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Reported Sunday, BridgeBio’s Encaleret Raises Bone Turnover, With 100% Of Phase 3 CALIBRATE Participants Reporting Improvement In At Least One ADH1 Symptom Versus 46% On Standard Of Care

Benzinga·10/12/2026 07:04:46
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- Encaleret administration increased bone turnover, based on its action to recover endogenous PTH secretion in patients with ADH1

- 100% of participants who received encaleret reported improvements in at least one ADH1 symptom compared to 46% of participants who received standard of care

- Improvements in ADH1-related impacts on daily functioning were also more frequently reported with encaleret compared to standard of care

- The FDA has accepted BridgeBio’s NDA for encaleret in ADH1 and granted Priority Review, with a PDUFA target action date of May 8, 2027; the Company also submitted an MAA to the EMA

- The first participant was dosed in RECLAIM-HP, the registrational Phase 3 study of encaleret in adults and adolescents with chronic hypoparathyroidism