Stockwinners Market Radar for September 18, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

21:32 EDT HSBC cuts prime and reference rate to 8.00% - HSBC Bank USA, N.A., and its affiliates announced today that they have reduced their prime and reference rate from 8.50% to 8.00%, effective tomorrow.

20:10 EDT Alphabet CEO sells $3.61M in common stock - In a regulatory filing, Alphabet disclosed that its CEO Sundar Pichai sold 22.5K shares of common stock on September 18th in a total transaction size of $3.61M.

19:50 EDT Banzai International Inc trading halted, news pending

19:04 EDT Williams-Sonoma CEO sells $5.81M in common stock - In a regulatory filing, Williams-Sonoma disclosed that its CEO Laura Alber sold 40K shares of common stock on September 16th in a total transaction size of $5.81M.

19:01 EDT Axonics prevails in patent infringement lawsuit with Medtronic - Axonics (AXNX) announced that the jury has returned a unanimous verdict in the patent infringement lawsuit brought by Medtronic (MDT) against Axonics in U.S. District Court for the Central District of California. The jury found that Axonics does not infringe any of the three patents-in-suit. "A jury of our peers recognized that Axonics' proprietary tined lead design and temperature sensor technology is differentiated from our competitor's intellectual property," said Raymond W. Cohen, chief executive officer. "As we have said since this case was first filed in late 2019, our view is that Medtronic's lawsuit was initiated to stifle competition, limit patient and physician choice, and protect the incumbent's monopoly in sacral neuromodulation. We are very pleased with the jury's finding and continue to remain focused on fulfilling our mission of positively impacting the lives of adults with bladder and bowel dysfunction."

17:56 EDT Webster Financial lowers prime lending rate to 8% from 8.5%, effective Sept. 19 - Webster Financial announced that it has lowered its prime lending rate to 8% from 8.5%, effective September 19.

17:31 EDT BloomZ discloses Nasdaq notice regarding continued listing - BloomZ announced today that, on September 12, 2024, it received a written notification from the Nasdaq Stock Market LLC advising the Company that it is not in compliance with the minimum market value of listed securities set forth in Nasdaq Listing Rules for continued listing on The Nasdaq Capital Market. Nasdaq Listing Rule 5550(b)(2) requires companies to maintain a minimum market value of listed securities of $35 million. Nasdaq Listing Rule 5810(c)(3)(C) provides that a failure to meet the Minimum Market Value of Listed Securities Requirement exists if the deficiency continues for a period of 30 consecutive business days. Based on the market value of listed securities of the Company from July 29, 2024 to September 11, 2024, the Company did not meet the Minimum Market Value of Listed Securities Requirement.

17:24 EDT Citizens Bank lowers prime rate to 8% from 8.5%, effective September 19 - Citizens Financial Group announced that Citizens Bank has decreased its prime lending rate to 8% from 8.5%, effective Thursday, September 19.

17:22 EDT Progyny discloses loss of 'significant client' - In a regulatory filing, Progyny stated: "Progyny was recently notified by a significant client that the Client has elected to exercise a 90-day option to terminate its services agreement with the Company, effective as of January 1, 2025. The Client confirmed that they had no issues of concern over the course of its multi-year relationship with the Company, including member satisfaction or quality of service or outcomes. There have not been any disputes with the Client during the course of service. As the existing agreement remains in effect for the remainder of this calendar year, the termination of these services is not expected to have an adverse impact on the Company's financial results for its fiscal year ending December 31, 2024. The Client, which represents approximately 670,000 members as of June 30, 2024, comprised 12% and 13% of the Company's revenue for the six-month period ending June 30, 2024, and the twelve-month period ending December 31, 2023, respectively. The Client comprises a smaller percentage of the Company's Adjusted EBITDA and no other existing client comprises more than a single digit percentage of revenue or Adjusted EBITDA. The Company continues to anticipate an increase in its overall member count in 2025 as compared to 2024. The Company remains disciplined in managing its business and is well-positioned to continue on its established path of achieving growth, profitability and cash flow by seeking to ensure that members are getting the right care at the right time as they realize their dreams of family building and ideal health."

17:17 EDT Palantir awarded $99.8M Army contract - Palantir was awarded a $99.8M firm-fixed-price contract for user licenses for the Maven Smart System AI tool, ancillary software support and hardware. Work locations and funding will be determined with each order, with an estimated completion date of September 24, 2029. Army Contracting Command is the contracting activity.

17:05 EDT Largo names Francesco D'Alessio chief commercial officer - Largo announced the promotion of Francesco D'Alessio to the role of Chief Commercial Officer, effective immediately. With Largo since 2019, the appointment of Mr. D'Alessio is part of a broader focus on the repositioning of Largo's sales and trading operations to capitalize on emerging opportunities in the vanadium market. Daniel Tellechea, Director and Interim CEO of Largo, commented: "Francesco has consistently demonstrated a strong commitment to enhancing our sales operations and is the right leader to guide our commercial strategy forward. His extensive background in vanadium sales and trading, combined with his strategic vision, will be critical as we aim to strengthen Largo's position in the vanadium market with a focus on our approach to global sales and trading to drive long-term value going forward."

17:03 EDT Aligos Therapeutics to announce Phase 2a topline results for ALG-055009 in MASH - Aligos Therapeutics "announced that the Company will share the topline results from the Phase 2a HERALD study of ALG-055009, a thyroid hormone receptor beta agonist, in metabolic-dysfunction associated steatohepatitis, or MASH, subjects on Thursday, September 19, 2024 prior to the market open.

17:01 EDT Inari Medical director sells $1.83M in common stock - In a regulatory filing, Inari Medical disclosed that its director William Hoffman sold 40K shares of common stock on September 16th in a total transaction size of $1.83M.

17:00 EDT Huntington Bancshares cuts prime rate to 8% from 8.5% - Huntington Bancshares Incorporated announced that its prime rate is decreasing from 8.5% to 8%, effective September 19, 2024.

16:56 EDT Argan increases quarterly dividend 25% to 37.5c per share - Argan declared a 25% increase in the quarterly cash dividend, raising it from 30c to 37.5c per common share. The dividend will be payable on October 31 to stockholders of record at the close of business on October 23.

16:45 EDT McDonald's Chairman Kempczinski sells $1.2M in company shares - The Chairman of McDonald's Christopher Kempczinski disclosed the sale of 3,934 shares of company stock at $300 per share on September 16, for a total transaction amount of $1,180,200.

16:39 EDT Santander Bank lowers prime rate to 8% from 8.5% - Santander Bank, N.A. announced it has lowered its prime rate from 8.50% to 8.00% effective September 18, 2024.

16:35 EDT Nasdaq sends Mountain Crest Acquisition expected deficiency notification letter - Mountain Crest Acquisition announced that it received an expected deficiency notification letter from the staff of The Nasdaq Stock Market on September 13 ... The Notice indicated that the Company was not in compliance with Nasdaq Listing Rule 5250(c)(1) as a result of its failure to timely file (i) its Quarterly Report on Form 10-Q for the quarter ended March 31 as described more fully in the Company's Form 12b-25 Notification of Late Filing filed with the Securities and Exchange Commission on April 2, and (ii) its Quarterly Report on Form 10-Q for the quarter ended June 30...The Company has made progress towards regaining compliance. In particular, on September 13 the Company filed the Q1 10-Q with the SEC. Then on September 16, the Company submitted a letter to Nasdaq setting forth the Company's plan to regain compliance with the Listing Rule. The Company also requested the Staff to provide an exception to allow the Company to regain compliance with the Listing Rule, by filing the Q2 10-Q, to October 14

16:31 EDT AIG names Keith Walsh as new CFO - American International Group announced that Keith Walsh will join the company as Executive Vice President, Chief Financial Officer, effective October 21, 2024. Mr. Walsh will report to AIG Chairman & Chief Executive Officer, Peter Zaffino and become a member of the Executive Leadership Team. He will be responsible for leading AIG's global Finance organization and will be based in New York. With more than 25 years of finance leadership experience, Mr. Walsh joins AIG from Marsh McLennan, where he served as Chief Financial Officer of Marsh.

16:30 EDT Regions Bank reduces prime lending rate to 8% from 8.5% - Regions Bank announced it is reducing the Regions prime lending rate to 8.00% from 8.50%, effective Thursday, Sept. 19, 2024.

16:26 EDT SciSparc submits SCI-110 new drug application to FDA - SciSparc said it has taken a major step forward with its proprietary SCI-110 for the treatment of Tourette Syndrome, with its submission of an investigational new drug application to the FDA for its phase IIb clinical trial, as previously announced on August 23. The phase IIb clinical trial will be conducted at three global leading centers of excellence: the Yale Child Study Center at the Yale School of Medicine in Connecticut, United States, the Hannover Medical School in Hannover, Germany, and at the Tel Aviv Sourasky Medical Center in Israel. The company has already secured the Institutional Review Board approvals from all three clinical sites, the Israeli Ministry of Health's approval for the clinical trial at Sourasky, and approval from the Federal Institute for Drugs and Medical Devices in Germany for conducting the trial at the Hannover Medical School. The objective of this clinical trial is to evaluate the efficacy, safety and tolerability of SciSparc's proprietary drug candidate SCI-110 in adult patients using a daily oral treatment. The patients will be randomized at a 1:1 ratio to receive either SCI-110 or a SCI-110-matched placebo. The primary efficacy objective of the trial will be to assess tic severity change using the Yale Global Tic Severity Scale, the most commonly used measure in clinical trials of this kind, as a continuous endpoint at weeks 12 and 26 of the double-blind phase compared to baseline. The primary safety objective of the trial is to assess absolute and relative frequencies of serious adverse events for the entire population and, separately, for the SCI-110 and placebo groups.

16:19 EDT Tupperware Brands trading halted, news dissemination

16:17 EDT Bentley Systems director sells $2.46M in common stock - In a regulatory filing, Bentley Systems disclosed that its director Barry Bentley sold 50K shares of common stock on September 16th in a total transaction size of $2.46M.

16:15 EDT Trinity Biotech provides update on CGM technology collaboration with Bayer - Trinity Biotech (TRIB) provided an update on its development and global launch plans for its next generation Continuous Glucose Monitoring CGM technology. CGMs are small patch-like wearable medical devices that use biosensor wires under the skin to measure glucose in real-time. These devices are increasingly popular in diabetes management and health monitoring. As previously announced, Trinity Biotech has entered into a non-binding Letter of Intent with Bayer (BAYRY) for the launch of a CGM device in China and India. As part of this, Trinity Biotech is launching an in-country study of the India market for CGMs. In this study, Trinity Biotech will gather feedback from people who have been diagnosed with diabetes and healthcare professionals. The insights from this study will support the refinement of the design of Trinity Biotech's next generation CGM solution to optimise it for an intended launch in the Indian market. David Ouston, Biosensor Marketing Director of Trinity Biotech, said, "We've made significant progress in the development of our next generation CGM, with an innovative reimagining of our modular design that enhances user experience while continuing to reduce cost and waste. To inform the continued refinement and optimization of our next generation technology, we're eager to gather more insights on CGM utilization and the patient experience in India. We are excited to explore collaboration with Bayer on this important journey."

