secwatch.observer — SEC 8-K summary
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Issuer:     AGIOS PHARMACEUTICALS, INC. (AGIO)
CIK:        0001439222
Form:       8-K
Filed at:   2025-01-13T23:59:59+00:00
Accession:  0001193125-25-004943
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Agios announces 2025 milestones: PYRUKYND PDUFA Sept 7; RISE UP topline in late 2025
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- FDA accepted sNDA for PYRUKYND in thalassemia; PDUFA goal date September 7, 2025.
- Phase 3 RISE UP topline results expected late 2025; potential U.S. commercial launch in 2026.
- Received $1.1B in milestone payments: $905M from Royalty Pharma, $200M from Servier post vorasidenib approval.
- Phase 3 ACTIVATE-Kids topline in early 2025; Phase 2b tebapivat enrollment completion late 2025.
- IND filing planned for AG-236 siRNA in polycythemia vera mid-2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1439222/000119312525004943/0001193125-25-004943-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1439222/000119312525004943/d131665d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-004943

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