Agios Reports $20M Q4 Revenues, AQVESME FDA Approval and $1.2B Cash
Agios reported Q4 net revenues of $20.0M and full-year 2025 revenues of $54.0M, while widening its Q4 net loss to $108.0M due to $88.1M in R&D expenses. The FDA approved AQVESME in December, and the U.S. launch is underway backed by $1.2B in cash at year-end.
1. Financial Results Overview
For the fourth quarter ended December 31, 2025, Agios generated net product revenue of $20.0 million for PYRUKYND, contributing to full-year net revenues of $54.0 million, but reported a net loss of $108.0 million driven by $88.1 million in R&D and $51.6 million in SG&A expenses.
2. Commercial Performance and Approval
U.S. PYRUKYND net revenues rose 49% year-over-year to $16.0 million in Q4, with ex-U.S. sales of $4.0 million, and the FDA approved AQVESME in December, making it the only treatment for anemia in alpha- and beta-thalassemia now available to U.S. adults.
3. R&D Pipeline Advances
Agios plans a pre-sNDA meeting with the FDA for mitapivat in sickle cell disease in Q1 2026 following positive Phase 3 topline data, while its Phase 2 trial of tebapivat in sickle cell disease is fully enrolled with results expected in H2 2026.
4. Cash Position and Outlook
The company closed 2025 with $1.2 billion in cash, cash equivalents and marketable securities, which it expects will fund the U.S. launch of AQVESME, a potential commercial launch in sickle cell disease, and advancement of its early-stage rare disease pipeline into 2026 and beyond.