Axogen's Avance® Nerve Graft Gets FDA Priority Review

TL;DR

FDA accepts Axogen's sBLA for Avance® Nerve Graft with Priority Review for expanded use in nerve repair.

AI Summary

Axogen, Inc. announced on August 22, 2025, that the U.S. Food and Drug Administration (FDA) has accepted for filing their supplemental Biologics License Application (sBLA) for their Avance® Nerve Graft. This sBLA seeks to expand the product's indication to include the surgical repair of peripheral nerve injuries. The FDA has granted Priority Review for this application, indicating a potentially significant improvement over existing therapies.

Why It Matters

This FDA Priority Review could lead to a broader use of Axogen's Avance® Nerve Graft, potentially benefiting more patients with peripheral nerve injuries and expanding the company's market reach.

Risk Assessment

Risk Level: medium — While Priority Review is positive, the ultimate approval and market adoption depend on the FDA's final decision and physician acceptance.

Key Players & Entities

• Axogen, Inc. (company) — Registrant
• Avance® Nerve Graft (product) — Product subject of sBLA
• U.S. Food and Drug Administration (FDA) (company) — Regulatory body
• August 22, 2025 (date) — Date of report

FAQ

Key Financial Figures

• $0.01 — ange on which registered Common Stock, $0.01 par value AXGN The Nasdaq Stock Market

Filing Documents

• axgn-20250822.htm (8-K) — 28KB
• ex991axgnpressreleasedated.htm (EX-99.1) — 11KB
• image_0a.jpg (GRAPHIC) — 30KB
• 0000805928-25-000112.txt ( ) — 199KB
• axgn-20250822.xsd (EX-101.SCH) — 2KB
• axgn-20250822_lab.xml (EX-101.LAB) — 21KB
• axgn-20250822_pre.xml (EX-101.PRE) — 12KB
• axgn-20250822_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure On August 22, 2025, Axogen, Inc. (the "Company") received a communication from the U.S. Food and Drug Administration (the "FDA") stating that the Company's recent submission of facility and manufacturing information, provided in response to an FDA information request, constitutes a Major Amendment to the Company's Biologics License Application ("BLA") for Avance Nerve Graft. The FDA indicated that the submission contained a substantial amount of new manufacturing or facility information not previously submitted to or reviewed by the Agency. As a result, the FDA has extended the Prescription Drug User Fee Act ("PDUFA") goal date for the BLA to December 5, 2025, representing the three-month extension from the previous goal date contemplated by FDA guidelines following a major amendment. The FDA also informed the Company that it now anticipates providing feedback on product labeling in November 2025. The information in this Item 7.01, including Exhibit 99.1, is being furnished and shall not be deemed to be "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section and shall not be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or Exchange Act, except as shall be expressly set forth by specific reference in such filing.

Forward-Looking Statements

Forward-Looking Statements This Current Report on Form 8-K, including the exhibit furnished herewith, contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential approval and timing of FDA review of Avance Nerve Graft and anticipated labeling feedback. Forward-looking statements are based on current expectations and involve risks and uncertainties. Actual results may differ materially from those expressed or implied due to factors such as the timing and outcome of regulatory review, potential delays, requests for additional information by the FDA, and other risks identified in Axogen' s filings with the SEC. Axogen undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law.

01 Financial Statements and Exhibits

Item 9.01 Financial Statements and Exhibits (d) Exhibits Exhibit No. Description 99.1 Axogen Inc. Press Release, dated August 25, 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. AXOGEN, INC. Dated: August 25, 2025 By: /s/ Marc Began Marc Began Executive Vice President, General Counsel and Chief Compliance Officer

View Full Filing

View this 8-K filing on SEC EDGAR