secwatch.observer — SEC 8-K summary
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Issuer:     CITIUS ONCOLOGY, INC. (CTOR)
CIK:        0001851484
Form:       8-K
Filed at:   2025-10-23T23:59:59+00:00
Accession:  0001213900-25-101737
Event type: other_material
Sentiment:  positive
Materiality: 0.60
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Citius Oncology corporate presentation confirms LYMPHIR launch in Q4 2025; $400M+ market
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- LYMPHIR (denileukin diftitox) FDA-approved Aug 2024 for relapsed/refractory CTCL; first new systemic therapy since 2018.
- Commercial launch readiness nearing completion; ~$90M invested to date, 12-18 month inventory manufactured.
- New permanent J-code (J9161) secured; NCCN guidelines inclusion; sales force hiring underway.
- Clinical data: 36% ORR (9% CR, 27% PR), median 1.4 months to response, 6.5 months median duration of response.
- Ongoing combo studies: with KEYTRUDA (27% ORR in solid tumors) and CAR-T; prelim data expected Q4 2025/Q1 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1851484/000121390025101737/0001213900-25-101737-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1851484/000121390025101737/ea0262328-8k_citiusonc.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-101737

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