---
schema_version: "secwatch.filing_event.v1"
accession: "0001439222-26-000023"
form_type: "8-K"
ticker: "AGIO"
cik: "0001439222"
company_name: "AGIOS PHARMACEUTICALS, INC."
filed_at: "2026-02-12T23:59:59+00:00"
generated_at: "2026-05-16T02:58:47.092370+00:00"
event_type: "earnings"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Agios Q4 net loss $108M; AQVESME approved for thalassemia, U.S. launch started

## Summary
- PYRUKYND worldwide net revenue $20M in Q4 ($16M U.S., $4M ex-U.S.), up 49% YoY in U.S.
- Full-year 2025 PYRUKYND revenue $54M; net loss $108M in Q4 vs $96.5M in Q4 2024.
- FDA approved AQVESME (mitapivat) for thalassemia in Dec 2025; U.S. launch began late Jan 2026.
- Pre-sNDA meeting with FDA for mitapivat in sickle cell disease expected Q1 2026.
- Phase 2 tebapivat trial in sickle cell disease fully enrolled; topline data in H2 2026.

## SEC filing metadata
- accession: 0001439222-26-000023
- form_type: 8-K
- ticker: AGIO
- cik: 0001439222
- company_name: AGIOS PHARMACEUTICALS, INC.
- filed_at: 2026-02-12T23:59:59+00:00
- event_type: earnings
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1439222/000143922226000023/0001439222-26-000023-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1439222/000143922226000023/agio-20260212.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001439222-26-000023
- JSON: https://secwatch.observer/filing/0001439222-26-000023.json
- Plain text: https://secwatch.observer/filing/0001439222-26-000023.txt

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