Stockwinners Market Radar for July 27, 2024 - Earnings, Upgrades downgrades, option trades, Best Stock Advisory Service

17:22 EDT Four Corners Property Trust acquires Taco Bell property for $1.7M - Four Corners Property Trust announced the acquisition of a Taco Bell property for $1.7M. The property is located in a strong retail corridor in Illinois and is franchisee-operated under a triple net lease to K-MAC Enterprises with approximately five years of term remaining. K-MAC is one of the largest Taco Bell franchisees in the United States, with over 340 Taco Bell restaurants across 10 states. The transaction was priced at a 7.5% cap rate on rent as of the closing date and exclusive of transaction costs.

17:19 EDT RTX awarded $325M Air Force contract modification - RTX has been awarded a $325M ceiling increase modification to a previously awarded contract for the StormBreaker Small Diameter Bomb Increment II. The modification brings the total cumulative face value of the contract from $275M to $600M. Work will be performed in Tucson, Arizona, and is expected to be completed by December 31, 2026. No funds are being obligated at the time of award. The Air Force Life Cycle Management Center is the contracting activity.

16:35 EDT vTv Therapeutics trading resumes

16:11 EDT Rail Vision receives Nasdaq notification over minimum bid requirements - Rail Vision announced that on July 22, 2024, the company received a written notice from the Nasdaq Stock Market LLC indicating that the company was not in compliance with Nasdaq Listing Rule 5550(a)(2), as the company's closing bid price for its Ordinary Shares was below $1.00 per share for the last 30 consecutive business days. Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), the company has been granted a 180-calendar day compliance period, or until January 21, 2025, to regain compliance with the minimum bid price requirement. During the compliance period, the company's Ordinary Shares will continue to be listed and traded on the Nasdaq Stock Market. To regain compliance, the closing bid price of the company's Ordinary Shares must meet or exceed $1.00 per share for at least 10 consecutive business days during the 180-calendar day compliance period.

14:56 EDT Verastem pancreatic cancer treatment granted orphan designation - Verastem's avutometinib and defactinib was granted orphan designation from the FDA as a treatment of pancreatic cancer, according to a post to the agency's website. Reference Link

13:03 EDT Baker Hughes reports U.S. rig count up 3 to 589 rigs - Baker Hughes reports that the U.S. rig count is up 3 from last week to 589 with oil rigs up 5 to 482, gas rigs down 2 to 101 and miscellaneous rigs unchanged at 6. The U.S. Rig Count is down 75 rigs from last year's count of 664 with oil rigs down 47, gas rigs down 27 and miscellaneous rigs down 1. The U.S. Offshore Rig Count is down 1 to 21, up 2 year-over-year. The Canada Rig Count is up 14 from last week to 211, with oil rigs up 14 to 144, gas rigs up 1 to 67. The Canada Rig Count is up 18 from last year's count of 193, with oil rigs up 23, gas rigs down 5 and miscellaneous unchanged at 0.

12:48 EDT Honeywell up 1% to $203.54 after Bloomberg report of possible Quantinuum IPO

12:01 EDT Oppenheimer Holdings falls -7.9% - Oppenheimer Holdings is down -7.9%, or -$4.60 to $53.34.

12:01 EDT Booz Allen falls -11.8% - Booz Allen is down -11.8%, or -$18.07 to $135.51.

12:00 EDT Everi Holdings rises 42.0% - Everi Holdings is up 42.0%, or $3.83 to $12.97.

11:50 EDT Peoples Financial raises quarterly dividend 50.6% to 61.75c per share - The Board of Directors of Peoples Financial Services Corp. (PFIS) declared a third quarter cash dividend of 61.75c per share. The dividend is payable September 13, 2024 to shareholders of record August 30, 2024. The dividend of 61.75c per share represents an increase of 50.6% compared to the dividend declared in the second quarter of 2024 and the third quarter in the prior year. On July 1, 2024, Peoples completed the previously announced merger of FNCB Bancorp, Inc. (FNCB) with and into Peoples. The increase to the dividend was contemplated as part of the Agreement and Plan of Merger between Peoples and FNCB.

11:39 EDT Kellanova raises dividend to 57c from 56c per share - Kellanova announced that its board of directors declared a dividend of 57c per share on the common stock of Kellanova, payable on September 13 to shareowners of record at the close of business on September 3, 2024. The ex-dividend date is September 3, the company noted.

11:24 EDT Calliditas announces partner approval, EUR 10M milestone payment - Calliditas Therapeutics announced that the European Commission has granted a full marketing authorization for Kinpeygo for the treatment of adults with primary immunoglobulin A nephropathy. The European Commission has granted a full marketing authorization of Kinpeygo. Kinpeygo is marketed in in the European Union and UK exclusively by Calliditas' commercial partner, Stada Arzneimittel. This approval triggers a milestone payment of EUR 10M to Calliditas, which will be recognized as revenue in Q3.

