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 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 (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.
Adial Pharmaceuticals has announced a transformative acquisition of Purnovate, a developer of non-opioid pain reduction therapies. This strategic move aims to diversify and expand Adial’s addiction-related pipeline, including its lead product AD04 for Alcohol Use Disorder, currently in Phase 3 trials. The acquisition is expected to enhance Adial’s drug portfolio and leverage Purnovate's expertise in adenosine analogs to tackle pain and addiction. However, successful completion is contingent on specific conditions, including a fair opinion from Adial’s financial advisor.
Adial Pharmaceuticals has announced that its lead drug candidate, AD04, targeted for the treatment of Alcohol Use Disorder (AUD), was featured on the Local 12: Healthy Perspective news segment. This follows a prior feature on WKRC in Cincinnati, which has reached numerous media outlets nationwide. AD04 is currently being evaluated in a Phase 3 clinical trial and has demonstrated promising results, reducing the frequency and quantity of alcohol consumption with no significant safety concerns reported. The drug may also treat other addictive disorders.
Adial Pharmaceuticals (NASDAQ:ADIL, ADILW) has signed a Common Stock Purchase Agreement with Keystone Capital Partners, allowing the sale of up to $15 million in common stock over time. The company, which has over $7 million in cash as of September 30, 2020, emphasizes that there are no immediate capital-raising plans. AD04, its lead drug for Alcohol Use Disorder, showed promise in clinical trials. The partnership aims to support future growth opportunities in the underserved addiction treatment market.
Adial Pharmaceuticals (NASDAQ:ADIL; ADILW) announced progress in its ONWARD™ Phase 3 trial for AD04, targeting Alcohol Use Disorder (AUD). All 25 investigative sites are active, with over 25% of the patient enrollment completed. The enrollment rate has improved for four consecutive months, aiming for full enrollment by Q2 2021. Preliminary data reading is expected in Q4 2021. AD04 shows promising safety with no serious adverse events reported, and the potential market for AD04 in the U.S. is estimated to exceed $35 billion, addressing an urgent public health crisis exacerbated by COVID-19.
Adial Pharmaceuticals (NASDAQ:ADIL; ADILW) announced that the FDA has reactivated its Investigational New Drug (IND) application for AD04, a treatment for Alcohol Use Disorder (AUD). The IND was previously on clinical hold due to insufficient manufacturing data. This reactivation allows the company to pursue U.S. expedited review programs and initiate a planned Phase 1 pharmacokinetics study. The CEO noted the urgency of addressing the AUD crisis, exacerbated by the COVID-19 pandemic. Adial is also currently enrolling patients for its pivotal Phase 3 clinical trial in Europe.
Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced an initial firm order for 10,000 Assure/FaStep® COVID-19 IgG/IgM Rapid Test Devices from a California-based tech firm. The FaStep test is the first FDA-approved serology point-of-care test using fingerstick blood samples, crucial for rapid COVID-19 assessment. CEO William Stilley emphasized the importance of this testing in managing the virus's prevalence as the U.S. reopens. Adial has opened multiple sales channels to distribute the test devices, enhancing their market presence.
Adial Pharmaceuticals (NASDAQ:ADIL; ADILW) announced the FDA's emergency use authorization (EUA) for its Assure/FaStep® COVID-19 IgG/IgM Rapid Test Device, the first point-of-care test using fingerstick blood samples. Previously, the test was restricted to venous blood samples. The EUA enables sales through iRemedy's network, tapping into a projected $3.52 billion market for rapid COVID-19 tests by year-end 2020. CEO William Stilley indicated this competitive advantage could boost adoption of their antibody tests to combat the COVID-19 pandemic.
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?
