Axogen shares surge 15.90% after-hours following FDA approval of Avance nerve repair biologic and analyst price target upgrades.

Axogen surged 15.90% in after-hours trading following the FDA’s approval of its Biologics License Application for Avance, an acellular nerve scaffold for treating peripheral nerve discontinuities. The approval transitioned Avance from a human tissue product to an FDA-recognized biologic, enhancing its regulatory clarity and market positioning. Analysts highlighted the milestone as a catalyst for broader adoption, with Jefferies raising its price target to $36 from $29 while maintaining a Buy rating. The approval, granted under the Accelerated Approval pathway, covers sensory, mixed, and motor nerve injuries in patients aged 1 month or older, with commercial availability expected in Q2 2026. Axogen’s management emphasized the approval’s significance in solidifying Avance’s role as a standard-of-care solution, supported by strong Q3 revenue growth (23.5% YoY) and upgraded 2025 guidance. The stock’s rally reflects optimism over expanded market access, competitive differentiation, and long-term revenue potential.