Citius: FDA OKs Biologics License Application for Lymphoma Candidate

 Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Biologics License Application (BLA) for denileukin diftitox ("I/ONTAK" or "E7777"), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK®. The PDUFA target action date is September 28, 2023. The BLA is supported by a pivotal Phase 3 study (NCT01871727).

https://finance.yahoo.com/news/citius-pharmaceuticals-inc-announces-u-123000919.html