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Myovant Sciences (NYSE: MYOV) will hold a live webcast and conference call on November 12, 2020, at 8:30 a.m. ET to discuss updates and financial results for Q2 2020, which ended on September 30, 2020. Investors can access the call via Myovant’s investor relations website. The company is focused on innovative therapies for women's and men's health, with its lead product, relugolix, under regulatory review for uterine fibroids and advanced prostate cancer. A replay will be available on their site post-event.
Myovant Sciences presented seven clinical study findings on relugolix combination therapy at the ASRM 2020 Virtual Congress, showcasing its efficacy for endometriosis and uterine fibroids. Notably, Phase 3 studies SPIRIT 1 and 2 demonstrated significant reductions in menstrual pain by 74.5% and 75.2%, respectively, compared to placebo. The LIBERTY program reported that 87.7% of participants achieved substantial menstrual blood loss reduction after one year. Relugolix is under FDA review, aiming for a June 1, 2021 decision for uterine fibroids treatment.
Myovant Sciences has appointed Ryan Crowe as vice president of investor relations. He will oversee daily interactions with analysts and investors while developing a global investor relations program, reporting to Frank Karbe, president and CFO. Crowe brings over 15 years of experience from Pfizer, where he advanced the investor relations department. The company is positioning itself for commercial growth in prostate cancer and women’s health, with multiple product launches on the horizon. This strategic hire aims to strengthen Myovant's connection with the investment community.
Myovant Sciences (NYSE: MYOV) reported results from the Phase 3 HERO study for relugolix, an oral treatment for advanced prostate cancer. The study showed similar rates of castration resistance-free survival with relugolix (74%) compared to leuprolide acetate (75%), but did not achieve statistical superiority (p = 0.84). Relugolix is under FDA Priority Review with a target action date of December 20, 2020, following positive Phase 3 results, including a 97% responder rate. Relugolix demonstrated a lower risk of major adverse cardiovascular events compared to leuprolide acetate.
Myovant Sciences (NYSE: MYOV) announced that relugolix, an oral GnRH receptor antagonist, showed comparable castration resistance-free survival rates to leuprolide acetate in men with metastatic prostate cancer in the Phase 3 HERO study, achieving 74% vs. 75% (p=0.84).
Relugolix is currently under Priority Review by the FDA, with a target action date of December 20, 2020. The HERO study reported a 97% responder rate and a significantly lower risk of major adverse cardiovascular events with relugolix.
Myovant Sciences (NYSE: MYOV) has launched the 'Forward for Health Equity' grant program, aimed at addressing healthcare access disparities among Black Americans affected by prostate cancer and uterine fibroids. The program will award up to $200,000 in total, with grants of up to $50,000 each for innovative nonprofit healthcare projects. Prostate cancer disproportionately impacts Black men, while uterine fibroids significantly affect Black women. Applications are open until December 31, 2020, focusing on initiatives that improve health equity and innovation in healthcare access.
Myovant Sciences (NYSE: MYOV) presented one-year data on bone mineral density (BMD) results from the Phase 3 LIBERTY program at the ASBMR 2020 Annual Meeting. The results confirmed that relugolix combination therapy maintains BMD over one year, consistent with untreated women. This therapy, aimed at women with uterine fibroids, significantly reduced menstrual blood loss and pain. The FDA is reviewing the relugolix combination tablet for uterine fibroids with a target action date of June 1, 2021, and also for advanced prostate cancer, targeting December 20, 2020.
Myovant Sciences (NYSE: MYOV) announced that the FDA has accepted its New Drug Application (NDA) for relugolix combination tablet intended for treating heavy menstrual bleeding associated with uterine fibroids. The FDA specified a target action date of June 1, 2021, and does not plan to hold an advisory committee meeting. The relugolix combination, which includes estradiol and norethindrone acetate, has shown significant efficacy in clinical trials. Myovant is also pursuing approvals for treating advanced prostate cancer and endometriosis.
Myovant Sciences (NYSE: MYOV) announced a series of corporate updates and financial results for Q1 FY 2020. The FDA accepted the New Drug Application for relugolix for advanced prostate cancer with a target action date of December 20, 2020. A second Phase 3 study for endometriosis achieved its co-primary endpoints. Myovant secured an additional USD 200 million low-interest loan from Sumitomo Dainippon Pharma, enhancing financial flexibility. The company reported a Q1 net loss of USD 32.9 million, a significant reduction from USD 67.9 million in the prior year, supported by license revenue of USD 33.3 million.
Myovant Sciences (NYSE: MYOV) recently presented additional data from the Phase 3 LIBERTY program, highlighting significant improvements in patient-reported outcomes for women with heavy menstrual bleeding due to uterine fibroids. Notably, relugolix combination therapy resulted in a 48.4-point reduction in distress from bleeding, outpacing placebo significantly. The therapy also improved hemoglobin levels in anemic women, with 55.7% of participants showing clinically meaningful increases. Furthermore, an ovulation inhibition study demonstrated 100% effectiveness in suppressing ovulation during treatment, with rapid return upon cessation.
