MYOV Myovant Sciences Ltd.

14.65
-0.71  -5%
Previous Close 15.36
Open 14.93
52 Week Low 4.14
52 Week High 23.04
Market Cap $1,320,687,538
Shares 90,149,320
Float 39,725,645
Enterprise Value $1,480,035,636
Volume 686,740
Av. Daily Volume 1,261,004
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Upcoming Catalysts

Drug Stage Catalyst Date
Relugolix
Advanced prostate cancer
PDUFA priority review
PDUFA priority review
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Relugolix - SPIRIT EXTENSION
Endometriosis
Phase 3
Phase 3
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Relugolix
Uterine fibroids
PDUFA
PDUFA
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Drug Pipeline

Drug Stage Notes
Relugolix - SPIRIT 1
Endometriosis-associated pain
Phase 3
Phase 3
Phase 3 data met co-primary endpoints June 23, 2020.
Relugolix - SPIRIT 2
Endometriosis-associated pain
Phase 3
Phase 3
Phase 3 data met co-primary endpoints - April 22, 2020.

Latest News

    • Seven oral and poster presentations presented at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress
    • Oral presentation on efficacy and safety data from Phase 3 SPIRIT program selected as the best clinical abstract in endometriosis
    • Oral presentation on efficacy and safety data from the LIBERTY long-term extension study in uterine fibroids selected as a prize paper

    BASEL, Switzerland, Oct. 21, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE:MYOV), a healthcare company focused on redefining care for women and for men, today announced the presentation of data from clinical studies of its once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis…

    • Seven oral and poster presentations presented at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress
    • Oral presentation on efficacy and safety data from Phase 3 SPIRIT program selected as the best clinical abstract in endometriosis
    • Oral presentation on efficacy and safety data from the LIBERTY long-term extension study in uterine fibroids selected as a prize paper

    BASEL, Switzerland, Oct. 21, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE:MYOV), a healthcare company focused on redefining care for women and for men, today announced the presentation of data from clinical studies of its once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis and in women with uterine fibroids. The data were presented in virtual oral and poster sessions during the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress, held October 17-21, 2020.

    "For millions of women, the symptoms of endometriosis and uterine fibroids, such as pain and heavy menstrual bleeding, can be highly debilitating and have a significant impact on their daily lives," said Juan Camilo Arjona Ferreira, M.D., chief medical officer of Myovant Sciences. "These additional data further support our vision for a one pill, once-a-day treatment that provides symptom relief with minimal side effects, potentially allowing for long-term treatment of women suffering from these common chronic conditions."

    Details of the presentations from studies of women with endometriosis are as follows:

    The Phase 3 SPIRIT program evaluated the efficacy and safety of once-daily relugolix combination therapy in women with endometriosis. The SPIRIT 1 and 2 studies achieved their co-primary endpoints, demonstrating clinically meaningful reductions in dysmenorrhea (menstrual pain) and non-menstrual pelvic pain.

    • Efficacy and Safety of Relugolix Combination Therapy in Women with Endometriosis-Associated Pain: Phase 3 Randomized, Double-Blind, Placebo-Controlled Study (SPIRIT 1 and 2) (oral presentation, O-187, Endometriosis Special Interest Group Prize Paper [Best in Clinical/Population Science])

      In the SPIRIT 1 and 2 studies, relugolix combination therapy resulted in a clinically meaningful reduction in dysmenorrhea (74.5% vs. 26.9% and 75.2% vs. 30.4% for SPIRIT 1 and 2, respectively) and non-menstrual pelvic pain in women with endometriosis (58.5% vs. 39.6% and 66.0% vs. 42.7% for SPIRIT 1 and 2, respectively) compared with placebo (p < 0.0001 for both co-primary endpoints in both studies). Dysmenorrhea rapidly decreased from severe at baseline to mild by Week 8 which was sustained through Week 24. Non-menstrual pelvic pain decreased from moderate at baseline to mild over 24 weeks. Both studies also met several key secondary endpoints including reduction in dyspareunia (painful intercourse) and the EHP-30 pain domain. Changes in bone mineral density over 24 weeks were minimal in the relugolix combination therapy group.

