AGIO AGIOS PHARMACEUTICALS, INC.

Q3 2025 10-Q
Filed: Oct 30, 2025Period ending Sep 30, 2025
Health Care
Pharmaceutical PreparationsSEC EDGAR

AGIOS PHARMACEUTICALS, INC. (AGIO) 10-Q quarterly report for Q3 2025, filed with SEC EDGAR on Oct 30, 2025 for the fiscal period ending Sep 30, 2025. This page provides AI-powered analysis including management discussion & analysis (MD&A), risk factor updates, and key quarterly financial data such as revenue and net income extracted from XBRL.

AI Filing Analysis
Q3 2025 10-Q

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
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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
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