PDUFA goal date extended by three months from September 7, 2025, to December 7, 2025 CAMBRIDGE, Mass., Sept. 04, 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 extended the Prescription Drug User Fee Act (PDUFA)... Read More

First regulatory approval for PYRUKYND in thalassemia, evaluated under SFDA’s Breakthrough Medicines Program Agios partnered with NewBridge Pharmaceuticals, a regional specialty company focused on the Middle East and North Africa, in 2024 to manage PYRUKYND commercialization in the Gulf Region CAMBRIDGE, Mass., Aug. 04, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a commercial-stage biopharmaceutical... Read More

$12.5 million in second quarter PYRUKYND ® (mitapivat) net revenues; ended second quarter with $1.3 billion dollars in cash, cash equivalents and marketable securities PYRUKYND sNDA for thalassemia under active review, with FDA PDUFA goal date of September 7, 2025 Topline results from RISE UP Phase 3 trial of mitapivat in sickle cell disease on track by year-end with potential U.S. commercial launch in 2026 Dosed first... Read More

CAMBRIDGE, Mass., July 14, 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, July 31, 2025, at 8:00 a.m. ET to report its second quarter 2025 financial results and business highlights. The live webcast will be... Read More

CAMBRIDGE, Mass., July 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 the appointment of Jay Backstrom, M.D., M.P.H., to its Board of Directors, effective immediately. Dr. Backstrom is an accomplished healthcare executive with a proven track record of advancing clinical... Read More

CAMBRIDGE, Mass., May 28, 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 its management team is scheduled to present at the Goldman Sachs 46 th Annual Global Healthcare Conference on Monday, June 9, 2025, at 8:40 a.m. ET. The live webcast will be accessible on the Investors... Read More

CAMBRIDGE, Mass., May 14, 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 new data on the company’s PK activators, mitapivat and tebapivat, will be featured in oral and poster presentations during the 30 th European Hematology Association (EHA) Congress (EHA 2025) in Milan,... Read More

CAMBRIDGE, Mass., May 09, 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 2025 RBC Capital Markets Global Healthcare Conference on Wednesday, May 21, 2025, at 8:00 am ET. The live webcast will be accessible on the Investors section of the... Read More

CAMBRIDGE, Mass., May 02, 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 BofA Securities 2025 Health Care Conference on Wednesday, May 14, 2025, at 8:00 am PT/11:00 am ET. The live webcast will be accessible on the Investors section of the... Read More

U.S. Regulatory Filing Under Active Review for Approval of PYRUKYND ® (mitapivat) in Thalassemia, with PDUFA Goal Date of September 7, 2025 Phase 3 RISE UP Study of Mitapivat in Sickle Cell Disease On Track, with Topline Results Expected in Late 2025; Potential U.S. Commercial Launch in 2026 Tebapivat Advancing in Clinical Trials for Lower-Risk Myelodysplastic Syndromes (LR-MDS) and Sickle Cell Disease PYRUKYND Net Revenue... Read More

CAMBRIDGE, Mass., April 17, 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, May 1, 2025, at 8:00 a.m. ET to report its first quarter 2025 financial results and business highlights. The live webcast will be... Read More

CAMBRIDGE, Mass., March 05, 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 grant of inducement equity awards outside of the Company’s 2023 Stock Incentive Plan to its newly appointed Chief Corporate Development & Strategy Officer, Krishnan Viswanadhan. The grants were approved... Read More

CAMBRIDGE, Mass., March 04, 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 following conferences: Leerink Global Healthcare Conference 2025: Fireside chat on Tuesday, March 11, 2025, at 10:50 a.m. ET Barclays 27 th Annual Global Healthcare... Read More

CAMBRIDGE, Mass., Feb. 20, 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 TD Cowen 45 th Annual Healthcare Conference on Monday, March 3, 2025, at 10:30 a.m. ET. The live webcast will be accessible on the Investors section of the company's... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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... Read More

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 43 rd 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... Read More

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... Read More

ENERGIZE-T Study Achieved Primary and All Key Secondary Endpoints in Adult Patients with Transfusion-Dependent Alpha- or Beta-Thalassemia ENERGIZE-T is First Phase 3 Study to Demonstrate Efficacy of an Oral, Disease-Modifying Treatment for Transfusion-Dependent Alpha- and Beta-Thalassemia Company Filed for Regulatory Approval of Mitapivat (PYRUKYND ® ) for the Treatment of Adult Patients with Non-Transfusion-Dependent and... Read More

