Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for ARD-101 in Prader-Willi Syndrome. The expected timing is based on the latest available company guidance and may change.
HERO Ph3 Trial. 10/7/25- Announces FDA alignment on protocol amendment to expand trial. Topline data readout in Q3 2026. 12/10/25:- First patient dosed in Australia; Canada/UK cleared; enrollment strong; still targeting HERO topline in Q3 2026. 02/10/26:- IRB okays protocol lowering age to seven; enrollment steady. HERO toplline on track Q3 2026. 02/27/26:- HERO Ph3 enrollment and dosing paused for cardiac findings; no longer expect topline Q3 2026; guidance Q2 2026. 03/23/26:- Details QRS prolongation findings; HERO/OLE remain voluntarily paused; still guiding to Q2 2026 program update. 05/07/26:- HERO Ph3 and OLE in PWS remain paused; ARD-101 program guidance still expected Q2 2026. 05/14/26:- FDA placed full clinical hold on ARD-101 HERO and OLE Ph3 studies; unblinding planned. 08/11/26:- HERO and OLE trials were terminated in June. Unblinded Phase 3 data will be assessed in Q3 2026; FDA hold discussions continue.
Verification
Confirm timing and program details against the company announcement or filing.