Adial Applauds Congressional Directive Advancing Alternative Clinical Trial Endpoints for Substance Use Disorders, Strengthening Regulatory Path for AD04
Rhea-AI Summary
Adial (NASDAQ: ADIL) applauded the Feb. 4, 2026 federal appropriations bill that includes a Congressional directive titled “Alternative Clinical Trial Endpoints for Substance Use Disorders.” The law directs the FDA and NIDA to collaborate on non‑abstinence endpoints—such as reduced cravings or disorder severity—that demonstrate meaningful clinical benefit.
Adial says the directive aligns with NIAAA’s updated recovery definition and could strengthen the regulatory pathway for its lead investigational therapy, AD04, which targets Alcohol Use Disorder using a precision medicine approach.
Positive
- Congress directed FDA and NIDA to consider non‑abstinence endpoints
- Directive explicitly cites reduced cravings and disorder severity
- Alignment with NIAAA updated recovery definition
- Company states directive could strengthen AD04 regulatory path
Negative
- FDA and NIDA must still define and implement the alternative endpoints
News Market Reaction
On the day this news was published, ADIL declined 25.79%, reflecting a significant negative market reaction. Argus tracked a trough of -11.0% from its starting point during tracking. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $2M from the company's valuation, bringing the market cap to $6M at that time. Trading volume was exceptionally heavy at 10.2x the daily average, suggesting significant selling pressure.
Data tracked by StockTitan Argus on the day of publication.
Market Reality Check
Peers on Argus
ADIL was down 1.58% with relatively light volume, while several biotech peers like ALZN, BCLI, TNFA, and CELZ also showed declines and VYNE was modestly higher. Momentum data flagged only one peer (AIM) moving down, supporting a stock-specific context rather than a broad sector rotation.
Previous Clinical trial Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Sep 16 | EOP2 FDA feedback | Positive | -0.9% | FDA backed adaptive Phase 3 design and biomarker-positive AUD strategy for AD04. |
| Sep 03 | Nasdaq compliance update | Negative | -0.7% | Nasdaq granted 180-day extension to regain $1.00 minimum bid price compliance. |
| Aug 20 | Legislative endpoint support | Positive | +0.5% | Senate backed expanded clinical endpoints beyond abstinence for AUD treatments. |
| Jun 11 | Phase 3 planning | Positive | -23.8% | Company advanced toward Phase 3 for AD04 using adaptive, data-driven trial design. |
| May 13 | Milestone payment | Positive | +3.8% | Received six-figure milestone and outlined up to $83M potential payments from Adovate. |
Clinical and regulatory updates for AD04 have often been positive qualitatively but produced mixed share reactions, with several favorable milestones coinciding with price declines.
Over the past months, Adial’s clinical news has focused on advancing AD04 for Alcohol Use Disorder. A September 2025 EOP2 FDA meeting endorsed a biomarker-positive strategy and confirmed primary endpoints centered on heavy drinking days. Earlier, the company highlighted U.S. Senate support for non‑abstinence endpoints and progress toward a Phase 3 adaptive design with genetic targeting. Separate clinical-tagged items covered Nasdaq bid-price extensions and milestone economics from Adovate. Today’s directive on alternative endpoints fits this pattern of regulatory and clinical framework building around AD04’s precision-medicine strategy.
Historical Comparison
Past clinical-trial-tagged news for ADIL moved the stock an average of -4.21%. Today’s -1.58% pre-news move is milder than typical for similar updates.
Clinical-trial-tagged history shows progression from Phase 3 planning for AD04, to favorable EOP2 FDA feedback, to legislative support for non-abstinence endpoints. Today’s directive further formalizes those alternative endpoints, reinforcing the same regulatory path for AD04’s precision AUD strategy.
Regulatory & Risk Context
An effective S-3 shelf filed on 2025-12-12 registers 13,823,512 shares underlying Series F warrants at a $0.31 exercise price. Adial estimates about $4.29 million of net proceeds if all warrants are exercised, but the registered block is large versus the existing equity base, creating potential dilution and stock overhang when sold.
Market Pulse Summary
The stock dropped -25.8% in the session following this news. A negative reaction despite constructive regulatory news would fit prior divergence episodes, where favorable AD04 updates coincided with declines, such as the Phase 3 advancement that saw a -23.77% move. Investors have also faced overhang from registered warrant shares totaling 13,823,512. Such structural pressures and financing needs could outweigh sentiment benefits from improved endpoint flexibility in the regulatory framework.
Key Terms
clinical trial endpoints medical
substance use disorders medical
alcohol use disorder (aud) medical
u.s. food and drug administration (fda) regulatory
national institute on drug abuse (nida) regulatory
national institute on alcohol abuse and alcoholism’s (niaaa) regulatory
precision medicine medical
AI-generated analysis. Not financial advice.
GLEN ALLEN, Va., Feb. 04, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today applauded the passage by Congress and signing into law by President Donald J. Trump of the Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriations Bill, 2026.
