the programs are self-funded, four are co-funded under joint ventures with SOQUEM, and the other four are partner-funded under option agreements with Rio Tinto, KGHM and Ophir Metals. A total of 3,001 rock, 1,385 till and 504 lake sediment samples have been collected since the start of the field season, and 3,449 m have been drilled on the Elmer project. Drilling is ongoing at Pilipas.

06:36 EDT Radisson enters MOU with IAMGold on milling assessment for O'Brien gold project - Radisson Mining Resources entered into a Memorandum of Understanding with IAMGOLD Corporation to assess the design criteria for processing mined material from Radisson's O'Brien Gold Project at the nearby Doyon gold mill, part of IAMGOLD's Doyon-Westwood mine complex. The Doyon mill is located 21 kilometres west of O'Brien within Quebec's Abitibi region and directly accessible along Trans-Canada Highway 117. If off-site processing at Doyon is deemed viable by both parties, Radisson intends to complete a Preliminary Economic Assessment for O'Brien, which will further consider mine design, mining methodology, mining rate and gold production profile, facilities requirements, development schedule and overall Project economics. The MOU facilitates the exchange of technical data between Radisson and IAMGOLD Corporation regarding metallurgy, flow-sheet configuration, potential mill modifications, and future processing and tailings disposal capacity. Each Party will be responsible for its own costs associated with the work. To conduct the assessment, Radisson has retained Ausenco Engineering Canada ULC and a program of metallurgical work has already commenced at the Lakefield, Ontario facilities of SGS Canada Inc. The MOU is non-binding and non-exclusive and contains no specific terms around potential commercial arrangements between the Parties. There is no certainty that any arrangement between the Parties will result from their dealings pursuant to the MOU.

06:33 EDT Broadstone Net Lease reports investments of $375.6M year-to-date - SEPTEMBER 2024 BUSINESS UPDATE: Invested $375.6M year-to-date, including $234.3M in new property acquisitions, $86.1M in development fundings, $52.2M in transitional capital, and $3M in revenue generating capital expenditures. Total investments consist of $248.6M in industrial properties, $124M in retail and restaurant properties, and $3M in an animal health services property. Committed $453.7M to fund developments and $8M to fund revenue generating capital expenditures with existing tenants as of September 8, 2024. Our commitments to fund developments include $446M of industrial properties and $7.7M of restaurant properties with varying construction start dates through 2024. We anticipate delivery and corresponding rent commencement by the end of 2025 for approximately one-third of those commitments, with the remaining two-thirds occurring in the first half of 2026. In conjunction with our growing development funding pipeline, we sold, on a forward basis, 2M shares of our common stock for gross proceeds of approximately $36.5M under our at-the-market common equity offering, none of which has settled. These sales may be settled, at our discretion, at any time prior to September 2025. Commenced contractually scheduled rent with our build-to-suit tenant, United Natural Foods, based on the substantial completion of construction in early September 2024. On a pro forma basis, including up to approximately $25.1M of additional development closeout expenses expected to be funded during the fourth quarter of 2024, UNFI will become our number two tenant based on annualized base rent. Resolved ongoing negotiations with Red Lobster in connection with its bankruptcy proceedings, resulting in the assumption of our master lease agreement and continued operation of all 18 of our Red Lobster locations, representing 1.6% of ABR as of June 30, 2024.

06:17 EDT Bitfarms reschedules special meeting of shareholders - Bitfarms (BITF) has rescheduled the Special Meeting of shareholders from October 29, 2024 to November 6, 2024. The Special Meeting has been called in response to a requisition made by Riot Platforms (RIOT) on June 24, 2024 and amended on September 3, 2024. The company said, "The Special Meeting was rescheduled to provide the Bitfarms Special Committee adequate time to review and respond to Riot's Amended Requisition and provide shareholders with sufficient time to evaluate the information relevant to this voting decision regarding the future of their investment in Bitfarms. The Bitfarms Board is focused on acting in the best interests of ALL Bitfarms shareholders. On the contrary, it is clear that Riot, as a direct competitor to Bitfarms, is only focused on taking steps to support its shareholders, not Bitfarms or its shareholders. Recognizing the high costs and distraction associated with a proxy contest, the Bitfarms Special Committee continues to seek to engage constructively with Riot in an effort to resolve the Amended Requisition so that Bitfarms need not expend its cash resources to protect the interests of its shareholders against the actions of Riot. To that end, the Bitfarms Special Committee has proposed the following terms set out in a settlement agreement forwarded to Riot: the addition of one mutually agreed upon Board nominee resulting in an increase of the size of the Board to six, and standstill and other customary provisions."

06:07 EDT Radware signs MSSP agreement with Cirion Technologies - Radware signed a managed security service provider agreement with Cirion Technologies. Based on the agreement, Cirion Technologies plans to invest in Radware's Cloud DDoS Protection Service and offer it as a service to customers across Latin America. The MSSP agreement represents an expansion of an existing channel relationship between Radware and Cirion.