    Details of the presentations from studies of women with uterine fibroids are as follows:

    The Phase 3 LIBERTY program evaluated the efficacy and safety of once-daily relugolix combination therapy in premenopausal women with heavy menstrual bleeding associated with uterine fibroids in two replicate studies, LIBERTY 1 and 2. The primary endpoint of both studies was met with a significant proportion of women treated with relugolix combination therapy achieving the responder criteria for reduction in menstrual blood loss compared with placebo after 24 weeks of treatment (p < 0.0001 in both studies). Eligible women who completed the studies were offered the opportunity to enroll in an active treatment extension study in which all women received relugolix combination therapy for an additional 28-week period, for a total treatment period of 52 weeks.

    • LIBERTY: Long-Term Extension Study Demonstrating One-Year Efficacy and Safety of Relugolix Combination Therapy in Women with Symptomatic Uterine Fibroids (oral presentation, O-1, Scientific Congress Prize Paper Session 1)

      In this first presentation of detailed data from the LIBERTY long-term extension study, 87.7% of women achieved the responder criteria for reduction in menstrual blood loss at one year. Women experienced, on average, a 90% reduction in menstrual blood loss from baseline at one year, with most women (70.6%) achieving amenorrhea. In addition, 59% of women with anemia at baseline experienced anemia improvement at one year. Lumbar spine and total hip bone mineral density were maintained over one year. The adverse event profile with relugolix combination therapy over one year was consistent with that observed in LIBERTY 1 and 2.

    • Quality-of-Life Improvement with Relugolix Combination Therapy in Patients with Heavy Menstrual Bleeding Associated with Uterine Fibroids: Results from the LIBERTY Phase 3 Program (oral presentation, O-205)

      In this pooled analysis of data from the LIBERTY 1 and 2 studies, women who received relugolix combination therapy experienced a significantly greater reduction in symptom severity (scale from 0 to 100 with higher scores indicating worse outcomes) from baseline to Week 24 than women receiving placebo (33.5 vs. 12.1, nominal p < 0.0001). Women who received relugolix combination therapy also experienced a significantly greater improvement in total quality of life scores (scale from 0 to 100 with higher scores indicating better outcomes) from baseline to Week 24 compared to women receiving placebo (37.6 vs. 13.1, nominal p < 0.0001), which included assessment of daily activities, emotional wellbeing, and sexual function.

    • Relugolix Combination Therapy Significantly Reduced Menstrual Blood Loss with First Treatment Cycle in Women with Heavy Menstrual Bleeding Associated with Uterine Fibroids: Results from the LIBERTY Phase 3 Program (oral presentation, O-206)

      In this pooled analysis of data from the LIBERTY 1 and 2 studies, women who received relugolix combination therapy experienced a significantly greater reduction in menstrual blood volume in their first cycle compared to women who received placebo (52.4% vs. 14.7%, nominal p < 0.0001). At Week 24, the reduction for women in the relugolix combination therapy group was 84.7% compared with 19.5% in the placebo group (nominal p < 0.0001).

    • Relugolix Combination Therapy Improves Uterine Fibroid-Associated Pain During Menstrual and Non-Menstrual Days: Results from the LIBERTY Phase 3 Program (poster presentation, P-308, 1st Place in Poster Competition)

      In this pooled analysis of data from the LIBERTY 1 and 2 studies, after 24 weeks of treatment, the proportion of women reporting minimal-to-no uterine fibroid-associated pain (maximum score of 1 on a 0 to 10 Numerical Rating Scale) during the last 35 days of treatment was significantly greater for women who received relugolix combination therapy versus placebo (45.2% vs. 13.9%, nominal p < 0.0001). The reduction of uterine fibroid-associated pain with relugolix combination therapy was rapid and sustained over time. Improvement of pain associated with uterine fibroids was demonstrated both during menstrual and non-menstrual days.

    Details of presentations from additional studies are as follows:

    • Characterization of Pituitary and Ovarian Hormone Concentrations During Treatment with Relugolix Combination Therapy (oral presentation, O-196)

      In a Phase 1 open-label, single-arm ovulation inhibition study, 67 healthy premenopausal women were evaluated over an 84-day treatment period (three cycles) to assess the effects of relugolix combination therapy on ovulation inhibition. During the study, relugolix combination therapy consistently suppressed pituitary and ovarian hormone concentrations, follicular growth, and endometrial proliferation, and resulted in 100% ovulation inhibition, with 100% return to ovulation or menses after discontinuation of treatment.  