10:51 EDT Junshi Biosciences announces positive CHMP opinion for toripalimab - Shanghai Junshi Biosciences and its wholly-owned subsidiary TopAlliance Biosciences announce that the Committee for Medicinal Products for Human Use of the European Medicines Agency has given a positive opinion for the marketing authorization application for toripalimab. The CHMP recommends approval for toripalimab for two indications: Toripalimab in combination with cisplatin and gemcitabine for the first-line treatment of adult patients with recurrent, not amenable to surgery or radiotherapy, or metastatic nasopharyngeal carcinoma; Toripalimab in combination with cisplatin and paclitaxel for the first-line treatment of adult patients with unresectable advanced, recurrent, or metastatic oesophageal squamous cell carcinoma. The European Commission will take into account the CHMP's positive opinion when making the final decision on the marketing application for toripalimab. The decision will be applicable to all 27 member states of the European Union, plus Iceland and Norway. If approved, toripalimab would become the first and only drug for the treatment of NPC and the only first-line treatment for advanced or metastatic ESCC regardless of PD-L1 status in Europe.

10:45 EDT Cel Sci trading halted, news pending

10:34 EDT White House says Apple signed onto voluntary commitments on AI - The White House issued a statement that reads in part: "Nine months ago, President Biden issued a landmark Executive Order to ensure that America leads the way in seizing the promise and managing the risks of artificial intelligence - AI. This Executive Order built on the voluntary commitments he and Vice President Harris received from 15 leading U.S. AI companies last year. Today, the administration announced that Apple has signed onto the voluntary commitments, further cementing these commitments as cornerstones of responsible AI innovation. In addition, federal agencies reported that they completed all of the 270-day actions in the Executive Order on schedule, following their on-time completion of every other task required to date. Agencies also progressed on other work directed for longer timeframes." Reference Link

10:01 EDT Baytex Energy falls -8.7% - Baytex Energy is down -8.7%, or -32c to $3.35.

10:00 EDT Everi Holdings rises 40.3% - Everi Holdings is up 40.3%, or $3.69 to $12.82.

10:00 EDT Finance of America rises 863.3% - Finance of America is up 863.3%, or $6.44 to $7.19.

09:51 EDT Stardust Power Inc trading halted, volatility trading pause

09:47 EDT Hilltop Holdings falls -8.4% - Hilltop Holdings is down -8.4%, or -$2.93 to $31.88.

09:47 EDT Deckers Outdoor rises 14.7% - Deckers Outdoor is up 14.7%, or $123.39 to $964.88.

09:47 EDT Everi Holdings rises 40.7% - Everi Holdings is up 40.7%, or $3.72 to $12.86.

09:35 EDT Psyence Group provides update on Filament Health commercial licensing agreement - As previously disclosed, Psyence Group and Filament Health (FLHLF) concluded an IP licensing agreement, relating to the supply and licensing of PEX010 by Filament in connection with phase II clinical trials evaluating nature derived psilocybin as a potential treatment for Adjustment Disorder within the context of palliative care. All right, title and interest in and to the R&D Licensing Agreement and the license contemplated therein has been assigned from Psyence Group to Psyence Biomed (PBM) so that Psyence Biomed may pursue the execution of its upcoming Phase IIb clinical trial. As further previously disclosed, Psyence Group and Filament Health Corp. also concluded a binding term sheet, relating to the commercial licensing of PEX010, which remained subject to the terms of a definitive agreement. Following further discussions, the parties have mutually agreed to terminate the Commercial Term Sheet. Filament will continue to support the supply of PEX010 for Psyence Biomed's upcoming Phase IIb trial while Psyence Biomed is evaluating two exclusive supply and license agreements with duly licensed suppliers operating in the United Kingdom and North America.

09:33 EDT Psyence Biomedical announces export of nature-derived psilocybin to Australia - Psyence Group announced that its NASDAQ-listed associate, Psyence Biomedical has announced the export of nature-derived psilocybin to Australia and provided an update on its upcoming Phase IIb clinical trial. According to a news release issued by Psyence Biomed on Wednesday, July 24, it has made substantial progress in preparing for its Phase IIb study, and reported that all parties responsible for the carrying out of the study are poised to initiate the study imminently. The successful export of Psyence Biomed's drug candidate, PEX010, is expected to activate the enrollment of patients for the study. The randomized, double-blind, placebo-controlled Phase IIb study will evaluate two therapeutic doses of nature-derived psilocybin against an active low-dose comparator in 84 patients in conjunction with psychotherapy. Psyence Biomed states in this news release that it "aims to execute an efficient yet rigorously designed study that, if successful, would best support advancement into future late-stage studies." Psyence Group currently holds 5,000,000 common shares in Psyence Biomed, equal to an approximate interest of 30.25%.

