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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.
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.
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.
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.
Urovant Sciences (Nasdaq: UROV) reported its financial results for the quarter ending December 31, 2020, highlighting a transformational merger with Sumitovant Biopharma at a 96% premium to its pre-announcement share price. The merger, valued at approximately $584 million, awaits shareholder approval at a special meeting expected by the end of Q1 CY2021. Additionally, Urovant achieved FDA approval for GEMTESA for overactive bladder and is set to launch the product shortly. However, the company's net loss for the quarter reached $46.8 million, with total cash of $71.3 million.
Urovant Sciences (Nasdaq: UROV) announced a positive recommendation from the independent Data and Safety Monitoring Board (DSMB) to proceed with the phase 2a trial of URO-902, a novel gene therapy for overactive bladder (OAB) and urge urinary incontinence (UUI). The trial aims to evaluate the efficacy and safety of URO-902 in patients who have failed oral therapies. The study will enroll around 80 female patients and assess changes in UUI episodes over 12 weeks. URO-902 could become the first gene therapy for OAB, targeting significant unmet needs in patient care.
Urovant Sciences (Nasdaq: UROV) has received FDA approval for GEMTESA® (vibegron), a once-daily 75 mg treatment for adults with overactive bladder (OAB) symptoms, marking its first product approval. This new oral medication, the first FDA-approved OAB treatment since 2012, aims to alleviate urge urinary incontinence, urgency, and frequency. GEMTESA's clinical trials involved over 4,000 patients, demonstrating significant improvements in OAB symptoms without increasing hypertension risks. Urovant plans to launch GEMTESA by late Q1 2021.
Urovant Sciences (Nasdaq: UROV) announced topline results from a Phase 2a trial assessing vibegron 75 mg for abdominal pain from irritable bowel syndrome (IBS). Among 222 enrolled women, only 40.9% of vibegron patients saw a 30% pain improvement versus 42.9% in the placebo group, failing the primary endpoint. Although a secondary endpoint showed 42.4% of vibegron patients reported global improvement compared to 33.3% in placebo, this lack of statistical significance raises concerns. Vibegron was well tolerated, with low discontinuation due to adverse events.
Urovant Sciences announces a definitive agreement for Sumitovant Biopharma to acquire Urovant for $16.25 per share, summing to an approximate $584 million equity value. This represents a 96% premium over its closing price of $8.28 on November 12, 2020. The transaction is unanimously approved by both boards and will close in Q1 2021, pending minority shareholder approval. Urovant aims to launch vibegron in 2021, pending FDA approval, reinforcing its market position in urology.
On November 12, 2020, Sumitovant Biopharma announced its definitive agreement to acquire the remaining 28% of Urovant Sciences' shares at $16.25 each in cash, totaling an equity value of $584 million. This purchase reflects a 96% premium over Urovant's closing price on the announcement date. The acquisition, which has been approved by Urovant's Board of Directors, aims to provide Urovant with access to capital and support the launch of its lead product, vibegron, for overactive bladder treatment. The transaction is expected to close in Q1 2021, subject to shareholder approval.
