Agios Pharmaceuticals: FDA Breakthrough Therapy Designation for Tibsovo in Myelodysplastic Syndrome
Agios Pharmaceuticals’ cancer drug Tibsovo is granted FDA breakthrough therapy designation for the treatment of relapsed or refractory myelodysplastic syndrome with an IDH1 mutation. Agios’ share price is further recovering after its down end of October. Since beginning of November, it gained more than 56% to USD 47.14 today.
The breakthrough designation was granted for Agios isocitrate dehydrogenase 1 (IDH1) inhibitor Tibsovo for the treatment of patients with myelodysplastic syndrome (MDS) IDH1 mutation. MDS is a disorder of the bone marrow characterized by uncontrolled bleeding and serious infections and can results in the development of acute myelogenous leukemia (AML).
The Breakthrough Therapy designation is based on the clinical outcomes of 12 patients in a Phase 1 study evaluating the efficacy and safety of Tibsovo in MDS.
The full press release of Agios Pharmaceuticals can be found here.