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Biotech Stocks Facing FDA Decision In June 2024

Amgen
Amgen

Amgen Inc. (AMGN) is seeking FDA approval to expand the use of Blincyto in early-stage, CD19-positive B-cell precursor acute lymphoblastic leukemia and a decision is due on June 21, 2024.

The drug is already approved in the U.S. for the treatment of CD19-positive B-cell precursor ALL in first or second complete remission with minimal residual disease (MRD) greater than or equal to 0.1% in adults and pediatric patients, and for relapsed or refractory CD19-positive B-cell precursor ALL in adults and pediatric patients.

Blincyto generated global sales of $861 million in full year 2023, compared to $583 million in the prior year.

AMGN closed Wednesday’s trading at $296.37, down 1.27%.