BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1
BridgeBio Pharma announced FDA acceptance of its New Drug Application for encaleret, a potential disease-modifying oral therapy for autosomal dominant hypocalcemia type 1 (ADH1). The FDA set a PDUFA date of May 8, 2027, and the company is prepared for launch upon approval. Encaleret has shown positive Phase 3 results, with potential to transform ca…