After Leukemia Trial, FDA Puts Partial Hold On Curis' Lymphoma Study

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  • The FDA has placed a partial clinical hold on Curis Inc's CRIS TakeAim Lymphoma study.
  • The TakeAim Lymphoma study is a Phase 1/2 open-label dose-escalating clinical trial investigating emavusertib in patients with B-cell malignancies.
  • This week's notification extends the partial hold across both lymphoma and leukemia studies. 
  • As previously announced, the Company had already voluntarily paused enrollment in the TakeAim Lymphoma study in connection to the FDA's partial clinical hold on the TakeAim Leukemia study.
  • While the partial hold on the TakeAim Lymphoma study is in place, no new patients will be enrolled in that study.
  • Current study participants benefiting from treatment may continue to be treated with emavusertib at doses of 300mg BID or lower after being reconsented.
  • Consistent with the previous notification, FDA is requesting additional safety, efficacy, and other data relating to emavusertib, including data on rhabdomyolysis and the determination of the Recommended Phase 2 Dose.
  • Price Action: CRIS shares are down 3.82% at $1.39 during the market session on the last check Monday.
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