ADIL

GLEN ALLEN, Va., May 11, 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 2026 first quarter ended March 31, 2026. “We are very encouraged by the continued progress we have made in early 2026 to advance AD04 toward late-stage development, particularly in light of several important regulatory and strategic developments that we believe meaningfully strengthen our path forward,” said Cary Claiborne, Chief Executive Officer of Adial. “Most notably, recent Food and Drug Administration (FDA) policy discussions indicating that, in certain scientifically justified cases, approval may be supported by one adequate and well-controlled study together with confirmatory evidence, rather than the traditional requirement of two independent pivotal trials, represents an increased emphasis on the FDA’s existing flexibility in the development landscape. Given that Phase 3 trials are the most capital-intensive stage of development, this evolving framework could substantially reduce costs, improve capital efficiency, and accelerate our potential timeline to NDA submission.” “At the same time, we are seeing growing bipartisan support and regulatory momentum toward more patient-centered clinical trial endpoints in Alcohol Use Disorder (AUD), including measures such as reductions in heavy drinking, cravings, and overall disease severity, where such measures reflect clinically meaningful improvement for patients, rather than strict abstinence alone. This shift is further reinforced by recent Congressional action, including the introduction of bipartisan legislation aimed at expanding access to emerging therapies for veterans suffering from AUD, which supports investigational treatments aligned with the government’s updated definition of recovery, including non-abstinence-based approaches and harm reduction outcomes. These developments are highly aligned with the clinical profile and intended real-world benefit of AD04, and we believe they further validate our approach to developing a differentiated, precision medicine treatment for AUD.” “From a strategic standpoint, we were also pleased to establish a collaboration fram...

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 our ability to execute a ri...

GLEN ALLEN, Va., Nov. 14, 2025 (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 third quarter of 2025. Cary Claiborne, CEO of Adial Pharmaceuticals, commented, “We continue to achieve meaningful milestones on our path toward U.S. Food and Drug Administration (FDA) approval and eventual commercialization of AD04, our lead investigational drug, a serotonin-3 receptor antagonist being developed for the treatment of Alcohol Use Disorder (AUD). A key highlight of our recent progress was the successful End of Phase 2 (EOP2) meeting with the FDA, where we received valuable guidance on critical elements of our planned adaptive Phase 3 study design — including the target population, clinical endpoints, inclusion and exclusion criteria, dosing regimen, and validation of both biomarker-positive and biomarker-negative groups.” “We are now implementing the FDA’s recommendations based on this meeting, positioning us to advance confidently toward registrational Phase 3 development. The AD04 program aims to deliver targeted and commercially focused success following approval, specifically for patients who are biomarker-positive for AG+, a subset of the AUD population identified through our proprietary genetic test. The AG+ biomarker is found in approximately 14% of the general population, as supported by large-scale epidemiological studies and previous AD04 clinical trial data.” “We are also encouraged by recent U.S. Senate support for expanding clinical trial endpoints beyond abstinence in evaluating treatments for Alcohol and Substance Use Disorders. The bipartisan Appropriations Committee’s recommendation for the FDA and the National Institute on Drug Abuse (NIDA) to consider additional measures, such as reduced cravings, decreased use, and lowered disorder severity, strongly reinforces our therapeutic approach and patient-centered philosophy. Our AD04 program has always focused on reducing alcohol consumption and cravings rather than enforcing an all-or-nothing abstinence model, and it is encouraging to see legislative recognition of the need for more realistic and compassionate treatment outcomes. This forward-l...

GLEN ALLEN, Va., Aug. 14, 2025 (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 second quarter of 2025. Cary Claiborne, CEO of Adial Pharmaceuticals, commented, “We believe we are at an inflection point in Adial’s journey. With the successful completion of our End of Phase 2 meeting with the Food and Drug Administration (FDA), we have received critical input from the FDA on the clinical and statistical design of our upcoming Phase 3 trial for AD04, our lead investigational drug and a serotonin-3 receptor antagonist being developed for the treatment of Alcohol Use Disorder (AUD). This includes agreement on key protocol elements—such as patient population, endpoints, biomarker stratification, and adaptive enrichment strategies—all of which are designed to increase the likelihood of success and support a streamlined path to approval. We expect to receive the official meeting minutes from the FDA within 30 days of the meeting date.” “Additionally, our collaboration with Cytel has been instrumental in shaping a precision-driven, data-informed strategy. By applying advanced machine learning tools and simulation modeling, we’ve identified genetically defined subgroups most likely to benefit from AD04. This enables us to pursue a highly targeted and efficient Phase 3 program, with the potential for interim analyses that could accelerate timelines and increase value creation for shareholders.” “In parallel, we have secured U.S.-based manufacturing agreements with Thermo Fisher Scientific and Cambrex to ensure robust drug product and drug substance supply. These partnerships not only provide the clinical and commercial manufacturing capacity we need but also reduce supply chain risk and strengthen our Chemistry, Manufacturing, and Controls (CMC) position for future NDA submission. The demonstration batches are already complete, and we’re well positioned to initiate registration and validation batches in support of the clinical program.” “We look forward to advancing the clinical program for AD04 and with our progress on the regulatory, clinical, and manufacturing fronts, we are optimistic about achieving a succ...

GLEN ALLEN, Va., May 15, 2025 (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 first quarter of 2025. Cary Claiborne, CEO of Adial Pharmaceuticals, commented, “We made meaningful progress during the first quarter of 2025, completing foundational steps that position us to advance swiftly toward the initiation of our Phase 3 clinical trial for AD04, our lead investigational drug for Alcohol Use Disorder (AUD).” “One of the key achievements this quarter was the successful completion of our pharmacokinetics bridging study, AD04-103, which confirmed that AD04 delivers favorable and consistent bioavailability, with or without food. This reinforces a flexible and patient-friendly dosing regimen that supports real-world use. Following this milestone, we have commenced manufacturing of our clinical trial supply, ensuring we are operationally ready to enter the next stage of development.” “We were also pleased to receive confirmation from the FDA supporting our proposed 505(b)(2) in vitro bridging strategy. This strategy leverages data from the AD04-103 study, along with in vitro dissolution data demonstrating equivalence between the formulation used in our prior Phase 3 ONWARD trial and the planned commercial formulation of AD04. This regulatory alignment represents a significant validation of our development plan and enables a more streamlined and efficient path into our next pivotal study. In parallel, we continue to strengthen our intellectual property portfolio with multiple granted patents that broaden and extend protection around AD04’s formulation, method of use, and its genetically guided patient targeting strategy—further enhancing the value and defensibility of our program.” “Looking ahead, we are preparing for our End of Phase 2 meeting with the FDA in July to finalize key aspects of our Phase 3 trial design and protocol. This engagement represents a pivotal milestone, offering regulatory clarity and ensuring alignment on our development plans. Given the strong progress made across clinical, regulatory, and operational fronts, we believe we are well-positioned to proceed efficiently. The foundation...