Agios Pharmaceuticals Inc. (Nasdaq: AGIO) reported a fourth-quarter net loss of $108 million on Thursday, even as the company saw significant revenue growth driven by its recently FDA-approved treatment for thalassemia, AQVESME™ (mitapivat). The Cambridge, Massachusetts-based biopharmaceutical company announced total net revenues of $20 million for the quarter, and $54 million for the full year 2025.
The financial results come as Agios focuses on the commercial launch of AQVESME, the first and currently only FDA-approved medicine for anemia in adults with non-transfusion-dependent and transfusion-dependent alpha- or beta-thalassemia. According to Agios CEO Brian Goff, the U.S. Launch is “off to a strong start,” with an “enthusiastic response from the thalassemia community.”
Despite the revenue increase, the fourth-quarter loss represents a widening gap compared to the $96.5 million loss reported for the same period in 2024. Agios maintains a strong cash position, reporting $1.2 billion in cash, cash equivalents, and marketable securities as of December 31, 2025, which the company intends to leverage for further expansion.
Agios is preparing for a pre-submission meeting with the Food and Drug Administration in the first quarter of 2026 to discuss mitapivat as a potential treatment for sickle cell disease. The company’s Phase 2 trial evaluating tebapivat in sickle cell disease is fully enrolled, with topline results anticipated in the second half of 2026. The company too intends to explore expanding its “PK activation franchise” into lower-risk myelodysplastic syndromes.
Agios will host a conference call and live webcast at 8:00 a.m. Eastern Time today to discuss the financial results and business updates in greater detail.
