BridgeBio submits FDA NDA for encaleret, a potential first therapy for ADH1, with Phase 3 success.

BridgeBio Pharma has submitted a New Drug Application (NDA) to the FDA for encaleret, targeting autosomal dominant hypocalcemia type 1 (ADH1). The Phase 3 CALIBRATE trial showed encaleret met all primary and key secondary endpoints, normalizing calcium levels in 76% of patients versus 4% on standard therapy. The drug demonstrated rapid, sustained benefits and a favorable safety profile, potentially becoming the first approved treatment for ADH1. BridgeBio plans a U.S. launch in early 2027 and will also seek approval in Europe while expanding trials to pediatric and chronic hypoparathyroidism populations.