Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Lorundrostat in Hypertension. The expected timing is based on the latest available company guidance and may change.
11/10/25:- Planning NDA submission for lorundrostat in hypertension in late 2025, with possible window into Q1 2026. 03/09/26:- FDA accepted NDA; PDUFA action date set for December 22, 2026. 03/12/26:- NDA acceptance and December 22, 2026 PDUFA date reiterated; Transform-HTN open-label extension trial ongoing. 05/06/26:- NDA acceptance and December 22, 2026 PDUFA date reiterated; Transform-HTN OLE and pre-commercial launch activities ongoing. 05/30/26:- ESH 2026 presented Launch-HTN CKD subgroup efficacy and safety; PDUFA date reiterated for December 22, 2026. 06/08/26:- Late-breaking ENDO 2026 poster June 14 shows post hoc proteomic biomarkers from Launch-HTN and Advance-HTN. 06/14/26:- ENDO 2026 proteomic analysis showed HF biomarker reductions; PDUFA remains December 22, 2026. 08/11/26:- FDA review continues; PDUFA decision remains December 22, 2026. Transform-HTN OLE continues; sales organization will be established before PDUFA.
Verification
Confirm timing and program details against the company announcement or filing.