Agios Pharmaceuticals Shares Fall on FDA Review Extension
By Natalie Weger
Shares of Agios Pharmaceuticals were lower after the company said the Food and Drug Administration has extended the goal review date for its drug to treat sickle cell disease.
Shares of Agios Pharmaceuticals dropped 19% to $30.26 Friday. The stock is up 12% year to date.
The goal date for the oral drug, called mitapivat, has now been extended to Feb. 1, three months after the original goal date. Agios Pharmaceuticals said it will continue labeling discussions with the FDA amid the ongoing review.
The FDA in early October requested additional information to evaluate whether a risk evaluation and mitigation strategy is necessary for the drug. After Agio submitted a response, including about nine months of updated safety data from other trials, the FDA issued its three-month review extension.
Agios Pharmaceuticals said there continues to be no cases of hepatocellular injury among patients with sickle cell disease that show a severity similar to a different clinical trial. The benefit-risk profile of mitapivat in sickle cell disease remains unchanged, Agios Pharmaceuticals said.
Write to Natalie Weger at natalie.weger@wsj.com.
(END) Dow Jones Newswires
October 30, 2026 11:20 ET (15:20 GMT)
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