Results from Phase 3 ENERGIZE-T Study of Mitapivat in Transfusion-dependent Thalassemia will be Presented in Oral Session Tebapivat Phase 1 Data in Sickle Cell Disease and Phase 2b Trial-in-progress Update in Lower-risk Myelodysplastic Syndromes will be Presented and Published Live and Webcast Investor Event with Agios Leadership and Medical Experts will be Hosted Onsite on Monday, December 9 CAMBRIDGE, Mass., Nov. 05, 2024... Read More

Completed Enrollment of the Phase 3 RISE UP Study of Mitapivat in Sickle Cell Disease; Topline Data from 52-Week Study Expected in Late 2025 Received $1.1 Billion in Payments from Royalty Pharma and Servier, Following FDA Approval of Vorasidenib Commenced Enrollment of the Phase 2b Study of Tebapivat in Lower-Risk Myelodysplastic Syndromes (LR-MDS); Granted FDA Orphan Drug Designation for Treatment of MDS PYRUKYND®... Read More

Topline Data from 52-week Phase 3 Study Expected in Late 2025 CAMBRIDGE, Mass., Oct. 23, 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 enrollment is complete for the Phase 3 RISE UP study. This global, double-blind, randomized, placebo-controlled trial is evaluating the... Read More

CAMBRIDGE, Mass., Oct. 17, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced the company will host a conference call and live webcast on Thursday, October 31, 2024, at 8:00 a.m. ET to report its third quarter 2024 financial results and business highlights. A live webcast of the presentation can be... Read More

CAMBRIDGE, Mass., Sept. 11, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to the company’s novel pyruvate kinase (PK) activator tebapivat (AG-946) for the treatment of myelodysplastic syndromes (MDS). “Receiving... Read More

CAMBRIDGE, Mass., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that the company is scheduled to present at the 2024 Cantor Global Healthcare Conference on Wednesday, September 18, 2024, at 10:20 a.m. ET. A live webcast of the presentation can be accessed under "Events & Presentations" in... Read More

Agios Expects to Receive $905 Million Payment from Royalty Pharma and $200 Million Payment from Servier in Q3 2024; Payments Increase Agios’ Pro-Forma Cash Position as of June 30, 2024, to $1.7 Billion Strong Cash Position to Enable Agios to Prepare for Potential PYRUKYND® (Mitapivat) Launches in Thalassemia in 2025 and Sickle Cell Disease in 2026 and Drive Pipeline Progress CAMBRIDGE, Mass., Aug. 06, 2024 (GLOBE NEWSWIRE)... Read More

Reported Positive Topline Data from Phase 3 ENERGIZE-T Study; Expect to File sNDA Based on ENERGIZE and ENERGIZE-T Studies Encompassing All Thalassemia Subtypes by End of 2024 Announced $905 Million Purchase Agreement for Vorasidenib Royalty with Royalty Pharma; Agios to Receive a Total of $1.1 Billion in Payments Upon FDA Approval of Vorasidenib Reported Results from Phase 3 ACTIVATE-KidsT Study of Mitapivat in Children... Read More

ACTIVATE-KidsT is Agios’ First Pediatric Data Readout; Safety Results Consistent with Safety Profile for Mitapivat Previously Observed in Adults with PK Deficiency Who are Regularly Transfused Prespecified Statistical Criterion for the Primary Endpoint in ACTIVATE-KidsT Was Not Met; Results Were Clinically Meaningful, with Observed Response Rates Higher for Mitapivat than Placebo for the Primary Endpoint of Transfusion... Read More

CAMBRIDGE, Mass., July 18, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced the company will host a conference call and live webcast on Thursday, August 1, 2024, at 8:00 a.m. ET to report its second quarter 2024 financial results and other business highlights. A live webcast of the presentation can be... Read More

ENERGIZE is the First Study to Demonstrate Efficacy of an Oral Treatment for Non-Transfusion-Dependent Alpha- and Beta-Thalassemia Additional ENERGIZE Poster Presentation Highlights Improvements in Fatigue and Exercise Capacity in Patients Treated with Mitapivat Compared to Placebo Agios to Webcast Virtual Investor Event on June 16, 2024 at 10 a.m. Eastern Time or 4 p.m. Central European Summer Time CAMBRIDGE, Mass., June... Read More

