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CRANFORD, N.J. - Citius Oncology, Inc. (NASDAQ:CTOR), a small-cap biotech company with a market capitalization of $156 million, announced Tuesday it has entered an exclusive distribution agreement with Integris Pharma S.A. to make its LYMPHIR therapy available to eligible patients through Named Patient Programs (NPPs) in Greece, Cyprus, and several Balkan countries. According to InvestingPro data, the company’s stock has shown significant volatility, with a remarkable 160% gain over the past six months despite recent pullbacks.
The agreement establishes a pathway for patients in these regions to access LYMPHIR (denileukin diftitox-cxdl), which received FDA approval in August 2024 for treating relapsed or refractory cutaneous T-cell lymphoma (CTCL) in adult patients who have undergone at least one prior systemic therapy. While the company operates with moderate debt levels, InvestingPro analysis indicates current short-term obligations exceed liquid assets, highlighting the importance of successful commercialization efforts.
Named Patient Programs allow physicians to request promising new medicines for individual patients before full marketing authorization in markets outside the United States. These programs operate where permitted by local law and do not constitute commercial approval.
"These programs allow us to serve patients who urgently need new treatment options, while also giving physicians valuable firsthand experience with LYMPHIR," said Leonard Mazur, Chairman and CEO of Citius Oncology, according to the company’s press release.
Integris Pharma, headquartered in Athens, will provide regulatory support, distribution, and patient-centric programs across the covered territories, which include Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro, and North Macedonia.
The company stated it is in discussions with additional distribution partners across European Union member states, South America, and select Middle Eastern territories to expand LYMPHIR’s availability.
LYMPHIR is a recombinant fusion protein that targets IL-2 receptors on tumor cells and regulatory T-cells. The therapy was previously approved in Japan in 2021 for treating relapsed or refractory CTCL and peripheral T-cell lymphoma.
In other recent news, Citius Oncology, Inc. has been active with several financial maneuvers and regulatory updates. The company successfully closed a $9 million public offering aimed at supporting its cancer therapy LYMPHIR, with 6,818,182 shares of common stock and warrants issued at a price of $1.32 per share. Additionally, Citius Oncology completed another $9 million financing through a registered direct offering and concurrent private placement, involving 5,142,858 shares of common stock and accompanying warrants priced at $1.75 per share.
In regulatory developments, Citius Oncology filed a prospectus supplement to update its S-1 registration statement to align with its recent quarterly report. Furthermore, the company issued warrants to a financial advisor for up to 360,000 shares of common stock, exercisable starting in 2026. The board of directors also approved an amendment to the 2024 Omnibus Stock Incentive Plan, doubling the authorized shares reserved for issuance under the plan from 15,000,000 to 30,000,000. These moves indicate a strategic effort to bolster the company’s financial and operational framework.
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