Adial Pharmaceuticals Welcomes U.S. Senate Backing for Broader Clinical Trial Endpoints in Alcohol and Substance Use Disorder Treatments
Legislative Support for Clinical Trials: The U.S. Senate has shown support for expanding clinical trial endpoints beyond abstinence in substance use disorder treatments, particularly for Alcohol Use Disorder (AUD), encouraging the FDA to consider measures like reduced cravings.
Adial Pharmaceuticals' Response: Adial Pharmaceuticals applauds this legislative move as it aligns with their patient-centric approach and supports the development of their lead drug candidate, AD04, aimed at reducing alcohol intake and cravings.
AD04's Development and Potential: AD04 is a serotonin-3 receptor antagonist currently in Phase 3 trials, showing promise in reducing drinking among patients with AUD and potentially applicable to other addictive disorders such as opioid use disorder and gambling.
Forward-Looking Statements and Risks: The company acknowledges that its future success depends on various factors including regulatory approvals, funding, and market acceptance, while also emphasizing the need for ongoing updates regarding their progress and risks involved.
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- Legislative Support for New Therapies: The 2026 Appropriations Bill passed by Congress mandates collaboration between the FDA and NIDA to establish alternative clinical trial endpoints, emphasizing non-abstinence outcomes like reduced cravings, which is expected to enhance the regulatory pathway for Adial's AD04 therapy.
- Precision Medicine Strategy: Adial's investigational therapy AD04 is designed to treat Alcohol Use Disorder (AUD) using a precision medicine approach, aligning with the new legislation's focus on non-abstinence recovery goals, potentially accelerating clinical trial timelines and broadening clinical relevance.
- Public Health Challenge: AUD remains a significant public health issue affecting millions, and the passage of the new bill may provide Adial with clearer regulatory frameworks to address this substantial unmet treatment need.
- Impact of Policy Change: Adial's CEO Cary Claiborne noted that this legislation reflects a meaningful evolution in the evaluation and treatment of substance use disorders, which may foster innovation and improve clinical outcomes for patients.
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- Significant Revenue Growth: The quarterly revenue reached $12.68 billion, exceeding the market estimate of $10.22 billion and representing a 123.76% increase from $5.68 billion in the same period last year, showcasing the company's strong market performance and growth potential.
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- Positive Stock Reaction: In pre-market trading, Super Micro's shares jumped 10.5% to $32.79, indicating a favorable market response to its strong earnings and optimistic outlook.
- Reverse Stock Split: Adial Pharmaceuticals announced a 1-for-25 reverse stock split effective Thursday, reducing outstanding shares from 27.8 million to approximately 1.1 million, aimed at regaining compliance with Nasdaq's minimum bid price requirement, although this led to a more than 20% drop in after-hours trading.
- AD04 Development Progress: The reverse split coincides with Adial's advancement of AD04, a genetically targeted treatment for Alcohol Use Disorder, with Phase 3 trial design completed, focusing on heavy drinkers and specific genotypes, indicating positive clinical progress for the company.
- FDA Regulatory Discussions: Adial has completed End-of-Phase-2 discussions with the FDA, receiving input on the Phase 3 adaptive trial design and broader clinical program, covering key elements such as patient population and endpoints, ensuring focus on biomarker-positive and negative groups.
- Strengthened Intellectual Property: The company has enhanced intellectual property protection for AD04, with an international patent application published, expected to safeguard core assets until at least 2045, reflecting a long-term strategic vision for market positioning.










