Stockwinners Market Radar for September 23, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

20:03 EDT Cathie Wood's ARK Investment buys 374K shares of 3D Systems today

19:50 EDT Beasley Broadcast trading halted, news pending

19:50 EDT Onconetix Inc trading halted, news pending

18:54 EDT Carvana exec sells $5.25M in common stock - In a regulatory filing, Carvana disclosed that its Chief Product Offercer Daniel Gill sold 30K shares of common stock on September 20th in a total transaction size of $5.25M.

18:09 EDT Novo Nordisk's coramitug granted FDA orphan designation - According to a post on the FDA's website, Novo Nordisk's treatment of transthyretin amyloidosis, coramitug, was granted orphan designation. Reference Link

17:48 EDT Swedish battery maker Northvolt to cut 1,600 jobs amid automotive headwinds - Volkwagen (VWAGY)-backed Swedish battery maker Northvolt announced plans to downsize in some areas..The company said, in part,earlier: "Following initial steps taken as part of its strategic review, Northvolt outlines a revised scope of operations in Sweden to ensure that its resources are focused on accelerating production in large-scale cell manufacturing at Northvolt Ett. These measures are expected to result in the redundancy of approximately 1,600 Northvolt employees, split across Skellefteundefined , Vasterundefineds and Stockholm . All redundancies are subject to ongoing union negotiations..Peter Carlsson, CEO and Co-Founder of Northvolt, commented: "While overall momentum for electrification remains strong, we need to make sure that we take the right actions at the right time in response to headwinds in the automotive market, and wider industrial climate. We now need to focus all energy and investments into our core business. Success in the ramp-up of production at Northvolt Ett is critical for delivering to our customers and enabling sustainable business operations. Recent production records at Northvolt Ett show that we are on the right path, but the decisions we're taking today, however tough, are required for Northvolt's future."...The Fly notes that German automaker BMW (BMWYY) canceled a $2.15B order for EV battery cells with Northvolt in June...Other companies in the electric vehicle battery space include: BYD (BYDDF), Albemarle (ALB), Panasonic (PCRFY), QuantumScape (QS), FMC Corporation (FMC), and Tesla (TSLA). Volkwagen (VWAGY)-backed Northvolt announced plans to downsize in some areas.. Reference Link

17:39 EDT Hawaiian Electric falls 9% to $9.90 after announcing $500M common stock offering

17:12 EDT Northrop Grumman awarded $127.56M Navy contract modification - Northrop Grumman was awarded a $127.56M modification to a previously awarded fixed-price incentive contract. This modification adds scope to procure weapon replaceable assemblies hardware to include: 292 advanced threat warning sensors; 54 control indicator unit replaceable replacements; 92 Department of the Navy, or DON, Large Aircraft Infrared Countermeasure, or LAIRCM, processor units; 62 Guardian laser transmitter assemblies for the Navy; 53 high capacity cards; 45 smart connector assemblies and 42 battery kits for the Navy; as well as associated systems engineering, technical support, analysis and studies in support of integration of the DON LAIRCM system onto various aircraft for the Navy, Marine Corps, Army, and the Air Force Special Operations Command. Naval Air Systems Command is the contracting activity.

17:02 EDT AptarGroup's N-Sorb nitrosamine mitigation solution accepted to FDA ETP - The company states: "AptarGroup announced that its N-Sorb nitrosamine mitigation solution has been accepted into the U.S. Food & Drug Administration's Emerging Technology Program, or ETP, which helps promote the adoption of innovative approaches to pharmaceutical product design and manufacturing. N-Sorb leverages Aptar CSP Technologies' proven 3-Phase Activ-Polymer(TM) platform technology to address the pressing issue of N-nitrosamine impurities in pharmaceuticals. These impurities, classified as probable human carcinogens, have raised significant regulatory concerns and prompted numerous drug product recalls. Nitrosamines can form during drug product storage or transport, posing risks to patient health. N-Sorb technology can be deployed in multiple formats by integrating active material science into polymers. For example, the technology can be incorporated into a blister format that integrates a piece of N-Sorb Activ-Film(TM) material into each individual Activ-Blister(TM) cavity. This same platform is currently trusted by global brands to protect sensitive Active Pharmaceutical Ingredients from degradation due to moisture and oxygen exposure. Alternatively, the technology can be seamlessly integrated into a container closure system. N-Sorb's intelligent design allows it to react with nitrosamine precursors in the packaging headspace to inhibit nitrosamine formation and scavenge nitrosamine impurities post-formation."

16:34 EDT Duolingo exec sells $1.35M in common stock - In a regulatory filing, Duolingo disclosed that its Chief Business Officer Robert Meese sold 5K shares of common stock on September 20th in a total transaction size of $1.35M.

16:32 EDT DBV Technologies completes patient screening for VITESSE trial - DBV Technologies announced that patient screening is complete for the Phase 3 trial, VITESSE, using the modified Viaskin Peanut Patch in children ages 4-7 years old with peanut allergy. The fully enrolled VITESSE Phase 3 trial in peanut-allergic children ages 4-7 is a 12-month study evaluating the efficacy and safety of the Viaskin Peanut Patch in more than 600 subjects, representing individuals across 86 sites in the U.S., Canada, Europe, the UK, and Australia. VITESSE is currently the largest treatment intervention study in peanut allergy.

16:31 EDT Luminar announces additional workforce reduction - In a regulatory 8-K filing, the company states: "On May 3, 2024, Luminar Technologies announced a restructuring plan, including a reduction in its workforce by approximately 20%. On September 20, 2024, the Company announced additional actions under the 2024 Restructuring Plan that represent a cumulative reduction in workforce of approximately 30% of the Company's full-time employees since the beginning of 2024. The additional actions associated with the 2024 Restructuring Plan are expected to begin immediately and be substantially complete by the end of 2025. The Company estimates that it will incur approximately $4 million to $6 million in additional cash charges associated with employee severance and related employee costs, plus charges related to acceleration of certain previously granted stock-based awards as part of severance packages for employees impacted under the 2024 Restructuring Plan. These charges are expected to be incurred primarily in the third and fourth quarters of 2024."

16:24 EDT Euroseas announces 3-year charter for M/V Synergy Busan - Euroseas announced a time charter contract for its 4,250 teu intermediate containership, M/V Synergy Busan, for a minimum period of 36 to a maximum period of 38 months at the option of the charterer, at a gross daily rate of $35,500. The new charter will commence in early December 2024, in direct continuation of its existing charter. Aristides Pittas, Chairman and CEO of Euroseas commented: "We are very pleased to announce that M/V Synergy Busan has extended its charter contract with a top-class charterer for 36-38 months, at a profitable rate of $35,500/day. This fixture, a strong increase compared to last-done, demonstrates that activity is starting to pick up again and charter market terms remain at very healthy and firm levels. It also seems to indicate that our investment decision to retrofit the vessel with energy saving devices nstalled during the ship's drydock last year, is appreciated by the market and paying off. This charter is expected to contribute in excess of about 29.0 million of EBITDA for the minimum contracted period and increase our remaining 2024 charter coverage to about 95%; it also increases our charter coverage for 2025 to about 50%."

16:23 EDT Ellomay Capital to sell tax credits of Texas solar projects for $19M - Ellomay Capita announced that the company has successfully entered into an agreement for the sale and transfer of Investment Tax Credit, or ITCs, linked to its Fairfield, Malakoff, Mexia and Talco solar projects, all located in the State of Texas. Through this transaction, the company expects to receive approximately $19M from the sale of Investment Tax Credits, representing approximately 32% of the expected total portfolio costs. The sale is facilitated under the Inflation Reduction Act's new transferability provisions, allowing Ellomay to retain 100% of the operating profits from these projects. Funds from the sale of the ITCs generated from a project will be disbursed after such project is placed in service and meets the applicable requirements. The company expects the Fairfield and Malakoff projects to be placed in service by the end of Q4, and the Mexia and Talco projects to be placed in service by the end of Q2 2025. The agreement includes customary indemnification obligations, including in connection with certain continued eligibility requirements and scope of the ITCs, for which the company provided a guarantee to the purchaser of the ITCs.

16:20 EDT Optex Systems announces $2.1M order for laser protected periscopes - Optex Systems Holdings announced it has been awarded contracts from two domestic customers in support of ongoing armored vehicle production. The total value is $2.1M with expected deliveries over the next 18 months. Danny Schoening, CEO, Optex Systems stated "Optex continues to support our domestic armored vehicle manufactures through the ongoing supply of laser protected periscopes. These units provide our customers with real-time situational awareness while protecting them from harmful laser strikes." With this order, the current Optex backlog is in excess of $45M...

16:17 EDT Acadia Pharmaceuticals names Catherine Owen Adams as new CEO - Acadia Pharmaceuticals (ACAD) announced that Catherine Owen Adams has succeeded Steve Davis as CEO and joined the Acadia Board of Directors. Most recently, she served as Senior Vice President and General Manager, U.S., at Bristol Myers Squibb (BMY), where she led a $20 billion commercial business, overseeing a large and diverse portfolio of promoted brands across Oncology, Cardiovascular, and Immunology.

16:16 EDT KKR announces Q3 monetization activity - The company states: "KKR announced income from monetization activity in excess of $535 million with respect to the period from July 1, 2024 through September 23, 2024 based on information available as of today. In its Asset Management segment, KKR has earned total realized performance income and realized investment income in excess of $450 million. This amount includes performance income from a K-Series vehicle that is expected to be crystallized at September 30, 2024. This monetization activity quarter-to-date is made up of approximately 70% realized performance income and approximately 30% realized investment income. In addition, in its Strategic Holding segment, KKR has earned net realized investment income of approximately $85 million. This net realized investment income does not include Strategic Holdings Operating Earnings. Monetization activity across both segments is primarily driven by a combination of public secondary sales and strategic transactions that have closed quarter-to-date, as well as dividends and interest income."

16:14 EDT Capital Clean Energy Carriers to sell five container sister vessels for $118.4M - Capital Clean Energy Carriers announced it has entered into five memoranda of agreement for the sale of five container sister vessels: the M/V Hyundai Prestige, the M/V Hyundai Premium, the M/V Hyundai Paramount, the M/V Hyundai Privilege and the M/V Hyundai Platinum to a third party. The vessels are expected to be delivered to their new owners progressively between November 2024 and January 2025. The total expected book gain from the sale is estimated at $118.4M. All five vessels are debt-free, and the cash proceeds will be used to pay down debt and for general corporate purposes. The divestment of container assets is fully consistent with the strategy outlined in November 2023 to pivot the company toward gas transportation.

16:11 EDT XTI Aerospace names Tobin Arthur as Chief Strategy Officer - XTI Aerospace announced the appointment of Tobin Arthur as Chief Strategy Officer, effective as of September 19, 2024. In this new role, Arthur will help guide the company's vision and oversee its sales, marketing, and investor relations.

16:09 EDT eBay names Samantha Wellington as Chief Legal Officer, General Counsel - eBay announced the appointment of Samantha Wellington as Senior Vice President, Chief Legal Officer, General Counsel and Secretary. In this role, Samantha will oversee all global aspects of eBay's legal department, including Government Relations, intellectual property, employment, litigation, regulatory and corporate work across our financial services, marketplaces, and product and technology organizations. Samantha will report directly to Jamie Iannone, eBay's CEO, and will join the company on October 7, 2024. Samantha joins eBay with a distinguished career in legal and business affairs, most recently serving as TriNet's Executive Vice President of Business Affairs, Chief Legal Officer, and Secretary.

16:08 EDT Pangaea Logistics, MTM to combine fleets of dry bulk vessels - Pangaea Logistics Solutions and M.T. Maritime Management announced a definitive agreement to merge fifteen handy-size dry bulk vessels into Pangaea's 26 vessel supramax, ultramax, panamax and post-panamax fleet. The handy vessels are currently owned by Strategic Shipping, a privately held company managed by MTM located in Southport, Connecticut. The fifteen handy-size vessels are valued at approximately $295M, inclusive of vessel related financing agreements of approximately $102M, resulting in a total net asset value of $193M. As consideration, Pangaea will issue approximately 19M shares of its common stock to SSI equal to approximately 29% of the company's outstanding common stock upon completion of the proposed transaction, which represents the relative net asset value of SSI's vessels compared to the estimated net asset value of Pangaea of approximately $478M, or about $10.20 per share. The transaction is expected to close in the fourth quarter 2024, subject to customary closing conditions and shareholder approval.

16:05 EDT Toll Brothers CEO Yearley sells 25,000 common shares - In a regulatory filing, Toll Brothers CEO Douglas Yearley, Jr. disclosed the sale of 25,000 common shares of the company on September 19 at a price of $153.0461 per share.

14:24 EDT Amazon and AWS expand deal with SLB to accelerate digital and decarbonization - Amazon Web Services or AWS, an Amazon company (AMZN) announced an extended partnership with SLB (SLB) at the SLB Digital Forum 2024 in Monaco to expand access to applications from the Delfi digital platform and explore the deployment of low carbon technologies for the energy industry. Energy Data Insights from AWS will also offer compatibility with SLB's new Lumi data and AI platform, which was launched at the SLB Digital Forum.During the Plenary Keynote at the SLB Digital Forum in Monaco, AWS CEO Matt Garman announced a new collaboration agreement to bring key technologies from SLB's Delfi digital platform to customers on AWS. The collaboration will focus on bringing Petrel subsurface software and Techlog wellbore software to AWS in 2024. Amazon and SLB have also entered into a multi-year strategic framework agreement to explore the deployment of low carbon technologies. This work will build on Amazon's goal and support our path to net zero. "There are many dynamic forces at play in our industry that can be addressed through the adoption of digital technologies," said Rakesh Jaggi, president, Digital and Integration, SLB. "Through this partnership, we will provide AWS cloud customers with our industry-leading software to optimize the energy systems of today and those of the future." Reference Link

14:12 EDT Cloudflare announces AI Audit for websites to control content used by AI - Cloudflare announced AI Audit, a set of tools to help websites of any size analyze and control how their content is used by artificial intelligence AI models. For the first time, website and content creators will be able to quickly and easily understand how AI model providers are using their content, and then take control of whether and how the models are able to access it. Additionally, Cloudflare is developing a new feature where content creators can reliably set a fair price for their content that is used by AI companies for model training and retrieval augmented generation or RAG..."AI will dramatically change content online, and we must all decide together what its future will look like," said Matthew Prince, co-founder and CEO, Cloudflare. "Content creators and website owners of all sizes deserve to own and have control over their content. If they don't, the quality of online information will deteriorate or be locked exclusively behind paywalls. With Cloudflare's scale and global infrastructure, we believe we can provide the tools and set the standards to give websites, publishers, and content creators control and fair compensation for their contribution to the Internet, while still enabling AI model providers to innovate."

