secwatch.observer — SEC 8-K summary
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Issuer:     CURIS INC (CRIS)
CIK:        0001108205
Form:       8-K
Filed at:   2022-04-11T23:59:59+00:00
Accession:  0001193125-22-101017
Event type: regulatory
Sentiment:  negative
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

FDA partial clinical hold on Curis' TakeAim Lymphoma study; no new enrollment
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- FDA placed partial clinical hold on Phase 1/2 TakeAim Lymphoma study of emavusertib in B-cell malignancies.
- No new patients can be enrolled; current participants benefiting may continue at 300mg BID or lower after reconsent.
- Hold follows prior partial hold on TakeAim Leukemia study announced April 4, 2022; company had already paused enrollment voluntarily.
- FDA requests additional safety, efficacy, and rhabdomyolysis data; company to provide updated guidance after holds resolved.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1108205/000119312522101017/0001193125-22-101017-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1108205/000119312522101017/d352125d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-22-101017

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