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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) acknowledges an article by Kate Julian in The Atlantic addressing the growing crisis of Alcohol Use Disorder (AUD) in the U.S., worsened by COVID-19 lockdowns. The company emphasizes that around 35 million Americans suffer from AUD annually, leading to significant health and economic burdens, costing roughly $250 billion yearly. Adial's investigational drug AD04 is currently being evaluated in the ONWARD™ Phase 3 trial aimed at treating AUD, showing promising results in previous trials.

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Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has successfully completed a $2.1 million private placement of 700,001 shares at $3.00 each. This transaction involved key investors including Bespoke Growth Partners and Keystone Capital Partners. Following SEC approval, the company received $1,809,000, having initially secured $291,003. Adial is currently conducting the ONWARD Phase 3 clinical trial for its lead drug candidate, AD04, targeting alcohol use disorder, with continued optimism regarding its market potential and expansion into other indications.

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Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) addresses the growing problem of addiction exacerbated by the COVID-19 pandemic. CEO William Stilley and CMO Dr. Bankole Johnson highlighted the alarming rise in alcohol abuse, termed the 'Second Pandemic of Addiction,' with increased fatalities projected. Adial's Phase 3 drug candidate, AD04, aims to combat Alcohol Use Disorder, showing promising results in earlier trials. The ONWARD clinical trial involves 290 participants across seven countries and targets a genetically specific patient population.

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Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced Dr. Bankole Johnson's interview on The Black News Channel, discussing the COVID-19 pandemic's long-term effects on mental health and addiction. The company focuses on developing treatments for addiction disorders, with its lead product, AD04, currently in a pivotal Phase 3 trial for Alcohol Use Disorder. Past results from a Phase 2b trial indicated a significant reduction in drinking frequency and quantity without major safety concerns. The replay of the interview is available on the company's website.

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Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has entered into Securities Purchase Agreements for a private placement of 700,001 shares of common stock at $3.00 each, raising $2,100,000. The funding includes an initial $291,003, with $1,809,000 to be provided upon share registration. Investors include members of management and Keystone Capital Partners. Adial focuses on addiction treatment, with its lead drug AD04 currently in a pivotal Phase 3 clinical trial for Alcohol Use Disorder (AUD). The trial is being conducted across 25 sites in seven countries.

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Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced a Town Hall meeting for shareholders on March 18, 2021, at 1 PM ET. The company focuses on developing addiction treatments, particularly its lead product, AD04, which is in a Phase 3 clinical trial for Alcohol Use Disorder (AUD). AD04 exhibited promising results in earlier trials. The ONWARD trial evaluates its efficacy in genetically selected patients across multiple locations in Europe. The company highlighted the necessity of ongoing clinical trials and regulatory approvals for its product candidates.

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Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced the exercise of 712,500 warrants, generating net proceeds of $1,425,000. The funds will aid in advancing the development of AD04, a treatment for Alcohol Use Disorder (AUD), currently undergoing pivotal Phase 3 trials called ONWARD. This trial includes genetically targeted patients and is being conducted across seven countries. Previous Phase 2b trials of AD04 showed significant reductions in drinking frequency and quantity, with no major safety issues reported.

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Adial Pharmaceuticals announced a significant milestone in its ONWARD™ pivotal Phase 3 clinical trial, achieving 50% enrollment for its lead drug candidate, AD04, targeting Alcohol Use Disorder. With 66% of planned patient screening visits completed, Adial expects to fully enroll by summer. 32% of screened patients are genetically positive for AD04, with a 75% enrollment rate among these patients. The trial retains an impressive 86% patient retention rate, surpassing the projected 70%. This trial, conducted across 25 clinical sites in Europe, investigates the drug's efficacy and safety.

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Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced its intention to file for Fast Track designation with the FDA for its lead drug candidate, AD04, aimed at treating Alcohol Use Disorder (AUD). This follows an earlier request submitted in September 2020. Adial believes that AD04 qualifies due to the seriousness of AUD and the unmet medical need it addresses. The FDA typically reviews Fast Track applications within 60 days, assessing factors like treatment impact and safety compared to existing therapies. AD04 is currently undergoing a pivotal Phase 3 clinical trial.

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Adial Pharmaceuticals will present an overview at the 23rd Annual ICR Conference on January 14, 2021, from 3:15 PM to 3:55 PM ET. CEO William Stilley will lead the presentation, which will focus on the company's advancements in treatments for addictions, particularly the investigational drug AD04 aimed at treating Alcohol Use Disorder (AUD). This drug is currently in a pivotal Phase 3 trial. A live webcast will be available on Adial's website, with replays accessible for 90 days.

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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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