13:43 EDT Commerce issues final determination in antidumping duty investigation - The U.S. International Trade Administration has issued a final determination in the antidumping duty and countervailing duty investigations of aluminum lithographic printing plates from the People's Republic of China and Japan. The final determination includes the imposition of duties of up to 317% on imported aluminum lithographic printing plates from China, a favorable decision for Eastman Kodak. Reference Link

12:53 EDT ReShape Lifesciences Inc trading resumes

12:47 EDT Alaska Air announces proposed Mileage Plan financing - Alaska Air (ALK) announced that it launched a proposed senior secured term loan facility and intends to issue additional pari passu senior secured debt. The aggregate principal amount of the Mileage Plan Financing is expected to be $1.5B. The borrower under the Mileage Plan Financing is AS Mileage Plan IP Ltd., an exempted company incorporated with limited liability under the laws of the Cayman Islands and an indirect, wholly owned subsidiary of the company. The Mileage Plan Financing will be (i) fully and unconditionally guaranteed on a senior secured basis, jointly and severally, by Alaska Airlines, Inc. and AS Mileage Plan Holdings Ltd. and on an unsecured basis by the company and (ii) secured, on a first-priority basis by the Guarantors' right, title and interest in certain collateral associated with Alaska's customer loyalty program, Alaska Airlines Mileage Plan. Borrower intends to use the borrowings under the Mileage Plan Financing, after deducting fees and expenses payable by the company, (i) to fund, in part, the reserve account for the Mileage Plan Financing and (ii) to fund, in part, a collection account, and the proceeds deposited into the collection account will be used to make an intercompany loan to Alaska on the closing date of the Mileage Plan Financing. Alaska intends to use the proceeds from the Intercompany Loan (i) to redeem certain outstanding debt acquired or assumed in the merger of the company with Hawaiian Airlines (HA) pursuant to an Agreement and Plan of Merger dated as of December 2, 2023 and (ii) for general corporate purposes and to support its liquidity position.

12:15 EDT AeroVironment says U.S. Army lifts stop work order on IDIQ contract - AeroVironment, in a regulatory filing earlier, said that the U.S. Army has lifted the stop work order it issued on the indefinite delivery, indefinite quantity contract with a ceiling value of $990M between the U.S. Army and AeroVironment related to the company's Switchblade systems. As a result of the lifting of the stop work order, the company will proceed with fulfilling the $128M delivery order issued under the contract. The lifting of the stop work order does not affect the U.S. Government Accountability Office's consideration of the protest filed earlier this month challenging the award of the contract to the company, AeroVironment said. Shares of AeroVironment are up nearly 8% in midday trading to $197.06.

12:00 EDT Vertical Aerospace falls -12.6% - Vertical Aerospace is down -12.6%, or -83c to $5.77.

12:00 EDT Granite Point Mortgage rises 12.7% - Granite Point Mortgage is up 12.7%, or 36c to $3.20.

12:00 EDT Four Seasons Education rises 17.9% - Four Seasons Education is up 17.9%, or $1.58 to $10.40.

11:44 EDT California sues Exxon Mobil over 'decades-long campaign of deception' - California Attorney General Rob Bonta announced the filing of a lawsuit against ExxonMobil "for allegedly engaging in a decades-long campaign of deception that caused and exacerbated the global plastics pollution crisis." In a complaint filed in the San Francisco County Superior Court, the Department of Justice alleges that ExxonMobil "has been deceiving Californians for half a century through misleading public statements and slick marketing promising that recycling would address the ever-increasing amount of plastic waste ExxonMobil produces." Through this lawsuit, the Attorney General seeks to compel ExxonMobil "to end its deceptive practices that threaten the environment and the public." Attorney General Bonta also seeks to secure an abatement fund, disgorgement, and civil penalties for the harm inflicted by plastics pollution upon California's communities and the environment. Reference Link

10:55 EDT Hyperscale Data Inc trading halted, news pending

10:00 EDT Ennis rises 6.5% - Ennis is up 6.5%, or $1.55 to $25.51.

10:00 EDT Biohaven rises 18.4% - Biohaven is up 18.4%, or $7.45 to $47.84.

10:00 EDT Korea Electric Power falls -7.4% - Korea Electric Power is down -7.4%, or -61c to $7.60.

09:48 EDT MultiPlan falls -6.9% - MultiPlan is down -6.9%, or -52c to $7.00.

09:48 EDT Miniso falls -16.8% - Miniso is down -16.8%, or -$2.76 to $13.70.

09:47 EDT Ameresco rises 6.1% - Ameresco is up 6.1%, or $2.20 to $38.27.

09:44 EDT Four Seasons Education (Cayman) Inc(ADR) trading resumes

09:43 EDT Biohaven jumps 19% to $48 after spinocerebellar ataxia study hits endpoints

09:42 EDT Knightscope reports four more clients upgrade to K5 ASR - Knightscope announces that four more clients have been upgraded to the fifth generation of its K5 Autonomous Security Robot. Two Casinos, a Class-A, twin-tower office complex and a storage facility all have the latest release of Knightscope's AI-powered devices that elevate safety at the places people live, work, study and visit.

09:39 EDT MSG family of companies partner with Lenovo, Motorola - Madison Square Garden Sports (MSGS), Madison Square Garden Entertainment (MSGE), and Sphere Entertainment (SPHR) announced an expansive partnership with global technology powerhouse Lenovo (LNVGY) and its subsidiary Motorola Mobility, a leading mobile smartphone manufacturer. As part of the multi-year partnership, Lenovo will be an Official Partner of Madison Square Garden, the Christmas Spectacular Starring the Radio City Rockettes, and the professional sports franchises the New York Knicks and New York Rangers, and will receive brand inclusion across MSG Networks. Motorola will become an Official Partner of Madison Square Garden, the New York Knicks and New York Rangers. The cornerstone of the partnership between the MSG Family of Companies and Lenovo is community engagement - with initiatives focused on small businesses and community organizations through programming with both the New York Knicks and the Christmas Spectacular Starring the Radio City Rockettes. The multi-faceted Motorola partnership will be anchored in high profile, in-venue assets - specifically as the exclusive title partner of Madison Square Garden's famed Celebrity Row.

09:37 EDT Traws Pharma Inc trading halted, volatility trading pause

09:34 EDT Crown Electrokinetics' PE Pipelines secures two contracts totaling $33M - Crown Electrokinetics announced that its PE Pipelines division has secured two contracts valued at $33 million for lead pipe remediation. The work is scheduled to begin in January 2025.

09:28 EDT Ree Automotive kicks off U.S. production with Roush Industries - REE Automotive announced has selected Roush Industries to assemble REE's P7 vehicles at Roush's Detroit-area factory. REE will continue to manufacture its proprietary REEcorner technology in its UK Coventry Integration Center. With a focus on speed to market and impeccable build quality, Roush's assembly team unites decades of design, engineering, machining, fabrication, testing, manufacturing, and supply chain expertise to deliver a scalable process for REE. Roush will be supported onsite by a joint REE and Motherson team, who will be responsible for overall quality assurance, logistics, and testing. Roush, as U.S. contract manufacture for the P7 lineup, will be responsible for the assembly of full vehicles according to REE's requirements. REE's software-defined electric trucks will be assembled at Roush's Detroit based site specifically chosen for REE's requirements and designed to have a yearly capacity of up to 5,000 trucks. Motherson, a leading global automotive part supplier with whom REE signed a strategic agreement, will manage global supply chain and logistics targeting cost reduction, improved unit economics and higher margines.

09:22 EDT SAIHEAT signs two MoUs for HEATNUC business line - SAIHEAT announces the signing of two Memorandums of Understanding for its HEATNUC business line. These agreements aim to strengthen cooperation within the small modular reactor industry in the Middle East and globally. These memorandums of understanding aim to enhance SAI.TECH's competitiveness in the Middle Eastern and global markets, and further promote its localization strategy in the region. The MoU signed with Jiangsu Shentong Nuclear Equipment Co., Ltd., signifies a strategic partnership focused on the export of electrical and instrumentation control system equipment for nuclear power and engineering projects. This includes butterfly valves, ball valves, check valves, instrument valves, air valves, sight glasses, pit filters, shellfish strainers, and rubber diaphragms, targeting the nuclear power and energy sectors. The collaboration also encompasses nuclear safety and quality management initiatives. The second MoU engaged with Shanghai Kaiquan Pump Co., Ltd., outlines plan for joint production of nuclear and Small Modular Reactor equipment and components. This collaboration aims to enhance competitiveness and localize production in the Middle East. Shanghai Kaiquan's products cover all types of Class II and III centrifugal pumps, including vertical/horizontal single-stage single-suction and horizontal single-stage double-suction centrifugal pumps, as well as vertical, etc. The collaboration aims to jointly manufacture nuclear and Small Modular Reactor equipment and components, focusing on boosting competitiveness and localization efforts.

09:19 EDT Agape ATP launches enhanced version of wellness supplement ATP2 - AGAPE ATP unveils the enhanced version of its wellness flagship supplement, ATP2. This product, improved with advanced scientific developments, is designed to address key health challenges including aging, metabolism, and chronic disease management. ATP2 represents a significant advancement in nutritional science, offering a holistic approach to improving health, boosting energy, and supporting overall well-being. At the launch, ATPC announced that the company is targeting to sell 5,000 units by the end of the year, driven by the product's unique blend of plant-based enzymes, minerals, amino acids, and cutting-edge hydrogen acetate technology. ATPC is confident that demand will surge as consumers increasingly seek natural solutions to improve their health and vitality.

09:17 EDT Altamaha Green Energy receives certified purchase power agreement - Altamaha Green Energy, a joint venture between Beasley Green Power, and Rayonier Advanced Materials , announced that the Georgia Public Service Commission has certified a Power Purchase Agreement for AGE to produce and sell up to 70 MW of electricity to Georgia Power Company for a 30-year period. This approval marks a significant milestone in AGE's development of a renewable energy project aimed at producing sustainable electricity for the state of Georgia. "Altamaha Green Energy was formed in response to Georgia Power's competitive and public bidding process for renewable energy solutions," said Darrell Beasley, Chairman of AGE.

09:14 EDT Kaival Brands enters merger, share exchange agreement with Delta Corp - Kaival Brands Innovations Group and Delta Corp Holdings announced that the companies have entered into a definitive merger and share exchange agreement whereby Kavial Brands and Delta will each become wholly owned subsidiaries of a specially created holding company incorporated under the laws of the Cayman Islands, Delta Corp Holdings. The closing of the transactions contemplated by the definitive agreement is subject to certain conditions, including, without limitation, the approval of the shareholders of Kaival Brands and the approval of the listing of the shares of Pubco on the Nasdaq Stock Market. Delta shareholders will become the majority shareholders of Pubco as further detailed below. Following closing of the transactions, which the parties expect will occur in the fourth quarter of 2024, the combined company would be traded on Nasdaq. The combined company will continue to operate under the Delta management team led by Mudit Paliwal, Chief Executive Officer and Founder; Peter Shaerf, Non-Executive Chairman; and Joseph Nelson, Chief Financial Officer, with Kaival Brands as a wholly owned subsidiary of the Pubco. The business combination will be effectuated through a holding company structure, whereby Kaival Brands and Delta will each become wholly-owned subsidiaries of Pubco. Under the agreement, shareholders of Kaival Brands will receive 1 ordinary share of Pubco for each share of Kaival Brands common stock they own as of the closing of the business combination, and Delta shareholders will exchange their shares of Delta for $270 million in ordinary shares of Pubco, subject to certain adjustments, at an implied value per share of $2.66, as set forth in the definitive agreement. Immediately prior to the closing of the business combination, the stockholders of Kaival Brands are anticipated to collectively own approximately 10.30% of the outstanding ordinary shares of Pubco, and Delta shareholders immediately following this closing are anticipated to collectively own approximately 89.70% of the outstanding ordinary shares of Pubco. The definitive agreement also includes an earnout to existing shareholders of Delta, which, if earned, consists of $30 million of additional ordinary shares of Pubco, which would be issued to Delta shareholders if the Surviving Public Company achieves or exceeds revenues of $700 million and either Earnings Before Interest, Taxes, and Depreciation and Amortization of $20 million or net income of $10 million, in each case for the fiscal year ending December 31, 2025. The definitive agreement contains customary representations, warranties and covenants made by Kaival Brands and Delta, including covenants relating to both parties using their commercially reasonably efforts to cause the transactions contemplated by the agreement to be satisfied, covenants regarding obtaining the requisite approval of Kaival Brands' shareholders, covenants regarding indemnification of directors and officers, and covenants regarding Kaival Brands' and Delta's conduct of their respective businesses between the date of signing of the agreement and the closing. The definitive agreement also contains certain termination rights for both Kaival Brands and Delta, and, in connection with the termination of the agreement under certain circumstances, Kaival Brands and Delta may be required to pay the other party a termination fee. The definitive agreement has been unanimously approved by the Board of Directors of Kaival Brands and by the Board of Directors of Delta. The Kaival Brands Board of Directors has also recommended to Kaival Brands' shareholders that they vote to approve the definitive agreement and the business combination. Kaival Brands also received a fairness opinion in connection with the business combination. The business combination is expected to close in the fourth quarter of 2024, subject to certain conditions set forth in the definitive agreement, including the approvals by the requisite shareholders of Kaival Brands described above, the listing of Pubco ordinary shares on Nasdaq, as applicable, and other customary closing conditions.

