BridgeBio reports encaleret Phase 3 results and begins chronic hypoparathyroidism study
BridgeBio Pharma presented 24-week Phase 3 CALIBRATE results for encaleret in autosomal dominant hypocalcemia type 1, with 91% of treated participants reaching at least the lower limit of normal for endogenous PTH versus 0% receiving standard care. The company said symptom improvements were reported by 100% of encaleret participants versus 46% on standard care. The FDA accepted BridgeBio’s encaleret NDA for review under its Priority Review process, with an agency action date of May 8, 2027, while BridgeBio dosed the first participant in the Phase 3 RECLAIM-HP study for chronic hypoparathyroidism.
Why it matters
The FDA review designation gives investors a stated regulatory decision date for encaleret in ADH1. The RECLAIM-HP dosing also starts a separate Phase 3 program that could broaden the drug’s potential use if the study succeeds.
Key facts
- 1In the 24-week CALIBRATE trial, encaleret brought endogenous PTH to or above the lower limit of normal for 91% of participants, compared with 0% on standard care. stocktitan.net
- 2ADH1 symptom improvement was reported by 100% of encaleret recipients versus 46% of participants receiving standard care. quiverquant.com
- 3The FDA accepted BridgeBio’s NDA for encaleret and granted Priority Review, setting May 8, 2027 as the target action date. tradingview.com
- 4BridgeBio administered the first dose in RECLAIM-HP, its registrational Phase 3 trial in adults and adolescents with chronic hypoparathyroidism. quiverquant.com
- 5RECLAIM-HP is planned to enroll approximately 160 participants, randomized 3:1 to encaleret or placebo during the 24-week double-blind treatment period. stocktitan.net
Summary written by AlphAI AI Desk from 8 of 8 sources. Not investment advice. Figures are as stated by the linked sources.