Adial Pharmaceuticals Highlights FDA Policy Direction That May Reduce Pivotal Trial Burden from Two Studies to One
Globenewswire· 2026-02-23 13:30
Core Insights - The FDA's recent policy shift allows for drug approval based on one adequate and well-controlled clinical investigation plus confirmatory evidence, rather than the traditional requirement of two pivotal studies, which could significantly lower costs and accelerate the NDA submission process for Adial's lead drug candidate, AD04 [1][2][3] Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders, with its lead investigational drug candidate, AD04, targeting Alcohol Use Disorder (AUD) in heavy drinking patients [5] - AD04 is a genetically targeted serotonin-3 receptor antagonist, and the company is preparing for a new Phase 3 clinical trial program, utilizing a proprietary diagnostic genetic test to identify target genotypes [5] Regulatory Impact - The FDA's modernization of evidentiary standards emphasizes trial quality and confirmatory support over the number of trials, which aligns with Adial's strategy to potentially conduct a single pivotal trial for AD04 [2][4] - Cary Claiborne, CEO of Adial, highlighted that this regulatory change could transform the company's development strategy by significantly lowering Phase 3 costs and improving capital efficiency [4] Clinical Development Strategy - Adial intends to engage closely with the FDA to align its evidentiary strategy for AD04 with current regulatory standards, which may enhance the strategic and economic profile of the asset [4][7] - The company believes that AD04 has the potential to treat other addictive disorders beyond AUD, including Opioid Use Disorder, gambling, and obesity [5]
Off The Hook to Host Investor Webinar to Discuss APEX Acquisition Expected to Add $30M in Revenue and Deliver $3M in Annual Cost Savings
Globenewswire· 2026-02-23 13:30
Wilmington, NC, Feb. 23, 2026 (GLOBE NEWSWIRE) -- Off The Hook YS Inc. (NYSE American: OTH) (“Off the Hook Yachts” or “Off the Hook” or “the Company”), a vertically integrated, AI-powered marine marketplace and the largest buyer and seller of used boats in the nation, is pleased to invite investors to a webinar on February 23, 2026, at 4:15 p.m. ET. The exclusive event, hosted by RedChip Companies, will feature Brian John, CEO of Off The Hook Yachts, who will discuss the Company’s recently announced definit ...
American Rebel Holdings, Inc. (NASDAQ: AREB) announces a partnership with Jefferson Distributing to launch American Rebel Light Beer in West Virginia’s Eastern Panhandle, expanding distribution across Jefferson, Morgan and Berkeley Counties
Globenewswire· 2026-02-23 13:30
American Rebel Holdings, Inc. American Rebel Holdings, Inc. (NASDAQ: AREB) announces a partnership with Jefferson Distributing to launch American Rebel Light Beer in West Virginia’s Eastern Panhandle Top-tier Anheuser-Busch network distribution partner Jefferson Distributing (WV) adds critical “footprint fill-in” coverage as American Rebel continues rapid national expansion with sustained execution of its Distribution-First strategy Nashville, TN, Feb. 23, 2026 (GLOBE NEWSWIRE) -- American Rebel Holding ...
ARKO Corp. Opens Newly Remodeled Apple Market with fas craves Food Concept in Hazard, KY
Globenewswire· 2026-02-23 13:30
Core Insights - ARKO Corp. has opened a newly remodeled Apple Market featuring the fas craves food concept, marking the fourth fas craves remodel and bringing the total to six locations nationwide [6][10] Group 1: Store Opening and Concept - The remodeled Apple Market store opened on February 16, 2026, with a grand opening celebration planned for early spring [7] - The fas craves concept aims to redefine the convenience store experience with high-quality, delicious, and affordable menu items [8] - The store features an updated exterior and interior, including modern digital menu boards and enhanced layout for improved guest flow [10] Group 2: Menu Offerings - The elevated menu includes Hot and Cold Grab-n-Go items, Roller Grill favorites, and a variety of popular food items such as breakfast sandwiches and chicken wings [8] - The beverage lineup includes trending options like dirty soda, nitro cold brew, and various iced drinks [9] Group 3: Customer Engagement and Loyalty - ARKO's fas REWARDS® loyalty program offers savings on everyday purchases, including stackable fuel rewards up to $2.50 per gallon [11][12] - The program enhances customer experience by providing personalized offers and better in-store pricing [12] Group 4: Company Overview - ARKO Corp. is a Fortune 500 company and one of the largest convenience store operators in the U.S., operating in four segments: retail, wholesale, fleet fueling, and GPM Petroleum [13][16]
rYojbaba Announces Participation in the Guardian Girls Aikido Project in Los Angeles, CA
Globenewswire· 2026-02-23 13:30
FUKUOKA, Japan, Feb. 23, 2026 (GLOBE NEWSWIRE) -- rYojbaba Co., Ltd. (Nasdaq: RYOJ) ("rYojbaba" or the "Company"), a Japanese consulting and health services company, collaborated with Guardian Girls USA and United Nations Population Fund (“UNFPA”) to launch the Guardian Girls Aikido (“GGA”) project at the Terasaki Budokan in downtown Los Angeles, California. The Guardian Girls Aikido project was originally launched in Bogotá, Colombia, in February 2024, in cooperation with the Embassy of Japan in Colombia. ...
