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Adial Pharmaceuticals ( (ADIL) ) has shared an update.
On September 16, 2025, Adial Pharmaceuticals announced receiving final meeting minutes from its End of Phase 2 meeting with the FDA, held on July 29, 2025. The FDA provided positive feedback on the AD04 Phase 3 clinical trial design, marking a significant milestone in its development for treating Alcohol Use Disorder (AUD). The FDA recognized AUD as an unmet need and supported Adial’s trial design, including key elements such as biomarker stratification and efficacy endpoints. This regulatory alignment positions Adial to advance AD04 towards registration, enhancing its clinical predictability and setting a benchmark for targeted therapeutics in neuropsychiatry. The milestone also opens opportunities for strategic partnerships, with AD04 poised to become the first genetically targeted therapy for AUD.
The most recent analyst rating on (ADIL) stock is a Buy with a $2.00 price target. To see the full list of analyst forecasts on Adial Pharmaceuticals stock, see the ADIL Stock Forecast page.
Spark’s Take on ADIL Stock
According to Spark, TipRanks’ AI Analyst, ADIL is a Underperform.
Adial Pharmaceuticals’ overall stock score is low due to ongoing financial struggles, including a lack of revenue and reliance on external funding. Technical analysis provides no strong directional signal, and valuation metrics are weak due to negative earnings. However, the recent FDA approval for AD04 offers a positive strategic outlook, but this is not enough to counteract the financial and operational challenges currently faced.
To see Spark’s full report on ADIL stock, click here.
More about Adial Pharmaceuticals
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing treatments for addictions and related disorders. The company’s lead investigational drug, AD04, is a serotonin-3 receptor antagonist aimed at treating Alcohol Use Disorder (AUD) in heavy drinking patients with specific genotypes. AD04 has shown promise in reducing drinking and has potential applications in treating other addictive disorders.
Average Trading Volume: 8,754,810
Technical Sentiment Signal: Sell
Current Market Cap: $7.64M
See more insights into ADIL stock on TipRanks’ Stock Analysis page.