Grandbrothers
- Axogen (NASDAQ:AXGN) on Friday announced the completion of rolling submission in the U.S. for its Biologics License Application (BLA), targeted at marketing approval for its Avance Nerve Graft, a surgical solution for peripheral nerve repair.
- The FDA’s feedback on whether the BLA is accepted for review is expected within roughly 60 days of submission. Simultaneously, the regulator is expected to communicate its decision on whether to grant the BLA its standard or priority review.
- Axogen (AXGN) has requested priority review for the BLA, which could reduce the review timeline to six months from the standard 10-month duration. The company expects that the BLA will be on track for a decision on approvability between April and September 2025.
- “We will continue to collaborate closely with the FDA as they review our application,” remarked Axogen (AXGN) CEO Michael Dale.