06:05 EDT reAlpha acquires Be My Neighbor, terms not disclosed - reAlpha Tech Corp. announced the acquisition of Be My Neighbor, a mortgage brokerage company founded by veterans licensed to operate in 26 U.S. states. This strategic acquisition adds mortgage lending and refinancing services under the reAlpha umbrella of real estate services and enhances the capabilities of its generative AI-powered, commission-free homebuying platform. Specifically, Be My Neighbor will enable reAlpha to provide integrated mortgage services to consumers who utilize the reAlpha platform to purchase homes. Acquiring mortgage services aligns with reAlpha's goal of vertically integrating the homebuying process, which reAlpha expects to result in a more seamless customer experience and increased revenue opportunities. Be My Neighbor will continue to operate under its brand by co-founders Christopher Griffith, Isabel Williams, and Nathan Knottingham, while benefiting from reAlpha's resources and generative AI platform.

06:03 EDT KBR Rose technology selected by Zhejiang Petroleum & Chemical - KBR announced that it has been awarded a contract for its Rose supercritical Solvent De-Asphalting, or SDA, technology from Zhejiang Petroleum & Chemical, a subsidiary of Rongsheng Petrochemical in China. Under the terms of the contract, KBR will provide technology licensing and proprietary engineering design to ZPC, the operator of China's largest refinery.

06:01 EDT Rockwell Medical enters product purchase agreement with dialysis provider - Rockwell Medical announced a product purchase agreement with an at-home and acute care dialysis provider in the United States. Under the terms of the agreement, Rockwell Medical will supply the Customer with the Company's liquid acid RenalPure and liquid bicarbonate SteriLyte, both of which will be packaged in either the Company's four-per-case packaging for larger dialysis settings or two-per-case packaging for smaller acute care and at-home care settings.

05:46 EDT Methanex to acquire international methanol business of OCI Global for $2.05B - Methanex announced that it has entered into a definitive agreement to acquire OCI Global's international methanol business for $2.05B. The transaction includes OCI's interest in two methanol facilities in Beaumont, Texas, one of which also produces ammonia. The transaction also includes a low-carbon methanol production and marketing business and a currently idled methanol facility in the Netherlands. As part of the transaction, Methanex expects to achieve approximately $30M of annual cost synergies from lower logistics costs and lower selling, general and administrative expenses. Methanex anticipates low integration costs because of OCI's similar operating model and expects that additional value can be obtained by applying its expertise and operational experience to the OCI assets. Methanex plans to integrate key operational practices at the facilities and will incorporate the OCI assets into its global risk-based management processes including turnaround and capital planning post-closing. As part of the transaction, Methanex will acquire the following: A methanol facility in Beaumont, Texas with an annual production capacity of 910,000 tons of methanol and 340,000 tons of ammonia. This plant was restarted in 2011 and since that time the plant has been upgraded with $800M of capital for full site refurbishment and debottlenecking. A 50% interest in a second methanol facility also in Beaumont, Texas, operated by the joint venture Natgasoline. The Natgasoline plant was commissioned in 2018 and has an annual capacity of 1.7M tons of methanol, of which Methanex's share will be 850,000 tons. OCI HyFuels, which produces low-carbon methanol and sells volumes with trading and distribution capabilities for renewable natural gas. A methanol facility in Delfzijl, Netherlands with an annual capacity to produce 1M tons of methanol. This facility is not currently in production due to unfavorable pricing for natural gas feedstock. Under a definitive agreement with OCI, the $2.05B purchase price will consist of $1.15B in cash, the issuance of 9.9M common shares of Methanex valued at $450M and the assumption of $450M in debt and leases. The purchase price implies a multiple of 7.5 times adjusted EBITDA at a $350/MT realized methanol price, including anticipated synergies. The North American operating assets have been acquired below reinvestment economics of brownfield or greenfield capacity. After the transaction Methanex will have approximately 77M shares outstanding, of which OCI will own approximately 13%. Methanex intends to fund the cash consideration of the transaction through a combination of cash on hand and new debt issuance. The company has obtained a fully committed debt financing package from Royal Bank of Canada to support the transaction. Closing of the transaction is expected in the first half of 2025. The transaction has been approved by the boards of directors of both companies and is subject to receipt of certain regulatory approvals and other closing conditions including TSX approval for the issuance of Methanex shares to OCI. The transaction is also subject to approval by a simple majority of the shareholders of OCI. The largest shareholder of OCI, has signed an agreement to vote for the transaction. There is currently a legal proceeding between OCI and its Natgasoline joint venture partner over certain shareholder rights. The obligation of Methanex to purchase OCI's 50% stake in Natgasoline is subject to the resolution of this legal proceeding. If it is not settled within a certain period, Methanex has the option to carve out the purchase of the Natgasoline joint venture and close only on the remainder of the transaction. If Methanex elects to complete the transaction on a carved-out basis, it will retain the right to acquire OCI's joint venture interest for a specified period thereafter at its sole option. Approximately 40% of the gross transaction and operating metrics are attributable to Natgasoline. Substantially all the debt in the total transaction is attributable to Natgasoline.

