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

Reuters12-08
BUZZ-Agios Pharma falls after FDA misses decision deadline on blood-disorder drug filing

** 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))

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