secwatch.observer — SEC 8-K summary
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Issuer:     AGIOS PHARMACEUTICALS, INC. (AGIO)
CIK:        0001439222
Form:       8-K
Filed at:   2025-10-30T23:59:59+00:00
Accession:  0001439222-25-000114
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Agios Q3 PYRUKYND rev $12.9M (+44% YoY); net loss $103.4M; thalassemia PDUFA Dec 7
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- Q3 PYRUKYND net revenue $12.9M (+44% YoY vs $9.0M); 149 U.S. patients on therapy.
- Net loss $103.4M in Q3 2025 vs net income $947.9M in Q3 2024 (prior-year milestone payments).
- Cash $1.3B; PDUFA goal date Dec 7, 2025 for PYRUKYND sNDA in thalassemia.
- CHMP positive opinion for PYRUKYND in thalassemia; EC decision expected early 2026.
- RISE UP Phase 3 sickle cell disease topline results by year-end; tebapivat Phase 2b topline early 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1439222/000143922225000114/0001439222-25-000114-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1439222/000143922225000114/agio-20251030.htm
  HTML page:      https://secwatch.observer/filing/0001439222-25-000114

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer