Welcome to our dedicated page for Citius Pharmaceuticals Common news (Ticker: CTXR), a resource for investors and traders seeking the latest updates and insights on Citius Pharmaceuticals Common stock.
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 (CTXR) announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, in New York City. CEO Leonard Mazur will present on September 10, 2024, at 9:00 am ET at the Lotte New York Palace Hotel and host one-on-one investor meetings.
Key business developments to be discussed include:
- FDA approval of LYMPHIR™ for cutaneous T-cell lymphoma treatment
- Merger of a subsidiary with TenX Keane, forming Citius Oncology (CTOR)
- Successful Phase 3 Pivotal Trial of Mino-Lok®, an antibiotic lock solution for catheter-related bloodstream infections
Investors can register on the conference website and join the live webcast presentation.
Citius Pharmaceuticals and Citius Oncology announced that LYMPHIR™ has been added to the NCCN Clinical Practice Guidelines in Oncology with a Category 2A recommendation. This inclusion supports LYMPHIR as an appropriate treatment option for patients with Cutaneous T-cell Lymphoma (CTCL) who have undergone at least one prior systemic therapy.
LYMPHIR, a novel immunotherapy targeting the interleukin-2 receptor on malignant T-cells and Tregs, was recently approved by the FDA based on results from the Phase 3 Pivotal Study 302. The addition to NCCN Guidelines is expected to facilitate adoption and ease reimbursement, particularly for patients eligible for CMS coverage.
Citius Pharmaceuticals (CTXR) reported fiscal Q3 2024 results and key developments:
- FDA approval of LYMPHIR™ for cutaneous T-cell lymphoma treatment
- Completed merger of oncology subsidiary with TenX Keane; Citius Oncology (CTOR) to start trading on Nasdaq
- Achieved primary and secondary endpoints in Mino-Lok® Phase 3 Trial
- $17.9 million cash as of June 30, 2024
- Net loss of $10.6 million ($0.06 per share) for Q3, compared to $8.5 million ($0.06 per share) in Q3 2023
- R&D expenses decreased to $2.8 million from $3.8 million year-over-year
- G&A expenses increased to $4.8 million from $3.7 million year-over-year
CEO Leonard Mazur highlighted the FDA approval of LYMPHIR and successful Mino-Lok trial as key milestones.
Citius Pharmaceuticals (CTXR) has completed the merger of its oncology subsidiary with TenX Keane Acquisition, forming Citius Oncology, Inc. The new entity is set to trade on Nasdaq under the ticker CTOR starting August 13, 2024. Citius Pharma retains approximately 90% ownership of Citius Oncology.
Key highlights include:
- FDA approval of LYMPHIR™ for treating cutaneous T-cell lymphoma
- Plans to distribute a portion of Citius Oncology shares to Citius Pharma shareholders
- Citius Pharma's Mino-Lok antibiotic lock solution achieved primary and secondary endpoints in Phase 3 Trial
The merger aims to provide greater financial and strategic flexibility, potentially unlocking value for both companies.
Citius Pharmaceuticals (Nasdaq: CTXR) has announced an investor call scheduled for Tuesday, August 13, 2024, at 8:30 AM ET. The call aims to discuss recent and upcoming developments within the company. Chairman and CEO Leonard Mazur will lead the discussion, joined by other members of the management team.
Investors can participate in the call via phone or webcast. The U.S. toll-free number is 1-888-243-4451, while the international number is 1-412-542-4135. A webcast option is also available, with registration required. A replay of the call will be accessible on the Citius website for 90 days following the event, providing an opportunity for those unable to attend live to catch up on the discussed developments.
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.
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