$UROV News
Last published 1y ago
- 1y agoUROVApproval of Gemtesa, Nda #213006 (Efficacy)FDA Approved DrugsApproval Date: 12/18/2024; Drug Name: Gemtesa, Nda #213006; Active Ingredients: VIBEGRON; Company: Urovant; Submission Status: Approval; Submission Classification: Efficacy; Application Number: 213006
- 2y agoUROVApproval of Gemtesa, Nda #213006 (Labeling)FDA Approved DrugsApproval Date: 10/08/2024; Drug Name: Gemtesa, Nda #213006; Active Ingredients: VIBEGRON; Company: Urovant; Submission Status: Approval; Submission Classification: Labeling; Application Number: 213006
- 4y agoUROVA Study of Vibegron in Pediatric Participants 2 Years to Less Than (<) 18 Years of Age With NDO and on CIC - NCT05491525ClinicalTrials.govChange from Baseline in maximum cystometric capacity (MCC) based on bladder filling urodynamics, Change from Baseline in MCC, Change from Baseline in number of overactive detrusor contractions until the end of bladder filling, (and 12 more...)
- 4y agoMYOVUROVUrovant Sciences to Present Interim Data from Phase 2a Study of Potential Novel Gene Therapy, URO-902, and New Analyses of Data from Phase 3 EMPOWUR Extension Trial of GEMTESA® (vibegron) 75 mg at 2022 American Urological Association Annual MeetingBusiness WireInterim 12-week analysis from a Phase 2a trial of the potential gene therapy, URO-902, in women with overactive bladder (OAB) and urge urinary incontinence (UUI) will be featured in a late breaker presentation by Kenneth M. Peters, M.D. during Friday
- 4y agoMYOVUROVUrovant Sciences Announces Positive Topline Results of Phase 2a Trial of its Potential Novel Gene Therapy, URO-902Business WireStudy 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 f
- 4y agoMYOVUROVUrovant Sciences Announces Publication in Advances in Therapy of Analyses of Patient-Perceived Meaningfulness of Improvement in Symptom Reduction for Overactive Bladder Patients Treated with GEMTESA® (vibegron) 75 mgBusiness WireData 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 mict
- 5y agoMYOVUROVUrovant Sciences Announces Publication in Blood Pressure Monitoring of Positive Ambulatory Blood Pressure Study Results for GEMTESA® (vibegron) 75 mg in Overactive Bladder PatientsBusiness WireData 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-
- 5y agoUROVComposur: Study to Understand the Performance of Vibegron in Participants With Overactive Bladder (OAB) - NCT05067478ClinicalTrials.govMean Satisfaction Domain Score as Assessed by the Overactive Bladder Satisfaction with Treatment Questionnaire (OAB-SAT-q), Percentage of Positive Responders to Individual Treatment Satisfaction Questions 1-3 and 11 as Assessed by the OAB-SAT-q, Mean Scores on the Side Effects, Endorsement, Convenience, and Preference Domains as Assessed by the OAB-SAT-q, (and 3 more...)
- 5y agoHTGCDASHMASSACEV+10Hercules Capital Reports Fourth Quarter and Full-Year 2020 Financial ResultsBusiness WirePALO 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 ...
- 5y agoUROVUrovant Sciences Provides Merger Update and Reports Third Quarter Fiscal Year 2020 ResultsBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) today reported financial results for its fiscal quarter ended December 31, 2020.
- 5y agoUROVUrovant Sciences Announces Progression of URO-902 Phase 2a Trial Following Positive Recommendation from the Data and Safety Monitoring BoardBusiness WireIRVINE, 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).
- 5y agoUROVSumitovant Biopharma Announces Urovant Sciences Receives U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)GlobeNewswireNEW 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...
- 5y agoUROVUrovant Sciences Announces U.S. FDA Approval of GEMTESA® (vibegron) 75 mg Tablets for the Treatment of Patients with Overactive Bladder (OAB)Business WireIRVINE, 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 fre ...
