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Investing.com -- Axogen (NASDAQ:AXGN) stock declined 9% after the U.S. Food and Drug Administration (FDA) extended its review timeline for the company’s Avance Nerve Graft by three months.
The FDA has pushed the Prescription Drug User Fee Act (PDUFA) goal date for Axogen’s Biologics License Application (BLA) to December 5, 2025, from the previous target. According to the company, the FDA deemed information submitted in response to an agency request as a "Major Amendment" to its BLA, which included substantial new manufacturing and facility data not previously reviewed.
The regulator also informed Axogen that it now plans to provide feedback on product labeling in November 2025, in line with standard PDUFA 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.
Despite the setback, analysts remain largely optimistic about the company’s prospects. Leerink analyst Mike Kratky, who maintains an outperform rating, views "the delayed PDUFA date as largely procedural but recognize that it adds some additional uncertainty on the setup through year-end."
Similarly, Cantor analyst Ross Osborn, who also rates the stock as outperform, commented that "while we are disappointed to learn of the delay in the PDUFA data, we remain confident in AXGN’s ability to transition to a BLA-approved biologic and believe the company will continue to execute ahead of approval."
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