FDA approved Rocket Pharmaceuticals’ gene therapy Kresladi (marne-cel) for leukocyte adhesion deficiency type I, the company said, adding a rare pediatric disease priority review voucher to the approval. Rocket said the treatment is the first BLA this year to pass CBER and that it plans to launch the product by year-end. The approval matters for gene-therapy commercialization timelines and manufacturing readiness, particularly for developers targeting single-dose, hematology-driven indications. Rocket is positioning marne-cel as its first product after years of clinical development focused on delivering MAC-1 via genetic modification. With priority review voucher earnings tied to the approval, the filing also underscores the continuing role of regulatory incentives in accelerating adoption and follow-on development strategies across rare-disease gene therapy.