FDA Rejects Rocket Pharmaceuticals' Gene Therapy For Rare Immune Disorder, Asks For More Data, Stock Slides
Portfolio Pulse from Vandana Singh
The FDA has issued a Complete Response Letter (CRL) to Rocket Pharmaceuticals' Biologics License Application for Kresladi, a gene therapy for severe leukocyte adhesion deficiency-I (LAD-I), requesting additional Chemistry Manufacturing and Controls (CMC) information. Despite positive Phase 1/2 study results, Rocket Pharmaceuticals' stock (NASDAQ:RCKT) fell by 9.01% following the news.
June 28, 2024 | 1:52 pm
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Rocket Pharmaceuticals' stock fell by 9.01% after the FDA issued a Complete Response Letter (CRL) for its gene therapy Kresladi, requesting additional CMC data. This regulatory setback comes despite positive Phase 1/2 study results showing 100% overall survival and significant clinical improvements in LAD-I patients.
The FDA's request for additional CMC data represents a regulatory hurdle that delays the potential approval and commercialization of Kresladi. Despite the positive clinical trial results, the market reacted negatively to the news, leading to a significant drop in Rocket Pharmaceuticals' stock price.
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