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Myovant Sciences Ltd. (MYOV)

NYSE - NYSE Delayed Price. Currency in USD
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21.82-0.78 (-3.45%)
At close: 4:00PM EDT
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Previous Close22.60
Open22.60
Bid0.00 x 1000
Ask21.95 x 1200
Day's Range21.74 - 23.04
52 Week Range4.14 - 23.04
Volume946,749
Avg. Volume833,960
Market Cap1.967B
Beta (5Y Monthly)2.46
PE Ratio (TTM)N/A
EPS (TTM)-2.85
Earnings DateNov. 09, 2020 - Nov. 13, 2020
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est30.86
  • GlobeNewswire

    Myovant Sciences Launches “Forward for Health Equity” Grant Program to Improve Healthcare Access in Prostate Cancer and Uterine Fibroids

    * 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 forwardforhealthequity@myovant.com.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. investors@myovant.comMedia Contact: Albert Liao  Director, Corporate Communications Myovant Sciences, Inc. media@myovant.com

  • GlobeNewswire

    Myovant Sciences Presents Additional Data on Bone Mineral Density in Women with Uterine Fibroids from Phase 3 LIBERTY Program and from Prospective Observational Study

    * 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 EventBASEL, 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. investors@myovant.comMedia Contact: Albert Liao Director, Corporate Communications Myovant Sciences, Inc. media@myovant.com

  • Is Myovant Sciences' (NYSE:MYOV) 152% Share Price Increase Well Justified?
    Simply Wall St.

    Is Myovant Sciences' (NYSE:MYOV) 152% Share Price Increase Well Justified?

    Unfortunately, investing is risky - companies can and do go bankrupt. But if you pick the right business to buy shares...