Lirafugratinib (RLY-4008)

FDA PDUFA Target Action Date · Elevar Therapeutics, Inc.

Sunday, September 27, 2026

Approved

approved

Note: Approved 2026-09-23 as LYRFIGTU (ORIG NDA220425). Auto-resolved from data/drugs.json by scripts/pdufa/resolve-outcomes.cjs on 2026-10-06; 4d from the PDUFA date.

Drug Information

Drug Name: Lirafugratinib (RLY-4008) (CT.gov)
Application Type: NDA
FDA Designations: Priority Review
Indication: Previously treated FGFR2 fusion/rearrangement-positive cholangiocarcinoma (second-line)
Approved As: Lirafugratinib (RLY-4008)

Filing Details

Company: Elevar Therapeutics, Inc. →
Source: company press release →

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: 2026-06-30. Report an issue