Encaleret - (CALIBRATE)

July 22, 2026: BridgeBio Pharma, Inc. (NASDAQ: BBIO) announced the FDA accepted for filing its New Drug Application (NDA) for encaleret to treat autosomal dominant hypocalcemia type 1 (ADH1). The FDA set a PDUFA target action date of May 8, 2027, and indicated it is not currently planning an advisory committee meeting for the application.

The NDA is supported by the Phase 3 CALIBRATE trial in ADH1, which BridgeBio said met all pre-specified primary and key secondary efficacy endpoints, demonstrating consistent efficacy across markers of CaSR-driven disease biology without the need for calcium and vitamin D supplements, with a favorable safety/tolerability profile. The company also noted oral presentations of additional results at ECE 2026 and ENDO 2026, including data showing simultaneous restoration of blood and urine calcium and restoration of physiologic parathyroid hormone (PTH) production.

Upcoming/regional filings and trials: BridgeBio intends to submit an EMA Marketing Authorization Application (MAA) for encaleret in ADH1 in 2H 2026; is enrolling CALIBRATE-PEDS (registrational Phase 2/3) in pediatric ADH1 (NCT07080385); and plans to initiate RECLAIM-HP, a global Phase 3 trial in chronic hypoparathyroidism, later in summer 2026.