| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | March 31, 2021 |
| Accession Number: | 0001193125-21-098129 | ||||||
| Submission Type: | POS AM | ||||||
| |||||||
| UNITED STATES | |
| SECURITIES AND EXCHANGE COMMISSION | |
| Washington, D.C. 20549 | |
| Notice of Effectiveness | |
| Effectiveness Date: | March 31, 2021 |
| Accession Number: | 0001193125-21-098129 | ||||||
| Submission Type: | POS AM | ||||||
| |||||||
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Study showed clinically meaningful impact on common symptoms of overactive bladder (OAB) compared to placebo from baseline to week 12 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 statistically significant effect on a number of relevant outcome measures in OAB including number of micturitions, urgency
Data from the 12-week EMPOWUR trial regarding patient perceptions of improvement of OAB symptoms show that significantly more patients treated once-daily with GEMTESA® (vibegron) experienced patient-perceived improvements due to the reduction in micturition frequency (urination), urinary urgency episodes, and urge urinary incontinence episodes vs. placebo. This analysis supports that the statistically significant reductions in clinical endpoints seen in the EMPOWUR trial are meaningful to patients. Urovant Sciences, Inc., a wholly-owned subsidiary of Sumitovant Biopharma Ltd., announced today that the journal Advances in Therapy has published patient-perception data supporting clinica
Data from a dedicated ambulatory blood pressure study showed once-daily treatment with GEMTESA® was not associated with statistically significant or clinically meaningful effects on blood pressure or heart rate Urovant Sciences, Inc., a wholly- owned subsidiary of Sumitovant Biopharma Ltd., announced today that the journal Blood Pressure Monitoring has published the ambulatory blood pressure data on its recently-approved overactive bladder (OAB) therapy, GEMTESA® (vibegron) in the U.S. The peer-reviewed publication is currently available online and the print article is scheduled to be published in an upcoming issue of the journal. In a dedicated, double-blind, placebo-controlled ambulat
Submission status for UROVANT SCIENCES GMBH's drug GEMTESA (ORIG-1) with active ingredient VIBEGRON has changed to 'Approval' on 12/23/2020. Application Category: NDA, Application Number: 213006, Application Classification: Type 1 - New Molecular Entity
Submission status for UROVANT SCIENCES GMBH's drug (ORIG-1) with active ingredient has changed to 'Approval' on 12/23/2020. Application Category: NDA, Application Number: 213006, Application Classification: Type 1 - New Molecular Entity
4 - Urovant Sciences Ltd. (0001740547) (Issuer)
4 - Urovant Sciences Ltd. (0001740547) (Issuer)
4 - Urovant Sciences Ltd. (0001740547) (Issuer)
SC 13D/A - Urovant Sciences Ltd. (0001740547) (Subject)
SC 13G/A - Urovant Sciences Ltd. (0001740547) (Subject)
15-12B - Urovant Sciences Ltd. (0001740547) (Filer)
EFFECT - Urovant Sciences Ltd. (0001740547) (Filer)
SC 13E3/A - Urovant Sciences Ltd. (0001740547) (Subject)