$AGIO News
Last published 6d ago
- 6d agoAGIOAGIOS PHARMACEUTICALS, INC. - EX-99.1Earnings ReleasesForm 8-K - Current report - Item 2.02 Item 9.01
- 6d agoAGIOAgios Reports Third Quarter 2026 Financial Results and Provides Business UpdateGlobeNewswireMitapivat (PYRUKYND® and AQVESME®) delivered worldwide net revenues of $55.4 million in third quarter of 2026, more than four times the $12.9 million reported in third quarter of 2025Strong U.S. demand for AQVESME in
- 1w agoAGIOAgios to Highlight Strength and Differentiation of Rare Hematology Portfolio with New Clinical Data for Mitapivat in Sickle Cell Disease and AG-236 in Polycythemia Vera at ASH 2026GlobeNewswire14 abstracts accepted at ASH 2026, including three oral presentations featuring new data across mitapivat clinical programs New analyses from RISE UP Phase 3 trial of mitapivat in sickle cell disease show durable
- 1w agoAGIOAgios Announces New PDUFA Goal Date of February 1, 2027, for Mitapivat Sickle Cell Disease sNDA; Company Is Launch-Ready and in Labeling Discussions with FDAGlobeNewswireFDA recently requested additional information to evaluate whether a REMS is necessary for mitapivat in sickle cell diseaseFDA classified Agios’ response to the information request as a major amendment to the mitapivat
- 3w agoAGIOIRONKROSPTGX+1A Phase 3 Win and a 130% Takeover Premium Lit Up Rare Blood-Disease Stocks on MondayPR NewswireNEW YORK, Oct. 20, 2026 /CNW/ -- Market Updates News Commentary - Two unrelated announcements on Monday put one of biotech's smaller corners in the spotlight. A company developing a treatment for a rare
- 1mo agoAGIOApproval of Aqvesme, Nda #216196 (Manufacturing (CMC))FDA Approved DrugsApproval Date: 09/28/2026; Drug Name: Aqvesme, Nda #216196; Active Ingredients: MITAPIVAT SULFATE; Company: Agios Pharms Inc; Submission Status: Approval; Submission Classification: Manufacturing (CMC); Application Number: 216196
- 1mo agoAGIOApproval of Pyrukynd, Nda #216196 (Manufacturing (CMC))FDA Approved DrugsApproval Date: 09/28/2026; Drug Name: Pyrukynd, Nda #216196; Active Ingredients: MITAPIVAT SULFATE; Company: Agios Pharms Inc; Submission Status: Approval; Submission Classification: Manufacturing (CMC); Application Number: 216196
- 3mo agoAGIOAgios Reports Second Quarter 2026 Financial Results and Provides Business UpdateGlobeNewswireMitapivat (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 2025Strong U.S. commercial launch of AQVESME in
- 3mo agoAGIOAgios Provides Update on Phase 2 Trial of Tebapivat in Sickle Cell DiseaseGlobeNewswireHemoglobin 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
- 4mo agoAGIOU.S. FDA Grants Priority Review to Agios’ sNDA for Mitapivat in Sickle Cell DiseaseGlobeNewswireFDA’s PDUFA goal date is November 1, 2026If 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
- 4mo agoAGIOAgios to Host Second Quarter 2026 Financial Results Conference Call and Webcast on July 30 at 8:00 a.m. ETGlobeNewswireCAMBRIDGE, Mass., June 29, 2026 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases,
- 5mo agoAGIOAgios Showcases RISE UP Phase 3 Results at EHA 2026 Plenary Session Reinforcing Strong Anti-Hemolytic Profile of Mitapivat in Sickle Cell DiseaseGlobeNewswireMitapivat demonstrated statistically significant improvement in hemoglobin response compared with placebo, with rapid onset and durable effectsNew analyses showed patients in mitapivat arm had clinically meaningful
- 5mo agoAGIOAgios Enters Exclusive Global License Agreement with Oscotec to Develop and Commercialize Next-Generation SYK Inhibitor CevidoplenibGlobeNewswireAgios obtains exclusive global rights to novel, late-stage, next-generation, oral SYK inhibitor Agreement diversifies Agios' rare hematology portfolio with expansion into immune thrombocytopenia, unlocking up to $1
- 5mo agoAGIOAgios Provides Update on Phase 2b Trial of Tebapivat in Lower-Risk Myelodysplastic SyndromesGlobeNewswireResults did not meet predefined threshold to support further development in LR-MDSTebapivat was well tolerated, with no new safety signals observed CAMBRIDGE, Mass., May 29, 2026 (GLOBE NEWSWIRE) -- Agios
