CRANFORD, N.J. - Citius Pharmaceuticals, Inc. (NASDAQ: NASDAQ:CTXR) recently held a Type C meeting with the U.S. Food and Drug Administration (FDA) to discuss the New Drug Application (NDA) pathway for its product Mino-Lok, following a successful Phase 3 clinical trial. The meeting, which took place this past week, aimed to address the FDA's inquiries regarding the trial data and to outline the steps necessary for a future submission.
Mino-Lok is an antibiotic lock solution designed to salvage infected central venous catheters, potentially offering an alternative to catheter removal. Citius Pharma believes that Mino-Lok can significantly improve the management of catheter-related bloodstream infections and reduce healthcare costs.
During the meeting, the FDA provided Citius Pharma with constructive feedback and guidance on regulatory considerations and the clinical data needed to support the NDA submission for Mino-Lok. Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals, expressed optimism about the FDA's comprehensive feedback and stated that the company remains dedicated to advancing the Mino-Lok program.
The company highlighted the clinical outcomes from the Phase 3 trial, suggesting that Mino-Lok could enhance patient care for those with central venous catheterization. Citius Pharma plans to continue updating on the regulatory and clinical developments of Mino-Lok.
Citius Pharma is focused on developing first-in-class critical care products, including Mino-Lok and other pipeline projects. The company's product LYMPHIR, a targeted immunotherapy, was approved by the FDA in August 2024 for the treatment of cutaneous T-cell lymphoma. The company has also completed a Phase 2b trial for Halo-Lido, a topical formulation for hemorrhoids.
The information in this article is based on a press release statement from Citius Pharmaceuticals, Inc.
In other recent news, Citius Pharmaceuticals has disclosed plans for a 1-for-25 reverse stock split, aiming to satisfy Nasdaq's minimum bid price condition for continued listing. The split will consolidate every twenty-five shares of issued and outstanding common stock into one share. The company has also been granted an extension by a Nasdaq Hearings Panel to regain compliance with the exchange's minimum bid price requirement.
Citius Pharmaceuticals has extended an employment agreement with Myron Holubiak, the company's Executive Vice Chairman, and certain warrant agreements, which could provide approximately $2.4 million in cash proceeds if fully exercised. The company has successfully deferred a significant FDA milestone payment for its product, LYMPHIR™, with the specifics of the deferral remaining undisclosed.
Citius Pharmaceuticals announced a merger with TenX Keane Acquisition, with Citius set to hold approximately 90% of the new entity, Citius Oncology, Inc. The merger is expected to enhance the potential commercialization of LYMPHIR™. The company also reported successful Phase 3 trials of Mino-Lok, an antibiotic lock solution. EF Hutton initiated coverage on Citius Pharmaceuticals, issuing a Buy rating. These are recent developments from Citius Pharmaceuticals.
InvestingPro Insights
As Citius Pharmaceuticals (NASDAQ: CTXR) progresses with its Mino-Lok program, investors should be aware of the company's current financial position and market performance. According to InvestingPro data, CTXR has a market capitalization of $25.85 million, reflecting its status as a small-cap biopharmaceutical company.
InvestingPro Tips highlight that CTXR holds more cash than debt on its balance sheet, which could be crucial for funding ongoing clinical trials and potential commercialization efforts for Mino-Lok. This financial stability is particularly important given that the company is not currently profitable, as indicated by its negative operating income of -$41.07 million over the last twelve months as of Q3 2023.
The stock's recent performance has been challenging, with InvestingPro data showing a significant price decline of 83.06% over the past year. This downturn is reflected in the stock's current price of $0.13, which is only 12.52% of its 52-week high. Despite these headwinds, analysts maintain a fair value estimate of $4.00 for CTXR, suggesting potential upside if the company can successfully navigate the regulatory pathway for Mino-Lok and capitalize on its recent FDA approval for LYMPHIR.
Investors considering CTXR should note that the company does not pay a dividend, which is common for early-stage biopharmaceutical firms reinvesting in research and development. The stock's volatility and recent performance underscore the speculative nature of investing in small-cap biotech companies.
For a more comprehensive analysis, InvestingPro offers 13 additional tips for CTXR, providing deeper insights into the company's financial health and market position.
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