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, Inc. (NASDAQ: ADIL; ADILW) announced the denial of its Fast Track Designation request from the FDA for its drug candidate AD04, aimed at treating Alcohol Use Disorder in pediatric and adult patients with Alcoholic Liver Disease. The FDA cited insufficient evidence of AD04's potential to address unmet medical needs given existing treatments. Despite FDA acknowledgment of the medical need, further data is required for reconsideration. The ongoing ONWARD Phase 3 trial continues to evaluate AD04's efficacy in genetically screened patients across multiple countries.
Adial Pharmaceuticals has announced plans to enter the genetic testing market following a Notice of Allowance from the U.S. Patent and Trademark Office. This patent covers the use of a genetic diagnostic panel in combination with its product AD04 for treating Alcohol Use Disorder (AUD) and potentially Opioid Use Disorder (OUD). The company estimates a multi-billion dollar market opportunity, anticipating that genetic evaluations can help identify patients likely to benefit from AD04. If approved, the patent will provide market exclusivity, enhancing Adial's commercial strategy.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) acknowledges an article by Kate Julian in The Atlantic addressing the growing crisis of Alcohol Use Disorder (AUD) in the U.S., worsened by COVID-19 lockdowns. The company emphasizes that around 35 million Americans suffer from AUD annually, leading to significant health and economic burdens, costing roughly $250 billion yearly. Adial's investigational drug AD04 is currently being evaluated in the ONWARD™ Phase 3 trial aimed at treating AUD, showing promising results in previous trials.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has successfully completed a $2.1 million private placement of 700,001 shares at $3.00 each. This transaction involved key investors including Bespoke Growth Partners and Keystone Capital Partners. Following SEC approval, the company received $1,809,000, having initially secured $291,003. Adial is currently conducting the ONWARD Phase 3 clinical trial for its lead drug candidate, AD04, targeting alcohol use disorder, with continued optimism regarding its market potential and expansion into other indications.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) addresses the growing problem of addiction exacerbated by the COVID-19 pandemic. CEO William Stilley and CMO Dr. Bankole Johnson highlighted the alarming rise in alcohol abuse, termed the 'Second Pandemic of Addiction,' with increased fatalities projected. Adial's Phase 3 drug candidate, AD04, aims to combat Alcohol Use Disorder, showing promising results in earlier trials. The ONWARD clinical trial involves 290 participants across seven countries and targets a genetically specific patient population.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced Dr. Bankole Johnson's interview on The Black News Channel, discussing the COVID-19 pandemic's long-term effects on mental health and addiction. The company focuses on developing treatments for addiction disorders, with its lead product, AD04, currently in a pivotal Phase 3 trial for Alcohol Use Disorder. Past results from a Phase 2b trial indicated a significant reduction in drinking frequency and quantity without major safety concerns. The replay of the interview is available on the company's website.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has entered into Securities Purchase Agreements for a private placement of 700,001 shares of common stock at $3.00 each, raising $2,100,000. The funding includes an initial $291,003, with $1,809,000 to be provided upon share registration. Investors include members of management and Keystone Capital Partners. Adial focuses on addiction treatment, with its lead drug AD04 currently in a pivotal Phase 3 clinical trial for Alcohol Use Disorder (AUD). The trial is being conducted across 25 sites in seven countries.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced a Town Hall meeting for shareholders on March 18, 2021, at 1 PM ET. The company focuses on developing addiction treatments, particularly its lead product, AD04, which is in a Phase 3 clinical trial for Alcohol Use Disorder (AUD). AD04 exhibited promising results in earlier trials. The ONWARD trial evaluates its efficacy in genetically selected patients across multiple locations in Europe. The company highlighted the necessity of ongoing clinical trials and regulatory approvals for its product candidates.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced the exercise of 712,500 warrants, generating net proceeds of $1,425,000. The funds will aid in advancing the development of AD04, a treatment for Alcohol Use Disorder (AUD), currently undergoing pivotal Phase 3 trials called ONWARD. This trial includes genetically targeted patients and is being conducted across seven countries. Previous Phase 2b trials of AD04 showed significant reductions in drinking frequency and quantity, with no major safety issues reported.
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.