The FDA Issued Complete Response Letter To Rocket Pharmaceuticals' Kresladi (Marnetegragene Autotemcel), Gene Therapy For Severe Leukocyte Adhesion Deficiency-i, The FDA Requested Limited Additional CMC Information
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The FDA issued a Complete Response Letter to Rocket Pharmaceuticals' gene therapy, Kresladi (Marnetegragene Autotemcel), for severe Leukocyte Adhesion Deficiency-i, requesting limited additional CMC information.
June 28, 2024 | 11:31 am
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The FDA issued a Complete Response Letter to Rocket Pharmaceuticals' gene therapy Kresladi, requesting additional CMC information. This may delay the approval and commercialization of the therapy.
The FDA's request for additional CMC information indicates a delay in the approval process for Rocket Pharmaceuticals' gene therapy. This could negatively impact the stock price in the short term due to the uncertainty and potential delay in revenue generation.
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