Zafgen halts obesity drug trial after second patient death
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Zafgen Inc said the U.S. Food and Drug Administration was putting a late-stage study testing its experimental obesity drug on complete hold after a second patient died during the trial.
The company's shares fell 7.4 percent to $5.81 in extended trading after closing down 60 percent on Wednesday.
A complete clinical hold is an order that the FDA issues to a sponsor to suspend all clinical work requested under the company's investigational new drug application.
Earlier on Wednesday, the company had said a patient receiving the obesity drug, beloranib, had died from a blockage in an artery in the lung.
Zafgen, which is testing beloranib for a rare genetic eating disorder called Prader-Willi syndrome, expects to report results from the study in the first quarter.
The company said it was working with experts to better understand the incidence and the occurrence of such artery blockages in Prader-Willi syndrome patients.
The company's shares fell 7.4 percent to $5.81 in extended trading after closing down 60 percent on Wednesday.
A complete clinical hold is an order that the FDA issues to a sponsor to suspend all clinical work requested under the company's investigational new drug application.
Earlier on Wednesday, the company had said a patient receiving the obesity drug, beloranib, had died from a blockage in an artery in the lung.
Zafgen, which is testing beloranib for a rare genetic eating disorder called Prader-Willi syndrome, expects to report results from the study in the first quarter.
The company said it was working with experts to better understand the incidence and the occurrence of such artery blockages in Prader-Willi syndrome patients.
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