05:38 EDT MSP Recovery launches initiative to secure new pacts in healthcare reimbursement - MSP Recovery announced an initiative to secure new agreements with health plans, providers, insurers and attorneys as it continues to make strides in healthcare reimbursement through data-driven solutions and strategic partnerships. This initiative is expected to generate revenue through fees charged on savings from unnecessary Medicare secondary payments.

05:33 EDT Summit soars after lung cancer drug shows benefits versus Keytruda - Summit Therapeutics (SMMT) over the weekend presented data from a Phase 3 Study of ivonescimab versus Merck's (MRK) Keytruda as first-line treatment for PD-L1- positive advanced non-small cell lung cancer. Ivonescimab demonstrated a statistically significant 5.3 months of improvement in progression free survival versus Keytruda, the company said. Shares of Summit Therapeutics are up 41%, or $4.98, to $17.25 in premarket trading while Merck is down 4% to $113.45. Reference Link

05:26 EDT Innate Pharma reports AstraZeneca presentation of results from NeoCOAST-2 study - Innate Pharma (IPHA) announced that AstraZeneca (AZN) presented interim results from the randomized NeoCOAST-2 Phase 2 platform study during the 2024 World Conference on Lung Cancer on September 8. The NeoCOAST-2 platform study is intended to assess the safety and efficacy of neoadjuvant durvalumab alone or combined with novel agents and chemotherapy in resectable, early-stage non-small cell lung cancer, or NSCLC, followed by adjuvant treatment with durvalumab with or without the novel agents. The preliminary data of three arms were presented at WCLC, namely: Arm 1: oleclumab in combination with durvalumab and platinum doublet chemotherapy in the neoadjuvant setting and durvalumab plus oleclumab in the adjuvant setting; Arm 2: monalizumab in combination with durvalumab and platinum doublet chemotherapy in the neoadjuvant setting and durvalumab plus monalizumab in the adjuvant setting and; Arm 4: datopotamab deruxtecan in combination with durvalumab and single agent platinum chemotherapy in the neoadjuvant setting, and durvalumab alone in the adjuvant setting. In this preliminary analysis on the first 60 of 72 patients randomized to Arm 2, monalizumab added to durvalumab plus platinum-based chemotherapy doublet induced a pathological complete response rate of 26.7% and a major pathological response rate of 53.3% which are numerically higher than the durvalumab plus platinum doublet approved regimen. Treatment in Arm 2 showed manageable safety profile and no impact on surgical rate.

05:19 EDT Immunovant announces update on batoclimab trial, IMVT-1402 IND clearance - Immunovant reported results from the Phase 2a trial of batoclimab in Graves' Disease. Immunovant also disclosed data from several proprietary market research studies that showed a consistent unmet need among ATD treated patients who are intolerant to, uncontrolled on or relapsed after ATDs. Finally, Immunovant also announced alignment with the FDA and investigational new drug application, or IND, clearance with initiation of a pivotal trial of IMVT-1402 in GD expected by December 31. As previously disclosed, the batoclimab phase 2a trial in uncontrolled GD enrolled patients who were hyperthyroid despite ATD therapy. Participants in the trial received 12 weeks of high dose batoclimab, 680 mg weekly by subcutaneous injection, or SC, followed by 12 weeks of lower dose batoclimab, 340 mg weekly SC. At the end of the first 12 weeks, participants experienced a mean IgG reduction of 77% leading to a 76% response rate. In addition, by the end of 12 weeks of higher dose batoclimab, 56% achieved an ATD-free response. Despite benefiting from a lower starting IgG level after 12 weeks of 680mg therapy, during Weeks 13 to 24, the lower 340mg dose of batoclimab resulted in mean IgG reduction of 65% with a correspondingly lower responder rate of 68%. In addition, a lower ATD-free response rate of 36% was also observed in the second 12 weeks. Finally, patients who achieved at least a 70% IgG reduction at the end of the trial had nearly a threefold higher ATD-free response rate than those who did not.

05:11 EDT IntercontinentalExchange gets notice from FCA on cessation of U.S. Dollar LIBOR - Intercontinental Exchange noted the final announcement from the U.K. Financial Conduct Authority, or FCA, regarding the cessation of U.S. dollar LIBOR. The FCA has confirmed that it will not use its powers under the U.K. Benchmarks Regulation, or BMR, to compel ICE Benchmark Administration, or IBA, the authorized and regulated administrator of LIBOR, to continue to publish the 1-, 3- and 6-Month "synthetic" U.S. dollar LIBOR settings after September 30. Accordingly, the FCA has issued a final announcement reminding users that these final three remaining LIBOR settings will cease after publication on this date. No new LIBOR settings will be published following September 30.