Fly News Breaks for December 8, 2019
Dec 8, 2019 | 18:40 EDT
Piper Jaffray analyst Tyler Van Buren said the initial 88% response rate reported by Agios Pharmaceuticals in its study of mitapivat in non-transfusion dependent beta thal patients was "very encouraging." Though it is early, mitapivat "now appears to be a competitive oral agent for beta thal" and the probability of success in sickle cell disease, which could result in a value five times greater than beta thal, has now increased as well, Van Buren tells investors. He reiterated his Overweight rating on Agios shares following the company's ASH meeting presentation.
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."