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Urovant Sciences presented new data from the Phase 3 EMPOWUR Extension Study of GEMTESA (vibegron) at AUA2022 in New Orleans. The study showed that GEMTESA was safe and well-tolerated in adults 65 and older with overactive bladder, leading to sustained reductions in daily urinary issues. Additionally, significant improvements in OAB questionnaire and Patient Global Impression scores were observed over 52 weeks. GEMTESA, FDA-approved for treating overactive bladder symptoms, underscores Urovant's commitment to effective urologic therapies.
Urovant Sciences presented positive interim results from a Phase 2a trial of its gene therapy URO-902 for overactive bladder (OAB) at AUA2022. The 12-week analysis showed significant improvements in symptoms among women unresponsive to oral treatments. The trial involved 80 patients, with both 24 mg and 48 mg doses demonstrating better efficacy than placebo. Key side effects included urinary tract infections, primarily noted at the 48 mg dosage. URO-902 could offer a new treatment option for OAB patients failing standard therapies.
Myovant Sciences (MYOV) reported a transformative fiscal year 2021 with total revenue of $231.0 million, up from $59.3 million in 2020. Net product revenue for ORGOVYX reached $94.3 million, contributing significantly to fourth-quarter revenues of $57.6 million. The company achieved European approval for ORGOVYX in April 2022 and entered an exclusive license agreement with Accord Healthcare worth up to $140.5 million. MYFEMBREE continues to lead in new prescriptions. As of March 31, 2022, Myovant holds $434.2 million in cash and equivalents.
Myovant Sciences (NYSE: MYOV) has entered into an exclusive licensing agreement with Accord Healthcare to commercialize ORGOVYX® (relugolix) for advanced hormone-sensitive prostate cancer in Europe. Myovant will receive an upfront payment of $50 million, with potential milestones of up to $90.5 million and tiered royalties on net sales. As part of the deal, Myovant will lead global relugolix development while Accord handles local clinical development and commercialization. ORGOVYX® is expected to launch in Europe in the second half of 2022.
Altavant Sciences announced its presentation of preclinical study results at ATS 2022 in San Francisco, showcasing rodatristat ethyl both as a monotherapy and in combination with ambrisentan for treating pulmonary arterial hypertension (PAH). The study demonstrated promising outcomes in reversing vascular occlusions and regulating mean pulmonary arterial pressure (mPAP). The presentation is scheduled for May 17, 2022, highlighting the therapeutic potential of rodatristat ethyl, which targets serotonin production, a contributor to PAH pathology.
Myovant Sciences (NYSE: MYOV) and Pfizer announced that the FDA has extended the review period for MYFEMBREE's supplemental New Drug Application (sNDA) regarding moderate to severe pain from endometriosis. The FDA requested more time to evaluate information related to bone mineral density, with the new target date set for August 6, 2022. MYFEMBREE is a previously approved treatment for heavy menstrual bleeding due to uterine fibroids. Myovant remains optimistic about MYFEMBREE's potential as a therapeutic option for endometriosis pain management.
Altavant Sciences announced positive preclinical results for ALTA-2530, its inhaled IL-1 receptor antagonist targeting bronchiolitis obliterans syndrome (BOS). Presented at the ISHLT meeting in Boston, the data indicated effective distribution to lung areas and superior binding affinity compared to IL-1α and IL-1β. Notable inhibition of the proinflammatory cytokine IL-6 was also observed. Experts at Altavant expressed optimism about ALTA-2530's potential to mitigate chronic transplant rejection post-lung transplant. Current development is focused on rare respiratory diseases.
The European Commission has approved ORGOVYX® (relugolix, 120 mg) for the treatment of advanced hormone-sensitive prostate cancer, marking its first oral androgen deprivation therapy in Europe. This approval spans all 27 EU member states and additional countries like Iceland and Norway. Myovant anticipates announcing a commercialization partner soon, ahead of market launches. ORGOVYX® demonstrated superior testosterone suppression in the Phase 3 HERO study compared to leuprolide acetate and offers a new treatment option to improve patient care.
Myovant Sciences (NYSE: MYOV) will host a webcast and conference call on May 10, 2022, at 8:30 a.m. ET to discuss corporate updates and financial results for Q4 and fiscal year 2021, ending March 31, 2022. Investors and the public can access the live webcast on Myovant's investor relations site. The replay, along with the earnings press release and presentation materials, will be available for one year. Myovant focuses on women's health and hormone-sensitive oncology and has achieved regulatory approvals for its treatments.
Urovant Sciences announced a post-hoc analysis of the EMPOWUR trial, published in the International Journal of Clinical Practice, showing that GEMTESA (vibegron) significantly reduced urgency episodes and urination in patients with both dry and wet overactive bladder (OAB). The analysis aligns with previous findings from the Journal of Urology highlighting GEMTESA's efficacy in treating OAB. The EMPOWUR study involved 1,518 patients and demonstrated favorable long-term safety and efficacy outcomes, establishing GEMTESA as a viable treatment option for an estimated 30 million Americans affected by OAB.
