Myovant Sciences Says FDA Places Phase 3 SERENE Study On Partial Clinical Hold

(RTTNews) - Myovant Sciences Ltd. (MYOV) said the Food and Drug Administration has placed a partial clinical hold on the Phase 3 SERENE study of its relugolix combination tablet proposed for the prevention of pregnancy pending amendment of the study protocol to add bone mineral density monitoring.

The FDA informed this on May 18, 2021 to the company by teleconference, Myovant said in an SEC filing dated May 19, 2021.

Myovant said it will work to implement the requested monitoring and submit the amended protocol to the FDA to resolve the issue.

On April 12, 2021, Myovant Sciences and Pfizer had announced that the first participant was dosed in the Phase 3 SERENE study. The two companies had announced a collaboration in December, 2020 to develop and commercialize relugolix.