Citius Pharmaceuticals Inc Stock Price, News & Analysis

Citius Pharmaceuticals and Citius Oncology announced preliminary results from a Phase I trial evaluating the combination of pembrolizumab (KEYTRUDA®) and LYMPHIR™ in patients with recurrent solid tumors, focusing on gynecological cancers like ovarian, endometrial, and cervical. The trial showed a 27% Objective Response Rate (ORR) and a 33% Clinical Benefit Rate (CBR) with a median Progression-Free Survival (PFS) of 57 weeks. The regimen was well-tolerated, with no serious immune-related adverse events. The study, nearing completion, will enroll three more patients. The results suggest LYMPHIR may enhance the efficacy of immune checkpoint inhibitors like pembrolizumab. The trial's promising outcomes support expanding research into a Phase II study to evaluate the combination's benefits across a broader range of solid tumors.

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.