Rocket Pharmaceuticals Provides Regulatory Update on KRESLADI™ (marnetegragene autotemcel; marne-cel) [Yahoo! Finance]
Rocket Pharmaceuticals, Inc. (RCKT)
Last rocket pharmaceuticals, inc. earnings: 3/5 07:00 am
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Source: Yahoo! Finance
advancing a sustainable pipeline of genetic therapies for rare disorders with high unmet needs, today 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 U.S. Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) in response to Rocket's Biologics License Application for KRESLADI™ wherein the FDA requested limited additional Chemistry Manufacturing and Controls (CMC) information to complete its review. Rocket met with FDA senior leaders from Center for Biologics Evaluation and Research (CBER) to align on the limited scope of additional CMC information needed to support the approval of KRESLADI™ as quickly as possible. "It is reassuring to have the FDA as a close collaborator who understands the high unmet medical need, clear clinical benefit and importance of timely patient access," said Gaurav Shah, M.D., Chief Executive Of
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News
- Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) had its "buy" rating re-affirmed by analysts at Chardan Capital. They now have a $62.00 price target on the stock.MarketBeat
- Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) had its price target lowered by analysts at Needham & Company LLC from $53.00 to $52.00. They now have a "buy" rating on the stock.MarketBeat
- Rocket Pharmaceuticals Provides Regulatory Update on KRESLADI™ (marnetegragene autotemcel; marne-cel)Business Wire
- Why Is Rocket Pharmaceuticals (RCKT) Down 4.8% Since Last Earnings Report? [Yahoo! Finance]Yahoo! Finance
- Rocket Pharmaceuticals, Inc. (NASDAQ: RCKT) had its "outperform" rating re-affirmed by analysts at William Blair.MarketBeat
RCKT
Earnings
- 5/6/24 - Beat
RCKT
Sec Filings
- 6/28/24 - Form 8-K
- 6/20/24 - Form 4
- 6/20/24 - Form 4
- RCKT's page on the SEC website