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Citius Pharmaceuticals Inc. (Nasdaq: CTXR) is a specialty biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Founded in 2007 and headquartered in Cranford, New Jersey, Citius focuses on providing innovative treatments in areas such as anti-infectives, oncology, and stem cell therapy.
The company's diversified pipeline includes several late-stage product candidates:
- Mino-Lok®: An antibiotic lock solution used to salvage infected catheters in patients with catheter-related bloodstream infections. This product is currently in pivotal Phase 3 clinical trials.
- Mino-Wrap®: A liquifying gel-based wrap designed to reduce tissue expander infections following breast reconstructive surgeries.
- Halo-Lido®: A topical corticosteroid-lidocaine formulation intended to provide anti-inflammatory and anesthetic relief for individuals suffering from hemorrhoids. Enrollment in its Phase 2b trial has been completed.
- LYMPHIR™ (denileukin diftitox): An IL-2-based immunotherapy for the treatment of cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). The Biologics License Application (BLA) for LYMPHIR is currently under review by the FDA, with a PDUFA target action date set for August 13, 2024.
- NoveCite™: A mesenchymal stem cell therapy aimed at treating acute respiratory distress syndrome.
Recently, Citius has made significant advancements:
- Completed the Phase 3 trial recruitment for Mino-Lok.
- Resubmitted the BLA for LYMPHIR, addressing FDA comments with no safety or efficacy concerns noted.
- Announced a merger of its oncology subsidiary with TenX to form a publicly listed company, enhancing financial flexibility and potential value for stakeholders.
- Secured $2.4 million in non-dilutive capital through New Jersey’s Net Operating Loss (NOL) program.
Financially, as of March 31, 2024, Citius reported $12.6 million in cash and cash equivalents and has recently expanded its cash runway by successfully completing a $15 million registered direct offering. The company remains focused on the commercialization of LYMPHIR, completion of the Mino-Lok Phase 3 trial, and planning for the Phase 3 trial of Halo-Lido.
With a commitment to innovation and a strong pipeline, Citius Pharmaceuticals continues to strive towards providing effective treatments for critical care needs across various medical fields.
Citius Pharmaceuticals (NASDAQ: CTXR) has received FDA approval for LYMPHIR™ (denileukin diftitox-cxdl), a novel immunotherapy for treating relapsed or refractory cutaneous T-cell lymphoma (CTCL) in adults. LYMPHIR is the first systemic treatment for r/r CTCL targeting the IL-2 receptor on malignant T-cells and Tregs, and the first FDA-approved product for Citius Pharma.
Key highlights:
- Expected market launch within 5 months
- First novel targeted systemic therapy approved for r/r CTCL since 2018
- Phase 3 study showed 36% Objective Response Rate
- Reduction in skin disease in 84% of patients
- Estimated market size: $300-$400 million
Citius Pharmaceuticals (Nasdaq: CTXR) announced that shareholders of TenX Keane Acquisition (Nasdaq: TENK) have approved the merger with Citius Pharma's oncology subsidiary. The newly combined public company will be renamed Citius Oncology, Inc. and continue trading on Nasdaq. Key points:
- Citius Pharma to receive 65.6 million shares of TenX Keane
- Citius Pharma to retain approximately 90% majority control post-transaction
- Transaction expected to support commercialization of LYMPHIR, if approved
- Merger to provide improved access to public equity markets
- Positions company to explore additional targeted oncology opportunities
The merger is expected to be completed in the coming weeks, subject to customary closing conditions. Leonard Mazur, Chairman and CEO of Citius Pharma, expressed optimism about unlocking and growing the value of their oncology asset.
Biotech stocks are racing towards solutions for Cutaneous T-Cell Lymphoma (CTCL), with the market projected to reach $1.38 Billion by 2030. Citius Pharmaceuticals (NASDAQ: CTXR) is approaching the FDA target date of August 13th for its LYMPHIR product candidate. The FDA has accepted the resubmission of Citius' Biologics License Application (BLA) for LYMPHIR, an IL-2-based immunotherapy for relapsed or refractory CTCL. EF Hutton initiated coverage of CTXR with a Buy recommendation and a $6.00 price target. Other companies like Soligenix and Takeda-Pfizer are also making progress in CTCL and lymphoma treatments, highlighting the growing interest and potential in this market.
Analysts are hunting for undervalued biotech stocks, with Citius Pharmaceuticals (NASDAQ: CTXR) gaining attention. EF Hutton initiated coverage with a Buy recommendation and $6.00 price target, citing low risk and high reward potential based on two late-stage therapeutics: Mino-Lok and LYMPHIR. Catalysts include a planned IPO for LYMPHIR and an early August PDUFA. The biotech sector saw a strong start in 2024, driven by M&A activity and potential interest rate declines. Morningstar highlighted several undervalued biotech stocks, including Intellia Therapeutics, Crispr Therapeutics, and Jazz Pharmaceuticals. The industry group has a Relative Strength Rating of 83, ranking in the top 17% of all industry groups in 12-month performance.
Investorideas.com published the second part of a series on blood infections treatment, featuring Citius Pharmaceuticals (NASDAQ: CTXR). Citius has made significant advances in its late-stage product candidates, particularly Mino-Lok® for catheter-related bloodstream infections (CRBSIs).
The Phase 3 trial of Mino-Lok® showed positive topline results, meeting primary and secondary endpoints with statistical significance. The primary endpoint was the time to catheter failure, with Mino-Lok achieving superior results compared to the control arm. The next steps include FDA submission and a Type B meeting.
Mino-Lok® could potentially set a new standard of care by offering a non-invasive alternative to catheter removal and replacement. The Phase 3 trial data indicates that Mino-Lok® is well-tolerated and effective, demonstrating a substantial delay in catheter failure events compared to the control group.
In addition, BD is addressing supply issues for blood culture vials, and CorMedix has launched DefenCath® for outpatient dialysis centers. Vir Biotechnology received FDA clearance for its hepatitis delta treatment combination, highlighting the ongoing innovations in the infection treatment market.
Investorideas.com has released a new series focusing on transformative biopharma innovation, featuring Citius Pharmaceuticals (NASDAQ: CTXR). The company has advanced two key late-stage candidates: Mino-Lok and LYMPHIR. Mino-Lok's Phase 3 trial showed significant efficacy in treating catheter-related bloodstream infections, and the company plans to submit it for FDA approval soon. Meanwhile, the FDA is reviewing LYMPHIR for treating cutaneous T-cell lymphoma, with a decision expected by August 13, 2024. Citius is preparing for potential commercialization if approved. Additionally, Citius is developing Halo-Lido for hemorrhoid treatment, which has shown promising Phase 2b results. The global biopharma market is expected to grow significantly, with AI and CRISPR technologies driving industry innovation. Citius aims to leverage these trends to create value and deliver effective treatments.
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.
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