UroGen Pharma Ltd.

UroGen Announces Start of Pivotal Single-Arm Phase 3 Trial for UGN-102, an Investigational Non-Surgical Treatment for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

Retrieved on: 
Thursday, February 3, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Private Securities Litigation Reform Act, Safety, Risk, Patient, Food, Atlantic Health System, Morristown Medical Center, Neoplasm, SEC, Probability, Bladder cancer, Twitter, Technology, COVID-19, TURBT, Recurrence, ATLAS, Disease, NMIBC, New Drug Application, Cancer, Trial of the century, Time, Regulation of tobacco by the U.S. Food and Drug Administration, NDA, FDA, Mitomycins, Solution, Nasdaq, Pharmaceutical industry, Medical device, Medical imaging, LG IR NMIBC, UroGen Pharma Ltd., LG IR NMIBC, UROGEN PHARMA LTD.

For the new Phase 3 trial, study participants will receive 6 once-weekly intravesical instillations of UGN-102.

Key Points: 
  • For the new Phase 3 trial, study participants will receive 6 once-weekly intravesical instillations of UGN-102.
  • Currently, the only effective primary treatment available is a surgical procedure known as transurethral resection of bladder tumor, or TURBT.
  • UroGen is a biopharmaceutical company dedicated to building novel solutions that treat urothelial and specialty cancers because patients deserve better options.
  • UroGens first commercial product, and investigational treatment UGN-102 (mitomycin) for intravesical solution for patients with low-grade non-muscle invasive bladder cancer, are designed to ablate tumors by non-surgical means.

UroGen Pharma Reports Third Quarter 2021 Financial Results and Recent Corporate Developments

Retrieved on: 
Monday, November 15, 2021
Biotechnology, Pharmaceutical, Health, TURBT, Urine, Bone marrow, Cancer, Female, Clinical trial, Swelling, Nephrectomy, Growth, COVID-19, Urinary tract infection, Perforation, Pain, Solution, Transitional epithelium, ATLAS, Safety, Abdomen, Kidney, Recurrence, Patient Information Advisory Group, Technology, Blood, Transitional cell carcinoma, Probability, Ureter, Vomiting, Fever, Fatigue, Clothing, Patient, FDA, Adult, Bladder cancer, View, Private Securities Litigation Reform Act, Medicine, Orphan drug, Breast milk, Risk, Twitter, UTUC, Urinary bladder, SEC, Urination, Man, Nausea, Sodium bicarbonate, Arm, Water, Birth, Stomach, Neoplasm, Company, Skin, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Generic drug, Jelmyto®, Upper Tract Urothelial Cancer (UTUC), UGN-102, the Phase 3 ATLAS Trial, UroGen Pharma Ltd., JELMYTO®, UPPER TRACT UROTHELIAL CANCER (UTUC), UGN-102, THE PHASE 3 ATLAS TRIAL, UROGEN PHARMA LTD.

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20211115005427/en/

The Journal of Urology Publishes Results of UroGen Pharma’s Phase 2b Study of UGN-102 in Patients with Low-Grade Intermediate Risk Non-Muscle Invasive Bladder Cancer (LG IR-NMIBC)

Retrieved on: 
Tuesday, October 5, 2021
Oncology, Health, Clinical Trials, General Health, Pharmaceutical, Biotechnology, Neoplasm, Bladder cancer, Probability, American Urological Association, Diagnosis, Radiology, Patient, Recurrence, Solution, Fatigue, CR, Risk, Intermediate, Private Securities Litigation Reform Act, Population, Disease, FACS, Twitter, Cancer, Hematuria, Principal, Company, Program, Growth, ATLAS, Journal, COVID-19, NYU Langone Health, Dysuria, Urinary bladder, Technology, View, TURBT, Urinary tract infection, Safety, Urologic disease, LG, Kaplan–Meier estimator, NMIBC, Nasdaq, SEC, The New England Journal of Medicine, Pharmaceutical industry, Medical imaging, the Phase 2b OPTIMA II Trial, UGN-102, UroGen Pharma Ltd., THE PHASE 2B OPTIMA II TRIAL, UGN-102, UROGEN PHARMA LTD.

