Axogen Initiates Rolling Submission Process With FDA For Biologics License Application For Licensure Of Avance Nerve Graft
Portfolio Pulse from Benzinga Newsdesk
Axogen has initiated the rolling submission process with the FDA for a Biologics License Application (BLA) for its Avance Nerve Graft. The company expects to complete the BLA filing by Q3 2024 and anticipates approval around mid-2025.
May 16, 2024 | 11:34 am
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Axogen has begun the rolling submission process with the FDA for its Avance Nerve Graft BLA, with completion expected by Q3 2024 and potential approval by mid-2025.
The initiation of the rolling submission process for the BLA is a significant regulatory milestone for Axogen. If the process proceeds as planned, it could lead to FDA approval by mid-2025, potentially boosting investor confidence and positively impacting the stock price in the short term.
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