16:10 EDT Real Good Food receives Nasdaq notice regarding potential delisting - The Real Good Food Company announced that on September 12 it received a notification from The Nasdaq Stock Market informing the Company that Nasdaq has initiated a process that could result in the delisting of the Company's securities from Nasdaq due to the Company's failure to comply with Nasdaq Listing Rule 5250(c)(1), which requires listed companies to file in a timely manner all required periodic financial reports with the Securities and Exchange Commission. The Nasdaq Staff has determined that the Company would not be able to become fully current with regards to the Company's late filings by Octob, and as a result, the Staff determined to initiate the delisting process. Accordingly, the Company intends to timely request a hearing before an independent Hearings Panel. The hearing request will automatically stay any suspension or delisting action through October 4. Concurrent with the hearing request, the Company intends to seek, subject to the Panel's discretion, an extended stay of suspension or delisting through the pendency of the hearing and the expiration of any additional extension period granted by the Panel following the hearing. Pursuant to the Nasdaq Listing Rules, the maximum amount of time that can be granted by the Panel runs through April 11. Despite the efforts described above, there can be no assurance that the Company will ultimately regain compliance with all applicable requirements for continued listing or that the Panel will grant the Company a further extension.

16:06 EDT Fifth Third to decrease prime lending rate to 8% - Fifth Third Bank, National Association, announced it will decrease its prime lending rate to 8.00%, effective immediately. The rate was last changed on July 26, 2023, when Fifth Third increased its prime lending rate from 8.25% to 8.50%

16:03 EDT Nasdaq grants Hydrofarm180 calendar day extension to regain bid price compliance - Hydrofarm Holdings Group manufacturer and distributor of branded hydroponics equipment and supplies for controlled environment agriculture, announced that it has received a 180 calendar day extension, until March 10, 2025, from the Nasdaq Stock Market to regain compliance with Nasdaq Marketplace Rule 5550(a)(2) . The Bid Price Rule stipulates that the bid price of the Company's common stock must close at $1.00 per share or more for a minimum of 10 consecutive business days. The Company will continue to monitor its stock price and plans to pursue available options to regain compliance with the Bid Price Rule, including potentially pursuing a reverse stock split. This notification from Nasdaq has no immediate effect on the listing or trading of the Company's shares, which currently trade on the Nasdaq Capital Market under the symbol "HYFM."

15:45 EDT Bank of Montreal decreases U.S. dollar prime lending rate to 8.00% - BMO announced that it is decreasing its U.S. dollar prime lending rate from 8.50% to 8.00%, effective September 19.

15:41 EDT OceanFirst Financial voluntarily settles fair lending claims by DOJ, HUD - Christopher D. Maher, Chairman and Chief Executive Officer, of OceanFirst Financial Corp., stated, "The commitments we are announcing today are consistent with our Bank's 122-year history of providing credit and other financial services to all residents of the communities we serve. We look forward to continuing the Bank's efforts in the New Brunswick-Lakewood market to help meet the lending and banking needs of families, businesses, schools and organizations."

14:37 EDT Oak Street Health to pay $60M to resolve alleged False Claims Act violations - According to a statement from the U.S. Justice Department's Office of Public Affairs, Oak Street Health, headquartered in Chicago and a wholly-owned subsidiary of CVS Health since 2023, has agreed to pay $60M to resolve allegations that it violated the False Claims Act by paying kickbacks to third-party insurance agents in exchange for recruiting seniors to Oak Street Health's primary care clinics. The Anti-Kickback Statute prohibits anyone from offering or paying, directly or indirectly, any remuneration - which includes money or any other thing of value - to induce referrals of patients or to provide recommendations of items or services covered by Medicare, Medicaid and other federally funded programs. Under the Medicare Advantage Program, also known as Part C, Medicare beneficiaries have the option to obtain their health care through privately-operated insurance plans known as MA plans. Some MA Plans contract with health care providers, including Oak Street Health, to provide their plan members with primary care services. The United States alleged that, in 2020, Oak Street Health developed a program to increase patient membership called the Client Awareness Program. Under the Program, third-party insurance agents contacted seniors eligible for or enrolled in Medicare Advantage and delivered marketing messages designed to generate interest in Oak Street Health. Agents then referred interested seniors to an Oak Street Health employee via a three-way phone call, otherwise known as a "warm transfer," and/or an electronic submission. In exchange, Oak Street Health paid agents typically $200 per beneficiary referred or recommended. These payments incentivized agents to base their referrals and recommendations on the financial motivations of Oak Street Health rather than the best interests of seniors. The settlement resolves allegations that, from September 2020 through December 2022, Oak Street Health knowingly submitted, and caused the submission of, false claims to Medicare arising from kickbacks to agents that violated the Anti-Kickback Statute. Reference Link

13:48 EDT T-Mobile introduces 'T-Priority' for first responders - During T-Mobile's (TMUS) Capital Markets Day, CEO Mike Sievert unveiled "T-Priority," which the company says is "a new solution built with first responders to deliver the unprecedented support they deserve every day and - especially - during massive emergencies." The company stated: "Built on T-Mobile's 5G Standalone Core, the network slice ensures first responders get lower latency and faster 5G speeds more consistently and it also gives them the highest priority across every single 5G band, even in times of extreme congestion. T-Priority comes with a complete and growing support system tailored to first responders' critical needs, with the latest technological solutions from top industry partners like Motorola Solutions (MSI), Ericsson (ERIC), and 3rd-Eye Technologies, Inc., who bring a proven heritage of supporting first responder missions." T-Mobile added: "T-Priority's new first responder rate plans launch later this year and are available for state, local and federal agencies. They're also available to businesses, like utility and transportation organizations, that provide critical support during emergencies."

13:42 EDT T-Mobile boosts quarterly dividend 35% to 88c per share - The company declared a cash dividend of 88c per share on its issued and outstanding shares of common stock, an increase of 23c per share or 35% from the previous quarter. The dividend is payable on December 12, to stockholders of record as of the close of business on November 27.

13:32 EDT Golden Sun Health Technology Group Ltd trading halted, volatility trading pause

12:59 EDT OpenAI CEO Sam Altman presenting at T-Mobile Capital Markets Day - Earlier today, T-Mobile announced a multi-year agreement with OpenAI that it said "will revolutionize the customer experience and reset customer success benchmarks for companies around the world."

12:42 EDT T-Mobile sees expanding fiber households to 12M-15M or more homes by 2030 - T-Mobile sees expanding 5G broadband to reach 12M subscribers in 2028. Guidance comments delivered by Mike Sievert and the T-Mobile (TMUS) senior leadership team at T-Mobile's Capital Markets Day meeting. Shares of broadband services providers Comcast (CMCSA) and Charter (CHTR) dipped in early afternoon trading in apparent response to T-Mobile's comments during its event.

12:37 EDT T-Mobile sees $38B-$39B in core adjusted EBITDA by 2027 - T-Mobile notes this guidance would see core adjusted EBITDA increasing by about $10B compared to 2023 results a the high end of the guidance range. Guidance comments delivered by Mike Sievert and the T-Mobile senior leadership team at T-Mobile's Capital Markets Day meeting.

12:01 EDT Interpublic Group names Alex Hesz as chief strategy officer - Interpublic Group announced the appointment of Alex Hesz as the company's Chief Strategy Officer. Hesz will collaborate closely with Interpublic's leadership team on the company's strategic priorities, including the company's go-to-market positioning and its integrated work with global clients, the company said in a statement. "Alex is an exceptional strategist who sees what's next and will help both our clients and Interpublic harness change to drive outstanding performance. He'll be invaluable in driving our company's strategic initiatives forward as we continue to evolve and grow. An area of long-standing focus for us is the intersection of media, technology and creative, and Alex can accelerate the pace at which we integrate these capabilities so that our teams can most efficiently grow business for brands," said Philippe Krakowsky, CEO of Interpublic.

12:01 EDT Ermenegildo Zegna falls -7.5% - Ermenegildo Zegna is down -7.5%, or -73c to $9.02.

12:00 EDT Bausch + Lomb rises 7.9% - Bausch + Lomb is up 7.9%, or $1.48 to $20.04.

11:57 EDT Sysco says Q1 industry traffic has 'softened a bit' vs prior quarter - During the 2024 Wells Fargo Consumer Conference, Sysco CEO Kevin Hourican said that traffic in Q4 was down roughly 3% at restaurants, and the for the current quarter, that global industry traffic has "softened a bit." "It's softer than that minus 3%, " Hourican said, "We said in our conference a couple of week sago that July was minus 5%." The CEO later added that, despite this softness, the company has "full confidence" in its 2025 guidance.

11:38 EDT T-Mobile announces multi-year agreement OpenAI - T-Mobile announced a multi-year agreement OpenAI "that will revolutionize the customer experience and reset customer success benchmarks for companies around the world." The company said: "Combining T-Mobile's deep expertise in cultivating customer relationships with OpenAI's cutting-edge AI technology knowledge and world-class research and development experts, the two companies are custom-building the first intent-driven AI-decisioning platform of its kind, called IntentCX. With secure access to T-Mobile data and its ability to comprehend customer intent and sentiment in real time, IntentCX will have the ability to apply meaningful understanding and knowledge of the customer to every interaction, offer solutions to resolve issues and even take proactive actions on their behalf. The initial goal is to apply the most advanced technology and business processes, to maximize the success of every customer's journey with T-Mobile, and in the process, create a blueprint applicable across industries." T-Mobile is actively testing use of IntentCX to incorporate it into its business operations and plans to begin implementing it in 2025.

