Quarterly ResultApr 29, 2026, 06:32 AM
AGIO Q1 Mitapivat Revenue +138% to $20.7M; Sickle Cell sNDA in Q2
AI Summary
Agios Pharmaceuticals reported Q1 2026 financial results, with worldwide net revenues for mitapivat (PYRUKYND® and AQVESME™) reaching $20.7 million, a 138% increase year-over-year. The U.S. commercial launch of AQVESME™ in thalassemia showed strong initial momentum with 242 prescriptions. The company plans to submit a supplemental New Drug Application (sNDA) for mitapivat in sickle cell disease in Q2 2026 under the U.S. accelerated approval pathway. Despite increased net loss to $99.1 million due to higher R&D and SG&A expenses, Agios maintains a strong financial position with $1.0 billion in cash, cash equivalents, and marketable securities.
Key Highlights
- Mitapivat worldwide net revenues: $20.7M in Q1 2026, up 138% from $8.7M in Q1 2025.
- AQVESME U.S. launch: 242 prescriptions for thalassemia written as of March 31, 2026.
- Mitapivat sNDA for sickle cell disease: Planned submission in Q2 2026 for accelerated approval.
- Cash, cash equivalents, and marketable securities: $1.0 billion as of March 31, 2026.
- Net loss: $99.1 million in Q1 2026, compared to $89.3 million in Q1 2025.
- R&D Expenses: $81.1 million in Q1 2026, up from $72.7 million in Q1 2025.
- SG&A Expenses: $48.3 million in Q1 2026, up from $41.5 million in Q1 2025.