A securities class action alleges Aardvark Therapeutics promised investors a "99% gut-restricted" drug with "no serious adverse events" and Phase 3 data in early 2026; instead, cardiac observations paused the HERO trial and the FDA imposed a full clinical hold.
NEW YORK, Sept. 2, 2026 /PRNewswire/ -- Levi & Korsinsky, LLP alerts 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 may be eligible to recover losses. You may also contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500.
Shares sold at $16.00 in the IPO closed at $4.57 on May 15, 2026, a decline of $11.43 per share, or 71.4%, from the offering price. The window to apply for lead plaintiff closes on October 13, 2026.
The Promise
The Company projected topline Phase 3 HERO data in early 2026 and told the market that ARD-101 "has limited systemic absorption, which we believe reduces the potential for systemic toxicity and has contributed to ARD-101 being well-tolerated in our clinical trials to date." Offering materials stated the drug was "approximately 99% restricted to the gut with minimal systemic exposure" and "resulted in no serious adverse events (SAEs)." Management represented that the program had aligned with the FDA on a design believed sufficient to support a new drug application.
The Reality
Results revealed a different picture. On February 27, 2026, the Company 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 stated it no longer anticipated topline HERO data in the third quarter of 2026. On May 14, 2026, the Company announced the FDA had placed a full clinical hold on the ARD-101 investigational new drug application, covering the HERO trial and the Phase 3 open-label extension.
Promise vs. Actual: By the Numbers
- Promised: no serious adverse events. Actual: cardiac observations prompting a voluntary trial pause.
- Promised: topline HERO data in early 2026. Actual: data no longer anticipated in the third quarter of 2026.
- Promised: an FDA-aligned pivotal path. Actual: a full clinical hold on all studies under the IND.
- IPO price of $16.00 per share versus a $4.57 close on May 15, 2026.
- Two disclosure-day declines: $7.02 per share (56.2%) and $2.16 per share (32.1%).
- IPO proceeds of $87,613,440 raised on 5,888,000 shares.
"Companies that make specific promises to investors about future performance have an obligation to disclose known risks to those projections. The gap alleged here between a drug described as producing no serious adverse events and a full FDA clinical hold merits close review." -- Joseph E. Levi, Esq.
Submit your information to learn more or call (212) 363-7500.
Levi & Korsinsky, LLP is a nationally recognized shareholder rights firm. Over the past 20 years, the firm has secured hundreds of millions of dollars for aggrieved shareholders. Ranked in ISS Top 50 for seven consecutive years.
Frequently Asked Questions About the AARD Lawsuit
Q: What specific misstatements does the AARD lawsuit allege? A: The complaint alleges Aardvark Therapeutics, Inc. made materially false or misleading statements regarding the safety and tolerability of ARD-101, including claims that it was approximately 99% gut-restricted with no serious adverse events, during the Class Period. When the voluntary Phase 3 HERO trial pause and the FDA's full clinical hold were disclosed, the stock price declined sharply.
Q: When did Aardvark Therapeutics, Inc. allegedly mislead investors? A: The Class Period runs from February 13, 2025 to May 14, 2026. The complaint alleges that corrective disclosures revealed information that caused a significant stock decline.
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: What do AARD investors need to do right now? A: Investors may gather brokerage records showing purchase dates, share quantities, and prices paid. Submit your information for a no-cost, no-obligation evaluation of your potential recovery. No immediate action is required to remain eligible as an absent class member.
Q: What is a lead plaintiff and why does it matter? A: A lead plaintiff is the investor appointed by the court to represent the entire class. Lead plaintiffs are typically investors with the largest documented losses. Being appointed does not increase individual recovery but gives direct oversight of how the case is run.
Q: What if I already sold my AARD shares -- can I still recover losses? A: Yes. Eligibility is based on when you purchased, not whether you still hold the shares. Investors who bought during the Class Period and sold at a loss may still be eligible to participate.
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: What if I missed the lead plaintiff deadline? A: The deadline applies only to investors seeking lead plaintiff appointment. Class members who miss it may still be able to participate in any potential settlement or recovery.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
jlevi@levikorsinsky.com
Tel: (212) 363-7500
Fax: (212) 363-7171
Attorney Advertising. Prior results do not guarantee similar outcomes.
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SOURCE Levi & Korsinsky, LLP