11:35 EDT Galmed trading halted, volatility trading pause

11:34 EDT GameStop CEO Cohen to pay $985,320 civil penalty to FTC - The Federal Trade Commission announced that Ryan Cohen, managing partner of RC Ventures and CEO of GameStop, will pay a $985,320 civil penalty to settle charges that his acquisition of Wells Fargo (WGC) shares violated the Hart-Scott-Rodino Act. According to the complaint, Cohen acquired more than 562,000 Wells Fargo voting securities resulting in aggregated holdings of Wells Fargo securities that exceeded HSR filing thresholds. Cohen's purchase triggered an obligation to file an HSR form with federal antitrust agencies and wait before completing the acquisition, yet Cohen failed to do so, the FTC said in a statement. Reference Link

11:21 EDT PayPal announces new partnership with Amazon Buy with Prime - PayPal (PYPL) announced a new partnership with Amazon (AMZN) Buy with Prime. "For participating brands integrating using the Buy with Prime API, PayPal is now available at checkout after shoppers log in to their Amazon account. And starting next year, Prime members will be able to perform a one-time link to their Amazon account to their PayPal account so that Prime free, fast shipping benefits are available automatically whenever they use PayPal while shopping with Buy with Prime on participating merchants' websites," PayPal said in a newsletter to investors. Reference Link

11:05 EDT Lockheed Martin awarded GeoXO LMX contract by NASA valued at $297M - NASA has awarded Lockheed Martin a contract to design and build the next-generation GeoXO Lightning Mapper instruments for the National Oceanic and Atmospheric Administration. The baseline contract is valued at approximately $297M for two instruments with options for two additional instruments. "Lockheed Martin improved upon the success of the Geostationary Lighting Mapper and added game-changing technologies to the GeoXO Lightning Mapper, including an advanced imaging sensor that will potentially detect 25% more lightning pulses," said Matthew Mahlman, director of Weather, Earth Science and Climate Intelligence at Lockheed Martin. "This advanced technology will give meteorologists a tool to create greater lead time in alerting people to severe storms and dangerous weather situations such as rapid intensifying hurricanes."

10:59 EDT Sify Technologies to implement ADS ratio change - Sify Technologies announced that it will change the ratio of its American Depositary Shares, or "ADSs," to equity shares from the current ratio, where one ADS represents one equity share, to a new ratio, where one ADS will represent six equity shares. The ADS Ratio Change is expected to become effective on or about October 4. "For the Company's ADS holders, the ADS Ratio Change will have the same effect as a one-for-six reverse ADS split and will have no impact on an ADS holder's proportional equity interest in the Company, except to the extent that the ratio change would have resulted in an ADS holder owning fractional ADSs. There will be no change to the Company's equity shares. On the Effective Date, registered holders of the Company's ADSs held in certificated form will be required on a mandatory basis to surrender their certificated ADSs to Citibank, N.A., the depositary bank (the "Depositary"), for cancellation and will receive one (1) new ADS in exchange for every six (6) existing ADSs surrendered. Holders of uncertificated ADSs in The Depository Trust Company and Direct Registration System will have their ADSs automatically exchanged and need not take any action. The exchange of every six (6) then-held (existing) ADSs for one (1) new ADS will occur automatically at the Effective Date, with the then-held ADSs being cancelled and new ADSs being issued by the Depositary," the company stated The company's ADSs will continue to be traded on the NASDAQ Capital Market under the symbol "SIFY".

10:55 EDT Comstock Mining trading halted, news pending

10:39 EDT YouTube Shopping expanding to Indonesia in partnership with Shopee - Johanna Voolich, Chief Product Officer of Alphabet's (GOOGL) YouTube, stated in a post to the YouTube Official Blog: "There are now over 250,000 creators in YouTube Shopping! The YouTube Shopping affiliate program is currently available in US and South Korea, and today, we're expanding to Indonesia, in partnership with Shopee. In the coming weeks, we'll bring the program to Thailand and Vietnam, so more of you across the globe can share your favorite products with fans and grow your businesses." Shoppee is the online-retail arm of Sea Limited (SE), whose shares are up $1.92, or 2%, to $82.29 in Wednesday morning trading in New York. Reference Link

10:33 EDT Marshall & Ilsley Corporation trading halted, volatility trading pause

10:20 EDT TC Biopharm (Holdings) PLC - ADR trading resumes

10:14 EDT NRC approves license renewal for FPL's Turkey Point Nuclear Power Plant - The U.S. Nuclear Regulatory Commission has approved the subsequent license renewal for Florida Power & Light Company's Turkey Point Nuclear Power Plant Units 3 and 4, enabling the continued safe operation of these units through 2052 and 2053, respectively. This significant approval ensures that the nuclear facility will continue to provide reliable, low-cost and clean energy to FPL customers for the next three decades.

10:07 EDT Xchg Ltd trading resumes

10:02 EDT Xchg Ltd trading halted, volatility trading pause

10:00 EDT ResMed falls -4.8% - ResMed is down -4.8%, or -$12.16 to $238.72.

10:00 EDT Emerald Holding falls -7.7% - Emerald Holding is down -7.7%, or -38c to $4.53.

10:00 EDT Braskem rises 7.7% - Braskem is up 7.7%, or 53c to $7.44.

09:52 EDT Neonode trading resumes

09:48 EDT Braskem rises 7.4% - Braskem is up 7.4%, or 51c to $7.42.

09:47 EDT LightInTheBox falls -6.2% - LightInTheBox is down -6.2%, or -20c to $3.04.

09:47 EDT Neonode trading halted, volatility trading pause

09:46 EDT iSpecimen Inc trading resumes

09:36 EDT iSpecimen Inc trading halted, volatility trading pause

09:31 EDT Plum Acquisition Corp I trading halted, volatility trading pause

09:30 EDT N2OFF says Solterra advances JV Solar PV project - N2OFF and Solterra Renewable Energy announced additional progress in connection with the integration of Solterra's Solar PV joint venture project in Melz, Germany. The municipal approval process for integrating the solar facility within Melz's zoning plan requires district approval before the municipality can proceed with presenting the statutory plan draft for public hearing. The JV took an important step forward by submitting the statutory plan draft to the city. N2OFF previously announced that Solterra obtained approval to connect the PV solar project to the power grid of a regional energy provider. Furthermore, the current project design requires a grid connection of 97 MW to deliver an aggregate capacity of 111 MWp. The approved grid connection capacity exceeds such requirement by approximately 10%, providing two potential pathways to maximize the value: increasing the project's capacity by up to 10%; or incorporating battery storage solutions.

09:28 EDT SAIC awarded $229M contract for DoD IT modernization - Science Applications International Corp. has been awarded a new $229 million contract by the U.S. Department of Defense to provide vital IT solutions under the NORAD/USNORTHCOM Information Technology Enterprise Services program.

09:17 EDT Mullen's Bollinger Motors announces pricing for 2025 B4 electric truck - Mullen Automotive's Bollinger Motors has released pricing for the 2025 Bollinger B4 Chassis Cab with a Manufacturers Suggested Retail Price of $158,758. The Bollinger B4 Chassis Cab is an all-new, all-electric Class 4 commercial truck designed from the ground up with extensive fleet and upfitter input. Bollinger's unique chassis design protects the 158-kwh battery pack and components to offer impressive capability and safety in the commercial market. The company commenced serial production of the B4 this week and will begin delivering vehicles to customers in October 2024. The all-electric Bollinger B4 Chassis Cab is now available for order. The Bollinger B4 will be available via Bollinger's national dealer network. The 2025 B4 will be eligible for combined federal and state incentives that could be in excess of $100,000. The base B4 can be enhanced with dealer accessories and several factory options, including an e-PTO unit to meet a fleet's specific needs.

09:15 EDT SuperCom secures first new contract in New York - SuperCom announced that it has secured its first new contract in a county in New York State. The company said this win, achieved through a competitive selection process, further strengthens SuperCom's strategic expansion across the US and marks another milestone in its ongoing growth.

09:12 EDT FDA grants Azitra's topically applied ATR-04 'fast track' EGFRi rash - Azitra announced the U.S. Food and Drug Administration FDA has granted Fast Track Designation for topically applied ATR-04 to treat moderate to severe Epidermal Growth Factor Receptor inhibitor EGFRi associated dermal toxicity. Francisco Salva, Azitra's CEO, stated, "We are thrilled to announce the FDA has granted Fast Track designation to ATR-04, demonstrating that the FDA recognizes the unmet need for treatment of EGFRi-associated skin rash. Many cancer patients receive EGFR inhibitors, which often have significant side effects, resulting in rashes that require off-label treatment with antibiotics, steroids or other medications, or discontinuation of EGFRi therapy. The skin toxicity creates a high burden for these cancer patients, with a profound impact on their quality of life. We look forward to potentially accelerating the development of ATR-04 to treat this condition." ...Azitra plans to initiate a multicenter, randomized, controlled Phase 1/2 clinical trial of ATR-04 in patients with dermal toxicity due to EGFR inhibitors by the end of 2024.

09:09 EDT Mondelez to source plastic from advanced recycling tech for Triscuit packaging - Mondelez will source plastic linked to advanced recycling technology for the production of packaging across the majority of SKUs for its Triscuit Crackers in the U.S. and Canada. Through this initiative, the Triscuit brand is contributing to the sourcing of recycled plastics via the ISCC mass balance approach, helping to support a more circular pack economy in the U.S. and Canada. This contributes to Mondelez International's goal of achieving about 5% recycled plastic content by 2025. In the past, soft plastic packaging has been considered a single-use material. By adopting this advanced recycling technology, Triscuit fans can snack easier knowing that the brand is playing a role in helping reduce plastic waste. As part of this effort, up to 50% of the plastic used in the protective bag-in-box liner films can be attributed to plastic sourced from advanced recycling technology through the ISCC PLUS certified mass balance approach. This advancement complements the current outer box used in Triscuit cracker packaging, which is already made from 100% recycled paperboard, promoting a more sustainable packaging structure for Triscuit crackers overall. Through this investment, the Triscuit brand aims to divert over one million pounds of plastic waste from landfills per year.

09:08 EDT SuperCom awarded first contract in a county in New York State - SuperCom announced that it has secured its first new contract in a county in New York State. This win, achieved through a competitive selection process, further strengthens SuperCom's strategic expansion across the US and marks another milestone in its ongoing growth. The contract leverages SuperCom's advanced electronic monitoring solutions to enhance public safety and provide reliable monitoring services to the county. By entering the new region of New York State, SuperCom continues to demonstrate its ability to deliver adaptable and innovative solutions tailored to the unique needs of government clients.

09:07 EDT Fat Brands announces launch co-branded online ordering experience - FAT Brands (FAT) announces the launch of Great American Cookies and Marble Slab Creamery's new co-branded online ordering experience in partnership with Rapturous, the digital restaurant transformation and customer experience wing of 3 Owl, and Olo (OLO), a leading technology provider for restaurants. "The new Great American Cookies and Marble Slab Creamery online ordering platform has set the bar high for a new industry standard with the help of our partners, 3 Owl and Olo," said Mason Wiederhorn, Chief Brand Officer of FAT Brands.

09:05 EDT Trex Company announces the launch of NexTrex Plastic Recycling - Trex Company announces the launch of the NexTrex Plastic Recycling Drop-Off Directory, the country's only online searchable platform dedicated to connecting eco-minded Americans with Trex recycling partners in their local communities. With locations in all 50 states, the nationwide directory fills a gap in the marketplace, offering a comprehensive resource that empowers individuals to contribute to a greener planet by diverting plastic bag and film waste from landfills and waterways.

09:04 EDT NexGel announces strategic partnership with James Maslow - NEXGEL announced a strategic partnership with James Maslow to promote Silly George's innovative eyelash collection. Adam Levy, CEO of NEXGEL, commented, "We are thrilled to partner with James Maslow. His charisma and influential presence are well aligned with our brand's vision of empowering individuals through beauty. The content also leverages the family aspect, as James is my nephew, and this has really resonated with his fans. This partnership is exciting, and we are eager to showcase our latest collection while bringing a new level of innovation and elegance to the world of eyelashes."

09:04 EDT Scilex announces the continuing support from Endeavor Distribution - Scilex announced the continuing support from Endeavor Distribution on Scilex's commercial products and the satisfaction of the FSF 33433 LLC $10 million loan under the Commitment Side Letter dated June 11, 2024. "I am very excited that this agreement with one of the premier healthcare and distribution services providers in the U.S. will expand access to ZTlido, ELYXYB, and GLOPERBA for thousands of patients suffering from acute and chronic pain. This partnership strengthens the progress we've achieved with key customers and point of care facilities over the past few months," says Scilex's Chief Executive Officer, Jaisim Shah, "Scilex remains committed to our goal of ensuring broad access to ZTlido and our other important non-opioid products."

09:02 EDT GRI Bio participates in virtual investor KOL Connect segment - GRI Bio announced its participation in a recent Virtual Investor KOL Connect segment. As part of the segment, Albert Agro, PhD, Chief Medical Officer of GRI Bio and Dr. Helen Parfrey, Respiratory Consultant at Royal Papworth Hospital and Affiliated Assistant Professor at the University of Cambridge, discuss IPF, the current patient journey, and how the Company is working to advance their lead program, GRI-0621, as a potential therapeutic solution that halts disease progression of fibrotic diseases such as IPF. IPF is a rare chronic progressive pulmonary disease with abnormal scarring of the lung blocking the movement of oxygen into the bloodstream. Currently available treatments for IPF are limited with only two approved drugs that come with significant side-effects, limited compliance and no impact on overall survival1 leaving significant opportunity to augment IPF treatment with a new therapeutic. GRI Bio's lead program, GRI-0621, is a small molecule RAR-beta dual agonist that inhibits the activity of human iNKT cells. In preliminary trials to date and previous trials with the oral formulation, GRI-0621 has been shown to improve fibrosis in multiple disease models and improve liver function tests and other markers of inflammation and injury in patients. GRI-0621 is currently being evaluated in a Phase 2a biomarker study and expects to report interim data in Q4 2024 and topline data in Q1 2025.

08:57 EDT G1 Therapeutics, Pharmacosmos announce closing of tender offer - Pharmacosmos and G1 Therapeutics announced that Pharmacosmos has completed the previously announced tender offer to acquire all outstanding shares of G1 Therapeutics for $7.15 per share net to the holder in cash, without interest and less any applicable withholding taxes, for a total equity value of approximately $405 million.

08:53 EDT Quest Diagnostics and Sentara Health Plans announce collaboration - Quest Diagnostics and Sentara Health Plans, the health plan division of Sentara Health, an integrated, not-for-profit health care delivery system, announced a multi-year strategic collaboration designed to expand access to high-quality, affordable and comprehensive laboratory testing for members of Sentara Health Plans. eginning January 1, 2025, Quest will be the exclusive independent national laboratory provider of clinical laboratory and anatomic pathology services for members of Sentara Health Plans, including commercial and its government programs. The agreement will apply to Sentara Health Plans members in Florida and Virginia, including those in Sentara's Florida-serving AvMed business. Sentara Health Plans and Quest will also collaborate on expanding Quest's patient service center network to support patient access in some geographies. In addition, the parties will consider avenues for educating Sentara Health Plans members and providers on the value of redirecting testing to Quest from higher-cost, out-of-network providers.

08:42 EDT Veea and Crowdkeep team for solution to track assets, people, and conditions - Crowdkeep, the leading Internet of Things or IoT, platform in asset, people, and condition tracking; and Veea have announced their partnership to integrate their respective technologies into a singular, tailored solution to track assets, people, and conditions across a variety of use cases complementing a plethora of edge applications, developed by Veea and its ecosystem partners, that together run on Veea Edge Platform. The combined capabilities of Crowdkeep and Veea is offered through an AI-enabled multiaccess edge computing platform with 4G or 5G connectivity, an IoT gateway and a comprehensive cloud backend for device and application management, and the associated data analytics, enabling organizations to maintain visibility on employees, students or guests at a venue, manage and track valuable assets along with visual displays of camera streams, event notifications, utilization rates and footfall analytics with heatmaps...The combined platform, with distributed computing nodes over a multiaccess mesh connectivity network, is capable of collecting enormous amounts of data from connected devices where a machine learning application can be employed to make data-driven predictions or decisions with fusion of logic derived from data collected from different sensors and cameras. The Edge AI is delivered through a computer vision application with the ability to interpret and analyze camera streams and time-lapse images to then turn them into actionable insights, detecting both anomalies and progress as well as workers' location on the job site and behavior. More complex features such as neural reasoning with digital twins can extract complex events and trigger alerts from captured data, for example, to reconstruct complex building structures and detect deviations. The combined offerings span across a range of other industries and verticals.

08:38 EDT M2i Global appoints Michael Sander to board of directors - M2i Global announced the appointment of Mr. Michael Sander as an independent director. The company said, "Bringing 30+ years of invaluable experience to the intersecting fields of technology, finance, and real estate. As a seasoned strategist and investment professional, Sander has consistently demonstrated his ability to identify and capitalize on high-potential opportunities."

08:36 EDT PodcastOne renews agreement with LadyGang podcast - PodcastOne (PODC), a subsidiary of LiveOne (LVO), announced that it has renewed their agreement for fan favorite podcast LadyGang from hosts Keltie Knight, Becca Tobin and Jac Vanek. LadyGang, which launched on PodcastOne in 2015, will remain with the network for the foreseeable future, thus extending the near decade long relationship between the two entities.

08:34 EDT Progress Software announces speaker lineup for MarkLogic World Tour US - Progress announced the speaker lineup for the MarkLogic World Tour US, taking place September 23-25, 2024, at the Bethesda Marriott in Maryland. Industry leaders, innovators and professionals on the front line of the data world will gather to discuss the future of data and address real-world challenges in areas such as generative AI, data visualization and knowledge management. Registration is open. With nearly 20 sessions, workshops and roundtables spanning three days, attendees will explore topics ranging from discovering the business value of GenAI, to building data visualization apps and implementing semantic knowledge modeling. Participants will learn how to tackle various data challenges related to complex data integration and security while harnessing the power of AI. They will hear directly from Progress customers and partners about how they have created value from data to drive diverse business initiatives and will have the opportunity to collaborate with forward-thinking peers across industries.

08:33 EDT Vaccinex announces exercise of warrants for $6.2M in gross proceeds - Vaccinex announced the entry into definitive agreements for the immediate exercise of outstanding warrants to purchase an aggregate of 1,067,492 shares of common stock at the reduced exercise price of $5.636 per share, resulting in the issuance of 827,483 shares and the pre-funding of 240,009 shares. In consideration for the immediate exercise of the warrants for cash and the payment of an additional $0.125 per new warrant, the exercising holders will also receive new warrants to purchase shares of common stock in a private placement pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended. The new warrants will be exercisable into an aggregate of up to 1,601,238 shares of common stock, at an exercise price of $5.636 per share and will expire five years after issuance. The gross proceeds to the Company from the exercise of the Existing Warrants together with the sale of the new warrants is expected to be approximately $6.2 million. The closing of the transaction is expected to occur on or about September 18, 2024, subject to satisfaction of customary closing conditions. Participants in the transaction include entities affiliated with by Maurice Zauderer, President and CEO of the Company, and Albert D. Friedberg, Chairman of the Company's board of directors. These entities accounted for approximately 51% of the securities in the transaction. Roth Capital Partners is acting as the Company's financial advisor for this transaction.

08:32 EDT Rogers Communications to become majority owner of MLSE for C$4.7B - Rogers Communications announced it has signed an agreement to buy Bell's 37.5% ownership stake in Maple Leaf Sports & Entertainment, MLSE, for C$4.7 billion. "MLSE is one of the most prestigious sports and entertainment organizations in the world and we're proud to expand our ownership of these coveted sports teams," said Tony Staffieri, President and CEO, Rogers. "As Canada's leading communications and entertainment company, live sports and entertainment are a critical part of our core business strategy."

08:29 EDT Orion Energy secures over $2M in LED lighting retrofit projects - Orion Energy Systems has been awarded projects totaling more than $2M from a longstanding automotive OEM customer. These projects encompass the project management, installation, and commissioning of LED lighting systems across multiple manufacturing facilities in the United States.

08:28 EDT HNR Acquisition changes name to EON Resources - EONR announced that the Company has changed its corporate name from HNR Acquisition Corp to EON Resources Inc. EON remains as an independent energy company focused on Energy, Oil, Natural Resources, and other aspects of the Energy Industry. Our current focus is as an upstream energy company with producing oil and gas properties in the Permian Basin. Our plans are to grow through acquisition and through the development and enhancement of onshore oil and natural gas properties in the United States. Effective as of the market open today, September 18, 2024, the Company will be listed under the NYSE American Exchange ticker symbol EONR for its Class A Common Stock and EONR WS for its publicly traded warrants. The CUSIP numbers for each will be unchanged as a result of the name and ticker symbol changes. No action is required by existing stockholders with respect to the name and ticker symbol changes.

08:26 EDT NioCorp to discuss plans to potentiall produce commercial grade RE oxides - NioCorp Developments will discuss at the 20 th Annual Rare Earth Conference in Washington, D.C. on October 15, 2024 its plans to potentially produce commercial grade magnetic rare earth oxides at its proposed Elk Creek, Nebraska Critical Minerals Project including the heavy rare earth oxides of dysprosium and terbium, and potentially recycle post-consumer RE permanent magnets. NioCorp also intends to explore the possibility of processing magnetic RE concentrates from multiple sources outside of China in order to increase its magnetic RE oxide production - including heavy REs such as dysprosium and terbium, beyond the Company's current plans. NioCorp CEO and Executive Chairman Mark A. Smith will present at the Conference at 9:30 a.m. Eastern Time on October 15, 2024. NioCorp's Elk Creek Project is designed to use a whole ore leach process to produce its targeted products, which include niobium, scandium, titanium and, potentially, magnetic RE oxides. Such a process could enable recycling of post-consumer neodymium-iron-boron permanent RE magnets back into separated RE oxides that can be used to make new NdFeB magnets. NioCorp's planned hydrometallurgical process could also open up the possibility of accepting mixed RE concentrate from other mines and extracting larger amounts of magnetic REs than the Company is currently contemplating. The Elk Creek Project Mineral Resource contains the largest indicated terbium resource in the U.S., as well as the 2nd largest indicated neodymium-praseodymium and dysprosium resources in the U.S.