    • Simulated Long-Term Effects of Relugolix Combination Therapy on Bone Mineral Density at the Lumbar Spine as Projected by a Validated Semi-Mechanistic Exposure-Response Model (poster presentation, P-598)

      To evaluate bone mineral density change associated with estradiol (E2) concentrations, a semi-mechanistic, exposure-response model was developed to describe bone mineral density change in the lumbar spine over time as a function of E2 concentrations in women with uterine fibroids or endometriosis. Simulations from this model were well correlated with the effect of relugolix combination therapy observed in the Phase 3 LIBERTY program and projected maintenance of bone minderal density with relugolix combination therapy in women with uterine fibroids for at least three years.

    Relugolix combination tablet is under review by the U.S. Food and Drug Administration (FDA) for the treatment of women with uterine fibroids, with a target action date of June 1, 2021. Myovant submitted a Marketing Authorization Application to the European Medicines Agency in March 2020 for relugolix combination tablet in uterine fibroids. Additionally, relugolix (120 mg) is under Priority Review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of December 20, 2020.

    About Relugolix

    Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone, a hormone known to stimulate the growth of prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer.

    About Myovant Sciences

    Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

    Forward-Looking Statements

    This press-release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements regarding Myovant Sciences' intent, belief, or expectations regarding future events or results and can be identified by words such as "anticipate," "aspire," "believe," "can," "continue," "could," "estimate," "expect," "intend," "likely," "may," "might," "objective," "ongoing," "plan," "potential," "predict," "project," "should," "to be," "will," "would," or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements and quotes regarding Myovant Sciences' aspirations to redefine care for women and for men; Myovant's vision for a one pill, once-a-day treatment that provides symptom relief with minimal side effects, potentially allowing for long-term treatment of women suffering from these common and chronic conditions; the characterizations of the data presented at the American Society for Reproductive Medicine (ASRM) 2020 Virtual Congress; the FDA target action date of December 20, 2020 under the Prescription Drug User Fee Act (PDUFA) for Myovant's NDA for the treatment of men with advanced prostate cancer and the target action date of June 1 for Myovant's NDA for the treatment of women with uterine fibroids. Myovant Sciences' forward-looking statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. Factors that could materially affect Myovant Sciences' operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to the risks and uncertainties listed in Myovant Sciences' filings with the United States Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Myovant Sciences' Quarterly Report on Form 10-Q filed on August 11, 2020, as such risk factors may be amended, supplemented or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

    Investor Contact:

    Ryan Crowe

    Vice President, Investor Relations

    Myovant Sciences, Inc.

     

    Media Contact:

    Albert Liao

    Director, Corporate Communications

    Myovant Sciences, Inc.

     

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  1. BASEL, Switzerland, Oct. 14, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE:MYOV), a healthcare company focused on redefining care for women and for men, today announced the appointment of Ryan Crowe as vice president, investor relations. In addition to managing day-to-day interactions with analysts and investors, Mr. Crowe will be responsible for developing and implementing a comprehensive and strategic global investor relations program. He will report to Frank Karbe, Myovant's president and chief financial officer.

    "We are delighted to welcome Ryan to Myovant," said Mr. Karbe. "He brings a deep knowledge of the pharmaceutical industry and, combined with his extensive investor relations experience, will continue to strengthen Myovant's…

    BASEL, Switzerland, Oct. 14, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE:MYOV), a healthcare company focused on redefining care for women and for men, today announced the appointment of Ryan Crowe as vice president, investor relations. In addition to managing day-to-day interactions with analysts and investors, Mr. Crowe will be responsible for developing and implementing a comprehensive and strategic global investor relations program. He will report to Frank Karbe, Myovant's president and chief financial officer.

    "We are delighted to welcome Ryan to Myovant," said Mr. Karbe. "He brings a deep knowledge of the pharmaceutical industry and, combined with his extensive investor relations experience, will continue to strengthen Myovant's relationship with the investment community."

    Mr. Crowe joins Myovant after nearly 16 years at Pfizer Inc., where he most recently served as senior director of investor relations and was responsible for conducting global investor relations activities for the company. Prior to his most recent role, he held positions of increasing responsibility on the Pfizer investor relations team as well as in Pfizer's tax department.

    "I am thrilled to join Myovant at this pivotal time," said Mr. Crowe. "With compelling data and multiple potential upcoming launches across prostate cancer and women's health, Myovant is poised to transition to a commercial-stage healthcare company and I look forward to regularly communicating our progress with the investment community."

