---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-22-233468"
form_type: "8-K"
ticker: "CRIS"
cik: "0001108205"
company_name: "CURIS INC"
filed_at: "2022-08-30T23:59:59+00:00"
generated_at: "2026-06-23T19:12:39.738172+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: "high"
source: SEC EDGAR
---

# FDA allows Curis to resume enrollment in Phase 1a of emavusertib leukemia study

## Summary
- FDA removed partial clinical hold on monotherapy dose-finding (Phase 1a) of TakeAim Leukemia study after reviewing rhabdomyolysis data.
- At least nine additional patients will be enrolled at the 200 mg dose level in Phase 1a.
- Partial hold remains on combination phase (Phase 1b) and expansion phase (Phase 2a) until FDA approves progression.
- Rhabdomyolysis side-effect management strategy was key to FDA clearance; similar to approach used with Odomzo and Cotellic.
- Preliminary clinical data update from TakeAim Leukemia study expected in 2023; company engaging FDA leukemia division on optimal dose and development path.

## SEC filing metadata
- accession: 0001193125-22-233468
- form_type: 8-K
- ticker: CRIS
- cik: 0001108205
- company_name: CURIS INC
- filed_at: 2022-08-30T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.6
- calibrated_materiality_score: 0.6
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1108205/000119312522233468/0001193125-22-233468-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1108205/000119312522233468/d397699d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-22-233468
- JSON: https://secwatch.observer/filing/0001193125-22-233468.json
- Plain text: https://secwatch.observer/filing/0001193125-22-233468.txt

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