Axogen Smashes 52-Week High On FDA Nod For Breakthrough Nerve Repair Treatment

The U.S. Food and Drug Administration (FDA) on Wednesday approved Axogen Inc.’s (NASDAQ:AXGN) Biologics License Application for Avance, an acellular nerve scaffold for adult and pediatric patients aged 1 month or older with sensory, mixed, and motor peripheral nerve discontinuities.

Avance Nerve Graft is a biologically active off-the-shelf processed human nerve allograft for bridging severed peripheral nerves without the comorbidities associated with a second surgical site.

Unlike some current treatments that require surgeons to remove healthy nerve tissue from another part of the patient’s body (creating a second surgical site), Avance is made using nerve tissue from deceased donors (cadavers) that has been specially processed to remove cells while preserving the natural structure that helps nerves regrow.

The indications for sensory nerve discontinuities >25mm and for mixed and motor nerve discontinuities were approved under the FDA’s Accelerated Approval pathway based on the effect on static two-point discrimination in sensory nerve gaps ≤25mm, which provided evidence to reasonably predict clinical benefit given similarities in pathophysiology and anticipated therapeutic effects.

Continued approval for these indications depends on verification and description of clinical benefit in confirmatory studies.

Commercial availability of the licensed Avance product is expected early in the second quarter of 2026. In the meantime, Avance remains available under the current tissue framework.

In August, Axogen received a communication from the FDA indicating that the information submitted by the company in response to an FDA information request, which included substantial new manufacturing and facility data not previously reviewed by the Agency, was deemed a Major Amendment to its BLA. 

Recent Earnings

Axogen reported third-quarter revenue was $60.1 million, a 23.5% increase year over year, beating the consensus of $56.81 million.

Adjusted earnings were 12 cents, beating the consensus of 7 cents.

The company raised 2025 revenue guidance to at least 19% growth, or $222.8 million, and expects gross margin for the year to be in the range of 73% to 75%.

The range reflects one-time costs, mainly related to an anticipated Avance Nerve Graft BLA approval, which is expected to negatively impact gross margin by approximately 1%, or $2 million.

The company reiterated that its net cash flow will be positive for the full year.

AXGN Price Action: Axogen shares were up 18.78% at $31.01 at the time of publication on Thursday. The stock is trading at a new 52-week high, according to Benzinga Pro data.

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