FDA approves Axogen's nerve repair graft

The U.S. Food and Drug Administration has approved Axogen's nerve repair graft, the health regulator said on Wednesday.

Reuters • Dec 3, 2025

Axogen Announces FDA Approval of Biologics License Application for AVANCE® (acellular nerve allograft–arwx)

ALACHUA, Fla. and TAMPA, Fla., Dec. 03, 2025 (GLOBE NEWSWIRE) -- Axogen, Inc. (NASDAQ: AXGN), a global leader in developing and marketing innovative surgical technologies for the restoration of peripheral nerve function, today announced that the U.S. Food and Drug Administration (the “FDA”) has approved the Biologics License Application (“BLA”) for AVANCE® (acellular nerve allograft-arwx).

GlobeNewsWire • Dec 4, 2025

Avance Nerve Graft FDA Verdict Approaches, Why Investors Are Watching Axogen

Axogen, Inc. delivered strong Q3 '25 results, with revenue up 23.7% and a return to profitability, fueling bullish momentum. Surgeon adoption is accelerating ahead of the December 5th FDA decision on Avance Nerve Graft, a pivotal regulatory inflection point. The BLA submission features over a decade of real-world outcomes, robust manufacturing validation, and clinical recovery rates in the low-80% range.

Seeking Alpha • Dec 1, 2025

Wasatch Micro Cap Value Fund Q3 2025 Contributors And Detractors

The strongest contributor to Wasatch Micro Cap Value Fund performance for the quarter was Bel Fuse, Inc. Axogen, Inc. (AXGN) was also a top contributor, providing surgical solutions for peripheral nerve repair. The greatest detractor from Fund performance for the quarter was Limbach Holdings, Inc. (LMB).

Seeking Alpha • Nov 5, 2025

Axogen, Inc. (AXGN) Q3 2025 Earnings Call Transcript

Axogen, Inc. ( AXGN ) Q3 2025 Earnings Call October 29, 2025 8:00 AM EDT Company Participants Michael Dale - President, CEO & Director Lindsey Hartley - Chief Financial Officer Rick Ditto Jens Schroeder Kemp - Chief Marketing Officer Conference Call Participants Christopher Pasquale - Nephron Research LLC Michael Sarcone - Jefferies LLC, Research Division Caitlin Cronin - Canaccord Genuity Corp., Research Division Jayson Bedford - Raymond James & Associates, Inc., Research Division Michael Kratky - Leerink Partners LLC, Research Division Ross Osborn - Cantor Fitzgerald & Co., Research Division David Turkaly - Citizens JMP Securities, LLC, Research Division Frank Takkinen - Lake Street Capital Markets, LLC, Research Division Anthony Petrone Yi Chen - H.C. Wainwright & Co, LLC, Research Division Presentation Operator Good morning.

Seeking Alpha • Oct 29, 2025

Axogen, Inc. Reports Third Quarter 2025 Financial Results

Raises Full Year Revenue Guidance to at Least 19% Growth or $222.8 million Raises Full Year Revenue Guidance to at Least 19% Growth or $222.8 million

GlobeNewsWire • Oct 29, 2025

AxoGen (AXGN) Q3 Earnings and Revenues Top Estimates

AxoGen (AXGN) came out with quarterly earnings of $0.12 per share, beating the Zacks Consensus Estimate of $0.09 per share. This compares to earnings of $0.07 per share a year ago.

Zacks Investment Research • Oct 29, 2025

INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Axogen, Inc. - AXGN

NEW YORK , Oct. 18, 2025 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Axogen, Inc. ("Axogen" or the "Company") (NASDAQ: AXGN). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext.

PRNewsWire • Oct 18, 2025

AXGN Investors Have Opportunity to Join Axogen, Inc. Fraud Investigation with the Schall Law Firm

LOS ANGELES--(BUSINESS WIRE)---- $AXGN--AXGN Investors Have Opportunity to Join Axogen, Inc. Fraud Investigation with the Schall Law Firm.

Business Wire • Oct 1, 2025

Axogen, Inc. Investigated for Securities Fraud Violations - Contact the DJS Law Group to Discuss Your Rights – AXGN

LOS ANGELES--(BUSINESS WIRE)--Axogen, Inc. Investigated for Securities Fraud Violations - Contact the DJS Law Group to Discuss Your Rights – AXGN.

Business Wire • Oct 1, 2025