Axogen Files 8-K: Regulation FD, Other Events, Exhibits

TL;DR

AXGN filed an 8-K on Dec 3rd covering Reg FD, other events, and exhibits. No major news yet.

AI Summary

Axogen, Inc. filed an 8-K on December 4, 2025, reporting events as of December 3, 2025. The filing includes information related to Regulation FD Disclosure, Other Events, and Financial Statements and Exhibits. No specific financial figures or material events were detailed in the provided excerpt.

Why It Matters

This filing indicates Axogen is providing updates or disclosures to the SEC, which could impact investor understanding of the company's current status and regulatory compliance.

Risk Assessment

Risk Level: low — The filing is a routine disclosure and does not appear to contain any immediately negative or significant new information.

Key Players & Entities

• Axogen, Inc. (company) — Registrant
• Minnesota (location) — State of Incorporation
• Alachua, Florida (location) — Principal Executive Offices

FAQ

Key Financial Figures

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

Filing Documents

• axgn-20251203.htm (8-K) — 31KB
• ex991axgnpressreleasedated.htm (EX-99.1) — 17KB
• image_0a.jpg (GRAPHIC) — 30KB
• 0000805928-25-000140.txt ( ) — 208KB
• axgn-20251203.xsd (EX-101.SCH) — 2KB
• axgn-20251203_lab.xml (EX-101.LAB) — 21KB
• axgn-20251203_pre.xml (EX-101.PRE) — 12KB
• axgn-20251203_htm.xml (XML) — 3KB

01 Regulation FD Disclosure

Item 7.01 Regulation FD Disclosure On December 3, 2025 , Axogen, Inc. ("Axogen" or the "Company") issued a press release announcing that the U.S. Food and Drug Administration (the "FDA") has approved the Company's Biologics License Application for Avance (acellular nerve allograft-arwx). A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated into this Item 7.01 by reference. 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.

01 Other Events

Item 8.01 Other Events On December 3, 2025 , the Company announced it received FDA approval of its Biologics License Application for Avance (acellular nerve allograft-arwx). Continued approval for these indications depends on verification and description of clinical benefit in confirmatory studies. The indications for sensory nerve discontinuities >25 mm and for mixed and motor nerve discontinuities were approved under FDA's Accelerated Approval pathway based on the effect on static two-point discrimination in sensory nerve gaps 25 mm, which provided empirical evidence to reasonably predict clinical benefit given similarities in pathophysiology and anticipated therapeutic effects. Continued approval for these indications depends on verification and description of clinical benefit in confirmatory studies. Commercial availability of the licensed Avance product is expected early in the second quarter of 2026. In the meantime, Avance remains available under the current tissue framework.

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 commercial availability of the licensed Avance (acellular nerve allograft-arwx) product. 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 December 3, 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: December 3, 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