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 announced a significant milestone in its ONWARD™ pivotal Phase 3 clinical trial, achieving 50% enrollment for its lead drug candidate, AD04, targeting Alcohol Use Disorder. With 66% of planned patient screening visits completed, Adial expects to fully enroll by summer. 32% of screened patients are genetically positive for AD04, with a 75% enrollment rate among these patients. The trial retains an impressive 86% patient retention rate, surpassing the projected 70%. This trial, conducted across 25 clinical sites in Europe, investigates the drug's efficacy and safety.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced its intention to file for Fast Track designation with the FDA for its lead drug candidate, AD04, aimed at treating Alcohol Use Disorder (AUD). This follows an earlier request submitted in September 2020. Adial believes that AD04 qualifies due to the seriousness of AUD and the unmet medical need it addresses. The FDA typically reviews Fast Track applications within 60 days, assessing factors like treatment impact and safety compared to existing therapies. AD04 is currently undergoing a pivotal Phase 3 clinical trial.
Adial Pharmaceuticals will present an overview at the 23rd Annual ICR Conference on January 14, 2021, from 3:15 PM to 3:55 PM ET. CEO William Stilley will lead the presentation, which will focus on the company's advancements in treatments for addictions, particularly the investigational drug AD04 aimed at treating Alcohol Use Disorder (AUD). This drug is currently in a pivotal Phase 3 trial. A live webcast will be available on Adial's website, with replays accessible for 90 days.
Adial Pharmaceuticals (NASDAQ:ADIL; ADILW) announced the receipt of a Notice of Allowance for its third U.S. patent for AD04, aimed at treating Opioid Use Disorder (OUD) in patients with a specific genetic biomarker. CEO William Stilley highlighted the significant market potential for AD04, emphasizing its similar physiological effects in treating alcohol and opioid addictions. The CDC noted that approximately 2 million people in the U.S. had OUD in 2018, a number expected to have increased during the pandemic. AD04 is currently undergoing a pivotal Phase 3 trial for Alcohol Use Disorder.
Adial Pharmaceuticals announced reaching a 35% enrollment milestone in its ONWARD™ Phase 3 trial, evaluating the efficacy of its drug candidate AD04 for treating Alcohol Use Disorder (AUD) in Europe. The company anticipates hitting 50% enrollment shortly, aided by a decrease in early termination rates and no reported serious adverse events. Amid the COVID-19 pandemic, adjustments have been made for remote participation. The urgent need for effective AUD treatments has intensified due to increased alcohol issues during lockdowns.
Adial Pharmaceuticals has appointed Dr. Jack Reich as its new Head of Regulatory, effective December 14, 2020. Dr. Reich brings over 35 years of experience from the pharmaceutical and biotechnology industries, previously co-founding significant firms like Gensia and Viagene. William Stilley, CEO of Adial, expressed optimism about Dr. Reich's role in advancing the company's lead candidate, AD04, for treating Alcohol Use Disorder (AUD). This strategic leadership change aims to enhance Adial's efforts in addressing regulatory opportunities and integrating upcoming assets.
Adial Pharmaceuticals (NASDAQ:ADIL; ADILW) announced a conference call on December 16, 2020, to discuss its planned acquisition of Purnovate and recent developments. The call will be accessible via phone and online, with a replay available for one year. Adial focuses on treatments for addiction, particularly its lead product AD04, which targets Alcohol Use Disorder (AUD). A Phase 2b trial of AD04 indicated statistical significance in reducing drinking behavior with no significant safety issues. The company aims to explore AD04's potential for other addictions.
Adial Pharmaceuticals has announced a transformative acquisition of Purnovate, a developer of non-opioid pain reduction therapies. This strategic move aims to diversify and expand Adial’s addiction-related pipeline, including its lead product AD04 for Alcohol Use Disorder, currently in Phase 3 trials. The acquisition is expected to enhance Adial’s drug portfolio and leverage Purnovate's expertise in adenosine analogs to tackle pain and addiction. However, successful completion is contingent on specific conditions, including a fair opinion from Adial’s financial advisor.
Adial Pharmaceuticals (NASDAQ:ADIL) issued a statement urging individuals struggling with substance use disorders to avoid driving under the influence, especially during the holiday season. CEO William Stilley emphasized the importance of understanding genetic factors in addiction treatment. The company is advancing its lead drug candidate, AD04, through clinical trials in seven countries, targeting Alcohol Use Disorder and potentially other addictions. A Phase 2b trial of AD04 demonstrated significant results in reducing drinking frequency and quantity without serious safety concerns.
Adial Pharmaceuticals has announced that its lead drug candidate, AD04, targeted for the treatment of Alcohol Use Disorder (AUD), was featured on the Local 12: Healthy Perspective news segment. This follows a prior feature on WKRC in Cincinnati, which has reached numerous media outlets nationwide. AD04 is currently being evaluated in a Phase 3 clinical trial and has demonstrated promising results, reducing the frequency and quantity of alcohol consumption with no significant safety concerns reported. The drug may also treat other addictive disorders.
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