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

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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

NEW YORK, LONDON, IRVINE, CA & BASEL, SWITZERLAND, March 29, 2021 (GLOBE NEWSWIRE) -- Sumitovant Biopharma and Urovant Sciences (formerly Nasdaq: UROV) jointly announced today the completion of the merger in which Sumitovant has acquired all outstanding shares of Urovant Sciences.   The merger agreement and the merger were approved on March 23, 2021 by the affirmative vote of holders of a majority of Urovant’s outstanding shares, and by holders of a majority of Urovant's outstanding shares that are not held by Sumitovant.   “As with other companies in the Sumitovant family, Urovant will be privately held and maintain its distinct culture and focus while benefiting from the strateg

PALO ALTO, Calif.--(BUSINESS WIRE)--Hercules Capital, Inc. (NYSE: HTGC) (“Hercules” or the “Company”), the largest and leading specialty financing provider to innovative venture, growth and established stage companies backed by some of the leading and top-tier venture capital and select private equity firms, today announced its financial results for the fourth quarter and full-year ended December 31, 2020. “Despite the unique challenges of 2020, Hercules was able to reach several new financial and operating milestones,” stated Scott Bluestein, chief executive officer and chief investment officer of Hercules. “Notably, we closed over $1.0 billion in new debt and equity commitments

IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) today reported financial results for its fiscal quarter ended December 31, 2020. “The third quarter of fiscal 2020 was transformational for Urovant. In November, we announced the signing of a definitive merger agreement with Sumitovant Biopharma, the majority shareholder of Urovant. Under the terms of the definitive agreement, Urovant will be acquire by Sumitovant Biopharma at a 96% premium to the closing price of our shares prior to the agreement being announced. We look forward to obtaining shareholder approval for the merger at a special general meeting that we expect to take place at the end

IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today that the independent Data and Safety Monitoring Board (DSMB) has recommended the continuation of the phase 2a study of URO-902, a novel gene therapy product, in patients with overactive bladder (OAB) and urge urinary incontinence (UUI). URO-902 has the potential to be the first gene therapy for patients with OAB. Following the recommendation of the DSMB, Urovant is proceeding with opening cohort 2 of the study with a dose of 48 mg or placebo. About the Phase 2a Study This randomized, double blind, placebo-controlled study will evaluate the efficacy, safety, and tolerability of a

NEW YORK, LONDON, IRVINE, Calif. & BASEL, Switzerland, Dec. 23, 2020 (GLOBE NEWSWIRE) -- Sumitovant Biopharma Ltd., today announced that Urovant Sciences (Nasdaq: UROV), a member of the Sumitovant family of companies, has received U.S. Food and Drug Administration (FDA) approval of its New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. GEMTESA is the first oral branded OAB medication to be approved by the FDA since 2012, and it is the first product approval for Urovant Sciences.   “Sumitova

IRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for once-daily 75 mg GEMTESA® (vibegron), a beta-3 adrenergic receptor (β3) agonist, for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence (UUI), urgency, and urinary frequency in adults. This approval marks the first new oral branded OAB medication approved by the FDA since 2012, and it is the first product approval for Urovant Sciences. “The FDA’s approval of GEMTESA is an important milestone for the tens of millions of patients living with overactive