- Curis ( NASDAQ: CRIS ) said the U.S. Food and Drug Administration (FDA) lifted the partial clinical hold on a phase 1/2 trial (TakeAim Lymphoma) of emavusertib in lymphoma after reviewing data submitted by the company.
- In April, the FDA placed separate partial clinical holds on the TakeAim Leukemia and TakeAim Lymphoma studies.
- The hold on the Leukemia study was carried out following a death of a patient with acute myeloid leukemia who experienced rhabdomyolysis, a previously identified dose-limiting toxicity of the candidate.
- Rhabdomyolys is a condition of rapid dissolution of damaged or injured skeletal muscle.
- Curis said in an Aug. 18 press release that the hold was lifted following agreement with the FDA on the company's strategy for rhabdomyolysis identification and management, and on the enrollment of at least nine additional patients at the 200 mg dose level of emavusertib in combination with ibrutinib.
- The company added that it expects preliminary clinical data update in 2023.
- CRIS +34.29% to $1.41 premarket Aug. 18
For further details see:
Curis stock soars 34% as FDA lifts partial clinical hold on emavusertib's lymphoma study