Agios rises as IDH2 inhibitor heads for submission

Agios Pharmaceuticals Inc. (NASDAQ:AGIO) jumped $9.66 (26%) to $46.98 on Wednesday after disclosing that partner Celgene Corp. (NASDAQ:CELG) plans to submit an NDA to FDA by year end seeking approval of enasidenib ( AG-221) to treat relapsed or refractory acute myelogenous leukemia (AML) in patients with an isocitrate dehydrogenase 2 ( IDH2) mutation.

The inhibitor of mutated IDH2 is in Phase III testing for refractory or relapsed AML; however, the application will be based on data from an ongoing Phase I/II study in patients with advanced hematologic malignancies with an IDH2 mutation, according to an Agios regulatory filing. An Agios spokesperson told BioCentury it will be up to FDA whether to review the application under the accelerated or standard review pathway (see BioCentury Extra, Nov. 5, 2015). ...