Curis Plummets To 52-Week Low After FDA Clinical Hold On Blood Cancer Trial

The FDA has placed a partial clinical hold on Curis Inc's CRIS TakeAim Leukemia Phase 1/2a study in relapsed or refractory (R/R) acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
The TakeAim Leukemia study is evaluating emavusertib (CA-4948) as monotherapy and in combination with azacitidine or venetoclax
No new patients will be enrolled in the study. Current study participants benefitting from treatment may continue to be treated with emavusertib at 300mg BID or lower doses.
The FDA is requesting additional data from the study, including data related to the death of an R/R AML patient who experienced rhabdomyolysis, which has previously been identified as dose-limiting toxicity of emavusertib.
Related: Curis Shares Drop After Updated CA-4948 Data From Mid-Stage Blood Cancer Trial.
Additionally, the FDA is requesting safety, efficacy, and other data, including data related to rhabdomyolysis and the Company's determination of the Recommended Phase 2 Dose for emavusertib in this study.
The partial hold does not affect the TakeAim Lymphoma Phase 1/2 trial investigating emavusertib in patients with B-cell malignancies.
But the Company has decided to pause enrollment of new patients in that study, pending resolution of the partial clinical hold in the TakeAim Leukemia study.
Price Action: CRIS shares are down 28.80% at $1.73 during the premarket session on the last check Monday.