Agios Showcases RISE UP Phase 3 Results at EHA 2026 Plenary Session Reinforcing Strong Anti-Hemolytic Profile of Mitapivat in Sickle Cell Disease

Agios presented detailed Phase 3 RISE UP trial results for mitapivat, an oral pyruvate kinase activator for sickle cell disease. The drug demonstrated statistically significant hemoglobin response improvement versus placebo with rapid onset and durable effects, clinically meaningful reduction in transfusion burden (41.1% relative reduction in patients requiring transfusions), and improvements in pain crises, fatigue, and quality of life measures among hemoglobin responders. Mitapivat was well-tolerated with a safety profile consistent with previous trials.

06/13/2026, 9:00 AM • GlobeNewswire

Agios Provides Update on Phase 2b Trial of Tebapivat in Lower-Risk Myelodysplastic Syndromes

Agios Pharmaceuticals announced it will not advance tebapivat, a pyruvate kinase activator, in lower-risk myelodysplastic syndromes (LR-MDS) after Phase 2b trial results failed to meet predefined efficacy thresholds. While the drug was well-tolerated with no safety concerns, clinical benefit was insufficient in patient populations tested. The company will continue development of tebapivat in sickle cell disease with Phase 2 data expected in the second half of 2026.

05/29/2026, 7:00 AM • GlobeNewswire

Why Agios Pharmaceuticals Stock Zoomed to a 13% Gain on Wednesday

Agios Pharmaceuticals stock surged 13% after reporting Q1 2026 earnings that beat analyst expectations. The company's lead drug mitapivat, marketed as Aqvesme and Pyrukynd, generated $20.7 million in revenue, up from $8.7 million year-over-year. The company plans to submit a supplemental FDA application for mitapivat in sickle cell disease treatment this quarter.

04/29/2026, 6:27 PM • The Motley Fool

Here's Why Agios Pharmaceuticals Crashed 23% Today

Agios Pharmaceuticals stock plummeted 23% after Novo Nordisk announced superior trial results for its sickle cell treatment etavopivat compared to Agios' mitapavit. Novo's drug met both primary endpoints and demonstrated statistically significant reduction in vaso-occlusive crises, while Agios' mitapavit failed to meet its primary endpoint. With Novo planning FDA approval filing in late 2026, Agios faces a longer and more uncertain path to market approval, significantly diminishing its mitapavit's commercial potential.

04/20/2026, 12:19 PM • The Motley Fool

Alpha Thalassemia (US, EU4, UK, and Japan) Market Insights, Epidemiology, and Forecasts 2022-2025 & 2025-2036

The alpha thalassemia market is expected to expand significantly through 2036, driven by rising prevalence and advancements in diagnostics and gene therapies. Key players Agios Pharmaceuticals and Novo Nordisk are leading development efforts with emerging drugs like PYRUKYND and etavopivat progressing through clinical trials, though no gene therapies are currently approved for the condition.

04/13/2026, 4:47 AM • GlobeNewswire

Agios to Host First Quarter 2026 Financial Results Conference Call and Webcast on April 29 at 8:00 a.m. ET

Agios Pharmaceuticals announced it will host a conference call on April 29, 2026, to report Q1 2026 financial results. The company is advancing mitapivat toward potential U.S. accelerated approval in sickle cell disease following a pre-sNDA meeting with the FDA, and has received approval for PYRUKYND (mitapivat) for adults with thalassemia in the United Arab Emirates.

04/06/2026, 7:00 AM • GlobeNewswire

Why Agios Pharmaceuticals Stock Is Up More Than 21% Today

Agios Pharmaceuticals stock surged over 21% after the FDA approved an accelerated approval pathway for its mitapivat drug to treat sickle cell disease. The company can now conduct an abbreviated confirmatory trial before seeking full FDA approval within months. While the drug shows promise in a market expected to grow from $4B to $14B by 2034, investors should note Agios remains unprofitable with significant losses despite recent gains.

