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, Inc. (NASDAQ: AGIO) announced positive results from the pivotal Phase 3 ACTIVATE-T study of PYRUKYND® (mitapivat) for adults with pyruvate kinase (PK) deficiency, published on August 18, 2022, in The Lancet Haematology. The study demonstrated a statistically significant reduction in transfusion burden, with 37% of patients achieving a ≥33% reduction in transfusion needs. PYRUKYND is the first disease-modifying treatment approved for this condition, having received FDA approval in February 2022. The findings suggest enhanced patient quality of life and support ongoing regulatory review in Europe.
Agios Pharmaceuticals (NASDAQ: AGIO) has announced the appointments of Rahul Ballal, Ph.D., and Cynthia Smith to its board of directors. This move aims to strengthen the company's leadership as it focuses on advancing therapies for genetically defined diseases. Dr. Ballal brings over 15 years of experience in business development and hemolytic anemias, while Ms. Smith has 25 years of expertise in commercial strategy and product launches. The company continues to push forward its clinical pipeline, including treatments for conditions like sickle cell disease and thalassemia.
Agios Pharmaceuticals (NASDAQ: AGIO) announced promising results from the Phase 2 study of PYRUKYND® (mitapivat) for treating non-transfusion-dependent α- and β-thalassemia, published in The Lancet. The study showed that 80% of patients experienced a hemoglobin increase of ≥1.0 g/dL from baseline, and significant safety results aligned with previous findings. Agios is actively enrolling subjects for the Phase 3 ENERGIZE studies to further investigate the drug's efficacy. The potential first oral therapy for thalassemia could transform treatment options for patients suffering from this debilitating condition.
Agios Pharmaceuticals has announced the grant of inducement equity awards to its new CEO, Brian Goff, effective August 8, 2022. This grant includes a nonstatutory option for 561,083 shares, 68,073 restricted stock units, and 170,183 performance stock units, all aimed at incentivizing Mr. Goff's commitment to the company. The option price is set at $29.38 per share, aligning with the closing price on the announcement date. The awards are part of Agios's strategy to attract and retain top executive talent.
Agios Pharmaceuticals reported $3.1 million in U.S. net revenue for PYRUKYND® in Q2 2022, marking its first full quarter of sales post-FDA approval. The company announced a leadership transition with Brian Goff becoming CEO on August 8, 2022, succeeding Jackie Fouse, who will serve as Chair of the Board. Agios has $1.1 billion in cash and marketable securities as of June 30, 2022, supporting its growth strategy. The company is enrolling patients in five pivotal studies for PYRUKYND® in various blood disorders, aiming for significant milestones by year-end.
Agios Pharmaceuticals (NASDAQ: AGIO) announced a conference call scheduled for August 4, 2022, at 8:00 a.m. ET, to discuss its Q2 2022 financial results and business updates. Investors can access the live webcast on the company's website, with an archived version available post-event. Agios focuses on therapies for genetically defined diseases and markets a first-in-class pyruvate kinase activator for PK deficiency. The company is also advancing multiple investigational medicines targeting various disorders including sickle cell disease and MDS-associated anemia.
Agios Pharmaceuticals (NASDAQ: AGIO) announced leadership changes effective August 8, 2022, with Jackie Fouse transitioning from CEO to Chair of the Board and Brian Goff appointed as the new CEO. Fouse highlighted Agios's success in divesting its oncology portfolio, launching its first genetically defined disease medicine, and initiating pivotal clinical trials. Goff comes with over 30 years of biopharmaceutical experience and aims to advance therapies for rare diseases, leveraging Agios's strong pipeline. This leadership transition is seen as a strategic move to enhance focus on genetically defined diseases.
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.
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