secwatch.observer — SEC 8-K summary
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Issuer:     CURIS INC (CRIS)
CIK:        0001108205
Form:       8-K
Filed at:   2022-04-04T23:59:59+00:00
Accession:  0001193125-22-094363
Event type: regulatory
Sentiment:  negative
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1108205/000119312522094363/0001193125-22-094363-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1108205/000119312522094363/d318642d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-094363

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