Citius Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration 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 BLA is supported by a pivotal Phase 3 study (NCT01871727).

The resubmission follows dialog 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.