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Adial Pharmaceuticals Commends Congress on Introduction of Bipartisan Legislation Expanding Access to Emerging AUD Therapies for Veterans

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Adial Pharmaceuticals (NASDAQ: ADIL) praised bipartisan H.R. 7091, the Expanding Veterans’ Access to Emerging Treatments Act, introduced March 24, 2026 to expand R&D access for veteran health conditions including Alcohol Use Disorder (AUD).

The bill recognizes non‑abstinence recovery outcomes and could support investigational therapies like Adial’s genetically targeted candidate AD04, which targets reductions in heavy drinking days as a clinical endpoint.

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News Market Reaction – ADIL

-8.15%
6 alerts
-8.15% News Effect
+7.0% Peak in 31 hr 1 min
-$232K Valuation Impact
$2.61M Market Cap
0.4x Rel. Volume

On the day this news was published, ADIL declined 8.15%, reflecting a notable negative market reaction. Argus tracked a peak move of +7.0% during that session. Our momentum scanner triggered 6 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $232K from the company's valuation, bringing the market cap to $2.61M at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

Year-end cash: $5.9M Net loss: $8.0M EU deal value: Nearly $60M +5 more
8 metrics
Year-end cash $5.9M Cash balance at end of 2025 fiscal year
Net loss $8.0M Net loss for 2025 fiscal year
EU deal value Nearly $60M Potential milestones and royalties from Molteni framework
Registered shares 13,823,512 shares Common shares issuable upon exercise of Series F warrants
Warrant exercise price $0.31 Exercise price of Series F common stock purchase warrants
Prior warrant proceeds $2.86M Gross proceeds from Series C-1 and Series E warrant exercises
Potential warrant proceeds $4.29M Estimated net proceeds if all Series F warrants exercised
AUD prevalence in veterans 40% Share of veterans experiencing Alcohol Use Disorder at some point

Market Reality Check

Price: $1.6400 Vol: Volume 47,699 is below th...
low vol
$1.6400 Last Close
Volume Volume 47,699 is below the 20-day average of 162,702, suggesting limited pre-news positioning. low
Technical Shares at $1.84 are trading below the 200-day MA of $7.55 and far under the 52-week high of $30.25.

Peers on Argus

ADIL was down 8% with low volume while 2 tracked biotech peers (e.g., AIM, IBO) ...
2 Down

ADIL was down 8% with low volume while 2 tracked biotech peers (e.g., AIM, IBO) in momentum scans also moved down (median about -5.6%), pointing to broader sector pressure rather than a purely idiosyncratic move.

Historical Context

5 past events · Latest: Mar 06 (Positive)
Pattern 5 events
Date Event Sentiment Move Catalyst
Mar 06 Earnings and update Positive -7.1% Reported 2025 results, positive AD04-103 PK, supportive FDA feedback, extended IP.
Mar 03 Partnership framework Positive -7.3% Signed exclusive AD04 collaboration framework with Molteni for European rights.
Feb 24 Nasdaq compliance Positive +4.7% Regained full compliance with Nasdaq minimum bid price listing requirement.
Feb 23 FDA policy highlight Positive -4.9% Highlighted FDA policy that may allow approval with one pivotal trial plus evidence.
Feb 17 Conference presentation Neutral -5.3% Announced CEO presentation and investor meetings at Oppenheimer healthcare conference.
Pattern Detected

Recent fundamentally positive updates on AD04, regulatory alignment, and partnerships often coincided with negative price reactions, except for the Nasdaq compliance news.

Recent Company History

Over recent months, Adial has focused on advancing AD04 toward Phase 3, improving regulatory alignment, and shoring up its listing status. A collaboration framework with Molteni in Europe, a regained Nasdaq minimum bid price, and constructive FDA policy signals all preceded this announcement recognizing AUD in new federal legislation. The pattern shows multiple clinically and strategically positive milestones with mixed-to-negative price reactions, framing today’s policy-aligned news within an already de‑risked regulatory narrative for AD04.

