BridgeBio says FDA accepts encaleret NDA for ADH1, sets May 8, 2027 PDUFA date
BBIO•The FDA accepted BridgeBio’s encaleret application for autosomal dominant hypocalcemia type 1 (ADH1) and granted Priority Review, with a target action date of May 8, 2027. BridgeBio also filed a marketing authorization application with the EMA for the same indication.
1. FDA review timeline
The FDA accepted BridgeBio’s new drug application for encaleret in autosomal dominant hypocalcemia type 1 and granted Priority Review. The agency set May 8, 2027, as the PDUFA target action date. BridgeBio also filed a marketing authorization application with the EMA for the indication.
