CEL-SCI Corporation announced on August 13, 2025, that a Breakthrough Medicine Designation application for Multikine was filed with the Saudi Food and Drug Authority (SFDA) in Saudi Arabia. The application was submitted by one of the Kingdom’s premier pharmaceutical and healthcare companies.
CEL-SCI previously signed a Memorandum of Understanding (MOU) with this Saudi pharma company for the commercialization of Multikine in Saudi Arabia, with a final partnership agreement expected during the third quarter of 2025. Multikine is a cancer immunotherapy administered before surgery for newly diagnosed previously untreated head and neck cancer.
According to the SFDA, the response time to a Breakthrough Medicine Designation application is approximately 60 days. Upon granting of the designation, Multikine would immediately become available for patient access and reimbursement/sale in Saudi Arabia, potentially improving longevity and well-being for head and neck cancer patients.
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