On Monday, EF Hutton initiated coverage on shares of Citius Pharmaceuticals (NASDAQ:CTXR), issuing a Buy rating and setting a price target of $6.00. The firm highlighted the pharmaceutical company's two late-stage therapeutics, Mino-Lok and LYMPHIR, which are nearing the end of the approval process. The products have shown promising efficacy and safety profiles.
Citius Pharmaceuticals recently reported positive top-line results for Mino-Lok in May 2024. This antibiotic lock solution aims to treat patients with bloodstream infections by salvaging infected catheters. The company anticipates submitting a New Drug Application (NDA) for Mino-Lok in the first half of 2025, with an expected six-month review period.
Moreover, LYMPHIR, Citius's novel IL-2R immunotherapy for cutaneous T-cell lymphoma, is currently under the FDA's review, with a target action date set for August 13, 2024. The therapy has received orphan drug designation for the treatment of both cutaneous T-cell lymphoma and peripheral T-cell lymphoma.
EF Hutton pointed out that the planned initial public offering (IPO) for Citius Oncology, which will focus on LYMPHIR as its main asset, is scheduled for this summer. This strategic move is expected to enhance value for Citius Pharmaceuticals.
The analyst from EF Hutton described the investment opportunity in Citius as "Low-Risk and High-Reward," citing the advanced stages of the approval process for both Mino-Lok and LYMPHIR as key factors. The upcoming PDUFA date and the IPO for Citius Oncology are seen as potential catalysts for the parent company's stock value.
In other recent news, Citius Pharmaceuticals announced the successful completion of its Phase 3 trial for Mino-Lok, an antibiotic lock solution designed to treat catheter-related bloodstream infections. The study, which involved 241 patients from the U.S. and India, met its primary endpoint, demonstrating overall treatment success.
The trial aimed to evaluate the efficacy of Mino-Lok in salvaging catheters in patients with central line-associated bloodstream infections. Patients treated with Mino-Lok experienced a significant delay in time to catheter failure event, and the treatment also showed a higher overall success rate compared to the control group.
Safety data suggested that Mino-Lok was well-tolerated, with no serious adverse events linked to the drug. CEO Leonard Mazur expressed satisfaction with the trial results, highlighting the potential of Mino-Lok to become a new standard of care for treating patients with bloodstream infections. The company plans to engage with the FDA for further discussions on the next steps for Mino-Lok.
InvestingPro Insights
As Citius Pharmaceuticals (NASDAQ:CTXR) navigates towards potentially pivotal moments with its late-stage therapeutics, real-time data from InvestingPro provides additional context for investors considering EF Hutton's optimistic outlook.
Despite the challenges of being unprofitable over the last twelve months, Citius holds a market capitalization of $134.42 million and has demonstrated a significant return over the last week with a 21.93% price total return. The company's stock movements have indeed been volatile, as evidenced by a 17.31% price total return over the last month, contrasting with a 1-year price total return of -38.33%.
InvestingPro Tips reveal that Citius holds more cash than debt on its balance sheet and that its liquid assets exceed short-term obligations, both of which are encouraging signs for the company's financial health. Moreover, there are 8 more tips available on InvestingPro for investors who want to delve deeper into Citius's financials and stock performance. To access these valuable insights, visit https://www.investing.com/pro/CTXR and consider using the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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