REGN

Regeneron Pharmaceuticals, Inc.

FDA PDUFA Target Action Date

Wednesday, August 19, 2026

85 days away

Drug Information

Drug Name: Garetosmab (CT.gov)
Application Type: BLA
FDA Designations: Priority ReviewOrphan DrugBreakthrough
Indication: Fibrodysplasia ossificans progressiva (FOP) in adults

Filing Details

Company: Regeneron Pharmaceuticals, Inc. →
Stock Ticker: REGN
SEC CIK: 0000872589
Source: Company IR →

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 Regeneron Pharmaceuticals, Inc.

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Data sourced from SEC EDGAR filings. Last updated: 2026-04-20. Report an issue