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, Inc. (NASDAQ: ADIL; ADILW) announced the engagement of The Keswick Group, LLC, led by Tony Goodman, to enhance its partnering efforts. This strategic move follows recent analysis of the ONWARD™ data, which highlighted significant results for the AD04 treatment in reducing heavy drinking days among specific genotypes. With promising outcomes from the Phase 3 clinical trial, Adial aims to secure strategic partnerships to expedite AD04's market entry, targeting both the U.S. and European regulatory environments. The company focuses on addiction therapies, with AD04 also positioned for potential treatment of opioid use disorder and other addictions.
Adial Pharmaceuticals, based in Charlottesville, Va., announces that Cary Claiborne, CEO, will present at the 35th Annual Roth Conference on March 14, 2023. The event takes place at The Ritz Carlton, Laguna Niguel in Dana Point, California, and Claiborne's presentation is scheduled for 12:00 PM PT. Investors can access a live audio webcast of the presentation via this link. Adial focuses on developing therapies for addiction; its lead drug AD04 targets Alcohol Use Disorder with promising results from its Phase 3 trial.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has announced a strategic update regarding its lead compound, AD04, for Alcohol Use Disorder (AUD). A Type C meeting with the FDA is confirmed for Q2 2023, alongside planned discussions with five European regulatory authorities. Recent analysis of ONWARD™ data has identified specific genotypes with promising responses to AD04, and market research indicates potential unit pricing could exceed previous estimates. The company aims to engage partners for U.S. and European commercialization, highlighting a significant market opportunity for AUD treatment.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) is set to host a conference call and webcast on March 7, 2023, at 8:15 a.m. ET, to discuss updates on its regulatory and partnering strategies in the United States and Europe. The call will also cover findings from a subgroup analysis of ONWARD data related to its lead investigational drug, AD04, aimed at treating Alcohol Use Disorder (AUD). During the ONWARD Phase 3 trial, AD04 showed promising results in reducing heavy drinking among targeted genotype patients. The event is accessible via a live webcast and telephone for wider participation.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced on February 24, 2023, that it will conduct a $0.75 million registered direct offering of common stock. The purchase price is set at $0.41 per share, totaling 1,829,269 shares to be sold. The offering is arranged through Joseph Gunnar & Co., LLC as the placement agent and is expected to close on February 24, 2023, pending customary conditions. The offering is registered under an effective Form S-3 registration statement with the SEC, and a prospectus supplement will be filed to provide further details.
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) announced plans for significant regulatory meetings in 2023, including a Type C meeting with the FDA in the second quarter. These discussions aim to advance clinical development for AD04, targeting alcohol use disorder (AUD). The company is also engaging with five European regulatory authorities, seeking guidance toward expedited approvals. CEO Cary Claiborne emphasized these meetings as crucial for completing AD04's development and exploring potential partnerships for funding and market strategies. The ONWARD™ Phase 3 trial showed promising results for AD04, potentially expanding its use to other addictions.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced a strategic focus on the late-stage development of AD04 for Alcohol Use Disorder (AUD) while potentially selling its subsidiary, Purnovate, to a new entity led by former CEO William Stilley. This option agreement allows Adenomed to purchase Purnovate's assets for $450,000, with Adial eligible for up to $83 million in milestones and royalties. The deal aims to reduce Adial's burn rate and extend its cash runway. Stilley plans to maximize Purnovate's drug candidates' value, emphasizing the potential of adenosine technology in unmet medical needs.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) is advancing its regulatory strategy for AD04, following promising Phase 3 ONWARD™ trial results for treating Alcohol Use Disorder (AUD). The company aims for commercialization in Europe and North America, positively impacting millions with AUD. Adial also reported financial results for Q3 2022, with a reduced net loss of $3.1 million ($0.12/share), down from $4.3 million in Q3 2021. Additionally, R&D expenses decreased by 26% to $1.3 million, while general and administrative costs fell by 18% to $1.9 million, highlighting improved cost management.
Adial Pharmaceuticals announced positive results for PNV-5030, a treatment for chronic pain, demonstrating significant pain reduction in animal models. In a study involving rats, PNV-5030 reduced pain by up to 76% compared to placebo and showed higher efficacy than acetaminophen. The drug exhibited over 1000-fold selectivity over the A1 receptor and improved solubility by more than 50 times compared to similar compounds. This breakthrough could lead to advancements toward human clinical trials, enhancing Adial's drug development pipeline.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has reported promising results for its PNV-6005, a selective adenosine 2A receptor agonist, in treating ulcerative colitis in an animal model. The study showed that PNV-6005 significantly reduced weight loss (over 50% inhibition) and prevented colon damage, suggesting strong anti-inflammatory properties. Conducted by experts at UC San Diego, the research aligns with Adial's strategy to advance this candidate towards human clinical trials amid a growing ulcerative colitis market projected to reach $10.8 billion by 2030.
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