Agios Pharmaceuticals Receives US FDA Priority Review for Mitapivat to Treat Sickle Cell Disease

Shots: The US FDA has accepted the sNDA & granted priority review to mitapivat, under FDA’s accelerated approval pathway, for the treatment of Sickle Cell Disease (PDUFA: Nov 1, 2026) sNDA was supported by the global P-II/III (RISE UP) trial assessing mitapivat (100mg, PO, BID; n=138) vs PBO (n=69) in 207 pts with SCD (≥16yrs.)…

ByRidhi RastogiJuly 7, 2026

Agios Pharmaceuticals Licenses Cevidoplenib from Oscotec in a ~$165M Deal

Shots: Oscotec has granted Agios exclusive global rights to cevidoplenib (PO), a spleen tyrosine kinase inhibitor, across all indications, incl. immune thrombocytopenia (ITP) As per the deal, Agios will assume full development & commercialization costs, while Oscotec will receive $25M upfront, ~$140M in development & regulatory milestones across ~3 indications in the US & EU,…

ByRidhi RastogiJune 1, 2026

Agios Reports the US FDA Approval of Aqvesme for Anemia in Alpha or Beta Thalassemia

Shots: The US FDA has approved Agios’ Aqvesme (mitapivat) for the treatment of anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia Approval was based on the global P-III (ENERGIZE) and (ENERGIZE-T) studies (n=452), which met all 1EPs and 2EPs, demonstrating significant improvements in hemoglobin, fatigue, and reductions in transfusion burden vs PBO Aqvesme…

ByPrince GiriDecember 25, 2025

Agios Pharmaceuticals Receives US FDA Priority Review for Mitapivat to Treat Sickle Cell Disease

Agios Pharmaceuticals Licenses Cevidoplenib from Oscotec in a ~$165M Deal

Agios Reports the US FDA Approval of Aqvesme for Anemia in Alpha or Beta Thalassemia

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