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.
BridgeBio reported Phase 3 CALIBRATE data showing encaleret increased bone turnover and improved symptoms versus standard care in ADH1. The FDA accepted the NDA for encaleret with Priority Review, and the PDUFA target date is May 8, 2027. The first participant was dosed in the RECLAIM-HP Phase 3 study.