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FDA Accepts BridgeBio Pharma NDA for Encaleret with Priority Review

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BBIO$65.35 0.48%

BridgeBio Pharma, Inc. (BBIO) announced that the U.S. Food and Drug Administration accepted its New Drug Application for encaleret under Priority Review. The application targets autosomal dominant hypocalcemia type 1 (ADH1). The submission is supported by Phase 3 CALIBRATE trial data, which demonstrated that encaleret increased bone turnover and improved patient symptoms compared to standard care.

The Priority Review status accelerates the regulatory assessment, establishing a Prescription Drug User Fee Act target decision date of May 8, 2027. In addition to its U.S. regulatory progress, BridgeBio Pharma, Inc. (BBIO) has submitted a Marketing Authorization Application to the European Medicines Agency to expand access into European markets.

Moving forward, the company has initiated dosing in its RECLAIM-HP Phase 3 trial, evaluating encaleret for chronic hypoparathyroidism. Investors and clinicians will be tracking upcoming regulatory decisions in both the United States and Europe, alongside progress in the broader hypoparathyroidism clinical program.

Key points

  • FDA accepted the New Drug Application for encaleret under Priority Review for ADH1.
  • Phase 3 CALIBRATE trial showed increased bone turnover and symptom improvements versus standard care.
  • The FDA set a target regulatory decision date of May 8, 2027.
  • BridgeBio submitted a Marketing Authorization Application to the European Medicines Agency.
  • Dosing began for the first participant in the Phase 3 RECLAIM-HP study for chronic hypoparathyroidism.

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Questions and answers

What is the FDA target decision date for BridgeBio Pharma's encaleret?

The FDA accepted the application with Priority Review and set a target PDUFA decision date of May 8, 2027.

How did encaleret perform in the Phase 3 CALIBRATE trial?

Phase 3 CALIBRATE trial results showed encaleret increased bone turnover and improved clinical symptoms compared to standard care in ADH1.

What other studies is BridgeBio conducting for encaleret?

BridgeBio has dosed the first patient in its RECLAIM-HP Phase 3 study to evaluate encaleret for chronic hypoparathyroidism.