24/7 Market News Snapshot 25 February, 2025 – Adial Pharmaceuticals, Inc (NASDAQ:ADIL)

February 25, 2025

DENVER, Colo., 25 February, 2025 (247marketnews.com) – (NASDAQ:ADIL) are discussed in this article.
Adial Pharmaceuticals, Inc. has recently demonstrated significant momentum, reflected in its pre-market trading surge, with shares rising 38.04% to $1.056. The stock’s impressive trading volume of 10.85 million shares underscores a notable increase in investor interest, potentially fueled by recent positive developments related to the company’s clinical pipeline.

In a pivotal advancement for the company, Adial received constructive feedback from the U.S. Food and Drug Administration (FDA) concerning its proposed in vitro bridging strategy for the treatment candidate AD04. This development is critical as it sets the stage for Adial to progress through the 505(b)(2) regulatory pathway, aiming for a breakthrough in addiction therapies. Following a submission on November 19, 2024, detailing its formulation strategy, the FDA’s response aligns with the company’s objectives for the upcoming Phase 3 clinical trials.

Cary Claiborne, CEO of Adial Pharmaceuticals, expressed optimism about the FDA’s endorsement, stating it brings the company closer to its goal of providing an effective treatment option for individuals grappling with addiction. The upcoming Phase 3 program is poised to begin in 2025, with preparations for manufacturing clinical supply materials already underway.

AD04, a serotonin-3 receptor antagonist, has shown efficacy in addressing Alcohol Use Disorder (AUD), particularly among heavy drinkers. Adial’s vision extends beyond AUD; the company is exploring AD04 as a potential treatment for various other addictive disorders, including Opioid Use Disorder and compulsive gambling.

As Adial Pharmaceuticals navigates its path towards market introduction, it remains committed to working collaboratively with regulatory authorities, fostering hope for patients in need of innovative therapeutic options.

Related news for (ADIL)

NASDAQ and NYSE quotes and data are delayed 15 minutes unless indicated otherwise. Market data and exchange information are provided for informational purposes only and is not intended for trading purposes. Neither 24/7 Market News Editors, 247 Market News, or data and content providers shall be liable for any errors or omissions, delays, misquotes or other market information relayed in any press materials. You should Use Realtime data to conduct due diligence before investing or trading, and trading in any stock is risky you could lose all your money.