
- The FDA has placed a partial clinical hold on Curis Inc's (NASDAQ: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.