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Adial Pharmaceuticals, Inc - ADILW STOCK NEWS

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.

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Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced promising results for its subsidiary, Purnovate's PNV-5032, in treating asthma. The in vivo study showed a 25% reduction in pulmonary flow resistance, which indicates improved airflow in an asthmatic model compared to controls. PNV-5032 exhibited over 1000-fold selectivity for the adenosine A1 receptor and demonstrated significantly higher solubility than similar compounds. The company aims to initiate first-in-human trials in 2023, supported by a patent application extending protection until 2047.

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Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) announced that the U.S. Patent and Trademark Office has sent a Notice of Allowance for patent application No. 16/784,051 concerning the treatment of opioid use disorder (OUD) using its drug AD04. This application is particularly focused on patients with a genetic biomarker for the serotonin-3 receptor. Currently, AD04 is being evaluated in the ONWARD Phase 3 trial for alcohol use disorder (AUD). The company expects long-term patent protection through 2036, supporting its goal to address the significant market of OUD.

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Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced that CEO William Stilley will present at the H.C. Wainwright BioConnect 2022 Conference from January 10-13, 2022. The presentation will be available on-demand starting January 10 at 7:00 AM ET, accessible for 90 days. Adial is developing AD04, a treatment for Alcohol Use Disorder, currently undergoing a pivotal Phase 3 clinical trial. The company aims to treat various addictions and is working on adenosine analogs for pain management and other disorders.

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Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced it received $720,000 from an $800,000 private placement, originally disclosed on November 10, 2021. The shares, priced at $4.00 each, were fully subscribed with 200,000 shares purchased. This funding was confirmed following the SEC's Notice of Effectiveness for the Form S-3 Registration Statement. Adial is focused on addiction therapies, particularly its lead investigational drug, AD04, which is under evaluation in the ONWARD™ Phase 3 trial aimed at treating Alcohol Use Disorder.

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Adial Pharmaceuticals has appointed Cary J. Claiborne as Chief Operating Officer, while he remains on the Board of Directors. Claiborne's role includes overseeing strategic growth initiatives and commercial preparations for AD04, aimed at treating Alcohol Use Disorder (AUD). CEO William Stilley emphasized Claiborne's extensive experience in the biopharmaceutical sector, particularly in addiction treatment. Claiborne expressed enthusiasm for advancing the company’s therapeutic pipeline, including the promising AD04 and Purnovate's adenosine platform, which holds significant market potential.

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Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) reported promising preclinical results for its lead compound PNV2 in treating triple negative breast cancer. The study showcased that PNV2 significantly reduced metastatic tumors in the lungs of mice compared to a control group, with luciferase activity indicating much lower cancer presence. Purnovate, Adial's subsidiary, plans to advance PNV2 to clinical trials in 2022, overcoming past solubility challenges associated with adenosine analogs. The company remains focused on its ongoing Phase 3 trial for its lead drug candidate for Alcohol Use Disorder.

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Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) will host a conference call on November 18, 2021, at 11:00 A.M. ET to discuss clinical updates and business developments. Investors can join via phone or listen online. The conference will feature information on the lead investigational drug, AD04, currently in a pivotal Phase 3 trial for Alcohol Use Disorder (AUD). AD04 showed promising Phase 2b results with significant reductions in drinking behaviors. A replay of the call will be accessible for a year, reflecting ongoing investor engagement.

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Adial Pharmaceuticals has secured $1,255,000 in funding to bolster its clinical trial initiatives for the non-opioid pain treatment candidate PNV-5030. This includes $800,000 from a private placement at $4.00 per share and $455,000 from the exercise of stock options by Mark Howard Peikin, the Chief Strategy Officer. Peikin's cash exercise supports drug development, enhancing Adial's financial position for ongoing and future trials, specifically the pivotal Phase 3 trial of its lead drug for Alcohol Use Disorder (AUD).

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Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) announced a conference call on November 18, 2021, at 11:00 A.M. ET to provide updates on its clinical trials and business progress. The company is developing AD04, a serotonin-3 receptor antagonist for treating Alcohol Use Disorder (AUD). AD04 is in a pivotal Phase 3 trial and has shown promising Phase 2b results, indicating a significant reduction in drinking frequency and quantity with no major safety concerns. Adial also explores treatments for other addictive disorders and develops adenosine analogs for pain management.

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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.

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FAQ

What is Adial Pharmaceuticals' main focus?

Adial Pharmaceuticals focuses on developing therapies for the treatment and prevention of addiction and related disorders.

What is AD04?

AD04 is Adial’s lead investigational new drug, a genetically targeted, serotonin-3 receptor antagonist for treating Alcohol Use Disorder (AUD) in heavy drinking patients.

What are the potential applications of AD04?

AD04 is believed to have potential applications in treating other addictive disorders such as Opioid Use Disorder, gambling, and obesity.

What was the outcome of the ONWARD™ Phase 3 clinical trial?

The ONWARD™ Phase 3 clinical trial showed promising results in reducing heavy drinking in patients with certain target genotypes, with no significant safety or tolerability concerns.

How does Adial identify patients for AD04 treatment?

Adial uses a proprietary companion diagnostic genetic test to identify patients with specific genotypes that respond to AD04 treatment.

What recent financial achievements has Adial Pharmaceuticals announced?

Adial recently reduced its general and administrative expenses significantly and received substantial funding from warrant exercises to support clinical and regulatory activities.

What are the latest developments in Adial’s intellectual property?

Adial has expanded its patent portfolio to cover AD04’s application for treating Opioid Use Disorder (OUD) and other drug dependencies, enhancing its market position.

What is the significance of Adial’s latest patents?

Recent patents protect AD04’s unique ability to target the serotonin transporter gene for treating OUD, representing a significant advancement in Adial’s intellectual property.

What are Adial’s plans for the future development of AD04?

Adial plans to conduct two parallel Phase 3 clinical trials to support potential approval of AD04 in the shortest timeframe possible, with ongoing partnership discussions to facilitate development and commercialization.

Where can I find more information about Adial Pharmaceuticals?

For more information, visit Adial Pharmaceuticals' official website at www.adial.com.

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