Shots:
The US FDA has accepted NDA for encaleret to treat ADH1, with a PDUFA date of May 8, 2027, & no advisory committee planned. BridgeBio is prepared for a potential launch, while an EU MAA filing is expected in H2’26
Encaleret was evaluated in the P-III (CALIBRATE) trial, which met its 1 & 2EPs,…
