BridgeBio says FDA accepts encaleret NDA for ADH1, sets May 8, 2027 PDUFA date - BBIO News | RalliesBridgeBio says FDA accepts encaleret NDA for ADH1, sets May 8, 2027 PDUFA date
B
BBIO• FDA accepts BridgeBio’s encaleret NDA for ADH1
- BridgeBio’s FDA accepted for filing its NDA for encaleret to treat autosomal dominant hypocalcemia type 1.
- PDUFA target action date set for May 8, 2027; the FDA is not currently planning an advisory committee meeting.
- The company plans to submit an EMA marketing application in 2H 2026.
