AGIO AGIOS PHARMACEUTICALS, INC.
FY2025 10-K
AGIOS PHARMACEUTICALS, INC. (AGIO) filed its fiscal year 2025 10-K annual report with the SEC on Feb 12, 2026. This page provides AI-powered analysis of the filing, including business overview, management discussion, risk factors, and key financial metrics from XBRL data.
AI Filing AnalysisFY2025 10-K
Business Overview
- • Core business: Commercial-stage biopharma focused on rare hematology diseases via PK activator small molecules
- • New regulatory approvals for mitapivat: FDA approval of AQVESME™ for thalassemia anemia (Dec 2025), Saudi Arabia approval for PYRUKYND®, EMA positive opinion pending final decision early 2026
Management Discussion & Analysis
- • Revenue from PYRUKYND® and AQVESME™ product sales began in 2022 and 2026 respectively; milestone income $200M in 2024 from Vorasidenib FDA approval
- • Net income $673.7M in 2024 driven by $1.09B total gain from Vorasidenib royalty rights sale and milestone payment, net loss $412.8M in 2025, net loss $352.1M in 2023
Risk Factors
- • Regulatory risk: FDA REMS requirements for AQVESME™ due to boxed warning on hepatocellular injury risk
- • Macroeconomic risk: geopolitical events like war impacting patient enrollment and clinical trial site operations internationally
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