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