Citius Pharmaceuticals, Inc. announced the Company has received additional guidance from the U.S. Food and Drug Administration (FDA) regarding the planned resubmission of the Company's Biologics License Application (BLA) for LYMPHIR (denileukin diftitox), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The FDA has agreed with the Company's plans to address the requirements outlined in the complete response letter (CRL) received July 28, 2023. The guidance from the FDA provides Citius with a path for completing the necessary activities to support the resubmission of the company's Biologics License Application (BLA) for denileukin diftitox.

No additional clinical efficacy or safety trials have been requested by FDA for the resubmission.