    During Mr. Crowe's tenure at Pfizer, the company's investor relations program was consistently ranked among the top three in the pharmaceuticals sector by Institutional Investor magazine, based on a survey of institutional portfolio managers and analysts. Additionally, in 2020, he was recognized as the "Best IR Professional" amongst all pharmaceutical companies. He earned an undergraduate degree in commerce and engineering sciences from Drexel University and a master's degree in business administration from the Leonard N. Stern School of Business at New York University.

    About Myovant Sciences

    Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

    Investor Contact:

    Ryan Crowe

    Vice President, Investor Relations

    Myovant Sciences, Inc.

    Media Contact:

    Albert Liao

    Director, Corporate Communications

    Myovant Sciences, Inc.

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    • Relugolix had a similar rate of castration resistance-free survival in the subgroup of men with metastatic disease compared to leuprolide acetate (74% vs. 75%, respectively) and did not achieve statistical superiority (p = 0.84)
    • Relugolix is under Priority Review with an FDA target action date of December 20, 2020, supported by positive Phase 3 HERO study results including a 97% responder rate and six positive key secondary endpoints

    BASEL, Switzerland, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE:MYOV), a healthcare company focused on redefining care for women and for men, today announced results of an additional secondary endpoint from the Phase 3 HERO study evaluating relugolix in men with advanced prostate cancer. Relugolix…

    • Relugolix had a similar rate of castration resistance-free survival in the subgroup of men with metastatic disease compared to leuprolide acetate (74% vs. 75%, respectively) and did not achieve statistical superiority (p = 0.84)
    • Relugolix is under Priority Review with an FDA target action date of December 20, 2020, supported by positive Phase 3 HERO study results including a 97% responder rate and six positive key secondary endpoints

    BASEL, Switzerland, Sept. 29, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE:MYOV), a healthcare company focused on redefining care for women and for men, today announced results of an additional secondary endpoint from the Phase 3 HERO study evaluating relugolix in men with advanced prostate cancer. Relugolix did not achieve statistical superiority for castration resistance-free survival compared to leuprolide acetate in men with metastatic disease through 48 weeks.

    "These new data from the Phase 3 HERO study show that three out of four men with metastatic prostate cancer remained castration resistance-free through 48 weeks while on oral relugolix, in-line with leuprolide acetate injections, the current standard of care," said Dan George, M.D., a professor of medicine and surgery at the Duke University School of Medicine and HERO program steering committee member. "I continue to be excited by relugolix as a potential new and differentiated treatment option for men with prostate cancer given its robust clinical and safety data, including the lower risk of major adverse cardiovascular events compared to leuprolide acetate."

    Castration-resistant prostate cancer is defined by disease progression despite achieving testosterone suppression to castrate levels (< 50 ng/dL). In the subgroup of men with metastatic disease treated with relugolix, 74% were castration-resistance free through 48 weeks compared to 75% men treated with leuprolide acetate (HR = 1.03 [95% CI: 0.68-1.57]; p = 0.84). In the secondary endpoint analysis, castration resistance-free survival was defined as the time from first dose to prostate-specific antigen (PSA) progression per the Prostate Cancer Clinical Trials Working Group 3 (PCWG3) criteria or death from any cause. PSA progression was defined as a PSA increase ≥ 25% and ≥ 2 ng/mL above the nadir, and confirmed by a second PSA value ≥ 3 weeks later.

    "We believe the totality of data – including previously reported data from the Phase 3 HERO program, published in the New England Journal of Medicine – presents compelling evidence for the potential use of relugolix in men with advanced prostate cancer," said Lynn Seely, M.D., chief executive officer of Myovant Sciences. "With our New Drug Application under Priority Review by the FDA, we look forward to our target action date in December 2020 and hope to advance our commitment to redefining care by bringing once-daily, oral relugolix to men with prostate cancer."

    The incidence of adverse events in the subgroup of men with metastatic disease was consistent with that observed in primary analysis of HERO with no new safety signals observed.



    Relugolix (120 mg) is under Priority Review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of December 20, 2020. In the Phase 3 HERO study, relugolix met the primary efficacy endpoint, with 96.7% of men treated with relugolix achieving sustained testosterone suppression to castrate levels (< 50 ng/dL) through 48 weeks versus 88.8% of men treated with leuprolide acetate. Relugolix also met six key secondary endpoints, demonstrating rapid and profound suppression of testosterone and PSA response, in addition to improved testosterone recovery after discontinuation of treatment. Men in the relugolix group had a 54% lower risk of major adverse cardiovascular events (MACE) compared to men in the leuprolide acetate group (2.9% vs. 6.2%, respectively). In men with a reported history of MACE, the relugolix group had 80% fewer MACE events reported compared to the leuprolide acetate group (3.6% vs. 17.8%, respectively). The overall incidence of adverse events in the relugolix and leuprolide acetate groups was comparable (92.9% vs. 93.5%, respectively).