09:16 EDT Crown Electrokinetics regains compliance with Nasdaq minimum bid price rule - Crown Electrokinetics has received a notification letter from the Listing Qualifications Department of the Nasdaq Stock Market dated July 25, 2024, informing the Company that it has regained compliance with the Nasdaq Listing Rule 5550(a)(2).

09:06 EDT Heart Test Laboratories announces analysis on MyoVista wavECG potential - Heart Test Laboratories announced an analysis published by the Innovation Value Institute titled "Introduction of AI assisted Digital Health Technology to Improve Cardiovascular Pathway Efficiency" focused on the MyoVista wavECG's potential to radically improve the cardiovascular pathway efficiency. Andrew Simpson, CEO of HeartSciences, said, "Along with improving patient care, one of the key goals for our AI-ECG technology is improving the efficiency of the cardiovascular care pathway. This analysis by the IVI demonstrates that our technology has the potential to do just that. We look forward to bringing this valuable technology to market."

09:04 EDT Eye-Net, SoftBank enter agreement with Japanese vehicle manufacturer - Foresight Autonomous (FRSX) announced that its wholly owned subsidiary, Eye-Net Mobile has signed a three-way multi-phase agreement for a paid proof of concept project with SoftBank Corp. (SFTBY) and a Japanese vehicle manufacturer. SoftBank will provide the required cellular network infrastructure and support for the project. The project is part of a multi-phase plan to be initiated during the third quarter of 2024. The initial phase will consist of an evaluation of Eye-Net Sense demonstration kit in a standalone mode. Upon successful evaluation, the parties may engage in the second phase of integrating Eye-Net Sense into the vehicle manufacturer's infotainment systems. Successful completion of the first two phases could lead to the integration of the Eye-Net Sense solution into the manufacturer's advanced driver assistance systems, potentially leading to full commercial deployment in the manufacturer's vehicles.

09:04 EDT Flex appoints Michael Hartung as President, Chief Commercial Officer - Flex appointed Michael Hartung as President, Chief Commercial Officer, effective immediately. Hartung has been at Flex for 20 years, most recently as President, Agility Solutions.

09:02 EDT Allarity announces postponement of Annual Stockholders Meeting - Allarity Therapeutics announced that its Board of Directors has decided to postpone the Annual Meeting of Stockholders, which was originally scheduled for 10:00 AM Eastern Time today, July 26, 2024. On July 25, 2024, the Board, exercising its authority under the Company's bylaws, opted to delay the meeting to a future date, which will be determined and announced in due course. The Company will provide updated information regarding the new date for the Annual Meeting and, if necessary, a new record date, as soon as it becomes available.

09:01 EDT Bank7 raises quarterly dividend 14.2% to 24c from 21c per share - Bank7 is pleased to announce that its Board of Directors has declared an increase to its quarterly cash dividend to 24c per common share from the current 21c per common share. This dividend represents a 14.2% increase to the current dividend and is the fifth consecutive annual increase in BSVN's quarterly cash dividend. The dividend will be paid on October 9 to shareholders of record as of the close of business on September 26.

08:50 EDT CEL-SCI reports results from Multikine bias analysis - CEL-SCI reported results from a bias analysis conducted for its concluded Phase 3 study of Multikine in the treatment of head and neck cancer. Conducting a bias analysis is a standard process used to identify, assess, and address potential sources of bias that could influence the outcomes and interpretations of study results. CEL-SCI's bias analysis concluded that the treatment group demographics and baseline characteristics were comparable for the Multikine treated and control arms of the Phase 3 study. There were no confounding baseline parameters in the Multikine-treated versus control population. No bias was present in the study and none was detected in favor of the investigational product, Multikine. As such, the study data are interpretable, statistically significant and have been shown to support the clinical effect of neoadjuvant Multikine immunotherapy in extending the life of these patients in the Phase 3 study. This is critically important information because CEL-SCI, with the FDA's agreement, will be conducting a 212-patient confirmatory registration study for Multikine. The target population for the confirmatory study shows a five-year survival in advanced primary head and neck cancer of 73% in Multikine treated patients vs. 45% survival in the control.

08:44 EDT - Premier Financial (PFC) and WesBanco (WSBC) announced the signing of a definitive merger agreement under which PFC will merge into WSBC in a stock-for-stock transaction. Under the terms of the merger agreement, shareholders of PFC will receive 0.80 shares of WSBC common stock for each share of PFC common stock. Premier Bank, a wholly owned subsidiary of PFC, will merge into Wesbanco Bank, Inc., a wholly owned subsidiary of WSBC. Based upon a closing price for WSBC as of July 25 of $34.28, the transaction is valued at approximately $987M, or $27.42 per common share of PFC. Upon closing, PFC shareholders will own approximately 30% of the combined company. The transaction is expected to close in the first quarter of 2025, subject to the approval of shareholders of both PFC and WSBC and regulatory approvals, as well as satisfaction or waiver of other customary closing conditions. Additional information can be found in the press release announcing the merger dated July 26.

