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AxoGen ( (AXGN) ) has issued an update.
On August 22, 2025, Axogen, Inc. announced that the FDA has extended the Prescription Drug User Fee Act (PDUFA) goal date for its Biologics License Application (BLA) for the Avance® Nerve Graft by three months to December 5, 2025. This extension follows the FDA’s classification of Axogen’s recent submission of new manufacturing and facility information as a Major Amendment, necessitating additional review time. The FDA also plans to provide feedback on product labeling in November 2025. This development is significant for Axogen as it continues to transition Avance Nerve Graft from a tissue product to a BLA-approved biologic, potentially impacting its market positioning and stakeholder interests.
The most recent analyst rating on (AXGN) stock is a Buy with a $17.00 price target. To see the full list of analyst forecasts on AxoGen stock, see the AXGN Stock Forecast page.
Spark’s Take on AXGN Stock
According to Spark, TipRanks’ AI Analyst, AXGN is a Outperform.
AxoGen’s overall score reflects strong revenue growth and strategic execution, as highlighted in the earnings call. Technical indicators show bullish momentum, though valuation remains a concern due to negative profitability metrics. The company’s financial performance is stable, but profitability challenges persist.
To see Spark’s full report on AXGN stock, click here.
More about AxoGen
Axogen, Inc. is a leading company specializing in the science, development, and commercialization of technologies for peripheral nerve regeneration and repair. The company’s product portfolio includes innovative solutions such as the Avance® Nerve Graft, Axoguard Nerve Connector®, Axoguard Nerve Protector®, Axoguard HA+ Nerve Protector™, Axoguard Nerve Cap®, and Avive+ Soft Tissue Matrix™, which are designed to restore nerve function and improve the quality of life for patients with peripheral nerve injuries. Axogen’s products are available in multiple countries, including the United States, Canada, Germany, the United Kingdom, Spain, and South Korea.
Average Trading Volume: 1,161,562
Technical Sentiment Signal: Strong Buy
Current Market Cap: $748.2M
See more insights into AXGN stock on TipRanks’ Stock Analysis page.