Curis Sinks as FDA Puts Partial Hold on Cancer Medicine
Curis Inc. (CRIS), a developer of cancer medicines, fell the most in more than three years after U.S. regulators placed a partial hold on a trial of its drug for solid tumors after a patient died from liver failure.
Curis dropped 21 percent to $3.08 at 10:16 a.m. New York time after falling to $3.03 in its biggest intraday decline since June 2010. The shares of the Lexington, Massachusetts-based company had risen 13 percent this year through yesterday.
The Food and Drug Administration said no new patients should be given the experimental medicine until an analysis of how to proceed is done, the company said today in a statement. The trial of CUDC-427 was in the first of three phases of studies generally required for regulatory approval. No patients are currently being treated with the drug, Curis said.
“Partial holds and development delays are not unusual, especially at this stage,” Adnan Butt, an analyst with RBC Capital Markets, wrote in a research note. “Nevertheless they add to perceived risk and delay developments by at least a couple of months potentially.”
The patient, who had breast cancer that had spread to the liver, lungs, bones and ovaries, developed problems with liver function and died a month after discontinuing the drug, the company said. No other participants had experienced similar liver issues, Curis said.
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