Axogen FDA review for Avance BLA delayed to Dec 5

Axogen, Inc. reported that the U.S. Food and Drug Administration has classified its recent facility and manufacturing information submission as a Major Amendment to the Biologics License Application for Avance® Nerve Graft.

Rhea-AI Filing Summary

Axogen, Inc. reported that the U.S. Food and Drug Administration has classified its recent facility and manufacturing information submission as a Major Amendment to the Biologics License Application for Avance® Nerve Graft. As a result, the FDA extended the Prescription Drug User Fee Act goal date to December 5, 2025, a three-month delay consistent with FDA guidelines for major amendments. The FDA also now expects to provide feedback on product labeling in November 2025, giving a clearer timeframe for the next regulatory milestone.

Positive

• None.

Negative

• FDA review timeline extended: Major Amendment classification for new manufacturing and facility information delays the Avance® Nerve Graft BLA PDUFA goal date by three months to December 5, 2025.

Insights

Biotech regulatory and pipeline analyst

FDA classified Axogen’s Avance BLA update as a Major Amendment, pushing the PDUFA goal date to December 5, 2025.

The FDA informed Axogen that the additional facility and manufacturing information submitted for Avance® Nerve Graft constitutes a Major Amendment to its Biologics License Application. The agency noted that the package contained a substantial amount of new manufacturing or facility data that had not been reviewed previously. This triggers a formal extension of the review clock under the Prescription Drug User Fee Act framework.

Because of this designation, the FDA extended the PDUFA goal date for the Avance BLA to December 5, 2025, a three‑month shift in line with FDA guidelines for major amendments. The FDA also indicated it now anticipates providing product labeling feedback in November 2025, which becomes a key checkpoint in the regulatory process. Overall impact is modestly negative, as approval timing is pushed back while the agency reviews the expanded manufacturing and facility information.

8-K Event Classification

2 items: 7.01, 9.01

2 items

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

Item 9.01 Financial Statements and Exhibits Exhibits

Financial statements, pro forma financial information, or exhibit attachments filed with this report.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did the FDA communicate to Axogen (AXGN) about the Avance BLA?

The FDA told Axogen that its recent facility and manufacturing information submission is a Major Amendment to the Biologics License Application for Avance® Nerve Graft because it includes a substantial amount of new manufacturing or facility data.

How did the FDA decision affect Axogen’s PDUFA date for Avance?

Due to the Major Amendment, the FDA extended the PDUFA goal date for Axogen’s Avance® Nerve Graft BLA to December 5, 2025, reflecting a three‑month extension under FDA guidelines.

When does Axogen expect FDA feedback on Avance product labeling?

The FDA informed Axogen that it now anticipates providing product labeling feedback for Avance® Nerve Graft in November 2025.

Why was Axogen’s recent submission considered a Major Amendment?

The FDA stated that Axogen’s submission contained a substantial amount of new manufacturing or facility information that had not been previously submitted to or reviewed by the agency, leading to the Major Amendment classification.

Does this 8-K filing indicate FDA approval of Avance Nerve Graft?

No. The disclosure explains that the FDA classified new information as a Major Amendment, extended the PDUFA goal date to December 5, 2025, and expects labeling feedback in November 2025; it does not state that Avance® Nerve Graft has been approved.

What forward-looking statements does Axogen make related to Avance in this filing?

Axogen includes forward-looking statements about the potential approval and timing of FDA review of Avance® Nerve Graft and anticipated labeling feedback, while cautioning that actual results may differ due to regulatory review timing, possible delays, and additional FDA information requests.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 08/25/2025 - 06:41 AM Learn about SEC filing dates

0000805928false00008059282025-08-222025-08-22

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)

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 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.

			AXOGEN, INC.
Dated: August 25, 2025			By:			/s/ Marc Began
						Marc Began
						Executive Vice President, General Counsel and Chief Compliance Officer