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.

Pfizer

Though the FDA identified deficiencies in Myovant's (MYOV) Myfembree sNDA for managing endometriosis-associated pain, a final decision on the application is yet to be communicated.

FDA Finds Deficiencies in Myovant (MYOV), Pfizer's Myfembree sNDA

The FDA has identified deficiencies with Myovant's regulatory filing for Myfembree.

Why Myovant Sciences Stock Is Crashing Today

Myovant Sciences Ltd (NYSE: MYOV) shares are trading significantly lower Tuesday after the company and Pfizer Inc (NYSE: PFE) announced an update on the Supplemental New Drug Application for MYFEMBREE for the management of moderate to severe pain associated with endometriosis. In.

What's Going On With Myovant Sciences Stock Today?

BASEL, Switzerland and NEW YORK, April 12, 2022 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer (NYSE: PFE) announced today an update on the Supplemental New Drug Application (sNDA) for MYFEMBREE® (relugolix 40 mg, estradiol 1 mg and norethindrone acetate 0.5 mg) for the management of moderate to severe pain associated with endometriosis.

Myovant Sciences and Pfizer Provide Update on Supplemental New Drug Application for MYFEMBREE® for the Management of Moderate to Severe Pain Associated with Endometriosis

IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Please replace the release with the following corrected version due to multiple revisions to the fifth and sixth paragraphs. The updated release reads: UROVANT SCIENCES ANNOUNCES APPOINTMENT OF SEF KURSTJENS AS EXECUTIVE VICE PRESIDENT AND CHIEF MEDICAL OFFICER Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced Sef Kurstjens, M.D., PhD., has been appointed Executive Vice President and Chief Medical Offi

CORRECTING and REPLACING Urovant Sciences Announces Appointment of Sef Kurstjens as Executive Vice President and Chief Medical Officer

IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced Sef Kurstjens, M.D., PhD., has been appointed Executive Vice President and Chief Medical Officer (CMO). Concurrent with this appointment, Dr. Kurstjens will step down as a member of Urovant's Board of Directors, a position he has held since July 2018, to pursue the full-time CMO role. “I am delighted to welcome Sef Kurstjens to the executive leadership

Urovant Sciences Announces Appointment of Sef Kurstjens as Executive Vice President and Chief Medical Officer

Supplemental New Drug Application of MYFEMBREE for pain associated with endometriosis has been submitted to FDA; PDUFA date of May 6, 2022 has been set.

Myovant: Approved Drugs And Upcoming Catalysts Make This A Great Long-Term Play

IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced the publication of a new review of data on GEMTESA (vibegron) 75 mg in the peer-reviewed journal, Therapeutics and Clinical Risk Management (https://bit.ly/Vibegron). Titled, ‘An evaluation of the efficacy and safety of vibegron in the treatment of overactive bladder,' the paper reviews published data from studies conducted over the past three years. “T

Urovant Sciences Announces Publication of New Review of Efficacy and Safety Data for GEMTESA® (vibegron) 75 mg in Overactive Bladder Patients in the Journal Therapeutics and Clinical Risk Management

IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences, a wholly-owned subsidiary of Sumitovant Biopharma Ltd., today announced positive topline results from its Phase 2a, double-blind, placebo-controlled exploratory study of URO-902, an investigational, novel, locally injected gene therapy product (plasmid human cDNA encoding maxi-K channel), in patients with overactive bladder (OAB), who were not well managed by oral therapies. “URO-902 showed a clinically meaningful and stati

Urovant Sciences Announces Positive Topline Results of Phase 2a Trial of its Potential Novel Gene Therapy, URO-902

BASEL, Switzerland, Feb. 25, 2022 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion recommending the approval of ORGOVYX® (relugolix, 120 mg) for the treatment of adult patients with advanced hormone-sensitive prostate cancer. The European Commission (EC) 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 ORGOVYX® (relugolix) for the Treatment of Advanced Prostate Cancer

LONDON and NEW YORK, Feb. 10, 2022 /PRNewswire/ -- Sumitovant Biopharma Ltd., in partnership with its parent company Sumitomo Dainippon Pharma Co., Ltd.

Sumitomo Dainippon Pharma and Sumitovant Biopharma Initiate Phase 1 Study on New Drug Candidate for Carbapenem-Resistant Bacterial Infections

Myovant Sciences Ltd. (MYOV) CEO Dave Marek on Q3 2021 Results - Earnings Call Transcript

Myovant Sciences (MYOV) delivered earnings and revenue surprises of -15.25% and 0.11%, respectively, for the quarter ended December 2021. Do the numbers hold clues to what lies ahead for the stock?

