Citius Oncology Launches Lymphir In US For Skin Cancer — Retail Traders Eye Major Upside

• FDA approved Lymphir for adults with relapsed or refractory Stage I–III cutaneous T-cell lymphoma.
• Phase 3 data showed a 36.2% response rate, with most patients seeing reduced skin tumor burden.
• Lymphir is available nationwide with a permanent J-code effective April to support reimbursement.

Citius Oncology (CTOR) said on Monday it has launched Lymphir, a newly approved cancer immunotherapy for adults with relapsed or refractory Stage I–III cutaneous T-cell lymphoma (CTCL), making the drug available nationwide through specialty distributors.

The U.S. Food and Drug Administration (FDA) approved Lymphir, also known as denileukin diftitox-cxdlfor adults with cutaneous T-cell lymphoma, a form of skin cancer that can cause painful, itchy lesions. The drug is an IL-2 receptor-directed fusion protein designed to kill IL-2R–expressing cancer cells while depleting regulatory T cells.

The stock jumped nearly 18% to $1.62 at the time of writing. 

Clinical Findings

The immunotherapy approval was supported by results from Phase 3 Study 302, which reported an objective response rate of 36.2%. According to Citius, 84% of evaluable patients saw reductions in skin tumor burden, and the median time to response was 1.4 months. The company said the therapy was not associated with cumulative toxicity.

Lymphir is the first FDA-approved systemic therapy for CTCL in more than seven years. It has been added to the National Comprehensive Cancer Network guidelines with a Category 2A recommendation, meaning the therapy is recommended, with uniform agreement from experts. 

Commercial Rollout 

Lymphir has a permanent J-code, effective since April, to support reimbursement. Citius is providing medical education, payer-access support and a patient assistance program, which includes reimbursement and benefits guidance as well as prior authorization support. 

Global Expansion Plans 

Outside the U.S., Citius holds rights to develop and commercialize Lymphir in all markets except India, Japan and certain parts of Asia. The company recently signed a distribution agreement with Integris Pharma to begin named-patient access programs in Greece, Cyprus and other Southern European and Balkan countries.

Stocktwits Users Turn ‘Extremely Bullish’

On Stocktwits, retail sentiment for Citius Oncology turned ‘extremely bullish’ from ‘bullish’ over the past 24 hours amid ‘high’ message volume.

One bullish user said, “interesting to see what happens here - back on the scanner!”

Another user suggested the stock could return to $5. 

CTOR stock rose nearly 43% so far this year. 

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