BridgeBio Pharma, Inc. (BBIO) on Tuesday said it has submitted a New Drug Application to the U.S. Food and Drug Administration for encaleret as a potential treatment for autosomal dominant hypocalcemia type 1 (ADH1), a rare genetic disorder characterized by low blood calcium levels.
The company said the Phase 3 CALIBRATE trial met all primary and key secondary efficacy endpoints, supporting encaleret's potential as a disease-modifying therapy by targeting the underlying genetic cause of ADH1.
If approved, encaleret would become the first therapy specifically indicated for patients living with ADH1, BridgeBio added.
The company expects a U.S. launch in early 2027 and also plans to initiate the RECLAIM-HP Phase 3 clinical study of encaleret in chronic hypoparathyroidism in summer 2026.
BridgeBio shares closed at $64.68 on Monday, down 4.02%.
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