09:12 EDT EnWave reaches civil litigation settlement with former CEO, employees - EnWave has reached global settlements of its civil claim in the Supreme Court of British Columbia against EnWave's former CEO, Timothy Durance, as well as three other former EnWave employees: Gary Sandberg, Bino Anand and Reihaneh Noorbakhsh. Pursuant to the settlement, Mr. Durance, Mr. Sandberg and Mr. Anand, together with three companies associated with Mr. Durance, including Dehydration Research, LLC and Durance Technologie), are permanently restrained and enjoined from, directly or indirectly, selling, attempting to sell, supplying, delivering or installing vacuum microwave dryers. The Durance Defendants are also obligated to assign all issued and pending patents in the name of the Durance Defendants to EnWave. EnWave has also reached settlements with all other defendants named in its civil claim, including B.C. Hop Company and Peregrine Precision Systems. EnWave will continue to vigorously protect its intellectual property and position as the global leader in vacuum-microwave dehydration technology.

09:10 EDT T2 Biosystems announces publication of article in The Lancet - T2 Biosystems highlighted a recently published article in The Lancet, a world-leading medical journal. The article titled "Changing the Culture of Blood Culture" was authored by Sally Davies, Richard A Marfuggi, Rick A Bright, Steve Brozak, and Michael Osterholm on September 20, 2024. The authors highlighted certain weaknesses of blood culture, the ideal characteristics of culture-independent diagnostics, how to move beyond the culture of blood culture, and how to implement rapid culture-independent diagnostics: Weaknesses of blood culture: blood culture has poor sensitivity, especially with low blood volumes; it is time-consuming, typically taking 24-72 hours for initial results; it is vulnerable to contamination; it has reduced effectiveness in people who have received antibiotics; and is a labor-intensive process requiring skilled technicians. Ideal characteristics of culture-independent diagnostics: culture-independent diagnostic tests need to display proven accuracy; they need to be accurate despite previous antimicrobial therapy; they need to provide results in 3-5 hours; they need to detect a range of bacterial, fungal, and antimicrobial resistance pathogens; they need to be low-cost, easy to use, and accessible; and they should have a low cross-contamination risk and low sample volume requirements. How to move beyond the culture of blood culture: the ongoing crisis in blood-culture availability should encourage the development and implementation of more efficient and resilient diagnostic methods. Moving beyond the culture of blood culture will require changes to reimbursement codes and practices for new diagnostic technologies. Governments, health-care systems, and private-sector entities should designate funding for new diagnostic technologies. Frugal innovation will be important in these efforts, combining state-of-the-art technologies with cost-effective solutions to make advancements accessible, even in resource-limited settings. Implementation of rapid, culture-independent diagnostics: rapid, accurate diagnostics should be integrated into antimicrobial-stewardship programs to enable targeted therapy. Once implemented, global collaboration is needed to share best practices, coordinate research efforts, and ensure equitable access to new diagnostics. Culture-independent diagnostics have the potential to improve health outcomes and strengthen the global response to infectious diseases.

09:08 EDT BorgWarner launches largest passenger car twin turbochargers - BorgWarner (BWA) has solidified an agreement to deliver its turbochargers for use on the General Motors (GM) Corvette ZR1 sports car platform, marking the largest passenger car twin turbochargers in the market to be released to date. Paired with the automaker's 5.5-liter flat plane crankshaft V8 engine, this "unthinkable" Corvette is capable of 1,064 horsepower and 828 pound-feet of torque.

09:07 EDT DTE Energy, DENSO announces leading mobility supplier enrolled in CleanVision - DENSO and DTE Energy announced that the leading mobility supplier has enrolled in DTE's CleanVision MIGreenPower program, one of the largest voluntary renewable energy programs in the U.S. DENSO's Belleville Logistics Center and one facility at its North American headquarters in Southfield will participate in the initiative. Through MIGreenPower, DENSO will attribute 100% of the electricity use at the participating facilities to DTE's Michigan-based wind and solar parks throughout the state for 10 years, going above and beyond the 15% renewable energy DTE already provides all electric customers.

09:06 EDT JetBlue, Aether Fuels sign MOU for supply of sustainable aviation fuel - Aether Fuels has signed a Memorandum of Understanding with JetBlue. Aether has developed a technology that utilizes a diverse array of waste feedstocks to produce sustainable liquid fuels at a lower cost and greater scale than existing approaches. The agreement creates a pathway for Aether to supply JetBlue with sustainable aviation fuel when commercial production begins. The MOU extends Aether's relationship with JetBlue that began when its venture capital subsidiary, JetBlue Ventures, invested in Aether's convertible note and Series A financings.

09:04 EDT Steelcase announces the release of its 2024 Impact Report - Steelcase announces the release of its 2024 Impact Report, "Our Work Toward Better Futures." The report shares recent goals and progress to build community and belonging in the workplace, as well as the company's new commitment to reduce carbon emissions to net zero by 2050.

09:03 EDT Quad/Graphics announces collaboration with Google Cloud - Quad/Graphic (QUAD) announced a collaboration with Google Cloud (GOOGL) to leverage its cloud services in the development of a data, creative and personalization powerhouse. Quad's leading-edge solutions are designed to give advertisers and marketers exceptional accuracy, transparency and cost-efficiency in making direct connections - on-line and off-line - with their customers.

09:02 EDT First Quantum Minerals reports fatality at Kansanshi - First Quantum Minerals regrets to announce that an employee at the Kansanshi operation passed away following a traffic accident involving a tracked dozer and a light vehicle. The Mine Safety Department and relevant local authorities have been notified about the accident and the Company will fully cooperate in their investigations. An internal investigation into the accident is also underway. The site of the accident was immediately secured and operations in the area of the accident have been temporarily suspended and will resume once it is determined that it can be done so in a safe manner.

09:00 EDT Kronos Bio highlights istisociclib data at Ovarian Cancer Research Symposium - Kronos Bio highlighted new preclinical data from a study of istisociclib. The poster presentation took place over the weekend at the American Association for Cancer Research 15th Biennial Ovarian Cancer Research Symposium. Kronos Bio is currently evaluating istisociclib, a CDK9 inhibitor, in an expansion cohort of a Phase 1/2 clinical trial to explore single agent activity in platinum-resistant high-grade serous ovarian cancer. From the presentation, "Preclinical and clinical data support clinical expansion of istisociclib, an oral CDK9 inhibitor, into platinum-resistant ovarian cancer," a summary of results is outlined below. In vitro data demonstrate that istisociclib induced apoptosis/cell death; Istisociclib resulted in the accumulation of gammaH2AX, a sensitive molecular marker of DNA damage; Istisociclib disrupted homologous recombination DNA damage repair by downregulating BRCA1 and RAD51 creating a "BRCAness" phenotype in platinum and PARP resistant HR-proficient ovarian cancer cells; From the dose escalation portion of the Company's ongoing Phase 1/2 trial of istisociclib in relapsed or refractory transcriptionally addicted advanced solid tumors, new pharmacokinetic/pharmacodynamic results were presented. From the dose and schedule optimization portion of the trial evaluating 60mg and 80mg of istisociclib administered once daily on a 4 days on/3 days off schedule:; Clinical exposures resulted in a long half-life of approximately 24 hours, and increased and prolonged weekly exposures consistent with efficacious levels observed in preclinical models; Concurrent with increased and prolonged istisociclib exposure, deeper and more sustained downregulation of CDK9-dependent genes was observed in peripheral blood mononuclear cells.

08:58 EDT Rizz Wireless selects Amdocs connectX to enable mobile experience - Amdocs announced that Rizz Wireless has chosen the Amdocs connectX cloud-native SaaS platform to support its new digital offering that enables subscribers to enjoy uninterrupted US local connectivity while traveling internationally.

08:55 EDT ReElement, Ivy Tech partner on training, degree pathway program - American Resources' ReElement Technologies Corporation announced the collaboration with Ivy Tech Community College of Indiana on a unique training and degree pathway program. This collaboration, under the Achieve Your Degree initiative, aims to offer an affordable means of access to an Ivy Tech education and technical training that can support ReElement's growing employee base and job growth in the exciting field of clean energy and material processing. The collaboration will allow for a cohesive program for employee attraction, retention, training and advancement. As previously announced, Marion, Indiana was selected by ReElement Technologies for this next phase of expansion after several months of careful analysis and examination of several potential sites throughout the Midwestern United States. Once fully operating, the ReElement Marion Advanced Technology Center will support over 300 fulltime jobs in the clean tech industry.

08:52 EDT TechPrecision appoints Richard Roomberg as CFO - TechPrecision has appointed a new CFO. The company announced that on September 19, 2024, it entered into an employment agreement with Richard Roomberg to become its CFO effective September 20, 2024. Management and the Board would like to thank Barbara Lilley for her hard work during this very difficult last year and note that with Mr. Roomberg's appointment, she has stepped down as CFO to become Controller. Roomberg has been the Chief Accounting Officer and Senior Financial Executive with several corporation.

08:44 EDT PolyAI partners with OpenTable to offer support using voice AI - PolyAI announced a partnership with Booking Holdings' OpenTable, expanding PolyAI's guest-led voice assistants to enterprise restaurants. Locations that opt in will be able to take reservations over the phone, answer questions, gain visibility in customer trends, and deliver on-brand experiences - all while alleviating staff time and resources.

08:43 EDT SpartanNash announces promotion of Weis to VP, Distribution Finance - SpartanNash announced the promotion of Paul Weis from Director, Financial Planning & Analysis to Vice President, VP, Distribution Finance. Weis will oversee finance for the Company's global supply chain and report to Executive Vice President and Chief Financial Officer Jason Monaco.

08:42 EDT Markforged enters settlement, patent license agreement in IP litigation - Markforged entered into a Settlement and Patent License Agreement in connection with the patent infringement litigation brought by Continuous Composites. The Settlement Agreement resolves all claims and counterclaims in this litigation, which is currently pending before the United States District Court for the District of Delaware. As previously disclosed in our public filings, in July 2021, Continuous Composites filed a patent-infringement lawsuit against Markforged. Four patents originally asserted against Markforged, comprising a total of nineteen patent claims, were removed from the case in April 2023, leaving four claims from a patent that was added to the case in 2022. Two of the four claims from the remaining patent were tried to a jury in April 2024. On April 11, 2024, the jury found one of the two remaining patent claims Continuous Composites asserted at trial against us to be invalid and not infringed. However, the jury found that we had infringed the other patent claim and awarded monetary damages to Continuous Composites in the amount of $17.34 million. We challenged this verdict through post-trial motions. Through its post-trial motions, Continuous Composites also asserted claims for additional royalty payments for sales of certain products manufactured and/or sold by Markforged in the United States after December 31, 2023. Under the terms of the Settlement Agreement, Markforged will make an upfront payment of $18 million to Continuous Composites, which is expected to occur in the fourth quarter of fiscal year 2024, and three additional installment payments thereafter of $1 million, $2 million and $4 million in the fourth quarters of fiscal years 2025, 2026 and 2027, respectively. In consideration of such payments, the Settlement Agreement provides for a dismissal of all claims with prejudice, cross-licenses of the parties' respective patent portfolios, a mutual release of claims for liabilities arising prior to the effective date of the Settlement Agreement and mutual covenants not to sue. As a condition to the effectiveness of the Settlement Agreement, the Company also entered into a Security Agreement with Continuous Composites pursuant to which the Company granted Continuous Composites a security interest in, among other assets, Markforged's patent intellectual property rights. The Settlement Agreement acknowledges that neither party admitted to any liability or wrongdoing with respect to the claims alleged in the Continuous Composites Lawsuit. The Settlement Agreement also requires the parties to file a joint dismissal of the dispute with prejudice with the District Court to dismiss all claims and counterclaims with prejudice. The Settlement Agreement is subject to review by the District Court.

08:41 EDT Thor Industries, Harbinger collaborate to deliver hybrid Class A motorhome - THOR Industries unveiled the world's first hybrid Class A motorhome, the THOR Test Vehicle. The vehicle is built on an electric vehicle platform developed by EV manufacturer Harbinger. THOR and Harbinger collaborated to integrate a low-emissions gasoline range extender that can recharge the electric battery system, delivering an estimated 500 miles of range. RVs utilizing the hybrid platform will be commercially available in 2025 from the THOR family of companies and are expected to qualify as a Near-Zero Emission Vehicle, NZEV, under the Advanced Clean Truck legislation, adopted by the California Air Resources Board, CARB.

08:39 EDT Slang.ai partners with OpenTable to offer restaurants with reservation support - Slang.ai, an Artificial Intelligence-powered phone answering platform built for restaurants and hospitality partners, announced a partnership with leading restaurant tech company, Booking Holdings' OpenTable to provide AI-powered service to restaurant partners in the U.S. and Canada. This marks a pivotal moment in the hospitality sector, as the collaboration can help drive efficiencies for restaurants, while elevating the booking experience for diners.

08:38 EDT Chesapeake Utilities releases 2023 Environmental Stewardship Report - Chesapeake Utilities Corporation announces the release of its 2023 Environmental Stewardship Report. The report is the second in a series of micro-reports and highlights the Company's continued progress in reducing emissions and contributing to a more sustainable future. "The focus on sustainability is supported and shared across our organization. Our team identifies and pursues emission-reducing projects, not only internally but also to support our customers' sustainability goals," said Jeff Householder, chair of the board, president and CEO of Chesapeake Utilities Corporation.

08:37 EDT Playa Hotels & Resorts completes the sale of Jewel Palm Beach - Playa Hotels & Resorts N.V. announced that it has closed on the sale of the Jewel Palm Beach resort for a total consideration of $68M in cash. The Company expects total net proceeds of approximately $64M.

