secwatch.observer — SEC 8-K summary
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Issuer:     UroGen Pharma Ltd. (URGN)
CIK:        0001668243
Form:       8-K
Filed at:   2024-01-17T23:59:59+00:00
Accession:  0001193125-24-009259
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 1.01, 8.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1668243/000119312524009259/0001193125-24-009259-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1668243/000119312524009259/d731454d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-24-009259

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer