- 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.
A Peek Into The Markets: US Stock Futures Up Following Thursday’s Plunge; Crude Oil Rises
Pre-open movers
U.S. stock futures traded higher in early pre-market trade ahead of the release of wholesale inventories data. The Dow Jones closed lower by more than 250 points on Thursday after jobless claims unexpectedly rose in the latest week.
