Agios Pharma (AGIO) Tops Q1 EPS by 16c

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Agios Pharma (AGIO) Reports FDA Approval of Supplemental New Drug Application for TIBSOVO

May 2, 2019 1:27 PM EDT

Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) today announced the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) to update the U.S. Prescribing Information for TIBSOVO®, an isocitrate dehydrogenase-1 (IDH1) inhibitor, to include adult patients with newly diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test who are 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. The sNDA was granted Priority Review and accepted under the FDA's Real-Time Oncology Review pilot program, which aims to make the... More