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; 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.
Adial Pharmaceuticals (ADIL) reports that its lead drug candidate, AD04, for treating Alcohol Use Disorder (AUD), has gained exposure on multiple television news programs. The coverage highlights the potential of AD04 to help individuals control cravings. The company is currently conducting a Phase 3 clinical trial for AD04, which previously demonstrated promising results in reducing drinking frequency and severity without significant safety concerns. This media attention is expected to raise awareness about AUD, especially during the holiday season.
Adial Pharmaceuticals (NASDAQ:ADIL, ADILW) has signed a Common Stock Purchase Agreement with Keystone Capital Partners, allowing the sale of up to $15 million in common stock over time. The company, which has over $7 million in cash as of September 30, 2020, emphasizes that there are no immediate capital-raising plans. AD04, its lead drug for Alcohol Use Disorder, showed promise in clinical trials. The partnership aims to support future growth opportunities in the underserved addiction treatment market.
Adial Pharmaceuticals (NASDAQ:ADIL; ADILW) announced progress in its ONWARD™ Phase 3 trial for AD04, targeting Alcohol Use Disorder (AUD). All 25 investigative sites are active, with over 25% of the patient enrollment completed. The enrollment rate has improved for four consecutive months, aiming for full enrollment by Q2 2021. Preliminary data reading is expected in Q4 2021. AD04 shows promising safety with no serious adverse events reported, and the potential market for AD04 in the U.S. is estimated to exceed $35 billion, addressing an urgent public health crisis exacerbated by COVID-19.
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