08:36 EDT Telos expands enrollment, renewal options by opening ten locations - Telos Corporation continues to expand locations to enroll consumers in the TSA PreCheck program by opening ten new locations in North Carolina, California, Colorado, Georgia, Indiana and Texas. These locations will begin offering enrollment services today, September 23, 2024. Telos now has 125 TSA PreCheck enrollment centers open across the U.S. The launch of these new enrollment centers represents the ongoing expansion of Telos' national TSA PreCheck enrollment footprint. Throughout 2024, Telos will continue delivering convenience to consumers by launching additional locations and extended hours of operation for enrollment and renewals.

08:36 EDT BIO-key says province of British Columbia places new orders - -BIO-key International announced that its long-time customer, the province of British Columbia, has placed new orders with BIO-key. 10,000 users will be added to their existing deployment of WEB-key software, integrated with Broadcom's SiteMinder infrastructure to streamline and strengthen access to a series of new applications via SAML 2.0 federation standards.

08:35 EDT Matthews announces proposed private offering of senior notes - Matthews International announced a proposed private offering of senior secured second lien notes due 2027. At or prior to the closing of the offering of the Notes, the Company intends to amend its senior credit facility to, among other things, permit the Notes to be secured by a second priority lien on substantially all of our and certain of our domestic subsidiaries' assets, and the Company and certain of its domestic subsidiaries intend to enter into a second amended and restated pledge and security agreement pursuant to which the Company and such subsidiaries will grant to the secured parties under the senior credit facility a first priority lien on substantially all of the Company's and such subsidiaries' assets. The Company intends to use the net proceeds of the offering, together with borrowings under the Company's senior credit facility, to redeem all of its outstanding 5.25% senior notes due December 1, 2025 on or about October 25, 2024, and to pay accrued and unpaid interest on the Existing 2025 Notes to, but not including, the date of redemption, and to satisfy and discharge the indenture governing the Existing 2025 Notes.

08:34 EDT Cidara Therapeutics doses first subjects in Phase 2b NAVIGATE trial of CD388 - Cidara Therapeutics announced the first subjects dosed in the Phase 2b NAVIGATE trial to evaluate the efficacy and safety of CD388 for the pre-exposure prophylaxis of influenza during the current flu season. The Phase 2b clinical trial is a randomized, double blind, controlled trial targeting 5,000 healthy unvaccinated adult subjects who are not at risk of complications from influenza. Three CD388 dose groups or placebo will be administered to subjects as a single dose at the beginning of the influenza season. Subjects will then be followed for the remainder of the influenza season to monitor for breakthrough cases. Rates of laboratory and clinically confirmed influenza will be compared between subjects receiving the various single doses of CD388 or placebo. The study will include sites in the US and UK.

08:33 EDT Borealis Foods introduces Woodles into U.S. school lunch programs - Borealis Foods announced that Woodles has successfully expanded distribution into over 4,000 school lunch programs across the United States. "We're excited to bring Woodles to schools across the nation," said Dr. Reza Soltanzadeh, Founder and CEO of Borealis Foods. "Our goal has always been to make healthy eating tasty, healthy and accessible, and we're proud to help schools meet their nutrition standards while making an impact on students' lifelong eating habits. We are working on expanding this offering across all states as we partner with school chefs to develop 'better-for-you' meals tailored for school programs."

08:32 EDT Sabre, Virgin Australia announces a strategic partnership - Sabre and Virgin Australia announced a strategic partnership to modernize the airline's retailing capabilities through the phased implementation of SabreMosaic, the revolutionary AI-driven platform built to transform airline retailing. This establishes Virgin Australia as the flagship customer and will enable the airline over time to adopt the broad suite of solutions within SabreMosaic, marking a significant milestone in the airline's journey towards modern retailing and the general market availability of the SabreMosaic solutions. The collaboration underscores the companies' commitment to innovation and industry leadership, as well as the airline's aim to be an early mover in the industry transition to offer-and-order based modern retailing.

08:29 EDT Kornit announces Monster Digital adopte 10 additional Kornit Apollo systems - Kornit Digital announced Monster Digital is significantly ramping up its digital production with 10 additional Kornit Apollo systems during 2025, expanding its on-going transition from screen printing to digital textile production. Headquartered in Miami Florida, Monster Digital is a US enterprise leader in on demand manufacturing of apparel and accessories, serving the largest global brands, retailers and ecommerce platforms. Traditionally a private label screen printer, the company has significantly expanded its digital production during the past several years - including building a fleet of 7 Apollos and 47 Kornit Atlas MAX systems. The expansion of 10 additional Apollos during 2025 will be executed in a mix of capital purchases and Kornit's new All-Inclusive Click Model. This major expansion will enable the company to capture massive new opportunities, and better meet existing customer demands, by shifting significant bulk production impressions from screen to digital production.

08:25 EDT Kratos welcomed congressman Gary Palmer to Birmingham facility - Kratos Defense & Security Solutions recently welcomed U.S. Representative Gary Palmer to Kratos SRE in Birmingham, Alabama, to showcase Kratos' expertise in the development, modeling and deployment of advanced technologies including materials for extreme environments, hypersonics, space systems, missile systems, missile defense, strategic deterrence, propulsion systems, RF technology integration, additive manufacturing, airborne ISR, and energy applications. Michael Johns, Senior Vice President of Kratos SRE, said, "We were honored to host Representative Palmer at our Kratos SRE facility in Birmingham. The Kratos SRE team is working on incredibly important programs for our national defense, exploration of space, and emerging technologies in many industries and we were excited to showcase all the team is doing on this engaging visit."

08:23 EDT Assembly Biosciences reports interim Phase 1a results from trial of ABI-5366 - Assembly Biosciences announced interim pharmacokinetic and safety results from healthy participants in the Phase 1a portion of its ongoing Phase 1a/b study evaluating ABI-5366, an investigational long-acting herpes simplex virus helicase-primase inhibitor candidate for recurrent genital herpes. Interim results exceeded Assembly Bio's objectives for this Phase 1a study and support ABI-5366's progression into Phase 1b. ABI-5366 was well-tolerated and showed a favorable safety profile with exposure of up to 70 days due to its extended PK profile. Single doses of ABI-5366 at dose levels reached in Phase 1a surpassed Assembly Bio's target plasma concentrations for antiviral efficacy, a target established from PK modelling and projected to achieve increased efficacy compared to approved therapies. ABI-5366's half-life across the doses evaluated to date of approximately 20 days when dosed orally supports both the company's once-weekly oral dosing target and the evaluation of a once-monthly oral dosing profile. With these data, Assembly Bio now plans to include both weekly and monthly dosing cohorts in Phase 1b in participants with recurrent genital herpes. Screening has begun for the Phase 1b portion of the study. Study Overview: ABI-5366-101 is a randomized, blinded and placebo-controlled Phase 1a/b clinical study of ABI-5366. Part A is ongoing, evaluating the safety, tolerability and PK of ABI-5366 following single ascending dose administration in healthy participants. Dosing is complete for four cohorts in Part A, evaluating doses of 10 mg, 30 mg, 100 mg and 350 mg, with each cohort randomized 6:2 between ABI-5366 and placebo, as well as an additional cohort at 30 mg to evaluate the potential for food effect. The study follow-up period in Part A began at 70 days and has been extended to 100 days after dosing, given the observed extended PK profile of ABI-5366. The study protocol includes the potential for one additional single-dose cohort in Part A, which Assembly Bio has the option to initiate in parallel with Part B. Safety and PK data reported here reflect data available as of the cut-off date. For safety, this data follow-up period ranges from 70 days after dosing for the 10 mg and 30 mg cohorts to 13 days after dosing for the most recent cohort of 350 mg. For PK, this data follow-up period ranges from 70 days after dosing for the first cohort of 10 mg to 8 days after dosing for the most recent cohort of 350 mg. The study remains blinded and the reported interim safety data includes data from both active and placebo treatment groups reported collectively. Results Across the Part A cohorts evaluated to date, ABI-5366 had a mean half-life of approximately 20 days when dosed orally, supporting once-weekly oral dosing, the target profile for ABI-5366, as well as the potential for once-monthly oral dosing. ABI-5366 doses within the range tested are projected, with weekly or monthly dosing, to maintain the target plasma concentrations for antiviral activity established by PK modelling. Assembly Bio plans to explore both once-weekly and once-monthly oral dosing regimens in the Part B portion of the study. In these cohorts to date, ABI-5366 was well-tolerated with a favorable safety profile observed with exposure of up to 70 days. Treatment-emergent adverse events were all mild to moderate in intensity and all were considered not related to study treatment by the study investigators; there were no serious AEs in any dose arm. There were no treatment-related grade 3 or 4 laboratory abnormalities and no protocol-defined stopping criteria were met. There were no clinically significant ECG abnormalities or patterns of AEs or laboratory abnormalities noted.

08:20 EDT Actuate Therapeutics announces publication on elraglusib's mechanism of action - Actuate Therapeutics announced the Scientific Reports publication of novel mechanistic data for its development candidate, elraglusib. The article, entitled, "Targeted inhibition of glycogen synthase kinase-3 using 9-ING-41 enhances CD8 T-cell-reactivity against neuroblastoma cells" is available online. "The mechanistic data published in Scientific Reports provides crucial evidence of elraglusib's ability to enhance activation of the immune system by tumor cells," said Daniel Schmitt, CEO. "By improving antigen presentation and enhancing the activation of CD8+ cytotoxic T cells, we are paving the way for more effective immunotherapeutic strategies including combinations of elraglusib with checkpoint inhibitors." Using neuroblastoma, which is typically refractory to checkpoint inhibitors, as a model system, these findings illustrate the potential to activate the immune system even in cancers that have not previously responded to checkpoint inhibitors and underscore elraglusib's potential as a highly innovative treatment for challenging cancers. The summary of key mechanistic findings: Elraglusib significantly enhances MHC-I molecule surface expression of neuroblastoma cells, improving their recognition by cytotoxic T lymphocytes; Treatment with elraglusib leads to the disruption of NK-B signaling, a key contributor to tumor cell survival, promoting cancer cell apoptosis and reducing treatment resistance; Elraglusib boosts IFNgamma signaling through the JAK/STAT pathway, particularly STAT1, which further supports improved antigen presentation and immune response; When combined with an anti-PD-1 treatment, elraglusib boosted CD8+ T cell proliferation and activation by neuroblastoma cells, showing potential for further development of these tumor immune response enhancing therapeutics.

08:17 EDT Golden Matrix's Meridianbet partners with Integrity Compliance 360 - Golden Matrix Group's Meridianbet has announced a strategic partnership with Integrity Compliance 360. The partnership comes as Meridianbet's Brazilian subsidiary, Meridian Gaming Brasil SPE, progresses in the licensing process for its entry into the Brazilian market, and will reinforce the Company's commitment to upholding the highest standards of integrity for its sports offering in line with global regulatory expectations and market best practices. The license application, filed under request number 56.195.600/0001-07, positions Meridianbet among a select group of global operators set to participate in one of the most highly anticipated market launches in the global sports betting and iGaming industry.

08:16 EDT Honeywell to develop AI-enabled agent powered by Qualcomm - Honeywell (HON) announced that it is working to develop an artificial intelligence-enabled Multi-Modal Intelligent Agent for Honeywell mobile devices powered by Qualcomm Technologies (QCOM). The agent will allow workers and customers in the distribution center and retail industries to interact naturally with their handheld devices through voice, pictures, and barcodes.

08:14 EDT Alaska Air expands cargo division, elects Morgan as VP of Cargo - Alaska Airlines board of directors elected Ian Morgan as the new Vice President, VP, of Cargo Alaska Airlines. In parallel, Jason Berry was made an Executive Vice President at the Alaska Air Group. Inc. parent company level, while also maintaining his role as President of Horizon Air.

08:13 EDT Miniso to acquire stake in Yonghui Superstores - MINISO Group announced that it has entered into share purchase agreements with certain shareholders of Yonghui Superstores to acquire an aggregate of 29.4% of the issued and outstanding shares of Yonghui for a total cash consideration of approximately RMB6.3 billion. Upon the consummation of the transaction, the Company expects to become the largest single shareholder of Yonghui.

08:12 EDT Provident Bank appoints Vivin Varghese as CISO - Provident Bank announced that Vivin Varghese has joined the organization as Senior Vice President, Chief Information Security Officer. Varghese will play a critical role in providing vision, leadership, oversight, and management of the overall information and cybersecurity policies, procedures, and practices of the organization and its subsidiaries. He will also advise the bank's Executive Leadership Team and staff on the appropriate administration of information security standards, assisting in developing plans within business units to manage risks effectively by understanding the fundamental aspects of business objectives. Most recently, he served as CISO of Customers Bank, with responsibility for digital and physical security, including business continuity, incident response, threat intelligence, and third-party risk.

08:11 EDT Ollie's Bargain Outlet announces 10 new openings in Texas - Ollie's announced the Grand Openings of 10 new stores in Texas! The new locations, all former 99 Stores, will bring even more brand name bargains to the Dallas, Houston, McAllen, and San Antonio markets. Shoppers will find everyday low prices on books, flooring, food, housewares, toys, electronics, stuff for your bedroom and bathroom, health and beauty products, pet supplies, and so much more for up to 70% off the fancy store prices!

08:10 EDT airBaltic, RTX's Pratt & Whitney unveil long-term maintenance deal - Latvian national airline airBaltic and Pratt & Whitney have announced a long-term EngineWise Comprehensive maintenance services agreement for the airline's GTF engine fleet. This agreement links airBaltic's maintenance costs to the utilization of the airline's engines. Pratt & Whitney is an RTX business. "Pratt & Whitney has been a long-term, trusted collaborator of airBaltic since we became the global launch operator of the Airbus A220-300 aircraft type back in 2016," said Martin Gauss, president and CEO of airBaltic. "The aircraft's PW1500G GTF engines have delivered a 25% reduction in fuel burn per seat compared to previous generations, resulting in significant cost savings. This agreement will support the growth plans of airBaltic towards a 100 Airbus A220-300 fleet by the year 2030. We are looking forward to many more years of successful cooperation with Pratt & Whitney."

