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Investing.com -- Axogen Inc (NASDAQ:AXGN) stock dropped 13.3% in Monday’s premarket trading after the company announced that the U.S. Food and Drug Administration (FDA) has extended the review period for its Biologics License Application (BLA) for Avance Nerve Graft.
The FDA pushed back the Prescription Drug User Fee Act (PDUFA) goal date by three months to December 5, 2025. The delay comes after the agency deemed Axogen’s response to an information request, which included substantial new manufacturing and facility data, as a "Major Amendment" to its BLA.
According to the company, the FDA informed Axogen on August 22, 2025, that it would need additional time to review the submission. The agency also indicated that feedback on product labeling is now expected 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.
The Avance Nerve Graft is a key product for Axogen, which specializes in peripheral nerve repair solutions. The extended review timeline has clearly disappointed investors, as reflected in the significant premarket decline.
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