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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): August 22, 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)
(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):
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| ☐ | 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:
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| 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 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
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. Press Release, dated August 25, 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.
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| AXOGEN, INC. |
| |
| Dated: August 25, 2025 | By: | /s/ Marc Began |
| | Marc Began |
| | Executive Vice President, General Counsel and Chief Compliance Officer |