08:24 EDT Avinger issued U.S. patent, receives notice of allowance for five more patents - Avinger announced the issuance of a new U.S. patent and the allowance of five additional U.S. patents that are expected to issue over the next four months. These patents expand intellectual property protection for Avinger's proprietary image-guided system and devices for both peripheral and coronary applications. The U.S. Patent and Trademark Office issued U.S. Patent No. 12,089,838 titled "Atherectomy Catheter with Laterally-Displaceable Tip" on September 17, 2024. Avinger has also received notices of allowance from the USPTO for five additional U.S. patents providing coverage for Avinger's proprietary optical coherence tomography system and image-guided devices, including: U.S. Application no. 18/499,555, Optical Coherence Tomography for Biological Imaging; U.S. Application no. 17/645,722, Atherectomy Catheter Drive Assemblies; U.S. Application no. 17/209,168, Occlusion Crossing Devices; U.S. Application no. 17/455,655, Atherectomy Catheter with Shaped Distal Tip; U.S. Application no. 17/046,066, Occlusion Crossing Devices.

08:23 EDT CommScope and AFL in pact for for Prodigy connectivity solutions, no terms - CommScope announced that it has licensed fiber optic solution leader AFL to manufacture CommScope Prodigy(R) universal fiber-to-the-home FTTH hardened connectivity solutions. Together, AFL and CommScope are addressing the growing needs of global FTTH installations, including business-as-usual and government-subsidized projects. The Prodigy line of connectivity solutions leverages revolutionary convertor technology that allows it to provide seamless, backwards compatibility with historical hardened connectivity solutions as well as enhanced density when deployed as a complete system. "We're proud to partner with CommScope to bring its proven Prodigy solutions to our own customers and more broadly to FTTH deployments around the world," stated Marc Bolick, President of Product Solutions at AFL. "As a leader in fiber optic solutions, we recognize the clear advantage in interoperability and ease-of-use that Prodigy offers, and we're looking forward to providing these licensed solutions to our customers in support of tomorrow's fiber networks."

08:22 EDT Stellantis deploys AI-enabled innovations to boost efficiency, sustainability - SStellantis' annual Factory Booster Day is a key part of driving manufacturing improvements to meet the demands of today's industry and leverage new technologies for the shop floor. Stellantis Deploys AI-enabled Innovations to Boost Manufacturing Efficiency, Sustainability and Improve Workplace. "We have proof that collaboration with our manufacturing partners works. Implementing innovations and continuous improvement have reduced our transformation costs 11%, energy consumption 23% and quality issues 40% since 2021," said Arnaud Deboeuf, Stellantis Chief Manufacturing Officer. "Stellantis workers are proud to build vehicles that deliver the emotional and world-class qualities of our iconic brands. Leveraging the latest technologies, especially AI, is a significant lever to achieve the level of excellence we are aiming for."

08:20 EDT IGC Pharma announces additional IGC-AD1 data - IGC Pharma announced data that reinforces the therapeutic potential of IGC-AD1 as a disease-modifying treatment for Alzheimer's disease. The data highlights IGC-AD1's effects on tau tangles and spatial memory. These results build on earlier data demonstrating IGC-AD1's potential to reduce amyloid plaque. IGC Pharma's findings from preclinical Alzheimer's cell line studies have revealed IGC-AD1's significant impact on tau pathology. The data shows that IGC-AD1 effectively reduced hyperphosphorylation of tau protein, a process strongly associated with the formation of neurofibrillary tangles, which are linked to cognitive decline. Notably, the combined active pharmaceutical ingredients in IGC-AD1 decreased the ratio of phosphorylated tau to total tau by approximately 10%, while the individual API tetrahydrocannabinol increased this ratio by 50%-75%. In addition, the combined APIs in IGC-AD1 reduced GSK3 enzyme expression by around 35%, an essential step in mitigating tangles. In addition, data also shows significant improvements in spatial memory from studies using an Alzheimer's mouse model. The Morris Water Maze tests revealed that mice treated with IGC-AD1 exhibited a 50% faster reduction in escape latency times compared to untreated Alzheimer's model mice. This data provides compelling preclinical evidence for the combination of APIs used in IGC-AD1 and its potential to improve cognitive function and enhance memory performance. Tau tangles are twisted fibers inside neurons, the brain cells responsible for thinking and memory. In Alzheimer's disease, these tangles cause neurons to die, leading to memory loss and cognitive decline. Along with amyloid plaques, tau tangles are one of the key markers of Alzheimer's, contributing to the progression of the disease. The company aims to position the drug for two large indications:agitation in Alzheimer's and as a disease-modifying anti-amyloid / anti-tangles Alzheimer's treatment. IGC-AD1 is currently in a Phase 2 clinical trial that is a multicenter, double-blind, randomized, placebo-controlled study designed to assess the safety and efficacy of IGC-AD1 in treating agitation in dementia due to Alzheimer's. Over 1,000 oral doses have been administered to date, with no dose-limiting adverse events observed, highlighting the safety profile of IGC-AD1. As the company progresses IGC-AD1 into additional clinical trials, the potential to decrease symptoms such as agitation while also modifying Alzheimer's disease progression could significantly enhance its value proposition in the market.

08:19 EDT Myriad Genetics to share new data on genetic testing advancements - Myriad Genetics announced it will showcase 10 studies highlighting its advancements in oncology and reproductive genetic testing at the National Society of Genetic Counselors, NSGC, 43rd Annual Conference, which will take place from Sept. 17-21, 2024, in New Orleans, LA. The research will highlight the value of genetic and genomic testing in patient care and will cover the company's MyRisk Hereditary Cancer Test, FirstGene Multiple Prenatal Screen, Prequel Prenatal Screen and Foresight Carrier Screen. "At Myriad, we're committed to partnering with genetic counselors in an effort to make genetic testing more accessible, affordable and easier to use for all patient populations," said Susan Manley, Senior Vice President of Medical Services, Myriad Genetics. "We're excited to share our new research with the genetic counselor community at this year's NSGC Conference and to showcase how our latest advancements may help better inform personalized care and improve outcomes for patients."

08:18 EDT Elutia announces new peer reviewed publication on EluPro - Elutia announced the publication of preclinical data demonstrating that EluPro, the world's first antibiotic-eluting biologic envelope cleared by the U.S. Food and Drug Administration, FDA, clears bacterial contamination associated with cardiovascular implantable electronic devices, CIEDs. Data published in Frontiers in Drug Delivery show that in an animal model, EluPro demonstrated the ability to reduce bacterial colonization with minimal systemic antibiotic exposure. "We believe these results greatly reinforce EluPro's potential to provide enhanced infection control for CIED procedures," said Michelle LeRoux Williams, Ph.D., Elutia's Chief Scientific Officer. "As the first FDA-cleared biologic antibiotic-eluting envelope, EluPro represents a significant step forward in implantable device protection. With our recent milestone of the first human implant, we are preparing for the commercial launch of EluPro in January 2025."

08:16 EDT Guardant Health publishes SCRUM-Japan GOZILA study results - Guardant Health announced the peer-reviewed journal Nature Medicine published results from the SCRUM-Japan GOZILA study confirming that selecting targeted therapy on the basis of Guardant360 CDx liquid biopsy results may significantly extend survival for patients with advanced cancer. The study, led by a research group out of National Cancer Center Hospital East in Kashiwa, Japan, investigated the effects of personalized treatment based on results of the Guardant360 CDx test in 4,037 patients with advanced cancer. The results showed that 24% of participants were able to receive targeted treatment tailored to them based on comprehensive genomic profiling results from the test, which analyzes 74 cancer-related genes. The patients who received targeted treatment guided by liquid biopsy results lived approximately twice as long as those who did not. Selecting therapies for patients based on the liquid biopsy results enabled study investigators to identify targeted treatment options they could not discern using traditional methods. The researchers then followed the progress of treated patients and analyzed their treatment response and survival time. Patients who received targeted therapy had a median survival of 18.6 months compared to 9.9 months for those who did not.

08:14 EDT Opal Fuels in pact for $11.1M sale of IRA tax credits to a subsidiary of Apollo - OPAL Fuels announced the sale of approximately $11.1M of Inflation Reduction Act IRA investment tax credits to a subsidiary of Apollo Global Management, Inc., a leading provider of alternative asset management and retirement solutions. This sale represents OPAL Fuels' stake in the investment tax credits generated by the Emerald RNG facility, a joint venture that is 50% owned by OPAL Fuels. The Inflation Reduction Act, signed into law in August 2022, provides for the issuance of transferable federal income tax credits for certain renewable fuel projects and products. The sale is OPAL Fuels' first IRA tax credit transaction. "The sale of IRA tax credits provides OPAL Fuels another source of liquidity to continue funding our strategic growth initiatives," said Jonathan Maurer, Co-Chief Executive Officer of OPAL Fuels. "We view the IRA as favorable for the renewable energy industry and an important driver of investment across our project pipeline over the next several years."

08:13 EDT McGrath RentCorp to receive $180M following termination of WillScot merger - McGrath RentCorp (MGRC) confirmed that WillScot (WSC) and the company mutually agreed to terminate their previously announced merger agreement. In accordance with the terms of the merger agreement, McGrath is receiving a termination fee of $180M. Joseph Hanna, president and CEO of McGrath, said: "Modular and portable storage solutions is a dynamic industry and, as we move forward, we will continue to grow and succeed through our unrelenting commitment to putting the customer first. The proposed transaction was a recognition of the enormous value created by our talented employees. Now, our team is energized and ready to execute our standalone strategy, and I am proud of the focus and tenacity the McGrath team demonstrated throughout this process. I look forward to actively engaging with our customers, partners and the financial community as we showcase the strategy that will lead McGrath's future success. Moreover, we have always been focused on generating shareholder value as demonstrated by 33 consecutive years of dividend return increases and remain dedicated to this important objective going forward."

08:11 EDT Immutep announces new data from EFTISARC-NEO - Immutep announces new data from EFTISARC-NEO, a Phase II investigator-initiated trial of eftilagimod alpha in combination with radiotherapy plus KEYTRUDA for patients with soft tissue sarcoma, STS, will be presented at the Connective Tissue Oncology Society, CTOS, 2024 Annual Meeting taking place 13-16 November 2024, in San Diego, California. EFTISARC-NEO is the first to evaluate efti in a neoadjuvant setting, which importantly provides access to tumour tissue before and after treatment to assess efti's impact on the tumour microenvironment. Initial efficacy data from this novel triple combination reported in May 2024 showed very encouraging results in the first six patients with the majority having deep responses rarely seen in STS patients with standard therapeutic approaches.

