FDA Grants BridgeBio Priority Review for Encaleret NDA
BridgeBio said Phase 3 CALIBRATE data showed encaleret increased bone turnover and improved symptoms versus standard care in ADH1. The FDA accepted the NDA for Priority Review, with a PDUFA target date of May 8, 2027; the first participant has also been dosed in the RECLAIM-HP Phase 3 study.