Welcome to our dedicated page for Adial Pharmaceuticals news (Ticker: ADILW), a resource for investors and traders seeking the latest updates and insights on Adial Pharmaceuticals stock.
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) is a clinical-stage biopharmaceutical company dedicated to developing therapies for the treatment and prevention of addiction and related disorders. The company leverages its extensive expertise in pharmacology and pharmacogenomics to create personalized treatment options.
Adial’s lead investigational drug, AD04, is a genetically targeted, serotonin-3 receptor antagonist. It is designed to treat Alcohol Use Disorder (AUD) in heavy drinking patients with specific genetic markers, as identified through Adial’s proprietary companion diagnostic genetic test. The ONWARD™ pivotal Phase 3 clinical trial demonstrated promising results in reducing heavy drinking among patients with these target genotypes, with no significant safety or tolerability concerns.
AD04’s therapeutic potential extends beyond AUD. It is believed to be effective in treating other addictive disorders such as Opioid Use Disorder (OUD), gambling, and obesity. Adial is constantly expanding its patent portfolio to cover these broader applications. Recent patents enhance the intellectual property protection around AD04, including its unique ability to target the serotonin transporter gene for treating OUD.
Adial’s innovative approach has garnered regulatory compliance and favorable feedback from both the U.S. and European agencies. The company is in active discussions with potential strategic partners to support the development and commercialization of AD04 internationally. Key patents issued in 2024 further solidify Adial’s market position in treating addiction with a personalized approach.
Financially, Adial has maintained a strong balance sheet, enabling accelerated development of AD04. The company has strategically streamlined its operations, reducing general and administrative expenses significantly in 2023. Recent financial reports indicate positive steps toward achieving regulatory milestones while maintaining a robust pipeline of development activities.
Adial also recently received significant funding from warrant exercises, which will support ongoing clinical and regulatory efforts. The company continues to advance its pharmacokinetics study for AD04, aiming to optimize the study design for upcoming Phase 3 trials under the FDA’s guidance.
Adial is committed to transforming the lives of those affected by addiction through innovative, genetically targeted treatments. With a focus on personalized medicine, the company strives to offer new hope to millions dealing with addiction disorders worldwide. For more information, visit www.adial.com.
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.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced key leadership changes, appointing Cary J. Claiborne as President and CEO, succeeding William Stilley, who will lead Adial's subsidiary, Purnovate. Kevin Schuyler has been appointed Chairman of the Board. Claiborne's extensive experience includes previous roles at Indivior PLC and Sucampo Pharmaceuticals. The leadership transition aligns with Adial's goal to advance its lead drug, AD04, which aims to treat Alcohol Use Disorder. The firm plans to engage with regulatory bodies regarding promising Phase 3 trial results and explore partnership opportunities.
Adial Pharmaceuticals reported positive topline results from its ONWARD Phase 3 trial for AD04, targeting Alcohol Use Disorder (AUD). The trial indicated a statistically significant reduction in heavy drinking days among certain patients. The company plans to submit results to both the FDA and EMA while exploring partnership opportunities. As of June 30, 2022, cash and cash equivalents stood at $9.2 million, up from $6.1 million at the end of 2021. AD04's market potential is estimated to be multi-billion dollars in the U.S. alone.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced successful results from its ONWARD trial, demonstrating a significant reduction in heavy drinking days among patients with Alcohol Use Disorder (AUD). AD04, the company's investigational drug, achieved a 79% reduction in heavy drinking days and an 84% decline in AUD severity compared to placebo. These results support the drug's safety and tolerability. Adial plans to submit these findings to regulatory agencies in Europe and the U.S. for product approval and is considering strategic partnerships for further development.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) is set to report topline results from its ONWARD™ Phase 3 clinical trial on July 20, 2022. The trial assesses the efficacy and safety of AD04 in treating Alcohol Use Disorder in genetically screened patients. Conducted across 25 sites in six countries, it includes heavy and very heavy drinkers. Previous Phase 2b results indicated significant reductions in drinking frequency and quantity without serious safety concerns. The ongoing research may expand to other addictive disorders, highlighting the drug's potential impact.
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