Citius Pharmaceuticals Inc. Common - CTXR STOCK NEWS

Citius Pharmaceuticals (CTXR) announced a Type B pre-BLA meeting with the FDA on July 12, 2022, for I/ONTAK, a treatment for cutaneous T-cell lymphoma (CTCL). The Company plans to submit a Biologics License Application (BLA) in the second half of 2022, following FDA guidance. I/ONTAK is a purified formulation of the previously approved ONTAK, designed to target IL-2 receptors. Approximately 3,000 new CTCL cases are reported annually in the U.S., highlighting the potential market for this treatment.

Citius Pharmaceuticals announced plans for a spinoff of its oncology asset I/ONTAK into a new publicly-traded company (NewCo) while retaining Mino-Lok and other pipeline assets. Citius will continue trading on Nasdaq under the ticker CTXR. The spinoff aims to optimize resources and attract investors by creating two focused companies. The IPO and stock distribution to shareholders are expected in the second half of 2022 and are structured to qualify as a tax-free transaction. Completion is subject to board and regulatory approvals.

Citius Pharmaceuticals (CTXR), a late-stage biopharmaceutical company, announced its presentation at the H.C. Wainwright Global Investment Conference scheduled for May 24, 2022. CEO Leonard Mazur will discuss recent business developments and milestones. The event will take place virtually and at the Fontainebleau Miami Beach Hotel. Registrants can access a live webcast and schedule 1-on-1 meetings with management. Citius is focused on innovative critical care products, including Mino-Lok^® and I/ONTAK, addressing serious medical conditions.

Citius Pharmaceuticals (CTXR) reported a net loss of $7.6 million for Q2 2022, up from $4.1 million in Q2 2021. Cash reserves stand at $55.8 million with no debt, ensuring operational sustainability through March 2023. Significant developments include the expansion of the Mino-Lok® Phase 3 trial to international sites, with completion expected by late 2022. Topline results for I/ONTAK (E7777) indicate consistency with prior formulations, and a biologics license application is anticipated in 2H 2022. R&D and G&A expenses increased due to new trials and operational scaling.

Citius Pharmaceuticals (Nasdaq: CTXR) announced its collaboration with Biorasi to expand its Phase 3 Mino-Lok trial internationally. This trial aims to assess the efficacy of Mino-Lok, an antibiotic lock therapy for central venous catheters, in addressing catheter-related bloodstream infections. With COVID-19 restrictions easing, the company seeks to accelerate patient recruitment to meet FDA guidelines for trial completion by year-end. Successful results could lead to a New Drug Application submission, enhancing its product pipeline and market presence.

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) provided a business update for Q1 2022, focusing on key developments and upcoming milestones. The company plans to file a biologics license application (BLA) for I/ONTAK in H2 2022, and reported that Phase 3 study results were consistent with the previously approved ONTAK formulation. Additionally, the Halo-Lido Phase 2b trial started in April 2022, with completion of patient enrollment expected by year-end. Citius remains optimistic about its progress and anticipates completing Mino-Lok Phase 3 trial enrollment by the end of 2022.

Citius Pharmaceuticals (Nasdaq: CTXR) has initiated a Phase 2b clinical study for Halo-Lido, a potential first FDA-approved prescription treatment for hemorrhoids. The study will enroll approximately 300 patients and aims to evaluate the efficacy of Halo-Lido in reducing hemorrhoidal symptoms such as pain and itching. Results are expected in the second half of 2023. Currently, no prescription treatments exist for hemorrhoids, suggesting a significant market opportunity if Halo-Lido is approved. Citius plans to seek strategic partnerships to optimize the drug's potential.

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR), a late-stage biopharmaceutical company, announces its participation in NobleCon18, scheduled for April 19-21, 2022. Executive Chairman Leonard Mazur will present on April 20 at 1:30 p.m. EST, discussing recent business advancements and future milestones. The conference will occur at Hard Rock Hotel & Casino in Hollywood, Florida. Citius focuses on critical care products, including Mino-Lok® and I/ONTAK (E7777). Mino-Lok has Fast Track designation from the FDA and targets catheter-related bloodstream infections.

Citius Pharmaceuticals (CTXR) has appointed Leonard Mazur as CEO and Chairman of the Board, effective May 1, 2022. Myron Holubiak transitions to Executive Vice Chairman to enhance commercial capabilities. Jaime Bartushak expands his role as Chief Business Officer, while Michael McGuire joins as VP, Program Leader for Anti-Infectives. This restructuring aims to prepare for the anticipated launches of I/ONTAK for cutaneous T-cell lymphoma and Mino-Lok®, with plans for regulatory submissions in 2023. The company is focused on strengthening its commercial strategy as it nears completion of two late-phase clinical trials.