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FDA to review clinical trial for rare-disorder drug after patient death
Published October 22, 2015
Zafgen Inc. said Thursday that the Food and Drug Administration (FDA) would review data from its clinical trial of a treatment for a rare genetic disorder, after the trial was halted by U.S. regulators this month following the death of a patient.
Shares of Zafgen, down 66 percent this month, gained 6.4 percent in premarket trading.
Zafgen said Thursday that it would end the randomized portion of the trial studying beloranib as a treatment for Prader-Willi syndrome and another treating patients with severe obesity complicated by Type 2 diabetes.
Zafgen said a sufficient number of patients have completed the treatment and closing the randomized portion early helps preserve the integrity of the data. The company will continue the open-label extension portion of the study to obtain ongoing efficacy and safety data.
Zafgen said it expects to report results from the trials in the first quarter of 2016. Zafgen said it expects the Prader-Willi syndrome trial to remain a pivotal clinical trial.
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