- The European Commission (EC) has approved Myovant Sciences Ltd's (NYSE: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.
