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URGN-News
URGN-Events
UroGen Pharma's UGN-103 NDA Accepted by FDA
UroGen Pharma announced FDA acceptance of the new drug application, or NDA, for investigational drug UGN-103 for intravesical solution for the treatment of adults with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer, or LG-IR-NMIBC. The FDA has assigned a Prescription Drug User Fee Act, or PDUFA, target action date of June 14, 2027.
UroGen Pharma Shares Drop 12.8% to $35.50
UroGen Pharma is down -12.8%, or -$5.20 to $35.50.
UroGen Pharma Signs Investment Agreement with IntraGel
UroGen Pharma announced an equity investment agreement and a strategic Option and Research License Agreement with IntraGel Therapeutics, developer of next generation long-acting injectables. In a related equity investment agreement, UroGen will invest up to $7M in the equity securities of IntraGel, which will support the Phase 2 clinical development of TumoCure, IntraGel's investigational therapy for advanced head and neck cancer. Under the related Option Agreement, UroGen receives an exclusive option to obtain an exclusive, worldwide license to develop and commercialize TumoCure following IntraGel's completion of a Phase 2 clinical study. In addition, UroGen gains access to IntraGel's proprietary SRGel platform, a biodegradable sustained-release formulation technology designed for localized drug delivery, through a research license and options to obtain an exclusive, worldwide license to develop and commercialize up to three additional oncology products combining the SRGel platform with compounds to be designated by UroGen. SRGel is a biodegradable depot technology designed to enable sustained release of therapeutic agents over extended periods. In oncology, SRGel has potential applicability across a broad range of solid tumor settings, including bladder, skin, brain, gastrointestinal and testicular cancers.
UroGen Pharma Receives Notice of Allowance for Patent Application
Earlier this morning, the company stated: "UroGen Pharma announced that it has received a Notice of Allowance from the U.S. Patent and Trademark Office for patent application no. 18/784,354 entitled "Treatment of Low-Grade Intermediate-Risk Non-Muscle-Invasive Bladder Cancer With a Thermally Gelling Pharmaceutical Composition Containing Mitomycin." The allowed claims cover methods of treating patients with recurrent, low-grade intermediate-risk non-muscle invasive bladder cancer without a transurethral resection of a bladder tumor, supported by data from the ENVISION and ATLAS clinical trials. The U.S. patent, once issued, will have an expiration date in July 2044. Building on the growing body of clinical evidence supporting ZUSDURI and UGN-103, UroGen remains focused on advancing its proprietary RTGel technology and developing innovative therapies that have the potential to expand non-surgical treatment options for patients with urothelial cancers and strengthen the company's long-term growth opportunities."
UroGen Pharma Receives FDA IND Clearance for UGN-501
UroGen Pharma announced that the FDA cleared the company's investigational new drug application, or IND, for UGN-501, an investigational oncolytic virus. The IND clearance enables initiation of a planned Phase 1 clinical study in patients with non-muscle invasive bladder cancer. The Phase 1 study is expected to begin in Q4 and will evaluate the safety, tolerability, and feasibility of intravesical administration of UGN-501.
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