Mitapivat (PYRUKYND® and AQVESME®) delivered worldwide net revenues of $55.4 million in third quarter of 2026, more than four times the $12.9 million reported in third quarter of 2025 Strong U.S. demand for AQVESME in thalassemia continues, with 619 cumulative prescriptions with completed start forms from REMS-certified physicians, plus 48 additional prescriptions with start forms in process as...
FDA recently requested additional information to evaluate whether a REMS is necessary for mitapivat in sickle cell disease FDA classified Agios' response to the information request as a major amendment to the mitapivat sNDA, resulting in a three-month review extension Mitapivat sNDA was submitted under the FDA's accelerated approval pathway and granted Priority Review, with an original PDUFA go...
Mitapivat (PYRUKYND® and AQVESME™) delivered worldwide net revenues of $44.7 million in the second quarter of 2026, compared to $12.5 million in the second quarter of 2025 Strong U.S. commercial launch of AQVESME in thalassemia, with 442 cumulative prescriptions written as of June 30, 2026 sNDA for mitapivat granted FDA Priority Review in sickle cell disease with PDUFA goal date of November 1, ...
Agios Pharmaceuticals said on Tuesday it will stop development of its sickle cell disease treatment, sending its shares down 14% in premarket trading.
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