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 focused on developing therapies for the treatment and prevention of addictions and related disorders. News about Adial often centers on the progress of its lead investigational drug, AD04, a genetically targeted serotonin-3 receptor antagonist being developed for Alcohol Use Disorder (AUD) in heavy drinking patients with specific genotypes.
On this page, readers can find coverage of Adial’s clinical development milestones, including updates on the ONWARD™ pivotal Phase 3 trial and preparations for a new Phase 3 adaptive program informed by End of Phase 2 (EOP2) feedback from the U.S. Food and Drug Administration (FDA). Company announcements describe FDA recognition of AUD as an unmet need, support for Adial’s adaptive trial design, and confirmation of primary efficacy endpoints based on heavy drinking days.
Adial’s news flow also highlights its precision medicine strategy. Releases describe a partnership with Genomind to validate a cheek swab genetic test that identifies SNPs in serotonergic system genes such as HTR3A, HTR3B, and SLC6A4, enabling selection of biomarker-positive patients, including those with the AG+ genotype. Additional stories cover intellectual property developments, such as provisional and international patent applications for AD04 that the company expects, once granted, to protect core assets to at least 2045.
Investors and observers can also follow capital markets and listing-related updates, including public offerings of stock and warrants, at-the-market sales agreements, Nasdaq compliance notices, and extensions related to minimum bid price requirements. Together, these items provide context on how Adial is financing and structuring its efforts to advance AD04 and its broader addiction treatment pipeline. Bookmark this page to review new regulatory, clinical, financing, and intellectual property announcements as they are reported.
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.