Loading...
•
Sep 30, 2025
Agios Q3 2025 Earnings Report
Agios reported its third quarter 2025 financial results, highlighting increased PYRUKYND net revenues and progress in its rare disease pipeline.
Key Takeaways
Agios Pharmaceuticals reported a net loss of $103.4 million in Q3 2025, a significant decrease from a net income of $947.9 million in Q3 2024, which was boosted by one-time payments. However, PYRUKYND net product revenue increased by 44% year-over-year to $12.9 million, demonstrating strong commercial performance for its key product. The company also made substantial progress in its clinical pipeline, with key regulatory milestones for PYRUKYND in thalassemia and completed enrollment for a Phase 2b trial of tebapivat in LR-MDS.
Net product revenue from PYRUKYND reached $12.9 million in Q3 2025, a 44% increase from Q3 2024.
Agios reported a net loss of $103.4 million for Q3 2025, compared to a net income of $947.9 million in Q3 2024 due to prior year's one-time gains.
The PDUFA goal date for PYRUKYND's U.S. sNDA in thalassemia was extended to December 7, 2025, and a positive CHMP opinion was adopted in Europe.
Cash, cash equivalents, and marketable securities stood at $1.3 billion as of September 30, 2025, providing financial independence for future launches and pipeline advancement.
Revenue by Segment
Forward Guidance
Agios anticipates several key milestones by year-end and early 2026, including potential U.S. approval for PYRUKYND in thalassemia, topline results for the RISE UP Phase 3 trial in sickle cell disease, and topline results for the Phase 2b tebapivat trial in LR-MDS.
Positive Outlook
- PDUFA goal date for PYRUKYND U.S. sNDA in thalassemia set for December 7, 2025.
- CHMP adopted positive opinion for PYRUKYND in thalassemia, with EC decision expected by early 2026.
- Topline results from RISE UP Phase 3 trial in sickle cell disease expected by year-end, potentially supporting a U.S. commercial launch in 2026.
- Phase 2b tebapivat trial in lower-risk MDS fully enrolled, with topline results expected in early 2026.
- PYRUKYND received approval in Saudi Arabia for thalassemia, with commercial launch activities underway.
Challenges Ahead
- The PDUFA goal date for PYRUKYND U.S. sNDA in thalassemia was extended by three months due to an FDA request for a REMS.
- No specific negative forward-looking statements were highlighted beyond the PDUFA extension reason.
Historical Earnings Impact
Analyze how earnings announcements historically affect stock price performance
Avg. Return Before/After Earnings
Loading earnings performance data...
Loading earnings reaction data...