AGIO News & Events

Agios Pharmaceuticals announced its 2026 strategic priorities and key milestones anticipated during the year. Key highlights: AQVESME U.S. commercial launch in thalassemia underway following December 2025 FDA approval; Pre-sNDA meeting with FDA for mitapivat in sickle cell disease anticipated in first quarter of 2026, with planned U.S. regulatory submission to follow; Company progressing early- and mid-stage pipeline in multiple high-value indications; path to profitability through the company's existing commercial presence in thalassemia and PK deficiency, with potential to achieve over $1 billion in peak global sales

After Agios announced that the FDA has approved Aqvesme for the treatment of anemia in adults with alpha- or beta-thalassemia, JPMorgan analyst Tessa Romero notes that the U.S. brand name is not Pyrukynd due to the REMS program that is specific for the thalassemia indication. The firm, which foresees a slower, gradual launch given the phase 3 thalassemia data, complexities of the patient population and the REMS to mitigate the risk of HCI, looks toward the firm's Healthcare Conference as a venue to further discuss the anticipated launch trajectory for Aqvesme and the outlook for 2026. JPMorgan has a Neutral rating on Agios shares.