---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-004943"
form_type: "8-K"
ticker: "AGIO"
cik: "0001439222"
company_name: "AGIOS PHARMACEUTICALS, INC."
filed_at: "2025-01-13T23:59:59+00:00"
generated_at: "2026-05-28T03:05:27.853209+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Agios announces 2025 milestones: PYRUKYND PDUFA Sept 7; RISE UP topline in late 2025

## Summary
- 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.

## SEC filing metadata
- accession: 0001193125-25-004943
- form_type: 8-K
- ticker: AGIO
- cik: 0001439222
- company_name: AGIOS PHARMACEUTICALS, INC.
- filed_at: 2025-01-13T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1439222/000119312525004943/0001193125-25-004943-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1439222/000119312525004943/d131665d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-004943
- JSON: https://secwatch.observer/filing/0001193125-25-004943.json
- Plain text: https://secwatch.observer/filing/0001193125-25-004943.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.