Mitomycins

UroGen Pharma Files Patent Infringement Action Against Teva Pharmaceuticals

Retrieved on: 
Wednesday, April 3, 2024
Legal, Biotechnology, Pharmaceutical, Public Relations, Investor Relations, Health, FDA, Communications, Professional Services, The Orange Book, Drug discovery, Carcinoma, Patent, District court, Mitomycins, Orange Book, Food, Generic drug

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 (“the ’074 patent”) and 9,950,069 (“the ’069 patent”).

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced that it has filed a lawsuit in the U.S. District Court for the District of Delaware against Teva Pharmaceuticals, Inc., Teva Pharmaceuticals USA, Inc., and Teva Pharmaceutical Industries, Ltd., alleging infringement of U.S. Patent Numbers 9,040,074 (“the ’074 patent”) and 9,950,069 (“the ’069 patent”).
  • Both patents are listed in the U.S. Food and Drug Administration’s (“FDA”) Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) for JELMYTO® (mitomycin) for pyelocalyceal solution.
  • JELMYTO® is indicated for the treatment of adults with low-grade, upper tract urothelial cancer (“LG-UTUC”) and utilizes UroGen’s RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology.
  • “UroGen pioneered a significant breakthrough and remains at the forefront of transforming urothelial cancer treatment,” said Liz Barrett, President and CEO, UroGen.

UroGen Pharma Delivers Double Digit JELMYTO® Growth and Prepares for the Next Phase of the Company with on Track Rolling Submission of UGN-102

Retrieved on: 
Thursday, March 14, 2024
Oncology, Health, FDA, Clinical Trials, Pharmaceutical, Biotechnology, Research, Biopsy, Conference, Carcinoma, Chemistry, Webcast, New Drug Application, Medac, Patient, Mitomycins, NDA, CMC, Software, Safety, Nephrectomy, Patent, Medicare, Investment, RTW, ATLAS, Ureteroscopy, Gesellschaft mit beschränkter Haftung, Food, Pharmaceutical industry

The first part of the submission was the Chemistry, Manufacturing and Controls (CMC) sections.

Key Points: 
  • The first part of the submission was the Chemistry, Manufacturing and Controls (CMC) sections.
  • The FDA indicated that evaluation of duration of complete response at 12-months from the pivotal ENVISION trial will be sufficient to support submission of the NDA.
  • The company plans to complete the submission in September 2024 with a potential FDA decision as early as the first quarter of 2025.
  • Generated annual net product revenue of $82.7 million in 2023, compared with $64.4 million in 2022 in representing ~28% annual growth.

UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Friday, March 8, 2024
Professional Services, Oncology, Health, Human Resources, Pharmaceutical, Biotechnology, Mitomycins, Employment, RSU

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 12 new employees in connection with their employment with UroGen.

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 the grants of inducement restricted stock units (“RSUs”) to 12 new employees in connection with their employment with UroGen.
  • Up to 35,000 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs.
  • The RSUs are subject to the terms and conditions of UroGen’s 2019 Inducement Plan and RSU grant notice and agreement thereunder.
  • The RSUs were granted as an inducement material to each employee entering into employment with UroGen in accordance with Nasdaq listing Rule 5635(c)(4).

UroGen Initiates Submission of a Rolling NDA to the FDA for UGN-102

Retrieved on: 
Wednesday, January 24, 2024
Biotechnology, Pharmaceutical, Health, Oncology, CMC, Mitomycins, Chemistry, Food, NDA, FDA, New Drug Application, Pharmaceutical industry

"The submission of the CMC portion of the NDA for UGN-102 marks a significant milestone for UroGen and underscores our dedication to advancing innovative therapies for the benefit of individuals grappling with low-grade, intermediate-risk non-muscle invasive bladder cancer,” said Liz Barrett, President and CEO, UroGen.

Key Points: 
  • "The submission of the CMC portion of the NDA for UGN-102 marks a significant milestone for UroGen and underscores our dedication to advancing innovative therapies for the benefit of individuals grappling with low-grade, intermediate-risk non-muscle invasive bladder cancer,” said Liz Barrett, President and CEO, UroGen.
  • “We look forward to working closely with the FDA throughout the review process and remain steadfast in our commitment to address unmet medical needs in the uro-oncology space and advance patient care."
  • The objective of the rolling NDA for UGN-102 is to facilitate early engagement with the FDA, and a more efficient and timely review of the NDA.
  • Based on its agreement with the FDA, UroGen will complete the submission of the rolling NDA for UGN-102 in 2024 with a potential FDA decision as early as the first quarter of 2025.

UroGen Secures Exclusive License from medac GmbH to Develop a Next-Generation Novel Mitomycin-Based Formulation for Urothelial Cancers

Retrieved on: 
Wednesday, January 17, 2024
Biotechnology, Pharmaceutical, Health, Oncology, Mitomycins, Food and Drug Administration, Patent, Food, Patient, Carcinoma, Safety, Gesellschaft mit beschränkter Haftung, Pharmaceutical industry

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced a licensing agreement with medac GmbH to develop a next-generation novel mitomycin-based formulation for urothelial cancers.

Key Points: 
  • UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing novel solutions that treat urothelial and specialty cancers, today announced a licensing agreement with medac GmbH to develop a next-generation novel mitomycin-based formulation for urothelial cancers.
  • UGN-103, UroGen’s RTGel® technology combined with medac’s licensed mitomycin, is a next-generation formulation that is planned to follow the anticipated U.S. Food and Drug Administration approval and launch of UGN-102.
  • UroGen plans to initiate a Phase 3 study in 2024 to explore the safety and efficacy of UGN-103 in LG-IR-NMIBC.
  • "The strategic alliance with medac fortifies our commitment to continuously innovate novel, non-surgical treatments for patients with urothelial cancers, including LG-IR-NMIBC,” said Liz Barrett, President and CEO of UroGen.

UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Friday, December 8, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Mitomycins, RSU, Employment

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 17 new employees in connection with their employment with UroGen.

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 the grants of inducement restricted stock units (“RSUs”) to 17 new employees in connection with their employment with UroGen.
  • Up to 57,600 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs.
  • The RSUs are subject to the terms and conditions of UroGen’s 2019 Inducement Plan and RSU grant notice and agreement thereunder.
  • The RSUs were granted as an inducement material to each employee entering into employment with UroGen in accordance with Nasdaq listing Rule 5635(c)(4).

UroGen Pharma Reports Third Quarter 2023 Financial Results

Retrieved on: 
Tuesday, November 14, 2023
Biotechnology, Pharmaceutical, Health, Oncology, NDA, Medicine, Webcast, Rated R, NMIBC, RTW, Chemistry, Risk, TURBT, Patient, Investment, Probability, Research, Carcinoma, LG, FDA, Mitomycins, Conference, ATLAS, Software, Death, CMC, Nephrectomy, Growth, CRR, Recurrence, URS, Role, Pharmaceutical industry, Medical imaging, Dietary supplement, Video game, Agency

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 third quarter ended September 30, 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 third quarter ended September 30, 2023, and provided an overview of recent developments.
  • “During the third quarter, UroGen achieved several notable milestones, including announcement of unprecedented positive results from our ENVISION and ATLAS Phase 3 trials of UGN-102 in LG-IR-NMIBC,” said Liz Barrett, President, and Chief Executive Officer of UroGen.
  • Activated sites on November 1, 2023 were 1,088, compared to 1,058 on August 1, 2023, while repeat accounts on November 1, 2023 were 296, compared to 267 on August 1, 2023.
  • Third Quarter 2023 Financial Results:
    JELMYTO Revenue: UroGen reported net product revenue of JELMYTO for the third quarter 2023 of $20.9 million, compared to $16.1 million in the third quarter of 2022.

Following Pre-NDA Meeting with the FDA, UroGen Announces Rolling NDA Submission for UGN-102 to Begin January 2024

Retrieved on: 
Tuesday, October 3, 2023
Oncology, FDA, Health, Clinical Trials, Pharmaceutical, Biotechnology, CMC, NDA, Bladder cancer, Mitomycins, Malignancy, Patient, Chemistry, CR, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Food, ATLAS, Pharmaceutical industry

The FDA also agreed that the UGN-102 NDA can utilize a rolling review, allowing for early submission of the Chemistry, Manufacturing and Controls (CMC) sections of the NDA, which is planned for January 2024.

Key Points: 
  • The FDA also agreed that the UGN-102 NDA can utilize a rolling review, allowing for early submission of the Chemistry, Manufacturing and Controls (CMC) sections of the NDA, which is planned for January 2024.
  • “We are very pleased with the outcome of our pre-NDA meeting where the FDA agreed with our plan to submit our NDA for UGN-102 once all patients reach 12 months post CR.
  • Our dialogue with the FDA during our recent pre-NDA meeting was very constructive and underscores the strength of our clinical program for UGN-102,” said Liz Barrett, President and CEO, UroGen.
  • “With the announcement of positive Phase 3 topline results from the ATLAS and ENVISION studies earlier this year, this meeting was a significant step in defining the path forward for NDA submission and potential approval for UGN-102.

UroGen Pharma Announces Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Friday, September 8, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Exercise, Mitomycins, Employment, RSU, Option, Pharmaceutical industry

UroGen Pharma Ltd. (Nasdaq: URGN), a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers, today announced the grants of inducement restricted stock units (“RSUs”) to 11 new employees, as well as options (“Options”) to one of the new employees, in connection with their employment with UroGen.

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 the grants of inducement restricted stock units (“RSUs”) to 11 new employees, as well as options (“Options”) to one of the new employees, in connection with their employment with UroGen.
  • Up to 37,300 ordinary shares of UroGen are issuable upon the vesting and settlement of the RSUs and up to 30,000 ordinary shares are issuable upon the vesting and exercise of the Options.
  • The RSUs and Options are subject to the terms and conditions of UroGen’s 2019 Inducement Plan and RSU and Option grant notice and agreements thereunder.
  • The RSUs and Options were granted as an inducement material to each employee entering into employment with UroGen in accordance with Nasdaq listing Rule 5635(c)(4).

UroGen Pharma Reports Record JELMYTO Quarterly Sales and Recent Corporate Developments

Retrieved on: 
Thursday, August 10, 2023
Biotechnology, Pharmaceutical, Health, Oncology, Database, Biopsy, Investment, Software, Nephrectomy, NDA, RDF, Rated R, Mitomycins, URS, Journal, Patient, Risk, RTW, Webcast, Growth, LG, Research, Urology, FDA, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Recurrence, Death, Food, Conference, The Journal of Urology, ATLAS, Pharmaceutical industry, Video game, Security (finance), Bank, TURBT

“We are in a transformative period for UroGen,” said Liz Barrett, President and Chief Executive Officer of UroGen Pharma.

Key Points: 
  • “We are in a transformative period for UroGen,” said Liz Barrett, President and Chief Executive Officer of UroGen Pharma.
  • UroGen hosted an event to discuss and highlight topline results from the Phase 3 ATLAS and ENVISION clinical trials on July 27th, 2023.
  • Generated record quarterly net product revenue of $21.1 million for the second quarter of 2023, representing ~27% growth over the second quarter of 2022.
  • The rate applied to cash payments incurred in 2023 is 13% based on global net product sales of JELMYTO in 2022.