Axogen Drops After FDA Review for Avance Nerve Graft Extended

Axogen shares dropped around 10% premarket after the FDA extended its review its Biologics License Application for Avance Nerve Graft by three months, pushing the decision date to Dec. 5, 2025.

• Extension triggered by Axogen’s August submission of substantial new manufacturing and facility data
• FDA labeled the update a “Major Amendment,” allowing more review time
• Agency expects to give feedback on product labeling in November

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Georgi Azar in New York at gazar4@bloomberg.net

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Zachary Fleming at zfleming2@bloomberg.net ...