Legend Biotech slips after FDA clinical hold on blood cancer study for CAR-T therapy

seekingalpha2022-02-15

Grandbrothers/iStock Editorial via Getty Images Legend Biotech (NASDAQ:LEGN) is trading ~6% lower in the pre-market on Tuesday after the company announced that the U.S Food and Drug Administration (...

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Rio999
2022-02-18
Rio999
淋巴癌不容易。主动暂停临床，是诚实公司的表现。调整配方后，继续实验。a good try anyway

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An autologous chimeric antigen receptor T-cell (CAR-T) therapy, LB1901, is designed to target cancerous CD4+ T-cells in the treatment of adults with relapsed or refractory T-cell lymphoma (TCL). The FDA informed its decision via e-mail on Feb. 11, and the federal agency had indicated that it would send the official clinical hold letter on Mar. 11, according to the company. Before the notification on clinical hold, the company had dosed only one patient in the study. However, after the patient experienced low CD4+ T-cell counts, Legend (LEGN) had decided to pause the trial and notified the FDA. “The patient has not experienced drug-related serious adverse events (SAEs) and is being monitored in accordance with the protocol,” the company added.  In October, Allogene (NASDAQ:ALLO) was slapped with a clinical hold by the FDA on its AlloCAR T trials. 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