08:11 EDT Vista Outdoor board recommends CSG transaction, rejects MNC Capital proposal - Vista Outdoor announced that its board of directors unanimously recommends stockholders vote for the transaction with Czechoslovak Group, or CSG, to acquire The Kinetic Group and invest in Revelyst, and unanimously rejects the last proposal from MNC Capital. Over the past six weeks as part of its subsequent review of strategic alternatives, Vista Outdoor engaged in discussions with multiple interested parties, including extensively negotiating with both MNC and CSG. Ultimately, CSG agreed to acquire The Kinetic Group for $2.15B, which is approximately $250M higher than the implied valuation of MNC's last proposal and agreed to purchase shares representing 7.5% of standalone Revelyst for $150M, valuing Revelyst at $2B. At the closing of the CSG transaction, Vista Outdoor stockholders will receive $28 in cash per share and one share of Revelyst common stock for each share of Vista Outdoor common stock. On September 15, the Private Equity Firm partnered with MNC reached out to Vista Outdoor. The company has subsequently been in active dialogue with the Private Equity Firm regarding a potential acquisition of Revelyst, separate from MNC. While no agreement has been reached, the board will continue its discussions with the Private Equity Firm. An agreement could be reached in conjunction with or independent of the CSG transaction. The board said it is confident that the CSG transaction enables stockholders to retain the ability to realize a potential change of control premium for Revelyst, is the optimal path to deliver the highest value to Vista Outdoor stockholders. The CSG transaction, which can be terminated after October 15, delivers cash consideration to stockholders. At the closing of the CSG transaction, Vista Outdoor stockholders will receive $28 in cash per share and one share of Revelyst common stock for each share of Vista Outdoor common stock, providing stockholders the opportunity to participate in the upside potential of Revelyst. Following the closing of the CSG transaction, Revelyst also plans to establish an initial $50M share repurchase program. Vista Outdoor and CSG have received all regulatory approvals required under the merger agreement and are prepared to close the CSG transaction in October, subject to receipt of stockholder approval and satisfaction of other customary closing conditions. After this engagement with MNC, Vista Outdoor received a revised proposal from MNC to acquire the Company for $43 in cash per share. Following consultation with its financial and legal advisors, the board has unanimously rejected this last MNC proposal and determined that it would not be more favorable to Vista Outdoor stockholders from a financial point of view than the CSG transaction. Revelyst expects to double adjusted EBITDA sequentially for the quarter and for the full year, with a path to $100M in run-rate cost savings by fiscal year 2027 and mid-teens EBITDA margin long-term. Revelyst is also gaining market share in its key categories through new product and partnership launches. Vista Outdoor urges stockholders to vote for the CSG transaction at the fast-approaching special meeting of stockholders on September 27 to lock in the value of the CSG transaction.

08:10 EDT GM opening up access to more than 17,800 Tesla Superchargers for GM customers - General Motors (GM) will open up access to more than 17,800 Tesla (TSLA) Superchargers for its customers, with the use of a GM approved NACS DC adapter, in a move that the company says "will help accelerate fast and convenient charging options for current and future EV drivers." Beginning today, with the addition of the Tesla Supercharger Network, GM customers will have access to more than 231,800 public Level 2 and DC fast chargers in North America, "a number which will grow as GM continues to help accelerate the deployment of infrastructure in communities and heavily-traveled corridors through its various charging collaborations," the company announced. GM approved NACS DC adapters will first be made available to customers in the United States, followed by availability for Canadian customers later this year, GM added. Reference Link

08:08 EDT PJT Partners enters into agreement to acquire deNovo Partners, no terms - PJT Partners announced that it has entered into an agreement to acquire deNovo Partners, a leading advisory firm focused on the Middle East and headquartered in Dubai. This acquisition builds upon the highly successful strategic alliance PJT Partners and deNovo entered into in 2020. ..."We are excited to join PJT Partners, a firm that shares our commitment to delivering the highest quality advice. We look forward to joining forces with this leading advisory firm," said May Nasrallah, Founder and Executive Chairwoman of deNovo. "I have worked closely with the PJT leadership team for decades and have a deep admiration for the world-class platform they have established in such a short period of time. Together, we will build upon this strong foundation by enhancing our capabilities and better serving clients globally."

08:06 EDT Kyverna announces presentation on KYV-101 at ECTRIMS - Kyverna Therapeutics announced the presentation of three posters outlining the design and methods of Kyverna's clinical trials evaluating KYV-101 in neuroinflammatory diseases at the 40th Congress of the European Committee for Treatment and Research in Multiple Sclerosis, or ECTRIMS, in Copenhagen, Denmark, taking place September 18-20. Kyverna also shared case reports from its ongoing clinical trials in stiff-person syndrome, myasthenia gravis and multiple sclerosis in a company-sponsored symposium. These case reports reinforce emerging clinical data from KYV-101, with individual patient vignettes continuing to demonstrate disease modification across trials and durability in some patients extending beyond one year and a well-tolerated safety profile. Across numerous company- and investigator-sponsored studies, KYV-101 is currently being evaluated in a range of B cell-driven autoimmune diseases. Kyverna is currently conducting three ongoing company-sponsored Phase 2 trials in neuroinflammatory diseases: KYSA-6 in myasthenia gravis, KYSA-7 in multiple sclerosis and KYSA-8 in stiff-person syndrome. At a company symposium titled, "KYV-101 Unlocking the Potential of CAR T-cell Therapy in Neuroinflammatory Diseases," to be held at 5:15 pm CET on September 18, 2024, Kyverna and investigators will highlight case report experience from 11 patients from several studies.

08:06 EDT BiomX to present data from Phase 1b/2a study of BX004 - BiomX announces the Company will present further data from BiomX's Phase 1b/2a study of BX004 for the treatment of cystic fibrosis patients with chronic Pseudomonas aeruginosa pulmonary infections. The findings will be presented in two sessions at the North American Cystic Fibrosis Conference in Boston. First, a poster titled "Safety and efficacy of nebulized phage in CF patients with chronic Pseudomonas aeruginosa pulmonary infection: A phase 1b/2a randomized, double-blind placebo-controlled, multicenter study" will be displayed with lead author present on Friday, September 27, 2024, 1:15-2:15 PM ET. On Saturday, September 28, 2024, Urania Rappo, MD will discuss the findings in Workshop 38 "Epidemiology & Management of Infection in CF.".

08:04 EDT Brera Holdings secures key wins for Brera Ilch, Brera Strumica - Brera Holdings celebrates recent significant victories for portfolio clubs Brera Ilch FC in Mongolia, and Brera Strumica FC in North Macedonia, marking a successful period under their new head coaches. Brera Ilch secured a crucial 1-0 win against SP Falcons on September 15th, while Brera Strumica achieved a dramatic 3-2 victory over KF Besa 1976 on the same date. In Mongolia, Brera Ilch FC, led by new Head Coach Toshiaki Imai, edged out SP Falcons with a narrow 1-0 win. The team's disciplined performance and tactical adjustments ensured the important three points. SP Falcons were favored to win the match, as they are the current champions of the Mongolian Premier League and will participate in the AFC Challenge League. In North Macedonia, Brera Strumica delivered an outstanding performance under the guidance of NEW Head Coach Gorazd Mihajlov. The team celebrated a thrilling 3-2 victory over Besa, gaining three vital points and boosting their confidence. The game was particularly notable for its second-half surge, during which Brera Strumica scored three goals in just 11 minutes.

08:03 EDT Certara, ICI shares results from its collaboration on ISB 2001 - Certara shared the results from its collaboration with Ichnos Glenmark Innovation, IGI, on the first-in-human dose prediction and selection for ISB 2001. IGI's drug candidate is a trispecific T-cell engager, TCE, being studied as a potential cancer treatment. Preclinical research and biosimulation findings were recently published in Nature Cancer. This publication highlighted ISB 2001's therapeutic potential for relapsed/refractory multiple myeloma patients. As a result of this collaboration, the clinical starting dose increased by approximately 50-100 fold over the conventional starting dose. Using this higher dose reduces the likelihood of exposing cancer patients to ineffective doses. Accepted by the U.S. FDA and Australian HREC, this approach paves the way for determining FIH dosing for ISB 2001 and other TCEs.

08:03 EDT Wiley CFO Christina Van Tassell to depart, Christopher Caridi named interim CFO - Wiley announced that Christopher Caridi, corporate controller and chief accounting officer, will assume the role of interim CFO, in addition to his current responsibilities, effective September 18. Caridi succeeds CFO Christina Van Tassell, who will be leaving the company on October 1. Caridi has over 35 years of corporate finance experience with 30 years in the industry. He has served as Wiley's corporate controller and chief accounting officer since 2017.

08:02 EDT Lotus Technology announces debut of Theory 1 concept car - Lotus Technology announced the debut of Theory 1, which it called "a revolutionary concept car that represents the pinnacle of innovation and sustainability in the automotive industry." The company said, "This groundbreaking vehicle redefines the future of driving with its cutting-edge technologies, striking design, and unparalleled environmental consciousness. Theory 1 introduces a pioneering driver system featuring soft robotics fabric, enhancing both comfort and control. This advanced material adapts seamlessly to the driver's movements, offering a dynamic and personalized driving experience. The soft robotics fabric not only improves ergonomics but also integrates with the car's interface to provide intuitive feedback and adjust to varying driving conditions."

07:51 EDT Safe Pro receives notice of allowance from USPTO for AI-processed drone imagery - Safe Pro Group has received a Notice of Allowance from the United States Patent and Trademark Office, for its technology that identifies, locates and maps explosives through its Artificial intelligence-powered SpotlightAI drone image analysis and reporting software platform. The Notice of Allowance confirms the patentability of all 21 claims in the Company's patent application entitled "Systems and Methods for Detecting and Identifying Explosives." These claims cover the autonomous detection, identification, and labeling of explosives in orthomosaic images utilizing AI processing of images from an unmanned aerial vehicle. A USPTO Notice of Allowance is the final step before the Company is awarded the formal patent, anticipated to expire in 2043. The patent would grant broad intellectual property protections for its SpotlightAI AI-powered drone image analysis and reporting software platform which is designed to address the massive global challenges created by landmines and unexploded ordinance. The Company also previously filed for global patent protection with the World Intellectual Property Organization under the Patent Cooperation Treaty which covers patent protection rights for 157 Contracting States including members of the EU, Asia, Latin and South America, Africa and the Middle East. Initial indications by the International Examiner may be found in the publicly available Written Opinion, indicating equivalent patent protection entitlement for the same 21 claims made by the Company, noting these claims meet "the PCT criteria for patentability" and possess novelty, inventive step and industrial applicability.

