Adial Pharmaceuticals, Inc - ADIL STOCK NEWS

Adial Pharmaceuticals (NASDAQ: ADIL) has filed a new patent application for AD04, its lead investigational therapeutic agent for Alcohol Use Disorder (AUD) in heavy drinking patients. The patent, if granted, is expected to protect Adial's core assets until at least 2044. This application follows an extensive review of data and information, initiated after the company hired new patent counsel to strengthen its intellectual property portfolio.

AD04 is a genetically targeted, serotonin-3 receptor antagonist designed to treat AUD in patients consuming 10 or more drinks per drinking day. The company is currently advancing the AD04 program with ongoing pharmacokinetics studies. CEO Cary Claiborne emphasized the importance of this patent application in extending protection for Adial's core assets.

Adial Pharmaceuticals (NASDAQ: ADIL) has advanced to the second cohort in its pharmacokinetics study of AD04, a genetically targeted therapeutic agent for Alcohol Use Disorder (AUD). The study, initiated in June 2024, is expected to conclude in Q4 2024 with topline results from both cohorts. This single-center, open-label study will enroll up to 30 healthy adult volunteers to compare the pharmacokinetic profile of AD04 when administered as an oral dose of 0.33 mg with or without food against a reference standard product.

CEO Cary Claiborne expressed satisfaction with the study's progress, noting that the results will provide important insights for designing their upcoming Phase 3 Clinical Trial. Adial plans to engage with the FDA after receiving the topline data to seek feedback on their Phase 3 program design.

Adial Pharmaceuticals has announced the publication of results from its Phase 3 ONWARD study in the European Journal of Internal Medicine. The study focuses on AD04, a precision medicine for treating Alcohol Use Disorder (AUD) in patients with specific genetic profiles. Results show AD04 significantly reduces heavy drinking days after six months compared to a placebo in patients with certain genotypes. AD04's adverse events (AEs) are similar to those of a placebo, highlighting its safety. Additionally, combining AD04 with psychosocial interventions may increase treatment uptake among AUD patients.

Adial Pharmaceuticals has started dosing the first patient in a pharmacokinetics study of AD04, targeting Alcohol Use Disorder (AUD). This significant milestone is part of the preparation for the U.S. Pivotal Phase 3 trials and aims to optimize study design elements.

The study, expected to last 6 months, will help determine the optimal dosing regimen and fulfill FDA requirements for Phase 3. Results are anticipated in early Q4 2024.

This study is a important component in Adial’s strategy to advance partnership discussions and support a 505(b)(2) regulatory pathway application. The study involves two cohorts and up to 30 healthy adult volunteers.

Adial Pharmaceuticals (NASDAQ: ADIL), a clinical-stage biopharmaceutical company specializing in addiction therapies, will participate in the Spring MicroCap Rodeo Conference on June 6, 2024, in New York City.

CEO Cary Claiborne will present at 2:00 p.m. ET, with the presentation available via live webcast.

Adial's management will also conduct one-on-one meetings with approved investors throughout the event.

Adial Pharmaceuticals (NASDAQ: ADIL), a clinical-stage biopharmaceutical company, reported its Q1 2024 financial results and provided a business update. The company is advancing its lead drug, AD04, with plans for two parallel Phase 3 trials, following positive FDA feedback. Key patents were awarded for AD04's effectiveness in treating addiction disorders, marking a potential $40 billion market in the U.S.

Financially, Adial's cash and equivalents rose to $5 million, bolstered by $4.3 million from recent warrant exercises. However, net loss increased to $6.5 million, primarily due to a $4.5 million non-cash warrant issuance charge. R&D expenses rose by $88K, while G&A expenses decreased by $512K.

Additionally, a peer-reviewed article highlighted AD04's promising clinical results and safety profile. New COO Tony Goodman is expected to drive forward strategic growth and clinical initiatives.

Adial Pharmaceuticals, a clinical-stage biopharmaceutical company, has been granted a key patent by the United States Patent and Trademark Office. The patent covers the combination of the Company's genetic diagnostic with their lead investigational drug, AD04, for the treatment of alcohol use disorder and other drug dependencies. This patent expands Adial's intellectual property protection and opens up a significant market opportunity in the U.S. healthcare industry.

Adial Pharmaceuticals announces positive results from a peer-reviewed article highlighting the safety and efficacy of AD04 in treating Alcohol Use Disorder (AUD) without significant adverse effects. The study emphasizes the liver safety profile of AD04 compared to placebo, indicating promising clinical outcomes and high patient compliance.

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) provided a business update and reported financial results for the 2023 fiscal year. The company made significant progress towards the potential approval and commercial launch of its lead investigational new drug product, AD04, to treat Alcohol Use Disorder. Adial received positive feedback from US and EU regulators, engaged expert advisors, and is finalizing its clinical development plan. Discussions with potential strategic partners are advancing, and the company received $4.3 million in gross proceeds from warrant exercises. Adial also announced key patents related to genetic diagnostics for the treatment of Alcohol Use Disorder and opioid use disorder. The company received awards for technology innovation and completed a reimbursement agreement with Adovate, Financially, Adial reported $2.8 million in cash and cash equivalents, with total gross proceeds of $4.3 million from warrant exercises. Research and development expenses decreased by 35%, and general and administrative expenses decreased by 37%. The net loss for 2023 was $5.1 million, an improvement from the previous year.