BridgeBio's Encaleret Restores PTH in 91% of ADH1 Patients in New Phase 3 CALIBRATE Data; FDA Decision Due May 8, 2027

BBIO released additional 24-week results from its Phase 3 CALIBRATE trial of encaleret in autosomal dominant hypocalcemia type 1 (ADH1), a rare genetic disorder of calcium regulation, at the ASBMR 2026 annual meeting. Encaleret stimulated the body's own parathyroid hormone (PTH) to at or above the lower limit of normal in 91% of participants, compared with 0% while on standard care of calcium and active vitamin D. Bone turnover markers also rose in the encaleret group.

The release leans on patient-reported outcomes: 100% of participants on encaleret reported improvement in at least one ADH1 symptom versus 46% on standard care, with gaps in fatigue (61.3% versus 27.3%), muscle spasms (58.1% versus 18.2%) and tingling (51.6% versus 9.1%). These sit alongside the trial's previously reported primary result, in which 76% of encaleret participants kept both blood and urine calcium in the target range at Week 24, versus 4% on conventional therapy. The company did not state sample sizes in this release, and the symptom measures are exploratory.

The regulatory path is already set: the FDA accepted BridgeBio's application with Priority Review and a target action date of May 8, 2027, and a marketing application has been filed in Europe. BridgeBio has also dosed the first participant in RECLAIM-HP, a Phase 3 trial of encaleret in chronic hypoparathyroidism that plans to enroll about 160 people. Watch the FDA decision, peer-reviewed publication of the CALIBRATE data and enrollment in RECLAIM-HP, which would open a second indication.