07:40 EDT Venus Concept announces Australian Regulatory Approval for Venus Bliss MAX - Venus Concept announced that it has clearance from the Therapeutic Goods Administration, TGA, in Australia to market the Venus Bliss MAX system. The Venus Bliss MAX is the Company's flagship platform that offers a comprehensive, world-class solution for all customers' body treatment needs and is currently available in select markets globally. "We are excited to introduce to the Australian market the Venus Bliss MAX, our device that offers aesthetic clinicians an all-in-one body solution to customers," said Dr. Hemanth Varghese, President and Chief Operating Officer of Venus Concept. "The Venus Bliss Max continues to receive strong positive feedback globally from service providers of its complete body offering, and we are confident the same success will be replicated in Australia."

07:39 EDT Harvard Bioscience to showcase solutions for preclinical, organoid applications - Harvard Bioscience will be showcasing its latest product innovations at the Safety Pharmacology Society Annual Meeting being held from September 22-25, 2024, in San Diego. The Company's Ponemah platform, known for its compliance with GLP standards, is a leading tool for managing and analyzing data from a wide range of preclinical studies. It now integrates with DSI's SoHo implantable telemetry and high-capacity VivaMARS behavior monitoring systems. Ponemah is the top solution for collecting and processing large in-vivo data sets and is well positioned to connect in-vivo studies with new in-vitro methods, like our Mesh MEA organoid platform. Ponemah also enables future use of machine learning algorithms to efficiently analyze large data pools. Introduced earlier this year, the Company's SoHo telemetry system is now in use by leading preclinical researchers to support their testing needs. The small footprint of the SoHo telemetry solution allows researchers to carry out studies using a wide range of animal models in high density and more natural shared housing environments. The SoHo system's new power management features create opportunities for longer duration longitudinal studies, and the Ponemah platform integration provides a powerful tool for collecting, managing, analyzing and reporting study data. SoHo supports the customer's business needs by reducing space needs, operating costs and test cycle times, and enabling increased testing throughput. The VivaMARS system provides a powerful and efficient platform for real-time, high-throughput behavioral testing in neuropharmacology safety and toxicology studies. Coupled with the Ponemah platform, the VivaMARS system provides an integrated, GLP-compliant solution ideally suited to meet the testing needs of CROs and pharma companies, in addition to longitudinal behavior studies carried out by leading research and academic institutes. VivaMARS's high level of automation supports the customer's business needs by reducing operating expenses and test cycle time. At SPS, the Company will be presenting a poster authored in cooperation with a leading CRO customer providing initial results with the VivaMARS system. The VivaMARS system represents a fundamental advance in highly automated behavioral testing and is currently available for shipment. The Company will also be highlighting its considerable progress toward adoption of its organoid-centric mesh Microelectrode Array platform. Designed for the emerging applications of organoids in research and discovery, safety pharmacology and toxicology, the new Mesh MEA platform allows researchers to capture precise electrophysiology measurements from inside the living organoid in real time. In addition, the Mesh MEA platform is expected to provide an efficient in-vitro screening option designed to reduce large population small model testing. The Mesh MEA platform is currently being evaluated at select test sites for neurological and cardiac research in addition to safety pharmacology and toxicology applications. The Company has also begun limited quantity shipments to early adopters, with full production expected in the first half of 2025.

07:36 EDT Opthea completes drug substance PPQ campaign for sozinibercept - Opthea announced the completion of its drug substance Process Performance Qualification campaign for sozinibercept. The PPQ campaign consisted of the production of three successful consecutive commercial-scale drug substance batches required for the validation of Opthea's manufacturing process. The batches have been produced following an extensive manufacturing process development program. "The successful completion of the drug substance PPQ campaign is an important step towards de-risking the program and a potential biologics license application filing of sozinibercept in wet AMD," commented Fred Guerard, PharmD, CEO. "While we continue to advance our two fully enrolled, pivotal Phase 3 trials of sozinibercept in wet AMD, we now have demonstrated our ability to consistently manufacture quality drug substance at commercial scale, which will serve as a key component of our BLA Chemistry, Manufacturing and Controls module."

07:35 EDT Organon to acquire Dermavant from Roivant Sciences for $1.2B - Organon (OGN) and Dermavant Sciences announced that they have entered into a definitive agreement, under which Organon will acquire Dermavant, a Roivant (ROIV) company dedicated to developing and commercializing innovative therapeutics in immuno-dermatology. Dermavant's novel product, Vtama cream, 1%, for the topical treatment of mild, moderate, and severe plaque psoriasis in adults, was approved by the FDA in May 2022. Vtama cream is a once-daily, steroid-free, topical applied to affected areas with no safety label warnings or precautions and without restrictions on location and duration of use or body surface area. The FDA is reviewing a supplemental new drug application, or sNDA, for Vtama cream as a potential treatment for atopic dermatitis, or AD, in adults and children two years of age and older, with PDUFA action expected in the fourth quarter of calendar year 2024. Organon has agreed to acquire Dermavant for aggregate consideration of up to approximately $1.2B, with an upfront payment of $175M and a $75M milestone payment upon regulatory approval in AD, as well as payments of up to $950M for the achievements of certain commercial milestones. In addition, Organon will pay Dermavant shareholders tiered royalties on net sales. Dermavant owns the rights to Vtama cream globally excluding China and has out licensed Japan rights. Completion of the transaction is subject to review under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. Closing of the transaction is currently expected to take place in the fourth quarter of 2024. Upon closing of the transaction, as part of the purchase price consideration, Organon would assume Dermavant liabilities with an approximate value of $286M reported by Roivant as of June 30, which would be subject to fair value accounting by Organon. Given the transaction is expected to close in the fourth quarter 2024, revenue contribution from Vtama as well as expenses associated with onboarding the product are not expected to impact the full year 2024 non-GAAP guidance ranges provided on August 6. The transaction is expected to be modestly dilutive to adjusted EBITDA in 2025, turning accretive in 2026. Organon expects net leverage to be elevated above 4.0x as a result of the transaction. The transaction is not expected to result in a revision to Organon's capital allocation priorities.

07:18 EDT TG Therapeutics presents updated data from ENHANCE Phase 3b trial of BRIUMVI - TG Therapeutics presented updated data from the ENHANCE Phase 3b trial evaluating BRIUMVI in patients with relapsing forms of multiple sclerosis, at the 2024 European Committee for Treatment and Research in Multiple Sclerosis annual meeting. Michael Weiss, CEO stated, "We are excited to present an update from our ENHANCE Phase 3b study which is evaluating potential optimized dosing regimens for BRIUMVI. This study initially focused on patients switching from a prior anti-CD20 therapy in a B-cell depleted state, and we believe the data emerging from this study continues to support that these patients can successfully make that transition conveniently and safely without the initial 150 mg, 4-hour BRIUMVI infusion.Separately, we are excited to present, for the first time, data exploring even faster infusions of BRIUMVI, from 1 hour down to 30 minutes for full doses starting at week 24. Notably, these rapid infusions are being accomplished with non-drowsy pre-medications and no required post-infusion observation time as per the protocol, consistent with the BRIUMVI prescribing information. We look forward to continuing to find ways to improve patient tolerability and convenience and working with regulatory agencies to transition these efforts into label-enabling studies." DATA HIGHLIGHTS: Poster Presentation: Efficacy and Tolerability of BRIUMVI after Transitioning from a Different Disease-Modifying Therapy: Updates from the ENHANCE Study: ENHANCE is a multi-center, open-label, 48-week study in participants with relapsing forms of multiple sclerosis designed to evaluate optimized dosing regimens for BRIUMVI with two primary objectives: Evaluating the elimination of the initial 150 mg BRIUMVI infusion in patients who are B-cell depleted; Exploring shorter infusion durations for the full 450 mg BRIUMVI infusions. Data continue to support that 450 mg of BRIUMVI may be safely administered in 1 hour as an initial infusion for participants who are B-cell depleted, with 97% of infusions being completed without interruption or slowing. 12 patients received 450 mg BRIUMVI infusions in 30 minutes at week 24, with all infusions completed without interruption or slowing, and infusions related reactions were limited to Grade 1.

07:13 EDT Aclara Resources provides update on Penco Module permitting process - Aclara Resources informs that the evaluation process of the Penco Module's Environmental Impact Assessment continues and has now formally received from the Environmental Service Assessment the consolidated report with the observations and questions received from the different agencies involved in the evaluation process. The Company is diligently working to file its response addressing questions and observations received by the end of Q1, 2025. The Company is committed to working with the SEA throughout the assessment and review process.

07:11 EDT Oxford Biomedica rebrands as OXB - OXB announces the launch of its new corporate brand. Oxford Biomedica is rebranding as OXB, unveiling a more modern and recognisable visual identity that reinforces its transformation into a global pure-play cell and gene therapy CDMO. The new identity reflects OXB's unique combination of technical excellence, innovation and unwavering commitment to deliver consistent high quality at every stage of viral vector development and manufacturing. The new branding represents the agile execution and creativity that enable OXB to deliver on clients' goals, while also conveying accountability, professionalism and teamwork - core values that underpin OXB's mission. Frank Mathias, CEO, commented: "The launch of our new brand identity reinforces OXB's significant transformation into a leading pure-play cell and gene therapy CDMO. This rebranding is more than just a new look - it reflects the global nature of our operations and our deep commitment to the success of our clients' drug development programmes. As OXB, with our new capabilities and global footprint, we are ideally positioned to communicate our end-to-end services to current and potential clients, and to interact with them from early-stage development through to commercial manufacturing."

07:10 EDT Lantronix showcases IoT solutions at GSX, ISE - Lantronix will display its IoT solutions, including its switches, routers, gateways and trackers, at Global Security Exchange's GSX tradeshow and the International Security Expo. Lantronix will be at booth #1649 at GSX, which is being held Sept. 23-25, 2024, at the Orange County Convention Center in Orlando, Fla. Lantronix will be at booth #C43 at ISE, which is being held Sept. 24-25, 2024, at Olympia Events in London. "We're excited to present our newest IoT solutions at this year's GSX and ISE events. A global leader in delivering award-winning switches, routers, gateways and trackers, Lantronix is a resource for IoT solutions, providing a suite of solutions all supported by our service team," said Mathi Gurusamy, chief strategy officer for Lantronix. Ideal for security, surveillance, smart buildings, smart cities and other high-demand IoT applications, Lantronix's 8-port SM8TBT2SA and 24-port SM24TBT4SA switches provide the ability to connect PoE++ and PoE+ devices to the same switch. Delivering reliable end-to-end performance with advanced Layer 2 features and an intuitive user interface, these new switches are ideal for powering and connecting multiple smart IoT appliances, such as intelligent LED lighting, smart building sensors and access points, IP cameras and surveillance systems. Lantronix PoE switches and Percepxion cloud management software simplify installation and management for small to large-scale network deployments. Designed for assets and fleet management, Lantronix's new FOX4 and Bolero40 edge compute tracker telematic gateways provide a complete package that merges connectivity and cloud device management with award-winning hardware. Both trackers feature customization capabilities that are facilitated by the intuitive Workbench tool, enabling easy customizations from performance optimization to unique functionality integration.

