REGENXBIO Announces Intention to File a Biologics License Application Using the Accelerated Approval Pathway for RGX-121, an AAV Therapeutic for the Treatment of MPS II

FDA will consider an accelerated approval pathway for RGX-121; BLA filing expected in 2024 Pivotal program is active and enrolling patients RGX-121 is a potential first-in-class, one-time gene therapy for the treatment of MPS II Internal cGMP manufacturing process expected to support BLA…