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. (NASDAQ: ADIL) is a clinical-stage biopharmaceutical company dedicated to developing treatments for addiction and related disorders. The company's primary focus is on creating personalized therapies that address the unique needs of individuals suffering from substance abuse. Adial's flagship product, AD04, is a serotonin-3 receptor antagonist aimed at treating Alcohol Use Disorder (AUD) in patients with specific genetic profiles. AD04 has shown promise in reducing excessive drinking in heavy drinking patients and has been investigated in the company's ONWARD™ pivotal Phase 3 clinical trial. The active ingredient in AD04 is ondansetron, which is commonly used to prevent nausea and vomiting, and now brings potential benefits in addiction treatment.
Adial leverages its expertise in pharmacogenomics to develop therapies that are tailored to the genetic makeup of patients. This approach has the potential to revolutionize the treatment of addiction by providing more effective and safer treatment options. The company recently regained compliance with Nasdaq's listing requirements by maintaining a stockholders' equity of at least $2.5 million. Adial has also been active in forming strategic partnerships, including an agreement with Adovate, LLC, which could yield up to $83 million in milestone payments and commercial royalties.
Adial's intellectual property portfolio is robust, with multiple patents protecting the combination of its genetic diagnostics and AD04 for the treatment of AUD, Opioid Use Disorder (OUD), and other dependencies. The company's recent awards include the 2023 Best Practices Technology Innovation Leadership Award from Frost & Sullivan. Financially, Adial is in a stable position, with cash and cash equivalents allowing it to fund operations into the first quarter of 2025. The company's research and development expenses have been judiciously managed, ensuring that resources are effectively utilized.
Recent studies have underscored the safety and efficacy of AD04, highlighting its favorable liver safety profile compared to placebo and its potential to treat other addictive disorders like gambling and obesity. Adial has initiated new activities related to its clinical development plan, including two parallel Phase 3 clinical trials of AD04 to support its approval in the shortest timeframe possible. The company is also engaging with the FDA to refine its study designs and enhance the likelihood of regulatory success.
Adial Pharmaceuticals continues to make significant strides in its mission to develop innovative solutions for addiction treatment, offering hope to millions affected by these disorders worldwide.
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.
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.
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