Broadcom named strategic vendor for Walmart virtualization solutions
ALACHUA, Fla. - The U.S. Food and Drug Administration has extended its review timeline for Axogen, Inc.’s (NASDAQ:AXGN) Biologics License Application for Avance Nerve Graft by three months, setting a new decision date of December 5, 2025. The company, currently trading at $16.26 with a market capitalization of $750 million, has shown strong momentum with a 30% return over the past year.
The FDA informed Axogen on August 22 that information submitted by the company in response to an agency request constituted a "Major Amendment" to its application. The submission included substantial new manufacturing and facility data that requires additional review time.
The regulatory agency also indicated it plans to provide feedback on product labeling in November 2025, in line with standard Prescription Drug User Fee Act review procedures.
"We appreciate the FDA’s thorough review and look forward to continuing our engagement with the agency to complete the transition of Avance Nerve Graft from a tissue product to a BLA-approved biologic," said Michael Dale, Axogen’s Chief Executive Officer, in a press release statement.
Avance Nerve Graft is a processed human nerve allograft designed for bridging severed peripheral nerves without requiring a second surgical site. The product is part of Axogen’s portfolio focused on peripheral nerve regeneration and repair technologies.
The company’s application seeks to transition the product from its current classification as a tissue product to an FDA-approved biologic. This regulatory review represents a significant milestone in the product’s regulatory pathway.
Axogen currently markets its nerve repair products in the United States, Canada, and several other countries worldwide.
In other recent news, AxoGen, Inc. reported strong financial results for the second quarter of 2025, surpassing both earnings and revenue forecasts. The company announced an adjusted earnings per share of $0.12, doubling the expected $0.06, and achieved revenue of $56.7 million, exceeding the forecast of $52.66 million. This revenue figure also represents a year-over-year growth of approximately 18.3%, driven by double-digit growth across the company’s product portfolio. Cantor Fitzgerald responded to these results by reiterating an Overweight rating on AxoGen and maintaining a price target of $26.00. Meanwhile, Jefferies raised its price target for AxoGen to $25.00 from $24.00, citing strong sales growth. Raymond James, however, lowered its price target to $20.00 from $21.00, while maintaining an Outperform rating, noting improved momentum with better revenue growth and gross margin performance. These developments reflect a positive sentiment among analysts regarding AxoGen’s recent performance.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.