---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-009259"
form_type: "8-K"
ticker: "URGN"
cik: "0001668243"
company_name: "UroGen Pharma Ltd."
filed_at: "2024-01-17T23:59:59+00:00"
generated_at: "2026-06-06T22:35:28.341284+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# UroGen licenses medac's mitomycin formulation for RTGel combo; plans Phase 3 for UGN-103

## Summary
- 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).

## SEC filing metadata
- accession: 0001193125-24-009259
- form_type: 8-K
- ticker: URGN
- cik: 0001668243
- company_name: UroGen Pharma Ltd.
- filed_at: 2024-01-17T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 1.01, 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1668243/000119312524009259/0001193125-24-009259-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1668243/000119312524009259/d731454d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-009259
- JSON: https://secwatch.observer/filing/0001193125-24-009259.json
- Plain text: https://secwatch.observer/filing/0001193125-24-009259.txt

## Key facts
- Material Agreements
  UroGen Pharma Ltd. entered into Agreement with Medac Gesellschaft für klinische Spezialpräparate m.b.H. (effective 2024-01-16).
  - Action: entry
  - Agreement: license
  - Counterparty: Medac Gesellschaft für klinische Spezialpräparate m.b.H.
  - Effective: 2024-01-16
  source text: On January 16, 2024, UroGen Pharma Ltd. (the “Company”) entered into a license and supply agreement (the “Agreement”) with Medac Gesellschaft für klinische Spezialpräparate m.b.H. (“medac”), pursuant to which medac granted to the Company an exclusive, worldwide, royalty-free, sublicensable license under medac’s intellectual property rights to develop, commercialize, import, export, use, distribute and register the pharmaceutical lyophilized product—a specific 80 mg formulation of mitomycin and 640 mg urea, manufactured according to medac’s proprietary lyophilization process (the “Product”)—as an integrated part of a pharmaceutical product that includes the Product and a reverse thermal gel, including the Company’s RTGel® reverse thermal hydrogels (the “Combined Product”).
  evidence_url: https://www.sec.gov/Archives/edgar/data/1668243/000119312524009259/0001193125-24-009259-index.htm

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.