Agios Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update

Core Insights - Agios Pharmaceuticals reported strong execution in 2025, highlighted by the U.S. approval and launch of AQVESME, the first treatment for anemia in adults with thalassemia, which has received positive feedback from the community [2][5] - The company aims to expand its product portfolio and pipeline, focusing on high-value indications such as sickle cell disease and myelodysplastic syndromes, while maintaining disciplined capital allocation [2] Financial Performance - For Q4 2025, Agios reported net revenues of $20.0 million from PYRUKYND, with a full-year total of $54.0 million, marking a 49% increase from Q4 2024 [5][12] - The net loss for Q4 2025 was $108.0 million, compared to a net loss of $96.5 million in Q4 2024 [8] - Total revenues for the year 2025 reached $54.0 million, up from $36.5 million in 2024 [15] Research and Development Highlights - AQVESME received FDA approval in December 2025 and is now available in the U.S. [6][12] - A pre-sNDA meeting with the FDA for mitapivat in sickle cell disease is scheduled for Q1 2026, with plans to submit a marketing application thereafter [5][6] - The Phase 2 trial of tebapivat in sickle cell disease has been fully enrolled, with topline results expected in the second half of 2026 [7] Cash Position - As of December 31, 2025, Agios had $1.2 billion in cash, cash equivalents, and marketable securities, down from $1.5 billion a year earlier [12][14] - The company anticipates that its financial resources will support the U.S. launch of AQVESME and the advancement of its clinical programs [12]