Catalyst overview
Research summary
This catalyst tracks a Approved update for Orladeyo (Berotralstat) in Hereditary angioedema . The expected timing is based on the latest available company guidance and may change.
5/14/25- FDA accepted NDA for use of oral, once-daily in pediatric patients aged 2-11 years. Original PDUFA Sep 12, 2025. 8/4/25-PDUFA date extended to December 12, 2025. 11/03/25:- PDUFA goal date for ORLADEYO granules in HAE children 2-<12 remains December 12, 2025. 12/12/25:- FDA approved ORLADEYO oral pellets for HAE prophylaxis in children 2-<12; EU and Japan filings ongoing. 02/11/26:- AAAAI 2026 will feature ORLADEYO pediatric APeX-P interim data and multiple real-world HAE outcomes analyses. 02/26/26:- 2025 ORLADEYO pellet approval for HAE children 2-<12 reiterated; no new regulatory milestones disclosed. 05/06/26:- PR No update. 05/13/26:- Two pediatric HAE real-world burden posters presented at ISPOR 2026 on May 18, 2026. 05/27/26:- EAACI 2026 poster June 13 presents APeX-P 48-week pediatric 2-<12 efficacy and safety. 06/12/26:- APeX-P 48-week pediatric data presented at EAACI June 12-15. 08/05/26:- Pediatric ORLADEYO pellet shipments began Aug 3; 47 prescriptions written year-to-date.
Verification
Confirm timing and program details against the company announcement or filing.