Published on 20 Jun 2024 on Benzinga · via Yahoo Finance
FDA Rejects Rocket Pharmaceuticals' Gene Therapy For Rare Immune Disorder, Asks...
FDA Rejects Rocket Pharmaceuticals' Gene Therapy For Rare Immune Disorder, Asks For More Data, Stock Slides
Rocket Pharmaceuticals Inc (NASDAQ:RCKT) stock is trading down after the company announced a regulatory update for Kresladi (marnetegragene autotemcel; marne-cel), a lentiviral (LV) vector-based gene therapy to treat severe leukocyte adhesion deficiency-I (LAD-I).
The FDA has issued a Complete Response Letter (CRL) to Rocket’s Biologics License Application for Kresladi, in which the FDA requested limited additional Chemistry Manufacturing and Controls (CMC) information to complete its review.