The study was published online and will be in the January print edition of The Journal of Urology.

Key Points: 
  • The study was published online and will be in the January print edition of The Journal of Urology.
  • Approximately 50-60% of the 81,000 estimated new cases of non-muscle invasive bladder cancer (NMIBC) diagnosed in the U.S. in 2020 were low-grade.
  • Some patients require multiple TURBT surgeries per year, which may lead to post-operative and long-term morbidity for this patient population.
  • The OPTIMA II Phase 2b results showed a significant treatment response with sustained durability in non-surgical chemoablation of LG IR-NMIBC.

UroGen Pharma Presents Data Showcasing Novel Clinical Data at 2021 American Urological Association (AUA) Annual Meeting

Retrieved on: 
Monday, September 13, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, the Phase 2b OPTIMA II Trial, UGN-102, the Phase 3 OLYMPUS Trial, Jelmyto®, UroGen Pharma Ltd., THE PHASE 2B OPTIMA II TRIAL, UGN-102, THE PHASE 3 OLYMPUS TRIAL, JELMYTO®, UROGEN PHARMA LTD.

The results were presented at the virtual 2021 American Urological Association (AUA) Annual Meeting and published as a supplement to the September 10, 2021 issue of The Journal of Urology.

Key Points: 
  • The results were presented at the virtual 2021 American Urological Association (AUA) Annual Meeting and published as a supplement to the September 10, 2021 issue of The Journal of Urology.
  • The most common adverse events were urinary tract infection, hematuria, ureteric stenosis, flank pain, vomiting, hydronephrosis, dysuria, and nausea.
  • UroGen is a biopharmaceutical company dedicated to building novel solutions that treat specialty cancers and urologic diseases because patients deserve better options.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210913005198/en/

 UroGen Pharma Reports Second Quarter 2021 Financial Results and Recent Corporate Developments

Retrieved on: 
Wednesday, August 4, 2021
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Chemical compounds, Health sciences, Organic compounds, Orphan drugs, Breakthrough therapy, Aziridines, Cancer treatments, Mitomycin C, Oncology, Fast track, Jelmyto®, Upper Tract Urothelial Cancer (UTUC), UGN-102, the Phase 3 ATLAS Trial, UroGen Pharma Ltd., JELMYTO®, UPPER TRACT UROTHELIAL CANCER (UTUC), UGN-102, THE PHASE 3 ATLAS TRIAL, UROGEN PHARMA LTD.

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma, Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210804005328/en/

UroGen Pharma Announces License and Supply Agreement with Neopharm to Pursue Regulatory Approval and Commercialization for Jelmyto® in Israel

Retrieved on: 
Wednesday, July 28, 2021
Biotechnology, Pharmaceutical, Health, Oncology, Chemical compounds, Organic compounds, Heterocyclic compounds, Aziridines, Breakthrough therapy, Mitomycin C, Oncology, Quinones, Jelmyto®, Upper Tract Urothelial Cancer (UTUC), UroGen Pharma Ltd., Neopharm, JELMYTO®, UPPER TRACT UROTHELIAL CANCER (UTUC), UROGEN PHARMA LTD., NEOPHARM

We are proud to be the first company outside the US to have started the regulatory approval and commercialization process for Jelmyto, demonstrating Israel's importance in geographic expansion.

Key Points: 
  • We are proud to be the first company outside the US to have started the regulatory approval and commercialization process for Jelmyto, demonstrating Israel's importance in geographic expansion.
  • I am confident that our well-established expertise and heritage of collaboration with innovative biopharmaceutical companies will make Jelmyto a success in Israel.
  • UroGen is committed to bringing the promise of Jelmyto to as many patients as possible, as quickly as feasible.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma, Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210728005968/en/

UroGen Pharma Reports Strong Preliminary Jelmyto® Sales for Second Quarter 2021

Retrieved on: 
Wednesday, July 14, 2021
Oncology, Health, Clinical trials, Research, Science, Pharmaceutical, Biotechnology, Chemical compounds, Organic compounds, Clinical medicine, Brand management, Brands, Intellectual property law, Product management, Trademark, Mitomycin C, Jelmyto®, Upper Tract Urothelial Cancer (UTUC), UroGen Pharma Ltd., JELMYTO®, UPPER TRACT UROTHELIAL CANCER (UTUC), UROGEN PHARMA LTD.

