Aardvark Therapeutics (AARD) FDA announcement summary

Introduction and purpose

• Review of ARD-101 development for hyperphagia in Prader-Willi syndrome (PWS), including the prematurely terminated HERO Phase 3 trial and open-label extension (OLE); findings are exploratory.

• ARD-101 is an investigational oral bitter taste receptor agonist designed to stimulate gut peptide hormone release and reduce hunger signaling.

Details of approval or decision

• FDA lifted the clinical hold on the ARD-101 IND and the HERO/OLE program in October 2026; this was not marketing approval, and ARD-101 remains investigational.

• Clinical development may resume following further FDA engagement and alignment on the Phase 3 design.

Impact on industry and stakeholders

• Hyperphagia remains a major burden for PWS families, and existing treatment and food-security measures do not fully address it.

• Clinician Lynne Bird said an oral twice-daily option could be practical for families; she noted responses to the approved treatment vary and more options are needed.