STOCK TITAN

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.

Rhea-AI Summary

Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced the completion of a $5,000,002 private placement of 1,666,668 shares at $3.00 each, funding its ONWARD™ Phase 3 trial for AD04, a treatment for Alcohol Use Disorder (AUD). The financing, totaling $7.1 million when combined with a previous round, supports trial completion until data read-out. CEO William Stilley expressed confidence in investor support and business outlook. AD04 aims to target specific genetic profiles in AUD treatment, with prior trials showing significant results without safety concerns.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
0.77%
Tags
none
-
Rhea-AI Summary

Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced that its CEO, William Stilley, has published an op-ed on Nasdaq.com, discussing the importance of addressing Alcohol Use Disorder (AUD). The op-ed highlights that over 30 million people in the U.S. are affected by AUD, leading to more than 95,000 deaths annually, and a cost of $250 billion to the nation. Stilley underscores the positive impact of their investigational drug AD04, currently in a pivotal Phase 3 trial for AUD. The trial's results from a Phase 2b study showed promising reductions in drinking frequency and no significant safety issues.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
2.08%
Tags
none
-
Rhea-AI Summary

Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) announced promising advancements in its adenosine analog development platform via its acquisition of Purnovate. The compounds developed show potency against targeted adenosine receptors while maintaining high solubility, achieving over 50 times more solubility than similar compounds. Initial studies indicate good oral bioavailability and pharmacological activity, particularly in reducing pain in rodents and demonstrating synergy with morphine and acetaminophen. These findings position Adial to potentially replace opioids and address addiction issues.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
4.2%
Tags
Rhea-AI Summary

Adial Pharmaceuticals (NASDAQ: ADIL; ADILW) has entered into Securities Purchase Agreements for a private placement of 1,666,667 shares at $3.00 each, totaling $5 million. Leading the placement is Bespoke Growth Partners, Inc., contributing $2.5 million. The investment will be funded in two tranches: $500,000 immediately and the remaining $4.5 million following share registration. Adial focuses on addiction treatments, with its lead product AD04 currently in a pivotal Phase 3 trial for Alcohol Use Disorder (AUD), showing promising results in earlier trials.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-2.82%
Tags
none
-
Rhea-AI Summary

Adial Pharmaceuticals announced key progress in its ONWARD Phase 3 clinical trial for AD04, aimed at treating Alcohol Use Disorder (AUD). The company achieved 100% screening and 90% enrollment targets, with 261 out of 290 expected subjects enrolled. Notably, 33% of screened patients tested positive for the genotype linked to AD04. The medication appears well-tolerated, with no serious adverse events reported. The retention rate stands at 84%, exceeding the projected 70%. Data from the trial is anticipated in Q1 2022.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-3.4%
Tags
-
News
Rhea-AI Summary

Adial Pharmaceuticals has been added to the Russell Microcap® Index effective June 28, 2021. This inclusion follows the annual reconstitution of Russell indexes. The CEO stated that this reflects progress in increasing shareholder value, particularly with the clinical development of AD04 for alcohol use disorder through its ONWARD™ Phase 3 trial. Membership may enhance awareness and liquidity among institutional investors, aligning Adial with a vast $10.6 trillion in assets benchmarked against Russell indexes.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
10.08%
Tags
none
Rhea-AI Summary

Adial Pharmaceuticals, Inc. (NASDAQ: ADIL; ADILW) announced the denial of its Fast Track Designation request from the FDA for its drug candidate AD04, aimed at treating Alcohol Use Disorder in pediatric and adult patients with Alcoholic Liver Disease. The FDA cited insufficient evidence of AD04's potential to address unmet medical needs given existing treatments. Despite FDA acknowledgment of the medical need, further data is required for reconsideration. The ongoing ONWARD Phase 3 trial continues to evaluate AD04's efficacy in genetically screened patients across multiple countries.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
-1.59%
Tags
none
-
Rhea-AI Summary

Adial Pharmaceuticals has announced plans to enter the genetic testing market following a Notice of Allowance from the U.S. Patent and Trademark Office. This patent covers the use of a genetic diagnostic panel in combination with its product AD04 for treating Alcohol Use Disorder (AUD) and potentially Opioid Use Disorder (OUD). The company estimates a multi-billion dollar market opportunity, anticipating that genetic evaluations can help identify patients likely to benefit from AD04. If approved, the patent will provide market exclusivity, enhancing Adial's commercial strategy.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
9.06%
Tags
none
-
Rhea-AI Summary

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.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
6.02%
Tags
none
Rhea-AI Summary

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.

Rhea-AI Impact
Rhea-AI Sentiment
End-of-Day
7.22%
Tags
none

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

ADIL Rankings

ADIL Stock Data

6.42M
6.41M
1.8%
4.43%
0.8%
Biotechnology
Pharmaceutical Preparations
Link
United States of America
CHARLOTTESVILLE