secwatch.observer — SEC 8-K summary
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Issuer:     CURIS INC (CRIS)
CIK:        0001108205
Form:       8-K
Filed at:   2023-07-06T23:59:59+00:00
Accession:  0001108205-23-000054
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1108205/000110820523000054/0001108205-23-000054-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1108205/000110820523000054/cris-20230706.htm
  HTML page:      https://secwatch.observer/filing/0001108205-23-000054

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer