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AxoGen Secures FDA Approval for Avance Nerve Scaffold

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AxoGen Secures FDA Approval for Avance Nerve Scaffold

TipRanks Cyber Monday Sale

AxoGen ( (AXGN) ) has shared an update.

On December 3, 2025, Axogen announced that the FDA approved its Biologics License Application for Avance®, an acellular nerve scaffold for treating peripheral nerve discontinuities. This approval, under the FDA’s Accelerated Approval pathway, marks a significant regulatory milestone for Axogen, transitioning Avance from a human tissue product to a biologic classification. This shift strengthens Axogen’s regulatory position and confirms Avance as a safe and effective therapeutic option, with commercial availability expected in early 2026. The approval is contingent upon confirmatory clinical studies, and Avance remains available under the current tissue framework until then.

The most recent analyst rating on (AXGN) stock is a Buy with a $40.00 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 Neutral.

AxoGen’s overall stock score reflects strong earnings call performance and technical analysis, indicating positive market sentiment and growth potential. However, concerns about profitability, cash flow challenges, and high valuation metrics weigh down the score. The company’s strategic progress and revenue growth are promising, but financial stability needs improvement.

To see Spark’s full report on AXGN stock, click here.

More about AxoGen

Axogen (NASDAQ: AXGN) is a company focused on the science, development, and commercialization of technologies for peripheral nerve repair. Its mission is to make nerve repair the expected standard of care, advancing the field through research, education, and collaboration with surgeons and healthcare providers globally. Axogen’s product portfolio includes Avance® (acellular nerve allograft-arwx) and other nerve repair products, available in several countries including the United States, Canada, and Germany.

Average Trading Volume: 869,168

Technical Sentiment Signal: Buy

Current Market Cap: $1.28B

For an in-depth examination of AXGN stock, go to TipRanks’ Overview page.

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