UroGen Pharma Ltd. is making strides in the development and commercialization of innovative solutions for urothelial and specialty cancers. The company announced key clinical milestones for UGN-102 and long-term durability data for Jelmyto, alongside its first-quarter 2024 financial results.
UGN-102 Shows High Probability of Disease-Free Survival
At the American Urological Association (AUA) 2024 Annual Meeting, a subgroup analysis from the UGN-102 ATLAS trial revealed that patients with new and recurrent low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC) treated with UGN-102 ± TURBT (transurethral resection of bladder tumor) had high probabilities of remaining event-free for disease-free survival (DFS) and high probabilities of remaining in complete response.
UroGen initiated a rolling New Drug Application (NDA) submission to the FDA in January 2024 for UGN-102 as a treatment for LG-IR-NMIBC and plans to complete the submission in Q3 2024, with a potential FDA decision as early as the first quarter of 2025. Liz Barrett, President, and Chief Executive Officer of UroGen, stated that UGN-102 could address a more than $3 billion market opportunity and potentially establish a new standard of care in LG-IR-NMIBC if approved.
Jelmyto Demonstrates Long-Term Durability
A post-hoc analysis of the OLYMPUS trial assessed the long-term effects of treating low-grade upper tract urothelial cancer (LG-UTUC) with Jelmyto. Of the 41 patients who achieved a complete response (CR), 20 enrolled in a 5-year rollover study. The initial 41 patients with CR showed a promising median duration of response of 47.8 months, based on a median follow-up of 28.1 months. In the 5-year rollover trial, 75% (N=15) showed no disease recurrence, indicating potential for extended disease-free periods.
Independent long-term real-world analyses presented at the AUA 2024 Annual Meeting also showed that Jelmyto treatment demonstrated favorable recurrence-free survival rates for patients with LG-UTUC who respond to initial induction, regardless of administration method, original tumor size, multifocality, or tumor location.
Advancing Next-Generation Mitomycin-Based Formulations
UroGen is also developing next-generation novel mitomycin-based formulations for urothelial cancers, UGN-103 and UGN-104, through a license and supply agreement with medac GmbH. These formulations combine UroGen’s RTGel® technology with medac’s licensed mitomycin formulation, potentially offering manufacturing efficiencies and IP protection.
The FDA accepted the company’s Investigational New Drug (IND) application for UGN-103 in April 2024. UroGen plans to initiate Phase 3 studies to explore the safety and efficacy of UGN-103 in LG-IR-NMIBC in 2024 and UGN-104 in LG-UTUC shortly thereafter. If approved, UGN-103 is expected to provide advantages related to production, cost, supply, and product convenience.
Financial Highlights
UroGen reported net product revenue of $18.8 million for Jelmyto in the first quarter of 2024, compared to $17.2 million in the first quarter of 2023, representing approximately 10% annual growth. The company is reiterating full-year 2024 net product revenues guidance from Jelmyto in the range of $95 to $102 million.
