Rocket Pharmaceuticals' stock dropped due to a CRL requesting additional CMC info for its gene therapy Kresladi.
Rocket Pharmaceuticals' stock fell after receiving a Complete Response Letter (CRL) from the FDA requesting additional Chemistry, Manufacturing, and Controls (CMC) information for its gene therapy Kresladi. Kresladi, developed to treat severe leukocyte adhesion deficiency-I (LAD-I), showed 100% overall survival at 12 months in a global Phase 1/2 study. Rocket is now working with the FDA to provide the requested information and support Kresladi's approval.
June 28, 2024
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