Myovant Stock Is Trading Lower After FDA Slapped Clinical Hold On Relugolix Combo Study

  • Myovant Sciences Ltd MYOV has received a partial clinical hold on its SERENE study (MVT-601-050) from the FDA.
  • The Phase 3 study was evaluating relugolix combination tablets for the prevention of pregnancy.
  • The FDA decision was pending an amendment to the study protocol “to add bone mineral density monitoring,” the company said.
  • “Myovant will work expeditiously to implement the requested monitoring and submit the amended protocol to FDA to resolve the partial clinical hold,” Myovant disclosed in a regulatory filing.
  • Price Action: MYOV shares are down 4.87% at $21.50 during the premarket session on the last check Wednesday.
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