    About the Phase 3 HERO Program in Advanced Prostate Cancer

    Myovant's Phase 3 clinical program for advanced prostate cancer consisted of a randomized, open-label, parallel-group, multinational clinical study designed to evaluate the safety and efficacy of relugolix in over 900 men with androgen-sensitive advanced prostate cancer who required at least one year of continuous androgen deprivation therapy. Men were randomized 2:1 to receive a single loading dose of relugolix 360 mg followed by relugolix 120 mg once daily, or to treatment with leuprolide acetate 3-month depot injection, respectively.

    About Prostate Cancer

    Prostate cancer is the second most prevalent form of cancer in men and the second leading cause of death due to cancer in men in the U.S. Cardiovascular mortality is the leading cause of death in men with prostate cancer and accounts for 34% of deaths in men with prostate cancer in the U.S. More than three million men in the U.S. are currently living with prostate cancer, and approximately 190,000 men are estimated to be newly diagnosed in 2020.

    Advanced prostate cancer is prostate cancer that has spread or come back after treatment and may include men with biochemical recurrence (rising PSA in the absence of metastatic disease on imaging), locally advanced disease, or metastatic disease. Front-line medical therapy for advanced prostate cancer typically involves androgen deprivation therapy, which reduces testosterone to very low levels, commonly referred to as castrate levels. GnRH receptor agonists, such as leuprolide acetate, are depot injections and the current standard of care for androgen deprivation therapy. However, GnRH receptor agonists may be associated with mechanism-of-action limitations, including the potentially detrimental initial surge in testosterone levels that can exacerbate clinical symptoms, which is known as clinical or hormonal flare, and delayed testosterone recovery after the drug is discontinued. Approximately 210,000 men are treated with androgen deprivation therapy with a GnRH agonist or antagonist each year.

    About Relugolix

    Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces testicular testosterone, a hormone known to stimulate the growth of prostate cancer, and ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. 

    About Myovant Sciences 

    Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

    Forward-Looking Statements

    This press-release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements regarding Myovant Sciences' intent, belief, or expectations regarding future events or results and can be identified by words such as "anticipate," "aspire," "believe," "can," "continue," "could," "estimate," "expect," "intend," "likely," "may," "might," "objective," "ongoing," "plan," "potential," "predict," "project," "should," "to be," "will," "would," or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements and quotes regarding Myovant Sciences' aspirations to redefine care for women and for men; the characterizations of the data from the HERO study, including the results of additional secondary endpoint of castration resistance-free survival; and the FDA target action date of December 20, 2020 under the Prescription Drug User Fee Act (PDUFA) for Myovant's NDA for the treatment of men with advanced prostate cancer. Myovant Sciences' forward-looking statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. Factors that could materially affect Myovant Sciences' operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to the risks and uncertainties listed in Myovant Sciences' filings with the United States Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Myovant Sciences' Quarterly Report on Form 10-Q filed on August 11, 2020, as such risk factors may be amended, supplemented or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

    Investor Contact:

    Frank Karbe

    President and Chief Financial Officer

    Myovant Sciences, Inc.

    Media Contact:

    Albert Liao 

    Director, Corporate Communications

    Myovant Sciences, Inc.

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    • Prostate cancer and uterine fibroids disproportionately impact Black Americans; racial disparities are exacerbated by inequities in healthcare access and COVID-19 pandemic
    • Myovant expands ongoing efforts to advance health equity with grant program to award up to $200,000 for innovative projects focused on improving access to healthcare

    BASEL, Switzerland, Sept. 23, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE:MYOV), a healthcare company focused on redefining care for women and for men, today announced the launch of its "Forward for Health Equity" grant program. The program will provide funding to nonprofit healthcare organizations with innovative projects focused on improving healthcare access, with an initial focus on reducing racial disparities…

    • Prostate cancer and uterine fibroids disproportionately impact Black Americans; racial disparities are exacerbated by inequities in healthcare access and COVID-19 pandemic
    • Myovant expands ongoing efforts to advance health equity with grant program to award up to $200,000 for innovative projects focused on improving access to healthcare

    BASEL, Switzerland, Sept. 23, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE:MYOV), a healthcare company focused on redefining care for women and for men, today announced the launch of its "Forward for Health Equity" grant program. The program will provide funding to nonprofit healthcare organizations with innovative projects focused on improving healthcare access, with an initial focus on reducing racial disparities in prostate cancer and uterine fibroids in the U.S. Myovant will award as many as four grants of up to $50,000 each, for a total of $200,000.

