UroGen Pharma Analysis: $497M Raised
What is UroGen Pharma?
FDA-approved RTGel drug delivery for bladder cancer treatment
Employees
201-500
Founded
2004
Valuation
496.90M
Product Features & Capabilities
- RTGel® drug delivery technology
- ZUSDURI™ (mitomycin) for intravesical solution
- Jelmyto® (mitomycin) for pyelocalyceal solution
- UGN-103 in Phase 3 UTOPIA trial
Use Cases
Deliver targeted therapy to bladder cancer patients via RTGel hydrogel; Administer ZUSDURI™ intravesically for recurrent low-grade intermediate-risk non-muscle invasive bladder cancer; Enable home instillation of ZUSDURI™ via Phase 3b feasibility study; Monitor long-term response durability with 5-year extension study of OPTIMA II trial; Support treatment of recurrent uro-oncology conditions with UGN-103 in Phase 3 UTOPIA trial
Investment Focus
UroGen Pharma primarily focuses on uro-oncology, specifically targeting treatments for urological cancers. The company is dedicated to developing innovative therapies that enhance treatment options for patients living with these conditions, utilizing breakthrough technology to create transformative therapies.
Other Considerations
FDA-approved ZUSDURI™ for recurrent bladder cancer; 72.2% 24-month response rate in Phase 3 ENVISION trial; 5-year long-term response durability demonstrated in OPTIMA II extension study; Phase 3 UTOPIA trial completed enrollment for UGN-103; Published in Reviews in Urology; Active investor and media engagement
Regulatory Approvals
UroGen Pharma has received regulatory approvals for several products and technologies, including: 1. Jelmyto® (mitomycin) for pyelocalyceal solution - This is the first FDA-approved treatment utilizing UroGen's novel RTGel® technology, which is designed for the treatment of patients with low-grade, intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). 2. UGN-102 - UroGen has submitted a New Drug Application (NDA) to the FDA for UGN-102, which is also aimed at treating LG-IR-NMIBC. The FDA has accepted this NDA, and UroGen anticipates potential approval in early 2025. These approvals highlight UroGen's commitment to developing innovative therapies for urological cancers.
Partnerships
UroGen Pharma has established several significant partnerships and collaborations in the biotech industry, including:
- MD Anderson Cancer Center - UroGen Pharma announced a strategic research collaboration with MD Anderson to advance investigational treatments for high-grade bladder cancer.
- Tanner Pharma Group - UroGen has engaged Tanner Pharma Group to administer a Named Patient Program for Jelmyto (mitomycin) for pyelocalyceal solution in select countries, indicating a partnership focused on expanding access to their treatment.
- Allergan plc - UroGen completed an agreement to license worldwide rights to its RTGel™ delivery system technology for use with neurotoxins to Allergan, showcasing a collaboration aimed at leveraging UroGen's innovative technology in broader applications.
These partnerships reflect UroGen's commitment to advancing its therapeutic offerings and expanding its reach in the biotech sector.
Key Innovations
UroGen Pharma has developed several key innovations and products in the biotech sector, particularly focused on urological cancers. Notable among these is the RTGel® reverse-thermal hydrogel, a proprietary sustained-release hydrogel-based platform technology designed to enhance the therapeutic profiles of existing drugs. Additionally, UroGen is advancing UGN-102, which has the potential to be the first FDA-approved medicine for the treatment of low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). The company is also involved in various clinical trials and has a robust pipeline aimed at improving treatment options for uro-oncology patients.
Latest Funding Round
UroGen Pharma announced a funding round on July 27, 2023, in which they raised approximately $120 million through a private placement of ordinary shares. This funding is intended to support their ongoing development and commercialization efforts.
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