Citius Pharma Expects Filing BLA For I/ONTAK In H2 - Quick Facts

(RTTNews) - Citius Pharmaceuticals, Inc. (CTXR) reported topline results from the phase 3 trial of I/ONTAK for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma. The company said the topline results for I/ONTAK were consistent with the prior formulation. No new safety signals were identified.

"The topline results demonstrated anti-tumor activity in the treatment of persistent or recurrent CTCL, an incurable disease. Based on the topline data, I/ONTAK provided disease control without cumulative toxicity. The topline data further demonstrate that I/ONTAK has an average time to response within one to two cycles of treatment in patients that have failed multiple prior therapies," said Myron Czuczman, Chief Medical Officer of Citius.

Based on the data, Citius expects filing a biologics license application with the FDA in the second half of 2022.