Citius Pharmaceuticals Inc. (NASDAQ: CTXR), a penny stock, has achieved a significant milestone by securing its first FDA approval for Lymphir (denileukin diftitox-cxdl), a drug developed to treat relapsed or refractory cutaneous T-cell lymphoma (CTCL) in patients who have undergone at least one prior systemic therapy. This approval is particularly noteworthy as it follows a previous rejection from the FDA in July 2023, where the agency required additional product testing and controls during the market application review.
Lymphir distinguishes itself as the only therapy for CTCL that targets the interleukin-2 (IL-2) receptor on malignant T-cells and regulatory T cells (Tregs). This approval not only marks the first FDA-approved product for Citius but also positions Lymphir to potentially reshape the CTCL treatment landscape.
The market for CTCL treatment is currently estimated to be between $300 million and $400 million, and Lymphir’s introduction is expected to significantly expand this market by offering a treatment that can rapidly reduce skin disease and alleviate symptomatic itching without cumulative toxicity.
The FDA's approval was based on compelling data from a phase 3 clinical trial, which demonstrated an overall response rate of 36% among patients. Notably, 52% of patients who responded maintained their response for at least six months. Additionally, 84.4% of patients experienced a reduction in skin tumor burden, with 12.5% achieving complete clearance of skin disease. Improvement in pruritis (itching) was also observed, with 31.7% of patients showing clinically significant improvement.
Citius plans to launch Lymphir in the U.S. within the next five months. Despite this positive news, Citius Pharmaceuticals' stock price closed 1.76% lower at $0.88 on the day of the announcement, reflecting potential investor caution or market volatility.
The approval of Lymphir represents a crucial development for both Citius Pharmaceuticals and the broader CTCL patient community, offering a new option for those battling this rare and often debilitating form of lymphoma.
Lymphir distinguishes itself as the only therapy for CTCL that targets the interleukin-2 (IL-2) receptor on malignant T-cells and regulatory T cells (Tregs). This approval not only marks the first FDA-approved product for Citius but also positions Lymphir to potentially reshape the CTCL treatment landscape.
The market for CTCL treatment is currently estimated to be between $300 million and $400 million, and Lymphir’s introduction is expected to significantly expand this market by offering a treatment that can rapidly reduce skin disease and alleviate symptomatic itching without cumulative toxicity.
The FDA's approval was based on compelling data from a phase 3 clinical trial, which demonstrated an overall response rate of 36% among patients. Notably, 52% of patients who responded maintained their response for at least six months. Additionally, 84.4% of patients experienced a reduction in skin tumor burden, with 12.5% achieving complete clearance of skin disease. Improvement in pruritis (itching) was also observed, with 31.7% of patients showing clinically significant improvement.
Citius plans to launch Lymphir in the U.S. within the next five months. Despite this positive news, Citius Pharmaceuticals' stock price closed 1.76% lower at $0.88 on the day of the announcement, reflecting potential investor caution or market volatility.
The approval of Lymphir represents a crucial development for both Citius Pharmaceuticals and the broader CTCL patient community, offering a new option for those battling this rare and often debilitating form of lymphoma.