CAMBRIDGE, Mass., June 06, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that the time of the company’s presentation at the Goldman Sachs 45th Annual Global Healthcare Conference has been updated to Monday, June 10, 2024 at 8:40 a.m. ET. A live webcast of the presentation can be accessed under... Read More

Study Achieved the Primary Endpoint; Mitapivat Demonstrated a Statistically Significant Transfusion Reduction Response Compared to Placebo Statistical Significance Achieved for All Key Secondary Endpoints Evaluating Additional Measures of Reduction of Transfusion Burden Compared to Placebo ENERGIZE-T is the First Phase 3 Study to Demonstrate Efficacy of an Oral, Disease-Modifying Treatment for Transfusion-Dependent Alpha-... Read More

CAMBRIDGE, Mass., May 30, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that the company is scheduled to present at the Goldman Sachs 45th Annual Global Healthcare Conference on Monday, June 10, 2024, at 1:20 p.m. ET. A live webcast of the presentation can be accessed under "Events & Presentations"... Read More

Royalty Pharma to Acquire Rights to Agios’ 15% Royalty on Potential Vorasidenib U.S. Net Sales for $905 Million Upfront upon FDA Approval of Vorasidenib; Agios to Share in Economics Above Certain Revenue Thresholds Agios Retains Rights to $200 Million Milestone Payment from Servier upon FDA Approval of Vorasidenib In Total, Agios to Receive $1.1 Billion in Payments upon FDA Approval of Vorasidenib; PDUFA Action Date of... Read More

Data from Phase 3 ENERGIZE Study of Mitapivat in Non-Transfusion-Dependent Thalassemia to be Presented in Plenary Session Additional Presentations to Highlight Quality of Life Data from ENERGIZE and Design of the Phase 3 RISE UP Study of Mitapivat in Sickle Cell Disease Agios to Webcast Virtual Investor Event on June 16, 2024, at 10 a.m. Eastern Time or 4 p.m. Central European Summer Time CAMBRIDGE, Mass., May 14, 2024... Read More

CAMBRIDGE, Mass., May 06, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that the company is scheduled to present at the BofA Securities 2024 Health Care Conference on Thursday, May 16, 2024, at 11:40 a.m. ET. A live webcast of the presentation can be accessed under "Events & Presentations" in the... Read More

CAMBRIDGE, Mass., May 03, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that the company is scheduled to present at the 2024 RBC Capital Markets Global Healthcare Conference on Tuesday, May 14, 2024, at 8:00 a.m. ET. A live webcast of the presentation can be accessed under "Events & Presentations"... Read More

Topline Data Readout from the Phase 3 ENERGIZE-T Study of Mitapivat in Adults with Transfusion-Dependent Alpha- or Beta-Thalassemia now expected in Q2 2024 Announced Positive Results from the Phase 3 ENERGIZE Study of Mitapivat in Adults with Non-Transfusion-Dependent Alpha- or Beta-Thalassemia in January Phase 3 Readouts from Mitapivat RISE UP Study in Sickle Cell Disease, ACTIVATE-KIDS and ACTIVATE KIDS-T in Pediatric PK... Read More

CAMBRIDGE, Mass., April 18, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced the company will host a conference call and live webcast on Thursday, May 2, 2024, at 8:00 a.m. ET to report its first quarter 2024 financial results and other business highlights. A live webcast of the presentation can be... Read More

Report Highlights Company’s Focus on Red Blood Cell Health; Diversity, Equity & Inclusion; and Strong Corporate Governance Aligns with the Sustainability Accounting Standards Board (SASB) Standards for the Biotechnology and Pharmaceuticals Industry and the United Nations Sustainable Development Goals (UN SDGs) CAMBRIDGE, Mass., April 09, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in... Read More

CAMBRIDGE, Mass., March 05, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, today announced that the company is scheduled to present at the Leerink Partners Global Biopharma Conference on Tuesday, March 12, 2024, at 10:00 a.m. ET. A live webcast of the presentation can be accessed under "Events & Presentations" in... Read More

