Penny Stock Citius Pharmaceuticals Secures Its First FDA Approval For Skin Cancer Drug A Year After FDA Rejection

Penny stock Citius Pharmaceuticals Inc CTXR secures FDA approval on Thursday for Lymphir (denileukin diftitox-cxdl) to treat relapsed or refractory cutaneous T-cell lymphoma (CTCL) in patients after at least one prior systemic therapy.

Lymphir is the only CTCL therapy that targets the interleukin-2 (IL-2) receptor found on malignant T-cells and Tregs. This is the first indication for Lymphir and Citius Pharma’s first FDA-approved product.

The company plans to launch Lymphir in the U.S. market within the next five months.

Last year in July, the FDA issued a Complete Response Letter regarding Citius Pharmaceuticals’ Biologics License Application (BLA) seeking approval for Lymphir.

The FDA required Citius to incorporate enhanced product testing and additional controls agreed to with the FDA during the market application review. 

“The introduction of Lymphir, with its potential to rapidly reduce skin disease and control symptomatic itching without cumulative toxicity, is expected to expand the CTCL treatment landscape and grow the overall market, currently estimated to be $300 to $400 million,” said Leonard Mazur, the CEO of Citius.

Also Read: Citius Pharma’s ‘Antibiotic Lock’ Effective In Patients With Catheter-Associated Bloodstream Infections.

CTCL is a rare and often debilitating chronic non-Hodgkin lymphoma that primarily affects the skin. Approximately 2,500-3,000 patients are diagnosed each year, with an estimated 40,000 living with the disease. 

The approval is based on data from the phase 3 trial, which showed that Lymphir provided an overall response rate of 36%.

52.0% of the patients had a duration of response of at least six months. 84.4% of skin evaluable subjects had a decrease in skin tumor burden, and 12.5% saw complete clearing of skin disease.

Pruritis was evaluated as an exploratory endpoint with 31.7% of patients demonstrating clinically significant improvement.

Price Action: CTXR stock closed lower by 1.76% at $0.88 on Thursday.

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