Aardvark Therapeutics is being sued by shareholders who say the company misrepresented the safety of ARD-101, its Prader-Willi Syndrome drug, before the FDA halted the Phase 3 HERO trial. The stock lost more than 56 percent in February and another 32.1 percent in May as cardiac observations surfaced and a full clinical hold followed.
Aardvark Therapeutics faces a securities class action after the FDA's full clinical hold halted its Phase 3 HERO trial of ARD-101.
"We're investigating the suit's allegations, including that Aardvark allegedly misled investors about ARD-101's development, its safety and efficacy," Reed Kathrein, the Hagens Berman partner leading the firm's investigation of the claims, said.
The complaint, pursued by Hagens Berman and Levi & Korsinsky, alleges Aardvark marketed ARD-101 as a "99% gut-restricted" therapy with "no serious adverse events" and promised Phase 3 data in early 2026. Instead, reversible cardiac observations — including QRS prolongation — surfaced at above-target doses in a healthy volunteer study, prompting Aardvark on Feb. 27, 2026, to voluntarily pause the HERO trial. Shares plunged more than 56 percent that day. On May 14, the FDA placed a full clinical hold on the investigational new drug application, halting the HERO and open-label extension trials; the stock fell another 32.1 percent.
The class period spans the Feb. 13, 2025, initial public offering through May 14, 2026. Investors seeking to lead the case face an Oct. 13, 2026, deadline to move the court.
ARD-101 is a small-molecule candidate targeting bitter taste receptors (TAS2Rs) to treat hyperphagia, the insatiable appetite that defines Prader-Willi Syndrome, a rare genetic disorder affecting roughly one in 15,000 births. The HERO trial was designed to measure hunger reduction, and the open-label extension tracked longer-term safety. The cardiac findings at above-target doses undercut the company's central claim that the drug stayed in the gut, a safety profile that had underpinned its valuation since the February 2025 IPO.
The regulatory freeze strands Aardvark's only clinical-stage program. With the promised early-2026 readout gone and litigation costs mounting on top of the share collapse, the company's next milestone is any resolution of the clinical hold or the court's appointment of a lead plaintiff in the class action.
This article is for informational purposes only and does not constitute investment advice.
