Agios Pharmaceuticals Shares Rise After FDA Grants Priority Review for Sickle Cell Disease Treatment

By Anvee Bhutani

Agios Pharmaceuticals shares rose Tuesday after the U.S. Food and Drug Administration granted priority review to the company's supplemental new drug application for mitapivat to treat sickle cell disease.

Shares of the biopharmaceutical company were recently up 13% at $42.29.

The FDA set a Prescription Drug User Fee Act, or PDUFA, goal date of Nov. 1 for the application, which was submitted under the accelerated approval pathway.

If approved, mitapivat would become the first oral pyruvate kinase activator for patients with sickle cell disease, Agios said.

The application is supported by data from the company's Phase 2 and Phase 3 RISE UP trials in patients aged 16 years and older with sickle cell disease. Mitapivat is already approved in the U.S. for pyruvate kinase deficiency and thalassemia.

The FDA's priority review designation shortens the target review timeline to six months from the standard 10 months for medicines that may provide significant improvements in treating serious conditions.

Write to Anvee Bhutani at anvee.bhutani@wsj.com