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REGENXBIO Inc Receives FDA Complete Response Letter for RGX-121
- FDA issues a Complete Response Letter to REGENXBIO for RGX-121, prompting a BLA resubmission plan.
- FDA concerns include study criteria and surrogate endpoints guiding the CRL scope.
- REGENXBIO plans collaboration with the FDA to resubmit the BLA for RGX-121.
- Company aims to clarify patient population and data ahead of next regulatory steps.
- RGX-121 has multiple FDA designations for rare diseases, supporting potential prioritization.
- REGENXBIO disclosed the CRL in the context of its February 9, 2026 filing.
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