Welcome to our dedicated page for Agios Pharmaceuticals news (Ticker: AGIO), a resource for investors and traders seeking the latest updates and insights on Agios Pharmaceuticals stock.
Agios Pharmaceuticals Inc. (AGIO) is a leader in developing therapies for rare hematologic and genetic disorders through its groundbreaking work in cellular metabolism. This page provides investors and industry professionals with timely updates on AGIO’s clinical advancements, regulatory milestones, and strategic initiatives.
Discover official press releases covering AGIO’s progress in treating conditions like pyruvate kinase deficiency, thalassemia, and sickle cell disease. The curated news includes updates on clinical trials, FDA communications, research collaborations, and pipeline expansions. Each update is sourced to ensure accuracy and relevance for informed decision-making.
Key areas of coverage include novel therapeutic developments, regulatory submissions, and strategic partnerships that underscore AGIO’s role in advancing precision medicine. Bookmark this page to stay informed about the company’s contributions to transforming rare disease treatment through metabolic science.
Agios Pharmaceuticals (NASDAQ: AGIO) recently shared positive results from its Phase 3 ACTIVATE study and extension studies for PYRUKYND® (mitapivat) in treating adult patients with pyruvate kinase deficiency (PK deficiency). Approximately 36% of treated patients achieved normal hemoglobin levels at least once. Patients reported significant improvements in PK deficiency symptoms including jaundice and fatigue. The therapy, which received FDA approval in February 2022, is also under review by the EMA. Agios is focused on enhancing treatment strategies and managing the complications associated with PK deficiency.
Agios Pharmaceuticals (NASDAQ: AGIO) announced a leadership transition as Sarah Gheuens, M.D., Ph.D., will become Head of R&D and Chief Medical Officer, while Bruce Car, Ph.D., steps down. The company will focus on late lead-optimization programs and aims to save $40-50 million annually starting in 2023. This evolution prioritizes sustainable pipeline growth and strategic in-licensing of promising assets. Agios expects its cash reserves will support its operations and growth without needing additional equity financing.
Agios Pharmaceuticals will present new patient-reported outcomes from its ACTIVATE Phase 3 Study of PYRUKYND (mitapivat) in adults with pyruvate kinase deficiency at the European Hematology Association Annual Congress from June 9-12, 2022. Key highlights include long-term normalization of hemoglobin levels and reduced transfusion needs. Additional data from the ESTIMATE Phase 2 Study in sickle cell disease will also be shared. An investor webcast is set for June 13, 2022, at 8 a.m. ET to review selected data.
Agios Pharmaceuticals (NASDAQ: AGIO) is set to present at the RBC Capital Markets Global Healthcare Conference on May 17, 2022, at 10:30 a.m. ET. The presentation will focus on Agios's pioneering work in therapies for genetically defined diseases and its leadership in cellular metabolism. A live webcast can be accessed via their website, with an archived replay available for two weeks. Agios develops treatments for conditions like pyruvate kinase deficiency, with a strong clinical pipeline addressing thalassemia, sickle cell disease, and more.
Agios Pharmaceuticals (NASDAQ: AGIO) has received FDA approval for PYRUKYND®, the first therapy for hemolytic anemia in adults with pyruvate kinase deficiency. The commercial launch is underway, generating approximately $0.8 million in net revenue in Q1 2022. The company has a cash position of $1.2 billion, enabling continued operations and R&D activities. Notable milestones for 2022 include additional clinical studies in thalassemia and sickle cell disease, as well as pediatric trials for PK deficiency. The net loss from continuing operations was $94.8 million in Q1 2022.
Agios Pharmaceuticals (NASDAQ: AGIO) will host a conference call on May 5, 2022, at 8:00 a.m. ET to discuss its Q1 2022 financial results and business highlights. Investors can access the live webcast on Agios's website, with a replay available two hours post-event. The company focuses on genetically defined diseases and has developed a first-in-class pyruvate kinase activator for PK deficiency. Agios is advancing a clinical pipeline targeting alpha- and beta-thalassemia, sickle cell disease, and more.
Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) announced data from the pivotal Phase 3 ACTIVATE study of PYRUKYND® (mitapivat) for adults with pyruvate kinase deficiency, published in the New England Journal of Medicine. The study revealed that 40% of patients treated with PYRUKYND® experienced significant hemoglobin increases, far surpassing placebo results. PYRUKYND® became the first FDA-approved disease-modifying treatment for this condition in February 2022. The results point to improved quality of life and reduced anemia symptoms for patients.
Agios Pharmaceuticals (NASDAQ: AGIO) has announced its participation in major investor conferences scheduled for March 2022, specifically the Cowen 42nd Annual Virtual Healthcare Conference on March 7, 2022, and the Oppenheimer 32nd Annual Virtual Healthcare Conference on March 16, 2022. The live presentations will be accessible via the company’s website, and replays will be available for two weeks after each event. Agios specializes in therapies for genetically defined diseases, including a first-in-class treatment for PK deficiency.
Agios Pharmaceuticals has received FDA approval for PYRUKYND® (mitapivat) as the first treatment for hemolytic anemia in adults with PK deficiency. This marks a significant advancement in Agios' genetically defined disease portfolio. The company reported a net loss of $98.6 million for Q4 2021, increasing from $84.5 million in Q4 2020. As of Dec. 31, 2021, Agios holds $1.3 billion in cash and equivalents, ensuring strong financial stability to support ongoing clinical trials, including pivotal studies for thalassemia and sickle cell disease.
Agios Pharmaceuticals has received FDA approval for PYRUKYND® (mitapivat) to treat hemolytic anemia in adults with pyruvate kinase (PK) deficiency, marking it as the first disease-modifying therapy for this rare condition. The approval is based on the successful ACTIVATE and ACTIVATE-T Phase 3 studies. Agios plans to enhance patient access through programs offering $0 copays and free medications for eligible individuals. PYRUKYND® is expected to be available in the U.S. shortly. The European Medicines Agency is also reviewing the drug for potential approval by the end of 2022.
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