Myovant Sciences (NYSE: MYOV) shares skyrocketed by over 160% on Tuesday morning after the Company reported positive results from its advanced prostate cancer treatment clinical trials.
The Company’s Phase 3 HERO study of once-daily, oral relugolix met its primary efficacy endpoint and all six key secondary endpoints in men with advanced prostate cancer.
The results support a New Drug Application (NDA) submission to the U.S. Food and Drug Administration in the second quarter of 2020 and future regulatory submissions in Europe and Japan.
“An oral gonadotropin-releasing hormone, or GnRH, antagonist for advanced prostate cancer has been an aspiration for many years,” said Neal Shore, M.D., Medical Director of the Carolina Urologic Research Center and HERO Program Steering Committee Member. “If approved, relugolix would become the first-of-its-kind oral option for men with advanced prostate cancer.”
“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,” said Lynn Seely, M.D., President and Chief Executive Officer of Myovant Sciences. “We are now closer to our goal of bringing a precision oral medicine to the broad spectrum of men with advanced prostate cancer.”
Following the upbeat clinical trial results, Myovant shares are still down 25.2% this year.