secwatch.observer — SEC 8-K summary
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Issuer:     Citius Pharmaceuticals, Inc. (CTXR)
CIK:        0001506251
Form:       8-K
Filed at:   2026-06-01T20:30:19+00:00
Accession:  0001213900-26-063531
Event type: other_material
Sentiment:  positive
Materiality: 0.50
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Citius Oncology reports Phase 1 combo data: 24% ORR, 33% in endometrial cancer; Phase 2 planned
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- Phase 1 trial of LYMPHIR + pembrolizumab in 25 heavily pre-treated gynecologic cancer patients showed 24% ORR (5 partial responses); median duration of response not reached.
- In endometrial cancer patients previously treated with checkpoint inhibitors, ORR was 33%; one response ongoing >3 years.
- 48% of 21 evaluable patients achieved clinical benefit; median PFS among that group was 20.5 months.
- Safety manageable: only one Gr 3 CLS at highest dose; no new safety signals or Gr 3+ immune-related AEs.
- A Phase 2 expansion study is being planned to further evaluate the combo in gynecologic cancers.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1506251/000121390026063531/0001213900-26-063531-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1506251/000121390026063531/ea0292904-8k_citius.htm
  HTML page:      https://secwatch.observer/filing/0001213900-26-063531

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