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

Agios Pharmaceuticals

08/12/2025 12:20

** Shares of drugmaker Agios Pharma AGIO.O fall 7.5% to $25.6 premarket

** Agios Pharmaceuticals says U.S. regulators have not yet made a decision on expanding the use of its rare blood disease drug mitapivat to patients with thalassemia, even though a target review date passed last week

** The drug mitapivat, sold under the brand name Pyrukynd for another rare blood disorder, is designed to boost the activity of a key enzyme in red blood cells

** Thalassemia is an inherited blood disease that leads to reduced hemoglobin and can cause severe anemia, bone problems and organ damage

** The FDA has not given Agios a new timeline for a final decision

** The company says it is working with the agency to wrap up the review

** AGIO stock was down 15.6% YTD

 (Reporting by Padmanabhan Ananthan)

 ((Padmanabhan.Ananthan@thomsonreuters.com))