- 5y agoUROVApproval of , Nda #213006 (Type 1 - New Molecular Entity)FDA Approved DrugsApproval Date: 12/23/2020; Drug Name: , Nda #213006; Active Ingredients: undefined; Company: Urovant Sciences Gmbh; Submission Status: Approval; Submission Classification: Type 1 - New Molecular Entity; Application Number: 213006
- 5y agoUROVApproval of Gemtesa, Nda #213006 (Type 1 - New Molecular Entity)FDA Approved DrugsApproval Date: 12/23/2020; Drug Name: Gemtesa, Nda #213006; Active Ingredients: VIBEGRON; Company: Urovant Sciences Gmbh; Submission Status: Approval; Submission Classification: Type 1 - New Molecular Entity; Application Number: 213006
- 5y agoUROVUrovant Sciences Announces Topline Data from Phase 2a Study of Vibegron for the Treatment of Irritable Bowel Syndrome (IBS) Pain Did Not Meet Primary EndpointBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) today reported topline data from the Phase 2a randomized, double blind, placebo-controlled clinical trial evaluating once-daily vibegron 75 mg in women with abdominal pain due to irritable bowel syndrome (IBS) with IBS-D (diarrhea) and IBS-M (mixed IBS).
- 5y agoDNKNHDSCEIXUROVMoore Kuehn Encourages DNKN, HDS, CEIX and UROV Investors to Contact Law FirmGlobeNewswireNEW YORK, Nov. 20, 2020 (GLOBE NEWSWIRE) -- Moore Kuehn, PLLC, a securities litigation law firm located on Wall Street in downtown New York City, is investigating potential claims concerning whether...
- 5y agoUROVUrovant Sciences Announces Positive Clinical Efficacy and Safety Data from Vibegron EMPOWUR Long Term Extension StudyBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) today announced positive efficacy and safety data from the vibegron EMPOWUR long term extension study with patient data over a total exposure of 52 weeks. The data demonstrate that vibegron improved quality of life (QoL) and incontinence efficacy endpoints with good long term tolerability in adult patients with o ...
- 6y agoUROVUrovant Sciences Enters Into Definitive Agreement for Sumitovant Biopharma to Acquire All Outstanding SharesBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today that it has entered into a definitive agreement in which Sumitovant Biopharma will acquire Urovant Sciences for $16.25 per share or approximately $584 million in total equity value on a fully diluted basis in an all-cash merger. The price represents a 96% premium over Urovant’s closing share price ...
- 6y agoUROVSumitovant Biopharma and Urovant Sciences Announce Sumitovant's Acquisition of Remaining Stake in UrovantPR NewswireSumitovant Biopharma and Urovant Sciences (Nasdaq: UROV) today announced that they have entered into a definitive merger agreement for Sumitovant to...
- 6y agoUROVUrovant Sciences to Present at the Jefferies Virtual London Healthcare ConferenceBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today that president and chief executive officer James Robinson will give a presentation at 6:10 p.m. GMT (10:10 a.m. PST / 1:10 p.m. EST) on Tuesday, November 17, 2020, at the Jefferies Virtual London Healthcare Conference.
- 6y agoUROVUrovant Sciences' (UROV) CEO Jim Robinson on Q2 2020 Results - Earnings Call TranscriptEarnings Call Transcripts
- 6y agoUROVUrovant Sciences Reports Second Quarter Fiscal Year 2020 ResultsBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) today reported financial results for its fiscal quarter ended September 30, 2020.
- 6y agoUROVUrovant Sciences to Report Second Fiscal Quarter 2020 Financial ResultsBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today that it will report financial results for its fiscal quarter ended September 30, 2020 after the close of U.S. financial markets on Monday, November 2, 2020.
- 6y agoUROVUrovant Sciences Announces Co-Promotion Agreement for Vibegron with Sunovion PharmaceuticalsBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) today announced it has entered into a five-year U.S. co-promotion agreement with Sunovion Pharmaceuticals Inc. to promote vibegron in the primary care segment upon receiving U.S. Food and Drug Administration (FDA) approval for the drug. In March 2020, the FDA accepted the New Drug Application (NDA) for vibegron i ...
