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Precigen Receives FDA Orphan Drug Designation for PRGN-3006 UltraCAR-T(TM) in Patients with Acute Myeloid Leukemia (AML) | P&T Community

By January 6, 2020News
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GERMANTOWN, Md., Jan. 6, 2020 /PRNewswire/ — Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cellular therapies to improve the lives of patients, today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to PRGN-3006, a first-in-class investigational therapy using Precigen’s non-viral UltraCAR-T™ therapeutic platform for patients with relapsed or refractory acute myeloid leukemia (AML) (clinical trial identifier: NCT03927261). Precigen announced in Q3 2019 that it had completed enrollment for the first cohort of this clinical trial and expects an initial data readout in the second half of 2020.

 

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