Myovant Sciences

Myovant Sciences Ltd. is a clinical-stage biopharmaceutical company, which engages in the development and commercialization of therapies for the treatment of women's health and endocrine diseases. It offers ORGOVYXTM, an oral gonadotropin-releasing hormone (GnRH) receptor antagonist for the treatment of adult patients with advanced prostate cancer, and MYFEMBREE, which is taken for the management of heavy menstrual bleeding associated with uterine fibroids. The company was founded on February 2, 2016 and is headquartered in London, the United Kingdom.

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Myovant Sciences is a biotech company that develops new treatments for infertility in women and prostate cancer in men. The company's product capabilities and help continue to deliver innovative therapies addressing unmet patient needs in prostate cancer and women’s health. Myovant Sciences was established in 2016 and is based in Brisbane, California.

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A lesser-known British biotech is among eight pharma companies the publication Kiplinger encouraged readers to monitor for important key clinical trial results or regulatory approvals.

Myovant and Partner Get Key Drug Approval

Myovant recently cleared another regulatory binary for relugolix as a treatment for uterine fibroids. On top of the clearance for advanced prostate cancer, Relugolix is now approved for two indications.

Myovant Sciences: Becoming A Blockbuster

BASEL, Switzerland, June 01, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, invites investors and the general public to listen to webcasts at the following investor conferences:

Myovant Sciences to Present at Upcoming Investor Conferences

Pfizer

The FDA has approved Myovant Sciences Ltd (NYSE: MYOV) and Pfizer Inc's (NYSE: PFE) relugolix combined with estradiol and norethindrone acetate for heavy menstrual bleeding linked to uterine fibroids in premenopausal women. The once-daily treatment will be marketed as Myfembree, with a treatment duration of up to two years.

Myovant - Pfizer's Uterine Fibroids Treatment Wins FDA Approval

BASEL, Switzerland and NEW YORK, May 26, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved MYFEMBREE® (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg), the first once-daily treatment for the management of heavy menstrual bleeding associated with uterine fibroids in premenopausal women, with a treatment duration of up to 24 months. The approval is supported by efficacy and safety data from the Phase 3 LIBERTY 1 and LIBERTY 2 studies, which were published in the New England Journal of Medicine . Under the terms of their previously announced collaboration, Myovant and Pfizer will jointly commercialize MYFEMBREE in the U.S. MYFEMBREE is expected to be available in June 2021.

Myovant Sciences and Pfizer Receive FDA Approval for MYFEMBREE®, the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids

LONDON and NEW YORK, May 26, 2021 /PRNewswire/ -- Sumitovant Biopharma, Inc. today announced that its portfolio of four wholly owned subsidiary companies (Urovant, Enzyvant, Altavant and Spirovant)  and Myovant Sciences (NYSE: MYOV), a publicly listed company that is majority owned by Sumitovant, achieved significant clinical and corporate milestones in the company's fourth quarter ending on March 31, 2021. Sumitovant Biopharma Has a Strong Fourth Quarter Across its Portfolio of Companies "We were delighted to see tremendous strides across the Sumitovant portfolio of companies in the fourth quarter including progress across clinical development, regulatory and commercialization milestones.

Sumitovant Biopharma Has a Strong Fourth Quarter with Significant Clinical Development and Corporate Achievements Across its Portfolio of Companies

European Medicines Agency's advisory committee issued a positive opinion recommending the approval of Myovant Sciences Ltd's (NYSE: MYOV) Ryeqo (relugolix, estradiol, and norethindrone acetate) for uterine fibroids. The final decision on the application is expected to be available in approximately two months.

Myovant Sciences' Relugolix Combo Tablet For Uterine Fibroids Scores EMA Backing For Approval

BASEL, Switzerland, May 21, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval of RYEQO® (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age. The European Commission will review the CHMP recommendation, and a final decision on the Marketing Authorization Application is expected to be available in approximately two months. The decision will be applicable to all 27 European Union member states plus Iceland, Norway, and Liechtenstein.

Myovant Sciences Receives Positive CHMP Opinion for RYEQO® (Relugolix Combination Tablet) for the Treatment of Women With Uterine Fibroids

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Myovant Sciences Ltd (NYSE: MYOV) has received a partial clinical hold on its SERENE study (MVT-601-050) from the FDA. The Phase 3 study was evaluating relugolix combination tablets for the prevention of pregnancy.

