Legend Biotech Corporation

LEGN

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Investigation Details

On November 28, 2023, the U.S. Food and Drug Administration (“FDA”) announced that it was “investigating the identified risk of T cell malignancy with serious outcomes, including hospitalization and death, and is evaluating the need for regulatory action” after “receiving reports of T-cell malignancies, including chimeric antigen receptor CAR-positive lymphoma, in patients who received treatment with BCMA- or CD19-directed autologous CAR T cell immunotherapies.” The FDA’s press release listed Legend’s Carvykti (ciltacabtagene autoleucel) as among the approved products in the class of products at issue.

On this news, Legend’s stock price fell $1.57 per share to close at $59.99 per share on November 28, 2023.

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