other material
confidence high
sentiment positive
materiality 0.85
BridgeBio reports positive Phase 3 results for encaleret in ADH1; 76% met primary endpoint
BridgeBio Pharma, Inc.
- 76% of encaleret-treated patients achieved both serum and urine calcium targets vs 4% on conventional therapy (p<0.0001).
- 91% on encaleret achieved intact PTH above lower limit vs 7% on conventional therapy (p<0.0001).
- Encaleret was well-tolerated with no discontinuations related to study drug.
- NDA submission to FDA planned H1 2026; EMA submission to follow.
- BridgeBio plans to initiate registrational trials in pediatric ADH1 and chronic hypoparathyroidism in 2026.