other material
confidence high
sentiment positive
materiality 0.75
UroGen licenses medac's mitomycin formulation for RTGel combo; plans Phase 3 for UGN-103
UroGen Pharma Ltd.
- Exclusive worldwide royalty-free license from medac for 80 mg mitomycin + 640 mg urea formulation combined with RTGel.
- Medac to manufacture and supply product; UroGen responsible for development, commercialization, and regulatory approvals.
- Medac may terminate if US regulatory approval for a Combined Product is not obtained by June 30, 2029.
- Phase 3 study for UGN-103 (next-gen UGN-102) planned for 2024 in low-grade intermediate-risk NMIBC.
- IP protection expected through June 2035 (medac) and December 2041 (UroGen patent applications).