Financial Performance - PYRUKYND net revenues for Q3 2025 were $12.9 million, a 44% increase from $9.0 million in Q3 2024 and a 3% increase from $12.5 million in Q2 2025[6] - The company reported a net loss of $103.4 million for Q3 2025, compared to a net income of $947.9 million in Q3 2024, which included milestone payments and royalty sales[9] - As of September 30, 2025, Agios had $1.3 billion in cash, cash equivalents, and marketable securities, down from $1.5 billion at the end of 2024[12] Drug Development and Trials - The PDUFA goal date for PYRUKYND's supplemental New Drug Application in thalassemia is set for December 7, 2025[5] - Enrollment in the Phase 2b tebapivat trial for lower-risk MDS is fully completed, with topline results expected in early 2026[5] - The RISE UP Phase 3 trial topline results in sickle cell disease are expected by year-end 2025, potentially leading to a U.S. commercial launch in 2026[5] Patient Enrollment and Therapy - 262 unique patients completed prescription enrollment forms for PYRUKYND, representing a 6% increase over Q2 2025[6] - 149 patients are currently on therapy in the U.S., reflecting a 5% increase from Q2 2025[6] Expenses - Research and Development expenses for Q3 2025 were $86.8 million, an increase of $14.3 million compared to Q3 2024[12] - Selling, General and Administrative expenses for Q3 2025 were $41.3 million, up $2.7 million from Q3 2024, driven by preparations for the potential U.S. launch of PYRUKYND[12]
Agios Pharmaceuticals(AGIO) - 2025 Q3 - Quarterly Results