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Mar 31, 2025
Agios Q1 2025 Earnings Report
Reported first quarter 2025 financial results and business highlights
Key Takeaways
Agios Pharmaceuticals reported a net loss of $89.3 million in the first quarter of 2025, compared to a net loss of $81.5 million in the same period last year. Revenue from PYRUKYND sales increased to $8.7 million from $8.2 million. The company is advancing its pipeline with key milestones anticipated in 2025, including a PDUFA goal date for PYRUKYND in thalassemia and expected topline results for the Phase 3 RISE UP study in sickle cell disease.
Generated $8.7 million in net revenue from PYRUKYND sales in Q1 2025, an increase from $8.2 million in Q1 2024.
Reported a net loss of $89.3 million for the first quarter of 2025.
Cash, cash equivalents and marketable securities stood at $1.4 billion as of March 31, 2025.
The sNDA for PYRUKYND in thalassemia has been accepted with a PDUFA goal date of September 7, 2025.
Revenue by Segment
Forward Guidance
Agios anticipates several key milestones in 2025, including a regulatory decision for PYRUKYND in thalassemia, topline results for the Phase 3 RISE UP study in sickle cell disease, and advancements in other clinical programs.
Positive Outlook
- Receive FDA regulatory decision for PYRUKYND in thalassemia (PDUFA goal date September 7, 2025).
- Announce topline results from the Phase 3 RISE UP study of mitapivat in sickle cell disease in late 2025.
- Potential U.S. commercial launch of mitapivat in sickle cell disease in 2026.
- Begin patient enrollment for the Phase 2 study of tebapivat in sickle cell disease in mid-2025.
- File an Investigational New Drug Application for AG-236 in mid-2025.
Challenges Ahead
- Review of regulatory applications with health authorities in the European Union, Kingdom of Saudi Arabia and United Arab Emirates is ongoing.
- No advisory committee meeting is planned by the FDA for the thalassemia sNDA.
- Completion of patient enrollment in the Phase 2b study of tebapivat for LR-MDS is expected in late 2025.
Historical Earnings Impact
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