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...
CAMBRIDGE, Mass., June 29, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with...
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...
Agios obtains exclusive global rights to novel, late-stage, next-generation, oral SYK inhibitor Agreement diversifies Agios’ rare hematology portfolio with expansion into immune thrombocytopenia,...
Results did not meet predefined threshold to support further development in LR-MDS Tebapivat was well tolerated, with no new safety signals observed CAMBRIDGE, Mass., May 29, 2026 (GLOBE NEWSWIRE)...
Avanzanite will commercialise and distribute PYRUKYND in Europe under its exclusive agreement with Agios Avanzanite is committed to collaborating with local authorities in the EU to enable...
PYRUKYND is the only medicine approved in the EU for adults with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemia Mitapivat is now approved for thalassemia in the U.S.,...
Agios Pharmaceuticals (NASDAQ:AGIO) executives said the company is focused on advancing mitapivat across rare hematologic diseases, highlighting early launch traction in thalassemia and a recently submitted...
sNDA submission follows agreement with FDA on confirmatory trial, a requirement of the accelerated approval pathway Confirmatory trial designed to demonstrate clinical benefit of mitapivat on reducing...
Detailed results from RISE UP Phase 3 trial of mitapivat in sickle cell disease selected for distinguished Plenary Abstracts Session Company to host investor conference call and webcast during...