ObsEva Shares Jump After Linzagolix Application For Uterine Fibroids Goes Under FDA Review

The FDA has accepted for review ObsEva SA's OBSV marketing application for linzagolix to manage heavy menstrual bleeding associated with uterine fibroids in premenopausal women.
The submission is based on data from the two Phase 3 PRIMROSE trials.
The FDA set a target action date of September 13, 2022.
The submission comprises 24-week treatment results from both studies and supportive results from Week 52 and the 76-week post-treatment follow-up.
Related Link: ObsEva Presents Linzagolix Data From Uterine Fibroid Trials.
The linzagolix European marketing application was validated by the European Medicine Agency (EMA) with an approval recommendation from the Committee for Medicinal Products for Human Use (CHMP) expected in Q4 2021.
ObsEva has entered into a partnership with Syneos Health to support the commercialization of linzagolix in the US and EU.
Linzagolix is a once-daily, oral GnRH receptor antagonist.
Price Action: OBSV shares are up 13.8% at $2.64 during the premarket session on the last check Monday.