BridgeBio announces FDA acceptance of NDA for encaleret in ADH1; PDUFA date May 8, 2027

BridgeBio Pharma, Inc.

FDA accepted NDA for encaleret for ADH1; PDUFA target action date May 8, 2027; no advisory committee planned.
Encaleret met all primary and key secondary endpoints in Phase 3 CALIBRATE trial, normalizing CaSR-driven markers.
Over 2,100 ADH1 patients diagnosed in U.S. since Oct 2023; BridgeBio plans MAA submission to EMA in H2 2026.
Company also enrolling pediatric Phase 2/3 (CALIBRATE-PEDS) and plans Phase 3 in chronic hypoparathyroidism (RECLAIM-HP).

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