Hereditary angioedema
PHVSPharvaris B.V.Catalyst overview
Research summary
This catalyst tracks a Phase 3 data readout for Deucrictibant immediate-release capsules (PHVS416) in Hereditary angioedema . The expected timing is based on the latest available company guidance and may change.
RAPIDe-1/2/3 studies. 3/18/24- RAPIDe-3 trial initiated. 4/7/25- Target enrollment achieved. 7/10/25- NDA submission in H1 2026. 12/3/25– Met all study endpoints. 01/12/26:- NDA filing H1 2026; RAPIDe-3 Phase 3 results to be presented at AAAAI 2026. 02/10/26:- RAPIDe-3 Phase 3 results to be presented as featured poster at AAAAI 2026. 03/02/26:- RAPIDe-3 (NCT06343779) met all endpoints; median relief 1.28h, complete resolution 11.95h. NDA filing H1 2026. 04/02/26:- NDA submission for deucrictibant IR on-demand HAE remains on-track H1 2026. RAPIDe-3 data presented at AAAAI 2026. 04/20/26:- CIIC 2026 analyses support IR+XR combined dosing safety margins. Marketing applications for IR on-demand HAE in preparation. 05/29/26:- EAACI June 12 oral and June 13 poster RAPIDe-3 results. Marketing authorization applications in preparation. 06/15/26:- EAACI 2026 detailed RAPIDe-3 EoP endpoint and patient voices. NDA submission still expected H1 2026. 07/06/26:- FDA accepted deucrictibant IR NDA; PDUFA action date set for April 23, 2027. 08/12/26:- RAPIDe-3 analyses will be presented September 4, 2026. PDUFA action is April 23, 2027; U.S. expanded access opened.
Verification
Confirm timing and program details against the company announcement or filing.