Business
Adial Pharmaceuticals Reports 2025 Fiscal Year Financial Results and Provides Business Update
GLEN ALLEN, Va., March 06, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical
About this update from Adial Pharmaceuticals, Inc
[{"type":"text","content":"GLEN ALLEN, Va., March 06, 2026 (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 provided a business update and reported its financial results for the 2025 fiscal year ended December 31, 2025. Key Highlights: Regulatory Progress: Achieved positive clinical study results from the AD04-103 pharmacokinetics (PK) study supporting AD04’s pharmacologic profile and regulatory strategy.Received a positive response from the U.S. Food and Drug Administration (FDA) regarding the Company’s proposed in vitro bridging strategy.Successfully completed its End-of-Phase 2 (EOP2) meeting, advancing regulatory alignment toward Phase 3 development. Expanded Intellectual Property Portfolio: Strengthened IP coverage with multiple U.S. patents issued covering genotype-specific treatment of opioid disorders and expanded genetic-based approaches for treating and diagnosing Alcohol Use Disorder (AUD) and other dependencies.Filed a Patent Cooperation Treaty (PCT) application to protect core assets and extend international exclusivity by 14 years through at least 2045. Strategic Partnerships & Development Support: Engaged Cytel Inc., a global leader in advanced clinical trial design and statistical methodologies, to support AD04 Phase 3 planning.Partnered with Genomind to implement precision medicine testing solutions aligned with genotype-guided therapeutic strategy. U.S.-Based Manufacturing Secured: Secured U.S. manufacturing supply partnerships with Cambrex and Thermo Fisher Scientific for drug substance and drug product supply in support of late-stage development and future commercialization readiness. “2025 was a pivotal year for Adial as we continued to advance AD04 scientifically, strategically, and within an evolving regulatory landscape,” said Cary Claiborne, Chief Executive Officer of Adial Pharmaceuticals. “Our positive AD04-103 pharmacokinetic results, productive End-of-Phase 2 meeting with the FDA, and supportive FDA feedback on our in vitro bridging strategy provided meaningful validation of our clinical and regulatory approach. Engaging Cytel for advanced statistical design and partnering with Genomind for precision medicine testing further strengthens o...