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 access to PYRUKYND for adult patients with thalassaemia AMSTERDAM --(BUSINESS WIRE)--May 22, 2026-- Avanzanite
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., Saudi Arabia, United Arab Emirates, and EU Avanzanite Bioscience B.V., a specialty pharmaceutical
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 transfusion burden in sickle cell disease CAMBRIDGE, Mass., May 12, 2026 (GLOBE NEWSWIRE) -- Agios
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 EHA 2026 on Saturday, June 13, at 9:00 a.m. ET ( 3:00 p.m.
Mitapivat (PYRUKYND ® and AQVESME™) generated worldwide net revenues of $20.7 million in the first quarter of 2026, compared to $8.7 million in the first quarter of 2025 Strong initial U.S. commercial launch of AQVESME in thalassemia, with 242 prescriptions written as of March 31, 2026 Company
CAMBRIDGE, Mass., April 06, 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 the company will host a conference call and live webcast on
Company has already submitted proposed confirmatory trial for FDA review, as required under accelerated approval pathway Company plans to submit mitapivat sNDA in sickle cell disease in the coming months, and is actively working with FDA to achieve alignment on confirmatory trial required for
PYRUKYND is the only medicine approved in the UAE for adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia NewBridge Pharmaceuticals, a regional specialty company, will continue to manage commercialization of PYRUKYND in the Gulf region CAMBRIDGE, Mass., March
PYRUKYND ® (mitapivat) worldwide net revenues of $20.0 million in fourth quarter and $54.0 million for full year AQVESME™ (mitapivat) for thalassemia now available in U.S. following FDA approval Company will have pre-sNDA meeting with FDA for mitapivat in sickle cell disease in first quarter of
CAMBRIDGE, Mass., Jan. 26, 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 the company will host a conference call and live webcast on
AQVESME™ (mitapivat) U.S. commercial launch in thalassemia underway following December 2025 FDA approval Pre-sNDA meeting with FDA for mitapivat in sickle cell disease anticipated in first quarter of 2026, with planned U.S. regulatory submission to follow Company progressing early- and mid-stage
CAMBRIDGE, Mass. , Jan. 05, 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 its management team is scheduled to present at the 44 th
AQVESME is the only FDA-approved medicine for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia Marketed under AQVESME brand name in the U.S. for thalassemia indication; PYRUKYND® (mitapivat) remains the U.S.
CAMBRIDGE, Mass. , Dec. 08, 2025 (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 U.S. Food and Drug Administration (FDA) has not yet