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Adial Pharmaceuticals, Inc - ADIL STOCK NEWS

Welcome to our dedicated page for Adial Pharmaceuticals news (Ticker: ADIL), a resource for investors and traders seeking the latest updates and insights on Adial Pharmaceuticals stock.

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) is a clinical-stage biopharmaceutical company dedicated to developing treatments for addiction and related disorders. The company's primary focus is on creating personalized therapies that address the unique needs of individuals suffering from substance abuse. Adial's flagship product, AD04, is a serotonin-3 receptor antagonist aimed at treating Alcohol Use Disorder (AUD) in patients with specific genetic profiles. AD04 has shown promise in reducing excessive drinking in heavy drinking patients and has been investigated in the company's ONWARD™ pivotal Phase 3 clinical trial. The active ingredient in AD04 is ondansetron, which is commonly used to prevent nausea and vomiting, and now brings potential benefits in addiction treatment.

Adial leverages its expertise in pharmacogenomics to develop therapies that are tailored to the genetic makeup of patients. This approach has the potential to revolutionize the treatment of addiction by providing more effective and safer treatment options. The company recently regained compliance with Nasdaq's listing requirements by maintaining a stockholders' equity of at least $2.5 million. Adial has also been active in forming strategic partnerships, including an agreement with Adovate, LLC, which could yield up to $83 million in milestone payments and commercial royalties.

Adial's intellectual property portfolio is robust, with multiple patents protecting the combination of its genetic diagnostics and AD04 for the treatment of AUD, Opioid Use Disorder (OUD), and other dependencies. The company's recent awards include the 2023 Best Practices Technology Innovation Leadership Award from Frost & Sullivan. Financially, Adial is in a stable position, with cash and cash equivalents allowing it to fund operations into the first quarter of 2025. The company's research and development expenses have been judiciously managed, ensuring that resources are effectively utilized.

Recent studies have underscored the safety and efficacy of AD04, highlighting its favorable liver safety profile compared to placebo and its potential to treat other addictive disorders like gambling and obesity. Adial has initiated new activities related to its clinical development plan, including two parallel Phase 3 clinical trials of AD04 to support its approval in the shortest timeframe possible. The company is also engaging with the FDA to refine its study designs and enhance the likelihood of regulatory success.

Adial Pharmaceuticals continues to make significant strides in its mission to develop innovative solutions for addiction treatment, offering hope to millions affected by these disorders worldwide.

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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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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.

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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.

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FAQ

What is the current stock price of Adial Pharmaceuticals (ADIL)?

The current stock price of Adial Pharmaceuticals (ADIL) is $1.015 as of November 5, 2024.

What is the market cap of Adial Pharmaceuticals (ADIL)?

The market cap of Adial Pharmaceuticals (ADIL) is approximately 6.4M.

What is Adial Pharmaceuticals' main focus?

Adial Pharmaceuticals focuses on developing personalized treatments for addiction and related disorders, leveraging pharmacogenomics to tailor therapies to individual genetic profiles.

What is AD04?

AD04 is Adial's lead investigational new drug, a serotonin-3 receptor antagonist used to treat Alcohol Use Disorder (AUD) in heavy drinking patients with specific genetic profiles.

What recent achievements has Adial Pharmaceuticals made?

Adial has regained compliance with Nasdaq's listing requirements, formed a strategic partnership with Adovate, LLC, and received multiple patents protecting its genetic diagnostics and AD04.

How is AD04 different from other treatments for AUD?

AD04 is genetically targeted, meaning it is tailored to patients with specific genetic profiles, enhancing its effectiveness and safety compared to conventional treatments.

What financial position is Adial Pharmaceuticals currently in?

Adial is financially stable, with cash and cash equivalents allowing it to fund operations into the first quarter of 2025. The company is also managing its research and development expenses efficiently.

What are the potential applications of AD04 beyond AUD?

AD04 has shown potential to treat other addictive disorders such as Opioid Use Disorder (OUD), gambling, and obesity.

How has Adial Pharmaceuticals engaged with regulatory agencies?

Adial has received favorable feedback from both US and European regulators, helping to refine its clinical development plan and enhance the likelihood of regulatory success for AD04.

What recent studies have been conducted on AD04?

Recent studies have highlighted AD04's safety profile, particularly its minimal impact on liver function, and its efficacy in reducing heavy drinking in patients with specific genetic markers.

What strategic partnerships has Adial Pharmaceuticals formed?

Adial has partnered with Adovate, LLC, securing potential milestone payments and royalties, and is in discussions with other potential strategic partners to support the development and launch of AD04.

What are the next steps for Adial's clinical development plan?

Adial plans to conduct two parallel Phase 3 clinical trials of AD04 and engage with the FDA to refine study designs, aiming for regulatory approval and commercialization.

Adial Pharmaceuticals, Inc

Nasdaq:ADIL

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ADIL Stock Data

6.41M
6.41M
1.8%
4.43%
0.8%
Biotechnology
Pharmaceutical Preparations
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United States of America
CHARLOTTESVILLE