CAMBRIDGE, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that the company is scheduled to present at the TD Cowen 44 th Annual Health Care Conference on Monday, March 4, 2024, at 2:10 p.m. ET. A live webcast of the presentation can be accessed under "Events & Presentations" in the... Read More

Announced Positive Results from the Phase 3 ENERGIZE Study of Mitapivat in Adults with Non-Transfusion-Dependent Alpha- or Beta-Thalassemia Presented Positive Results from Phase 2 Portion of the RISE UP Pivotal Study in Sickle Cell Disease at 65th ASH Annual Meeting and Exposition Two Additional Phase 3 Readouts of Mitapivat Expected in 2024, with a Total of Four Phase 3 Readouts by the End of 2025 U.S. PYRUKYND ®... Read More

CAMBRIDGE, Mass., Feb. 02, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced the company will host a conference call and live webcast on Thursday, February 15, 2024, at 8:00 a.m. ET to report its fourth quarter and year end 2023 financial results and other business highlights. A live webcast of the... Read More

Industry-leading PK Activator Franchise Has Demonstrated Clinical Efficacy in Four Hematological Diseases, Including New Positive Phase 3 Data in Non-Transfusion-Dependent Thalassemia Company Expects Four Additional Phase 3 Readouts by the End of 2025, with Potential FDA Approvals in Thalassemia in 2025 and Sickle Cell Disease in 2026 Strong Cash Position Expected to Support Completion of Ongoing Programs and Disciplined... Read More

Mitapivat Demonstrated a Statistically Significant Increase in Hemoglobin Response Rate Compared to Placebo Statistical Significance Also Achieved for Key Secondary Endpoints of Change From Baseline in Both FACIT-Fatigue Score and Hemoglobin Concentration ENERGIZE is the First Phase 3 Study to Demonstrate Efficacy of an Oral Treatment for Non-Transfusion-Dependent Alpha- and Beta-Thalassemia Agios to Host Investor Webcast... Read More

CAMBRIDGE, Mass., Jan. 02, 2024 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that the company is scheduled to present at the 42 nd Annual J.P. Morgan Healthcare Conference on Wednesday, January 10, 2024, at 7:30 a.m. PT. A live webcast of the presentation can be accessed under "Events & Presentations" in... Read More

Treatment with Mitapivat Demonstrated Statistically Significant Improvement in Hemoglobin Response Compared to Placebo Improvements Observed in Annualized Rates of Sickle Cell Pain Crises, Markers of Hemolysis and Erythropoiesis in Participants Treated with Mitapivat Agios to Host Live and Webcast Investor Event on Dec. 11, 2023, at 7:00 a.m. Pacific Time CAMBRIDGE, Mass., Dec. 09, 2023 (GLOBE NEWSWIRE) -- Agios... Read More

40 Percent of Low Transfusion Burden Cohort Achieved Transfusion Independence One Study Patient Achieved Hemoglobin Response Endpoint Safety Profile Consistent with Data Reported in Healthy Volunteers Study Company Expects to Initiate Phase 2b Study in Mid-2024 CAMBRIDGE, Mass., Nov. 20, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for... Read More

Both Mitapivat Dose Arms Achieved Statistically Significant Hemoglobin Response in Phase 2 Portion of RISE UP Pivotal Study in Sickle Cell Disease, Compared to the Placebo Arm; Data Support Advancement to Phase 3 Portion of RISE UP Agios to Highlight Additional Data on the Burden of Disease in Pyruvate Kinase (PK) Deficiency and Alpha- and Beta-Thalassemia New Preclinical Data for Novel PK Activator AG-946 Suggest... Read More

First Patient Dosed in Phase 3 Portion of the RISE UP Pivotal Study of Mitapivat in Sickle Cell Disease Completed Enrollment in Phase 3 ACTIVATE-KidsT Pediatric Study of Mitapivat in PK Deficiency; ACTIVATE-Kids Study Achieves >50% Enrollment On Track for Data Readouts in Two Phase 3 Trials of Mitapivat in Thalassemia Next Year and Topline Data for AG-946 in LR-MDS by Year-end 2023 U.S. PYRUKYND ® (mitapivat) Net Revenue of... Read More

CAMBRIDGE, Mass., Oct. 19, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced the company will host a conference call and live webcast on Thursday, Nov. 2, 2023, at 8:00 a.m. ET to report its third quarter 2023 financial results and other business highlights. A live webcast of the presentation can be... Read More