- 5mo agoAGIOAvanzanite Bioscience's Partner Agios Announces PYRUKYND® (mitapivat) Approval in the European Union for Adults with ThalassaemiaBusiness WireAvanzanite 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
- 5mo agoAGIOAgios' PYRUKYND® (mitapivat) Approved in the European Union for Adults with ThalassemiaGlobeNewswirePYRUKYND is the only medicine approved in the EU for adults with transfusion-dependent and non-transfusion-dependent alpha- or beta-thalassemiaMitapivat is now approved for thalassemia in the U.S., Saudi Arabia, United
- 6mo agoAGIOAgios Submits sNDA to FDA for U.S. Accelerated Approval of Mitapivat in Sickle Cell DiseaseGlobeNewswiresNDA 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
- 6mo agoAGIOAgios to Present New Data at EHA 2026 Reinforcing the Significant Therapeutic Impact of Mitapivat Across Multiple Rare Hemolytic AnemiasGlobeNewswireDetailed 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,
- 6mo agoAGIOAgios Reports First Quarter 2026 Financial Results and Provides Business UpdateGlobeNewswireMitapivat (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 2025Strong initial U.S. commercial launch of
- 7mo agoAGIOAgios to Host First Quarter 2026 Financial Results Conference Call and Webcast on April 29 at 8:00 a.m. ETGlobeNewswireCAMBRIDGE, 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,
- 7mo agoAGIOAgios Advances Mitapivat Toward Potential U.S. Accelerated Approval in Sickle Cell Disease Following Pre-sNDA Meeting with FDAGlobeNewswireCompany 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
- 8mo agoAGIOAgios' PYRUKYND® (mitapivat) Approved for Adults with Thalassemia in the United Arab EmiratesGlobeNewswirePYRUKYND 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
- 9mo agoAGIOQ4 and FY 2025 Agios Financial Results and Business Highlights - AGIOS PHARMACEUTICALS INCEarnings Call TranscriptsGood morning and welcome to Agios Pharmaceuticals fourth quarter and full year 2025 conference call. At this time, all participants are in a listen-only mode. There will be a question and answer session at the end. Pleas
- 9mo agoAGIOAgios Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business UpdateGlobeNewswirePYRUKYND® (mitapivat) worldwide net revenues of $20.0 million in fourth quarter and $54.0 million for full yearAQVESME™ (mitapivat) for thalassemia now available in U.S. following FDA approvalCompany will
- 9mo agoAGIOAgios to Host Fourth Quarter and Full Year 2025 Financial Results Conference Call and Webcast on February 12 at 8:00 a.m. ETGlobeNewswireCAMBRIDGE, 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,
- 10mo agoAGIOAgios Outlines 2026 Strategic Priorities and Key Milestones to Accelerate Rare Disease Portfolio GrowthGlobeNewswireAQVESME™ (mitapivat) U.S. commercial launch in thalassemia underway following December 2025 FDA approvalPre-sNDA meeting with FDA for mitapivat in sickle cell disease anticipated in first quarter of 2026, with
- 10mo agoAGIOAgios to Present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026GlobeNewswireCAMBRIDGE, 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,
- 10mo agoAGIOAQVESME (mitapivat) FDA Approval - AGIOS PHARMACEUTICALS INCEarnings Call TranscriptsGood day and welcome to AGIOS Pharmaceuticals Investor Conference Call and Webcast. At this time, all participants are in the listen-only mode. There will be a question and answer session at the end. Please be advised th
- 10mo agoAGIOU.S. FDA Approves Agios' AQVESME™ (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-ThalassemiaGlobeNewswireAQVESME is the only FDA-approved medicine for anemia in both non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemiaMarketed under AQVESME brand name in the U.S. for thalassemia indication;
- 10mo agoAGIOApproval of Pyrukynd, Nda #216196 (Efficacy)FDA Approved DrugsApproval Date: 12/23/2025; Drug Name: Pyrukynd, Nda #216196; Active Ingredients: MITAPIVAT SULFATE; Company: Agios Pharms Inc; Submission Status: Approval; Submission Classification: Efficacy; Application Number: 216196
- 11mo agoAGIOAgios Provides Update on U.S. sNDA for Mitapivat in ThalassemiaGlobeNewswireCAMBRIDGE, 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,
