Welcome to our dedicated page for Adial Pharmaceuticals news (Ticker: ADIL), a resource for investors and traders seeking the latest updates and insights on Adial Pharmaceuticals stock.
Adial Pharmaceuticals Inc (ADIL) is a clinical-stage biopharmaceutical company pioneering personalized treatments for alcohol use disorder through advanced pharmacogenomics. This page provides investors and healthcare professionals with essential updates on ADIL's clinical trials, regulatory milestones, and strategic initiatives.
Access timely announcements about the company's lead investigational drug AD04—a serotonin-3 receptor antagonist designed for genetically identified patient groups. Stay informed about clinical study results, FDA communications, intellectual property developments, and partnership opportunities that demonstrate ADIL's progress in addiction medicine.
Key updates include progress reports on the 505(b)(2) regulatory pathway, companion diagnostic advancements, and peer-reviewed research publications. All content is curated to help stakeholders track the company's evidence-based approach to treating addictive disorders through precision medicine.
Bookmark this page for direct access to primary source materials and analysis-free reporting on ADIL's scientific and corporate developments. Check regularly for new filings, trial data disclosures, and strategic announcements that shape the company's trajectory in biopharmaceutical innovation.
Adial Pharmaceuticals (NASDAQ: ADIL) announced completion of analytical validation for a cheek swab collection method and companion gene test developed with Genomind to identify serotonergic SNPs (HTR3A, HTR3B, SLC6A4) for AD04 clinical and future commercial use.
Genomind validated accuracy, reproducibility, and robustness across diverse samples and operators, reporting 100% concordance. The test detects long/short SLC6A4 promoter forms. FDA confirmed use of the test in Phase 3 is Non‑Significant Risk (NSR) and an IDE is not required. The AG+ biomarker is present in ~14% of the population. Adial also noted a new patent filing for AD04 expected to extend exclusivity to 2045.
Adial Pharmaceuticals (NASDAQ: ADIL) has received positive feedback from the FDA following their End-of-Phase 2 (EOP2) meeting regarding AD04, their lead drug candidate for Alcohol Use Disorder (AUD). The FDA has aligned with Adial's proposed Phase 3 adaptive trial design for AD04, a serotonin-3 receptor antagonist targeting AUD patients with specific genotypes.
Key elements approved include the biomarker-positive patient strategy, targeting the AG+ biomarker present in approximately 14% of the population. The FDA confirmed primary efficacy endpoints focusing on zero heavy drinking days during months 5 and 6 of the observation period. The agency also supported Adial's plans for interim analyses and provided guidance on statistical analysis plans.
The company views this regulatory milestone as pivotal for advancing toward Phase 3 trials and potentially becoming the first genetically targeted therapy for AUD. This development, combined with their recent patent filing potentially extending market exclusivity to 2045, positions AD04 as a significant commercial opportunity.
Adial Pharmaceuticals (NASDAQ: ADIL), a clinical-stage biopharmaceutical company focused on addiction treatment therapies, has received a 180-day extension from Nasdaq to regain compliance with the minimum bid price requirement. The extension follows the expiration of an initial 180-day compliance period on September 1, 2025.
The company now has until March 2, 2026 to maintain a minimum closing bid price of $1.00 per share for at least 10 consecutive business days. The notification does not immediately affect ADIL's listing status, and shares will continue trading on the Nasdaq Capital Market.
Adial Pharmaceuticals (NASDAQ: ADIL) welcomes recent U.S. Senate legislative support for expanding clinical trial endpoints beyond abstinence in substance use disorder treatments, particularly for Alcohol Use Disorder (AUD). The Senate Appropriations Committee passed a report with a bipartisan 26-3 vote, encouraging the FDA and NIDA to consider alternative endpoints such as reduced cravings and decreased disorder severity.
This development aligns with Adial's clinical strategy for AD04, their lead investigational drug, a serotonin-3 receptor antagonist designed to treat AUD in patients with specific genotypes. The legislative support validates the company's approach of focusing on reducing alcohol intake and cravings rather than complete abstinence.
Adial Pharmaceuticals (NASDAQ: ADIL) reported Q2 2025 financial results and provided significant updates on its AD04 drug development program for Alcohol Use Disorder (AUD). The company successfully completed its End of Phase 2 FDA meeting, receiving crucial input for its upcoming Phase 3 trial design. Cash position strengthened to $5.9 million as of June 30, 2025, up from $2.4 million in Q1, supported by a $3.0 million public offering.
Key developments include securing U.S. manufacturing partnerships with Thermo Fisher Scientific and Cambrex, regaining Nasdaq compliance, and filing an updated provisional patent expected to protect core assets until 2045. The company reported a reduced net loss of $2.0 million compared to $2.5 million in Q2 2024, with decreased R&D expenses by 28% and G&A expenses by 10%.
Adial Pharmaceuticals (NASDAQ:ADIL) has successfully completed its End of Phase 2 meeting with the FDA regarding AD04, its lead investigational drug for Alcohol Use Disorder (AUD). The FDA provided crucial input for the Phase 3 adaptive design clinical trial, focusing on treating AUD in individuals with heavy drinking and select genotypes, particularly the AG+ genotype.
The meeting aligned key elements including population selection, endpoints, inclusion/exclusion criteria, and dose regime. The company utilized advanced statistical analytics and simulation modeling to refine the trial design. CEO Cary Claiborne emphasized that this regulatory clarity is expected to enhance ongoing partnership discussions.
Adial Pharmaceuticals (NASDAQ: ADIL), a clinical-stage biopharmaceutical company focused on addiction treatment therapies, has successfully regained compliance with Nasdaq's listing requirements. The company received notice from Nasdaq on July 14, 2025 confirming its compliance with Rule 5550(b)(1), which mandates maintaining stockholders' equity of at least $2.5 million.
CEO Cary Claiborne emphasized this achievement as a crucial step in strengthening investor confidence and supporting the company's long-term growth strategy, while highlighting their commitment to disciplined financial management and pipeline advancement.
Adial Pharmaceuticals (NASDAQ: ADIL) has filed an update to its provisional patent application for AD04, its lead investigational therapeutic agent for Alcohol Use Disorder (AUD). The patent application, following the original filing in July 2024, aims to protect the company's core technology until at least 2045.
AD04 is a genetically targeted, serotonin-3 receptor antagonist designed to treat AUD in heavy drinking patients who consume more than 10 drinks per drinking day. The company is preparing for an End-of-Phase 2 (EOP2) Meeting with the FDA on July 29th. The updated patent application follows an extensive data review by newly hired patent counsel to strengthen Adial's intellectual property portfolio.
Adial Pharmaceuticals (NASDAQ: ADIL) has secured strategic manufacturing agreements with Cambrex and Thermo Fisher Scientific for the production of AD04 (0.33 mg ondansetron tablets), its lead drug candidate for Alcohol Use Disorder (AUD). Cambrex will supply the ondansetron HCL drug substance, while Thermo Fisher will handle drug product manufacturing.
The agreements cover manufacturing for upcoming Phase 3 clinical trials and New Drug Application (NDA) submission to the FDA, including demonstration, clinical, registration, and validation batches. The collaboration has already yielded results with the completion of required demonstration batches.
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