secwatch.observer — SEC 8-K summary
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Issuer:     Citius Pharmaceuticals, Inc. (CTXR)
CIK:        0001506251
Form:       8-K
Filed at:   2025-12-01T23:59:59+00:00
Accession:  0001213900-25-116760
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Citius Oncology launches LYMPHIR for CTCL; first marketed product
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- LYMPHIR (denileukin diftitox-cxdl) now commercially available in U.S. for relapsed/refractory Stage I–III CTCL after prior systemic therapy.
- Phase 3 pivotal study: ORR 36.2%, 84% skin tumor burden reduction, median response time 1.4 months, no cumulative toxicity.
- Estimated U.S. market >$400M; permanent J-code (J9161) effective April 1, 2025; NCCN Category 2A recommendation.
- International expansion via Integris Pharma distribution agreement for Southern Europe and Balkan countries.
- Patient assistance program (Citius Advantage) and HCP portal (lymphirhcp.com) launched to support access.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1506251/000121390025116760/0001213900-25-116760-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1506251/000121390025116760/ea0267562-8k_citius.htm
  HTML page:      https://secwatch.observer/filing/0001213900-25-116760

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