BridgeBio Pharma's Encaleret Shows Positive Phase 3 Results for Rare Genetic Calcium Disorder, FDA Grants Priority Review

BridgeBio Pharma announced encouraging results from its Phase 3 CALIBRATE trial for encaleret, an experimental drug for autosomal dominant hypocalcemia type 1 (ADH1). The trial demonstrated significant symptom improvements in 100% of treated patients and normalized parathyroid hormone levels in 91% after 24 weeks, suggesting it addresses the underlying cause of the disorder. The FDA has accepted BridgeBio's New Drug Application (NDA) for encaleret and granted it Priority Review, with a target action date of May 8, 2027.