Myovant Stock Is Trading Lower After FDA Slapped Clinical Hold On Relugolix Combo Study

Shares of Myovant Sciences Ltd. were down 5.7% in premarket trading on Wednesday after the company told investors that the Food and Drug Administration had placed a partial clinical hold on a study assessing an experimental birth control.

Myovant's stock falls after FDA puts partial clinical hold on trial for contraceptive candidate

Myovant Sciences Ltd. (MYOV) CEO Dave Marek on Q4 2020 Results - Earnings Call Transcript

Myovant Sciences (MYOV) delivered earnings and revenue surprises of 10.10% and 1.17%, respectively, for the quarter ended March 2021. Do the numbers hold clues to what lies ahead for the stock?

Myovant Sciences (MYOV) Reports Q4 Loss, Tops Revenue Estimates

Shares of Myovant Sciences (NYSE:MYOV) moved higher by 4.5% in pre-market trading after the company reported Q4 results. Quarterly Results Earnings per share decreased 21.92% over the past year to ($0.89), which beat the estimate of ($0.99).

Myovant Sciences: Q4 Earnings Insights

BASEL, Switzerland, May 11, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced corporate updates and financial results for the fourth fiscal quarter and fiscal year ended March 31, 2021.

Myovant Sciences Announces Corporate Updates and Financial Results for Fourth Fiscal Quarter and Fiscal Year Ended March 31, 2021

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The FDA is currently reviewing the relugolix combination therapy for symptoms of Uterine Fibroids and set a PDUFA date on 6/1/2021. Myovant is currently successfully launching its first approved product ORGOVYX in partnership with Pfizer.

Why The Misunderstood Pfizer Deal Makes Myovant A Great Low-Risk Investment

BASEL, Switzerland, May 04, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced it will host a webcast and conference call to discuss corporate updates and financial results for its fourth fiscal quarter and fiscal year 2020, ended March 31, 2021. The webcast and conference call will be held at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time on May 11, 2021.

Myovant Sciences to Host Fourth Fiscal Quarter and Fiscal Year 2020 Earnings Conference Call at 8:30 a.m. Eastern Time on May 11, 2021

Myovant (MYOV) and Pfizer (PFE) initiate dosing in the phase III SERENE study evaluating the contraceptive efficacy of the relugolix combination tablet.

Myovant (MYOV), Pfizer Start Dosing in Relugolix Combo Study

BASEL, Switzerland and NEW YORK, April 12, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the first participant has been dosed in the Phase 3 SERENE study evaluating the contraceptive efficacy of relugolix combination tablet (relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg) in healthy women ages 18-35 years who are at risk for pregnancy.

Myovant Sciences and Pfizer Announce First Participant Dosed in Phase 3 SERENE Study Evaluating Contraceptive Efficacy of Once-Daily Relugolix Combination Tablet

BASEL, Switzerland, April 05, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced the appointment of Lauren Merendino as Chief Commercial Officer of Myovant Sciences, Inc., effective April 5, 2021. Ms. Merendino brings over 20 years of pharmaceutical and biotech leadership experience to Myovant, with expertise in building and leading commercial teams accompanied by a record of successful product launches. She most recently served as Vice President, Neurological Rare Diseases at Genentech. Ms. Merendino will be a member of Myovant's Executive Committee, reporting directly to Chief Executive Officer David Marek.

Myovant Sciences Appoints Lauren Merendino as Chief Commercial Officer

BASEL, Switzerland, March 29, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced the European Medicines Agency (EMA) has validated the Marketing Authorization Application (MAA) for relugolix for the treatment of advanced prostate cancer. The validation of the application confirms the submission is sufficiently complete for the EMA to begin the formal review process.

Myovant Sciences Announces European Medicines Agency Validation of Marketing Authorization Application for Relugolix for the Treatment of Advanced Prostate Cancer

Myovant (MYOV) and partner Pfizer report positive data from the phase III LIBERTY study evaluating relugolix combination therapy for treating women with uterine fibroids.

Myovant's (MYOV) Data on Relugolix for Uterine Fibroids Positive

Myovant Sciences Ltd (NYSE: MYOV) and Pfizer Inc (NYSE: PFE) have announced positive data from the Phase 3 LIBERTY randomized withdrawal study evaluating relugolix combination therapy in women with uterine fibroids. The therapy includes relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg.

News for Myovant Sciences Stock (MYOV)