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RCKT·Rocket Pharmaceuticals

KRESLADI

Genericmarnetegragene autotemcel
gene therapylentiviral ITGB2 transfer (LAD-I)

KRESLADI (marnetegragene autotemcel) is a one-time ex vivo lentiviral gene therapy developed by Rocket Pharmaceuticals for leukocyte adhesion deficiency type I (LAD-I) — an ultra-rare, fatal pediatric immune disorder in which ITGB2 gene mutations prevent white blood cells from reaching sites of infection, leaving patients unable to fight bacteria. The therapy harvests a patient's own blood stem cells, inserts a functional ITGB2 gene via lentiviral vector, and reinfuses the corrected cells after myeloablative conditioning to restore immune function. Without treatment, severe LAD-I is typically fatal in infancy; KRESLADI received FDA Priority Review and would be Rocket's first commercial gene therapy.

Upcoming catalysts

1 of 1

Programs

1 program
completedRare Disease

Fanconi Anemia

Fanconi anemia is an ultra-rare inherited DNA repair disorder causing progressive aplastic anemia requiring transfusions, a high risk of AML, and associated developmental abnormalities; without treatment, most patients require hematopoietic stem cell transplantation with significant morbidity and limited donor availability. KRESLADI delivers a functional FANCA gene into the patient's own blood stem cells via lentiviral vector; it received FDA Priority Review and, if approved at the 2026 PDUFA, would be Rocket's first commercial gene therapy.

Trial
NCT04693598n=12completed
Phase 2 Marnetegragene in Fanconi Anemia Type A
Primary completion: Dec 30, 2025
PDUFA
OCT 092026·5 monthsEXACT
KRESLADI BLA PDUFA (Fanconi Anemia Type A)

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