Adial Pharmaceuticals Advances AD04 with FDA Approval

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Adial Pharmaceuticals Advances AD04 with FDA Approval

Adial Pharmaceuticals ( (ADIL) ) has issued an announcement.

On February 25, 2025, Adial Pharmaceuticals announced a positive response from the FDA regarding its in vitro bridging strategy for AD04, following a submission made on November 19, 2024. This agreement with the FDA marks a significant regulatory milestone, allowing Adial to proceed with manufacturing clinical supplies for the upcoming Phase 3 clinical program in 2025, advancing AD04 toward potential market approval as a treatment for addiction.

More about Adial Pharmaceuticals

Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders. The company’s lead investigational product, AD04, targets Alcohol Use Disorder in heavy drinking patients and has shown promising results in clinical trials. AD04 is also believed to have potential applications in treating other addictive disorders such as opioid use disorder, gambling, and obesity.

YTD Price Performance: -27.83%

Average Trading Volume: 153,543

Technical Sentiment Consensus Rating: Buy

Current Market Cap: $4.95M

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