BridgeBio Pharma, Inc. announced that the FDA has accepted for filing its New Drug Application (NDA) for encaleret to treat autosomal dominant hypocalcemia type 1 (ADH1). The FDA has assigned a PDUFA target action date of May 8, 2027, and the company is preparing to launch the therapy upon approval. BridgeBio is also planning to submit a Marketing Authorization Application (MAA) to the EMA in the second half of 2026. BridgeBio Pharma, Inc. is a biopharmaceutical company focused on developing medicines for genetic conditions.
