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
HQ Full Address
Princeton, New Jersey, United States
Product Features & Capabilities
- RTGel® drug delivery technology
- ZUSDURI™ (mitomycin) for intravesical solution
- Jelmyto® (mitomycin) for pyelocalyceal solution
- 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
- Jelmyto® (mitomycin) for pyelocalyceal solution
- 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.
Partnerships
- 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.
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.
