---
schema_version: "secwatch.filing_event.v1"
accession: "0001108205-23-000054"
form_type: "8-K"
ticker: "CRIS"
cik: "0001108205"
company_name: "CURIS INC"
filed_at: "2023-07-06T23:59:59+00:00"
generated_at: "2026-06-13T11:35:22.896869+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# FDA lifts partial clinical hold on Curis leukemia study; RP2D set at 300 mg BID

## Summary
- FDA removed partial clinical hold on TakeAim Leukemia Phase 1/2 study of emavusertib (CA-4948).
- Recommended Phase 2 dose (RP2D) for monotherapy established at 300 mg BID in AML/MDS patients.
- At 300 mg BID, 2 of 3 FLT3-mutant AML patients achieved CR; 2 of 3 spliceosome-mutant achieved CR/CRh.
- Company plans to enroll targeted AML patients and initiate front-line combination study with azacitidine/venetoclax.
- Expects updated monotherapy data, registrational study design, and initial combo data in 2024.

## SEC filing metadata
- accession: 0001108205-23-000054
- form_type: 8-K
- ticker: CRIS
- cik: 0001108205
- company_name: CURIS INC
- filed_at: 2023-07-06T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1108205/000110820523000054/0001108205-23-000054-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1108205/000110820523000054/cris-20230706.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001108205-23-000054
- JSON: https://secwatch.observer/filing/0001108205-23-000054.json
- Plain text: https://secwatch.observer/filing/0001108205-23-000054.txt

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