Core Viewpoint - Adial Pharmaceuticals has executed agreements with Cambrex and Thermo Fisher to support the production of its lead investigational drug AD04, aimed at treating Alcohol Use Disorder (AUD) in the U.S. [1][2][3] Company Overview - Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for addiction and related disorders, with AD04 being a genetically targeted serotonin-3 receptor antagonist [4]. - The company recently conducted the ONWARD™ pivotal Phase 3 clinical trial for AD04, which showed promising results in reducing drinking among heavy drinking patients without significant safety concerns [4]. Agreements and Collaborations - The collaboration with Thermo Fisher as the Contract Development and Manufacturing Organization (CDMO) and Cambrex as the drug substance supplier has commenced, focusing on the completion of demonstration batches necessary for clinical trials [2][3]. - The agreements encompass all manufacturing phases for clinical supplies and the Chemistry, Manufacturing, and Controls (CMC) documentation required for the NDA submission to the FDA [2]. Strategic Importance - The selection of CDMOs with proven track records in both drug substance development and manufacturing was crucial for the agreements [2]. - The partnerships are expected to be vital for meeting timelines for the upcoming Phase 3 clinical trials and addressing commercial demands for AD04, especially considering recent tariff implications [3]. Future Potential - AD04 is not only targeted for AUD but is also believed to have potential applications in treating other addictive disorders such as Opioid Use Disorder, gambling, and obesity [4].

GLEN ALLEN, Va., June 17, 2025 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) ("Adial" or the "Company"), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced the pricing of its "reasonable best efforts" public offering for the purchase and sale of 11,100,000 shares of common stock of the Company (or common stock equivalents in lieu thereof), together with Series D warrants to purchase ...

"Adial's collaboration with Cytel reinforces our commitment to disciplined capital deployment and data-driven execution," said Cary Claiborne, CEO at Adial. "By leveraging advanced analytics and adaptive design, we are in a strong position to generate meaningful clinical data while minimizing time and spend. We believe this strategy materially increases the probability of success for AD04 and creates significant value for patients and shareholders alike." Adial's platform is focused on developing geneticall ...

Other Developments Adovate, LLC On May 13, 2025, Adial announced that it has received a six-figure development milestone payment from Adovate, LLC, following the commencement of a Phase 1 clinical trial evaluating Adovate's lead compound for asthma, ADO-5030. This milestone payment follows Adovate's exercise of its option to acquire the assets and business of Purnovate, Inc., a wholly owned subsidiary of Adial Pharmaceuticals, as previously disclosed. Under the terms of the agreement with Adovate, Adial is ...

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].

Core Viewpoint - Adial Pharmaceuticals has received a new patent for a treatment method targeting a wide range of alcohol-related disorders and opioid-related disorders using its investigational drug AD04, which is tailored for genetically identified patients [1][2][3] Group 1: Patent and Intellectual Property - The newly issued patent number 12,274,692 covers a precision medicine approach for administering AD04 to patients with specific genetic markers related to serotonin [2] - The patent includes claims for treating various alcohol-related disorders, such as alcohol-induced anxiety, bipolar disorder, sexual dysfunction, sleep disorders, gambling disorder, and alcohol withdrawal [2] Group 2: Company Mission and Development - The CEO of Adial Pharmaceuticals emphasized the significance of this patent as a milestone in providing targeted treatments for individuals suffering from alcohol and opioid use disorders [3] - The company is committed to advancing AD04 through clinical development and regulatory pathways to meet the urgent need for effective, personalized addiction treatments [3] Group 3: Product and Clinical Trials - AD04 is a genetically targeted serotonin-3 receptor antagonist aimed at treating Alcohol Use Disorder (AUD) in heavy drinking patients, with promising results from the ONWARD™ pivotal Phase 3 clinical trial [4] - The ONWARD trial demonstrated effectiveness in reducing heavy drinking without significant safety or tolerability concerns [4]