---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-24-023483"
form_type: "8-K"
ticker: "CTXR"
cik: "0001506251"
company_name: "Citius Pharmaceuticals, Inc."
filed_at: "2024-03-18T23:59:59+00:00"
generated_at: "2026-06-04T15:03:56.530525+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Citius Pharma: FDA accepts BLA resubmission for LYMPHIR (CTCL); PDUFA Aug 13, 2024

## Summary
- FDA accepted BLA resubmission for LYMPHIR (denileukin diftitox) to treat relapsed/refractory cutaneous T-cell lymphoma.
- PDUFA target action date set for August 13, 2024.
- Resubmission addresses July 2023 CRL; no safety or efficacy issues cited, no additional trials required.
- BLA supported by pivotal Phase 3 study (NCT01871727).

## SEC filing metadata
- accession: 0001213900-24-023483
- form_type: 8-K
- ticker: CTXR
- cik: 0001506251
- company_name: Citius Pharmaceuticals, Inc.
- filed_at: 2024-03-18T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1506251/000121390024023483/0001213900-24-023483-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1506251/000121390024023483/ea0202010-8k_citius.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-24-023483
- JSON: https://secwatch.observer/filing/0001213900-24-023483.json
- Plain text: https://secwatch.observer/filing/0001213900-24-023483.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.