Myovant Sciences (MYOV) Reports Q3 Loss, Misses Revenue Estimates

Industry veteran brings extensive experience including tissue-based and regenerative therapies Industry veteran brings extensive experience including tissue-based and regenerative therapies

Enzyvant Appoints Johanna Rossell as Chief Commercial Officer

BASEL, Switzerland, Jan. 26, 2022 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced financial results for the third quarter of fiscal year 2021 and other corporate updates.

Myovant Sciences Announces Financial Results for Third Quarter of Fiscal Year 2021 and Corporate Updates

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Biotechs have been one of the worst performers for 2021 as the pandemic has wrought havoc in the sector. 2022 will likely entail a rotation out of high valuation sectors like technology into more depressed sectors like healthcare.

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BASEL, Switzerland, Jan. 12, 2022 (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 third fiscal quarter 2021, ended December 31, 2021. The webcast and conference call will be held at 8:30 a.m. Eastern Time / 5:30 a.m. Pacific Time on January 26, 2022.

Myovant Sciences to Host Third Fiscal Quarter 2021 Earnings Conference Call at 8:30 a.m. Eastern Time on January 26, 2022

BASEL, Switzerland, Jan. 10, 2022 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced preliminary financial results for the third quarter of fiscal year 2021. The financial information presented in this press release may be adjusted at a later date following the completion of customary quarterly financial reviews and audit procedures.

Myovant Sciences Announces Preliminary Financial Results for Third Quarter of Fiscal Year 2021

BASEL, Switzerland, Jan. 03, 2022 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, today announced that David Marek, Chief Executive Officer of Myovant Sciences, Inc., will present at the 40th Annual J.P. Morgan Healthcare Conference on Wednesday, January 12, 2022 at 3:00 p.m. Eastern Time.

Myovant Sciences to Present at the 40th Annual J.P. Morgan Healthcare Conference

Due to the combination of a market downturn and other issues, Myovant shares depreciated substantially. Nevertheless, there are powerful fundamental advancements that signal much more upsides going into New Year 2022.

Myovant: Catalysts Powering More Upside

IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences, Inc. announced publication of patient-perception data for its FDA-approved OAB therapy, GEMTESA® (vibegron), compared to placebo.

Urovant Sciences Announces Publication in Advances in Therapy of Analyses of Patient-Perceived Meaningfulness of Improvement in Symptom Reduction for Overactive Bladder Patients Treated with GEMTESA® (vibegron) 75 mg

LONDON and NEW YORK, Dec. 10, 2021 /PRNewswire/ -- Sumitovant Biopharma, Inc. today announced that its portfolio of four wholly-owned subsidiary companies (Urovant, Enzyvant, Altavant and Spirovant) and Myovant (NYSE: MYOV), a publicly listed company that is majority-owned by Sumitovant, achieved significant clinical, regulatory and commercial milestones during the company's second quarter of fiscal year 2021 ending in October. "The second quarter of 2021 was marked by progress on significant regulatory milestones.

Sumitovant Biopharma Highlights Significant Clinical, Regulatory and Commercial Achievements Across its Portfolio of Companies in the Second Quarter of FY2021

BASEL, Switzerland, Nov. 23, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV), a healthcare company focused on redefining care for women and for men, will participate in the Evercore ISI 4th Annual HealthCONx Conference on November 30, 2021. David Marek, Chief Executive Officer of Myovant Sciences, Inc. will participate in a fireside chat at 11:45 a.m. Eastern Time.

Myovant Sciences to Participate in the Evercore ISI 4th Annual HealthCONx Conference

Relugolix is approved and launched in two indications and could establish itself as a new Standard of Care. The inked 4.2 billion deal with top-class partner Pfizer verifies the blockbuster potential of Relugolix

Review Myovant Sciences And A Consideration Of Steps Following Commercial Launch

IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences Announces Publication of Ambulatory Blood Pressure Study Results for GEMTESA® (vibegron) 75 mg in Overactive Bladder Patients

Urovant Sciences Announces Publication in Blood Pressure Monitoring of Positive Ambulatory Blood Pressure Study Results for GEMTESA® (vibegron) 75 mg in Overactive Bladder Patients

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