CEL-SCI Files for Breakthrough Designation for Multikine in Saudi Arabia, Plans 212-Patient Enrollment in 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 29 2025
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Source: Newsfilter
- Clinical Trial Progress: CEL-SCI is preparing for a 212-patient Confirmatory Registration Study for newly diagnosed head and neck cancer patients, with enrollment expected to begin in Spring 2026, paving the way for potential early approval in the U.S. and significantly enhancing market competitiveness.
- Survival Rate Improvement: Multikine demonstrated a long-term survival rate of 73% in prior Phase 3 studies compared to 45% in the control group, significantly reducing the risks associated with developing cancer therapies and boosting investor confidence.
- Market Expansion in Saudi Arabia: CEL-SCI has applied for Breakthrough Medicine Designation in Saudi Arabia and is collaborating with a local company to support the Kingdom's Vision 2030, further solidifying its leadership position in the global biotechnology sector.
- Financial Condition Improvement: As of September 30, 2025, CEL-SCI's net loss decreased to $25.4 million, with R&D expenses down 13%, reflecting the company's proactive efforts in cost control and resource optimization.
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Analyst Views on CVM
About CVM
CEL-SCI Corporation is a late clinical-stage biotechnology company. It is engaged in research and development directed at improving the treatment of cancer and other diseases by using the immune system, the body’s natural defense system. It is focused on the development of product candidates and technologies, including Multikine and Ligand Epitope Antigen Presentation System technology (LEAPS). Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, which is designed to help the immune system target the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. LEAPS is designed to stimulate the human immune system to more effectively fight bacterial, viral and parasitic infections as well as autoimmune conditions, allergies, transplantation rejection and cancer, when it cannot do so on its own. The LEAPS candidates include CEL-2000, CEL-4000 and DerG-PG275(Cit) (aka, CEL-5000).
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Cel-Sci CEO Buys Shares, Stock Rises 7%
- CEO Share Purchase: Cel-Sci's CEO Geert R. purchased 38,023 shares at $5.26 each on January 22 for approximately $200,000, increasing his total holdings to 120,815 shares, reflecting confidence in the company's future prospects.
- Clinical Trial Preparation: The company is preparing for a confirmatory registration study for its experimental cancer treatment Multikine, aiming to enroll 212 patients with newly diagnosed resectable head and neck cancer, with enrollment expected to begin in spring 2026 and potential approval by 2028 based on generated data.
- Improved Financial Performance: For the fiscal year ending in September, Cel-Sci reported a net loss of $25.4 million, down from $27.6 million in fiscal 2024, indicating efforts to control costs and improve financial health.
- Positive Market Sentiment: On Stocktwits, retail sentiment around CVM stock remained in the 'bullish' territory, with message volume rising from 'high' to 'extremely high', suggesting investor optimism about the company's future developments.
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CEL-SCI Files for Breakthrough Designation for Multikine in Saudi Arabia, Plans 212-Patient Enrollment in 2026
- Clinical Trial Progress: CEL-SCI is preparing for a 212-patient Confirmatory Registration Study for newly diagnosed head and neck cancer patients, with enrollment expected to begin in Spring 2026, paving the way for potential early approval in the U.S. and significantly enhancing market competitiveness.
- Survival Rate Improvement: Multikine demonstrated a long-term survival rate of 73% in prior Phase 3 studies compared to 45% in the control group, significantly reducing the risks associated with developing cancer therapies and boosting investor confidence.
- Market Expansion in Saudi Arabia: CEL-SCI has applied for Breakthrough Medicine Designation in Saudi Arabia and is collaborating with a local company to support the Kingdom's Vision 2030, further solidifying its leadership position in the global biotechnology sector.
- Financial Condition Improvement: As of September 30, 2025, CEL-SCI's net loss decreased to $25.4 million, with R&D expenses down 13%, reflecting the company's proactive efforts in cost control and resource optimization.
Continue Reading