03/31/2026, 12:08 PM • The Motley Fool

Insider Sells AGIO Shares Worth $82,000 -- But Context Is Everything

Viswanadhan Krishnan, Chief Corporate Development and Strategy Officer at Agios Pharmaceuticals, sold 2,959 shares worth ~$82,000 on March 5, 2026. However, this was a routine, pre-planned tax-withholding sale triggered by RSU vesting, not a discretionary sale indicating loss of confidence. Krishnan retains 16,200 unvested RSUs and recently received fresh compensation grants, signaling growing equity stake. Agios' lead drug PYRUKYND showed strong 86% revenue growth, and the company announced plans to pursue FDA accelerated approval for sickle cell disease.

03/31/2026, 12:03 PM • The Motley Fool

Agios to Host Fourth Quarter and Full Year 2025 Financial Results Conference Call and Webcast on February 12 at 8:00 a.m. ET

Agios Pharmaceuticals announced it will host a conference call and live webcast on February 12, 2026, at 8:00 a.m. ET to report its fourth quarter and full year 2025 financial results and business highlights. The company also outlined its 2026 strategic priorities and key milestones to accelerate rare disease portfolio growth.

01/26/2026, 7:00 AM • GlobeNewswire

Here's Why Shares in Agios Pharmaceuticals Popped Today

Agios Pharmaceuticals shares surged over 18% following FDA approval of AQVESME (mitapivat) for treating alpha- and beta-thalassemia. The company priced the drug at $425,000 annually in the U.S. and projects $1 billion in global peak-year sales across thalassemia and pyruvate kinase deficiency indications. Management's positive conference call and expansion plans drove investor enthusiasm.

12/24/2025, 12:03 PM • The Motley Fool

U.S. FDA Approves Agios’ AQVESME™ (mitapivat) for the Treatment of Anemia in Adults with Alpha- or Beta-Thalassemia

The FDA has approved Agios Pharmaceuticals' AQVESME (mitapivat), an oral pyruvate kinase activator, for treating anemia in adults with alpha- or beta-thalassemia. AQVESME is the only FDA-approved medicine for both non-transfusion-dependent and transfusion-dependent forms of the disease. The approval is based on Phase 3 ENERGIZE and ENERGIZE-T trials showing significant improvements in hemoglobin levels, fatigue, and transfusion burden. The drug will be available in late January 2026 under a REMS program due to hepatocellular injury risks observed in clinical trials.

12/23/2025, 7:45 PM • GlobeNewswire

Sickle Cell Disease Market is Predicted to Exhibit Remarkable Growth at a CAGR of 22.1% During the Forecast Period (2025–2034) Across 6MM, Owing to the Increasing Prevalence, Awareness, and Advancements in Gene Therapies | DelveInsight

The sickle cell disease market is projected to grow at a 22.1% CAGR by 2034, driven by increasing disease prevalence, awareness, and advancements in gene therapies, with emerging treatments from multiple pharmaceutical companies.

12/03/2025, 1:00 PM • GlobeNewswire

Why Shares in Agios Pharmaceuticals Got Crushed Today

Agios Pharmaceuticals' stock dropped nearly 50% after mixed Phase 3 trial results for its sickle cell disease drug mitapavit. The drug met one primary endpoint of hemoglobin response but failed to significantly reduce sickle cell pain crises.

11/19/2025, 1:33 PM • The Motley Fool

Agios’ PYRUKYND® (mitapivat) Receives Positive CHMP Opinion for Adults with Thalassemia

Agios Pharmaceuticals received a positive opinion from the European Medicines Agency for PYRUKYND, a treatment for thalassemia in adults. The drug shows promise in treating anemia associated with alpha- and beta-thalassemia, with a final European Commission decision expected in early 2026.

10/17/2025, 8:00 AM • GlobeNewswire

Agios to Host Third Quarter 2025 Financial Results Conference Call and Webcast on October 30 at 8:00 a.m. ET

Agios Pharmaceuticals will host a Q3 2025 financial results conference call on October 30, and announced an FDA PDUFA goal date extension for PYRUKYND in thalassemia treatment. The company also received approval for PYRUKYND in Saudi Arabia.

10/16/2025, 7:00 AM • GlobeNewswire