Mitomycin C

UroGen Pharma Meets Revenue Goal, Reports First Quarter 2023 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, May 11, 2023
Science, Biotechnology, Research, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Ureter, American Urological Association, Society, Investment, Software, AUA, New Drug Application, Clinical trial, NDA, RNU, SUO, Mitomycins, UTUC, Patient, OLYMPUS, Physician, Guideline, RTW, Webcast, Growth, LG, Neoplasm, Conference, Safety, ATLAS, Pharmaceutical industry, Medical imaging, Video game, Bank, Mitomycin C

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the first quarter ended March 31, 2023, and provided an overview of recent developments.

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced financial results for the first quarter ended March 31, 2023, and provided an overview of recent developments.
  • Generated net product revenue of $17.2 million for the first quarter of 2023, representing ~27% growth over the first quarter of 2022.
  • Activated sites on May 1, 2023 were 1,009, compared to 983 on March 1, 2023, while repeat accounts on May 1, 2023 were 235, compared to 214 on March 1, 2023.
  • First Quarter 2022 Financial Results:
    Jelmyto Revenue: UroGen reported net product revenue of Jelmyto for the first quarter 2023 of $17.2 million, compared to $13.6 million in the first quarter of 2022.

UroGen Pharma Reports Third Quarter 2022 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, November 10, 2022
Medical Devices, Medical Supplies, Hospitals, Clinical Trials, Other Health, Biotechnology, General Health, Pharmaceutical, Health, Oncology, Adult, Clothing, Risk, Transitional epithelium, Patient Information Advisory Group, Stomach, Company, Pharmakon—Danish College of Pharmacy Practice, Kidney, Recurrence, Blood, Ureter, Swelling, Birth, Urination, Urinary tract infection, SEC, NMIBC, Water, Time, Cancer, Orphan drug, Neoplasm, Patient, UTUC, Urine, COVID-19, Vomiting, Private Securities Litigation Reform Act, Sodium bicarbonate, Bone marrow, Medicine, Clinical trial, Breast milk, Fatigue, Skin, Growth, Abdomen, Nausea, Perforation, NDA, FDA, Trial of the century, Urinary bladder, Fever, Technology, View, Man, Safety, Female, Pain, Transitional cell carcinoma, Nephrectomy, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Generic drug, Mitomycins, Mitomycin C

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/20221110005284/en/

UroGen Pharma Reports Second Quarter 2022 Financial Results and Recent Corporate Developments

Retrieved on: 
Thursday, August 11, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Nausea, Trial of the century, Female, SEC, Cancer, Clinical trial, Urine, Pain, Blood, Fever, Patient, Swelling, Skin, Clothing, Sodium bicarbonate, Perforation, Breast milk, Disease, Risk, NDA, Technology, Private Securities Litigation Reform Act, UTUC, Patient Information Advisory Group, Recurrence, Ureter, Safety, Water, Birth, Growth, Neoplasm, Man, Fatigue, NMIBC, Bladder cancer, Bone marrow, COVID-19, Stomach, Urinary bladder, Urination, Kidney, Time, Orphan drug, Transitional cell carcinoma, FDA, Vomiting, Abdomen, Nephrectomy, Company, Twitter, View, TURBT, Urinary tract infection, Transitional epithelium, Medicine, Adult, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Generic drug, Pharmakon—Danish College of Pharmacy Practice, Mitomycin C, Mitomycins

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.
  • UroGen are registered trademarks of UroGen Pharma Ltd.
    View source version on businesswire.com: https://www.businesswire.com/news/home/20220811005112/en/

Panavance Therapeutics Announces Publication of Promising Preclinical Data Evaluating GP-2250 for the Treatment of Malignant Peritoneal Mesothelioma

Retrieved on: 
Monday, August 8, 2022
FDA, Apoptosis, Mesothelioma, Respiration (physiology), CEO, Forward-looking statement, GLOBE, La Trobe Institute for Molecular Science, Population, Breast, Synergy, Cancer, Cisplatin, Flow cytometry, ST, Quality of life, Patient, University of Duisburg-Essen, Therapy, Company, International Journal of Molecular Sciences, Pancreatic cancer, Organ (anatomy), Manuscript, General officer, Canadian International Council, Mitomycin C, Melanoma, University, Ovarian cancer, Ruhr University Bochum, Necrosis, Pharmaceutical industry, Panaveli

BERWYN, Pa., Aug. 08, 2022 (GLOBE NEWSWIRE) -- Panavance Therapeutics Inc. (“Panavance” or the “Company”), a clinical-stage pharmaceutical company advancing the development of a novel oncology therapeutic designed to disrupt cancer’s energy metabolism and improve quality of life for patients, today announced the publication of positive preclinical data from a 3-D in vitro study evaluating GP-2250 for the treatment of malignant peritoneal mesothelioma. The manuscript titled, “Substance GP-2250 as a New Therapeutic Agent for Malignant Peritoneal Mesothelioma—A 3-D In Vitro Study1,” was published in the peer-reviewed journal, International Journal of Molecular Sciences. 

Key Points: 
  • This preclinical study is the first to investigate effects of the novel agent GP-2250 on malignant mesothelioma.
  • As we progress its development for the treatment of pancreatic ductal adenocarcinoma, amassing a growing body of data provides valuable validation and guidance.
  • We look forward to further exploring the potential of GP-2250, commented Greg Bosch, Chairman and CEO of Panavance Therapeutics.
  • GP-2250 showed promising antineoplastic effects on malignant mesothelioma cells in vitro especially in combination with cisplatin/mitomycin C even when used at lower concentrations.

