Myovant Sciences' Relugolix For Hormone-Sensitive Prostate Cancer Approved In Europe

  • The European Commission (EC) has approved Myovant Sciences Ltd's MYOV Orgovyx (relugolix, 120 mg) for advanced hormone-sensitive prostate cancer. 
  • This approval was supported by data from the Phase 3 HERO study.
  • In the HERO study, Orgovyx met the primary endpoint and achieved sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks in 96.7% of men, compared with 88.8% of men receiving leuprolide acetate injections, the current standard of care.
  • Also See: What's Going On With Myovant Sciences Stock Today?
  • Orgovyx also achieved several key secondary endpoints compared to leuprolide acetate, including suppression of testosterone to castrate levels and profound testosterone suppression. 
  • The FDA approved Orgovyx in December 2020.
  • Price Action: MYOV shares closed at $9.31 on Friday.
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