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Myovant Sciences (NYSE: MYOV) announced a conference call to discuss its third fiscal quarter 2021 financial results on January 26, 2022, at 8:30 a.m. ET. The call will cover corporate updates and will be available to the public via a live webcast. Myovant has made significant progress with five Phase 3 clinical trials and received two FDA approvals for prostate cancer and uterine fibroids treatments. Additionally, it has two regulatory submissions under review, focusing on advanced prostate cancer and endometriosis. A Phase 3 study for pregnancy prevention is also underway.
Myovant Sciences announced preliminary financial results for Q3 FY2021, estimating total revenue between $54.0-$55.0 million, with net product revenue expected at $28.8-$29.8 million. Revenue from ORGOVYX is projected at $24.2-$24.6 million, marking a 40% sequential volume growth. In addition, MYFEMBREE is estimated to contribute $2.3-$2.6 million. The company remains well-capitalized with $527.8 million in cash and equivalents. Myovant is set to present at the J.P. Morgan Healthcare Conference on January 12, 2022.
Myovant Sciences (NYSE: MYOV) will have CEO David Marek present at the 40th Annual J.P. Morgan Healthcare Conference on January 12, 2022, at 3:00 p.m. ET. This event invites both investors and the public to access the presentation via Myovant's website. Myovant focuses on innovative healthcare solutions for women's and men's health, with notable achievements including two FDA approvals for advanced prostate cancer and heavy menstrual bleeding. The company is also pursuing additional regulatory submissions and clinical trials.
Urovant Sciences announced the publication of patient-perception data from the 12-week EMPOWUR trial in the journal Advances in Therapy, demonstrating significant symptom improvement in overactive bladder (OAB) patients treated with GEMTESA® (vibegron) compared to placebo. Results showed more patients experienced reduced micturition frequency, urgency, and urge urinary incontinence. Lead author Dr. Jeffrey Frankel emphasized the clinical relevance of these findings, indicating GEMTESA's meaningful benefits for patients. This publication reinforces Urovant's commitment to patient-centric outcomes.
Sumitovant Biopharma reported significant clinical, regulatory, and commercial advancements for its subsidiaries, including Enzyvant and Myovant, for Q2 FY2021 ending in October. Key highlights include FDA approval of Enzyvant's RETHYMIC® for congenital athymia and FDA acceptance of Myovant's MYFEMBREE® supplemental application for endometriosis pain management, with a target decision date of May 6, 2022. Data from clinical presentations showcased the efficacy of Myovant’s products. Myovant also lifted a clinical hold on a Phase 3 study, with patient screening initiated in September 2021.
Myovant Sciences (NYSE: MYOV) will participate in the Evercore ISI 4th Annual HealthCONx Conference on November 30, 2021. CEO David Marek will engage in a fireside chat at 11:45 a.m. Eastern Time. Investors and the public can access the discussion via the Investors & Media section of Myovant's website.
Founded in 2016, Myovant focuses on redefining care for women and men through innovative science and advocacy, with several successful Phase 3 trials and regulatory approvals in oncology and women’s health.
Urovant Sciences announced that the Blood Pressure Monitoring journal published a study on GEMTESA® (vibegron), demonstrating it does not significantly affect blood pressure or heart rate. In a double-blind trial with 214 patients, results showed no clinically meaningful differences when compared to placebo. This reinforces GEMTESA's safety profile, as noted by executives from Urovant. The therapy is aimed at treating overactive bladder, a condition affecting approximately 30 million Americans.
Myovant Sciences (NYSE: MYOV) appointed Dr. Nancy Valente as an independent Board member, enhancing its leadership with her extensive experience in oncology and hematology. Dr. Valente, previously a Senior VP at Roche, has over 20 years in drug development and will chair the Nominating and Corporate Governance Committee. Myovant aims to leverage her expertise to advance its pipeline and sustain long-term growth. The company recently achieved three regulatory approvals and product launches in the past year, reflecting its commitment to providing new treatment options for patients.
Spirovant Sciences will present pre-clinical data for its gene therapy compound, SP-101, at the 2021 North American Cystic Fibrosis Conference from November 2-5. SP-101 targets patients with cystic fibrosis who don't respond to current treatments, including about 20% of CF patients. Presentations will include oral and poster sessions, featuring data on how SP-101 restores CFTR function in human CF airway epithelial cultures and in ferret models. Key presentations will occur on November 3 and November 4, led by Dr. Katherine Excoffon.
Myovant Sciences (NYSE: MYOV) reported second fiscal quarter 2021 revenues of $77.9 million, with net product revenues for ORGOVYX® at $18.7 million and MYFEMBREE® at $0.6 million. Approximately 8,000 patients received ORGOVYX, while about 600 received MYFEMBREE, as of September 2021. The FDA accepted a supplemental NDA for MYFEMBREE for endometriosis, with a decision expected by May 6, 2022. The launch of RYEQO in Europe was also highlighted. Myovant remains well-capitalized with $657.3 million in cash and equivalents as of September 30, 2021.
