BridgeBio Pharma (BBIO) reported Sunday a new phase 3 trial showing its investigational therapy encaleret increased bone turnover and improved participant-reported symptoms in autosomal dominant hypocalcemia type 1.
The company said 100% of encaleret-treated participants reported improvement in at least one symptom after 24 weeks, compared with 46% on standard of care.
BridgeBio said encaleret also improved reports of fatigue, muscle cramps, muscle spasms, tingling and brain fog, according to data presented at the American Society for Bone and Mineral Research's 2026 annual meeting.
The US Food and Drug Administration has granted the company's new drug application for encaleret and granted priority review, assigning a regulatory action date of May 8, 2027, BridgeBio said.
The drugmaker has also submitted a marketing application in Europe and has begun dosing in a registrational phase 3 study in chronic hypoparathyroidism, it added.
Separately, BridgeBio said it had dosed the first participant in RECLAIM-HP, a registrational Phase 3 study evaluating encaleret in adults and adolescents with chronic hypoparathyroidism.