Securities Class Action Targets Aardvark Therapeutics Over ARD-101 Safety Disclosures

A securities class action has been filed against Aardvark Therapeutics Inc. (NASDAQ: AARD) in the U.S. District Court for the Southern District of California, docketed as 26-cv-04643, according to a Pomerantz LLP announcement. The suit, filed on behalf of investors who bought Aardvark common stock in its February 13, 2025 initial public offering or traded shares between that date and May 14, 2026, alleges the company and certain officers made materially false and misleading statements about the safety and viability of its lead drug candidate, ARD-101.

Aardvark is a clinical-stage biopharmaceutical company developing small-molecule therapies targeting bitter taste receptors (TAS2Rs) to treat hunger-related metabolic conditions, including Prader-Willi Syndrome (PWS), a neurodevelopmental disorder characterized by extreme, insatiable hunger. Its lead candidate, ARD-101, is a gut-restricted agonist of TAS2Rs intended to suppress hyperphagia through secretion of endogenous signaling molecules such as cholecystokinin and GLP-1.

The IPO, conducted on or about February 13, 2025, raised approximately $87.6 million by issuing 5.88 million shares at $16.00 each. Offering documents described preclinical data suggesting ARD-101 "shows potential to be a well-tolerated, satiety-inducing drug," according to the Robbins LLP announcement.

**Alleged Misrepresentations**

The complaint, as detailed across multiple law firm notices, alleges the company and its executives failed to disclose that ARD-101 was less safe than represented, that its clinical and commercial prospects were overstated, and that public statements were therefore materially false and misleading. Specifically, the suit claims the company did not inform investors about cardiac safety issues observed during trials.

According to the Hagens Berman Sobol Shapiro LLP announcement, the undisclosed cardiac observations included "reversible cardiac observations (such as QRS prolongation) at above-target doses."

**Truth Emerges: Trial Pause and FDA Hold**

The first significant disclosure came on February 27, 2026, when Aardvark announced it was voluntarily pausing its Phase 3 Hunger Elimination or Reduction Objective (HERO) trial. The company attributed the pause to "reversible cardiac observations at above target therapeutic doses found during routine safety monitoring in a healthy volunteer study."

The stock fell $7.02 per share, or 56.2%, to close at $5.47 on March 2, 2026, according to multiple law firm releases.

Then on May 14, 2026, Aardvark announced that the U.S. Food and Drug Administration had placed a full clinical hold on its investigational new drug application for ARD-101. The hold applied to all ongoing studies, including the Phase 3 HERO trial and a Phase 3 open-label extension trial. The stock fell another $2.16 per share, or 32.1%, to close at $4.57 on May 15, 2026.

**Lawsuit Details and Lead Plaintiff Deadline**

The lawsuit asserts violations of the Securities Act of 1933 and the Securities Exchange Act of 1934. Multiple shareholder rights firms — including Pomerantz LLP, Robbins LLP, Hagens Berman Sobol Shapiro LLP, Schall Brown & Schwartz LLP, and Bernstein Liebhard LLP — are publicizing the case and the lead plaintiff deadline.

Investors who wish to serve as lead plaintiff must file motions by October 13, 2026. The lead plaintiff acts as a representative party for the class. Investors are not required to seek lead plaintiff status to share in any potential recovery.

"We're investigating the suit's allegations, including that Aardvark allegedly misled investors about ARD-101's development, its safety and efficacy," said Reed Kathrein, the Hagens Berman partner leading the firm's investigation of the claims, as quoted in the firm's announcement.

Brian J. Robbins, founding partner of Robbins LLP, stated: "Companies have an obligation to provide investors with complete and accurate information so that markets can function fairly and efficiently."

The class has not yet been certified. Aardvark has not publicly commented on the litigation.