- 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
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