BridgeBio Files Encaleret NDA After 76% Phase 3 Success, Targets Early 2027 Launch
BridgeBio submitted its NDA to the FDA for encaleret to treat ADH1 following Phase 3 CALIBRATE results showing 76% of patients achieved target serum and urine calcium at Week 24 versus 4% on standard therapy (p<0.0001). The company expects FDA priority review and plans a U.S. launch in early 2027.
1. NDA Submission for Encaleret
BridgeBio has submitted a New Drug Application to the FDA seeking approval of encaleret for autosomal dominant hypocalcemia type 1, marking its first regulatory filing for a targeted ADH1 therapy.
2. Phase 3 CALIBRATE Trial Results
In the CALIBRATE study, 76% of participants on encaleret achieved both target serum and urine calcium at Week 24 compared with 4% on standard therapy (p<0.0001), with improvements observed by Day 3 and durable through Week 24.
3. Regulatory and Commercial Outlook
Encaleret may qualify for FDA priority review, with BridgeBio anticipating a U.S. launch in early 2027 and planning a Marketing Authorization Application to the EMA in the second half of 2026 for European approval.
4. Pipeline Expansion Plans
BridgeBio intends to initiate the RECLAIM-HP Phase 3 trial in chronic hypoparathyroidism in Summer 2026 and continues enrollment in pediatric ADH1 trials, expanding encaleret’s potential applications beyond ADH1.