Rocket Pharma receives FDA Complete Response Letter for KRESLADI BLA; limited CMC info requested

ROCKET PHARMACEUTICALS, INC.

FDA issued Complete Response Letter for KRESLADI (marne-cel) BLA; requested limited additional CMC information.
Company met with FDA CBER senior leaders to align on scope of additional CMC info to support approval expeditiously.
Phase 1/2 data: 100% overall survival at 12 months in 9 patients; all endpoints met; no treatment-related serious AEs.

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