secwatch.observer — SEC 8-K summary
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Issuer:     AGIOS PHARMACEUTICALS, INC. (AGIO)
CIK:        0001439222
Form:       8-K
Filed at:   2025-02-13T23:59:59+00:00
Accession:  0001439222-25-000007
Event type: earnings
Sentiment:  neutral
Materiality: 0.70
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Agios Q4: PYRUKYND revenue $10.7M, mitapivat PDUFA Sept 7, 2025; cash $1.5B
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- PYRUKYND net revenue $10.7M in Q4 (+20% QoQ), full year $36.5M vs $26.8M in 2023.
- Filed for mitapivat approval in thalassemia in US, EU, KSA, UAE; PDUFA goal date Sept 7, 2025.
- Phase 3 RISE UP for sickle cell disease fully enrolled (>200 patients); topline results late 2025, potential launch 2026.
- Cash, cash equivalents and marketable securities $1.5B as of Dec 31, 2024; net loss Q4 $96.5M, full year net income $673.7M.
- Board member David Schenkein to step down effective Feb 28, 2025; remains as strategic advisor.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1439222/000143922225000007/0001439222-25-000007-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1439222/000143922225000007/agio-20250213.htm
  HTML page:      https://secwatch.observer/filing/0001439222-25-000007

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