Agios Pharmaceuticals(AGIO)2025-05-01 10:32Financial Performance - PYRUKYND generated net revenue of $8.7 million in Q1 2025, up from $8.2 million in Q1 2024, representing a year-over-year increase of 6.1%[3] - The net loss for Q1 2025 was $89.3 million, compared to a net loss of $81.5 million in Q1 2024, reflecting an increase of 9.8%[7] - Cash, cash equivalents, and marketable securities totaled $1.4 billion as of March 31, 2025, down from $1.5 billion at the end of 2024[8] Expenses - Research and Development (R&D) expenses for Q1 2025 were $72.7 million, an increase of 5.2% compared to $68.6 million in Q1 2024[5] - Selling, General and Administrative (SG&A) expenses rose to $41.5 million in Q1 2025, compared to $31.0 million in Q1 2024, marking a 33.9% increase[7] Patient Enrollment - The total number of unique patients who completed prescription enrollment forms for PYRUKYND increased by 5% from Q4 2024, reaching 234 patients[3] Regulatory and Clinical Developments - The FDA accepted the supplemental New Drug Application (sNDA) for PYRUKYND for thalassemia treatment, with a PDUFA goal date of September 7, 2025[2] - The Phase 3 RISE UP study for mitapivat in sickle cell disease is on track, with topline results expected in late 2025 and a potential U.S. commercial launch in 2026[2] - Agios plans to file an Investigational New Drug Application for AG-236, targeting TMPRSS6 for polycythemia vera, in mid-2025[5] Strategic Focus - The company is advancing its pipeline with a focus on transformative therapies for rare diseases, aiming to create significant value for shareholders[2]