Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Ralinepag in Pulmonary arterial hypertension (PAH). The expected timing is based on the latest available company guidance and may change.
ADVANCE OUTCOMES trial. 10/30/24- Enrollment ongoing. 5/19/25- Presented interim long-term data at ATS'25. 6/23/25- Enrollment completed. Accrue clinical worsening events through the end of 2025 and report further data in 2026 03/02/26:- Ph3 ADVANCE OUTCOMES met primary endpoint. NDA submission planned in H2 2026. 05/11/26:- ADVANCE OUTCOMES Ph3 results to be presented at ATS May 20, 2026. 05/17/26:- Full ADVANCE OUTCOMES results presented at ATS. NDA submission still planned in H2 2026. 08/24/26:- NDA accepted; PDUFA action date set for June 24, 2027.
Verification
Confirm timing and program details against the company announcement or filing.