Brief: Axogen Initiates License Application To US FDA For Avance Nerve Graft®
May 16 (Reuters) - AxoGen Inc AXGN.O :
* AXOGEN INC. INITIATES ROLLING SUBMISSION OF BIOLOGICS
LICENSE
APPLICATION TO U.S. FOOD AND DRUG ADMINISTRATION (FDA) FOR
AVANCE NERVE GRAFT®
* AXOGEN INC - ANTICIPATE BLA FILING TO BE COMPLETED IN Q3
OF 2024
* AXOGEN INC - BELIEVE PROCEDURAL TIMELINES FOR REVIEW
COMBINED
WITH ROLLING SUBMISSION PROCESS WILL ALLOW FOR APPROVAL AROUND
MID-2025
Source text for Eikon: ID:nGNX224mlW
Further company coverage: AXGN.O
((Reuters.Briefs@thomsonreuters.com;))