secwatch.observer — SEC 8-K summary
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Issuer:     Axogen, Inc. (AXGN)
CIK:        0000805928
Form:       8-K
Filed at:   2025-08-25T23:59:59+00:00
Accession:  0000805928-25-000112
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA extends PDUFA date for Axogen's Avance Nerve Graft BLA to Dec 5, 2025
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- FDA deemed Axogen's August 22 submission a Major Amendment, extending PDUFA goal date by three months to Dec 5, 2025.
- FDA now anticipates providing product labeling feedback in November 2025.
- Submission included substantial new manufacturing and facility data not previously reviewed by the Agency.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/805928/000080592825000112/0000805928-25-000112-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/805928/000080592825000112/axgn-20250822.htm
  HTML page:      https://secwatch.observer/filing/0000805928-25-000112

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer