Upper Tract Urothelial Cancer (UTUC)

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/

 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.

Centers for Medicare & Medicaid Services (CMS) Issues Permanent J-Code for UroGen’s Jelmyto® Effective January 1, 2021

Retrieved on: 
Wednesday, November 11, 2020
Biotechnology, Pharmaceutical, Health, Oncology, Health, Healthcare reform in the United States, Federal assistance in the United States, Liberalism in the United States, Medicare, Presidency of Lyndon B. Johnson, Mitomycin C, Reimbursement, Jelmyto®, Upper Tract Urothelial Cancer (UTUC)

J-codes are reimbursement codes used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B drugs like Jelmyto that are administered by a physician.

Key Points: 
  • J-codes are reimbursement codes used by commercial insurance plans, Medicare, Medicare Advantage, and other government payers for Medicare Part B drugs like Jelmyto that are administered by a physician.
  • 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.
  • Before receiving JELMYTO, tell your healthcare provider about all your medical conditions, including if you:
    are pregnant or plan to become pregnant.

UroGen Pharma Reports Third Quarter 2020 Financial Results and Recent Corporate Developments

Retrieved on: 
Monday, November 9, 2020
Biotechnology, Hospitals, Health, Pharmaceutical, Oncology, Health sciences, Health, Breakthrough therapy, Clinical medicine, Orphan drugs, Antineoplastic drugs, Aziridines, Mitomycin C, Quinones, Fast track, Transitional cell carcinoma, Jelmyto®, Upper Tract Urothelial Cancer (UTUC), UGN-102, the Phase 2b OPTIMA II Trial

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.
  • Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S.
  • Our primary focus is on the health and well-being of patients, caregivers, and UroGen employees at this critical juncture.

UroGen Pharma Reports Second Quarter 2020 Financial Results and Recent Corporate Developments

Retrieved on: 
Monday, August 10, 2020
Biotechnology, Pharmaceutical, Health, Life sciences, Industries, Biotechnology, Specialty drugs, Jelmyto®, Upper Tract Urothelial Cancer (UTUC), UGN-102, the Phase 2b OPTIMA II Trial

UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, today announced financial results for the second quarter ended June 30, 2020 and provided an overview of the Companys recent developments.

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 financial results for the second quarter ended June 30, 2020 and provided an overview of the Companys recent developments.
  • Second Quarter 2020 Financial Results; 2020 Guidance
    UroGen recorded net product sales of Jelmyto for the second quarter ended June 30, 2020 of approximately $371,500.
  • Research and development expenses for the second quarter ended June 30, 2020 were $8.1 million, including non-cash share-based compensation expense of $1.6 million.
  • UroGen adjusted expense guidance down for 2020, driven by change in estimated non-cash share-based compensation expense for 2020.

UroGen Pharma Reports First Quarter 2020 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, May 7, 2020
Oncology, Health, FDA, Other Health, Clinical trials, Pharmaceutical, Biotechnology, Health, Articles, Life sciences, Fast track, Orphan drug, Breakthrough therapy, Transitional cell carcinoma, Food and Drug Administration, the Phase 3 OLYMPUS Trial, JelmytoTM, Upper Tract Urothelial Cancer (UTUC)

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.
  • Urothelial cancer is the ninth most common cancer globally and the eighth most lethal neoplasm in men in the U.S.
  • Our primary focus is on the health and well-being of patients, caregivers, and UroGen employees at this critical juncture.