---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-001809"
form_type: "8-K"
ticker: "AGIO"
cik: "0001439222"
company_name: "AGIOS PHARMACEUTICALS, INC."
filed_at: "2025-01-06T23:59:59+00:00"
generated_at: "2026-05-28T10:28:21.617256+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA adds liver injury warning to PYRUKYND label for PK deficiency

## Summary
- FDA approved update to PYRUKYND USPI: liver injury observed in patients with another condition at higher doses.
- New Warnings: obtain liver tests before initiation, monthly for first 6 months, interrupt if ALT >5x ULN.
- All patients with liver injury discontinued PYRUKYND and improved upon discontinuation.
- Adverse Reactions section updated to reflect hepatocellular injury in another condition.

## SEC filing metadata
- accession: 0001193125-25-001809
- form_type: 8-K
- ticker: AGIO
- cik: 0001439222
- company_name: AGIOS PHARMACEUTICALS, INC.
- filed_at: 2025-01-06T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 7.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1439222/000119312525001809/0001193125-25-001809-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1439222/000119312525001809/d911895d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-001809
- JSON: https://secwatch.observer/filing/0001193125-25-001809.json
- Plain text: https://secwatch.observer/filing/0001193125-25-001809.txt

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