- 6y agoUROVUrovant Sciences to Present at the H.C. Wainwright & Co. Annual Global Investment ConferenceBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today that president and chief executive officer James Robinson will give a presentation at 7:30 a.m. Pacific / 10:30 a.m. Eastern on Tuesday, September 15, 2020, at the H.C. Wainwright & Co. Annual Global Investment Conference, which is being held virtually.
- 6y agoUROVUrovant Sciences Ltd. (UROV) CEO James Robinson on Q1 2020 Results - Earnings Call TranscriptEarnings Call Transcripts
- 6y agoUROVUrovant Sciences Reports Fiscal First Quarter 2020 ResultsBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) today reported financial results for the three months ended June 30, 2020.
- 6y agoUROVUrovant Sciences to Report First Fiscal Quarter 2020 Financial ResultsBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today that it will report 2020 first fiscal quarter financial results after the close of U.S. financial markets on Thursday, August 13, 2020.
- 6y agoUROVSumitovant Biopharma Announces Urovant Sciences Collaboration with Sunovion PharmaceuticalsGlobeNewswireLONDON and NEW YORK, June 19, 2020 (GLOBE NEWSWIRE) -- Sumitovant Biopharma Ltd. today announced that Urovant Sciences (Nasdaq: UROV), a member of the Sumitovant Biopharma family of companies, has...
- 6y agoUROVUrovant Sciences Reports Fiscal Year and Fourth Quarter 2019 ResultsBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) today reported financial results for the three months and 2019 fiscal year ended March 31, 2020.
- 6y agoUROVUrovant Sciences Announces Collaboration with Sunovion PharmaceuticalsBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) today announced it has entered into an exclusive three-year distribution agreement with Sunovion Pharmaceuticals Inc. (Sunovion) for services to support the commercialization of vibegron, an investigational agent for the treatment of overactive bladder. Both companies are subsidiaries of Sumitomo Dainippon Pharma ...
- 6y agoUROVUrovant Sciences to Report Fiscal Year and Fourth Quarter 2019 ResultsBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today that it will report fiscal year and fourth quarter 2019 results after the close of U.S. financial markets on Thursday, June 18, 2020.
- 6y agoUROVUrovant Sciences Appoints Walt Johnston as Senior Vice President of Commercial, Kenton Stewart as Senior Vice President of Market AccessBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) today announced the appointment of Walt Johnston as Senior Vice President of Commercial and Kenton Stewart as Senior Vice President of Market Access, both reporting to Urovant CEO James Robinson.
- 6y agoUROVUrovant Sciences Appoints James Hindman to Board of DirectorsBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) today announced the appointment of Jim Hindman to the company’s Board of Directors. A veteran of the pharmaceutical, biologics and medical device industries, Mr. Hindman brings more than 30 years of financial and strategic experience to his new role.
- 6y agoUROVUrovant Sciences Presents Positive Clinical Efficacy & Safety Data on Lead Drug Candidate Vibegron at Virtual American Urological Association Annual MeetingBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today that data from the vibegron EMPOWUR 52-week extension study (NCT03583372) and data by age groups from the 12-week placebo-controlled EMPOWUR study (NCT03492281) will be presented virtually by the authors during the 2020 American Urological Association (AUA) Annual Meeting and will be available for ...
- 6y agoUROVUrovant Sciences Appoints James Robinson as President and Chief Executive OfficerBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) today announced the appointment of accomplished industry veteran Jim Robinson to the position of President and Chief Executive Officer. Mr. Robinson will continue his service as a member of the Urovant Board of Directors. Mr. Robinson is succeeding Urovant’s founding CEO Keith Katkin, who will transition to the r ...
