FDA accepts BridgeBio NDA for encaleret to treat ADH1
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BridgeBio Announces FDA Acceptance of NDA for Encaleret for ADH1
July 22, 2026 7:30 AM EDT- PDUFA target action date of May 8, 2027
- If approved, encaleret will be the first and only approved therapy specifically indicated for individuals living with ADH1, representing a potential blockbuster opportunity for BridgeBio
- Encaleret demonstrated consistent efficacy across all pre-specified primary and key secondary efficacy endpoints normalizing key markers of CaSR-driven disease biology without the need for calcium and vitamin D supplements, with a favorable safety and tolerability profile
- BridgeBio is also currently enrolling CALIBRATE-PEDS, a registrational Phase 2/3 trial to study encaleret in pediatric ADH1 and intends to... More
