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Zafgen's beloranib on full clinical hold after second death

December 3, 2015 1:48 AM UTC

FDA placed a full clinical hold on studies of beloranib ( ZGN-440) from Zafgen Inc. (NASDAQ:ZFGN). The move followed the company's announcement that a second patient receiving beloranib died with pulmonary emboli in the Phase III bestPWS (ZAF-311) trial to treat Prader-Willi syndrome.

The patient was in the six-month open-label extension of bestPWS. In October, the company reported a patient death in the trial's randomized portion (see BioCentury Extra, Oct. 22). ...