Category: Myovant

Myovant Sciences Announces 97% Response Rate in Positive Phase 3 HERO Study of Once-Daily, Oral Relugolix in Men with Advanced Prostate Cancer

Primary efficacy endpoint met with 96.7% of men achieving sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks Achieved all six key secondary endpoints, including superiority to leuprolide acetate on rapid suppression of testosterone and prostate-specific antigen (PSA), all with p-values < 0.0001 New Drug Application (NDA) submission expected in the second…

Myovant Sciences Completes Patient Recruitment for Phase 3 SPIRIT 1 Study Evaluating Relugolix Combination Therapy in Women with Endometriosis

Top-line results for SPIRIT 2 and SPIRIT 1 expected in the first and second quarters of 2020, respectively Studies support potential regulatory submission for a single tablet, once-daily treatment of moderate-to-severe endometriosis-associated pain BRISBANE, Calif. and BASEL, Switzerland, Oct. 21, 2019 (GLOBE NEWSWIRE) — Myovant Sciences (NYSE: MYOV), a healthcare company focused on developing innovative treatments for women’s health and prostate…

Myovant Sciences Announces Positive Results from Second Phase 3 Study Evaluating Once-Daily Relugolix Combination Therapy in Women with Uterine Fibroids and Positive Results from Bioequivalence Study

Primary efficacy endpoint met with 71.2% response rate (p < 0.0001); women experienced, on average, an 84.3% reduction in menstrual blood loss (p < 0.0001) Achieved six key secondary endpoints including reduction in pain, with a well-tolerated safety profile including low incidence of hot flashes and bone mineral density maintained comparable to placebo Single-tablet relugolix…

Myovant Sciences and Evidation Health Announce Partnership and Launch Digital Insights Study on Menstruation

Digital insights study to include over 20,000 people and evaluate women’s menstrual experiences, including symptoms such as heavy menstrual bleeding and menstrual pain PERIOD. Inc., a Myovant partner and nonprofit dedicated to menstrual equity and destigmatization, contributed to the development of survey questions focused on education and attitudes of women and men regarding menstruation Companies…

Myovant Sciences Announces Positive Phase 3 Results from LIBERTY 1 Study Evaluating Once Daily Relugolix Combination Therapy in Women with Uterine Fibroids

Phase 3 study met primary efficacy endpoint with highly statistically significant 73.4% response rate (p < 0.0001); women experienced, on average, an 84.3% reduction in menstrual blood loss Achieved six key secondary endpoints including reduction in menstrual blood loss (p < 0.0001), reduction in pain (p < 0.0001), and improvement in quality of life (p…

Myovant Sciences Announces Completion of Enrollment in Phase 3 HERO Trial of Relugolix in Men with Advanced Prostate Cancer

– Top-line data expected in fourth quarter of 2019 BASEL, Switzerland, Oct. 24, 2018 /PRNewswire/ — Myovant Sciences (NYSE: MYOV) today announced it has completed patient enrollment in its pivotal Phase 3 clinical trial, HERO, which is evaluating the safety and efficacy of relugolix for the treatment of men with advanced prostate cancer. The HERO…