Levi & Korsinsky Reminds Shareholders of a Lead Plaintiff Deadline of October 13, 2026 in Aardvark Therapeutics, Inc. Lawsuit - AARD

A securities class action alleges Aardvark Therapeutics' SEC filings warned about clinical risk in generic terms while describing ARD-101 as "99% restricted to the gut" with "no serious adverse events" and "no renal or hepatic safety limitations" — language the complaint contends did not disclose the specific cardiac safety issues that later drew a full FDA clinical hold.

NEW YORK, Sept. 9, 2026 /PRNewswire/ -- Levi & Korsinsky, LLP notifies investors in Aardvark Therapeutics, Inc. (NASDAQ: AARD) that a securities class action has been filed on behalf of shareholders who purchased or acquired securities between February 13, 2025 and May 14, 2026, and/or pursuant to the Company's February 2025 initial public offering. Find out if you might be eligible to recover losses. You may also contact Joseph E. Levi, Esq. at [email protected] or (212) 363-7500.

AARD shares were sold to the public at $16.00 per share, raising $87,613,440 in net proceeds. The stock closed at $4.57 on May 15, 2026, approximately $11.43 below the offering price, a decline of roughly 71.4%. The lead plaintiff deadline is October 13, 2026.

What the Company Disclosed

SEC filings stated that ARD-101 "has limited systemic absorption, which we believe reduces the potential for systemic toxicity," and that the compound "was found to be approximately 99% restricted to the gut with minimal systemic exposure, and was well-tolerated at all dose levels." The Offering Documents added that ARD-101 "resulted in no serious adverse events (SAEs), no renal or hepatic safety limitations." Similar tolerability language was repeated in the Company's Form 10-K filed March 31, 2025 and subsequent quarterly reports.

Disclosure Gaps Alleged

• Cardiac safety was allegedly addressed only through generalized statements about reduced systemic toxicity, rather than as a specific monitored risk.
• Registration Statement language allegedly presented "99% gut-restricted" preclinical mouse and monkey pharmacokinetic data as support for a broad tolerability conclusion.
• The complaint challenges whether disclosures adequately conveyed that safety observations could arise at above-target therapeutic doses in healthy volunteer studies.
• Guidance that topline HERO data would arrive in early 2026 allegedly carried no disclosure of risks to that timeline.
• The complaint asserts that ARD-101's clinical, regulatory, and commercial prospects were overstated as a result.

Regulatory Reality

On February 27, 2026, Aardvark announced a voluntary pause of the Phase 3 HERO trial, citing "reversible cardiac observations at above target therapeutic doses found during routine safety monitoring in a healthy volunteer study," and said it no longer anticipated announcing topline HERO data in the third quarter of 2026. Shares fell $7.02, or 56.2%, to close at $5.47 on March 2, 2026. On May 14, 2026, the Company announced that the FDA had placed a full clinical hold on the ARD-101 IND covering all ongoing studies. Shares fell $2.16, or 32.1%, the following session.

"Generic risk factor language cannot substitute for disclosing specific, known problems that are already affecting a company's operations. The complaint alleges Aardvark's filings described ARD-101 as gut-restricted and free of serious adverse events, and investors are entitled to have that question tested." -- Joseph E. Levi, Esq.

Submit your information to learn more or call (212) 363-7500.

ABOUT THE FIRM — For over two decades, Levi & Korsinsky has represented shareholders in securities class actions. Ranked in ISS Top 50 for seven consecutive years. Investors who suffered losses have until October 13, 2026 to seek appointment as lead plaintiff.

Frequently Asked Questions About the AARD Lawsuit

Q: What court was the AARD class action filed in? A: The case was filed in the United States District Court for the Southern District of California, governed by the Private Securities Litigation Reform Act of 1995.

Q: Who are the defendants named in the AARD lawsuit? A: The complaint names Aardvark Therapeutics, Inc. and individual defendants including senior executives and directors who signed SEC filings, made public statements, or certified financial disclosures.

Q: What specific misstatements does the AARD lawsuit allege? A: The complaint alleges Aardvark Therapeutics made materially false or misleading statements regarding the safety and tolerability profile of ARD-101, including that it was approximately 99% gut-restricted with no serious adverse events, during the Class Period. When the Phase 3 HERO trial pause and the FDA's full clinical hold were disclosed, the stock price declined sharply.

Q: What documents do I need to to submit my information? A: Brokerage statements or trade confirmations showing purchase dates, share quantities, prices paid, and any subsequent sale dates and prices.

Q: What happens after I contact Levi & Korsinsky? A: An attorney will review your trading history at no cost and provide an initial assessment of your potential eligibility.

Q: What does it cost me to participate? A: There is no upfront cost to submit your information and review whether you may be eligible to recover. Should you choose to participate in the securities class action, they are generally handled on a contingency basis, with any attorneys' fees and expenses subject to court approval.

Q: Do I need to go to court or give testimony? A: No. The overwhelming majority of class members never appear in court or give depositions. If there is a settlement or recovery, eligible class members generally submit a claim form to seek their portion.

Q: What if I live outside the United States? A: U.S. securities class actions generally cover purchases on U.S. exchanges regardless of the investor's country of residence.

CONTACT:\
Levi & Korsinsky, LLP\
Joseph E. Levi, Esq.\
Ed Korsinsky, Esq.\
33 Whitehall Street, 27th Floor\
New York, NY 10004\
[email protected]\
Tel: (212) 363-7500\
Fax: (212) 363-7171

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SOURCE Levi & Korsinsky, LLP