Aardvark Therapeutics announces FDA alignment on HERO trial protocol amendment

Aardvark Therapeutics (AARD) announces alignment with the U.S. Food and Drug Administration on a protocol amendment to the company’s Phase 3 HERO trial of ARD-101 for the treatment of hyperphagia associated with Prader-Willi Syndrome. The protocol amendment changes the minimum age of eligibility to participate in the trial from 13 to 10 years old. “Expansion of the Phase 3 HERO trial to include children 10 years of age and older will allow us to reach a larger segment of the PWS patient population to potentially serve more patients in need,” said Tien Lee, CEO. “This decision to expand eligibility is driven by support from the PWS community, alongside historical data showing that younger patients are more likely to benefit from early intervention. We look forward to our topline data readout for this potentially pivotal trial in the third quarter of 2026.”