FDA aligns with Regenxbio on path to refile MPS II gene therapy BLA
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REGENXBIO Announces Alignment with FDA on Path Forward for NAVSUNLI™ BLA Resubmission for Accelerated Approval; First Potential Gene Therapy for MPS II
June 22, 2026 7:30 AM EDTFDA 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/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced it has aligned with the U.S. Food and... More
