Welcome to our dedicated page for Citius Pharmaceuticals news (Ticker: CTXR), a resource for investors and traders seeking the latest updates and insights on Citius Pharmaceuticals stock.
Citius Pharmaceuticals Inc. (CTXR) delivers innovative therapies for critical care needs through its pipeline of novel oncology treatments and anti-infective solutions. This news hub provides investors and healthcare professionals with timely updates on clinical developments, regulatory milestones, and strategic initiatives shaping the company's progress.
Access verified information about CTXR's FDA interactions, trial results for therapies like LYMPHIR™ and Mino-Lok®, and partnership announcements. Our curated collection ensures you stay informed about material events without promotional bias, supporting data-driven decision-making in this specialized biopharmaceutical sector.
Key updates include progress reports on late-stage clinical programs, manufacturing expansions, and peer-reviewed research publications. All content undergoes strict verification to maintain compliance with financial disclosure standards while preserving accessibility for both medical and investment audiences.
Bookmark this page for streamlined tracking of CTXR's advancements in targeted immunotherapies and critical care innovations. Combine regular monitoring with professional financial advice to maintain perspective on the company's evolving market position.
Citius Pharmaceuticals (Nasdaq: CTXR), a biopharma company, has outlined key milestones for the second half of 2024, hinging on two late-stage candidates: Mino-Lok® and LYMPHIR™. Mino-Lok® has shown positive Phase 3 results for catheter-related bloodstream infections (CRBSIs) and awaits FDA submission and a Type B meeting. LYMPHIR™, an IL-2-based immunotherapy for cutaneous T-cell lymphoma (CTCL), is under FDA review with a decision expected by August 13, 2024. If approved, Citius aims for commercialization in 2024, potentially benefiting from 12 years of exclusivity. The company is also advancing Halo-Lido, a topical treatment for hemorrhoids, and has secured $15 million to strengthen its financial position. Additionally, Citius plans to merge a subsidiary with TenX Keane Acquisition (Nasdaq: TENK) to form Citius Oncology, Inc., pending regulatory approval.
Citius Pharmaceuticals, a late-stage biopharmaceutical company, announced a scheduled investor call to discuss the topline results of its Phase 3 Trial of Mino-Lok antibiotic lock solution. The call will take place on Monday, June 3, 2024, at 8:30 AM ET. Citius Chairman and CEO, Leonard Mazur, alongside the management team, will address the trial results and the clinical need for Mino-Lok in treating catheter-related bloodstream infections. A Q&A session will follow the discussion. The conference call will be accessible via a U.S. toll-free number, an international dial-in number, and a webcast, with a replay available on the company's website for 90 days.
Citius Pharmaceuticals announced positive topline results from its Phase 3 clinical trial of Mino-Lok, an antibiotic lock solution for catheter-associated infections. The trial achieved its primary endpoint with a statistically significant improvement in time to catheter failure (p=0.0006). Secondary endpoints showed a higher percentage of patients retaining their catheters compared to the control arm (p=0.0025). The study involved 241 patients and demonstrated Mino-Lok's efficacy and safety. The company plans to engage with the FDA for further development.
Citius Pharmaceuticals (CTXR) reported its fiscal Q2 2024 financial results and provided a business update. Key highlights include:
- The FDA accepted LYMPHIR's BLA with a PDUFA target date of Aug 13, 2024.
- Topline results for Mino-Lok’s Phase 3 trial expected in Q2 2024.
- Continued engagement with FDA for Halo-Lido’s development.
- Merger with TenX Keane Acquisition progressing, awaiting SEC and TENK shareholder approval.
- Completed a $15M direct offering in April 2024, extending cash runway to Dec 2024.
Financial highlights:
- $12.6M in cash as of Mar 31, 2024.
- R&D expenses decreased to $3.6M from $4.7M YoY; G&A expenses slightly decreased to $4.3M from $4.8M YoY.
- Net loss improved to $8.5M, $0.05 per share, from $10.5M, $0.07 per share YoY.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) will participate in the upcoming EF Hutton and H.C. Wainwright investor conferences. CEO Leonard Mazur will host one-on-one investor meetings at the EF Hutton Annual Global Conference on May 15, 2024, and present at the H.C. Wainwright BioConnect Investor Conference on May 20, 2024.
Citius Pharmaceuticals Inc. (Nasdaq: CTXR) closed a registered direct offering, raising $15 million through the sale of 21,428,574 shares and warrants. The offering was facilitated by H.C. Wainwright & Co. The company plans to utilize the funds for general corporate purposes, including product development and working capital.
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