OBSV - ObsEva submits marketing application for Yselty in Europe for uterine fibroids

ObsEva (OBSV) has submitted a Marketing Authorization Application ((MAA)) to the EMA for Yselty (linzagolix 100mg and 200mg) for the management of heavy menstrual bleeding ((HMB)) associated with uterine fibroids. The application is being submitted at this time as both Phase 3 studies, PRIMROSE 1 and PRIMROSE 2 have met their success criteria. The EMA will notify ObsEva in December 2020 regarding the outcome of its validation to ensure all essential regulatory elements are included in the application.Yesterday's close was $1.91. Shares +2% after-hours.

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ObsEva submits marketing application for Yselty in Europe for uterine fibroids