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AXGN AXOGEN INC US FDA Inspections 8-K Filing

XGN

XGN

AXOGEN INC

(AXGN)

2025 8-K

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Summary

FDA Amendment Update

Financial Statements

Appointing a new CFO

Corporate Presentation

Financial Results

Financial Results

Q3 Financial Results

FDA Application Submitted

Appointment of CEO and Chai...

Earnings Reports

Annual Meeting Results

Annual Meeting and Voting R...

Earnings Reports

Resignation of Chief Resear...

Regulation FD Disclosure

Earnings Report

Corporate Presentation Update

Departure of CFO

Financial Performance and C...

Appointment of Director

Appointment of CFO

Financial Results and Corpo...

Retirement of Named Executi...

Annual Meeting of Shareholders

Financial Results and Corpo...

Agreement Amendment

Earnings Reports

Shareholder Director Nomina...

External Links:

On August 22, 2025, Axogen, Inc. received communication from the FDA about a Major Amendment to their Biologics License Application for Avance® Nerve Graft, extending the review deadline to December 5, 2025. This extension was due to new manufacturing information provided and feedback on product labeling is expected in November 2025.

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AXOGEN INC

2025

8 K

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