AARD Aardvark Therapeutics

Aardvark terminates Phase 3 HERO/OLE trials for ARD-101 in PWS

Company terminated both the Phase 3 HERO and OLE trials in June 2026 and does not intend to resume them as previously designed. FDA placed a full clinical hold on the ARD-101 IND in May 2026. Unblinded data from the terminated trials will be assessed in Q3 2026 to determine next steps.

Aardvark: FDA places full clinical hold on ARD-101 IND

FDA converted the company’s voluntary pause into a full clinical hold on the ARD-101 IND, halting both the Phase 3 HERO trial and the OLE trial. The company will unblind accumulated HERO and OLE data to evaluate efficacy and safety and to guide next steps with the agency.

Aardvark pauses Phase 3 HERO trial of ARD-101 in PWS

The company voluntarily paused enrollment and dosing in the Phase 3 HERO and OLE trials of ARD-101 after reversible cardiac observations in a healthy-volunteer study. It is working with the FDA to determine next steps and expects to provide further guidance in Q2 2026. ARD-201 development was also paused.

Aardvark pauses Phase 3 HERO/OLE and ARD-201 trials; guidance Q2 2026

Aardvark voluntarily paused enrollment and dosing in the Phase 3 HERO and OLE trials of ARD-101 for PWS hyperphagia and paused the ARD-201 obesity program after reversible QRS prolongation signals were seen in healthy-volunteer cardiac-safety studies. The company is reviewing data with the FDA and will provide further guidance on both programs in Q2 2026.