Axogen's Avance Nerve Graft Gets Three-Month FDA Review Extension as Manufacturing Data Triggers Major Amendment

Axogen (NASDAQ: AXGN) revealed that the U.S. Food and Drug Administration has pushed back its decision timeline for the Biologics License Application (BLA) covering Avance Nerve Graft. The new PDUFA target date is now set for December 5, 2025, marking a three-month postponement from the original schedule.

The regulatory delay stems from a formal reclassification of the company’s recent submission. On August 22, following a substantial package of manufacturing and facility information from Axogen, the FDA designated the updated filing as a Major Amendment. This classification—used when submissions contain significant new data requiring comprehensive Agency review—automatically triggers an extended evaluation window under FDA procedures.

What Triggered the Extended Timeline

The extension wasn’t unexpected. Axogen had responded to an FDA information request with extensive manufacturing and operational data that hadn’t undergone Agency scrutiny before. This fresh material necessitated additional review cycles, prompting the formal amendment designation and the three-month extension.

Per standard FDA protocol, product labeling feedback is anticipated to arrive in November 2025. This staging aligns with typical PDUFA procedures and suggests the Agency is maintaining an active dialogue with the company through the review process.

The Broader Context: From Tissue to Biologic

This regulatory journey represents a significant milestone for Axogen’s Avance Nerve Graft. The product is transitioning from its original classification as a tissue-based graft to a BLA-approved biologic—a regulatory shift that requires comprehensive revalidation of manufacturing processes and quality standards.

CEO Michael Dale commented on the development: “We appreciate the FDA’s thorough review and look forward to continuing our engagement with the agency to complete the transition of Avance Nerve Graft from a tissue product to a BLA-approved biologic.”

About Axogen’s Peripheral Nerve Portfolio

Axogen specializes in peripheral nerve regeneration solutions. Beyond Avance Nerve Graft, the company markets several complementary products: Axoguard Nerve Connector, an extracellular matrix coaptation aid; Axoguard Nerve Protector, designed to wrap and shield damaged nerves; Axoguard HA+ Nerve Protector, a next-generation variant with hyaluronate-alginate coating for enhanced nerve gliding; Axoguard Nerve Cap, for protecting nerve ends; and Avive+ Soft Tissue Matrix, an amniotic membrane allograft for surgical site protection.

These products address the critical challenge of peripheral nerve injuries—whether from trauma or surgical procedures—where severed or damaged nerves result in motor dysfunction, sensory loss, or chronic pain. Axogen’s offerings aim to provide surgeons with clinically proven, economically viable repair solutions.

The Axogen portfolio is currently available across the U.S., Canada, Germany, the United Kingdom, Spain, South Korea, and select other markets.

What Comes Next

With the December 5, 2025 PDUFA goal date now locked in, stakeholders are watching for labeling feedback expected in November. The three-month extension, while requiring patience, underscores the FDA’s commitment to rigorous evaluation of manufacturing standards—a necessary step in converting Avance from a tissue-based product to a fully approved biologic under the BLA framework.

The regulatory pathway for Axogen’s nerve graft remains on track, albeit on an extended timeline that reflects the complexity of reclassifying an established surgical product.