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Investing.com -- Citius Oncology Inc (NASDAQ:CTOR) stock surged 27.7% on Monday following the commercial launch of its novel therapy LYMPHIR for cutaneous T-cell lymphoma (CTCL) patients.
The company announced that LYMPHIR (denileukin diftitox-cxdl), an IL-2 receptor-directed fusion protein, is now available through specialty distributors nationwide. The therapy was approved by the FDA in August 2024 for adult patients with relapsed or refractory Stage I-III CTCL who have received at least one prior systemic therapy.
LYMPHIR is the first FDA-approved systemic therapy for CTCL in more than seven years. According to the company, the therapy demonstrated a 36.2% objective response rate in its pivotal trial, with 84% of evaluable patients experiencing a reduction in skin tumor burden. The median time to response was 1.4 months.
"LYMPHIR addresses a clear clinical need in a disease with limited treatment options," said Leonard Mazur, Chairman and CEO of Citius Oncology. The company estimates that LYMPHIR is entering a growing U.S. market valued at over $400 million, with potential for international expansion.
To support the launch, Citius Oncology has established a dedicated portal for healthcare providers at www.lymphirhcp.com and implemented the Citius Advantage patient assistance program to help improve access to treatment. The therapy has been assigned a permanent J-code effective April 1, 2025, to facilitate reimbursement.
The company has also secured a distribution agreement with Integris Pharma S.A. to initiate named-patient access programs in Greece, Cyprus, and other Southern European and Balkan countries as part of its international strategy.
LYMPHIR has been included in the National Comprehensive Cancer Network Guidelines for CTCL with a Category 2A recommendation.
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