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Precigen's bone marrow cancer drug gets US FDA orphan-drug tag


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Precigen's bone marrow cancer drug gets US FDA orphan-drug tag

Intrexon Corp. said its investigational therapy PRGN-3006 received the U.S. Food and Drug Administration's orphan-drug designation to treat a type of cancer that affects the blood and bone marrow.

PRGN-3006, which was developed using Precigen's Ultracar-T technology, is intended to treat patients with relapsed or refractory acute myeloid leukemia. The company is studying the medicine in an early-stage clinical trial and expects to post an initial data readout in the second half of 2020.

The U.S. FDA grants orphan-drug designation to therapies that can treat, diagnose or prevent rare disorders that affect fewer than 200,000 people in the U.S. Such treatments then receive incentives such as market exclusivity, if approved.

According to the American Cancer Society, about 21,450 new cases of acute myeloid leukemia were expected to be diagnosed in the U.S. in 2019.

Precigen recently changed its name from Intrexon Corp.