AXGN

Axogen, Inc.

FDA PDUFA Target Action Date

Friday, December 5, 2025

172 days ago

pending

Drug Information

Drug Name: AVANCE (acellular nerve allograft) (CT.gov)
Application Type: BLA
Indication: Peripheral nerve discontinuities

Filing Details

Company: Axogen, Inc. →
Stock Ticker: AXGN
SEC CIK: 0000805928
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 Axogen, Inc.

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

View Pipeline → FDA Calendar →

Data sourced from SEC EDGAR filings. Last updated: 2026-03-22. Report an issue