Regulatory & Risk Context

Active S-3 Shelf
Shelf Active
Active S-3 Shelf Registration 2025-12-12

An effective S-3 shelf dated 2025-12-12 registers up to 13,823,512 shares of common stock for resale upon exercise of Series F warrants. Adial would receive cash only if these warrants are exercised, while the large registered share amount relative to its equity base creates potential dilution and stock overhang.

Market Pulse Summary

The stock moved -8.2% in the session following this news. A negative reaction despite policy support...
Analysis

The stock moved -8.2% in the session following this news. A negative reaction despite policy support from H.R. 7091 would fit a pattern where positive clinical, regulatory, or partnership updates (e.g., Molteni framework, favorable FDA signals) still saw selling pressure. With shares far below the 200-day MA of $7.55 and an effective shelf registering 13,823,512 shares for resale, overhang and a short interest of 25.12% could amplify downside moves even on seemingly supportive news.

Key Terms

alcohol use disorder, aud, food & drug administration, harm reduction, +2 more
6 terms
alcohol use disorder medical
"specifically including Alcohol Use Disorder (AUD). Alcohol Use Disorder remains a significant issue"
A chronic medical condition characterized by an inability to control or stop drinking despite negative effects on health, work, relationships or safety; it ranges from mild to severe based on frequency, loss of control, and withdrawal symptoms. Investors care because its prevalence and treatment options affect markets for pharmaceuticals, medical services and health-related productivity—think of it like a long-running equipment fault in a factory that reduces output and creates demand for repairs and preventive solutions.
aud medical
"specifically including Alcohol Use Disorder (AUD). Alcohol Use Disorder remains a significant issue"
AUD is the international currency code for the Australian dollar, the official money used in Australia and several nearby territories. Investors watch AUD because changes in its value act like a price tag or thermometer for assets and transactions denominated in that currency — affecting export revenues, import costs, commodity prices, and the value of overseas investments. Movements in AUD can change returns and risk for portfolios with exposure to Australia or Australian-dollar contracts.
food & drug administration regulatory
"existing Food & Drug Administration-approved treatment options are abstinence based"
The Food and Drug Administration is the U.S. government agency that reviews and approves medicines, medical devices, vaccines, and certain foods to make sure they are safe and work as claimed. Investors watch its decisions like a referee’s call, because an approval can open large markets and boost a company’s value, while delays, restrictions, or recalls can cut sales and raise costs.
harm reduction medical
"policy recognizing harm reduction and reductions in heavy drinking as meaningful"
Harm reduction is a set of products, services and policies aimed at lowering the negative health and social effects of risky behaviors—such as smoking, drug use or unsafe sex—without insisting that people stop the behavior entirely. For investors, it matters because harm-reduction approaches create new markets and revenue streams, alter regulatory and legal risk, and can change consumer preferences and brand value, so companies pursuing these strategies may have different growth and risk profiles compared with those focused only on traditional products.
substance use disorders medical
"advance innovative approaches for Substance Use Disorders (SUD), including Alcohol Use Disorder"
A substance use disorder is a medical condition in which a person’s use of drugs or alcohol becomes compulsive, persists despite harmful consequences, and interferes with daily life; it changes brain pathways that control judgment and self-control, similar to a damaged navigation system that keeps sending someone the wrong directions. Investors should care because prevalence, treatment demand, approval of therapies, regulatory scrutiny, litigation, and related healthcare costs can materially affect the revenue, expenses, and risk profile of companies in health care, pharmaceuticals, insurers, and employers.
sud medical
"advance innovative approaches for Substance Use Disorders (SUD), including Alcohol Use Disorder"
Substance use disorder (SUD) is a diagnosed medical condition in which a person’s use of drugs or alcohol becomes compulsive and harmful, disrupting work, relationships or health — similar to a worn track that keeps pulling a person off course. Investors watch SUD because it determines the size of the market for treatments, affects regulatory and insurance decisions, and can directly influence revenue outlooks and valuations for healthcare and pharmaceutical companies.

AI-generated analysis. Not financial advice.

