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Rocket Pharmaceuticals Receives FDA Accelerated Approval for Kresladi
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Rocket Pharmaceuticals Receives FDA Accelerated Approval for Kresladi
Mar 27, 2026 5:02 AM

07:41 AM EDT, 03/27/2026 (MT Newswires) -- Rocket Pharmaceuticals ( RCKT ) said Friday it has received accelerated approval from the U.S. Food and Drug Administration for Kresladi, a gene therapy for children with severe leukocyte adhesion deficiency-I due to biallelic ITGB2 variants without a suitable donor for stem cell transplant.

The approval was based on increased neutrophil CD18 and CD11a surface expression, the company said.

Rocket said that the FDA granted it a Rare Pediatric Disease Priority Review Voucher and that it plans to evaluate strategic options to monetize it to enhance "financial flexibility and maximize shareholder value."

Rocket shares were up more than 9% in Friday pre-bell activity.

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