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Regenxbio Concludes Pre-biologics License Application Meeting For RGX-121 For Mucopolysaccharidosis Type II, Where It Finalized Details Of Its Application With The FDA, Expects To Initiate Submission Of A Rolling BLA In Q3 Of 2024

Author: Benzinga Newsdesk | June 18, 2024 07:11am
  • Aligned with FDA on content of BLA and plans for submission:
    • Submission of a rolling BLA using the accelerated approval pathway expected to start in Q3 2024
    • Confirmatory trial expected to begin in H2 2025
    • FDA confirmed RGX-121 commercial bulk drug is comparable to clinical material
  • Positive biomarker, neurocognitive and systemic data will be part of BLA submission

Posted In: RGNX


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