USFDAJul 22, 2026, 07:33 AM
BridgeBio FDA Accepts NDA for Encaleret for ADH1; PDUFA May 8, 2027
AI Summary
BridgeBio Pharma announced that the FDA has accepted for filing its New Drug Application (NDA) for encaleret, a treatment for autosomal dominant hypocalcemia type 1 (ADH1). The FDA has assigned a PDUFA target action date of May 8, 2027, and is not currently planning an advisory committee meeting. The company views encaleret as a potential blockbuster opportunity, being the first and only approved therapy for ADH1 if approved. BridgeBio is also advancing encaleret in pediatric ADH1 and chronic hypoparathyroidism studies, and plans an EMA submission in the second half of 2026.
Key Highlights
- FDA accepted New Drug Application (NDA) for encaleret for autosomal dominant hypocalcemia type 1 (ADH1).
- PDUFA target action date set for May 8, 2027.
- Encaleret, if approved, would be the first and only therapy for ADH1, representing a potential blockbuster opportunity.
- FDA is not currently planning to hold an advisory committee meeting for the application.
- Phase 3 CALIBRATE trial achieved all primary and key secondary efficacy endpoints.
- BridgeBio is enrolling CALIBRATE-PEDS (pediatric ADH1) and plans RECLAIM-HP (chronic hypoparathyroidism) Phase 3 study.
- Company intends to submit a Marketing Authorization Application (MAA) to the EMA in H2 2026.
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