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Details:
UGN-103 (mitomycin) selectively inhibits the synthesis of deoxyribonucleic acid, it is being developed for the treatment of low-grade intermediate-risk nonmuscle-invasive bladder cancer.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: UGN-103
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 15, 2024
Details:
UGN-102 (mitomycin) is a DNA synthesis inhibitor which is currently being evaluated in phase 3 clinical trials for the treatment of low-grade, intermediate-risk non-muscle invasive bladder cancer.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: UGN-102
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 24, 2024
Details:
Under the agreement, UroGen will develop a next-generation novel mitomycin-based formulation, UGN-103, UroGen’s RTGel® technology combined with medac’s licensed mitomycin, for urothelial cancers.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: UGN-103
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: UroGen Pharma
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 17, 2024
Details:
UGN-102 (mitomycin) selectively inhibits the synthesis of deoxyribonucleic acid and is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. It is being developed for the treatment of LG-IR-NMIBC.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: UGN-102
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 03, 2023
Details:
The proceeds will be used for non-clinical and clinical development activities for company's product candidates including, UGN-102 (mitomycin), an investigational therapy in development for primary chemoablation of low-grade, non-muscle invasive bladder cancer.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: UGN-102
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: BofA Securities
Deal Size: $120.0 million Upfront Cash: Undisclosed
Deal Type: Private Placement July 27, 2023
Details:
UGN-102 (mitomycin) selectively inhibits the synthesis of deoxyribonucleic acid and is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. It is being developed for the treatment of LG-IR-NMIBC.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: UGN-102
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 27, 2023
Details:
UGN-102 (mitomycin) selectively inhibits the synthesis of deoxyribonucleic acid (DNA), designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means. It is being developed for the treatment of LG-IR-NMIBC.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: UGN-102
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 15, 2023
Details:
Jelmyto® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for primary chemoablative treatment of LG-UTUC in adults.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: Jelmyto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 11, 2023
Details:
Mitosol (Mitomycin-C) is an antibiotic, isolated from the broth of Streptomyces verticillus Yingtanensis, intended for topical application to the surgical site of glaucoma filtration surgery.
Lead Product(s): Mitomycin
Therapeutic Area: Ophthalmology Product Name: Mitosol
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 03, 2023
Details:
Utilizing UroGen’s proprietary RTGel technology, a sustained release, hydrogel-based formulation, Jelmyto (UGN-102) is designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: Jelmyto
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 19, 2022
Details:
JELMYTO® (mitomycin) for pyelocalyceal solution is indicated for the treatment of adult patients with low-grade Upper Tract Urothelial Cancer (LG-UTUC). JELMYTO is contraindicated in patients with perforation of the bladder or upper urinary tract.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: Jelmyto
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 02, 2022
Details:
JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for primary chemoablative treatment of LG-UTUC in adults.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: Jelmyto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 01, 2022
Details:
JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for primary chemoablative treatment of LG UTUC in adults.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: Jelmyto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 14, 2022
Details:
GP-2250, a new therapeutic agent demonstrated promising antineoplastic effects on malignant mesothelioma cells in vitro, especially in combination with cisplatin/mitomycin C.
Lead Product(s): GP-2250,Cisplatin,Mitomycin
Therapeutic Area: Oncology Product Name: GP-2250
Highest Development Status: PreclinicalProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable August 08, 2022
Details:
JELMYTO® (mitomycin) for pyelocalyceal solution is a mitomycin-containing reverse thermal gel containing 4 mg mitomycin per mL gel indicated for primary chemoablative treatment of LG UTUC in adults.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: Jelmyto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 16, 2022
Details:
New data on in-office nephrostomy tube administration of Jelmyto (mitomycin) for pyelocalyceal solution, the only non-surgical, kidney-sparing treatment for adults with low-grade upper tract urothelial cancer.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: Jelmyto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 13, 2022
Details:
The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: UGN-102
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 21, 2021
Details:
Studies suggest that bladder cancer treated with a combination of a TLR-7 agonist and an anti-CTLA4 antibody using our RTGel technology, produces improved survival relative to treatment with other checkpoint inhibitors in RTGel, either alone or in combination with UGN-201.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: UGN-102
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 10, 2021
Details:
UGN-102 (mitomycin) intravesical solution Utilizing the RTGel™ Technology Platfor is an investigational drug formulation of mitomycin for the treatment of low-grade intermediate risk non-muscle invasive bladder cancer.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: UGN-102
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable October 05, 2021
Details:
Neopharm will lead the regulatory process in Israel, which is supported by the results from the Phase 3 OLYMPUS trial that showed Jelmyto achieved clinically significant disease eradication in adults with LG-UTUC.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: Jelmyto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Neopharm Labs Inc
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement July 28, 2021
Details:
UroGen’s 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.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: UGN-102
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable July 07, 2021
Details:
RTW will also receive tiered, future cash payments on worldwide annual net product sales of UGN-102, if approved, in the low single digits based on certain annual sales thresholds.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: Jelmyto
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: RTW Investments
Deal Size: $75.0 million Upfront Cash: Undisclosed
Deal Type: Funding March 18, 2021
Details:
Treatment with UGN-102 was generally well tolerated and the safety profile was consistent with previously reported results. The Company anticipates submitting the data for presentation at an upcoming medical meeting as well as potential publication in a peer-reviewed journal.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: UGN-102
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable November 17, 2020
Details:
Trial results showed that 65% (41/63) of patients treated with UGN-102 achieved a complete response (CR) three months after the start of therapy.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable May 15, 2020
Details:
The Phase 2b OPTIMA II trial demonstrated a complete response (CR) rate at three months following onset of treatment of 65% (41/63 patients).
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable April 03, 2020
Details:
In December 2019, the U.S. FDA accepted for filing and granted priority review for the Company’s UGN-101 application and assigned a Prescription Drug User Fee Act action date of April 18, 2020.
Lead Product(s): Mitomycin
Therapeutic Area: Oncology Product Name: Undisclosed
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2020
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