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 been granted a new U.S. patent (No. 12,226,401) on February 18, 2025, expanding its genetic-based approach to treating and diagnosing alcohol use disorder and drug dependencies. The patent covers methods for identifying genetic markers in patients with alcohol or opioid-related disorders.
The patent specifically focuses on identifying genotypes including the AC genotype of rs17614942 in the HTR3B gene and the AG genotype of rs1150226 in the HTR3A gene. This advancement will enable healthcare providers to develop tailored treatment plans using AD04, Adial's investigational drug product. The precision medicine approach aims to optimize treatment outcomes while minimizing risks associated with standardized treatments.
Adial Pharmaceuticals (NASDAQ: ADIL) has been awarded U.S. patent number 12,221,654 on February 11, 2025, expanding its molecular genetic approach to diagnosing and treating addiction disorders. The patent covers methods for identifying patients with specific genetic markers linked to substance use disorders and treating them with AD04, the company's investigational drug.
The treatment specifically involves detecting the TT genotype of rs1042173 in the serotonin transporter gene (SLC6A4) and administering AD04 to patients. This approach is designed for treating various conditions including opioid dependence, opioid abuse, and alcohol dependence. The company aims to deliver personalized treatments by combining genetic diagnostics with precision medicine, targeting patients who may not respond to conventional therapies.
Adial Pharmaceuticals (NASDAQ: ADIL) has announced positive results from its AD04-103 pharmacokinetics study for AD04, a drug candidate being developed to treat Alcohol Use Disorder (AUD). The study, involving 30 healthy volunteers across two cohorts, demonstrated predictable bioavailability and dose proportionality in pharmacokinetic exposure.
The study confirmed that ondansetron pharmacokinetic exposure increased proportionally between AD04 0.33 mg tablets and marketed ondansetron 4 mg tablets, with no food effect on administration. These results support Adial's plans to pursue FDA approval under the 505(b)(2) regulatory pathway.
The company has submitted the results to the FDA and plans an End-of-Phase 2 meeting in the first half of the year to discuss the Phase 3 program design. The successful completion of this bridging study is expected to facilitate ongoing partnership discussions.
Adial Pharmaceuticals (NASDAQ: ADIL) has been granted U.S. patent number 12150931 on November 26, 2024, expanding its intellectual property coverage for treating alcohol and drug dependence. The patent covers broader genotype combinations identified by the company's proprietary genetic diagnostic for targeted treatment of alcohol use disorder (AUD) with AD04, their lead investigational drug. The patent specifically includes HTR3A, HTR3B, and SLC6A4 receptor sites, supporting their precision medicine approach to addiction treatment. This patent protection extends through 2031.
Adial Pharmaceuticals (NASDAQ: ADIL) announced positive topline results from the AD04-103 Pharmacokinetics Study for their alcohol use disorder treatment. The study, involving 30 healthy adult volunteers, confirmed AD04's relative bioavailability to reference ondansetron, demonstrated dose-proportional increases in pharmacokinetic exposure, and showed no food effect. The study met FDA requirements for upcoming Phase 3 trials and will help optimize the study design. Results showed AD04 0.33mg delivered lower ondansetron exposure than the 4mg reference tablet, with proportional increases across a 3-fold dose range. The company plans to engage with FDA in Q4 2024 to discuss Phase 3 study program.
Adial Pharmaceuticals (NASDAQ: ADIL) reported Q3 2024 financial results and business updates. The company achieved database lock for AD04's pharmacokinetics study in Alcohol Use Disorder (AUD) treatment. Cash position stood at $5.2 million as of September 30, 2024, expected to fund operations into H2 2025. Q3 net loss increased to $2.2 million from $1.4 million year-over-year. R&D expenses rose 399% due to clinical trial and CMC costs. The company partnered with Boudicca Dx for companion diagnostic development and secured new patent allowances.
Adial Pharmaceuticals (NASDAQ: ADIL) has appointed Vinay Shah as Chief Financial Officer, effective November 16, 2024. Shah brings over 25 years of experience in pharmaceutical and healthcare sectors, previously serving as CFO at Virpax Pharmaceuticals. His track record includes raising over $150 million at Aravive and contributing to Pacira Pharmaceuticals' IPO. The current CFO, Joseph Truluck, will resign on November 15, 2024, but will continue as a consultant through March 31, 2025, to ensure a smooth transition. Truluck's departure is not related to any disagreements with the company's operations or practices.
Adial Pharmaceuticals (NASDAQ: ADIL) has announced its participation in The ThinkEquity Conference on October 30, 2024, at the Mandarin Oriental Hotel in New York. CEO Cary Claiborne will deliver a presentation at 8:30 a.m. ET, and management will conduct one-on-one investor meetings throughout the day. The conference brings together institutional investors, corporate clients, and industry professionals to showcase innovations and financial strategies. Investors can register to attend and schedule meetings, with the presentation available via live stream.
Adial Pharmaceuticals (NASDAQ: ADIL) has received a Notice of Allowance from the United States Patent and Trademark Office for a new patent. This patent will expand Adial's intellectual property protection for its lead investigational drug, AD04, designed to treat alcohol use disorder (AUD). The patent covers additional genotype combinations identified through the Company's proprietary genetic diagnostic tool, enhancing AD04's precision medicine approach.
Cary Claiborne, CEO of Adial Pharmaceuticals, stated that this milestone broadens their patent estate and provides greater flexibility in advancing AD04. He emphasized the company's commitment to delivering innovative, genetically-targeted treatments for addiction. The patent notification reinforces Adial's focus on using cutting-edge science to develop more effective treatments with fewer side effects for those affected by addiction.
Adial Pharmaceuticals (NASDAQ: ADIL) commends the National Institute on Alcohol Abuse and Alcoholism (NIAAA) for its updated definition of recovery, which now includes non-abstinence solutions. This aligns with Adial's AD04 program for alcohol use disorder (AUD), which offers patients flexibility in reducing drinking and/or achieving abstinence.
The NIAAA's new definition, emphasized in its 2025 Professional Judgement Budget, recognizes that effective recovery solutions can focus on harm reduction and improved quality of life. This shift validates Adial's approach and potentially broadens its commercial and government market potential.
Cary Claiborne, CEO of Adial Pharmaceuticals, stated that AD04 is uniquely positioned to provide a therapeutic option for those seeking reduction in alcohol use or complete abstinence. The company is optimistic that NIAAA's new perspective will stimulate additional support for programs like AD04 in both commercial and government sectors.
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