regulatory
confidence high
sentiment positive
materiality 0.80
BridgeBio submits NDA to FDA for encaleret in ADH1; Phase 3 data shows 76% achieved target calcium levels
BridgeBio Pharma, Inc.
- NDA submitted for encaleret, a potential first approved therapy for autosomal dominant hypocalcemia type 1 (ADH1).
- Phase 3 CALIBRATE trial met all primary and key secondary endpoints: 76% on encaleret vs 4.4% on standard of care achieved both serum and urine calcium targets at Week 24 (p<0.0001).
- BridgeBio anticipates U.S. launch in early 2027; NDA may be eligible for priority review.
- Planned MAA submission to EMA in H2 2026; also plans to initiate RECLAIM-HP Phase 3 study in chronic hypoparathyroidism in Summer 2026.
- Safety profile favorable: no discontinuations in encaleret arm; low rates of serious adverse events similar between arms.