Citius Submits Biologics License Application for T-Cell Lymphoma

  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 Company has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for denileukin diftitox (I/ONTAK), 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 BLA is supported by a pivotal Phase 3 study (NCT01871727). Results of the study were consistent with the prior FDA-approved formulation.

https://finance.yahoo.com/news/citius-pharmaceuticals-inc-submits-biologics-123000646.html