07:13 AM EDT, 08/25/2025 (MT Newswires) -- Axogen ( AXGN ) said Monday the US Food and Drug Administration has extended the review deadline for its marketing application for the Avance Nerve Graft by three months.

The company said that the extension was due to the submission of substantial new manufacturing and facility data, which was requested by the FDA and deemed a 'major amendment' to its application.

Axogen ( AXGN ) added that the FDA is now expected to make a decision on the application by Dec. 5 and provide feedback on product labeling in November, in line with standard review procedures.

Shares of the company fell more than 10% in Monday's premarket activity.

Price: 14.51, Change: -1.75, Percent Change: -10.76