---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-094363"
form_type: "8-K"
ticker: "CRIS"
cik: "0001108205"
company_name: "CURIS INC"
filed_at: "2022-04-04T23:59:59+00:00"
generated_at: "2026-06-26T09:41:50.718331+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA partial clinical hold on Curis leukemia study after patient death; lymphoma study paused

## Summary
- FDA partial clinical hold on TakeAim Leukemia Phase 1/2a (NCT04278768); no new patients enrolled.
- Hold triggered by death of R/R AML patient; rhabdomyolysis identified as dose-limiting toxicity.
- Current patients may continue on emavusertib at ≤300mg BID; FDA requests additional safety data.
- Curis voluntarily pauses enrollment in TakeAim Lymphoma study (NCT03328078) pending hold resolution.
- FDA also requests data on Recommended Phase 2 Dose determination for emavusertib.

## SEC filing metadata
- accession: 0001193125-22-094363
- form_type: 8-K
- ticker: CRIS
- cik: 0001108205
- company_name: CURIS INC
- filed_at: 2022-04-04T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1108205/000119312522094363/0001193125-22-094363-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1108205/000119312522094363/d318642d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-094363
- JSON: https://secwatch.observer/filing/0001193125-22-094363.json
- Plain text: https://secwatch.observer/filing/0001193125-22-094363.txt

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