BUZZ-Agios Pharma falls after FDA misses decision deadline on blood-disorder drug filing

Reuters
2025.12.08 12:20
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Agios Pharmaceuticals' shares fell 7.5% premarket after the FDA missed the decision deadline on expanding the use of its drug mitapivat for thalassemia. The drug, already approved for another blood disorder, aims to enhance enzyme activity in red blood cells. The FDA has not provided a new timeline, and Agios is collaborating with the agency to conclude the review. AGIO stock is down 15.6% year-to-date.