Citius Pharmaceuticals Resubmits the Biologics License Application of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma [Yaho...
Citius Pharmaceuticals, Inc. (CTXR)
NASDAQ:AMEX Investor Relations:
ir.citiuspharma.com
Company Research
Source: Yahoo! Finance
CRANFORD, N.J. Feb. 13, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today announced the resubmission of the Company's Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for LYMPHIR™ (denileukin diftitox), an IL-2-based immunotherapy for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The resubmission follows ongoing engagement with the FDA resulting from a Complete Response Letter (CRL) received on July 28, 2023 . Citius believes it has addressed enhanced product testing and additional manufacturing controls noted in the letter. There were no safety or efficacy issues cited and no additional trials required. Based on Center for Drug Evaluation and Research timelines, FDA acceptance of the com
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News
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- Citius Pharmaceuticals Announces $15 Million Registered Direct Offering [Yahoo! Finance]Yahoo! Finance
- Citius Pharmaceuticals Announces $15 Million Registered Direct OfferingPR Newswire
- Citius Pharmaceuticals Announces Addition of City of Hope to UMN's Phase 1 Trial of LYMPHIR in Combination with CAR-T for the Treatment of B-Cell Lymphoma [Yahoo! Finance]Yahoo! Finance
CTXR
Earnings
- 2/14/24 - Miss
CTXR
Analyst Actions
- 2/14/24 - HC Wainwright
CTXR
Sec Filings
- 4/30/24 - Form 8-K
- 4/26/24 - Form 424B5
- 4/5/24 - Form 8-K
- CTXR's page on the SEC website