secwatch.observer — SEC 8-K summary
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Issuer:     CURIS INC (CRIS)
CIK:        0001108205
Form:       8-K
Filed at:   2022-08-30T23:59:59+00:00
Accession:  0001193125-22-233468
Event type: regulatory
Sentiment:  neutral
Materiality: 0.60
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1108205/000119312522233468/0001193125-22-233468-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1108205/000119312522233468/d397699d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-233468

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