June 22, 2026 12:32 PM GMT Regenxbio Inc | North America FDA Alignment Reached on MPS II Resubmission Key Takeaways Following a string of announced realignments with FDA by drug developers, RGNX has announced that it has reached alignment with the agency on next steps with respect to the potential BLA resubmission for Navsunli (RGX-121) for MPS II. In a discussion that followed the recent CRL, the FDA acknowledged that the existing data for Navsunli is sufficient to be considered for the accelerated approva ...