08:09 EDT AAR Corp. awarded five-year contract of approximately $1.2B - AAR has been awarded a five-year indefinite delivery / indefinite quantity contract with an aggregate ceiling value of approximately $1.2B by the U.S. Navy's Naval Air Systems Command, NAVAIR, to perform P-8A Poseidon depot airframe maintenance and depot field team support for the U.S. Navy, government of Australia, and foreign military sales, FMS, customers.

08:08 EDT Jabil expands silicon photonics capabilities at Canada site - Jabil announced its continued investment in silicon photonics-based products and capabilities to support the increasing demands of hyperscalers and next-wave cloud and AI data center growth. The company is set to roll out additional capabilities at its Ottawa, Canada, site in the fourth calendar-year quarter of 2024 to support customers' advanced photonics packaging new product introductions, or NPIs. The new product introduction, or NPI, line will feature innovative capabilities designed to assist photonics customers quickly scale from proof of concept to mass production, such as fluxless flip-chip, fiber attachment, precise die bonding, and wire bonding. These advancements will support silicon photonics chip packaging, particularly in high-speed connectivity applications such as co-packaged optics and high-speed on-board connections.

08:07 EDT Oryzon Genomics presents final data from PORTICO trial of vafidemstat - Oryzon Genomics will present the final data from its Phase IIb PORTICO trial of vafidemstat in patients with Borderline Personality Disorder as an oral presentation at the New Medications Symposium, a special symposium focused on clinical trials of new compounds within the 37th European College of Neuropsychopharmacology congress, which is currently being held in Milan. Oryzon's oral presentation, titled "Final results: Phase 2b PORTICO Study: Efficacy of Vafidemstat in Borderline Personality Disorder", will be delivered by Dr. Michael Ropacki, Oryzon's Chief Medical Officer for CNS. In addition to the oral presentation, the results will also be presented as a poster at ECNP-2024. PORTICO was a global double-blind, randomized, placebo-controlled, adaptive 14-week Phase IIb trial evaluating the efficacy and safety of vafidemstat at 1.2 mg/day in a BPD population. The study recruited a total of 211 patients, randomized 1:1 in two arms. The trial had two independent primary endpoints: reduction of agitation and aggression and overall disease improvement in BPD severity. In the absence of a well-established regulatory endpoint, the trial also included two secondary endpoints also exploring the reduction of agitation and aggression and overall disease improvement in BPD severity by different scales. PORTICO included a total of 27 clinical sites, 14 in the U.S. and 13 in Europe. Presentation Data Highlights: The final data show a significant overall improvement compared to the preliminary top-line data released in January. Notably, the agitation and aggression of patients, as measured by the secondary endpoint STAXI-2 Trait Anger scale, showed a substantial, statistically significant, and clinically meaningful reduction in the vafidemstat arm compared to placebo, with a p-value of 0.0071 across Weeks 8-12. The relative reduction in the vafidemstat-treated group over the placebo group reached a maximum of 92.1% at Week 10, with an average reduction of 58.6% across Weeks 8-12. Additionally, the secondary endpoint Borderline Evaluation of Severity, an overall measure of BPD severity, also showed an improvement compared to TLD, with a p-value of 0.0260 across Weeks 8-12. The maximal relative reduction in the vafidemstat-treated group over the placebo group reached 38.9% at Week 10, with an average reduction of 30.9% across Weeks 8-12. The p-values for the primary endpoints also improved compared to the preliminary TLD, but did not reach statistical significance. Interestingly, a trend of improvement in depression measured by the BDI-II Total Score by Weeks 8-12 was detected, with an average reduction over the placebo group of 42.2% across Weeks 8-12. The T-Forest plot analysis showed that all results continued to consistently favor vafidemstat treatment over placebo across all primary and secondary efficacy endpoints. Notably, the final analysis confirmed now a global treatment effect favoring vafidemstat by the Global Statistical Test, with the GST p-value showing a statistical significance, particularly when considering global improvement in the severity of the disease and in agitation/aggression. The GST is designed to assess whether a treatment is effective across different aspects of a condition, efficiently summarizing the overall treatment effect, especially when dealing with complex, multifactorial diseases. Vafidemstat was, as in all previous clinical studies, safe and well-tolerated. Adverse events were generally consistent with the safety profile of vafidemstat seen to date, with no new safety findings. Treatment-Emergent Adverse Events were slightly lower in those receiving vafidemstat, though Treatment-Related TEAEs were similar between groups. An observation of interest was that vafidemstat-treated patients showed a reduced inclination towards self-harm compared to the ones receiving placebo. All these data have been presented to the FDA in an end-of-Phase II meeting held recently to discuss a registrational Phase III study for the treatment of BPD.

08:07 EDT Amneal Pharmaceuticals debuts Crexont extended-release for Parkinson's treatment - Amneal Pharmaceuticals announced that it has launched CREXONT or carbidopa and levodopa, extended-release capsules for the treatment of Parkinson's disease. CREXONT is a novel, oral formulation of carbidopa/levodopa or CD/LD, that combines both immediate-release granules and extended-release pellets. CREXONT is now broadly available at U.S. pharmacies. "We are pleased to launch CREXONT and make it broadly available to healthcare providers and patients. The product's innovative formulation provides a longer duration of "Good On" time with less frequent dosing compared to immediate release CD/LD. As a leader in the Parkinson's space, Amneal has a long history of working closely with movement disorder specialists and neurologists. We are excited to build on this foundation with the rollout of a comprehensive education program and extensive services to help healthcare providers and patients access this innovative therapy," said Joe Renda, Senior Vice President, Chief Commercial Officer - Specialty.

08:06 EDT Braskem selected by DOE to negotiate terms of $50M award - Braskem announced that the company has been selected by the U.S. Department of Energy's Office of Manufacturing and Energy Supply Chains to negotiate terms of a $50M award under the Bipartisan Infrastructure Law. This landmark funding would expand Braskem's ultra-high molecular weight polyethylene production capabilities in La Porte, Texas, specifically targeting the lithium-ion battery separator market.

08:05 EDT Moleculin Biotech announces presentation of in vivo efficacy data of Annamycin - Moleculin Biotech announced the recent presentation of positive in vivo efficacy data of Annamycin in orthotopic and experimental lung metastatic models of sarcoma. Key Highlights: Annamycin demonstrated high uptake and retention in lung parenchyma of mice and rats. The therapeutic effects of doxorubicin, DOX, are diminished due to low lung DOX uptake as demonstrated in the tested in vivo models. In contrast, Annamycin exhibits consistent efficacy in vivo in orthotopic and experimental lung metastatic models of sarcoma, breast, and colon cancer. This correlated with high Annamycin concentration in lungs, which exceeded DOX levels by 10- to 30-fold. Preclinical tests clearly demonstrate a better cardiac safety profile of Annamycin when compared to DOX and no cardiotoxicity of Annamycin in the in vivo models. No cardiotoxicity of Annamycin has been noted in ongoing clinical studies. The observed organotropic properties of Annamycin, its efficacy in vivo, and its promising safety profile warrant further translational studies to evaluate Annamycin in patients with primary or metastatic lung cancers, as a single agent and in combination with currently used therapeutics.

08:05 EDT Theriva Biologics achieves target patient enrollment in VIRAGE Phase 2b trial - Theriva Biologics has achieved their target patient enrollment in the VIRAGE Phase 2b clinical trial evaluating the Company's lead product candidate VCN-01 plus standard-of-care chemotherapy as a first line therapy for patients with metastatic pancreatic ductal adenocarcinoma. VCN-01 is a systemically-administered, tumor selective, stroma-degrading oncolytic adenovirus that has been granted Orphan Drug Designation and Fast Track Designation by the U.S. Food and Drug Administration for the treatment of PDAC.

08:03 EDT First Onsite presents live burn, education seminar - First Onsite Property Restoration is co-hosting a Live Burn and Education Seminar on September 30 at the Stephenson County Fairgrounds in Freeport, Illinois. First Onsite is partnering with FireTech Inc, Fire and Explosion Investigations and fire expert John Knapp along with Todd Davis, an insurance educator, who will be conducting his "Stop, Drop & Roll" class which will offer CE credits. The class will feature lessons on fire behavior, fire safety, and controlled burns of a two-room structure, as well as two vehicles. This educational event is geared toward Claims Adjusters, Claims Advocates, CSRs, and SIU Representatives. The general public and media are welcome to attend. The Freeport Fire Department will be assisting and training as part of the event.

08:01 EDT Ventyx Biosciences announces $27M investment from Sanofi - Ventyx Biosciences (VTYX) announced that Sanofi (SNY) has agreed to make a $27 million strategic investment in the Company at an as-converted price of $3.8243 per share of common stock, pursuant to which Sanofi will purchase 70,601 of the Company's Series A non-voting convertible preferred stock, each share of which is initially convertible into 100 shares of common stock. The closing of the transaction is expected to occur on September 23, 2024. In connection with the equity investment, the Company has agreed to grant Sanofi an exclusive right of first negotiation with respect to certain VTX3232 program rights. The proceeds from the investment are expected to further strengthen the Company's cash position, and current cash, cash equivalents and marketable securities, inclusive of the proceeds from the investment, are expected to be sufficient to fund planned operations into at least the second half of 2026.

07:46 EDT Jeffs' Brands says Fort Products classified as Key Account by Amazon UK - Jeffs' Brands' subsidiary, Fort Products, has been classified as a Key Account, granting eligibility for the Amazon Top Seller Program. The recognition is based on Fort Products' robust sales performance and its organic visibility score. By optimizing product listings and enhancing marketing efforts, the Company expects to capitalize on the potential sales uplift opportunities identified across different business areas.

07:37 EDT Nevada King Gold announces assay results from Atlanta Gold Mine Project - Nevada King Gold announces assay results from twenty reverse circulation holes and one core hole recently completed at its Atlanta Gold Mine Project located 264km northeast of Las Vegas, Nevada, in the prolific Battle Mountain Trend. Today's holes are plotted in plan and along sections 22-10N, 22-11N, 22-12N, and 22-13N.

07:37 EDT Cosciens Biopharma provides update on merger integration, succession plans - COSCIENS Biopharma provided an update on the progress of its merger integration with Ceapro, including planned changes to its management team and advancements across its current business. "With the initial integration efforts now well underway, I believe now is the ideal time for the next generation of leaders to make their mark on the future of COSCIENS. To that end, with my full support, our Board has engaged an executive recruiting firm to identify the next President and CEO of COSCIENS. I remain fully committed to lead and support COSCIENS while that search is underway and will provide whatever support my successor needs through the transition," stated Gilles Gagnon, CEO of COSCIENS. "The reason for creating COSCIENS and the stated goals of the Aeterna Zentaris and Ceapro combination was, and remains: broadening the revenue base, product offering and pipeline; evaluating our combined product portfolio in an effort to create a mix of near-term revenue generating products with longer term, potentially higher reward products, while also diversifying our respective risks; right-sizing our administrative costs and prioritize capital with a clear focus on products and programs that have the best chance to succeed and create value inflection points; and taking steps to recruit future leadership talent and expertise to execute on our strategy and take COSCIENS to the next level. The first two goals will take time to achieve - we want to ensure that we are looking at comprehensive data and market information when making key product related decisions. We also want to ensure that the next President and CEO will have a voice in key decisions as they chart the future direction of COSCIENS." Management has already initiated and is continuing towards further cost reduction measures, including efforts to right size the combined business through the elimination of a number of managerial and technical positions. As part of those efforts, COSCIENS is also reducing the spend on certain programs pending completion of data review. The Company continues to review the results from the Phase 3 DETECT-Trial of macimorelin for the treatment of childhood growth hormone deficiency and, while that is occurring, is looking for opportunities to reduce its associated spend while still supporting macimorelin in its approved indication, adult human growth hormone deficiency. The Company has also made the decision to discontinue further spend on the preclinical research program to evaluate the potential use of macimorelin for the treatment of amyotrophic lateral sclerosis. The ALS program has taken far longer and will cost more than was first anticipated and the Company does not have sufficient confidence from the data obtained to date that it will ultimately provide the much needed treatment for ALS patients that it once hoped."

07:36 EDT Riot Platforms, Bitfarms enter settlement agreement - Riot Platforms (RIOT) issued this press release pursuant to Part 3 of Canadian National Instrument 62-103 - The Early Warning System and Related Take-Over Bid and Insider Reporting Issues and Part 5 of Canadian National Instrument 62-104 - Take-Over Bids and Issuer Bids in respect of Bitfarms (BITF). On September 23, Riot and the company entered into a settlement agreement, pursuant to which Andres Finkielsztain resigned from the company's board of directors; Amy Freedman was appointed to the board, the governance and nominating committee and the compensation committee of the board, and will be appointed to each special committee of independent directors of the board that is currently constituted or may be constituted from time to time provided that she is independent for purposes of the mandate of the special committee and Riot has withdrawn its requisition for a special meeting of shareholders of the company. Immediately prior to, and immediately after, the entering into of the agreement, Riot beneficially owned 90,110,912 common shares of Bitfarms, representing approximately 19.9% of the issued and outstanding common shares. Riot intends to review its investment in the company on a continuing basis and, subject to the terms of the agreement, and depending upon various factors, including without limitation, any discussion between Riot, the company and/or the board and its advisors regarding, among other things, the company's financial position and strategic direction, overall market conditions, other investment opportunities available to Riot, and the availability of securities of the company at prices that would make the purchase or sale of such securities desirable, Riot may increase or decrease its position in the company through, among other things, the purchase or sale of securities of the company, including through transactions involving the common shares and/or other equity, debt, notes, other securities, or derivative or other instruments that are based upon or relate to the value of securities of the company in the open market or otherwise, enter into transactions that increase or hedge its economic exposure to the common shares without affecting its beneficial ownership of the common shares or consider or propose one or more of the actions described in subparagraphs (a) - (k) of Item 5 of Riot's early warning report filed in accordance with applicable Canadian securities laws, including submitting a revised proposal to acquire the company.