08:41 EDT Safe & Green announces approval of 2024 audit of ESR certification - Safe & Green Holdings announced in May 2024 that the Company received recertification of its ESR for certification and use of shipping containers in modular construction from the International Code Council. We are now pleased to announce the company has completed its annual audit for 2024 performed by the ICC Evaluation Service for 2024/2025. In 2017, Safe & Green Holdings Corp. received the first ESR certification ever issued for a recycled product to be re-used as a construction material.

08:39 EDT Tiber Ventures announces preliminary tender offer results - Tiber Ventures announced the preliminary results of its modified "Dutch auction" tender offer to purchase with cash up to $6.16 million shares of its common stock, which expired one minute after 4:59 P.M. Eastern Daylight Time on July 25, 2024. Based on the preliminary count by the depositary for the Tender Offer, a total of 171,699 Shares were validly tendered and not validly withdrawn at a price per Share of not less than $6.75 and not more than $7.25 per Share. In accordance with the terms and conditions of the Tender Offer and based on the preliminary count by the depositary, the Company may purchase up to 171,699 Shares through the Tender Offer at a maximum price of $7.25 per Share, for a total cost not to exceed $1,244,817.75, excluding fees and expenses. The total of 171,699 Shares that the Company expects to accept for purchase represents approximately 6.8% of the Company's total shares of Common Stock outstanding as of June 7, 2024. The number of Shares expected to be purchased in the Tender Offer and the purchase price per Share are preliminary and subject to change. The preliminary information contained in this press release is subject to confirmation by the depositary and is based on the assumption that all Shares tendered through notice of guaranteed delivery will be delivered within the required two business day period. The final number of Shares to be purchased in the tender offer and the final purchase price per Share will be announced following the expiration of the guaranteed delivery period and the completion by the depositary of the confirmation process. Payment for the Shares accepted for purchase pursuant to the Tender Offer, and the return of all other Shares tendered and not purchased, will occur promptly following the completion of the confirmation process. The Company expects to fund the purchase of Shares in the Tender Offer, together with all related fees and expenses, with cash and cash equivalents on hand. Georgeson LLC is serving as information agent for the Tender Offer, and Computershare, Inc. is serving as the depositary for the Tender Offer.

08:36 EDT Vista Outdoor shareholder Gates Capital believes MNC's offer superior to CSG's - Vista Outdoor shareholder Gates Capital, an alternative asset manager that owns approximately 9.6% of the shares of Vista, stated its belief that the $42 all-cash offer for Vista from MNC Capital is superior to the proposed sale of The Kinetic Group to Czechoslovak Group and reiterated its opposition to the CSG proposal. Gates stated that if shareholders assume CSG and MNC are each paying the same $2.15B for The Kinetic Group, then MNC is also paying approximately $900M additional cash for Revelyst, which generated approximately $40M of EBITDA the last twelve months, and that the MNC proposal would pay shareholders approximately 22x LTM EBITDA for Revelyst. Gates notes that on July 24, ISS recommended that shareholders vote against the latest CSG merger proposal. Gates also stated that they believe Vista should set a more current record date in light of delaying the vote on the CSG proposal several times.

08:34 EDT DexCom sinks 38% to $66.50 after guidance cut, analyst downgrades

08:31 EDT Stanley Black & Decker names Deborah Wintner as Chief Human Resources Officer - Stanley Black & Decker announced the appointment of Deborah Wintner as Senior Vice President, Chief Human Resources Officer. She will join the executive team, reporting to Donald Allan, Jr., President & CEO of Stanley Black & Decker, effective August 1, succeeding John Lucas. Most recently, Wintner served as Stanley Black & Decker's Senior Vice President of Human Resource Operations and CHRO, Tools and Outdoor. In her new role, Wintner will be responsible for the company's global human resources strategy and operations; talent management, including recruitment and leadership development; and compensation and benefits.

08:24 EDT Diller says pursuit of Paramount 'over' for IAC - Barry Diller signaled IAC (IAC) was no longer in the race to buy Paramount Global (PARA), stating in an interview on CNBC that the deal conclusion is "hard to predict, but think it's over for us." Paramount announced a deal with David Ellison's Skydance Media early in July and Diller added in the interview with CNBC's Andrew Ross Sorkin that he will be "shocked" if there is not a huge amount of litigation regarding the planned merger.