CAMBRIDGE, Mass., Aug. 29, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that the company is scheduled to present at the Morgan Stanley 21 st Annual Global Healthcare Conference on Tuesday, September 12, 2023, at 7:30 a.m. EST. A live webcast of the presentation can be accessed under "Events &... Read More

Announced Positive Results from Phase 2 Portion of the RISE UP Pivotal Study of Mitapivat in Sickle Cell Disease; On Track to Enroll First Patient in Phase 3 Portion of the Study in Q4 2023 Completed Enrollment in Phase 3 ENERGIZE and ENERGIZE-T Studies of Mitapivat in Thalassemia and Phase 2a Study of AG-946 in Lower-Risk MDS Announced Exclusive Worldwide License Agreement with Alnylam Pharmaceuticals to License Alnylam’s... Read More

Preclinical siRNA Targeting TMPRSS6 is a Potential Disease-Modifying Treatment for Polycythemia Vera Agreement Combines Agios’ Scientific Expertise and Capabilities in Rare Hematologic Diseases with Alnylam’s Industry-Leading siRNA Platform Alnylam to Receive a $17.5 million Upfront Payment and is Eligible to Receive Potential Future Development and Commercial Milestone Payments and Royalties CAMBRIDGE, Mass., Aug. 03, 2023... Read More

CAMBRIDGE, Mass., July 13, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced the company will host a conference call and live webcast on Thursday, Aug. 3, 2023, at 8:00 a.m. ET to report its second quarter 2023 financial results and other business highlights. A live webcast of the presentation can be... Read More

Study’s Primary Efficacy Endpoint Achieved, with 46.2% of Patients in the 50 mg BID Mitapivat Arm and 50.0% of Patients in the 100 mg BID Mitapivat Arm Achieving a Hemoglobin Response, Compared to 3.7% of Patients in the Placebo Arm A Trend in Sickle Cell Pain Crisis Reduction was Observed in Both Mitapivat Dose Arms Compared to Placebo Company Expects to Enroll First Patient in Phase 3 Portion of Study in Q4 2023, Report... Read More

CAMBRIDGE, Mass., June 05, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that the company is scheduled to present at the Goldman Sachs 44 th Annual Global Healthcare Conference on Thursday, June 15, 2023, at 11:00 a.m. EDT. A live webcast of the presentation can be accessed under "Events &... Read More

John Maraganore Completes Tenure on Agios Board After Nearly a Dozen Years of Service Kaye Foster to Be Appointed Lead Independent Director CAMBRIDGE, Mass., May 25, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that Catherine Owen has been appointed to its board of directors, effective June 13, 2023.... Read More

Agios to Present New Analyses from ACTIVATE, ACTIVATE-T and Long-Term Extension Studies in Adults with PK Deficiency Reinforcing Clinical Benefit of PYRUKYND ® (mitapivat) on Hemoglobin, Hemolysis, Iron Overload and Patient-Reported Outcomes Agios to Present Updated Real-World Data on the Burden of Disease in Pyruvate Kinase (PK) Deficiency and Alpha- and Beta-Thalassemia Updated Clinical Data to Be Presented from... Read More

On Track for PYRUKYND ® (mitapivat) Data Readouts of the Phase 2 Portion of the RISE UP Study in Sickle Cell Disease in Mid-2023 and the Phase 3 ENERGIZE and ENERGIZE-T Studies in Thalassemia in 2024 U.S. PYRUKYND ® Net Revenue of $5.6 Million in Q1; $1.0 Billion of Cash, Cash Equivalents and Marketable Securities as of March 31, 2023 CAMBRIDGE, Mass., May 04, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq:... Read More

CAMBRIDGE, Mass., April 25, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that the company is scheduled to present at the RBC Capital Markets Global Healthcare Conference on Tuesday, May 16, 2024, at 9 a.m. ET. A live webcast of the presentation can be accessed under "Events & Presentations" in the... Read More

Board Member Paul Clancy Will Step Down at the End of His Term CAMBRIDGE, Mass., April 19, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that Jeffrey Capello has been appointed to its board of directors. Agios also announced that Paul Clancy will step down from the board of directors at the end of his... Read More

