Myovant Sciences' Relugolix Combo Tablet For Uterine Fibroids Scores EMA Backing For Approval

  • European Medicines Agency's advisory committee issued a positive opinion recommending the approval of Myovant Sciences Ltd's MYOV Ryeqo (relugolix, estradiol, and norethindrone acetate) for uterine fibroids.
  • The final decision on the application is expected to be available in approximately two months.
  • Gedeon Richter will commercialize Ryeqo for uterine fibroids, if approved, in Europe under an agreement announced in March 2020.
  • Relugolix combination tablet for uterine fibroids is also under review by the FDA with a target action date of June 1.
  • Price Action: MYOV shares are up 2.56% at $22.81 during the market session on the last check Friday.
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