Citius pharmaceuticals, inc. receives a complete response letter from the u.s. food and drug administration (fda) for lymphir™ (denileukin diftitox) for the treatment of patients with relapsed or refractory cutaneous t-cell lymphoma

No clinical efficacy or safety issues raised citius committed to working toward approval cranford, n.j. , july 29, 2023 /prnewswire/ -- citius pharmaceuticals, inc. ("citius" or the "company") (nasdaq: ctxr) today announced that the u.s. food and drug administration (fda) has issued a complete response letter regarding the company's biologics license application (bla) seeking approval for denileukin diftitox ("lymphirtm"), 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.
CTXR Ratings Summary
CTXR Quant Ranking