Axogen (NASDAQ: AXGN) wins FDA Accelerated Approval for Avance nerve graft, eyes Q2 2026 launch

Rhea-AI Filing Summary

Axogen, Inc. announced that the U.S. Food and Drug Administration has approved its Biologics License Application for Avance® (acellular nerve allograft-arwx), a nerve repair product. Some indications, including sensory nerve discontinuities greater than 25 mm and mixed and motor nerve discontinuities, were cleared under the FDA’s Accelerated Approval pathway based on improvements in static two-point discrimination in smaller sensory nerve gaps. Continued approval for these uses depends on confirmatory studies that verify and describe clinical benefit. The company expects the licensed Avance product to be commercially available in early second quarter 2026, while Avance remains available under the current tissue framework until then.

Insights

Biotech and regulatory analyst

FDA approval of Avance is a major regulatory milestone with future confirmatory study obligations.

Axogen has received FDA approval for its Biologics License Application for Avance® (acellular nerve allograft-arwx), formally recognizing the product under the biologics framework. This validates prior clinical evidence and supports broader clinical adoption, particularly as Avance targets challenging nerve repair settings.

Key indications for sensory nerve discontinuities greater than 25 mm and for mixed and motor nerve discontinuities were granted via the FDA’s Accelerated Approval pathway. That pathway relies on improvements in static two-point discrimination in sensory nerve gaps of 25 mm or less as an empirical surrogate for clinical benefit. Continued approval for these indications depends on verification and description of clinical benefit in confirmatory studies, adding an execution and data-generation requirement.

The company expects licensed Avance to become commercially available in early Q2 2026, while remaining available under the current tissue framework in the meantime. This timing gives a clear transition from the legacy framework to the licensed biologic, and future disclosures around confirmatory study progress and results will be important in determining the durability of the accelerated approval indications.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

Form 8-K

Current Report

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): December 3, 2025

AXOGEN, INC.

(Exact Name of Registrant as Specified in Charter)

Minnesota

(State or Other Jurisdiction of

Incorporation or Organization)

001-36046

(Commission File Number)

41-1301878

(I.R.S. Employer Identification No.)

13631 Progress Boulevard, Suite 400 Alachua, Florida

(Address of principal executive offices)

32615

(Zip Code)

(386) 462-6800

(Registrant's telephone number, including area code)

N/A

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐			Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐			Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐			Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐			Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e- 4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class			Trading Symbol(s)			Name of exchange on which registered
Common Stock, $0.01 par value			AXGN			The Nasdaq Stock Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

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.

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

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.

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

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