- 6y agoUROVUrovant Sciences Announces Publication of Phase 3 EMPOWUR Trial Results in the Journal of UrologyBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today the publication of the efficacy and safety results of vibegron in patients with overactive bladder (OAB) from the international Phase 3 EMPOWUR trial. The peer-reviewed publication is currently available online and the print article is scheduled to be published in the August issue of Journal of Ur ...
- 6y agoUROVUrovant Sciences to Present at Cowen and Company’s 40th Annual Health Care ConferenceBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today that Chief Executive Officer Keith Katkin will give a presentation at 5:40 a.m. Pacific / 8:40 a.m. Eastern on Tuesday, March 3, 2020, at Cowen and Company’s 40th Annual Health Care Conference in Boston.
- 6y agoHTGCTELAMYOVUROV+2Hercules Capital Reports Fourth Quarter and Record Full-Year 2019 Financial ResultsBusiness WirePALO 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 ...
- 6y agoUROVUrovant Sciences Reports 2019 Third Fiscal Quarter Financial ResultsBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) today reported financial results for the 2019 third fiscal quarter ended December 31, 2019.
- 6y agoUROVUrovant Sciences to Report 2019 Third Fiscal Quarter Financial ResultsBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today that it will report 2019 third fiscal quarter financial results after the close of U.S. financial markets on Thursday, February 13, 2020.
- 6y agoUROVUrovant Sciences Announces Publication of Results from Phase 1 Clinical Trials Evaluating URO-902 Gene Therapy in Patients with Overactive BladderBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today the publication of the safety and efficacy results of URO-902 in female patients with overactive bladder (OAB) from two double-blind, placebo-controlled randomized Phase 1 trials. The first trial was conducted with instillation therapy and the second trial with direct injections into the bladder w ...
- 6y agoUROVUrovant Sciences to Ring the Nasdaq Stock Market Opening BellBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today that Chief Executive Officer Keith Katkin and other Urovant executives will ring the opening bell of the Nasdaq Stock Market on Tuesday, January 21, 2020, at 9:30 a.m. Eastern.
- 6y agoUROVUrovant Sciences Announces Submission of New Drug Application for Vibegron for the Treatment of Overactive BladderBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) announced today that it has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of once-daily 75mg vibegron for the treatment of patients with overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
- 6y agoUROVUrovant Sciences Enters into $300 Million Term Loan Agreement with Sumitomo Dainippon PharmaBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) (“Urovant”) announced today that it has entered into a $300 million term loan facility with Sumitomo Dainippon Pharma Co., Ltd. (TSE: 4506) (“Sumitomo Dainippon Pharma”), a leading global Japanese pharmaceutical company. Urovant plans to use proceeds from this facility to repay existing debt, fund ongoing develop ...
- 6y agoUROVUrovant Sciences Majority Shareholder, Roivant Sciences, and Sumitomo Dainippon Pharma Complete Transaction for Strategic AllianceBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV) (“Urovant”) announced today that its majority shareholder, Roivant Sciences Ltd. (“Roivant”), and Sumitomo Dainippon Pharma Co., Ltd. (TSE: 4506) (“Sumitomo Dainippon Pharma”), a leading global Japanese pharmaceutical company, have completed their transaction that creates a significant, multinational Sumitomo Dai ...
- 6y agoUROVUrovant Sciences Initiates Patient Enrollment in Phase 2a Study of URO-902Business WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV), announced today that the first patient has been enrolled in a Phase 2a study evaluating the efficacy and safety of URO-902, a novel gene therapy product, in patients with overactive bladder (OAB) suffering with urge urinary incontinence (UUI).
- 7y agoUROVUrovant Sciences Ltd. (UROV) CEO Keith Katkin on Q2 2019 Results - Earnings Call TranscriptEarnings Call Transcripts
- 7y agoUROVUrovant Sciences Reports 2019 Second Fiscal Quarter Financial ResultsBusiness WireIRVINE, Calif. & BASEL, Switzerland--(BUSINESS WIRE)--Urovant Sciences (Nasdaq: UROV), a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions, today reported financial results for the 2019 second fiscal quarter ended September 30, 2019.