07:35 EDT Comtech's former CEO nominate full slate of candidates for board - Fred Kornberg and Michael Porcelain, significant stockholders and former Chief Executive Officers of Comtech Telecommunications, issued an open letter to fellow Comtech stockholders. Michael Porcelain also announced that he has nominated a slate of eight highly qualified director candidates for election to the Comtech Board of Directors at the upcoming 2024 Annual Meeting of Stockholders. Collectively, the Nominees beneficially own approximately 7.6% of the outstanding shares of Comtech's common stock. If elected, the Nominees intend to pursue a thorough evaluation of strategic options for Comtech's 911 Public Safety business, the appointment of an external CEO & COO, and other initiatives aimed at enhancing long-term stockholder value. Kornberg and Porcelain wrote in the letter, "We believe the recommendations we made to the Board and the election of the new director candidates listed at the end of this letter are important for positioning Comtech for long-term success and maximizing stockholder value. As dedicated stakeholders and former leaders of Comtech, we stand ready to assist the Company and help it achieve its full potential. We appreciate the engagement of many stockholders and other stakeholders who share our commitment to Comtech's success."

07:34 EDT Stardust Power appoints Paramita Das as CSO - Stardust Power announced that Paramita Das will join as Chief Strategy Officer and Senior Advisor. She will directly advise the Company's CEO and Founder, Roshan Pujari. Das has agreed to serve as Stardust Power's lead external adviser, supporting the Company's next phase of commercialization and development. Previously, she spent over 8 years at Rio Tinto, most recently serving as the Global Head of Marketing, Development and ESG, Metals and Minerals for various Rio Tinto Corporate listed entities.

07:32 EDT BioAtla, Context Therapeutics enter exclusive license agreement for BA3362 - BioAtla (BCAB) and Context Therapeutics (CNTX) announced that the companies have entered into an agreement under which Context has obtained from BioAtla an exclusive, worldwide license to develop, manufacture and commercialize BA3362, BioAtla's Nectin-4 x CD3 TCE. Context will assume and fund all development and commercialization activities. Under the terms of the agreement, BioAtla is eligible to receive up to $133.5 million in aggregate payments, including $15.0 million in upfront and near-term milestones with additional potential clinical, development and commercial milestones totaling $118.5 million, as well as tiered royalties on net sales.

07:29 EDT Avicanna announces medical cannabis real world evidence study - Avicanna announced a large-scale medical cannabis real world evidence study through the MyMedi.ca medical cannabis care platform. The Study is to be led by Hance Clarke, MD, FRCPC, PhD. Dr. Clarke is the current President of The Canadian Pain Society and the Canadian Consortium for the Investigation of Cannabinoids. The prospective, non-interventional, observational study aims to enroll 1,000 patients across the country to understand the potential therapeutic use of medical cannabis and potential impact of medical cannabis on pain, sleep, anxiety, depression, and epilepsy. Utilizing validated questionnaires, the study seeks to understand the potential impact of various medical cannabis products and evaluate the change in use of concomitant medication over a 24-week duration. The study was originally initiated by Medical Cannabis by Shoppers and was part of Avicanna's commitment to provide continuation of care to the platforms' patients but also the advancement of medical research. Avicanna's medical cannabis care platform MyMedi.ca will providing the necessary infrastructure, patient support, and education for all participating HCPs nationwide. Participating patients will have access to the platform's products including Avicanna's own RHO Phyto formulary in addition to products from select licensed producers that are supporting the study.

07:26 EDT Staar Surgical opens expanded Experience Center for ophthalmic professionals - STAAR Surgical Company announces the expansion and new location of the STAAR Surgical Experience Center. Located at STAAR's headquarters in Lake Forest, California, near John Wayne Airport SNA , the center serves as a dynamic hub for comprehensive, hands-on training and education in lens-based vision correction. The new Experience Center is a critical addition to customer training, education and support as the demand for EVO ICL continues to surge among surgeons and refractive practices, driven by the escalating global myopia epidemic. The prevalence of myopia in Americans is 42%3, having doubled over the past three decades3, while laser refractive procedure volume is declining. EVO ICL is rapidly disrupting the refractive market. STAAR Surgical is on track to sell more ICLs between 2024 and 2026 than in the first 25 years of ICL sales combined, reflecting the transformative impact of this technology following FDA approval and market launch. "We are thrilled to open our expanded Experience Center, offering cutting-edge resources and training for ophthalmic professionals," said Tom Frinzi, President and CEO of STAAR Surgical. "The center reflects our commitment to supporting the growing demand for EVO ICL and advancing its global adoption."

07:24 EDT Repare: Endometrial cancers with CCNE1 amplifications carry poor prognosis - Repare Therapeutics presented new data on Friday highlighting the impact of alterations in FBXW7, PPP2R1A and CCNE1 in patients with metastatic ovarian and endometrial cancers based on an analysis in approximately 2,000 patients from Cancer Genome Atlas Research Network and Memorial Sloan Kettering's Metastatic Events and Tropisms. The poster presentation was shared at the American Association of Cancer Research's, AACR, 15th Annual Ovarian Cancer Research Symposium in Seattle, underscores inherent chemotherapy resistance and the lack of treatment options for metastatic gynecologic cancer patients with these biomarkers. "Patients with recurrent ovarian and endometrial cancers are already at a disadvantage when it comes to treatment options," said Maria Koehler, MD, PhD, Executive Vice President and Chief Medical Officer of Repare. "These new data highlight the urgent need for innovative therapeutic approaches to address the specifically poor prognosis associated with FBXW7, PPP2R1A and CCNE1 alterations treated with standard of care-based chemotherapy. We look forward to reporting data from our MYTHIC dose expansion trial evaluating lunresertib in combination with camonsertib in patients with ovarian and endometrial cancers with these biomarkers in the fourth quarter of 2024."

07:22 EDT OTC Markets Group welcomes Maquia Capital Acquisition to OTCQX - OTC Markets Group announced Maquia Capital Acquisition Corp has qualified to trade on the OTCQX Best Market. Maquia Capital Acquisition Corp previously traded on NASDAQ.

07:20 EDT Bank of America to open more than 165 financial centers by end of 2026 - Bank of America announced it is on track to open more than 165 new centers across 63 markets by the end of 2026, including nearly 40 this year. This is in addition to the more than 100 centers the company opened over the last two years. "We are reaching more and more clients through the expansion and modernization of our financial centers," said Aron Levine, President of Preferred Banking at Bank of America. "While most clients are using our digital capabilities for their everyday banking, they are visiting our centers for in-person conversations about their more complex financial needs and advice on their life priorities and financial goals."

07:17 EDT Optimi Health joins S&P/ASX 300 Index - Opthea announced that the Company joins the S&P/ASX 300 Index, effective Monday, September 23, 2024, prior to market open in Australia.

07:14 EDT Orgenesis board approves 1-for-10 reverse stock split - Orgenesis Board of Directors has approved a 1-for-10 reverse stock split of the Company's common stock, par value $0.0001, which will be effective at 5:00 pm Eastern Time on September 24, 2024. The Company's common stock will continue to be traded on The Nasdaq Capital Market on a split-adjusted basis beginning on September 25, 2024, under the Company's existing trading symbol "ORGS". The reverse stock split is intended to regain compliance with the minimum bid price requirement of $1.00 per share of the Company's common stock for continued listing on The Nasdaq Capital Market. The new CUSIP number following the reverse stock split will be 68619K303. The Company filed a Certificate of Change with the Nevada Secretary of State on September 20, 2024 to effect the reverse split.

07:12 EDT Kamada expands plasma collection operations in Texas - Kamada announced the expansion of its plasma collection operations with the opening of a new plasma collection center in Houston, TX. The new 12,000 square foot center is operated by Kamada's wholly owned subsidiary, Kamada Plasma, and is planned to support over 50 donor beds with an estimated total collection capacity of approximately 50,000 liters annually. Kamada intends to submit to the FDA a prior approval supplement to Kamada Plasma's existing Biologics License Application for the approval of the Houston site, as well as a plasma master file to the European Medicines Agency, during the first half of 2025. The FDA and EMA's regulatory process for obtaining approval for plasma collection centers includes onsite inspection. During the review process, the company is authorized to collect plasma donations at the center. Kamada currently anticipates approval decisions within 9-12 months of submissions. In addition to the new Houston center, the company has begun construction of its third plasma collection site in San Antonio, TX, which is expected to open during the first half of 2025. Each collection center is expected to contribute annual revenues of $8 million to $10 million in sales of normal source plasma at its full capacity.

07:11 EDT Invivyd provides virology data, analysis of SARS-CoV-2 structural biology - Invivyd provided detailed virology data supporting previously communicated neutralization activity results, along with a genetic and structural analysis of past and present SARS-CoV-2 variant spike proteins, including the established molecular target of pemivibart. As part of Invivyd's ongoing monitoring of antiviral activity, Invivyd contracts with LabCorp's Monogram Biosciences lab to provide independent, robust virology assessments in a consistent lineal chain that allows for consideration of potential changing pemivibart potency as SARS-CoV-2 evolves. Pemivibart potency against contemporary viruses KP.3.1.1 and LB.1 remains in-line with the totality of predominant variants dating back to 2022, including isolates identified during the conduct of the CANOPY Phase 3 clinical trial from late 2023 to early 2024. "Quantitative neutralization assays exhibit marked intrinsic variability. Since discovery, pemivibart has exhibited impressively stable neutralization results across a wide range of SARS-CoV-2 variants, including and through contemporary variants tested," said Robert Allen, Ph.D., Chief Scientific Officer of Invivyd. "The values we observe thus far generally fall within the expected variability of the assay systems we employ." Invivyd also provided an update to ongoing structural analysis showing no meaningful mutational change in the pemivibart binding site since the Omicron shift late in 2021.The pemivibart binding site is defined as a region of amino acid residues on the spike protein within 5 angstroms of the interaction between pemivibart and spike protein in a crystal structure and consists of 19 key amino acids. Invivyd's ongoing genetic and structural analyses of these residues provide the underlying biological rationale for the company's ongoing expectation for neutralization activity of pemivibart in the face of constant and convergent mutation in the SARS-CoV-2 spike protein. Analysis to date of all 19 amino acids presented below shows de minimis mutational change with ongoing stability to the binding site since the Omicron shift.

07:09 EDT Tonix Pharmaceuticals announces data presentations on TNX-102 SL - Tonix Pharmaceuticals Holding announced data in two oral presentations and a poster presentation at the 11th Global Conference on Pharmaceutics and Novel Drug Delivery Systems, held September 19-21, 2024, in Rome, Italy. Prof. Marino Nebuloni, Director, Qualified Person, Redox Analytical Science Srl, in an oral presentation titled, "Mannitol as Eutectic Forming Agent for Improved Sublingual Delivery of Cyclobenzaprine HCl," described the eutectic formation of cyclobenzaprine HCl and mannitol and how it provides a stable product that dissolves rapidly and delivers cyclobenzaprine by the transmucosal route efficiently into the bloodstream. The eutectic protects cyclobenzaprine HCl from interacting with the basifying agent that is also part of the formulation and required for efficient transmucosal absorption. The work described included studies by Giorgio Reiner and his team at APR Applied Pharma Research S.A. and the team at Tonix. Bruce Daugherty, Ph.D., Executive Vice President, Research at Tonix Pharmaceuticals, in the second oral presentation titled, "Pharmacokinetic Properties of TNX-102 SL, a Sublingual Formulation of Cyclobenzaprine Hydrochloride," outlined the clinical pharmacology of TNX-102 SL via single dose and multiple dosage administration. The formulation of TNX-102 SL was designed specifically for sublingual administration and transmucosal absorption for bedtime dosing to target disturbed sleep, while reducing the risk of daytime somnolence. Clinical pharmacokinetic studies indicated that the addition of a basifying agent was necessary for efficient transmucosal absorption. The addition of a basifying agent resulted in higher levels of exposure during the first 2 hours after dosing and resulted in deceased levels of the long-lived active metabolite, norcyclobenzaprine in both single dose and multiple dose studies, consistent with bypassing first pass hepatic metabolism. At steady state after 20 days of dosing TNX-102 SL, the dynamic peak level of cyclobenzaprine is higher than the background level of norcyclobenzaprine. In contrast, after 20 days of dosing oral cyclobenzaprine, the simulated peak level of cyclobenzaprine is lower than the simulated background level of norcyclobenzaprine. Tonix believes that TNX-102 SL's dynamic levels of cyclobenzaprine exceeding norcyclobenzaprine levels after steady state modeling of chronic dosing, contributes to the durability of its clinical benefits. Dr. Daugherty also presented evidence showing that cyclobenzaprine interacts as an antagonist at four different receptors in the brain, which are believed to play roles in sleep quality supporting the multi-functional mechanism of TNX-102 SL. The presentation also illustrated the prevalence of fibromyalgia and the unmet need for new treatments in the U.S., despite the availability of three FDA-approved drugs. In the Phase 3 RESILIENT study in fibromyalgia, TNX-102 SL met the pre-specified primary endpoint of significantly reducing daily pain as compared to placebo. TNX-102 SL also demonstrated broad syndromal benefits with statistically significant improvement in all six pre-specified key secondary endpoints including those related to improving sleep quality, reducing fatigue, and improving patient global ratings and overall fibromyalgia symptoms and function. TNX-102 SL was well tolerated with an adverse event profile comparable to prior studies and no new safety signals were observed. Siobhan Fogarty, Executive Vice President, Product Development at Tonix Pharmaceuticals, in the poster presentation titled, "The Importance of In Vitro Discriminatory Tests in the Development of a Sublingual Dosage Form of TNX-102 SL Tablets," presented the development of in vitro techniques used to assess characteristics of the TNX-102 SL tablet including dissolution, "disintegration time" and a proprietary "wetting time" test. These in vitro tests assessed the impact of the particle size, excipient variation and compression force. The data presented indicate that a dissolution test does not discriminate between tablets made with intentional modifications to particle size, excipient content or compression strength. However, both "disintegration time" and "wetting time" are sensitive tests to discriminate differences in particle size, concentration of the excipient Pearlitol Flash and compression strength.

