The FDA has placed a partial clinical hold on the Phase I trial of Curis' (CRIS) CUDC-427 treatment for advanced and refractory solid tumors or lymphomas.
The FDA ordered the halt following the death a patient who suffered liver failure a month after discontinuing treatment with CUDC-427.
Curis won't be able to enroll new patients for the study until it has met various FDA requirements; all the subjects in the trial have stopped taking the drug due to disease progression, or patient or physician discretion
The company licensed CUDC-427 from Roche's (RHHBY) Genentech.
Curis' shares sink 10.5%.
Curis' Q3 results. (PR)