The complaint, filed in the United States District Court for the Southern District of California, targets the period between February 13, 2025, and May 14, 2026. Shareholders allege that while Aardvark’s SEC filings touted ARD-101 as being 99% restricted to the gut with no serious adverse events, the company failed to disclose that cardiac safety issues had emerged during healthy volunteer studies. These omissions supposedly left investors unaware of the clinical risks that ultimately triggered a full FDA clinical hold.
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Aardvark Therapeutics Faces Class Action Over ARD-101 Safety Disclosures
Investors in Aardvark Therapeutics, Inc. have until October 13, 2026, to file for lead plaintiff status in a securities class action. The lawsuit centers on allegations that the company masked specific cardiac risks associated with its drug candidate, ARD-101, behind broad claims of gut-restricted safety and minimal toxicity.
The financial impact on early investors has been stark. Shares issued during the company’s February 2025 initial public offering at $16.00 plummeted to $4.57 by May 15, 2026, marking a decline of approximately 71.4%. The stock price suffered two major drops: first in February 2026, when the company paused its Phase 3 HERO trial, and again in May 2026 following the FDA’s intervention. Joseph E. Levi, the attorney representing the class, argues that generic risk disclosures provided by the company were insufficient given the specific safety observations already known to management at the time.
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