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.
Hemoglobin response rates for tebapivat, a PK activator, were consistent with the class of medicine, but Phase 2 results did not establish a differentiated profile to support continued development in sickle cell disease Safety and tolerability of tebapivat were consistent with prior sickle cell disease trials sNDA for mitapivat, company's foundational PK activator, is under FDA Priority Review ...
FDA's PDUFA goal date is November 1, 2026 If approved, mitapivat is positioned to become the first oral PK activator for patients with sickle cell disease CAMBRIDGE, Mass., July 07, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases, today announced that the ...
Mitapivat demonstrated statistically significant improvement in hemoglobin response compared with placebo, with rapid onset and durable effects New analyses showed patients in mitapivat arm had clinically meaningful reduction in transfusion burden compared with placebo Patients in mitapivat arm who achieved hemoglobin response had clinically meaningful benefits across measures of sickle cell pa...
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