# FDA Accepts BridgeBio Pharma NDA for Encaleret with Priority Review

- URL: https://stocks.freetheai.org/news/fda-accepts-bridgebio-pharma-nda-for-encaleret-with-priority-review-57f64a
- Published: 2026-10-11T15:42:00Z
- Category: company_news; sentiment: bullish; impact: high
- Symbols: [NASDAQ:BBIO](https://stocks.freetheai.org/symbols/NASDAQ-BBIO)
- Written by our AI from expert market sources across the web for FreeTheAI Stocks, built by Vibhek Soni
- How write-ups are made: https://stocks.freetheai.org/how-we-write
- Not financial advice: https://stocks.freetheai.org/disclaimer

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.

## 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.