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

by Vandana Singh, Benzinga Editor

May 19, 2021 8:03 AM | 1 min read |

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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