medac CDMO Supports UroGen Pharma in Advancing UGN-103 Toward NDA Submission

Wedel, November 27, 2025 medac CDMO has announced a partnership with UroGen Pharma to support the development and supply chain of UGN-103, using medac’s licensed mitomycin formulation and manufacturing services. The collaboration is aimed at advancing the candidate therapy and enabling reliable access to treatment for patients.

UroGen Pharma reported new preliminary results from the Phase 3 UTOPIA trial, showing a three-month complete response rate of 77.8 per cent in patients with recurrent low-grade intermediate-risk non-muscle invasive bladder cancer. The company stated that the outcome is consistent with results observed in the pivotal ENVISION trial. UroGen also confirmed that the U.S. Food and Drug Administration has agreed that the UTOPIA data may support submission of a New Drug Application for UGN-103.

UGN-103 is intended to provide improvements over ZUSDURI, the approved mitomycin treatment for adults with recurrent disease. These include a shorter manufacturing process and a simplified reconstitution procedure, while maintaining prolonged drug exposure within the bladder. UroGen holds patents relating to the combination of its RTGel technology with medac’s proprietary lyophilised mitomycin formulation.

Liz Barrett, President and Chief Executive Officer of UroGen, said the UTOPIA results reinforce the potential of UGN-103, describing the FDA’s agreement on the NDA pathway as a regulatory milestone.

The collaboration between medac CDMO and UroGen Pharma combines medac’s contract manufacturing capabilities with UroGen’s uro-oncology development, supporting progress toward a planned NDA submission in 2026.