(Reuters) -Rocket Pharmaceuticals said on Tuesday the U.S. Food and Drug Administration had placed a clinical hold on its mid-stage gene therapy trial after a patient died due to a serious adverse event, sending its shares tumbling 62% before the bell.
The patient experienced clinical complications related to a capillary leak syndrome, a condition where fluid and proteins leak out of tiny blood vessels into surrounding tissues, causing swelling and low blood pressure, the company said.
The company said it has voluntarily paused further dosing in the study after the event.
(Reporting by Christy Santhosh and Kamal Choudhury in Bengaluru; Editing by Savio D’Souza and Shilpi Majumdar)
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