IP Strategy Launches Treasury Yield-Enhancement Program
Globenewswire· 2026-02-23 13:30
Core Insights - The company has launched a new treasury yield-enhancement program that has achieved an average monthly yield of 3.96%, equating to a compounded annualized yield of 59.37% [1][2] Group 1: Program Performance - In the first four weeks, the program generated $167,324 in gross income without selling any $IP tokens [2] - The initial allocation for the program involved 3 million $IP tokens, utilizing a structured covered-call strategy to enhance recurring treasury income while maintaining exposure to the ecosystem [2][3] Group 2: Future Strategy - The company plans to gradually expand the strategy to fund a significant portion of its operating costs through recurring treasury income, while preserving the majority of its token holdings for its validator infrastructure business [3] - This approach aims to enhance capital efficiency and support sustainable growth by integrating disciplined treasury yield strategies with validator cash flows [4] Group 3: Company Overview - IP Strategy Holdings, Inc. is the first Nasdaq-listed company to hold $IP tokens as a primary reserve asset and operates a validator for the Story Protocol, providing investors exposure to the $80 trillion programmable intellectual property economy [5] - The company’s treasury reserve of $IP tokens allows for direct participation in the Story ecosystem, facilitating on-chain registration, licensing, and monetization of intellectual property [5] Group 4: Share Repurchase Program - The board of directors has authorized a share repurchase program for up to 1 million shares of common stock during 2026, representing nearly 10% of the issued and outstanding shares [4]
FibroBiologics Granted Extension by Nasdaq to Regain Compliance
Globenewswire· 2026-02-23 13:30
Core Viewpoint - FibroBiologics, Inc. has received an extension from a Nasdaq Hearings Panel to regain compliance for continued listing on The Nasdaq Capital Market, providing a clear path for the company to maintain its stock listing [1][2]. Group 1: Compliance Conditions - The company must meet an equity standard of $2.5 million under Nasdaq Listing Rule 5550(b)(1) by February 27, 2026, as an alternative to the $35 million minimum Market Value of Listed Securities under Listing Rule 5550(b)(2) [2]. - FibroBiologics is required to meet the minimum bid price requirement of $1.00 per share by April 13, 2026, as per Nasdaq Listing Rule 5550(a)(2) [2]. - The company must comply with all applicable criteria for continued listing on Nasdaq by April 13, 2026 [2]. Group 2: Company Overview - FibroBiologics is a clinical-stage biotechnology company based in Houston, focusing on developing therapeutics and potential cures for chronic diseases using fibroblast cells and fibroblast-derived materials [4]. - The company holds over 270 patents issued and pending in the US and internationally, covering various clinical pathways including wound healing, multiple sclerosis, disc degeneration, psoriasis, orthopedics, human longevity, and cancer [4]. - FibroBiologics represents a new generation of medical advancements in cell therapy and tissue regeneration [4].
CISO Global Appoints Dhaval Damania as EVP of Cybersecurity & IT
Globenewswire· 2026-02-23 13:30
Experienced AI and enterprise IT operations leader joins Company to accelerate scalable growth, strengthen security architecture, and advance next-generation cyber software innovation Scottsdale, Ariz., Feb. 23, 2026 (GLOBE NEWSWIRE) -- CISO Global, Inc. (NASDAQ: CISO) (“CISO Global” or the “Company”), a provider of AI-powered cybersecurity software and compliance services, today announced the appointment of Dhaval Damania as Executive Vice President of Cybersecurity & IT. This appointment reinforces its co ...
Fulton Financial Corporation and Blue Foundry Bancorp Announce Regulatory Approvals and Anticipated Merger Closing Date
Globenewswire· 2026-02-23 13:30
LANCASTER, Pa. and RUTHERFORD, N.J., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Fulton Financial Corporation (Nasdaq: FULT) (“Fulton”) and Blue Foundry Bancorp (Nasdaq: BLFY) (“Blue Foundry”) today jointly announced the receipt of all required regulatory approvals for the previously announced all-stock transaction pursuant to which Fulton will acquire Blue Foundry. Regulatory approvals have been granted by the Board of Governors of the Federal Reserve System and the Office of the Comptroller of the Currency. Blue Fo ...
Milestone Scientific Launches CompuFlo® Advisor Program to Accelerate Commercial Adoption and Drive Utilization Growth in Select MAC Jurisdictions; Plans National Expansion
Globenewswire· 2026-02-23 13:30
ROSELAND, N.J., Feb. 23, 2026 (GLOBE NEWSWIRE) -- Milestone Scientific Inc. (NYSE: MLSS), a leading developer of computerized drug delivery instruments that provide objective, pressure-guided precision, today announced the launch of the CompuFlo® Advisor Program. This strategic initiative is designed to drive mainstream commercial adoption, increase recurring disposable revenue, and generate the clinical data necessary to optimize long-term Medicare reimbursement rates. The program, which commenced on Febru ...