    Prostate cancer is the second deadliest cancer in men in the U.S. and has the largest racial disparity of any major cancer, killing Black men twice as often as white men. Uterine fibroids can cause debilitating symptoms such as heavy menstrual bleeding and pain, leading to over 250,000 hysterectomies each year in the U.S., with Black women more likely to undergo more invasive surgical procedures. Studies have also shown that Black men and women have less access to healthcare, and access issues such as lack of insurance coverage have been shown to contribute to the racial disparities in prostate cancer and uterine fibroids.

    "Myovant is committed to redefining care for women and for men, not only through the development of new medicines but also through initiatives that aim to address the broader societal issues that lead to health inequities," said Jarrad Aguirre, M.D., head of corporate strategy and advocacy at Myovant Sciences. "We have forged multiple cross-sector partnerships to advocate for a world in which everyone can move forward on their journey with confidence and health, and we are proud to expand our commitment with the launch of the Forward for Health Equity grant program."

    Myovant previously launched the Female Forward Together coalition in partnership with Evidation Health, Flo Health, HealthyWomen, and PERIOD, with coalition projects including the development of a digital tool to evaluate menstrual blood loss and the creation of a storytelling initiative to reduce stigma around menstruation. Myovant also recently launched the Forward Momentum coalition in partnership with BlackDoctor.org, Evidation Health, and Movember to improve representation of Black men and women in research studies and to develop digital tools for men with prostate cancer.

    "Prostate cancer and uterine fibroids have a disproportionate impact on Black men and women, and studies have shown those populations may experience worse outcomes from these diseases due to societal inequities and disparities in healthcare access," said Reggie Ware, chief executive officer of BlackDoctor.org. "These disparities have been exacerbated by the COVID-19 pandemic, making an effort like Myovant's Forward for Health Equity grant program an urgent priority and an important initiative."

    The "Forward for Health Equity" grant program will accept applications through December 31, 2020. Applicants must be U.S.-based nonprofit healthcare organizations. Applicants may not be individual healthcare professionals. Applications will be evaluated based on 1) greatest potential to improve health equity, 2) degree of innovation, and 3) focus on healthcare access. Applications will be reviewed by a committee consisting of Myovant employees and external leaders and advocates.

    For more information on how to apply, please contact .

    About Myovant Sciences 

    Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

    Investor Contact:

    Frank Karbe

    President and Chief Financial Officer

    Myovant Sciences, Inc.

    Media Contact:

    Albert Liao 

    Director, Corporate Communications

    Myovant Sciences, Inc.

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    • Relugolix combination therapy maintained bone mineral density through one year, consistent with bone mineral density changes observed in untreated women
    • Findings presented at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting Virtual Event

    BASEL, Switzerland, Sept. 14, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE:MYOV), a healthcare company focused on redefining care for women and for men, today announced the presentation of one-year data on bone mineral density (BMD) from the Phase 3 LIBERTY program evaluating the safety and efficacy of once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids. The BMD results from the LIBERTY…

    • Relugolix combination therapy maintained bone mineral density through one year, consistent with bone mineral density changes observed in untreated women
    • Findings presented at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting Virtual Event

    BASEL, Switzerland, Sept. 14, 2020 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE:MYOV), a healthcare company focused on redefining care for women and for men, today announced the presentation of one-year data on bone mineral density (BMD) from the Phase 3 LIBERTY program evaluating the safety and efficacy of once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with uterine fibroids. The BMD results from the LIBERTY program demonstrated maintenance of BMD through one year and were consistent with those observed in a separate prospective observational study of untreated, age-matched women with uterine fibroids. The findings were presented at the American Society for Bone and Mineral Research (ASBMR) 2020 Annual Meeting Virtual Event, held September 11-15, 2020.

    "Uterine fibroids are a chronic condition, but the duration of use for existing treatment options has been limited by concerns about potential bone loss while on therapy," said Michael McClung, M.D., founding director of the Oregon Osteoporosis Center. "These new data show relugolix combination therapy maintained bone mineral density over one year of treatment, consistent with that of untreated, age-matched women with uterine fibroids in a concurrent study."

