BBIO

BBP-418 (ribitol)

FDA PDUFA Target Action Date · BridgeBio Pharma, Inc.

Friday, November 27, 2026

142 days away

Drug Information

Drug Name: BBP-418 (ribitol) (CT.gov)
Application Type: NDA
FDA Designations: Priority Review
Indication: Limb-girdle muscular dystrophy type 2I/R9 (LGMD2I/R9)

Filing Details

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

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

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Data sourced from SEC EDGAR filings. Last updated: 2026-06-29. Report an issue