Agios Reports Q1 2026 Results and Plans Q2 sNDA Submission for Mitapivat in Sickle Cell Disease

Agios Pharmaceuticals reported first-quarter 2026 financial results, highlighted by total net product revenue of $20.7 million, a significant increase from $8.7 million in Q1 2025. This growth was primarily driven by the U.S. commercial launch of AQVESME (mitapivat) in thalassemia, which saw 242 prescriptions written since late January 2026. The company reported a net loss of $99.1 million for the quarter. On the regulatory front, Agios plans to submit a supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease under the FDA's accelerated approval pathway in Q2 2026. Additionally, the Emirates Drug Establishment approved PYRUKYND for thalassemia in the UAE. The company's pipeline includes tebapivat, with Phase 2b results in lower-risk MDS expected in H1 2026 and Phase 2 results in sickle cell disease expected in H2 2026. Agios ended the quarter with $1.0 billion in cash, cash equivalents, and marketable securities.