Regenxbio says FDA clears path for NAVSUNLI accelerated-approval BLA resubmission in Q3 2026

REGENXBIO, Inc.

REGENXBIO, Inc.

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  • Regenxbio aligned with the FDA on a path to resubmit the NAVSUNLI BLA for accelerated approval in Q3 2026.
  • The FDA confirmed no additional studies or patient enrollment are required, reversing its earlier request for an untreated control arm.
  • A Type A meeting is expected in July to review longer-term biomarker and clinical data from the CAMPSIITE study.
  • The FDA plans an expedited review of the resubmission, with labeling discussions set to start shortly after filing.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Regenxbio Inc. published the original content used to generate this news brief via PR Newswire (Ref. ID: PH88506) on June 22, 2026, and is solely responsible for the information contained therein.

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