Short answer
AGIOS PHARMACEUTICALS, INC. (AGIO) filed its Q3 2025 10-Q quarterly report on Oct 30, 2025 for the quarter ended Sep 30, 2025. Quarterly revenue was $13M (up 43.7% year over year) with net income of −$103M.
Q3 2025 key financials · XBRL
- Revenue
- $13M
- +43.7% YoY · +3.4% QoQ
- Net income
- −$103M
- −110.9% YoY · +7.7% QoQ
- Operating margin
- -907.4%
- EPS (diluted)
- −$1.78
- −110.8% YoY · +8.2% QoQ
Source: XBRL data from the AGIOS PHARMACEUTICALS, INC. (AGIO) Q3 2025 10-Q on SEC EDGAR. USD.
AGIOS PHARMACEUTICALS, INC. Q3 2025 10-Q analysis
AI summary of MD&A and risk factor updates
Management Discussion & Analysis
- Revenue $12.9M, up $3.9M (44%) YoY in Q3 2025 driven by PYRUKYND® volume increase
- Net loss $103.4M vs net income $947.9M YoY in Q3 due to prior year Vorasidenib royalty sale gains
- Best segment: PYRUKYND® product revenue $12.9M in Q3 2025; Worst: Overall net loss driven by increased R&D and SG&A expenses
- Cash, cash equivalents, and marketable securities $1.3B at Sept 30, 2025; operating cash used $276.8M YTD
- Outlook: Expect increased expenses for PYRUKYND® commercialization in thalassemia/SCD and pipeline advancement; no committed external funds except retained earn-out rights
Risk Factors
- New regulatory risk: FDA extended PYRUKYND® sNDA PDUFA date to Dec 7, 2025 due to proposed REMS submission for hepatocellular injury risk
- Material update clinical risk: USPI updated January 2025 adding liver injury safety info for PYRUKYND® at higher doses in thalassemia patients
- Most impactful legal/compliance risk: Potential additional REMS requirements by FDA based on safety concerns could delay prescribing and restrict use
- Operational risk near-term: Clinical trial enrollment delays due to limited patient pools in orphan diseases and geopolitical risks in Middle East sites
- Financial risk concentration: Up to $130M development/regulatory milestones plus royalties owed under Alnylam license for siRNA candidate AG-236
Generated from the filing text; verify against the original. 10-K vs 10-Q vs 8-K
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