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Rocket Pharmaceuticals announces FDA acceptance of Kresladi BLA resubmission

Rocket Pharmaceuticals (RCKT) announced that the FDA has accepted the resubmission of the biologics license application for Kresladi, a lentiviral vector-based investigational gene therapy for severe Leukocyte Adhesion Deficiency-I, a rare genetic immune disorder that predisposes patients to recurrent and fatal infections and is near-uniformly fatal in childhood without an allogeneic hematopoietic stem cell transplant. The PDUFA date set by the FDA is March 28, 2026.

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