Why Is Axogen Stock Down 15% In Pre-Market Today?

Axogen, Inc. (AXGN) announced on Monday that the U.S. Food and Drug Administration (FDA) has postponed the date by which it would decide on the company’s application requesting approval for Avance Nerve Graft.

Shares of the company tumbled 15% in Monday’s pre-market session after the company announced that the agency pushed the date of the decision by three months to Dec. 5, 2025. Avance Nerve Graft is a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves.

An “off-the-shelf” processed human nerve allograft is a biologically active implant made from donated human nerve tissue that is surgically treated to remove cellular and non-cellular debris, preserving the native nerve’s structural integrity. Unlike traditional autografts, allografts are “off-the-shelf,” meaning they are immediately available for surgical use.

On Stocktwits, retail sentiment around AXGN stock fell from ‘neutral’ to ‘bearish’ territory over the past 24 hours while message volume remained at ‘low’ levels.

The company said that it received communication from the FDA on August 22, indicating that the information it submitted in response to an FDA information request was deemed a major amendment to its initial application filed in September 2024 and accepted by the agency in November. The company submitted fresh data, including substantial new manufacturing and facility data, in response to the request.

FDA subsequently extended the date for making its decision, allowing for additional time to review the submission. The FDA also told the company that it now expects to provide feedback on product labelling in November.

CEO Michael Dale said that the company looks forward to continuing engagement with the FDA to get Avance approved.

AXGN stock is down by 1% this year but up by about 28% over the past 12 months. 

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