US biotech firm Zafgen (Nasdaq: ZFGN) saw its share plunge on Wednesday after it announced that it had learned of a patient death which occurred in the company’s ongoing double-blind, randomized, placebo-controlled Phase III bestPWS study of its lead product candidate beloranib in Prader-Willi syndrome, a rare genetic disorder with a high rate of mortality linked to obesity and its co-morbidities. The cause of death remains unknown at this time.
According to normal practice, Zafgen said, the event was reported to the US Food and Drug Administration, at which point the agency initiated a discussion with the company. Zafgen is working with the FDA to expedite a review and understanding of this event, and to determine implications of the event on the conduct of the trial, and anticipates providing an update as its discussions with the agency progress.
The company's shares, which had lost about 54%of its value in the past two days, when the company cancelled planned investor meetings for no apparent reason, fell as much as 30% to a record low on Wednesday. Zafgen now trades at around $12.50 a share - well below its $16 per share initial public offering (IPO) price in June 2014, noted Xcomomy
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