STAT Plus: Wagering on FDA changes, Regenxbio will submit Duchenne gene therapy for approval STAT 13:03 Wed, 24 Jun
Regenxbio Completes Dosing in Confirmatory Study of Rgx-202, Marking Completion of Registrational Development Program and Supporting Planned Bla Submission in Q3 2026 PR Newswire (Press Release) 12:09 Wed, 24 Jun
FDA changes rare disease tune again as it clears path for Regenxbio’s gene therapy Pharmaceutical Technology 15:09 Tue, 23 Jun
Regenxbio Gets Breath Of Fresh Air From US FDA For Navsunli In MPS II Scrip Pharma Intelligence 22:24 Mon, 22 Jun
Regenxbio Stock Gains 11% Over Alignment With FDA For Navsunli Bla Resubmission RTT News 16:08 Mon, 22 Jun
Regenxbio Rises In Premarket As FDA Says No New Studies Needed For Navsunli Bla Resubmission RTT News 14:04 Mon, 22 Jun
Regenxbio Announces Alignment with FDA on Path Forward for Navsunli™ Bla Resubmission for Accelerated Approval; First Potential Gene Therapy for Mps II PR Newswire (Press Release) 12:36 Mon, 22 Jun
STAT Plus: FDA reverses course on Regenxbio’s childhood gene therapy after rejection STAT 11:55 Mon, 22 Jun