Agios plunges after FDA delays expanded approval of blood disorder drug

Shares of drugmaker Agios Pharmaceuticals AGIO.O fall 13.2% to $35.25

AGIO says the FDA pushed 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

Including session's move, AGIO stock up 6.5% YTD