BBIO

planned

FDA PDUFA Target Action Date · BridgeBio Pharma, Inc.

Saturday, May 8, 2027

230 days away

Drug Information

Drug Name: planned (CT.gov)
Application Type: Priority Review

Filing Details

Company: BridgeBio Pharma, Inc. →
Stock Ticker: BBIO
SEC CIK: 0001743881
Source: SEC 8-K Filing →

What is a PDUFA Date?

A PDUFA (Prescription Drug User Fee Act) date is the FDA's target deadline to complete review of a drug application. The FDA aims to make an approval decision by this date.

Standard Review: 10 months from filing acceptance
Priority Review: 6 months from filing acceptance
Possible Outcomes: Approval, Complete Response Letter (CRL), or extension

Explore BridgeBio Pharma, Inc.

View BridgeBio Pharma, Inc.'s full pipeline, approved drugs, and clinical trials.

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Data sourced from SEC EDGAR filings. Last updated: 2026-08-10. Report an issue