Citius Pharmaceuticals Inc Stock Price, News & Analysis

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.

Citius Pharmaceuticals (CTXR) reported its fiscal Q1 2022 results on February 10, 2022. The company had cash and equivalents of $65.4 million and a net loss of $9.2 million (or ($0.06) per share). R&D expenses decreased to $5.5 million, while G&A expenses rose to $2.9 million. Key developments include the completion of the Phase 3 trial for I/ONTAK, with topline results expected in H1 2022. New executives have been added to strengthen regulatory and clinical capabilities, supporting the late-stage pipeline.

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced its participation in two virtual conferences in January 2022. Presentations will be accessible on-demand beginning January 10, 2022. The events include the H.C. Wainwright BioConnect Conference from January 10-13 and Biotech Showcase™ 2022 on January 10-12 and 17-19. Archived webcasts will be available for 90 days on the Citius website. The company focuses on critical care products, including Mino-Lok® and I/ONTAK, both in late-stage development. For more details, visit www.citiuspharma.com.

Citius Pharmaceuticals (Nasdaq: CTXR) reported its fiscal year 2021 results, highlighting significant advancements and financial activities. The company completed the subject treatment in the pivotal Phase 3 trial of I/ONTAK and expects topline results in the first half of 2022, with a BLA submission set for the second half. They raised $120.6 million in financing, boosting cash reserves to $70.1 million. However, the net loss increased to $23.1 million, primarily due to rising R&D and G&A expenses. Citius is positioned for growth with a robust pipeline and anticipates multiple milestones in 2022.