08:21 EDT Casey's General Stores to acquire Fikes Wholesale for $1.15B in cash - Casey's General Stores announced an agreement to acquire Fikes Wholesale, owner of CEFCO Convenience Stores, or CEFCO, in an all-cash transaction for $1.15B. The purchase price includes tax benefits valued at approximately $165M for a net after-tax purchase price of $980M. Casey's acquisition of Fikes will include 198 retail stores and a dealer network. The proposed transaction will increase Casey's footprint to nearly 2,900 stores. The acquisition will bring 148 additional stores to Texas, as well as 50 stores in the southern states of Alabama, Florida, and Mississippi. In addition to the retail stores and dealer locations, the transaction includes a fuel terminal and a commissary to support the Texas stores. The company plans to finance the transaction through balance sheet cash and bank financing. The net investment of $980M represents an approximate multiple of 11 times CEFCO's pro forma adjusted 2023 EBITDA. The company expects to achieve approximately $45M in annual run-rate synergies upon the completion of kitchen installations in the acquired stores. The transaction is anticipated to close during the fourth quarter of calendar year 2024, subject to customary closing conditions and regulatory approval.

08:13 EDT ARIA Cybersecurity to highlight cybersecurity risks at Rockwell Automation Fair - ARIA Cybersecurity Solutions has been selected to update the industry on how to measure the cybersecurity risks facing industrial operations-and how to guard against them-at the Rockwell Automation Fair hosted by Rockwell Automation. Taking place November 18th - 21st in Anaheim, California, the event will bring together 10,000 leaders from across the industry to discuss the latest challenges facing industrial automation, including the sharp increase in cybersecurity attacks on critical infrastructure. ARIA will showcase its award-winning cybersecurity solution, AZT PROTECT, in the exhibition and will present in the conference program. In the session, "How to Measure the Risk of a Cybersecurity Attack," ARIA chief executive Gary Southwell will present an in-depth review of the latest attack techniques and their financial impact. He will outline how insurance providers are measuring this risk and how companies can comply with new insurance and regulatory requirements. Southwell will share a range of use cases to demonstrate how companies can apply reduction techniques to reduce measurable risk.

08:10 EDT Golden Matrix to offer over 1M betting options for 2024 Paris Olympics - Meridianbet, a global sports betting operator and subsidiary of Golden Matrix Group, unveils an array of betting options for sports enthusiasts and Olympics fans alike. Meridianbet is set to offer 383 distinct betting options for each event across all 45 Olympic sports. With 2,600 different prices available for each match or competition, this amounts to over 1 million unique betting opportunities throughout the Games.

08:09 EDT Predictive Oncology announces exercise of warrants for $1.26M in gross proceeds - Predictive Oncology entered into a definitive agreement for the exercise of certain existing warrants to purchase an aggregate of 958,117 shares of its common stock having a current exercise price of $14.00 originally issued in February 2021, June 2021 and May 2022, at a reduced exercise price of $1.32 per share. The issuance and/or resale of the shares of common stock issuable upon exercise of the existing warrants, as applicable, are registered pursuant to effective registration statements on Form S-1, Form S-3 and Form S-3. The gross proceeds to Predictive Oncology from the exercise of the existing warrants are expected to be approximately $1.26 million, prior to deducting placement agent fees and transaction expenses payable by the Company. H.C. Wainwright & Co. is acting as the exclusive placement agent for the transaction. In consideration for the immediate exercise of the warrants for cash, Predictive Oncology will issue new unregistered Series A warrants to purchase up to 958,117 shares of common stock and new Series B warrants to purchase up to 958,117 shares of common stock. The new warrants will have an exercise price of $1.07 per share, will be exercisable immediately upon issuance and have a term equal to five years from the date of issuance, with respect to Series A warrants, and 18 months from the date of issuance, with respect to Series B warrants. The transaction is expected to close on or about July 26, 2024, subject to satisfaction of customary closing conditions. The Company intends to use the net proceeds from the transaction, coupled with an additional $3.58 million in net proceeds raised in May 2024 through the Company's at-the-market facility, for working capital and other general corporate purposes.

