secwatch.observer — SEC 8-K summary
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Issuer:     Citius Pharmaceuticals, Inc. (CTXR)
CIK:        0001506251
Form:       8-K
Filed at:   2024-03-18T23:59:59+00:00
Accession:  0001213900-24-023483
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1506251/000121390024023483/0001213900-24-023483-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1506251/000121390024023483/ea0202010-8k_citius.htm
  HTML page:      https://secwatch.observer/filing/0001213900-24-023483

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