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Biotech Stocks Facing FDA Decision In September

ObsEva
ObsEva

ObsEva SA’s (OBSV) Linzagolix, proposed for the treatment of uterine fibroids, is at the FDA altar, with a decision anticipated on September 13.

Linzagolix, an oral GnRH antagonist, was approved in Europe as recently as June of this year for the treatment of moderate to severe symptoms of Uterine Fibroids in adult women (over 18 years of age) of reproductive age, and is marketed under the brand name Yselty.

Recently, the company was notified by the FDA of review issues regarding deficiencies in the New Drug Application for Linzagolix for uterine fibroids. The resolution of the identified review issues may not be feasible by the decision date, according to the company.

OBSV closed Friday’s trading at $0.19, down 13.99%.