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ObsEva Files US Application For Linzagolix For Uterine Fibroids

  • ObsEva SA (NASDAQ: OBSV) has submitted a marketing application to the FDA seeking approval for linzagolix for uterine fibroids. 
  • Linzagolix is an oral GnRH receptor antagonist. 
  • Related Link: ObsEva Shares Gains On Positive Linzagolix Data In Uterine Fibroids Study.
  • The Company believes that if approved, linzagolix will be the only GnRH antagonist in uterine fibroids with a low dose non-add-back therapy (ABT) option.
  • The submission includes 52-week treatment results from the Phase 3 PRIMROSE 1 (the U.S. only; n=574) and PRIMROSE 2 (Europe and U.S.; n=535) clinical studies as supportive results from the 76-week post-treatment follow-up study. 
  • Concurrently, ObsEva is also working closely with the European Medicine Agency (EMA) to achieve marketing approval for Linzagolix. 
  • CHMP opinion for Linzagolix is expected in Q4 2021.
  • Related content: Benzinga’s Full FDA Calendar.
  • Price Action: OBSV stock is up 5.32% at $3.17 during the premarket session on the last check Wednesday.

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