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FDA calls partial halt to Phase I trial of Curis cancer drug

  • 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)
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