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Myovant Sciences (NYSE: MYOV) announced it will host a webcast and conference call on July 28, 2021, at 8:30 a.m. ET to discuss its corporate updates and financial results for Q1 fiscal 2021, which closed on June 30, 2021. The event can be accessed via the investor relations page on Myovant's website. Myovant has two FDA-approved products: ORGOVYX™ for advanced prostate cancer and MYFEMBREE® for heavy menstrual bleeding in women. The company is also advancing multiple candidates under regulatory review and in clinical studies.
Myovant Sciences (NYSE: MYOV) announced participation in upcoming investor conferences, including the Goldman Sachs 42nd Annual Global Healthcare Virtual Conference on June 8, 2021, at 4:40 p.m. ET, and the JMP Securities Life Sciences Conference on June 17, 2021, at 10:00 a.m. ET. Management will engage in fireside chats at both events. These presentations will be accessible through the Myovant website. Myovant focuses on innovative healthcare solutions for women and men, with FDA-approved products like ORGOVYX™ and MYFEMBREE®.
Myovant Sciences has received FDA approval for MYFEMBREE (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg), marking it as the first once-daily treatment for heavy menstrual bleeding linked to uterine fibroids in premenopausal women. The approval is based on successful results from the Phase 3 LIBERTY 1 and LIBERTY 2 studies, demonstrating response rates of 72.1% and 71.2% at Week 24, with significant reductions in menstrual blood loss. MYFEMBREE is expected to be available in June 2021 through a collaboration with Pfizer.
On May 26, 2021, Sumitovant Biopharma announced substantial clinical and corporate advancements for its subsidiary Myovant Sciences (NYSE: MYOV) in Q4 ending March 31, 2021. Key highlights include the EMA validating Myovant's Marketing Authorization Application for relugolix, an oral therapy for advanced prostate cancer. Myovant also reported positive Phase 3 results for relugolix in uterine fibroids and ongoing trials with Urovant for overactive bladder therapy. Additionally, Urovant successfully transitioned to a wholly owned subsidiary, further consolidating Sumitovant's portfolio.
Myovant Sciences (NYSE: MYOV) announced a positive opinion from the CHMP recommending the approval of RYEQO® for treating uterine fibroids in women of reproductive age. The decision is based on data from the Phase 3 LIBERTY program. If approved by the European Commission, Gedeon Richter will commercialize RYEQO in Europe. The U.S. FDA is also reviewing RYEQO with a target action date of June 1, 2021. Uterine fibroids affect over 25% of women, causing significant health issues and limited treatment options.
Myovant Sciences (MYOV) reported total revenues of $24.6 million for Q4 2020, with net product revenue from ORGOVYX at $3.6 million. The FDA is expected to decide on the relugolix combination tablet for uterine fibroids by June 1, 2021. The company maintained a solid cash position of $726.2 million as of March 31, 2021. ORGOVYX prescriptions exceeded 2,000 patients with coverage at 43% for commercial plans. Myovant's CEO highlighted strong demand and marketing efforts for ORGOVYX. The company is on track for upcoming regulatory submissions in 2021.
Myovant Sciences (NYSE: MYOV) will host a conference call on May 11, 2021, at 8:30 AM ET to discuss corporate updates and financial results for its fiscal year ending March 31, 2021. Investors can access the call via the investor relations page on Myovant's website. The company is focused on redefining care for women's and men's health and has products under regulatory review for various conditions, including advanced prostate cancer and uterine fibroids, which may significantly impact future revenue.
Myovant Sciences and Pfizer announced the initiation of the Phase 3 SERENE study, assessing the contraceptive efficacy of the relugolix combination tablet in healthy women aged 18-35. Enrollment targets 900 women, monitoring pregnancy rates using the Pearl Index as the primary endpoint. This follows a Phase 1 study showing 100% ovulation inhibition. The relugolix combination tablet is also under FDA review for uterine fibroids, with a decision expected by June 1, 2021. A New Drug Application for endometriosis is anticipated in early 2021.
Myovant Sciences (NYSE: MYOV) appointed Lauren Merendino as Chief Commercial Officer, effective April 5, 2021. Merendino, a seasoned leader with over 20 years of experience, previously served at Genentech and has a track record in launching products across various therapeutic areas. This appointment comes after the FDA's approval of Myovant's ORGOVYX™ for advanced prostate cancer and aligns with the company's focus on upcoming regulatory milestones for uterine fibroids and endometriosis. Her expertise is expected to enhance the company's commercial strategies.
Myovant Sciences (NYSE: MYOV) announced that the European Medicines Agency has validated its Marketing Authorization Application for relugolix, potentially the first oral androgen deprivation therapy for advanced prostate cancer in Europe. Relugolix is already FDA-approved in the U.S. under the name ORGOVYX™. If Pfizer exercises its exclusive option for commercialization outside the U.S. and Canada, Myovant could receive $50 million and royalties. The MAA is supported by Phase 3 HERO study data involving over 1,000 men.
