>
pdufa.bio

Encaleret

Updated ยทnext FDA decision on the calendar

Encaleret is a BridgeBio Pharma, Inc. program. Its PDUFA date is May 8, 2027, the FDA's goal date to complete review of the application. Every date links its source.

BBIO catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: BridgeBio Pharma, Inc. (BBIO). Market-cap tier at the time we tracked it: Large. We track 1 catalyst event for this program: 1 upcoming and 0 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · May 8, 2027BBIO

Questions

When is Encaleret's next FDA decision or readout?

Encaleret's PDUFA date is May 8, 2027. That is the FDA's goal date to complete review of the application; the agency can act earlier or extend it.

What happened at Encaleret's most recent FDA decision?

No FDA decision for Encaleret is in our archive yet.

Who makes Encaleret?

BridgeBio Pharma, Inc. (BBIO).

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.