Agios Pharmaceuticals, Inc. (AGIO)

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Agios Pharmaceuticals, Inc. (the “Company”) today announced that its collaboration partner Celgene Corporation (“Celgene”) expects to submit a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for enasidenib (AG-221), a first-in-class, oral, selective, potent inhibitor of mutant isocitrate dehydrogenase-2 (“IDH2”), in relapsed and/or refractory acute myeloid leukemia (“AML”). The NDA will be based on data from the ongoing phase 1/2 study of AG-221 in patients with advanced hematologic malignancies with an IDH2 mutation. The NDA submission is expected to occur by year-end 2016. Celgene will be discussing the planned enasidenib NDA submission at the Citi 11th Annual Biotech Conference in Boston in a webcast event on Wednesday, September 7, 2016 at 12:00 pm ET.