Catalyst overview
Research summary
This catalyst tracks a PDUFA approval decision for Encaleret in Autosomal Dominant Hypocalcemia Type 1 . The expected timing is based on the latest available company guidance and may change.
CALIBRATE trial. 12/22/22- Initiated pivotal study. Full enrollment in 2024 & topline data in 2025. 10/29/25– Reported topline results; NDA submission planned H1 2026. 05/05/26:- CALIBRATE Ph3 ADH1 data to be presented at ECE May 9-12, 2026. 05/12/26:- NDA submitted. CALIBRATE Ph3 met endpoints; ECE 2026 oral presentation. 06/22/26:- CLARIFY ADH1/2 pediatric burden and quality-of-life poster at ICCBH 2026 on June 29. 07/22/26:- NDA accepted; PDUFA May 8, 2027. CALIBRATE-PEDS enrolling; RECLAIM-HP Ph3 later Summer 2026.
Verification
Confirm timing and program details against the company announcement or filing.