- 11mo agoAGIOAgios Announces Topline Results from RISE UP Phase 3 Trial of Mitapivat in Sickle Cell DiseaseGlobeNewswireTrial met primary endpoint of hemoglobin response and key secondary endpoints of change from baseline in hemoglobin concentration and indirect bilirubin Trial showed trend favoring mitapivat but did not meet statistical
- 1y agoAGIOAgios to Present New Mitapivat Data in Rare Blood Disorders at 67th ASH Annual Meeting and ExpositionGlobeNewswireCAMBRIDGE, Mass., Nov. 03, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases,
- 1y agoAGIOAgios Reports Third Quarter 2025 Financial Results and Provides Business UpdateGlobeNewswire$12.9 million in third quarter PYRUKYND® (mitapivat) net revenuesPDUFA goal date for PYRUKYND U.S. sNDA in thalassemia set for December 7, 2025CHMP adopted positive opinion for PYRUKYND in thalassemia; EC decision
- 1y agoAGIOAvanzanite Bioscience's Partner Agios Announces Positive CHMP Opinion for PYRUKYND® (mitapivat) for Adults with ThalassemiaBusiness WireAvanzanite entered an exclusive partnership with Agios in June 2025 to manage PYRUKYND commercialization across Europe European Commission will now review the CHMP's opinion, with the final decision expected by
- 1y agoAGIOAgios' PYRUKYND® (mitapivat) Receives Positive CHMP Opinion for Adults with ThalassemiaGlobeNewswireCAMBRIDGE, Mass., Oct. 17, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare diseases,
- 1y agoAGIOAgios to Host Third Quarter 2025 Financial Results Conference Call and Webcast on October 30 at 8:00 a.m. ETGlobeNewswireCAMBRIDGE, Mass., Oct. 16, 2025 (GLOBE NEWSWIRE) -- Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a commercial-stage biopharmaceutical company focused on delivering innovative medicines for patients with rare
- 1y agoAGIOAgios Provides Update on U.S. PDUFA Goal Date for PYRUKYND® (mitapivat) in ThalassemiaGlobeNewswirePDUFA 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
- 1y agoAGIOAgios' PYRUKYND® (mitapivat) Approved for Adults with Thalassemia in Saudi ArabiaGlobeNewswireFirst 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
- 1y agoAGIOAgios Pharmaceuticals, Inc. (AGIO) Q2 2025 Earnings Call TranscriptEarnings Call Transcripts
- 1y agoAGIOAgios Reports Second Quarter 2025 Financial Results and Provides Business UpdateGlobeNewswire$12.5 million in second quarter PYRUKYND® (mitapivat) net revenues; ended second quarter with $1.3 billion dollars in cash, cash equivalents and marketable securitiesPYRUKYND sNDA for thalassemia under active
- 1y agoAGIOAgios to Host Webcast Conference Call of Second Quarter Financial Results on July 31, 2025 at 8:00am ETGlobeNewswireCAMBRIDGE, 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
- 1y agoAGIOAvanzanite Announces Pan-European Partnership with Agios to Launch PYRUKYND® in Rare Blood DisordersBusiness WirePYRUKYND® (mitapivat) is a first-in-class pyruvate kinase (PK) activator, approved by the European Commission for adults with PK deficiency The agreement includes commercialization and distribution rights for
- 1y agoAGIOAgios to Present at Goldman Sachs 46th Annual Global Healthcare Conference on June 9, 2025GlobeNewswireCAMBRIDGE, 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
- 1y agoAGIOAgios to Highlight Pyruvate Kinase Activation Portfolio with New Data in Rare Blood Disorders at 30th EHA CongressGlobeNewswireCAMBRIDGE, 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
- 1y agoAGIOAgios to Present at the 2025 RBC Capital Markets Global Healthcare Conference on May 21, 2025GlobeNewswireCAMBRIDGE, 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
- 1y agoAGIOAgios to Present at the BofA Securities 2025 Health Care Conference on May 14, 2025GlobeNewswireCAMBRIDGE, 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
- 1y agoAGIOAgios Reports First Quarter 2025 Financial Results and Recent Business HighlightsGlobeNewswire– 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,
- 1y agoAGIOAgios to Webcast Conference Call of First Quarter Financial Results on May 1, 2025GlobeNewswireCAMBRIDGE, 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
- 1y agoAGIOAgios Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) to Newly Appointed Chief Corporate Development & Strategy OfficerGlobeNewswireCAMBRIDGE, 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