- Zacks
FDA Rejects Rocket's (RCKT) Gene Therapy BLA for Rare Disease
Per the FDA, Rocket (RCKT) needs to submit additional manufacturing information on Kresladi gene therapy to secure approval for severe leukocyte adhesion deficiency-I (LAD-I), a rare genetic disorder.
- Benzinga
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. Ro
- Zacks
Why Is Rocket Pharmaceuticals (RCKT) Down 4.8% Since Last Earnings Report?
Rocket Pharmaceuticals (RCKT) reported earnings 30 days ago. What's next for the stock? We take a look at earnings estimates for some clues.
