Agios Pharmaceuticals, Inc.

Agios Pharmaceuticals stock surged over 14% after the FDA accepted its supplemental New Drug Application for mitapivat for sickle cell disease with Priority Review status and set a decision goal date of November 1. While the drug failed to meet its primary endpoint for reducing sickle cell pain crises, the FDA's accelerated approval pathway indic...

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 pat...

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 com...

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 treatm...

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 ...