Citius receives regulatory guidance from U.S. FDA on BLA for LYMPHIR

Citius Pharmaceuticals announces 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, 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 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 for denileukin diftitox. No additional clinical efficacy or safety trials have been requested by FDA for the resubmission. “We are encouraged by the constructive engagement with the FDA,” stated Leonard Mazur, Chairman and CEO of Citius. “Based on the clear feedback from the FDA, Citius plans to complete the CRL remediation activities by the end of the year and file the resubmission in early 2024. We do not expect these efforts will impact our cash runway.”