(RTTNews) - Rocket Pharmaceuticals, Inc. (RCKT) announced the FDA has accepted the resubmission of the Biologics License Application for KRESLADI or marnetegragene autotemcel; marne-cel, a lentiviral vector-based investigational gene therapy for severe Leukocyte Adhesion Deficiency-I. The PDUFA date is March 28, 2026.
"We value the continued dialogue with the FDA and believe the BLA moves Rocket closer to our goal of delivering a one-time gene therapy to patients facing the devastating effects of severe LAD-I," said Gaurav Shah, CEO, Rocket Pharma.
Shares of Rocket Pharmaceuticals are up 8% in pre-market trade on Tuesday.
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