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, with additional results showing simultaneous restoration of blood & urine calcium, as well as restoration of physiologic PTH production; data presented at ECE’26 & ENDO’26
- Encaleret is being evaluated in the P-II/III (CALIBRATE-PEDS) for pediatric ADH1 (currently enrolling), with the company planning to initiate P-III (RECLAIM-HP) for chronic hypoparathyroidism later this summer
Ref: Globenewswire | Image: BridgeBio | Press Release
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