---
schema_version: "secwatch.filing_event.v1"
accession: "0000805928-24-000127"
form_type: "8-K"
ticker: "AXGN"
cik: "0000805928"
company_name: "Axogen, Inc."
filed_at: "2024-09-06T23:59:59+00:00"
generated_at: "2026-05-31T06:08:48.312983+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Axogen completes BLA submission to FDA for Avance Nerve Graft; priority review requested

## Summary
- FDA submission for Avance Nerve Graft completed under rolling review process on Sept. 6, 2024.
- Company requested priority review; if granted, review timeline could be 6 months vs. standard 10 months.
- Avance previously received RMAT designation from FDA under 21st Century Cures Act.
- FDA expected to notify acceptance and confirm review timeline within approximately 60 days.
- Company on track for FDA approvability determination between April and September 2025.

## SEC filing metadata
- accession: 0000805928-24-000127
- form_type: 8-K
- ticker: AXGN
- cik: 0000805928
- company_name: Axogen, Inc.
- filed_at: 2024-09-06T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/805928/000080592824000127/0000805928-24-000127-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/805928/000080592824000127/axgn-20240906.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000805928-24-000127
- JSON: https://secwatch.observer/filing/0000805928-24-000127.json
- Plain text: https://secwatch.observer/filing/0000805928-24-000127.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.