Myovant Sciences Ltd. (NYSE: MYOV) shares more than doubled on Tuesday after the firm announced results from its late-stage prostate cancer study. Specifically, these results come from the Phase 3 Hero study of relugolix.
Results from this study were ultimately positive, with relugolix meeting its primary efficacy endpoint and all six key secondary endpoints in men with advanced prostate cancer.
In the primary endpoint responder analysis, 96.7% of men receiving once-daily, oral relugolix achieved sustained testosterone suppression to castrate levels. For the study to be successful, the lower bound of the 95% confidence interval of the response rate had to be at least 90%.
In the relugolix group, 3.5% of men discontinued the study early due to adverse events compared with 2.6% of men in the leuprolide acetate group. The most frequently reported adverse events, reported in at least 10% of men in the relugolix group, were hot flashes, fatigue, constipation, diarrhea and arthralgia.
If approved, relugolix would become the first of its kind oral option for men with advanced prostate cancer.
It’s worth pointing out that these results support a New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the second quarter of 2020 and future regulatory submissions in Europe and Japan.
Lynn Seely, M.D., president and CEO of Myovant, commented:
With the exciting results from the HERO study demonstrating the potential of relugolix to provide unique benefits compared to leuprolide, we look forward to submitting an NDA to the FDA. We are now closer to our goal of bringing a precision oral medicine to the broad spectrum of men with advanced prostate cancer.
Shares of Myovant traded up about 145% on Tuesday, at $14.85 in a 52-week range of $4.14 to $26.02. The consensus price target is $24.60.