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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 appointment of Cary J. Claiborne to its Board of Directors, expanding the board to seven members. Claiborne brings extensive experience, having previously served as CFO of Indivior PLC and Sucampo Pharmaceuticals. His expertise in governance and finance is expected to support Adial as it advances its Phase 3 clinical trial of AD04 for alcohol use disorder and prepares for potential commercialization. Adial aims to leverage Claiborne's track record to enhance its corporate governance and strategic initiatives.
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) announced promising pre-clinical results for PNV-5030, a potential pain treatment. The compound showed over 1000-fold selectivity over the adenosine A1 receptor and significantly reduced pain in a mouse model. When combined with morphine, PNV-5030 achieved similar pain reduction to higher morphine doses. Purnovate, a subsidiary of Adial, plans to advance PNV-5030 into clinical trials in 2022, aiming to provide an alternative or complement to opioid use.
Adial Pharmaceuticals announced positive pre-clinical results for PNV-5030, indicating its potential to reduce opioid use and alleviate pain. PNV-5030 exhibited over 1000-fold selectivity over the adenosine A1 receptor and demonstrated superior solubility compared to other compounds in its class. In mouse models, PNV-5030 alone provided significant pain relief similar to low doses of morphine, and remarkably, when combined with morphine, it achieved pain relief equivalent to a higher morphine dose. The company plans to advance PNV-5030 into clinical trials in 2022.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has announced that CEO William Stilley will present at the Dawson James Securities Small Cap Growth Conference on October 21, 2021, at 9:45 am ET. The conference will take place at the Wyndham Grand Hotel in Jupiter, Florida, where Stilley will also hold one-on-one meetings with investors. Adial is focused on therapies for addiction, with its lead product AD04 currently in a pivotal Phase 3 clinical trial for Alcohol Use Disorder. Live webcast details can be found on Adial's investor relations website.
Adial Pharmaceuticals (NASDAQ:ADIL;ADILW) has been invited to present at the virtual MicroCap Rodeo Fall Harvest - Best Ideas Conference on October 5, 2021, at 2:30 PM ET. CEO William Stilley will present live, followed by one-on-one meetings during the event. Adial focuses on developing therapies for addiction, with its lead product, AD04, currently in a pivotal Phase 3 clinical trial for Alcohol Use Disorder. The company aims to address various addictive disorders, including Opioid Use Disorder.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has reported that over 50% of patients have completed the ONWARD™ Phase 3 trial for AD04, targeting Alcohol Use Disorder (AUD) based on specific genetic profiles. This 24-week trial, involving 25 sites across Scandinavia and Eastern Europe, aims to analyze the efficacy and safety of AD04. With 303 patients enrolled, the study anticipates a favorable safety profile and is expected to meet its primary endpoint by early 2022. The trial is designed to complement behavioral therapy, enhancing the potential treatment landscape for AUD.
Adial Pharmaceuticals has announced a research collaboration with Dr. Mark Roeser from the University of Virginia to create new adenosine formulations for transdermal application, targeting wound healing. Under the agreement, Purnovate will supply lead compounds while Dr. Roeser's team evaluates them for efficacy and optimal absorption. The University will fund pre-clinical studies, with jointly developed intellectual property. The pressure ulcer wound market is projected to hit $11.2 billion by 2026, highlighting significant market potential for these therapies.
Adial Pharmaceuticals, focused on addiction treatments, announced that CEO William Stilley will present at the H.C. Wainwright 23rd Annual Global Investment Conference from September 13-15, 2021. The presentation will be available on-demand starting September 13 at 7:00 AM Eastern Time. Adial's lead drug, AD04, is being studied in its ONWARD™ Phase 3 trial for Alcohol Use Disorder (AUD) targeting specific genetic profiles, following promising Phase 2b results. The company also explores treatments for other addictions and related disorders.
Adial Pharmaceuticals has successfully closed enrollment for its ONWARD™ Phase 3 trial, achieving 302 patients across 25 clinical sites, exceeding the target of 290. This trial is assessing AD04 for Alcohol Use Disorder (AUD) in patients with specific genetic markers. The company anticipates completing patient dosing by Q1 2022 and looks forward to releasing top-line data shortly thereafter. Preliminary retention rates and safety data indicate AD04 is well-tolerated, potentially positioning it favorably against existing AUD treatments.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has completed enrollment for its ONWARD™ Phase 3 clinical trial, targeting 290 participants with Alcohol Use Disorder (AUD) related to specific genetic markers. The trial is expected to conclude in Q1 2022. CEO William Stilley highlighted strong patient interest, with 33% of screened subjects testing positive for targeted genetics. The market potential for AD04, a novel treatment for AUD, is estimated to exceed $36 billion in the U.S. Additionally, the trial retention rate is high with no serious adverse events reported, enhancing the drug's safety profile.
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