regulatory
confidence high
sentiment negative
materiality 0.80
FDA partial clinical hold on Curis' TakeAim Lymphoma study; no new enrollment
CURIS INC
- 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.