The final legislation incorporates Senate Report 119-55, which includes a significant Congressional directive to the U.S. Food and Drug Administration (FDA) and the National Institute on Drug Abuse (NIDA) to collaborate on the establishment of alternative clinical trial endpoints for medications treating substance use disorders, including Alcohol Use Disorder (AUD). The directive, titled “Alternative Clinical Trial Endpoints for Substance Use Disorders,” calls for endpoints beyond abstinence that demonstrate meaningful clinical benefit.
Specifically, Congress directed the FDA to consider endpoints such as reduced cravings or reduced disorder severity, where such measures reflect clinically meaningful improvement for patients. These non-abstinence-based outcomes align with the National Institute on Alcohol Abuse and Alcoholism’s (NIAAA) updated definition of recovery, which recognizes improvements in functioning and symptom reduction as valid and impactful treatment goals.
Adial’s lead investigational therapy, AD04, is designed to address AUD using a precision medicine approach and is aligned with these non-abstinence recovery outcomes. As federal agencies including the FDA and NIDA are now formally directed to collaborate on defining and implementing these alternative endpoints, the measures are expected to strengthen the regulatory framework for innovative therapies such as AD04.
“This Congressional directive reflects a meaningful evolution in how substance use disorders are evaluated and treated,” said Cary Claiborne, President and Chief Executive Officer of Adial. “By embracing endpoints that recognize real-world clinical improvement beyond abstinence alone, policymakers are helping to modernize regulatory expectations and support innovation. We believe this action enhances the regulatory path for AD04 and reinforces Adial’s strategy to address the substantial unmet need in AUD with precision-based therapies.”
AUD remains a significant public health challenge, with millions of affected individuals and limited treatment options that achieve durable outcomes. Adial believes that regulatory clarity around alternative endpoints may help accelerate development timelines and broaden the clinical relevance of emerging therapies.
About Adial Pharmaceuticals, Inc.
Adial Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the development of treatments for addictions and related disorders. The Company’s lead investigational new drug product, AD04, is a genetically targeted, serotonin-3 receptor antagonist, therapeutic agent for the treatment of Alcohol Use Disorder (AUD) in heavy drinking patients. Adial is currently planning to conduct a new Phase 3 clinical trial program for the treatment of AUD in subjects with certain target genotypes identified using the Company’s proprietary diagnostic genetic test. ONWARD showed promising results in reducing drinking in heavy drinking patients, with no overt safety or tolerability concerns. AD04 is also believed to have the potential to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Additional information is available at www.adial.com.
Forward-Looking Statements
This communication contains certain “forward-looking statements” within the meaning of the U.S. federal securities laws. Such statements are based upon various facts and derived utilizing numerous important assumptions and are subject to known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Statements preceded by, followed by or that otherwise include the words “believes,” “expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans” and similar expressions or future or conditional verbs such as “will,” “should,” “would,” “may” and “could” are generally forward-looking in nature and not historical facts, although not all forward-looking statements include the foregoing. The forward-looking statements include statements regarding designing AD04 to address AUD using a precision medicine approach, the measures strengthening the regulatory framework for innovative therapies such as AD04, the policymakers helping to modernize regulatory expectations and supporting innovation, the action enhancing the regulatory path for AD04 and reinforcing Adial’s strategy to address the substantial unmet need in AUD with precision-based therapies, regulatory clarity around alternative endpoints helping to accelerate development timelines and broaden the clinical relevance of emerging therapies and the potential of AD04 to treat other addictive disorders such as Opioid Use Disorder, gambling, and obesity. Any forward-looking statements included herein reflect our current views, and they involve certain risks and uncertainties, including, among others, our ability to pursue our regulatory strategy, our ability to advance ongoing partnering discussions, our ability to obtain regulatory approvals for commercialization of product candidates or to comply with ongoing regulatory requirements, our ability to develop strategic partnership opportunities and maintain collaborations, our ability to obtain or maintain the capital or grants necessary to fund our research and development activities, our ability to complete clinical trials on time and achieve desired results and benefits as expected, regulatory limitations relating to our ability to promote or commercialize our product candidates for specific indications, acceptance of our product candidates in the marketplace and the successful development, marketing or sale of our products, our ability to maintain our license agreements, the continued maintenance and growth of our patent estate and our ability to retain our key employees or maintain our Nasdaq listing. These risks should not be construed as exhaustive and should be read together with the other cautionary statement included in our Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q and current reports on Form 8-K filed with the Securities and Exchange Commission. Any forward-looking statement speaks only as of the date on which it was initially made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise, unless required by law.
Contact:
Crescendo Communications, LLC
David Waldman / Alexandra Schilt
Tel: 212-671-1020
Email: adil@crescendo-ir.com
FAQ
What did Adial (ADIL) announce about the Feb. 4, 2026 Congressional directive?
How does the new directive affect the regulatory path for AD04 (ADIL)?
Which alternative clinical endpoints did Congress ask FDA and NIDA to consider on Feb. 4, 2026?
Does the directive change the NIAAA definition of recovery mentioned by Adial (ADIL)?
What remains to be done before alternative endpoints affect AD04 clinical trials?
