Agios Q1 Mitapivat Sales Jump to $20.7M with 242 AQVESME Prescriptions
Agios booked $20.7 million in Q1 mitapivat revenues, up from $8.7 million year-over-year, driven by a U.S. AQVESME launch with 242 prescriptions written by March 31. It holds $1.0 billion in cash, plans a Q2 sNDA submission for sickle cell disease and targets two Phase 2 tebapivat readouts in 2026.
1. Q1 Financial Results
Agios reported $20.7 million in mitapivat net revenues for Q1 2026, up from $8.7 million in Q1 2025, driven by $18.8 million in U.S. sales and $1.9 million ex-U.S. The quarter ended with a net loss of $99.1 million and $1.0 billion in cash, cash equivalents and marketable securities.
2. Commercial Launch of AQVESME
AQVESME launched in the U.S. for thalassemia in late January 2026, with 242 prescriptions written by REMS-certified physicians as of March 31. Ex-U.S. demand for PYRUKYND in Saudi Arabia and recent UAE approval for broad thalassemia use expand the medicine’s global footprint.
3. Pipeline and Regulatory Milestones
Agios plans to submit a supplemental NDA for mitapivat in sickle cell disease in Q2 under an accelerated approval pathway, with a confirmatory trial to follow. The company also expects topline data from Phase 2 tebapivat studies in lower-risk myelodysplastic syndromes in the first half of 2026 and in sickle cell disease in the second half.
4. Expense and Cash Position
Research and development expenses rose to $81.1 million from $72.7 million year-over-year due to pipeline advancement and process development, while SG&A costs increased to $48.3 million from $41.5 million to support the AQVESME commercial launch and higher stock-based compensation.