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) has received a Notice of Allowance from the United States Patent and Trademark Office for a new patent. This patent will expand Adial's intellectual property protection for its lead investigational drug, AD04, designed to treat alcohol use disorder (AUD). The patent covers additional genotype combinations identified through the Company's proprietary genetic diagnostic tool, enhancing AD04's precision medicine approach.
Cary Claiborne, CEO of Adial Pharmaceuticals, stated that this milestone broadens their patent estate and provides greater flexibility in advancing AD04. He emphasized the company's commitment to delivering innovative, genetically-targeted treatments for addiction. The patent notification reinforces Adial's focus on using cutting-edge science to develop more effective treatments with fewer side effects for those affected by addiction.
Adial Pharmaceuticals (NASDAQ: ADIL) commends the National Institute on Alcohol Abuse and Alcoholism (NIAAA) for its updated definition of recovery, which now includes non-abstinence solutions. This aligns with Adial's AD04 program for alcohol use disorder (AUD), which offers patients flexibility in reducing drinking and/or achieving abstinence.
The NIAAA's new definition, emphasized in its 2025 Professional Judgement Budget, recognizes that effective recovery solutions can focus on harm reduction and improved quality of life. This shift validates Adial's approach and potentially broadens its commercial and government market potential.
Cary Claiborne, CEO of Adial Pharmaceuticals, stated that AD04 is uniquely positioned to provide a therapeutic option for those seeking reduction in alcohol use or complete abstinence. The company is optimistic that NIAAA's new perspective will stimulate additional support for programs like AD04 in both commercial and government sectors.
Adial Pharmaceuticals (NASDAQ: ADIL) has announced the database lock for its pharmacokinetics study of AD04, the company's lead investigational treatment for Alcohol Use Disorder (AUD) in heavy drinking patients. The study, which enrolled 30 healthy adult volunteers, compared the pharmacokinetic profile of AD04 at a 0.33 mg oral dose, with or without food, against a reference standard product.
Topline results are expected in the fourth quarter of 2024. The data has been transferred to independent statisticians for analysis, which will inform Adial's next FDA interaction and help shape the clinical strategy for the upcoming Phase 3 study. The company believes these results will strengthen its position for potential strategic collaborations and future clinical development of AD04.
Adial Pharmaceuticals (NASDAQ: ADIL), a clinical-stage biopharmaceutical company focused on addiction treatment therapies, has announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference. The event will take place from September 9-11, 2024 at the Lotte New York Palace Hotel in New York City.
CEO Cary Claiborne will represent Adial at the conference. The company's presentation will be available on-demand to registered attendees starting September 9, 2024, at 7:00 AM Eastern Time. Investors can access the presentation webcast through the conference platform or Adial's investor relations website.
Additionally, Adial's management team will be conducting one-on-one meetings with qualified investors throughout the conference. Interested parties can request meetings by contacting adil@crescendo-ir.com.
Adial Pharmaceuticals (NASDAQ: ADIL) reported its Q2 2024 financial results and provided a business update. Key highlights include:
1. Initiated a pharmacokinetics study of AD04, their lead investigational drug for Alcohol Use Disorder (AUD), with topline results expected in Q4 2024.
2. Collaborated with Boudicca Dx to develop a companion diagnostic genetic test for AD04.
3. Filed a new patent application extending intellectual property protection to 2044.
4. Published two peer-reviewed articles supporting AD04's potential efficacy and safety profile.
5. Cash and cash equivalents were $3.3 million as of June 30, 2024.
6. Net loss was $2.5 million for Q2 2024, compared to a net income of $1.1 million in Q2 2023.
7. R&D expenses increased by $583,000 and G&A expenses increased by $228,000 compared to Q2 2023.
Adial Pharmaceuticals (NASDAQ: ADIL) has partnered with Boudicca Dx to advance the regulatory strategy for its companion diagnostic genetic test. This test is designed to accompany AD04, Adial's lead investigational asset for Alcohol Use Disorder (AUD) treatment. Boudicca Dx will support Adial in ensuring the test's compliance with FDA guidelines, a important step in Adial's regulatory strategy and preparation for its planned Phase 3 program.
The collaboration aims to validate the companion diagnostic both technically and clinically, supporting patient identification and recruitment for AD04 trials. This partnership is seen as a key component in Adial's mission to develop a first-in-class precision medicine for AUD treatment, addressing a significant unmet need in a disease affecting over 30 million people in the US and causing 3 million deaths worldwide annually.
Adial Pharmaceuticals (NASDAQ: ADIL) has announced the completion of patient dosing in the pharmacokinetics study of AD04, their lead investigational treatment for Alcohol Use Disorder (AUD). The study, involving 30 healthy adult volunteers, aims to optimize dosing and enhance efficacy and safety for AUD patients. Topline results are expected in the fourth quarter of 2024.
The single-center open-label study compares the pharmacokinetic profile of AD04 at a 0.33 mg oral dose, with or without food, against a reference standard. This milestone brings Adial closer to initiating their Phase 3 clinical trial and supports ongoing partnership discussions. The company plans to review the data thoroughly and engage with the FDA to align their development plan with regulatory expectations.
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.