08:05 EDT Trxade Health acquires Scienture in all-stock transaction valued at $103M - TRxADE HEALTH and Scienture announced the closing of TRxADE's business combination with Scienture in an all-stock transaction. TRxADE acquired all of Scienture's assets in exchange for shares of TRxADE stock, in a combination of common stock and non-voting convertible preferred stock. TRxADE will change its name to "Scienture Holdings, Inc." subsequent to the future conversion of the non-voting convertible preferred stock and the combined company is intended to continue as a Nasdaq-listed company. The Business Combination results in a combined company that will be focused on bringing to market innovative branded, specialty pharmaceutical products that significantly enhance the standard of care, while adding value to patients, caregivers and the healthcare system. Scienture's current portfolio of products is supported by an accomplished leadership and management team with many years of multidisciplinary experience across Product Development, Clinical Operations, Manufacturing and Commercial Operations. Scienture is passionate about improving the lives of patients by delivering unique solutions through its novel specialty product concepts. By combining a patient-centric approach and a well thought out development and go to market commercial strategy, Scienture intends to shift the dynamic of care to revolve around the patient for a wide range of therapeutic areas. The Business Combination is structured as a stock for stock exchange whereby all of the outstanding equity securities of Scienture are to be exchanged for a combination of TRxADE common stock and non-voting convertible preferred stock. Upon completion of the proposed Business Combination and future conversion of the non-voting convertible preferred stock, on a pro forma basis and based upon the number of TRxADE shares to be issued in the proposed Business Combination, current Scienture stockholders are expected to own approximately 82.99% of the equity interests in the combined company and current TRxADE stockholders are expected to own approximately 17.01% of the equity interests combined company, in each case subject to certain adjustments in the Agreement and Plan of Merger, and resulting in a combined publicly traded company valued in the Agreement and Plan of Merger at approximately $103 million on a fully diluted basis. TRxADE stockholders will continue to own approximately 83.34% of the combined company's voting securities until the non-voting convertible preferred stock received by the Scienture stockholders is converted into TRxADE common stock. The boards of directors of both companies have unanimously approved the Business Combination. Suren Ajjarapu, TRxADE's current Chairman and CEO will continue to serve as Chairman and CEO of the combined company. The current members of the Board of Directors of TRxADE will continue to serve on the Board of Directors of the combined company with the addition of two members designated by Scienture.

08:01 EDT Saia sees 2024 net capex $1B - The company said, "In 2024, we anticipate that net capital expenditures will be approximately $1 billion, subject to ongoing evaluation of market conditions."

07:47 EDT Genfit announces positive CHMP opinion for Ipsen's Iqirvo - GENFIT (GNFT) announced the positive opinion issued by the Committee for Medicinal Products for Human Use of the European Medicines Agency's for Ipsen's (IPSEY) Iqirvo for the treatment of Primary Biliary Cholangitis in combination with ursodeoxycholic acid in adults with an inadequate response to UDCA or as a monotherapy in patients unable to tolerate UDCA. Elafibranor, a molecule marketed and commercialized in the United States by Ipsen under the trademark Iqirvo since June 2024, was developed by GENFIT, from initial discovery to the conclusion of a 52-week Phase 3 clinical study. Ipsen licensed the exclusive worldwide rights to elafibranor from GENFIT in 2021. The European Commission will now consider the CHMP recommendations, and a final decision on marketing authorization for Iqirvo is anticipated in the second half of 2024.

07:36 EDT Geron announces updated NCCN guidelines recommending Rytelo - Geron announced that the National Comprehensive Cancer Network, or NCCN, has updated its Clinical Practice Guidelines in Oncology, or NCCN Guidelines, for the treatment of Myelodysplastic Syndromes, or MDS, to recommend Rytelo as a Category 1 and 2A treatment of symptomatic anemia in patients with lower-risk MDS. Treatments are classified as Category 1 and 2A when there is uniform NCCN consensus of 85% that the intervention is appropriate. The MDS NCCN Guidelines categorize lower-risk MDS patients without the del abnormality and with symptomatic anemia on the basis of ring sideroblasts percentage and serum EPO levels, without specifying red blood cell transfusion burden. For RS- lower-risk MDS patients with symptomatic anemia, Rytelo is recommended as a Category 1 second-line treatment after either erythropoiesis-stimulating agents or luspatercept in patients with serum EPO 500 mU/mL, and as a Category 2A first-line treatment in patients with serum EPO greater than500 mU/mL and unlikely to respond to immunosuppressive therapy. For RS+ lower-risk MDS patients with symptomatic anemia, Rytelo is recommended as a Category 1 second-line treatment after luspatercept in patients with serum EPO =500 mU/mL, and as a Category 2A first-line treatment in patients with serum EPO greater than 500 mU/mL.

07:29 EDT Nexstar announces $1.5B share repurchase authorization - Nexstar announced that its board of directors declared a quarterly cash dividend of $1.69 per share of its common stock. The dividend is payable on Friday, August 23 to shareholders of record on Friday, August 9. In addition, the board of directors also approved a new share repurchase program authorizing the company to repurchase up to $1.5B of its common stock. The new share repurchase authorization is in addition to Nexstar's existing share repurchase program announced in July 2022, of which $496M remained as of May 8.

07:18 EDT Apollo leads $700M capital solution for Sony Music Group - Apollo (APO) announced that, on behalf of its affiliated and third-party insurance clients and other investors, it has provided a $700 million capital solution to Sony Music Group, an affiliate of Sony Group Corporation (SONY), for investments in the music industry.