    "We believe these findings add to the unique and growing evidence supporting relugolix combination tablet as a potential long-term treatment option for women with uterine fibroids," said Juan Camilo Arjona Ferreira, M.D., chief medical officer of Myovant Sciences. "These data further support our vision of providing a one pill, once-a-day treatment that may provide substantial reductions in menstrual blood loss and symptom relief while maintaining bone health."

    Details of the presentations are as follows:

    Relugolix Combination Therapy Preserves Bone Mass in Patients with Uterine Fibroids: Results from Phase 3 LIBERTY Program (Abstract # P-641)

    The Phase 3 LIBERTY program evaluated the safety and efficacy of once-daily relugolix combination therapy in premenopausal women with heavy menstrual bleeding due to uterine fibroids. The program met its primary endpoints and demonstrated that relugolix combination therapy significantly reduced menstrual blood loss and pain. In this analysis, pooled data from 768 women in the LIBERTY 1 and LIBERTY 2 studies showed that mean changes in lumbar spine bone mineral density (LS BMD) were comparable for relugolix combination therapy and placebo (Week 12: -0.63% vs. 0.34%; Week 24: -0.23% vs. 0.18%, respectively).

    Evaluation of Relugolix Combination Therapy to Maintain Bone Mass in Women with Uterine Fibroids Through 52 Weeks: LIBERTY Long-Term Extension Study (Abstract # P-639)

    Eligible women who completed the LIBERTY 1 or LIBERTY 2 studies were offered the opportunity to enroll in an active treatment extension study in which all women received relugolix combination therapy for an additional 28-week period, for a total treatment period of up to 52 weeks. In this analysis, data from 163 women who entered the extension study after receiving 24 weeks of relugolix combination therapy demonstrated maintenance of BMD through 52 weeks of treatment (Week 52: LS BMD -0.80%).

    A Prospective Observational Study of Bone Mineral Density in Premenopausal Women with Uterine Fibroids (Abstract # P-552)

    This prospective observational study was designed to characterize longitudinal BMD in 262 premenopausal women with uterine fibroids. Mean LS BMD showed minimal changes over the 52-week observational period (0% at Week 24 and -0.41% at Week 52).

    Relugolix combination tablet is under review by the U.S. Food and Drug Administration (FDA) for the treatment of women with uterine fibroids, with a target action date of June 1, 2021. Myovant submitted a Marketing Authorization Application to the European Medicines Agency in March 2020 for relugolix combination tablet in uterine fibroids. Additionally, relugolix (120 mg) is under Priority Review by the FDA for the treatment of men with advanced prostate cancer, with a target action date of December 20, 2020. Myovant has also reported positive data from two replicate Phase 3 studies evaluating relugolix combination therapy in women with endometriosis.

    About the Phase 3 LIBERTY Program in Uterine Fibroids

    Myovant's Phase 3 clinical program for uterine fibroids consisted of two multinational, replicate pivotal clinical studies (LIBERTY 1 and LIBERTY 2) of relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with heavy menstrual bleeding associated with uterine fibroids for 24 weeks. Eligible women who completed the LIBERTY 1 or LIBERTY 2 studies were offered the opportunity to enroll in an active treatment extension study in which all women received relugolix combination therapy for an additional 28-week period for a total treatment period of 52 weeks, designed to evaluate the safety and efficacy of longer-term treatment. Upon completion of this 52-week total treatment period, eligible women could elect to participate in a second 52-week randomized withdrawal study designed to provide two-year safety and efficacy data on relugolix combination therapy and to evaluate the need for maintenance therapy. Across studies, a response was defined as a menstrual blood loss volume of less than 80 mL and a 50% or greater reduction from baseline in menstrual blood loss volume during the last 35 days of treatment measured using the alkaline hematin method.

    LIBERTY 1 and 2 met the primary endpoint (p < 0.0001) with 73.4% and 71.2% of women receiving relugolix combination therapy achieving the responder criteria compared with 18.9% and 14.7% of women receiving placebo at 24 weeks, respectively. On average, women receiving relugolix combination therapy in both studies experienced an 84.3% reduction in menstrual blood loss from baseline (p < 0.0001). Bone mineral density was comparable between the relugolix combination therapy and placebo groups in LIBERTY 1 and 2. The distribution of the change in bone mineral density, including outliers, was similar for the relugolix combination therapy and placebo groups at 24 weeks, as assessed by dual energy x-ray absorptiometry (DXA). The overall incidence of adverse events in the relugolix combination and placebo groups was comparable in both studies.

