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 the database lock for its ONWARD™ Phase 3 trial, which is crucial for evaluating the efficacy of AD04 in treating Alcohol Use Disorder (AUD). With data now set, professional statisticians will analyze the results, with top-line findings expected by mid-July 2022. The ONWARD trial involves patients genetically screened for specific polymorphisms and is pivotal for FDA approval of AD04. Adial emphasizes the importance of its research in addiction medicine, reflecting a strong commitment to advancing treatment options.
Adial Pharmaceuticals has locked the database for its ONWARD Phase 3 clinical trial and transferred the data to independent statistical consultants for analysis. Results are expected to be announced in July 2022. The trial aims to evaluate the efficacy and safety of AD04 in reducing heavy drinking days among patients with Alcohol Use Disorder. Notably, no drug-related serious adverse events were reported. ONWARD is crucial for potential regulatory approval of AD04 based on targeted genetic screening of patients, paving the way for treatment options in alcohol addiction.
Adial Pharmaceuticals announced the issuance of patent number 11,351,154 on June 7, 2022, covering a genetic diagnostic panel linked to its lead product, AD04, aimed at treating Alcohol Use Disorder (AUD) and Opioid Use Disorder (OUD). This patent enhances their intellectual property portfolio, now exceeding 90 patents worldwide, ensuring market protection until at least 2031. With an estimated 35 million individuals in the U.S. suffering from AUD, the company anticipates significant opportunities in both AD04 and its diagnostic test. Results from the pivotal ONWARD Phase 3 trial are expected soon.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced a research collaboration between its subsidiary, Purnovate, and the Medical College of Wisconsin. The focus is on developing adenosine analogs as treatments for diabetes and non-alcoholic steatohepatitis (NASH). The collaboration aims to test Purnovate's compounds in preclinical models, which could potentially address significant unmet medical needs. The global NASH market is projected to exceed $54 billion by 2027, highlighting the potential market impact of these developments.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) is nearing the completion of its ONWARD™ Phase 3 trial for AD04, aimed at treating Alcohol Use Disorder (AUD), with results expected this quarter. The company ended Q1 2022 with a cash balance of $12.7 million, up from $6.1 million in Q4 2021. R&D expenses dropped to $0.6 million, and net loss improved to $2.9 million. With AUD representing a $36 billion U.S. market and 35 million affected individuals, Adial plans to advance discussions for potential commercialization of AD04, which is designed for easy oral administration.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has announced a collaboration with UC San Diego to explore its adenosine analogs for treating inflammatory bowel disease (IBD). This partnership aims to validate the therapeutic potential of Purnovate’s compounds in preclinical models of IBD, conditions such as Crohn's disease, and ulcerative colitis. The global IBD treatment market is projected to reach USD 27.8 billion by 2028, indicating significant unmet medical needs. Adial's CEO expresses optimism about their compounds addressing IBD and other inflammatory conditions.
Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) will have CEO William Stilley participate in the 2022 Virtual Growth Conference from March 28-30. The event, hosted by Maxim Group LLC and M-Vest, requires prior membership to attend. Stilley's pre-recorded corporate update will be accessible throughout the conference. This event will feature presentations from various sectors, including Biotech and Healthcare. Adial is focused on developing treatments for addiction, with its lead drug AD04 currently in a pivotal Phase 3 trial for Alcohol Use Disorder.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced the completion of patient enrollment in its ONWARD™ Phase 3 trial, focusing on AD04 for treating Alcohol Use Disorder (AUD). The trial included 302 participants across 25 sites in Europe, surpassing initial targets. The CEO highlighted the significance of this milestone, emphasizing the need for effective AUD treatments amid rising public health concerns. Topline results are expected in Q2, aiming to demonstrate a statistically significant reduction in heavy drinking days for those treated with AD04 compared to a placebo.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has successfully closed a registered direct offering, generating around $10 million. A single accredited institutional investor purchased approximately 2,322,250 shares of common stock, along with pre-funded warrants and additional warrants to acquire about 3,977,888 shares. The effective purchase price was $2.40 per share/warrant. The net proceeds will enhance Adial's balance sheet as it advances its Phase 3 ONWARD™ trial for AD04, targeting addiction treatments.
Adial Pharmaceuticals has entered into a securities purchase agreement with an institutional investor to raise approximately $10 million through a registered direct offering of common stock and related warrants. The agreement includes the sale of 4,187,250 shares at an effective purchase price of $2.40 per share, alongside warrants for 3,977,888 shares with an exercise price of $2.52. The closing date is anticipated on February 15, 2022, subject to customary conditions. The offering is being facilitated by Maxim Group LLC.
FAQ
What is Adial Pharmaceuticals' main focus?
What is AD04?
What are the potential applications of AD04?
What was the outcome of the ONWARD™ Phase 3 clinical trial?
How does Adial identify patients for AD04 treatment?
What recent financial achievements has Adial Pharmaceuticals announced?
What are the latest developments in Adial’s intellectual property?
What is the significance of Adial’s latest patents?
What are Adial’s plans for the future development of AD04?
Where can I find more information about Adial Pharmaceuticals?
