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Investing.com -- CEL-SCI Corporation (NYSE American:CVM) stock surged 25% after announcing a partnership with a leading Saudi pharmaceutical company for its cancer immunotherapy Multikine.
The agreement covers regulatory and commercial activities in Saudi Arabia, with the Saudi partner expected to file a Breakthrough Medicine Designation application for Multikine with the Saudi Food and Drug Authority (SFDA) in the coming weeks. If granted, this designation would allow immediate patient access and commercialization in the Saudi market.
According to CEL-SCI, the SFDA typically responds to Breakthrough Medicine Designation applications within approximately 60 days. The company stated that several Saudi funds have expressed interest in investing in Multikine, CEL-SCI, or a potential joint venture targeting the Middle East and North Africa region.
"We have been directly, and through our representative, First Berlin of Germany and its local Saudi representatives, engaging with medical, regulatory and financial experts in Saudi Arabia in preparation for the regulatory filing to the SFDA," said CEL-SCI CEO Geert Kersten.
Multikine is an immunotherapy administered before surgery for newly diagnosed head and neck cancer. The company reports that in a clinical study across 20 countries, Multikine increased the 5-year survival rate of the target patient population to 73% compared to 45% in patients treated with standard care alone, reducing the 5-year risk of death from 55% to 27%.
The formal agreement with the unnamed Saudi pharmaceutical partner is expected to be signed in the near future, with both companies developing a comprehensive commercialization plan that leverages the partner’s expertise in the local healthcare market.
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