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): ~~August~~October 2229, 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 2.02 Results of Operations and Financial Condition

On October 29, 2025, Axogen, Inc. (the “Company”) issued a press release announcing its third quarter 2025 financial results. A copy of the press release is furnished as Exhibit 99.1.

The information furnished pursuant to Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of such section, nor shall it be incorporated by reference into future filings by the Company under the Securities Act of 1933, as amended (the “Securities Act”), or under the Exchange Act, unless the Company expressly sets forth in such future filing that such information is to be considered “filed” or incorporated by reference therein.

Item 7.01 Regulation FD Disclosure

On ~~August 22~~October 29, 2025, ~~Axogen, Inc. (~~the “Company”) ~~received~~posted a ~~communication~~third ~~from~~quarter ~~the~~2025 ~~U.S.~~financial ~~Food~~results ~~and~~presentation ~~Drug~~to ~~Administration~~its ~~(the~~website ~~“FDA”)~~at ~~stating~~https://ir.axogeninc.com/news-events. ~~that~~The ~~the~~ Company’s ~~recent~~may ~~submission~~use ofthe ~~facility~~financial ~~and~~results ~~manufacturing~~presentation ~~information,~~from ~~provided~~time into ~~response~~time toin anconversation ~~FDA~~with ~~information~~analysts, ~~request~~investors, ~~constitutes~~and ~~a Major Amendment to the Company’s Biologics License Application (“BLA”) for Avance® Nerve Graft~~others. ~~The~~A ~~FDA~~copy ~~indicated~~of ~~that~~ the ~~submission~~presentation ~~contained~~is afurnished ~~substantial~~as ~~amount~~Exhibit ~~of new manufacturing or facility information not previously submitted to or reviewed by the Agency~~99. 2.

AsThe ainformation ~~result~~in this Item 7.01, ~~the~~including ~~FDA~~Exhibit ~~has~~99.2, ~~extended~~is ~~the~~being ~~Prescription~~furnished ~~Drug~~and ~~User~~shall ~~Fee~~not ~~Act~~be (deemed to be “~~PDUFA~~filed”) ~~goal~~for ~~date~~purposes ~~for~~of Section 18 of the ~~BLA~~Exchange toAct ~~December~~or 5,otherwise ~~2025,~~subject ~~representing~~to the ~~three-month~~liabilities ~~extension~~of ~~from~~that ~~the~~section ~~previous~~and ~~goal~~shall ~~date~~not ~~contemplated~~be deemed incorporated by ~~FDA~~reference ~~guidelines~~into ~~following~~any afiling ~~major~~under ~~amendment~~the Securities Act or Exchange Act, except as shall be expressly set forth by specific reference in such filing.

~~The~~Item ~~FDA~~9.01. ~~also~~Financial ~~informed~~Statements ~~the~~and ~~Company that it now anticipates providing feedback on product labeling in November 2025.~~Exhibits

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

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.

Item 9.01 Financial Statements and Exhibits

(d) Exhibits

Exhibit No.			Description
99.1			Axogen Inc. Earnings Press Release, dated ~~August~~October 2529, 2025
99.2			Axogen Inc. Third Quarter Financial Results Presentation, dated October 29, 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: August 25, 2025	By:	/s/ Marc Began
Dated: October 29, 2025	By:	/s/ Marc Began
		Marc Began
		Executive Vice President, General Counsel and Chief Compliance Officer

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