Upcoming FDA decision · May 8, 2027
Encaleret PDUFA date: FDA decision expected May 8, 2027
202 days to goBridgeBio Pharma, Inc. (BBIO) →
The FDA is expected to decide on Encaleret from BridgeBio Pharma, Inc. in autosomal dominant hypocalcemia type 1 (ADH1) by the PDUFA target action date of May 8, 2027. For autosomal dominant hypocalcemia type 1 (ADH1). NDA filing. Extracted from SEC filing: EXHIBIT 99.1
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 18, 2026. Confirm dates against the company's or the FDA's announcement before acting.
May 8
Target action date
Phase 3
Stage
Verified
Date confidence
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FDA designations
Questions about this FDA decision
- When is the PDUFA date for Encaleret?
- The FDA's PDUFA target action date for Encaleret is May 8, 2027. The FDA can act before that date, and the review can be extended.
- What is Encaleret being reviewed for?
- The application under FDA review covers autosomal dominant hypocalcemia type 1 (ADH1).
- Which company is developing Encaleret?
- BridgeBio Pharma, Inc. (BBIO).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).