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Urovant Sciences has announced that data from the Phase 2a trial of URO-902, a gene therapy for overactive bladder (OAB), will be presented at the American Urological Association's annual meeting in New Orleans from May 13-16, 2022. The presentation will include interim efficacy and safety results. Additionally, new analyses from the Phase 3 EMPOWUR Extension Study of GEMTESA® (vibegron) 75 mg will be presented, focusing on long-term efficacy and safety, particularly in patients aged 65 and above. These updates aim to enhance treatment options for patients with OAB.
Myovant Sciences (NYSE: MYOV) and Pfizer (NYSE: PFE) have announced an update on the Supplemental New Drug Application (sNDA) for MYFEMBREE regarding its use in treating moderate to severe endometriosis pain. On April 6, 2022, the FDA identified deficiencies in the application but has not made a final decision. The companies are collaborating with the FDA to address these issues. MYFEMBREE is significant as it represents a new treatment option for women experiencing pain associated with endometriosis, following positive indications for other conditions.
Urovant Sciences announced the appointment of Sef Kurstjens, M.D., PhD., as the new Executive Vice President and Chief Medical Officer effective April 1, 2022. Dr. Kurstjens, who previously held a board position since July 2018, will now focus on advancing Urovant's clinical and medical affairs. His extensive experience in urology and leadership will support the company's efforts to expand access to GEMTESA® and develop its product pipeline. Urovant aims to innovate in urology and other unmet medical needs.
Urovant Sciences announced the publication of a review in Therapeutics and Clinical Risk Management, highlighting studies on GEMTESA (vibegron) for overactive bladder (OAB). The review indicates that vibegron is efficacious, safe, and well-tolerated, based on two Phase 3 trials and other studies. Significant improvements in OAB symptoms were observed compared to placebo. Serious adverse events were comparable to placebo, and no clinically meaningful effects on blood pressure were noted. The paper calls for further research into vibegron's real-world effectiveness.
Urovant Sciences announced positive topline results from the Phase 2a study of URO-902, a novel gene therapy for patients with overactive bladder (OAB). The study showed a statistically significant improvement in symptoms such as micturitions and urgency episodes compared to placebo 12 weeks post-administration. The trial involved 80 female patients and demonstrated good tolerability, with urinary tract infections being the most common side effect. URO-902 could potentially be the first gene therapy for OAB patients inadequately managed by existing treatments.
Myovant Sciences (MYOV) announced that the European Medicines Agency's CHMP has recommended the approval of ORGOVYX® (relugolix, 120 mg) for adult patients with advanced hormone-sensitive prostate cancer. This would make ORGOVYX® the first oral androgen deprivation therapy available in Europe. The recommendation is based on findings from the Phase 3 HERO study, and a final approval decision by the European Commission is expected in about two months. Myovant is also pursuing international partnership opportunities for relugolix in oncology.
Sumitovant Biopharma and its parent Sumitomo Dainippon Pharma have launched a phase 1 study in the U.S. for KSP-1007, a new drug candidate targeting carbapenem-resistant bacterial infections. This initiative addresses a critical medical need, particularly for complicated urinary tract and intra-abdominal infections. Nonclinical data suggest KSP-1007 effectively inhibits β-lactamases, enhancing the efficacy of the widely used carbapenem antibiotic, meropenem. The development of this novel treatment is crucial as antimicrobial resistance continues to rise globally.
Myovant Sciences (NYSE: MYOV) announced participation in investor conferences, including the 11th Annual SVB Leerink Global Healthcare Conference on February 18, 2022, and the Cowen 42nd Annual Health Care Conference on March 8, 2022. CEO David Marek and the executive team will engage in a fireside chat, with webcasts available to the public on the Myovant website. The company aims to redefine care for women and men through innovative treatments, having achieved two FDA approvals and additional regulatory submissions currently under review.
Myovant Sciences (MYOV) reported total revenues of $54.4 million for Q3 FY2021, a significant increase from $1.4 million in the same quarter last year. Net product revenue from ORGOVYX® was $24.4 million, reflecting a 40% sequential growth, while MYFEMBREE® generated $2.4 million. The company treated approximately 11,000 patients with ORGOVYX and 1,400 with MYFEMBREE. Myovant holds $527.8 million in cash and equivalents, positioning them for future growth, with several upcoming FDA decisions expected by May 2022.
