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.
About Adial Pharmaceuticals Inc.
Adial Pharmaceuticals Inc. (NASDAQ: ADIL) is a clinical-stage biopharmaceutical company dedicated to transforming the treatment landscape for addiction and related disorders through precision medicine. Headquartered in Glen Allen, Virginia, the company leverages cutting-edge pharmacogenomics and companion diagnostics to develop innovative therapies tailored to individual genetic profiles, addressing the growing need for personalized treatment solutions in addiction care.
Core Focus and Lead Product
The company's flagship investigational product, AD04, is a genetically targeted serotonin-3 receptor antagonist designed to treat Alcohol Use Disorder (AUD) in heavy-drinking patients. AD04's mechanism of action focuses on reducing alcohol cravings by modulating the 5HT3 pathway, offering a novel and complementary approach to existing AUD therapies. This targeted therapy is supported by Adial's proprietary companion diagnostic test, which identifies specific genotypes (such as rs1150226-AG and rs1176713-GG) that are most likely to benefit from the treatment. This innovative approach not only enhances treatment efficacy but also minimizes adverse effects, ensuring a safer and more tailored patient experience.
Pipeline and Expansion Potential
Beyond AUD, Adial is exploring the potential of AD04 to treat a range of other addictive disorders, including Opioid Use Disorder, gambling addiction, and obesity. This expansion underscores the versatility of their pharmacogenomic platform and their commitment to addressing unmet medical needs in addiction care. The company's robust intellectual property portfolio, including patents covering their molecular genetic approach, positions them as a leader in genetically targeted addiction therapies.
Scientific Innovation and Clinical Progress
Adial's research and development efforts are grounded in rigorous clinical science. The company recently completed pivotal pharmacokinetics studies for AD04, demonstrating its bioavailability and safety profile. These findings, coupled with promising results from the ONWARD™ Phase 3 clinical trial, highlight AD04's potential to significantly reduce heavy drinking days among genetically predisposed patients. The company's alignment with the FDA's 505(b)(2) regulatory pathway further enhances their prospects for expedited approval and commercialization.
Market Position and Competitive Edge
Operating within the highly competitive biopharmaceutical sector, Adial Pharmaceuticals differentiates itself through its precision medicine approach. By combining genetic diagnostics with targeted therapies, the company addresses a critical gap in addiction treatment—offering solutions for patients who may not respond to traditional methods. This strategic focus not only strengthens their market position but also aligns with emerging trends in personalized healthcare.
Commitment to Transformative Healthcare
Adial Pharmaceuticals is driven by a mission to revolutionize addiction treatment through innovative science and patient-centric solutions. With a clear focus on leveraging genetic insights and pharmacology, the company is poised to make a meaningful impact on the lives of individuals struggling with addiction. As they advance their pipeline and prepare for regulatory milestones, Adial remains committed to delivering therapies that are both effective and accessible.
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.
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.
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