Citius: FDA To Review BLA For Denileukin Diftitox - Quick Facts

(RTTNews) - Citius Pharmaceuticals, Inc. (CTXR) announced the FDA has accepted the company's Biologics License Application for denileukin diftitox, an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma.

"With an anticipated PDUFA date of September 28, 2023, we look forward to the potential approval of this therapeutic for patients with persistent or recurrent cutaneous T-cell lymphoma, a rare disease for which patients with advanced disease have limited treatment options," said Leonard Mazur, CEO of Citius.

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