Aardvark Therapeutics Faces Class Action Over Failed Drug Safety Claims

A securities class action has been filed against Aardvark Therapeutics, alleging the company misled investors by claiming its lead drug candidate was nearly gut-restricted and free of serious adverse events, only for the FDA to later impose a full clinical hold following unexpected cardiac observations in trial participants.

Corp and Tech·September 2, 2026·reads: 2,267

The lawsuit, 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 claim Aardvark promoted ARD-101 as a breakthrough with 99% gut restriction and minimal systemic toxicity. These assurances supported the company's February 2025 initial public offering, which raised approximately $87.6 million at $16.00 per share.

The narrative shifted in early 2026 when Aardvark announced a voluntary pause of its Phase 3 HERO trial due to reversible cardiac issues discovered during routine safety monitoring. By May 14, 2026, the FDA escalated the situation by placing a full clinical hold on the drug's investigational application. Shares plummeted following these disclosures, closing at $4.57 on May 15, 2026—a 71.4% decline from the IPO price.

Joseph E. Levi of Levi & Korsinsky, LLP, the firm representing the plaintiffs, stated that the discrepancy between the company’s safety promises and the subsequent regulatory action demands rigorous legal scrutiny. Investors who purchased AARD securities during the specified window have until October 13, 2026, to apply for lead plaintiff status. The litigation seeks to recover losses for shareholders who acquired stock based on the allegedly incomplete or misleading safety disclosures.