Citius Pharmaceuticals Announces FDA Acceptance of the BLA Resubmission of LYMPHIR™ (Denileukin Diftitox) for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma ...
Citius Pharmaceuticals, Inc. (CTXR)
NASDAQ:AMEX Investor Relations:
ir.citiuspharma.com
Company Research
Source: Yahoo! Finance
March 18, 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 that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of the Company's Biologics License Application (BLA) 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 FDA has assigned a PDUFA goal date of August 13, 2024 "The acceptance of the BLA resubmission reflects the completeness of our response to the enhanced product testing and additional controls highlighted by the FDA in their July 2023 CRL. No concerns relating to safety or efficacy were noted in the letter, and we remain confident in the robustness of the clinical data package included with the initial BLA sub
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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