Core Viewpoint - Adial Pharmaceuticals is progressing towards a Phase 3 clinical trial for its lead drug candidate AD04, aimed at treating Alcohol Use Disorder (AUD), with an important FDA meeting scheduled for July 25, 2025 to discuss the clinical development plan and trial design [2][3]. Company Overview - Adial Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders [4]. - The lead investigational drug, AD04, is a genetically targeted serotonin-3 receptor antagonist designed for heavy drinking patients with AUD [4]. - AD04 has shown promising results in the ONWARD™ pivotal Phase 3 clinical trial, demonstrating effectiveness in reducing drinking without significant safety concerns [4]. Clinical Development - The FDA has granted Adial an End of Phase 2 meeting to discuss the proposed clinical development plan and seek guidance on the Phase 3 adaptive trial design for AD04 [2]. - The company has confirmed its 505(b)(2) regulatory bridging strategy with the FDA, indicating strong progress in trial design [3]. - The target patient population for AD04 has been reinforced through recent analyses, supporting its potential effectiveness in treating AUD and related conditions [3]. Future Prospects - The company is optimistic about aligning with the FDA on key requirements to advance AD04 and plans to provide a comprehensive update after the July meeting [3]. - AD04 is also believed to have potential applications in treating other addictive disorders, including Opioid Use Disorder, gambling, and obesity [4].

Herbal Oasis Expands Southeast Presence with New Distribution Agreement in North CarolinaMay 07, 2025 11:04 AM EDT | Source: cbdMDCharlotte, North Carolina--(Newsfile Corp. - May 7, 2025) - Herbal Oasis ("Oasis"), the hemp derived THC-infused social seltzer brand redefining how people connect, unwind, and celebrate life, is now proud to be distributed by Carolina Premium Beverage, serving Charlotte NC and surrounding counties. Starting in May, consumers will be able to find Oasis on shelves ac ...

Madrigal Pharmaceuticals (MDGL) Q1 2025 Earnings Call May 01, 2025 08:00 AM ET Speaker0 Good day, and thank you for standing by. Welcome to Magical Pharmaceuticals First Quarter twenty twenty five Earnings Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. As a reminder, today's conference call is being recorded. I would now like to introduce Ms. Tina Ventura, Chief Investor Relations Officer. Please go ah ...

OPKO Health (OPK) Q1 2025 Earnings Call April 30, 2025 04:30 PM ET Company Participants Yvonne Briggs - Investor Relations and Corporate Development ExecutivePhillip Frost - Chairman & CEOElias Zerhouni - President & Vice ChairmanAdam Logal - SVP & CFOJeffrey Cohen - MD - Equity ResearchBilly Smith - Equity ResearchMichael Petusky - Managing Director Conference Call Participants James Stamos - AnalystYi Chen - Managing Director & Senior AnalystEdward Tenthoff - Sr. Research AnalystYale Jen - Senior Managing ...

– Survey Respondents Reported That AUD Diagnosis and Decision to Seek Treatment Were Driven by Negative Consequences of Drinking – – Respondents Cited the Influence of Their Healthcare Providers and the Positive Impact of Treatment on Their Lives –DUBLIN, April 30, 2025 /PRNewswire/ -- A new online survey conducted by The Harris Poll on behalf of Alkermes, Inc., a subsidiary of Alkermes plc (Nasdaq: ALKS), sought to understand utilization of and experiences with treatment among 300 adults between ages 21-64 ...

TORONTO, April 10, 2025 (GLOBE NEWSWIRE) -- Quantum BioPharma Ltd. (NASDAQ:QNTM) (CSE:QNTM) (FRA: 0K91) ("Quantum BioPharma" or the "Company"), today announced its licensee – Celly Nutrition Corporation ("Celly Nutrition"), the company behind unbuzzd™ – the beverage that accelerates alcohol metabolism, restores mental clarity, and reduces hangover symptoms – has secured a landmark partnership with the Asian American Trade Associations Council ("AATAC") to expand the retail availability of unbuzzd™, increase ...