AxoGen (AXGN) Initiates BLA Submission for Avance Nerve Graft

AxoGen, Inc. (AXGN) announced the initiation of rolling submission of a Biologics License Application (BLA) seeking licensure for its human nerve allograft candidate, Avance Nerve Graft, to the FDA on May 15.The initial submission includes the complete non-clinical data package. The company will submit the remaining Clinical and Chemistry, Manufacturing and Controls components in the upcoming months. The rolling submission is expected to be completed by the third quarter of 2024.Following a potential approv ...