Agios plunges after FDA delays expanded approval of blood disorder drug

Agios Pharmaceuticals

04/09/2025 13:27

** Shares of drugmaker Agios Pharmaceuticals AGIO.O fall 21.2% to $32 premarket

** AGIO says the FDA pushes back decision on expanded approval of Pyrukynd to Dec. 7

** Delay follows Agios submitting a proposed safety program (REMS) to address potential liver injury risk; no new efficacy or safety data was requested, the company says

** Agios seeks to broaden Pyrukynd's use to adults with alpha- or beta‑thalassemia, including those who do and don't need regular transfusions

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

** Pyrukynd is already FDA‑approved for hemolytic anemia in adults with PK deficiency

** As of last close, AGIO stock up 23.6% YTD

 (Reporting by Padmanabhan Ananthan)

 ((Padmanabhan.Ananthan@thomsonreuters.com))