MYOV - Myovant Sciences tumbles on FDA clinical hold on late-stage study for relugolix tablet

Myovant Sciences (MYOV) has lost ~7.1% in the pre-market after announcing that the FDA has placed a partial clinical hold on its SERENE study (MVT-601-050).The FDA decision was pending an amendment to the study protocol “to add bone mineral density monitoring,” the company said.The Phase 3 trial was designed to evaluate the relugolix combination pill for the prevention of pregnancy.“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.In December 2020, Myovant signed a deal with Pfizer to jointly develop the relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in women’s health in the U.S. and Canada.

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Myovant Sciences tumbles on FDA clinical hold on late-stage study for relugolix tablet