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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 announces a 1-for-25 reverse stock split of its common stock, effective August 4, 2023. The split will reduce outstanding shares from 30.5 million to 1.2 million. The reverse split aims to bring the company into compliance with Nasdaq's minimum bid price requirement and attract a broader group of investors.
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Adial Pharmaceuticals provides an update on its clinical development plan for AD04, a treatment for Alcohol Use Disorder. The company received positive feedback from regulators and plans to focus on the US market. They will conduct two Phase 3 trials to support potential approval, with a total cost of approximately $25 million. AD04 is expected to be registered with the FDA in Q3 2025.
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Adial Pharmaceuticals provides business update and financial results for Q1 2023. The company conducted meetings with regulatory agencies and received upfront cash from the sale of Purnovate assets. They also engaged The Keswick Group for partnering efforts. Adial closed a registered direct offering and ended Q1 with $2.3 million in cash.
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Adial Pharmaceuticals announced that Adovate has exercised its option to acquire the assets and business of Purnovate. Adial will receive an upfront payment of $450,000 and expense reimbursement of approximately $0.9 million. They are also entitled to receive up to $83 million in milestone payments and a 19.9% equity stake in Adovate.
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Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced a business update for the fiscal year 2022, concluding with $4.0 million in cash and cash equivalents. Key highlights include the pivotal ONWARD™ Phase 3 trial's positive results for AD04 in reducing heavy drinking days among patients with Alcohol Use Disorder. The company is pursuing regulatory approvals, having secured meetings with the U.S. FDA and European agencies. Adial also closed a $0.75 million share offering and engaged The Keswick Group to enhance partnership activities. The company reported a reduced net loss of $12.7 million for the year, down from $19.4 million in 2021.

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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.

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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.

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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.

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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.

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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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