BridgeBio Pharma Inc. (NASDAQ: BBIO) submitted a New Drug Application to the FDA for encaleret, a potential treatment for autosomal dominant hypocalcemia type 1 (ADH1), the company announced.

The submission follows results from the Phase 3 CALIBRATE trial, which met all pre-specified primary and key secondary efficacy endpoints. In the study, 76% of participants taking encaleret achieved target serum and urine calcium levels at Week 24, compared to 4% of the same individuals while on conventional therapy at Week 4.

The trial showed encaleret restored endogenous parathyroid hormone in 91.1% of participants compared to 0% on standard care at Week 24. Improvements in calcium metabolism were observed by Day 3, with sustained effects through Week 24. No participants discontinued treatment in the encaleret arm.

BridgeBio anticipates a U.S. launch in early 2027 if approved. The drug may be eligible for priority review. The company also plans to submit a Marketing Authorization Application to the European Medicines Agency in the second half of 2026.

Encaleret has received Fast Track Designation from the FDA and Orphan Drug Designation in the U.S., European Union, and Japan. If approved, it would be the first therapy specifically indicated for ADH1.

The company is enrolling CALIBRATE-PEDS, a Phase 2/3 study in pediatric ADH1, and plans to initiate RECLAIM-HP, a Phase 3 study in chronic hypoparathyroidism, in Summer 2026.