10:28 AM EDT, 06/28/2024 (MT Newswires) -- Rocket Pharmaceuticals ( RCKT ) said Friday that the US Food and Drug Administration has issued a Complete Response Letter following its Biologics License Application for Kresladi to treat severe leukocyte adhesion deficiency-I.

The company said the FDA requested limited additional Chemistry Manufacturing and Controls information to complete its review.

Rocket said it met with FDA senior leaders from Center for Biologics Evaluation and Research to align on the limited scope of additional CMC information needed to support the approval of Kresladi "as quickly as possible."

"CBER leadership's direct involvement and commitment to working expeditiously to deliver this therapy to patients gives us great hope on behalf of the primary immunodeficiency community," said CEO Gaurav Shah.

Shares of Rocket Pharmaceuticals ( RCKT ) were down about 4% in recent trading.

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