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Zafgen Management Really Believes It Will Have Clinical Hold Removed; Decision Could Come In 4-6 Months, Analyst Says

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Leerink said Zafgen Inc ZFGN 1.67% management believes it will have clinical hold removed on beloranib and the brokerage expects a FDA decision in the next 4-6 months.

In December 2015, the FDA placed a clinical hold on beloranib investigational new drug (IND) application to treat Prader-Willi syndrome (PWS), a genetic disorder that causes learning difficulties, growth abnormalities, and obsessive eating.

"We expect the beloranib (Prader-Willi Syndrome [PWS]) risk mitigation proposal submitted by ZFGN to the FDA to present strong reasoning for removal of the full clinical hold; however, we continue to believe the threshold for establishing a positive risk/ benefit argument remains high, a decision is likely several months away, and it is difficult to handicap the FDA's response," analysts including Joseph Schwartz wrote in a note to clients.

"Although the timing of ZFGN's complete response...