07:08 EDT Criteo announces senior executive promotions - Criteo announced the promotion of leaders. Brian Gleason, who joined Criteo in April 2022 as Chief Revenue Officer, will assume the expanded role of Chief Revenue Officer and President, Retail Media. Prior to joining Criteo, Gleason was Global Chief Commercial Officer of GroupM, a WPP subsidiary. He also served as CEO of Xaxis and in senior roles at various advertising and technology companies. Ryan Damon, formerly Chief Legal and Corporate Affairs Officer, will assume the expanded role of Chief Legal and Transformation Officer. Prior to joining Criteo in 2018, Damon served as Senior Vice President, General Counsel and Secretary at Riverbed Technology. He has also held senior legal roles at Charles Schwab and was an attorney with the law firm of Gunderson Dettmer in Silicon Valley. Connor McGogney, formerly EVP, Corporate Development, has been promoted to Chief Business Development Officer. Previously, McGogney was Vice President, Global M&A and Corporate Development at Nielsen. He also served as VP, Media and Technology Investment Banking at Credit Suisse.

07:06 EDT Lifeist Wellness' Mikra on track building out, executing FOCUS marketing plan - Lifeist Wellness announced that its U.S. biosciences subsidiary Mikra Cellular Sciences is on track building out and executing the marketing plan for FOCUS, its first product with six time MLB All-Star, three time Silver Slugger and Olympic medal winner Jose Bautista. Mikra's new product combines a precision blend of citicoline, tyrosine and pure lion's mane mushroom to deliver improved memory, total concentration and faster cognition without any caffeine or stimulants. The company said, "The Mikra team has had the pleasure of working closely with Mr. Bautista throughout a comprehensive product development process during which we leveraged extensive 3rd party clinical research and evaluated a range of active ingredients and dosage combinations in order to arrive at the optimal formula for FOCUS. We deeply appreciate his contributions as an accomplished entrepreneur and businessman, bringing a wealth of resources and experience to the table in helping Mikra build out a multichannel marketing plan for the upcoming FOCUS launch in late September."

07:04 EDT Osisko Development reports lifting of fire evacuation order near Cariboo - Osisko Development announced that the previously issued wildfire evacuation order announced on July 22, 2024, has been lifted by the BC Wildfire Service. Normal course operations and site activities at the Company's 100%-owned Cariboo Gold Project will resume immediately following the return of non-essential employees to site. The mine site infrastructure was unaffected by the wildfires and all access roads to the Project are accessible. Osisko Development would like to thank all emergency services personnel who are on the front lines fighting the forest fires impacting the BC province and more broadly in Canada, and extend our thoughts to the communities that have been and continue to be affected by these fires. The Company will continue to closely monitor the wildfire situation to ensure safety and welfare of its employees.

07:02 EDT Legend Biotech sees 1H adjusted net loss ($94.7M)-($109.7M) - For the six-months ended June 30, 2024, Legend Biotech expects to record an adjusted net loss for the period of approximately $94.7 million to $109.7 million.

06:51 EDT IGT Gaming & Digital business, Everi Holdings to be acquired by Apollo for $6.3B - International Game (IGT) and Everi Holdings (EVRI) announced that they have entered into definitive agreements whereby IGT's Gaming & Digital business and Everi will be simultaneously acquired by a newly formed holding company owned by funds managed by affiliates of Apollo Global (APO) in an all-cash transaction that values the acquired businesses at approximately $6.3B on a combined basis. On February 29, IGT and Everi announced that they had entered into definitive agreements pursuant to which IGT would separate the IGT Gaming business by way of a taxable spin-off to IGT shareholders and then immediately combine such business with Everi. Under the terms of the new agreements, the Apollo Funds will acquire IGT Gaming and Everi. Following closing, IGT Gaming and Everi will be privately owned companies that are part of one combined enterprise. Under the terms of the new agreements, Everi stockholders will receive $14.25 per share in cash, representing a 56% premium over Everi's closing share price on July 25. IGT will receive $4.05B of gross cash proceeds for IGT Gaming. IGT expects significant portions of the cash proceeds to be used to repay debt and to be returned to shareholders. De Agostini S.p.A., a societa per azioni organized under the laws of Italy, the majority shareholder of IGT, has committed to make a minority equity investment in the combined enterprise at the closing of the transaction. Upon completion of the sale of IGT Gaming to the Apollo Funds, IGT will change its name and stock ticker symbol. The transaction with the Apollo Funds has been unanimously approved by a special committee of the IGT board of directors and unanimously approved by all members of the Everi board of directors, and the previous transaction agreements between IGT and Everi entered into on February 28 have been terminated.