UroGen Pharma Reports First Quarter 2022 Financial Results and Recent Corporate Developments

Retrieved on: 
Tuesday, May 10, 2022
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, Ureter, Birth, Swelling, Kidney, Safety, Urination, Patient Information Advisory Group, Risk, Skin, Female, NMIBC, View, SEC, Trial of the century, Technology, Nausea, Stomach, Pain, Twitter, Water, Perforation, Company, Probability, Patient, Urine, Clinical trial, FDA, Nephrectomy, Sodium bicarbonate, Vomiting, Private Securities Litigation Reform Act, Bone marrow, Medicine, Neoplasm, NDA, Time, Fatigue, UTUC, Clothing, Growth, Man, COVID-19, Transitional cell carcinoma, Abdomen, Fever, Cancer, Blood, Orphan drug, Urinary bladder, Urinary tract infection, Adult, Breast milk, Transitional epithelium, Recurrence, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Generic drug, Mitomycins, Mitomycin C, Pharmakon—Danish College of Pharmacy Practice

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/20220510005510/en/

Mobius Therapeutics™ Customers to Advocate Use of Mitosol®

Retrieved on: 
Tuesday, May 10, 2022
Mobius, ST, Moebius, LLC, Timm, Patient, Mitomycins, Temperature, Caregiver, FDA, Pharmacy, CEO, Social media, Therapy, Pharmaceutical industry, Mitomycin C

ST. LOUIS, May 10, 2022 /PRNewswire/ -- Mobius Therapeutics™, LLC, a St. Louis-based perioperative ophthalmic pharmaceutical company, will initiate a social media presence featuring interviews and live streaming of customers to support the value proposition of its flagship product, Mitosol®.

Key Points: 
  • ST. LOUIS, May 10, 2022 /PRNewswire/ -- Mobius Therapeutics, LLC , a St. Louis-based perioperative ophthalmic pharmaceutical company, will initiate a social media presence featuring interviews and live streaming of customers to support the value proposition of its flagship product, Mitosol .
  • Mitosol customers have the option to purchase compounded copies of our approved formulation from pharmacies and outsourcing facilities," said Ed Timm, CEO of Mobius Therapeutics.
  • Mobius Therapeutics is a commercial stage venture focused on sterile perioperative ophthalmic pharmaceuticals.
  • Mitosol (mitomycin for solution) 0.2 mg/vial, Kit for Ophthalmic Use , is the only formulation of mitomycin-c bearing an ophthalmic indication.

UroGen Pharma Reports Fourth Quarter and Full-year 2021 Financial Results and Recent Corporate Developments

Retrieved on: 
Monday, March 21, 2022
Biotechnology, Health, Pharmaceutical, Clinical Trials, Oncology, Private Securities Litigation Reform Act, Risk, Adult, Fatigue, SEC, Urination, Cancer, Medicine, Neoplasm, Breast milk, Sodium bicarbonate, Technology, Twitter, UTUC, Patient Information Advisory Group, Trial of the century, Time, NDA, Ureter, Urine, Recurrence, Transitional cell carcinoma, Kidney, Nausea, Pain, View, Clothing, Perforation, Swelling, Female, Nephrectomy, Vomiting, NMIBC, Clinical trial, Growth, Urinary tract infection, Man, Urinary bladder, FDA, Patient, Birth, Abdomen, Company, Stomach, ATLAS, Skin, Bone marrow, Fever, Safety, Orphan drug, COVID-19, Arm, Transitional epithelium, Blood, TURBT, Water, Pharmaceutical industry, Medical imaging, Health insurance, Birth control, Tanning (leather), Phosphorus, Generic drug, Mitomycin C, Mitomycins, JELMYTO®, UPPER TRACT UROTHELIAL CANCER (UTUC), UGN-102, THE PHASE 3 ENVISION TRIAL, THE PHASE 3 ATLAS TRIAL, UROGEN PHARMA LTD., JELMYTO®, UPPER TRACT UROTHELIAL CANCER (UTUC), UGN-102, THE PHASE 3 ENVISION TRIAL, 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/20220321005260/en/

UroGen Secures $100 Million Non-Dilutive Term Loan Financing with Pharmakon Advisors Allowing Funding to Cash Flow Breakeven

Retrieved on: 
Tuesday, March 8, 2022
Biotechnology, Other Health, Health, Pharmaceutical, Oncology, Private Securities Litigation Reform Act, Patient, Â, Investor, Twitter, Solution, Webcast, SEC, Company, COVID-19, Trial of the century, Neoplasm, Risk, Technology, Partnership, Nasdaq, Mitomycins, Pharmaceutical industry, Security (finance), Mitomycin C

The loan facility will be available to UroGen, subject to the terms and conditions of the loan agreement, as follows:

Key Points: 
  • The loan facility will be available to UroGen, subject to the terms and conditions of the loan agreement, as follows:
    Senior secured term loan of up to $100 million in two tranches.
  • At its option, UroGen may draw up to an additional $25 million before December 31, 2022.
  • The facility will mature five years from initial funding and be interest only for the first 48 months.
  • Based on our revenue projections and current financial models, we believe we have the tools to reach cash flow breakeven, said Liz Barrett, Chief Executive Officer of UroGen.

 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/