Exhibit 99.1 Agios Reports Fourth Quarter and Full Year 2024 Financial Results and Recent Business Highlights – Filed for Regulatory Approval of Mitapivat (PYRUKYND ) for the Treatment of Adult Patients with Non-Transfusion-Dependent and Transfusion-Dependent Alpha- or Beta-Thalassemia in U.S., European Union, Kingdom of Saudi Arabia and United Arab Emirates; PDUFA Goal Date of September 7, 2025 – ® – Completed Enrollment for Phase 3 RISE UP Study of Mitapivat in Sickle Cell Disease; Topline Results Expecte ...

– Filed for Regulatory Approval of Mitapivat (PYRUKYND®) for the Treatment of Adult Patients with Non-Transfusion-Dependent and Transfusion-Dependent Alpha- or Beta-Thalassemia in U.S., European Union, Kingdom of Saudi Arabia and United Arab Emirates; PDUFA Goal Date of September 7, 2025 – – Completed Enrollment for Phase 3 RISE UP Study of Mitapivat in Sickle Cell Disease; Topline Results Expected in Late 2025, with Potential U.S. Commercial Launch in 2026 – – Early- and Mid-Stage Pipeline Offers Strong Fo ...

– ACTIVATE-Kids is the First Study to Demonstrate Efficacy of an Oral Therapy for Children with PK Deficiency Who Are Not Regularly Transfused – – Safety Results Consistent with Safety Profile for Mitapivat Previously Observed in Adults with PK Deficiency Who Are Not Regularly Transfused – – First Mitapivat Pediatric Clinical Program for a Rare Hemolytic Anemia; Double-blind Period Completed for Both PK Deficiency Trials ACTIVATE-Kids and ACTIVATE-KidsT – CAMBRIDGE, Mass., Feb. 13, 2025 (GLOBE NEWSWIRE) -- ...

– ACTIVATE-Kids is the First Study to Demonstrate Efficacy of an Oral Therapy for Children with PK Deficiency Who Are Not Regularly Transfused – – Safety Results Consistent with Safety Profile for Mitapivat Previously Observed in Adults with PK Deficiency Who Are Not Regularly Transfused – – First Mitapivat Pediatric Clinical Program for a Rare Hemolytic Anemia; Double-blind Period Completed for Both PK Deficiency Trials ACTIVATE-Kids and ACTIVATE-KidsT – CAMBRIDGE, Mass., Feb. 13, 2025 (GLOBE NEWSWIRE) -- ...

CAMBRIDGE, Mass., Feb. 06, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced the company will host a conference call and live webcast on Thursday, February 13, 2025, at 8:00 a.m. ET to report its fourth quarter and full year 2024 financial results and business highlights. The live webcast will be accessible on the Investors section of the company’s website (www.agios ...

– FDA Accepted Agios’ Supplemental New Drug Application for PYRUKYND® (mitapivat) in Adult Patients with Non-Transfusion-Dependent and Transfusion-Dependent Alpha- or Beta-Thalassemia; PDUFA Goal Date is September 7, 2025 – – Topline Results from Phase 3 RISE UP Study of Mitapivat in Sickle Cell Disease to be Announced in Late 2025, with Potential U.S. Commercial Launch in 2026 – – Strong Financial Position Provides Opportunity to Maximize Potential PYRUKYND Commercial Launches, Advance Early- and Mid-Stage ...

Agios Pharmaceuticals (AGIO) announced that the FDA has accepted its supplemental new drug application (sNDA) seeking label expansion for its sole marketed drug, Pyrukynd, in thalassemia indication.A final decision is expected by Sep. 7, 2025. If approved, Pyrukynd will become the first oral therapy for use in all thalassemia subtypes. A commercial launch in this indication is expected before this year’s end.The sNDA is supported by data from two phase III studies, ENERGIZE and ENERGIZE-T, which evaluated P ...

CAMBRIDGE, Mass., Jan. 08, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) accepted the company’s supplemental New Drug Application (sNDA) for PYRUKYND® (mitapivat) for the treatment of adult patients with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. The review classification for th ...

CAMBRIDGE, Mass., Jan. 03, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that its management team is scheduled to present at the 43rd Annual J.P. Morgan Healthcare Conference on Wednesday, January 15, 2025, at 7:30 a.m. PT / 10:30 a.m. ET. The live webcast will be accessible on the Investors section of the company's website (www.agios.com) under the “Events & Presentations” tab. A ...

CAMBRIDGE, Mass., Dec. 18, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and pyruvate kinase (PK) activation pioneering therapies for rare diseases, today announced that the European Commission has adopted a positive decision for the designation of mitapivat, an oral, small molecule PK activator, as an orphan medicinal product (OMP) for the treatment of sickle cell disease. Earlier, in November 2020, the U.S. Food and Drug Administration (FDA) also gran ...