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Dec 31, 2025
Agios Q4 2025 Earnings Report
Agios reported its financial results for the fourth quarter and full year ended December 31, 2025.
Key Takeaways
Agios Pharmaceuticals reported a net loss of $108.0 million in Q4 2025, an increase from $96.5 million in Q4 2024. Despite the loss, the company saw strong performance in PYRUKYND® U.S. net revenue, which increased by 49% year-over-year to $16.0 million. The historic U.S. approval and launch of AQVESME™ for thalassemia and progress in its sickle cell disease programs were key highlights.
PYRUKYND® (mitapivat) worldwide net revenues reached $20.0 million in Q4 2025 and $54.0 million for the full year.
AQVESME™ (mitapivat) for thalassemia is now available in the U.S. following FDA approval.
Agios plans a pre-sNDA meeting with the FDA for mitapivat in sickle cell disease in Q1 2026.
The company holds $1.2 billion in cash, cash equivalents, and marketable securities as of December 31, 2025.
Revenue by Segment
Forward Guidance
Agios expects its cash, cash equivalents, and marketable securities, combined with anticipated product revenue and interest income, to provide financial independence for the U.S. commercial launch of AQVESME in thalassemia, preparation for the potential U.S. commercial launch of mitapivat in sickle cell disease, advancement of existing clinical programs, and opportunistic pipeline expansion.
Positive Outlook
- Financial independence to execute the U.S. commercial launch of AQVESME in thalassemia.
- Preparation for the potential U.S. commercial launch of mitapivat in sickle cell disease.
- Advancement of existing clinical programs.
- Opportunistic expansion of its pipeline through both internally and externally discovered assets.
- Focus on driving a high-impact U.S. launch of AQVESME and expanding the PK activation franchise into additional high-value indications.
Challenges Ahead
- Uncertainty regarding the timing and outcome of regulatory approvals for mitapivat in sickle cell disease.
- Risks associated with the successful commencement and completion of preclinical and clinical development phases for product candidates.
Historical Earnings Impact
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Avg. Return Before/After Earnings
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