Agios Pharmaceuticals’ mitapivat shows significant promise in Phase 3 ENERGIZE study

Agios Pharmaceuticals’ mitapivat shows significant promise in Phase 3 ENERGIZE study

Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a pioneer in cellular metabolism and pyruvate kinase (PK) activation therapies, unveiled detailed results from the Phase 3 ENERGIZE study of mitapivat for non-transfusion-dependent (NTD) alpha- or beta-thalassemia. The findings, presented at the European Hematology Association 2024 (EHA2024) Hybrid Congress in Madrid, Spain, demonstrated significant improvements in hemoglobin levels and […]

Agios Pharmaceuticals’ mitapivat meets primary endpoint in Phase 3 thalassemia trial

Agios Pharmaceuticals’ mitapivat meets primary endpoint in Phase 3 thalassemia trial

Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), renowned for its innovative therapies in cellular metabolism and pyruvate kinase (PK) activation, has announced promising results from its global Phase 3 ENERGIZE-T study. The study focused on mitapivat, a novel treatment for adults with transfusion-dependent alpha- or beta-thalassemia, achieving its primary endpoint of significant transfusion reduction, along with all […]

Agios Pharmaceuticals gets PYRUKYND FDA approval for hemolytic anemia

Agios Pharmaceuticals gets PYRUKYND FDA approval for hemolytic anemia

Agios Pharmaceuticals has secured approval for PYRUKYND (mitapivat) from the US Food and Drug Administration (FDA) for the treatment of hemolytic anemia in adult patients having pyruvate kinase (PK) deficiency. PYRUKYND is an oral pyruvate kinase activator, which is now the first approved disease-modifying therapy for the rare, debilitating, lifelong hemolytic anemia. The FDA approval […]

FDA approves Agios Pharmaceuticals’ Tibsovo for targeted acute myeloid leukemia treatment

FDA approves Agios Pharmaceuticals’ Tibsovo for targeted acute myeloid leukemia treatment

The US Food and Drug Administration (FDA) has granted approval to Agios Pharmaceuticals for Tibsovo (ivosidenib), designed for the treatment of acute myeloid leukemia (AML) in patients exhibiting specific genetic mutations and whose condition is either relapsed or refractory. This marks a significant advancement in the targeted therapy landscape for AML. Tibsovo, an isocitrate dehydrogenase-1 […]

FDA approves Agios Pharmaceuticals’ TIBSOVO for acute myeloid leukemia

FDA approves Agios Pharmaceuticals’ TIBSOVO for acute myeloid leukemia

The US Food and Drug Administration (FDA) has granted approval to Agios Pharmaceuticals’ TIBSOVO (ivosidenib) for the treatment of adult patients with acute myeloid leukemia (AML) who have relapsed or refractory conditions and are confirmed to have an isocitrate dehydrogenase-1 (IDH1) mutation. This approval marks a significant advancement in targeted cancer therapy, offering new hope […]