REGENXBIO Announces Alignment with FDA on Path Forward for NAVSUNLI™ BLA Resubmission for Accelerated Approval; First Potential Gene Therapy for MPS II

FDA confirmed no additional studies required, existing longer-term data from the CAMPSIITE® study will be reviewed on an expedited basis for approval via the accelerated approval pathway The Company expects to resubmit the BLA in Q3 2026 ROCKVILLE, Md., June 22, 2026 /PRNewswire/ --...

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