secwatch.observer — SEC 8-K summary
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Issuer:     Citius Pharmaceuticals, Inc. (CTXR)
CIK:        0001506251
Form:       8-K
Filed at:   2024-05-21T23:59:59+00:00
Accession:  0001213900-24-045573
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Citius Pharma: Mino-Lok Phase 3 trial meets primary endpoint (p=0.0006) in CLABSI/CRBSI
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- Primary endpoint: time to catheter failure significantly delayed for Mino-Lok vs control (p=0.0006); hazard ratio 0.53.
- Median time-to-failure for control arm: 33 days; Mino-Lok arm median not reached (NE; CI 50 days-NE).
- Secondary endpoint overall success: 57.1% Mino-Lok vs 37.7% control (p=0.0025).
- No drug-related serious adverse events reported; safety profile supports well-tolerated designation.
- Company plans to engage with FDA to determine next regulatory steps for Mino-Lok.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1506251/000121390024045573/0001213900-24-045573-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1506251/000121390024045573/ea0206620-8k_citius.htm
  HTML page:      https://secwatch.observer/filing/0001213900-24-045573

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