Agios rise after European drug regulator panel issues positive opinion for blood disorder drug

Agios Pharmaceuticals

17/10/2025 16:22

** Shares of drugmaker Agios Pharmaceuticals AGIO.O up 2.6% at $42.57

** Company says that European Medicines Agency’s (EMA) Committee issues positive opinion for Pyrukynd in adults with transfusion-dependent and non-dependent alpha- or beta-thalassemia

** Thalassemia is an inherited blood disorder that reduces healthy red blood cells

** European Commission decision expected early 2026, expanding Pyrukynd's reach beyond pyruvate kinase deficiency

** The positive opinion is based on late-stage study data in which Pyrukynd showed a positive impact on several hematologic markers across all genotypes and levels of transfusion burden

** H.C. Wainwright believes that this development is "significant as it de-risks Pyrukynd's European expansion"

** H.C.Wainwright adds "despite the PDUFA date being delayed 3 months following Agios' submission of a proposed risk evaluation and mitigation strategy to account for liver function monitoring, we remain confident that Pyrukynd will get approved"

** Including session moves, stock up 29% YTD

 (Reporting by Siddhi Mahatole)

 ((siddhi.mahatole@thomsonreuters.com))