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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 has announced the publication of results from its Phase 3 ONWARD study in the European Journal of Internal Medicine. The study focuses on AD04, a precision medicine for treating Alcohol Use Disorder (AUD) in patients with specific genetic profiles. Results show AD04 significantly reduces heavy drinking days after six months compared to a placebo in patients with certain genotypes. AD04's adverse events (AEs) are similar to those of a placebo, highlighting its safety. Additionally, combining AD04 with psychosocial interventions may increase treatment uptake among AUD patients.

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Adial Pharmaceuticals has started dosing the first patient in a pharmacokinetics study of AD04, targeting Alcohol Use Disorder (AUD). This significant milestone is part of the preparation for the U.S. Pivotal Phase 3 trials and aims to optimize study design elements.

The study, expected to last 6 months, will help determine the optimal dosing regimen and fulfill FDA requirements for Phase 3. Results are anticipated in early Q4 2024.

This study is a important component in Adial’s strategy to advance partnership discussions and support a 505(b)(2) regulatory pathway application. The study involves two cohorts and up to 30 healthy adult volunteers.

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Adial Pharmaceuticals (NASDAQ: ADIL), a clinical-stage biopharmaceutical company specializing in addiction therapies, will participate in the Spring MicroCap Rodeo Conference on June 6, 2024, in New York City.

CEO Cary Claiborne will present at 2:00 p.m. ET, with the presentation available via live webcast.

Adial's management will also conduct one-on-one meetings with approved investors throughout the event.

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Adial Pharmaceuticals (NASDAQ: ADIL), a clinical-stage biopharmaceutical company, reported its Q1 2024 financial results and provided a business update. The company is advancing its lead drug, AD04, with plans for two parallel Phase 3 trials, following positive FDA feedback. Key patents were awarded for AD04's effectiveness in treating addiction disorders, marking a potential $40 billion market in the U.S.

Financially, Adial's cash and equivalents rose to $5 million, bolstered by $4.3 million from recent warrant exercises. However, net loss increased to $6.5 million, primarily due to a $4.5 million non-cash warrant issuance charge. R&D expenses rose by $88K, while G&A expenses decreased by $512K.

Additionally, a peer-reviewed article highlighted AD04's promising clinical results and safety profile. New COO Tony Goodman is expected to drive forward strategic growth and clinical initiatives.

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Adial Pharmaceuticals, a clinical-stage biopharmaceutical company, has been granted a key patent by the United States Patent and Trademark Office. The patent covers the combination of the Company's genetic diagnostic with their lead investigational drug, AD04, for the treatment of alcohol use disorder and other drug dependencies. This patent expands Adial's intellectual property protection and opens up a significant market opportunity in the U.S. healthcare industry.
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Adial Pharmaceuticals announces positive results from a peer-reviewed article highlighting the safety and efficacy of AD04 in treating Alcohol Use Disorder (AUD) without significant adverse effects. The study emphasizes the liver safety profile of AD04 compared to placebo, indicating promising clinical outcomes and high patient compliance.
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Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) provided a business update and reported financial results for the 2023 fiscal year. The company made significant progress towards the potential approval and commercial launch of its lead investigational new drug product, AD04, to treat Alcohol Use Disorder. Adial received positive feedback from US and EU regulators, engaged expert advisors, and is finalizing its clinical development plan. Discussions with potential strategic partners are advancing, and the company received $4.3 million in gross proceeds from warrant exercises. Adial also announced key patents related to genetic diagnostics for the treatment of Alcohol Use Disorder and opioid use disorder. The company received awards for technology innovation and completed a reimbursement agreement with Adovate, Financially, Adial reported $2.8 million in cash and cash equivalents, with total gross proceeds of $4.3 million from warrant exercises. Research and development expenses decreased by 35%, and general and administrative expenses decreased by 37%. The net loss for 2023 was $5.1 million, an improvement from the previous year.
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Adial Pharmaceuticals, Inc. announces the immediate exercise of warrants, raising $3.5 million. H.C. Wainwright & Co. acts as the exclusive placement agent for the offering.
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Adial Pharmaceuticals strengthens its patent portfolio with a new patent covering AD04's ability to target the serotonin transporter gene for treating opioid use disorder. The patent was issued by the United States Patent and Trademark Office, highlighting the company's commitment to developing therapies for addiction and related disorders.
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Adial Pharmaceuticals, Inc. (NASDAQ:ADIL) announces participation in Winter Wrap-Up MicroCap Rodeo Conference. CEO Cary Claiborne to present on February 20, 2024, and host one-on-one meetings with investors. Register at webcaster4.com and MicroCap Rodeo.
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FAQ

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

The current stock price of Adial Pharmaceuticals (ADIL) is $1.005 as of November 4, 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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6.42M
6.41M
1.8%
4.43%
0.8%
Biotechnology
Pharmaceutical Preparations
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