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-0.000509683995922608 -0.00101936799184503 -0.000254841997961213 0.00152905198776764 0.00458715596330274 -0.000764525993883821 -0.00280326197757389 -0.00407747196738014
Stock impact report

Rocket Stock Down More Than 30% in Past Six Months: Here's Why [Yahoo! Finance]

Rocket Pharmaceuticals, Inc. (RCKT) 
Last rocket pharmaceuticals, inc. earnings: 3/5 07:00 am Check Earnings Report
US:NASDAQ Investor Relations: rocketpharma.com
Company Research Source: Yahoo! Finance
The company is developing its gene therapy candidate, Kresladi (marnetegragene autotemcel) to treat patients with severe leukocyte adhesion deficiency-I (LAD-I), a rare genetic disorder. In June 2024, the FDA issued a complete response letter (CRL) to Rocket's biologics license application (BLA) seeking approval for Kresladi to treat LAD-I. Per the CRL, the FDA sought "limited" additional information on the Chemistry Manufacturing and Controls (CMC), which is part of the BLA submission. The goal of CMC is to ensure that every batch of the final product is identical in terms of its safety, purity, potency and performance. This was the primary reason for the stock's decline in the said time. Image Source: Zacks Investment Research Setbacks in Kresladi Development Plans & Other Pipeline Updates The abovementioned CRL is the second time the FDA has requested additional information from the company on Kresladi's CMC. In February 2024, the FDA extended the review period of the Show less Read more
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