07:09 EDT GSK announces topline data on co-administration of Arexvy, Shingrix - GSK announced topline data from the phase 3 trial in adults 50 years and older evaluating the immunogenicity, reactogenicity and safety of Arexvy when co-administered with Shingrix, both AS01-adjuvanted vaccines. The data were presented as a late-breaking abstract at the European Geriatric Medicine Society, or EuGMS, Congress in Valencia, Spain. Shingrix is approved for the prevention of shingles in adults aged 50 years and older. Arexvy is approved for the prevention of lower respiratory tract disease caused by respiratory syncytial virus in individuals 60 years of age and older, as well as individuals 50 through 59 years of age who are at increased risk for LRTD caused by RSV. The data showed a non-inferior immune response when the vaccines were co-administered compared to when they were administered at separate visits. Co-administration was also well tolerated, with acceptable reactogenicity and safety profiles. In both groups, the most frequently reported adverse events were pain at the injection site, fatigue, and myalgia. The duration of solicited adverse events was comparable across the two groups. Results from this trial will be submitted for peer-reviewed scientific publication and will be used to support regulatory submissions to the FDA, the European Medicines Agency and other regulators.

07:06 EDT Tilray Medical launches Redecan brand in Australia - Tilray Medical announced the launch of Redecan EU-GMP certified medical cannabis products in Australia. The following Redecan products are now available for medical cannabis patients in Australia: Redecan PC THC28 Purple Churro - 15g; Redecan SA THC28 Space Age Cake - 15g.

07:05 EDT Vivos receives FDA 510k clearance to treat pediatric sleep apnea, snoring - Vivos Therapeutics announced receipt of what is believed to be the first ever U.S. Food and Drug Administration, FDA, 510(k) clearance to treat moderate to severe OSA and snoring in children using Vivos' proprietary flagship oral medical device. Kirk Huntsman, Chairman and CEO of Vivos, stated, "The FDA 510(k) clearance announced today is, to our knowledge, the first time any oral medical device has ever been approved to treat moderate to severe OSA in children. This clearance is the latest in a series of regulatory wins for Vivos, not just in the United States, but globally. It represents the culmination of a growing body of research and regulatory approvals confirming and validating the extraordinary potential and efficacy of our proprietary Vivos technology. In addition, this landmark clearance opens up an exciting and vast new market and enables us to directly address the needs of millions of children who currently suffer from sleep-related breathing disorders such as OSA."

07:05 EDT PowerFleet to acquire Fleet Complete for $200M - Powerfleet announced it has entered into a definitive agreement for the acquisition of Fleet Complete, a prominent player in connected vehicle technology and fleet management. With 2.6M total combined subscribers and forecasted combined revenue of over $400M, the acquisition is expected to solidify Powerfleet's position as a true global leader in the rapidly expanding AIoT market, driving toward "Rule of 40" SaaS financial performance in the medium term. Benefits expected from the transaction include: hteaddition of Fleet Complete strengthens Powerfleet's strategic position as a leader in the AIoT SaaS market, with a combined subscriber base of 2.6 million. The acquisition strengthens Powerfleet's North American presence and fuels top-line growth in key international markets, including Europe and Australia. The acquisition significantly enhances the scale of Unity's data ingestion, integration capabilities, and cross-sell/upsell potential with the addition of 600,000 new subscribers. The acquisition opens significant cross-selling opportunities through Fleet Complete's well-established indirect channel relationships, especially with major US and Canadian telecommunication carriers, offering considerable growth potential. Highly accretive transaction, valued at 8 times pre-synergy and 5 times post-synergy adjusted EBITDA, with improved geographical revenue mix and multiple avenues for accelerated topline growth driving toward "Rule of 40" SaaS financial performance in the medium term. Total transaction value of $200M. Incorporating Fleet Complete's annual recurring revenue and EBITDA Guidance of $105M and $25M, respectively, combined business is projected to generate revenue of $405M, including $300+ million in high-margin recurring SaaS revenue, and $85M in adjusted EBITDA for FY25. Transaction is subject to customary closing conditions and is expected to close on October 1.

07:03 EDT TG Therapeutics announces updated data on five-year data from ULTIMATE trials - TG Therapeutics announced updated data presentations including new five-year data from the ULTIMATE I & II Phase 3 trials evaluating BRIUMVI in patients with relapsing forms of multiple sclerosis, at the 2024 European Committee for Treatment and Research in Multiple Sclerosis, ECTRIMS, annual meeting. DATA HIGHLIGHTS: Poster Presentation: Five years of BRIUMVI in relapsing multiple sclerosis: Results from the open-label extension of ULTIMATE I and II studies. Patients who continued BRIUMVI treatment exhibited low and decreasing annualized relapse rate throughout the observation period. During Year 1 of the open label extension, patients who switched from teriflunomide to BRIUMVI experienced a significant reduction in ARR. After 5 years of continuous BRIUMVI treatment, 8% of patients had Confirmed Disability Progression lasting 24 weeks compared to 14.3% of patients who switched from teriflunomide to BRIUMVI, and 92% remained progression free with continuous BRIUMVI treatment. 17% of patients treated with BRIUMVI continuously for 5 years achieved Confirmed Disability Improvement lasting at least 24 weeks compared to 12.2% of patients who switched from teriflunomide to BRIUMVI, resulting in one in six patients experiencing improvement in disability after 5 years of continuous BRIUMVI treatment. The overall safety profile of BRIUMVI remained consistent over 5 years of continuous treatment in an exposure-adjusted analysis of adverse events.

07:00 EDT Becton Dickinson announces commercial release of BD Neopak XtraFlow - Becton Dickinson announced the commercial release of the BD Neopak XtraFlow Glass Prefillable Syringe and the latest capacity expansion of the BD Neopak Glass Prefillable Syringe platform to serve the growing market for biologic therapies.

06:56 EDT Aecom selected by San Diego County Regional Airport Authority - AECOM announced it has been selected by the San Diego County Regional Airport Authority to provide program management services supporting the Capital Improvement Plan and other projects at the San Diego International Airport, or SAN. Once complete, the projects will improve critical infrastructure, access, and sustainability features to meet the needs of the airport's current and future demand for travel. This includes management of the $3.8 billion New Terminal 1 (NT1) program and the modernization of Terminal 2 East, or T2E, that will transform the traveling experience at SAN. In its role, AECOM will provide a full range of program, project and construction management services, as well as diversified specialized services. NT1, the airport's biggest project ever, will include a new, on-airport entrance road to provide travelers with a faster route to the airport.

06:47 EDT Telus Digital officially launches global rebrand - Telus Digital officially launched its global rebrand, transitioning from Telus International to Telus Digital. The new name reflects the company's commitment to providing a digital-first experience across every service it delivers to clients, ensuring a seamless integration of digital, AI-powered and human interactions that optimize customer journeys and employee experiences.

06:32 EDT Purple Biotech reports new biomarker findings for CM24 - Purple Biotech reported new positive biomarker findings for its lead oncology therapeutic candidate CM24. These data were presented yesterday at the American Association for Cancer Research, or AACR, Special Conference on Advances in Pancreatic Cancer Research currently ongoing in Boston, in a poster titled, "Exploratory biomarker evaluation of the randomized Phase 2 cohort of CM24 in combination with nivolumab and chemotherapy in advanced/metastatic pancreatic cancer". Purple Biotech's Phase 2 study is evaluating CM24 in combination with Bristol Myers Squibb's PD-1 inhibitor nivolumab plus standard of care, or SoC, chemotherapy as a second line treatment of patients with PDAC and compared to SoC chemotherapy alone. Sixty-three patients have been enrolled in the randomized study across 18 centers in the U.S., Spain, and Israel. The following is a summary of findings presented in the poster: CM24 blocks CEACAM1 interactions, which have key roles in cancer progression, immune escape and metastasis. CEACAM1 is part of the NET complex, involved in tumor immune evasion, metastasis and cancer-associated thrombosis, affecting patient survival. Purple Biotech has previously presented data that demonstrates that CM24 binds to CEACAM1 on NETs, suppresses NET-induced migration of cancer cells and inhibits in-vivo tumor metastasis. In the poster, Purple Biotech presents data that demonstrates that CM24 also inhibits NET-induced platelet aggregation, an in-vitro assay imitating the thrombosis process.

06:07 EDT i-80 Gold appoints Richard Young as CEO - i-80 Gold announce that Richard Young has been appointed as CEO and a director effective immediately, succeeding Ewan Downie following his retirement as CEO. This appointment completes the previously announced succession process. Mr. Downie will also step down as a director of the company and will continue as an advisor to the company.

06:04 EDT AstraZeneca's Fasenra approved in U.S. to treat adults with EGPA - AstraZeneca's Fasenra has been approved in the U.S. for the treatment of adult patients with eosinophilic granulomatosis with polyangiitis, or EGPA, a rare, immune-mediated vasculitis that can result in damage to multiple organs, and without treatment, can be fatal. Ruud Dobber, Executive Vice President, BioPharmaceuticals Business Unit, AstraZeneca said: "Fasenra is already well established for the treatment of severe eosinophilic asthma, and with this approval, physicians in the US will now be able to offer an important new, convenient single monthly subcutaneous injection to their patients with EGPA. Today's news demonstrates the potential of Fasenra to help patients suffering from eosinophilic diseases beyond severe asthma."

05:14 EDT Tupperware Brands initiates Chapter 11 proceedings in U.S. Bankruptcy Court - Tupperware Brands announced that the company and certain of its subsidiaries have voluntarily initiated Chapter 11 proceedings in the United States Bankruptcy Court for the District of Delaware. Tupperware will seek court approval to continue operating during the proceedings and remains focused on providing its customers with its award-winning, innovative products through Tupperware sales consultants, retail partners and online. The company will also seek court approval to facilitate a sale process for the business in order to protect its iconic brand and further advance Tupperware's transformation into a digital-first, technology-led company. Following the appointment of a new management team within the last year, Tupperware has implemented a strategic plan to modernize its operations, bolster omnichannel capabilities and drive efficiencies to ignite growth.