07:07 EDT uniQure receives Orphan Drug Designation for AMT-191 in Fabry Disease - uniQure announced that the U.S. Food and Drug Administration has granted Orphan Drug Designation to AMT-191, uniQure's investigational gene therapy for the treatment of Fabry disease, a rare, inherited genetic disease. In August 2024, uniQure announced the dosing of the first patient in its U.S., multi-center, open-label Phase I/IIa trial of AMT-191. The Phase I/IIa clinical trial of AMT-191 will be conducted in the United States. The multicenter, open-label trial consists of two cohorts with up to six adult male patients each: a low-dose cohort of 6x1013 gc/kg and a high-dose cohort of 3x1014 gc/kg delivered through a one-time intravenous infusion. Patients will continue to receive their regular enzyme replacement therapy until the criteria for withdrawal is met and will be followed for a period of 24 months. The trial will explore the safety, tolerability, and early signs of efficacy by measuring the expression of lysosomal enzyme aGLA-A.

07:06 EDT Black Diamond announces initial Phase 2 data of BDTX-1535 - Black Diamond Therapeutics reported initial Phase 2 data demonstrating encouraging clinical responses and durability of BDTX-1535 in patients with relapsed/refractory epidermal growth factor receptor-mutant non-small cell lung cancer. Phase 2 preliminary data overview: The phase 2 trial began in August of 2023, and enrolled relapsed/refractory patients with non-classical EGFR mutations and those with C797S resistance mutations. Safety assessment and dose selection were based upon the first 40 patients randomized to receive BDTX-1535 once daily at either 100 mg or 200 mg across both Cohorts. Preliminary response rate and durability were assessed in 27 patients at 200 mg with an August 17, 2024, data cutoff, including 22 response-evaluable patients who met protocol eligibility criteria. Key takeaways: 200 mg daily selected for pivotal clinical development. Dose selection was based primarily on pharmacokinetics, safety and tolerability data from 20 patients at 100 mg, and 20 patients at 200 mg. Favorable tolerability profile at 200 mg, consistent with prior BDTX-1535 clinical data. The majority of adverse events were mild or moderate, and no new safety signals were observed. The most common on-target treatment-related adverse events were rash and diarrhea. There were 2 cases of grade 3 rash, and no reported cases of grade 4 rash or grade 3/4 diarrhea. Preliminary objective response rate of 42% achieved in 19 patients. For the 22 response-evaluable patients, the preliminary ORR was 36%. Nineteen of these 22 patients expressed known osimertinib resistance mutations: either C797S or P-loop alpha-C helix compressing. Of these 19 patients, 8 achieved a response: 5 with a confirmed partial response, including 1 patient who converted from a PR to an unconfirmed complete response at 8 months; and 3 with an unconfirmed PR at first scan and awaiting a confirmatory scan. An additional 9 patients experienced stable disease. Encouraging durability observed, with duration of response of approximately 8 months or more for first 3 patients with PR; 14 of 19 patients remain on therapy. Mean follow-up time is 4.7 months. Black Diamond continues to enroll patients in the second- and third-line cohorts, as well as in the first-line setting for patients with non-classical EGFR mutations. In Q1 2025, the Company expects to disclose initial results from the first-line cohort and to outline potential registrational paths in the recurrent setting based on FDA feedback.

07:04 EDT Origin Materials to reduce workforce by 28% - Origin Materials announced an organizational realignment that reflects the reallocation of resources to its caps and closures business and reduces overall cash burn to accelerate Origin's timeline to profitability. Origin expects the workforce changes to be largely completed by the end of this quarter. The company anticipates that it will incur approximately $0.6M in restructuring charges in connection with the roughly 28% workforce reduction, consisting of cash expenditures of approximately $0.5M and non-cash expenses of approximately $0.1M. Origin is maintaining its financial guidance for 2024 revenue and net cash burn, with revenue of $25 million to $35 million and net cash burn between $55M and $65M. In addition, Origin's first commercial-scale PET cap mass production system is on track to start producing PET caps later this year, with caps revenue ramp-up to begin in the first quarter of 2025.

07:04 EDT Akamai receives company-wide ISO 14001 attestation - Akamai Technologies announces that it has achieved a company-wide ISO 14001 attestation - demonstrating its adherence to the highest standards for its environmental management system aligned across the entire Akamai Connected Cloud.

07:02 EDT D-Wave Quantum appoints Sophie Ames as chief human resources officer - D-Wave Quantum announced it is expanding its executive team with the appointment of Sophie Ames as chief human resources officer. At D-Wave, Ames will lead the global human capital innovation strategy essential to the company's next phase of growth and will focus on building strong connections between the company's performance, people and processes across the entire employee lifecycle engagement.

06:59 EDT CGI selected by Harley-Davidson to modernize loan origination system - CGI (GIB) announced its selection by Harley-Davidson (HOG) to modernize their loan origination system. By replacing disparate IT platforms with the unified CGI Credit Studio, Harley-Davidson will gain an AI-enabled financing process that introduces flexibility for their dealers and delivers a buying experience for motorcycle enthusiasts.

06:58 EDT Wabash enters partnership with Kodiak for TaaS offering - Wabash announced that Kodiak Robotics has entered into a partnership with Wabash to utilize Wabash's Trailers as a Service offering. Wabash's TaaS will provide Kodiak a flexible solution with access to a growing fleet of safe, reliable trailers nationwide. Wabash's TaaS offering provides Kodiak with a holistic solution that supports the full life cycle of the trailer, from acquisition to maintenance and uptime management. Unlike traditional leasing, TaaS delivers fully maintained capacity with new or certified trailers, ensuring minimal downtime through Wabash's managed care services. With a subscription that includes maintenance, repair and managed care support, Kodiak can focus on developing the Kodiak Driver. Wabash's hyperfocus on offering the best-maintained trailers aligns with Kodiak's high maintenance standards, ensuring optimal performance and safety.

06:56 EDT Tempur Sealy provides update on proposed Mattress Firm acquisition - Tempur Sealy provided an update with respect to the company's agreement to acquire Mattress Firm, which is currently being challenged in federal court by the Federal Trade Commission, or FTC. The litigation process continues to progress, with hearings currently scheduled to begin on November 12 and expected to last two weeks. The company continues to believe that a successful litigation process can be completed in the coming months, which would allow the transaction to close in late 2024 or early 2025, consistent with previous expectations. In conjunction with the planned Mattress Firm acquisition, Tempur Sealy has entered into a purchase agreement with MW SO Holdings, an independently owned bedding specialty retailer, for the sale of 73 Mattress Firm retail locations and the company's Sleep Outfitters subsidiary, which includes 103 specialty mattress retail locations and seven distribution centers. Tempur Sealy will continue to supply its Tempur-Pedic, Stearns & Foster, and Sealy products to the divested Mattress Firm and Sleep Outfitters stores. The divestiture is subject to the closing of Tempur Sealy's acquisition of Mattress Firm and other customary closing conditions. It is expected to close approximately one quarter after the closing of the Mattress Firm transaction. Upon the closing of the Mattress Firm transaction and this divestiture, Tempur Sealy expects to operate over 2,800 retail locations worldwide and anticipates that half of its North American sales will come from the Mattress Firm operations. The company continues to expect to realize annual run-rate synergies of $100M by the end of year four after closing the Mattress Firm transaction.

06:54 EDT Azimut Exploration, KGHM announce high-grade nickel discovery on Kukamas - Azimut Exploration announced the discovery of a high-grade nickel zone on the Kukamas Property in the Eeyou Istchee James Bay region of Quebec. The prospecting discovery, which includes significant copper and platinum group element grades, is still at an early stage but provides an exciting outlook for the project. Additional work is ongoing to further delineate the zone, including a magnetic and electromagnetic ground survey. Budgeting and planning are underway to initiate a maiden drilling program. The Perseus Zone is associated with an ultramafic volcanic unit and its features indicate a highly fertile system, underscoring the Property's excellent prospectivity. Best grades reach up to 9.35% Ni, 3.04% Cu, 3.78 g/t Pt and 8.99 g/t Pd from different sawed samples. Perseus is spatially linked to a north-trending string of strong EM conductors, 2 kilometres long, which correlates well with a strong nickel-copper-cobalt footprint in lake sediments. Another nickel showing discovered in 2023 on the Property is also associated with a 1-kilometre-long strong EM conductor. Other significant ultramafic bodies remain underexplored on the 41-kilometre-long Property. Since signing a joint venture option agreement with KGHM International, Azimut has carried out significant exploration activities on Kukamas and is the operator of the partner-funded program. The summer work program to date comprised a prospecting phase and an infill lake sediment sampling survey. Most results are still pending and will be disclosed once they become available. HIGHLIGHTS: High-grade mineralization defines a curvilinear steeply dipping, north- to southwest-trending outcropping zone, measuring approximately 56 metres long by up to 9 metres wide. Perseus appears open along strike and to the east. Thick overburden surrounding the mineralized zone limited the extent of the sampling coverage. The rock samples collected from the discovery outcrop comprise twenty-four 1-metre-long channel samples from two channels, each 12 metres long, and twenty grab samples cut with a saw. Channels were cut perpendicularly to the orientation of the mineralized zone. Note that grab samples are selective by nature and unlikely to represent average grades. Channel #1: Oriented N90o; total horizontal length of 12.0 metres, including two offset samples taken 4.9 m south of the main channel due to a local outcrop discontinuity along the main channel. 2.98% Ni, 0.32% Cu, 2.25 g/t PGE over 8.0 m including 3.74% Ni, 0.41% Cu and 2.82 g/t PGE over 6.0m. Channel #2: Oriented N150o; total horizontal length of 12.0 m. 1.10% Ni, 0.15% Cu, 1.02 g/t PGE over 9.0 m, including 1.42% Ni, 0.19% Cu, and 1.36 g/t PGE over 6.0 m.

06:49 EDT Kosmos announces early results of cash tender offers - Kosmos Energy announced the early tender results of its previously announced series of tender offers to purchase for cash up to $400,000,000 aggregate principal amount of the Offeror's outstanding 7.125% Senior Notes due 2026 and up to $100,000,000 aggregate principal amount of the Offeror's outstanding 7.750% Senior Notes due 2027 and its 7.500% Senior Notes due 2028 subject, in the case of the 2027 Notes, to an additional sub-cap of $50,000,000 aggregate principal amount. The Tender Offers are being made pursuant to the terms and conditions set forth in the Offer to Purchase, dated September 9, 2024 which is available on the transaction website: https://projects.sodali.com/kosmos, subject to eligibility confirmation and registration. The Company refers investors to the Offer to Purchase for the complete terms and conditions of the Tender Offers. As of 5:00 p.m., New York City time, on September 20, 2024, according to information provided to Sodali & Co., the tender and information agent for the Tender Offers, the aggregate principal amount of each series of Notes listed in the table below has been validly tendered and not validly withdrawn in each Tender Offer. Withdrawal rights for the Notes expired at 5:00 p.m., New York City time, on the Early Tender Time.

06:46 EDT Meridian Mining UK reports assay results at Santa Helena - Meridian Mining UK. announced several of the results to date from its Santa Helena Au-Cu-Ag & Zn VMS deposit, part of the greater Au-Cu Cabacal Project, in the state of Mato Grosso, Brazil. High-grade highlights include CD-574, returning 15.9m @ 3.9g/t AuEq / 2.6% CuEq from 58.2m and CD-556: 22.4m @ 3.2g/t AuEq / 2.2% CuEq from 9.2m, amongst many strong near-surface intersections. These results both extend and infill Santa Helena's high-grade continuous mineralization and will be included in the pending resource estimate in Q4 2024. Meridian is also reporting that the results of multiple geophysical programs have been combined to map Santa Helena's massive sulphides and to identify potential targets for blind extensions to its main mineralized trend. Further assays are pending. Meridian's Santa Helena drill program reports continued high-grade Au-Cu-Ag & Zn mineralization; Meridian intercepts more shallow high-grade Au-Cu-Ag & Zn mineralization at Santa Helena; CD-574: 15.9m @ 3.9g/t AuEq / 2.6% CuEq from 58.2m; Including: 5.5m @ 9.0g/t AuEq / 6.0% CuEq from 60.1m; CD-556: 22.4m @ 3.2g/t AuEq / 2.2% CuEq from 9.2m; Including: 5.5m @ 7.8g/t AuEq / 5.2% CuEq from 21.3m ; CD-512: 7.7m @ 4.9g/t AuEq / 3.3% CuEq from 61.1m; Including: 4.0m @ 8.9g/t AuEq / 6.0% CuEq from 61.6m; CD-549: 11.3m @ 3.1g/t AuEq / 2.1% CuEq from 43.4m; Including: 5.4m @ 5.7g/t AuEq / 3.8% CuEq from 43.4m; CD-548: 3.5m @ 10.0g/t AuEq / 6.7% CuEq from 47.6m; CD-568: 4.8m @ 7.6g/t AuEq / 5.1% CuEq from 48.0m; Santa Helena's geophysical program has outlined near-mine open upside to test; and Open targets to test for potential massive sulphide extensions defined by Mise-a-la-Masse, new BHEM tool, and surface surveys.