Additionally, operating expenses in the second quarter of 2021 are anticipated to be in the range of $33 to $38 million.

Key Points: 
  • Additionally, operating expenses in the second quarter of 2021 are anticipated to be in the range of $33 to $38 million.
  • We look forward to reporting our full results for the second quarter of 2021 in early August.
  • The Company expects to report full financial results for the second quarter ended June 30, 2021, and host a conference call on Wednesday, August 4, 2021.
  • JELMYTO and UroGen are registered trademarks of UroGen Pharma, Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20210714005260/en/

UroGen Pharma Reports First Quarter 2021 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, May 13, 2021
Oncology, Health, Hospitals, Other Health, Pharmaceutical, Biotechnology, Health sciences, Pharmacology, Health, Breakthrough therapy, Orphan drugs, Antineoplastic drugs, Aziridines, Enones, Mitomycin C, Hydrogel, Fast track, Modified-release dosage, Jelmyto®, Upper Tract Urothelial Cancer (UTUC), UGN-102, the Phase 3 ATLAS Trial, UroGen Pharma Ltd., JELMYTO®, UPPER TRACT UROTHELIAL CANCER (UTUC), UGN-102, THE PHASE 3 ATLAS TRIAL, UROGEN PHARMA LTD.

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • It is important that you receive all 6 doses of JELMYTO according to your healthcare provider\xe2\x80\x99s instructions.
  • If you miss any appointments, call your healthcare provider as soon as possible to reschedule your appointment.
  • UroGen has developed RTGelTM reverse-thermal hydrogel, a proprietary sustained release, hydrogel-based platform technology that has the potential to improve therapeutic profiles of existing drugs.

UroGen Pharma Reports Fourth Quarter and Full Year 2020 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, March 18, 2021
Oncology, Health, General Health, Research, Science, Pharmaceutical, Biotechnology, Health sciences, Health, Breakthrough therapy, Orphan drugs, Antineoplastic drugs, Cancer treatments, Aziridines, Mitomycin C, Fast track, Jelmyto®, Upper Tract Urothelial Cancer (UTUC), UGN-102, the Phase 3 ATLAS Trial, UroGen Pharma Ltd.

The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.

Key Points: 
  • The U.S. FDA previously granted Orphan Drug, Fast Track, and Breakthrough Therapy Designations to Jelmyto for the treatment of LG-UTUC.
  • On April 15, 2020, the FDA approved Jelmyto, making it the first drug approved for the treatment of LG-UTUC in adult patients.
  • You should not receive JELMYTO if you have a hole or tear (perforation) of your bladder or upper urinary tract.
  • Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with JELMYTO.

UroGen Pharma Announces $75 Million of Non-Dilutive Funding from RTW Investments

Retrieved on: 
Thursday, March 18, 2021
Biotechnology, Pharmaceutical, Health, Oncology, UroGen Pharma Ltd., RTW Investments, LP

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that the Company has entered into a strategic funding agreement with RTW Investments, LP and its affiliated entities (RTW).

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced that the Company has entered into a strategic funding agreement with RTW Investments, LP and its affiliated entities (RTW).
  • The future payments on both Jelmyto and UGN-102 will terminate following the date that RTW has received an aggregate amount pursuant to such payments of $300 million.
  • We are proud to partner with the UroGen management team and look forward to supporting the Companys goal of building a leading uro-oncology company.
  • RTW Investments, LP (RTW) is a New York-based, global, full life-cycle investment firm that focuses on identifying transformational and disruptive innovations in biopharmaceutical and medical technologies.