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 reports developments across its critical care and targeted oncology business, including activity at majority-owned subsidiary Citius Oncology. The company’s recurring updates center on LYMPHIR (denileukin diftitox-cxdl), an engineered IL-2 diphtheria toxin fusion protein approved for adults with relapsed or refractory Stage I–III cutaneous T-cell lymphoma after at least one prior systemic therapy.
Company news also covers LYMPHIR commercialization, U.S. launch progress, international access through Named Patient Programs, and investigator-initiated oncology studies involving gynecologic cancers and diffuse large B-cell lymphoma. Capital updates include registered direct offerings, warrant issuances, non-dilutive funding and other financing actions that support product commercialization and development programs.
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.
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.