** 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