# Encaleret PDUFA Event: Autosomal dominant hypocalcemia type 1

Canonical URL: https://biopharmsignal.com/pdufa-calendar/BBIO/encaleret-autosomal-dominant-hypocalcemia-type-1

Ticker: BBIO

Company: BridgeBio

Event date: 2027-05-08

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: NDA

FDA decision expected. FDA assigned May 8, 2027 as the PDUFA target action date for the encaleret NDA in autosomal dominant hypocalcemia type 1.

## Event Timeline

### May 8, 2027 — FDA decision expected

FDA assigned May 8, 2027 as the PDUFA target action date for the encaleret NDA in autosomal dominant hypocalcemia type 1.

[BridgeBio — NDA acceptance and PDUFA date](https://www.sec.gov/Archives/edgar/data/1743881/000174388126000027/R10.htm)

### May 2026 — FDA accepted the NDA for review

FDA accepted BridgeBio's NDA for encaleret as a targeted treatment candidate for autosomal dominant hypocalcemia type 1.

[BridgeBio — FDA acceptance disclosure](https://www.sec.gov/Archives/edgar/data/1743881/000174388126000027/R10.htm)

### May 12, 2026 — BridgeBio submitted the NDA

BridgeBio submitted the encaleret NDA after reporting positive topline data for its late-stage autosomal dominant hypocalcemia type 1 program.

[BridgeBio — encaleret regulatory update](https://www.sec.gov/Archives/edgar/data/1743881/000174388126000027/R10.htm)

## Related Pages

- BBIO PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/BBIO.md

- BBIO company profile: https://biopharmsignal.com/company/BBIO.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

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