Axogen shares surge 20.01% intraday on FDA approval of Avance biologics license application, transitioning product to FDA-approved biologic.

Axogen Inc. (NASDAQ:AXGN) surged 20.01% intraday following the U.S. Food and Drug Administration’s approval of its Biologics License Application (BLA) for Avance, an acellular nerve scaffold for treating peripheral nerve discontinuities. The approval, announced December 3, 2025, reclassifies Avance from a human tissue product to an FDA-approved biologic, enhancing its regulatory standing and commercial potential. The milestone, achieved via the Accelerated Approval pathway, supports broader adoption for sensory, mixed, and motor nerve injuries in patients aged 1 month or older. Analysts at Jefferies and Citizens upgraded price targets to $36 and $34, respectively, while Mizuho reiterated an Outperform rating with a $40 target, citing the product’s potential to become the standard of care in nerve repair. Commercial availability is expected in Q2 2026, with the product remaining accessible under its existing tissue framework until then. The approval and analyst optimism directly correlate with the stock’s intraday rally, reflecting confidence in Axogen’s regulatory progress and market expansion prospects.