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GLEN ALLEN, Va. - Adial Pharmaceuticals, Inc. (NASDAQ:ADIL), a micro-cap pharmaceutical company currently valued at $8 million with shares trading at $0.37, welcomed recent U.S. Senate legislative support for expanding clinical trial endpoints beyond abstinence in substance use disorder treatments, including Alcohol Use Disorder (AUD). According to InvestingPro data, the company maintains a strong liquidity position with more cash than debt on its balance sheet.
The Senate Appropriations Committee, in a report that advanced with a bipartisan 26-3 vote, encourages the U.S. Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA) to support alternative clinical endpoints such as reduced craving, decreased alcohol use, and lower disorder severity. While the company pursues these regulatory developments, InvestingPro analysis shows the company faces financial challenges, with a weak overall Financial Health Score of 1.57 out of 10.
This legislative direction aligns with Adial’s development strategy for AD04, its lead investigational drug for AUD treatment in individuals with specific genetic profiles. AD04 is a serotonin-3 receptor antagonist designed to reduce alcohol cravings and consumption.
"We are encouraged by this legislative momentum, which mirrors the very foundation of our AD04 program," said Cary Claiborne, CEO of Adial Pharmaceuticals, according to the company’s press release. "Our therapy is designed to reduce cravings and harmful alcohol consumption, rather than enforce an all-or-nothing abstinence model."
The company reported that AD04 was recently investigated in a Phase 3 clinical trial called ONWARD, which showed reduced drinking in AUD patients with no overt safety concerns.
The Senate Committee’s approach acknowledges real-world recovery patterns by moving beyond abstinence as the sole measure of treatment success, potentially creating a more supportive regulatory environment for medications targeting addiction disorders.
Adial believes AD04 may also have potential applications for other addictive disorders including opioid use disorder, gambling, and obesity.
The information in this article is based on a company press release statement.
In other recent news, Adial Pharmaceuticals completed an End of Phase 2 meeting with the U.S. Food and Drug Administration concerning its lead drug candidate, AD04, for Alcohol Use Disorder. The company received FDA input on its planned Phase 3 adaptive design clinical trial. Additionally, shareholders approved an increase in the authorized number of common shares from 50,000,000 to 100,000,000 at its 2025 Annual Meeting. This amendment to the Certificate of Incorporation was filed with the Delaware Secretary of State and is now effective.
Adial Pharmaceuticals also announced it has regained compliance with Nasdaq’s minimum stockholders’ equity requirement. This compliance follows an equity offering that brought its stockholders’ equity above the required $2.5 million threshold. Furthermore, the company filed an update to its provisional patent application for AD04, potentially extending protection for its core assets until at least 2045. In manufacturing news, Adial has signed agreements with Thermo Fisher Scientific and Cambrex to produce AD04 for upcoming clinical trials and a planned New Drug Application submission to the FDA.
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