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. reports developments as a commercial-stage biopharmaceutical company focused on rare diseases and hematology. Its recurring updates center on mitapivat, an oral pyruvate kinase activator marketed as PYRUKYND® and AQVESME™, including product revenue, U.S. and ex-U.S. commercialization, thalassemia approvals, and activity in pyruvate kinase deficiency, sickle cell disease, and other hemolytic anemias.
Company news also covers FDA interactions, supplemental application activity, conference presentations, and pipeline progress for tebapivat, a next-generation PK activator, and other rare disease programs. International commercialization themes include regulatory approvals and distribution activity in Gulf Cooperation Council markets through NewBridge Pharmaceuticals.
Agios (Nasdaq: AGIO) has submitted a supplemental New Drug Application (sNDA) to the FDA seeking U.S. accelerated approval of mitapivat, an oral PK activator, for sickle cell disease. The filing follows agreement on a required confirmatory trial.
The 52-week, global, randomized Phase 3 trial will enroll about 159 patients ≥12 years and assess transfusion-free status from Week 4–52. The sNDA is supported by RISE UP Phase 2/3 data, and Agios expects FDA filing acceptance timing in Q3 2026.
Agios (Nasdaq: AGIO) will present extensive new mitapivat data at EHA 2026, including detailed Phase 3 RISE UP sickle cell results in a Plenary Abstracts Session and long-term ENERGIZE thalassemia outcomes. A collaborator-led SATISFY Phase 2 study and other abstracts will also be featured.
Agios will host an investor webcast on June 13, 2026, at 9:00 a.m. ET.
Agios (NASDAQ: AGIO)/b) reported first-quarter 2026 results: (Q1 2026), including $18.8M U.S. and $1.9M ex-U.S.. AQVESME U.S. launch produced 242 prescriptions as of March 31, 2026. The company plans an sNDA submission for sickle cell disease in Q2 2026, expects two tebapivat Phase 2 readouts in 2026, reported a net loss of $99.1M for Q1, and held $1.0B cash, cash equivalents, and marketable securities as of March 31, 2026.
Agios (Nasdaq: AGIO) will hold a conference call and live webcast on April 29, 2026 at 8:00 a.m. ET to report first quarter 2026 financial results and business highlights.
The live webcast will be available on the company’s Investors site under Events & Presentations, and a replay will be posted approximately two hours after the event.
Agios (Nasdaq: AGIO) said it will pursue U.S. accelerated approval for mitapivat in sickle cell disease after a March 31, 2026 pre-sNDA meeting with the FDA. The company has submitted a proposed confirmatory trial protocol and plans to file an sNDA in the coming months while working to align with FDA on trial design.
Agios said the proposed confirmatory trial uses a different primary endpoint informed by RISE UP data, and current planning expects operating expense guidance to remain approximately flat versus 2025.
Agios (Nasdaq: AGIO) announced EDE approval of PYRUKYND (mitapivat) on March 2, 2026 for adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia in the United Arab Emirates.
The approval makes PYRUKYND the only medicine authorized in the UAE for this adult thalassemia population and is based on global Phase 3 ENERGIZE and ENERGIZE-T trial results. NewBridge Pharmaceuticals will continue regional commercialization across the Gulf, following an existing GCC distribution agreement.
Agios (Nasdaq: AGIO) reported Q4 2025 results and business updates on Feb 12, 2026. Key highlights include AQVESME FDA approval and U.S. availability for thalassemia, PYRUKYND Q4 net revenue $20.0M ($16.0M U.S., $4.0M ex-U.S.), full-year PYRUKYND revenue $54.0M, and $1.2B cash as of Dec 31, 2025.
The company recorded a $108.0M Q4 net loss, plans a pre-sNDA FDA meeting for mitapivat in sickle cell disease in Q1 2026, and expects tebapivat Phase 2 topline data in H2 2026.
Agios (Nasdaq: AGIO) will host a conference call and live webcast on Thursday, February 12, 2026 at 8:00 a.m. ET to report fourth quarter and full year 2025 financial results and business highlights. The live webcast will be available on the company’s Investors website under the "Events & Presentations" tab. A replay will be posted on the company website approximately two hours after the event.
Agios (Nasdaq: AGIO) outlined 2026 strategic priorities focused on commercializing AQVESME (mitapivat) in thalassemia and advancing a pipeline of rare-disease programs.
Key points: AQVESME received U.S. FDA approval in December 2025 for anemia in adults with alpha- or beta-thalassemia and is expected to be available in the U.S. in late January 2026 after REMS implementation. Agios plans a pre-sNDA FDA meeting for mitapivat in sickle cell disease in Q1 2026 with a planned U.S. regulatory submission to follow. Multiple topline readouts are expected across 2026 for tebapivat, AG-236, and AG-181. The company projects a clear path to profitability and cites potential for over $1 billion in peak global sales from its PK activation franchise.
Agios (Nasdaq: AGIO) announced its management will present at the 44th Annual J.P. Morgan Healthcare Conference on January 14, 2026 at 8:15 a.m. PST / 11:15 a.m. EST. The presentation will be available via a live webcast on the company’s Investors site under “Events & Presentations.” A replay will be archived on the company website for at least two weeks after the presentation.