Caitlin Cronin

David Turkaly

Jayson Bedford

Michael Sarcone

Christopher Pasquale

Ross Osborn

Frank Takkinen

Michael Kratky

Brett Gasaway

Chris Pasquale

Matthew Park

Mike Kratky

- The U.S. Food and Drug Administration (FDA) has **extended the review period** for Axogen's Biologics License Application (BLA) for the Avance Nerve Graft by **three months to December 5, 2025**.  **[805928_e22f9c20d96d47f1ac1225b176003118]** 
- This extension was triggered by the submission of **substantial new manufacturing and facility information**, which the FDA classified as a **'major amendment'**.  **[805928_e22f9c20d96d47f1ac1225b176003118]** 
- The FDA anticipates providing feedback on **product labeling in November 2025**.  **[805928_e22f9c20d96d47f1ac1225b176003118]** 
- Despite the delay, analysts maintain a **'Buy' rating** on Axogen stock with a **price target of $17.00**, citing strong revenue growth and strategic execution.  **[805928_e22f9c20d96d47f1ac1225b176003118]** 
- Axogen's share price experienced a **notable drop in premarket trading** following the FDA's decision.  **[805928_e22f9c20d96d47f1ac1225b176003118]**

Axogen Avance Nerve Graft Review Extended by FDA

Axogen (AXGN)