H.R. 7091 Supports Development of Investigational Treatments for Alcohol Use Disorder and Aligns with Evolving Federal Recovery Standards

GLEN ALLEN, Va., March 24, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on the development of treatments for addiction and related disorders, today commended members of the U.S. Congress for introducing H.R. 7091, the Expanding Veterans’ Access to Emerging Treatments Act, bipartisan legislation aimed at expanding research and development of emerging therapies for conditions affecting U.S. veterans, specifically including Alcohol Use Disorder (AUD).

Alcohol Use Disorder remains a significant issue within the veteran population, with nearly 40% of veterans experiencing AUD at some point in their lives. Despite the prevalence and impact of the condition, existing Food & Drug Administration-approved treatment options are abstinence based, limiting therapeutic approaches for many patients.

H.R. 7091 specifically includes AUD among the conditions eligible for expanded research and development efforts. The legislation supports investigational pharmaceutical therapies that meet the U.S. Government’s updated definition of recovery, which includes non-abstinence based treatment options. This definition reflects evolving federal policy recognizing harm reduction and reductions in heavy drinking as meaningful clinical outcomes.

Adial’s lead investigational product candidate, AD04, is being developed as a genetically targeted therapy for Alcohol Use Disorder. AD04 follows a non-abstinence based treatment approach and aligns with FDA supported endpoints focused on harm reduction and reduction in heavy drinking days, consistent with direction provided by Congress in the federal Appropriations package.

“We applaud members of Congress for introducing this important bipartisan legislation and for specifically recognizing AUD as a critical issue affecting our nation’s veterans,” said Cary Claiborne, Chief Executive Officer of Adial Pharmaceuticals. “By expanding support for emerging therapies that align with the government’s updated definition of recovery, including non-abstinence treatment options, this bill represents meaningful progress for veterans in need of additional treatment options.”

The bill has been referred to the House Committee on Veterans’ Affairs and reflects bipartisan recognition of the need to advance innovative approaches for Substance Use Disorders (SUD), including Alcohol Use Disorder, which is often underemphasized within broader SUD policy initiatives.

Adial believes that H.R. 7091 reinforces federal support for harm reduction based treatment paradigms and may help advance development efforts for emerging investigational therapies such as AD04.

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 expanding research and development of emerging therapies for conditions affecting U.S. veterans, specifically including AUD, developing AD04 as a genetically targeted therapy for AUD, H.R. 7091 reinforcing federal support for harm reduction based treatment paradigms and helping advance development efforts for emerging investigational therapies such as AD04 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, including our ability to finalize and enter into a definitive agreement regarding the planned partnership with Molteni, 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 as well as the Parties’ ability to enter into a definitive agreement. 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 does H.R. 7091 mean for Adial Pharmaceuticals (ADIL) and its AD04 candidate?

It may improve research access for AD04 by recognizing non‑abstinence outcomes in AUD trials. According to Adial, H.R. 7091 includes AUD in eligible conditions and aligns investigational endpoints with harm‑reduction measures that AD04 targets.

How does H.R. 7091 change federal recovery standards for Alcohol Use Disorder relevant to ADIL (ADIL)?

H.R. 7091 supports an updated federal recovery definition that includes non‑abstinence outcomes like reduced heavy drinking. According to Adial, this reflects evolving policy and endorses harm‑reduction endpoints used in AD04 development.

What stage is Adial’s AD04 in and how might the bill affect its development timeline?

AD04 is described as a clinical‑stage, genetically targeted investigational therapy for AUD. According to Adial, the bill could reinforce federal support for trials using harm‑reduction endpoints, potentially aiding development pathways but not guaranteeing timelines.

Does H.R. 7091 specifically prioritize veterans with Alcohol Use Disorder for investigational therapies?

Yes, H.R. 7091 explicitly includes AUD among conditions eligible for expanded R&D for veterans. According to Adial, the legislation aims to advance emerging therapies and broaden treatment approaches for veterans with AUD.

What is the current legislative status of H.R. 7091 mentioned by Adial (ADIL)?

H.R. 7091 has been introduced and referred to the House Committee on Veterans’ Affairs. According to Adial, the bill is at the referral stage and reflects bipartisan interest but has not yet become law.
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