CAMBRIDGE, Mass., April 13, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced the company will host a conference call and live webcast on Thursday, May 4, 2023, at 8:00 a.m. ET to report its first quarter 2023 financial results and other business highlights. A live webcast can be accessed under “Events &... Read More

EMERYVILLE, Calif. , April 12, 2023 /PRNewswire/ -- Totus Medicines , the drug discovery and development company committed to ending the era of untreatable disease, announced today the appointment of Dr. Lewis Cantley , Dr. Hope Rugo , and Josep Tabernero to the company's Scientific Advisory Board (SAB). Totus has created the first biosearch technology that scans, maps, and decodes effective new drugs thousands of times... Read More

Report Highlights Continued Progress on Patient Access, Health Equity, Diversity and Flexibility Aligns with the Sustainability Accounting Standards Board (SASB) Standards for the Biotechnology and Pharmaceuticals Industry and the United Nations Sustainable Development Goals (UN SDGs) CAMBRIDGE, Mass., April 03, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism... Read More

CAMBRIDGE, Mass., March 02, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that the company is scheduled to present at the following March investor conferences: Cowen 43rd Annual Health Care Conference on Monday, March 6, 2023 at 1:30 p.m. ET; and Oppenheimer 33rd Annual Healthcare Conference on Monday,... Read More

CAMBRIDGE, Mass., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced the launch of a multi-stakeholder advocacy advisory council for hemolytic anemias including PK deficiency, thalassemia and sickle cell disease. The council will bring together patients, caregivers and physicians from these... Read More

Completed Enrollment in Phase 2 RISE UP Study of PYRUKYND ® (mitapivat) in Sickle Cell Disease On Track to Complete Enrollment in Phase 3 ENERGIZE and ENERGIZE-T Studies of PYRUKYND ® in Thalassemia by Mid-2023 U.S. PYRUKYND ® Launch Provides Capability Building Platform to Support Expected Future Product Growth and Expansion; Net Revenue of $4.3 Million in Q4 $1.1 Billion of Cash, Cash Equivalents and Marketable Securities... Read More

CAMBRIDGE, Mass., Feb. 02, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced the company will host a conference call and live webcast on Thursday, February 23, 2023, at 8:00 a.m. ET to report its fourth quarter and year end 2022 financial results and other business highlights. A live webcast can be accessed... Read More

Consistent and compelling clinical data across rare hematological diseases support five ongoing pivotal trials in thalassemia, sickle cell disease and pediatric pyruvate kinase (PK) deficiency Driving toward two additional PYRUKYND ® indications, with potential FDA approvals in thalassemia in 2025 and sickle cell disease in 2026 Strong cash position expected to enable completion of ongoing programs and pipeline expansion to... Read More

CAMBRIDGE, Mass., Jan. 03, 2023 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced the grant of inducement equity awards outside of the Company’s 2013 Stock Incentive Plan to its newly appointed Chief Commercial Officer, Tsveta Milanova. The grants were approved by the Board of Directors effective as of January... Read More

CAMBRIDGE, Mass., Dec. 21, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in the field of cellular metabolism pioneering therapies for rare diseases, today announced that the company is scheduled to present at the 41st Annual J.P. Morgan Healthcare Conference on Wednesday, January 11, 2023, at 7:30 a.m. PT. A live webcast of the presentation can be accessed under "Events & Presentations" in the... Read More

Data Suggest Long-term Treatment with PYRUKYND ® in Adults with PK Deficiency is Associated with Improvements in Hemoglobin, Iron Overload, Transfusion Burden and Patient-reported Outcomes, Regardless of Transfusion Status Additional Data Presented at ASH Characterize Disease Complications and Co-morbidities of PK Deficiency in Pediatric Populations, Supporting Ongoing Pivotal ACTIVATE-Kids and ACTIVATE-KidsT Studies of... Read More

Actively Enrolling Phase 3 ENERGIZE and ENERGIZE-T Studies Evaluating PYRUKYND ® in Adults with Non-transfusion-dependent and Transfusion-dependent α- or β-Thalassemia, Respectively Agios to Host Live and Webcast Investor Event on Dec. 12, 2022, at 7 a.m. CT CAMBRIDGE, Mass., Dec. 10, 2022 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ: AGIO), a leader in the field of cellular metabolism pioneering therapies for... Read More