(RTTNews) - Axogen, Inc. (AXGN) announced that the U.S. Food and Drug Administration has approved the Biologics License Application (BLA) for AVANCE, an acellular nerve allograft (arwx).
AXGN closed Wednesday's regular trading at $28.33, up $0.64 or 2.31%. In overnight trading, the stock continued its upward momentum, rising to $30.07, a gain of $1.74 or 6.14%, as of 8:07 PM EST.
AVANCE is an acellular nerve scaffold designed for the treatment of adult and pediatric patients aged one month or older who suffer from sensory, mixed, or motor peripheral nerve discontinuities. This innovative therapy provides a new option for patients requiring nerve repair across a wide range of clinical scenarios.
The FDA granted approval for indications involving sensory nerve discontinuities greater than 25mm, as well as mixed and motor nerve discontinuities, under its Accelerated Approval pathway. The decision was based on evidence demonstrating improvements in static two-point discrimination in sensory nerve gaps exceeding 25mm. These findings provided empirical support to reasonably predict clinical benefit, given the similarities in pathophysiology and anticipated therapeutic effects.
Continued approval for these indications will depend on the verification and description of clinical benefit in confirmatory studies, ensuring that the therapy delivers sustained and measurable outcomes for patients.
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.
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