Lirafugratinib (RLY-4008)
FDA PDUFA Target Action Date · Elevar Therapeutics, Inc.
Sunday, September 27, 2026
7 days away
Note: Selective irreversible FGFR2 inhibitor (originally Relay Therapeutics RLY-4008; Elevar holds the U.S. NDA). FDA accepted NDA and granted Priority Review (Mar 30, 2026); PDUFA Sept 27, 2026. Basis = Phase 1/2 ReFocus trial (confirmed ORR 46.5%). Elevar is a private subsidiary of HLB Co., Ltd. (no U.S. ticker).
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)
Filing Details
- Company
- Elevar Therapeutics, Inc.
- SEC CIK
- 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
Track All FDA Decisions
View all upcoming PDUFA dates and AdCom meetings on our FDA Calendar.
View FDA Calendar →Data sourced from SEC EDGAR filings. Last updated: 2026-06-30. Report an issue