06:42 EDT GrafTech sees FY24 CapEx $35M-$40M - "We expect demand for graphite electrodes in the near term will remain weak, reflecting persistent challenges in the commercial environment as steel industry production remains constrained by global economic uncertainty. Given these trends, challenging pricing dynamics have persisted in most regions. As a result, we remain selective in the commercial opportunities we choose to pursue. Sales volume in the third quarter of 2024 is expected to be broadly in line with sales volume for the second quarter of 2024 and we continue to expect a modest year-over-year improvement in sales volume for the full year. We continue to expect a mid-teen percentage point decline in our full year 2024 cash cost of goods sold per MT compared to 2023. This significant improvement in our year-over-year cost structure reflects (1) the deliberate actions we have taken to reduce our fixed manufacturing costs, (2) the benefit of additional actions we are taking to reduce our variable costs and (3) the anticipated year-over-year improvement in our sales and production volume levels. In addition, we continue to closely manage our working capital levels and capital expenditures. We continue to anticipate our full-year 2024 capital expenditures will be in the range of $35 million to $40 million. Longer term, we remain confident that the steel industry's accelerating efforts to decarbonize will lead to increased adoption of the electric arc furnace method of steelmaking, driving long-term demand growth for graphite electrodes. We also anticipate the demand for petroleum needle coke, the key raw material we use to produce graphite electrodes, to accelerate driven by its utilization in producing synthetic graphite for use in lithium-ion batteries for the growing electric vehicle market. We believe that the near-term actions we are taking, supported by an industry-leading position and our sustainable competitive advantages, including our substantial vertical integration into petroleum needle coke via our Seadrift facility, will optimally position GrafTech to benefit from that long-term growth."

06:34 EDT NatWest Group continues to target CET1 ratio in the range of 13%-14% - The company said, "Capital - we continue to: target a CET1 ratio in the range of 13-14%. expect RWAs to be around GBP 200 billion at the end of 2025, including the impact of Basel 3.1, however this remains subject to final rules and approval. expect to pay ordinary dividends of around 40% of attributable profit and maintain capacity to participate in directed buybacks from the UK Government, recognising that any exercise of this authority would be dependent upon HMT's intentions. We will also consider further on-market buybacks as appropriate."

06:31 EDT NatWest Group expects 2024 return on tangible equity above 14% - The company said, "In 2024 we now expect: to achieve a return on tangible equity above 14%. income excluding notable items to be around GBP 14.0 billion. Group operating costs, excluding litigation and conduct costs, to be broadly stable compared with 2023 excluding around GBP 0.1 billion increase in bank levies and GBP 24 million of costs in relation to the potential retail share offering by HM Treasury. our loan impairment rate for 2024 to be below 15 basis points."

05:41 EDT CrowdStrike CEO says nearly all devices back online after outage - CrowdStrike CEO George Kurtz said in a LinkedIn post Thursday that 97% of the Windows sensors that went offline during last week's global IT outage are now back up-and-running. "This progress is thanks to the tireless efforts of our customers, partners, and the dedication of our team at CrowdStrike... However, we understand our work is not yet complete, and we remain committed to restoring every impacted system. Our recovery efforts have been enhanced thanks to the development of automatic recovery techniques and by mobilizing all our resources to support our customers. We published a preliminary incident report detailing how this happened and the measures we're taking to prevent such incidents in the future. CrowdStrike is committed to building on our mission to stop breaches, with a renewed focus on customer controls and resilience. Customer obsession has always been our guiding principle, and this experience has only strengthened our resolve." Reference Link

05:15 EDT Immix Biopharma awarded $8M CLIN2 grant - Immix Biopharma announced that the California Institute for Regenerative Medicine, or CIRM, has awarded Immix Biopharma cell therapy division Nexcella an $8M CLIN2 grant award to support clinical development of chimeric antigen receptor T-cell therapy NXC-201 for the treatment of relapsed/refractory AL Amyloidosis.

05:10 EDT AbbVie announces European Commission approval of Skyrizi - AbbVie announced that the European Commission has approved Skyrizi for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to, lost response to, or were intolerant to conventional therapy or a biologic therapy.

05:05 EDT Vertical Aerospace VX4 prototype completes first tethered piloted flight - Vertical Aerospace has seen its latest VX4 prototype perform its first tethered piloted flight as it begins the "wheels up" phase of testing. This VX4 performed a piloted flight while loosely tethered to the ground, during which Vertical measured over 20,000 flight and system parameters to verify thrust, handling qualities and system performance. The tethered piloted flight took place after the UK Civil Aviation Authority, or CAA, had issued Vertical with a Permit to Fly for its VX4 prototype, having rigorously evaluated the engineering, design, test data and aircraft, effectively conducting a "mini certification" program of the aircraft. Vertical must submit documentation to the CAA to move through each flight phase, including extensive, detailed documentation covering every aspect from safety protocols and engineering specifications to operational procedures. Following initial tethered flights, and once it has received permission from the CAA to expand the flight envelope, the VX4 will enter the next phase of testing which will start with further thrustborne flight testing. This will see the VX4 take-off and land vertically and conduct low speed flight maneuvers with lift generated by the propellers. Wingborne or conventional flight and the final critical test stage of piloted transition flight will follow, only once the CAA's rigorous approval for this final phase of testing has been granted.