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Fly News Breaks for December 9, 2019
AGIO
Dec 9, 2019 | 07:01 EDT
BMO Capital analyst George Farmer raised his price target on Agios Pharmaceuticals to $49 and kept his Outperform rating after its mitapivat Phase 2 trial data in patients with non-transfusion-dependent thalassemia. The analyst notes that while not addressing the root cause of thalassemia, the trial findings may have "significant implications" for the ultimate mitapivat potential beyond pyruvate kinase deficiency. Farmer added that further upcoming data should demonstrate increased PK activity in unhealthy red blood cells purified from patients representing a wide disease spectrum.
News For AGIO From the Last 2 Days
AGIO
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."