    The open-label extension study also met the primary endpoint with relugolix combination therapy demonstrating an 87.7% response rate at one year, showing the durability of the response observed in LIBERTY 1 and 2. In addition, women experienced, on average, an 89.9% reduction in menstrual blood loss from baseline. Changes in bone mineral density through one year, as assessed by DXA every three months, were consistent with LIBERTY 1 and 2. The incidence of adverse events over one year was consistent with that observed in LIBERTY 1 and 2, with no new safety signals observed.

    About Uterine Fibroids

    Uterine fibroids are noncancerous tumors that develop in or on the muscular walls of the uterus and are among the most common reproductive tract tumors in women. In addition to an individual's genetic predisposition, estrogens are well known to play an important role in the regulation of fibroid growth. Although uterine fibroids are benign tumors, they can cause debilitating symptoms such as heavy menstrual bleeding (frequently resulting in anemia and fatigue), pain (including painful periods, abdominal pain, painful intercourse, backache), increased abdominal girth and bloating, urinary frequency or retention, constipation, pregnancy loss, and, in some cases, infertility. These symptoms can also lead to loss of productivity at work, limitations in normal activities of daily living, and social embarrassment.

    An estimated five million women in the U.S. suffer from symptoms of uterine fibroids, and an estimated three million women are inadequately treated by current medical therapy and require further treatment.

    About Relugolix

    Relugolix is a once-daily, oral gonadotropin-releasing hormone (GnRH) receptor antagonist that reduces ovarian estradiol, a hormone known to stimulate the growth of uterine fibroids and endometriosis, and testicular testosterone, a hormone known to stimulate the growth of prostate cancer. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer.

    About Myovant Sciences

    Myovant Sciences aspires to redefine care for women and for men through purpose-driven science, empowering medicines, and transformative advocacy. Our lead product candidate, relugolix, is a once-daily, oral GnRH receptor antagonist. Relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) is under regulatory review in Europe and the U.S. for women with uterine fibroids and is under development for women with endometriosis. Relugolix monotherapy tablet (120 mg) is under regulatory review in the U.S. for men with advanced prostate cancer. We are also developing MVT-602, an oligopeptide kisspeptin-1 receptor agonist, which has completed a Phase 2a study for female infertility as part of assisted reproduction. Sumitovant Biopharma, Ltd., a wholly owned subsidiary of Sumitomo Dainippon Pharma Co., Ltd., is our majority shareholder. For more information, please visit our website at www.myovant.com. Follow @Myovant on Twitter and LinkedIn.

    Forward-Looking Statements

    This press-release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements regarding Myovant Sciences' intent, belief, or expectations regarding future events or results and can be identified by words such as "anticipate," "aspire," "believe," "can," "continue," "could," "estimate," "expect," "intend," "likely," "may," "might," "objective," "ongoing," "plan," "potential," "predict," "project," "should," "to be," "will," "would," or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. In this press release, forward-looking statements include, but are not limited to, statements and quotes regarding Myovant Sciences' aspirations to redefine care for women and for men; the FDA target action dates under the Prescription Drug User Fee Act (PDUFA) for Myovant's NDAs for the treatment of women with heavy menstrual bleeding associated with uterine fibroids; and for the treatment of men with advanced prostate cancer; the characterization of data from Myovant's clinical studies, including the LIBERTY program and the prospective observational study of relugolix combination therapy relating to bone mineral density; the statements and quotes regarding relugolix combination tablet as a potential long-term treatment option for women with uterine fibroids; and Myovant's vision of providing a one pill, once-a-day treatment that may provide substantial reductions in menstrual blood loss and symptom relief while maintaining bone health. Myovant Sciences' forward-looking statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties, assumptions and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. Factors that could materially affect Myovant Sciences' operations and future prospects or which could cause actual results to differ materially from expectations include, but are not limited to the risks and uncertainties listed in Myovant Sciences' filings with the United States Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Myovant Sciences' Quarterly Report on Form 10-Q filed on August 11, 2020, as such risk factors may be amended, supplemented or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time. You should not place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof, and, except as required by law, Myovant Sciences undertakes no obligation to update these forward-looking statements to reflect events or circumstances after the date of such statements.

    Investor Contact:

    Frank Karbe

    President and Chief Financial Officer

    Myovant Sciences, Inc.

    Media Contact:

    Albert Liao

    Director, Corporate Communications

    Myovant Sciences, Inc.

     

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