Citius Pharmaceuticals Inc Stock Price, News & Analysis

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.

Citius Pharmaceuticals (Nasdaq: CTXR) announced positive topline results from its Phase 3 trial of I/ONTAK (E7777) for the treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL). The trial demonstrated an Objective Response Rate (ORR) of 36.2% based on independent review and 42.3% based on investigator assessments. No new safety concerns were identified, and the company plans to file a biologics license application (BLA) with the FDA in H2 2022. This marks a significant step towards potentially launching its first commercial product.

Citius Pharmaceuticals (Nasdaq: CTXR) will present at two investor conferences in March 2022. Leonard Mazur, Executive Chairman, will discuss recent developments and future milestones. The conferences include the 34^th Annual ROTH Conference (March 13-15 at Ritz-Carlton, Laguna Niguel, California) and Maxim's 2022 Virtual Growth Conference (March 28-30, virtual). Participants can view on-demand presentations and schedule 1-on-1 meetings.

Citius focuses on oncology, anti-infectives, and stem cell therapies, with products like Mino-Lok® and I/ONTAK in late-stage trials.

Citius Pharmaceuticals (CTXR) announced the FDA's acceptance of its Investigational New Drug (IND) application for Halo-Lido, a treatment for hemorrhoids. This proprietary formulation combines halobetasol and lidocaine, aiming to alleviate painful symptoms associated with hemorrhoids, which affect over 10 million individuals annually in the U.S. The company plans to initiate a Phase 2b clinical trial in 2022, involving 300 participants to assess the efficacy of Halo-Lido. This development marks a significant step toward providing relief for patients suffering from hemorrhoidal disease.