Fly News Breaks for December 11, 2019
Dec 11, 2019 | 05:20 EDT
Piper Jaffray analyst Tyler Van Buren says Agios Pharmaceuticals remains a favorite name ahead of the company's beta thalassemia and sickle cell disease updates in the first half of 2020. The disclosure at ASH that seven out of the eight initial mitapivat beta thalassemia patients responded was by far the biggest update during the conference, Van Buren tells investors in a research note. During the first half of next year, Agios could see initial sickle cell data from patients treated with mitapivat, which represents an opportunity that is five-fold larger, adds the analyst. He recommends that investors continue to own Agios shares through next year and keeps an Overweight rating on the name.
News For AGIO From the Last 2 Days
Oct 19, 2020 | 04:55 EDT
Agios Pharmaceuticals announced Friday the withdrawal of its European Marketing Authorization Application for Tibsovo for the treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-1 mutation. The decision is based on feedback from the European Medicine Agency's Committee for Medicinal Products for Human Use that the available clinical data from the company's single arm, uncontrolled Phase 1 study do not sufficiently support a positive benefit-risk balance for the proposed indication. "We are disappointed not to be able to bring TIBSOVO to AML patients in the EU based on our current data in the relapsed/refractory setting, given the tremendous need for new targeted treatment options for this devastating disease," said Chris Bowden, M.D., chief medical officer at Agios. "We continue to believe in the benefit of TIBSOVO(R) for patients with AML and are advancing our two ongoing Phase 3 randomized controlled trials evaluating TIBSOVO(R) combinations in newly diagnosed AML. If these trials are positive, we anticipate pursuing approvals in these indications in both the U.S. and EU."