The company’s shares rose about 3 percent to $1.97 in premarket trading on Thursday. Cell Therapeutics said it received the notification from the regulator on December 26. The FDA placed the hold after a patient treated with a combination of the drug, tosedostat, and a chemotherapy drug died of a heart muscle infection. Under the hold, the company could not enroll new patients in any trials of tosedostat. The regulator asked for more information on all heart-related events in patients treated with the drug. Tosedostat is being tested in mid-stage trials in the United States and European Union on elderly patients with two forms of blood cancer - acute myeloid leukemia and myelodysplastic syndrome.
FDA lifts hold on studies testing Cell Therapeutics' cancer drug.