06:42 EDT Signing Day Sports identifies synergies from Swifty acquisition - Signing Day Sports provided an update regarding its financial position and its plans to acquire Dear Cashmere Group Holding Company, doing business as Swifty Global, highlighting the strategic and financial synergies that are expected to drive accelerated growth and operational efficiency for both companies. As of September 23, 2024, the outstanding convertible senior secured promissory notes of the Company, with an original balance of more than $0.6 million, had been fully extinguished, primarily from conversion into shares of common stock. The improved financial position strengthens the Company's prospects for growth and future capital raising. As previously announced, Signing Day Sports entered into a binding term sheet to acquire 95-99% of the issued and outstanding shares of Swifty, a global online sports and casino technologies company. Swifty is debt-free with a proven track record of growth, revenue generation and profitability. The acquisition is expected to significantly enhance Signing Day Sports' revenue generation, technical capabilities and profitability from the expansion of both companies. Strong Financial Performance: Swifty achieved revenues of over $128 million and a net profit of approximately $2.44 million for the fiscal year ended December 31, 2023, despite significant investments of nearly $3.1 million in software development and licensing. Global Expansion: Swifty is expanding internationally. Swifty recently acquired licenses to offer a full integrated suite of products in Ireland and South Africa, which are expected to have significant online sports and casino markets with limited competition. Fast Development of Revenue Generating Technology: Swifty plans to offer data feed services for the online sports gambling industry in the near future. Swifty has determined that data feed services are expensive and limited in choice, which creates an opportunity for Swifty, and that many sports, like boxing, have limited or no live data feed available to allow real-time betting. The Signing Day Sports team has significant experience working with critical sports datapoints and creating sports measurement technologies, which could assist Swifty in developing this revenue stream. The integration of Swifty is expected to bring several operational advantages and new revenue opportunities for Signing Day Sports: Cost Efficiency: Swifty's in-house engineering team is expected to reduce Signing Day Sports' operating costs by over 50%, enabling the company to reinvest those savings into growth initiatives. It is also expected to increase the speed at which Signing Day Sports can roll out new products and technological enhancements to its current offering and optimize monetization of the product and user base. Revenue Growth in SaaS: At their core, both Signing Day Sports and Swifty are SaaS model businesses. Swifty's scalability, technological resources, and technology initiatives are expected to bolster the growth of Signing Day Sports' app user base, enhance user retention and provide additional opportunities to monetize renewing subscribers with additional revenue streams. New Revenue Streams: Swifty is expected to further expand Signing Day Sports' current product offering while also broadening the Company's exposure to new sports and athletes outside the U.S. Signing Day Sports has accumulated more than 10,000 registered users, which it plans to increase at an accelerated rate in the fourth quarter of 2024 and 2025. The Company's focus is to develop new strategic revenue streams, and improve revenue metrics per user, with the same aim of fully monetizing this growing user base. New Market Exposure: Since its beginning as a football student-athlete recruitment platform provider, Signing Day Sports has expanded its platform to support baseball, softball, and men's and women's soccer. Swifty is expected to bring exposure to new markets in Europe, Africa and the Middle East, as well as exposure to emerging sports without established recruitment models. The Company anticipates that early adopters in these emerging sports markets are a significant market and plans to broaden its platform to capitalize on these prospective revenue streams. Enhanced User Engagement: Swifty's team is expected to introduce exciting new features to Signing Day Sports, including gamification elements such as live scoreboards, top competitor leaderboards, fantasy leagues and real-time performance tracking, which are designed to boost engagement, organic user acquisition and user retention.

06:39 EDT Xoma notes FDA approval of Zevra's MIPLYFFA in patients with NPC - XOMA Royalty Corporation (XOMA) announced Zevra Therapeutics (ZVRA) has received approval from the U.S. Food and Drug Administration for MIPLYFFA. MIPLYFFA is approved for use in combination with miglustat for the treatment of neurological manifestations of Niemann-Pick disease type C in adult and pediatric patients two years of age and older. It is the sixth commercial asset in XOMA Royalty's growing royalty and milestone portfolio. In June 2023, XOMA Royalty announced it had paid LadRx a $5 million upfront payment plus a share of future event-based milestones to acquire a mid-single digit royalty on arimoclomol's commercial sales and up to $52.6 million, net, in potential milestone payments from Zevra.

06:35 EDT Matador prices private offering of $750M of senior notes due 2033 - Matador Resources Company previously announced Friday, September 20 that it priced a private offering of $750 million of 6.250% senior unsecured notes due 2033 at a price of 100% of their face value. The offering is expected to close on September 25, 2024, subject to customary closing conditions. Matador intends to use the net proceeds from the offering to repay borrowings outstanding under Matador's credit facility, including all of the $250 million in outstanding borrowings under Matador's term loan, making the offering debt neutral.

06:33 EDT Ennis board declares one-time special dividend of $2.50 per share - On September 20, 2024 the Board of Directors declared a quarterly cash dividend of 25.0 cents per share on the Company's common stock. The Board of Directors also approved a one-time special dividend of $2.50 per share. The ordinary dividend and special dividend are both payable on November 8, 2024 to shareholders of record on October 11, 2024.

06:16 EDT Almirall to present new data on biologices for psoriasis, atopic dermatitis - Almirall announced its participation in the 33rd Congress of the European Academy of Dermatology and Venereology, taking place in Amsterdam from September 25 to 28, 2024. This year, Almirall marks its 80th anniversary, celebrating eight decades of innovation and commitment to delivering products positively impacting people's health and lives. At the congress, Almirall will present 34 abstracts detailing the latest research on lebrikizumab for moderate-to-severe atopic dermatitis in adolescents and adults, tildrakizumab and Almirall's CAL/BDP cream for moderate-to-severe plaque psoriasis in adults, as well as tirbanibulin for actinic keratosis. The company will also host two symposia, providing a platform for experts to discuss current data, share insights, and facilitate discussions about the treatment of these chronic conditions with advanced biologics. Impact of the treatment of psoriasis on patient wellbeing: new data from the POSITIVE study: Almirall will unveil new interim data on the treatment of adults with moderate-to-severe plaque psoriasis with tidrakizumab at 52 weeks from the POSITIVE clinical study. The POSITIVE study is the first clinical trial in dermatology to use the WHO-5 Wellbeing Index as a primary endpoint. The 5-item World Health Organization Wellbeing Index is a validated questionnaire that assesses health-related subjective psychological wellbeing in a variety of chronic diseases. The different sub-analyses presented during the congress reinforce the effectiveness of tildrakizumab on signs and symptoms in skin and beyond. Almirall will host the symposium "Advancing Psoriasis Management for Long-Term Patient Outcomes", featuring experts such as Prof. Dr. Diamant Thaci from the University of Lubeck, Prof. Dr. Ulrich Mrowietz from the University Medical Center Schleswig-Holstein, and Prof. Anna Lopez Ferrer from the Hospital de la Santa Creu i Sant Pau in Barcelona. The discussion will emphasize on the importance of tailoring treatments to individual patients, the latest real-world evidence, and practical strategies for clinical success managing psoriasis, with opportunities for interactive discussion with leading experts. Advancing atopic dermatitis disease management: Almirall will also present new data on lebrikizumab, a biologic approved for the treatment of moderate-to-severe atopic dermatitis. The late-breaking presentation will report lebrikizumab's data over three years of continuous treatment, alongside new data on the rates of absolute endpoints and its effectiveness in patients inadequately controlled or ineligible for cyclosporine. The Almirall symposium entitled "Precision in AD: How Lebrikizumab is Changing the Treatment Paradigm" will feature the experts Marjolein Bruin-Weller, from the National Expertise Center for Atopic Dermatitis at the Department of Dermatology and Allergology of the University Medical Center Utrecht; Andrew Blauvelt from Portland, US, and Sascha Gerdes from the Center for Inflammatory Skin Diseases of the University Medical Center Schleswig-Holstein Campus Kiel. Discussions will focus on the clinical impact of lebrikizumab and offer a chance for participants to engage with leading specialists in this field.

06:14 EDT AstraZeneca: Datopotamab deruxtecan didn't achieve statistical significance - AstraZeneca said that high-level results from the TROPION-Breast01 Phase III trial of datopotamab deruxtecan compared to investigator's choice of chemotherapy, which previously met the dual primary endpoint of progression-free survival, did not achieve statistical significance in the final overall survival analysis in patients with inoperable or metastatic hormone receptor -positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy. This analysis follows the positive PFS results presented at the 2023 European Society for Medical Oncology Congress which showed datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement in PFS. An improvement in patient-reported outcomes was also seen. The PFS data and additional results for key secondary endpoints were published this month in the Journal of Clinical Oncology. Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "The metastatic HR-positive breast cancer treatment landscape has advanced remarkably in the last several years to the benefit of patients. Based on the TROPION-Breast01 results, there is evidence of the clinical value of datopotamab deruxtecan in this setting. We will continue discussions with regulatory authorities and apply insights from these results to our clinical development programme for datopotamab deruxtecan in breast cancer."

06:07 EDT Uranium Energy to acquire Wyoming assets from Rio Tinto for $175M - Uranium Energy Corp. (UEC) announced that it has entered into an agreement with Rio Tinto (RIO) to acquire 100% of Rio Tinto's Wyoming assets, comprised of the wholly-owned and fully-licensed Sweetwater Plant and a portfolio of uranium mining projects with approximately 175 million pounds of historic resources. The purchase price payable at closing is $175M, subject to customary working capital adjustments, and will be funded with UEC's available liquidity. In addition, the transaction provides UEC critical scale in the Great Divide Basin, with opportunities to realize synergies from shared infrastructure and project personnel expertise. Addition of approximately 175M pounds of uranium resources, at an in-situ valuation multiple well below UEC's current trading levels. Approximately half of these resources appear amenable to ISR mining methods and half to conventional mining. ISR amenable resources will be prioritized for development and near-term production, with conventional resources providing substantial optionality for further production growth. The transaction adds more than 53,000 acres of land for future exploration along with an extensive geological database gathered from over 6.1M feet of drilling facilitating historical resource conversion and more effective exploration. Combined with UEC's existing 54,615 acres of mining rights in the Great Divide Basin, this will establish a portfolio of approximately 108,000 acres of mining and exploration prospects.

06:04 EDT Sharps Technology announces $3.5M bridge financing - Sharps Technology has entered into definitive agreements with institutional investors for a secured bridge loan financing of approximately $3.5 million. The Bridge Financing consisted of the sale of approximately $3.5 million in securities, with purchasers agreeing to buy, for each $1,000 invested, $1,250 in aggregate principal amount of secured notes and 1,628.57 shares of common stock or pre-funded warrants in lieu of shares of Common Stock, for an aggregate of $4,375,000 in principal amount of the Notes and 5,700,006 shares of Common Stock. The Pre-Funded Warrants will be immediately exercisable, at a price of $0.0001, subject to registration and may be exercised at any time until exercised in full. For each Pre-Funded Warrant sold in the offering, the number of shares of Common Stock in the offering will be decreased on a one-for-one basis. Aggregate gross proceeds to the Company are expected to be approximately $3.5 million, before deducting fees and expenses. The transaction is expected to close on or about September 23, 2024, subject to the satisfaction of customary closing conditions. The Company expects to use the net proceeds from the offering, together with its existing cash, for general corporate purposes and working capital. Aegis Capital Corp. is acting as Exclusive Placement Agent for the private placement. Sichenzia Ross Ference Carmel LLP is acting as U.S. counsel to the Company. Kaufman & Canoles, P.C. is acting as counsel to Aegis Capital Corp.

06:02 EDT BNP Paribas to buy HSBC's German private banking arm - BNP Paribas (BNPQY) announced that it has signed an agreement with HSBC (HSBC) for the acquisition of their Private Banking activities in Germany, with the ambition to position BNP Paribas Wealth Management among the top players in Germany and bringing its AuM1 to more than EUR 40B. "This acquisition is a new crucial step in positioning BNP Paribas Wealth Management among the leading players in Germany, where we believe our model is best suited to serve the long-term needs of entrepreneurial clients, leveraging on the strong franchises of the Group to both address their personal and corporate needs. It will therefore contribute to consolidate our position as the first Wealth Management player in the Eurozone," comments Vincent Lecomte, CEO of BNP Paribas Wealth Management. The closing of this transaction is expected during the second semester of 2025, once regulatory approvals have been obtained. Reference Link

05:23 EDT Teva announces new analysis from European cohort of RIM-TD study - Teva announced that a new analysis from the European cohort of the RIM-TD open-label extension, or OLE, study revealed that deutetrabenazine treatment of patients with Tardive Dyskinesia, or TD, was associated with long term improvement of TD symptoms. The improvement in symptoms was sustained throughout the three-year study, and deutetrabenazine was well tolerated. The data were presented at the European College of Neuropsychopharmacology, or ECNP, annual congress in Milan. RIM-TD is a three-year study which enrolled patients who had completed one of the two pivotal deutetrabenazine phase 3 studies, ARM-TD6 and AIM-TD.7 Whilst RIM-TD was conducted in both the United States and Europe, the post hoc subgroup analysis focused on patients from the European countries. Treatment success was defined as 'much improved' or 'very much improved' on the Clinical Global Impression of Change or Patient Global Impression of Change. The majority of patients achieved treatment success with 65% of patients for CGIC and 56% for PGIC. Deutetrabenazine was generally well tolerated, regardless of which arm of the two Phase 3 trials the patients had previously been treated in. Deutetrabenazine has now been evaluated in ARM-TD, AIM-TD as well as RIM-TD, all of which demonstrated that the treatment provides rapid, sustained, and clinically meaningful improvements in motor function in patients with Tardive Dyskinesia.

05:18 EDT Marqeta announces Fouzi Husaini as chief artificial intelligence officer - Marqeta (MQ) announced that Fouzi Husaini has joined the company as its chief artificial intelligence officer. Husaini will play a role in scaling Marqeta's AI organization. Most recently, Husaini served as the VP of machine learning engineering at Capital One (COF), where he focused on building machine learning models to support Capital One's credit products and services, including marketing, fraud, small business and more.

05:11 EDT Donaldson launches filtration services in France, Germany and Austria - Donaldson is expanding its presence in the food and beverage markets by launching its filtration services in France, Germany and Austria. This initiative reinforces the company's commitment to product and process integrity, with Donaldson specialists delivering directly to customers' locations. The launch of filtration services for food and beverage, and adjacent markets, in France, Germany and Austria is expected to set the stage for expanding this offering across Europe.

05:08 EDT Nokia enters 5G equipment deal with Viettel Group in Vietnam - Nokia announced that it has signed a major new deal with Viettel Group to deploy 5G equipment for the first time nationwide in Vietnam. The ambitious project will cover 22 provinces across the country and support Viettel's strategy of advancing 5G infrastructure and digital transformation. The project will also see Nokia modernize Viettel's 4G infrastructure. Deployment will begin this year. Under the deal, Nokia will supply equipment from its 5G AirScale portfolio for the first time in Vietnam covering 2,500 sites.