FDA Accepts UroGen’s Investigational New Drug Application for Bladder Cancer Treatment

The FDA has accepted UroGen Pharma’s (Nasdaq: URGN) Investigational New Drug (IND) application for UGN-103, a next-generation novel mitomycin-based formulation for low-grade intermediate-risk non-muscle invasive bladder cancer (LG-IR-NMIBC). UGN-103 uses UroGen’s RTGel® platform technology, a proprietary sustained-release, reverse-thermal hydrogel that can improve the therapeutic profiles of existing drugs. The company’s share price was up 0.13% to reach $15.12 in intraday trading on Monday following the news.

UGN-103 is anticipated to provide several advantages related to production, cost, supply, and product convenience if approved. The company plans to initiate a Phase 3 study in 2024 to explore the safety and efficacy of UGN-103 for the treatment of LG-IR-NMIBC, a highly recurrent disease.

Commenting on the news, President and Chief Executive Officer of UroGen. Liz Barrett, said, “We are delighted by the FDA’s acceptance of our IND for UGN-103, marking a significant step forward in our mission. We eagerly anticipate commencing a clinical trial with UGN-103 this year, as we strive to continually advance and develop treatments for patients with high unmet need.”

UroGen expects to complete a rolling new drug application (NDA) submission for UGN-102 in September 2024.

UGN-103 is an innovative drug formulation of mitomycin that utilizes UroGen’s proprietary RTGel® technology, a sustained release, hydrogel-based formulation designed to enable longer exposure of bladder tissue to mitomycin, thereby enabling the treatment of tumors by non-surgical means.

About UroGen Pharma Ltd.

UroGen is a biotech company dedicated to developing and commercializing innovative solutions that treat urothelial and specialty cancers because patients deserve better options. UroGen has developed RTGel® reverse-thermal hydrogel, a proprietary sustained-release, hydrogel-based platform technology that has the potential to improve the therapeutic profiles of existing drugs. UroGen’s sustained release technology is designed to enable longer exposure of the urinary tract tissue to medications, making local therapy a potentially more effective treatment option. Our first product to treat LG-UTUC 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. UroGen is headquartered in Princeton, NJ with operations in Israel. To learn more, visit www.urogen.com or follow us on X (Twitter), @UroGenPharma.

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FDA Accepts UroGen’s Investigational New Drug Application for Bladder Cancer Treatment

Catie Corcoran

Biotech Editor