Shares of CEL-SCI Corporation (AMEX:CVM) surged 25% following the announcement of a new partnership with a prominent Saudi pharmaceutical firm to advance the regulatory and commercial rollout of its flagship cancer immunotherapy, Multikine, in Saudi Arabia.
Under the newly announced collaboration, the Saudi partner will lead the application process for Breakthrough Medicine Designation with the Saudi Food and Drug Authority (SFDA), a move that could enable expedited approval and patient access. CEL-SCI noted that the SFDA generally responds to such applications within 60 days.
The company also revealed that various Saudi investment funds have expressed interest in backing Multikine through direct investment in CEL-SCI or via a potential joint venture focused on expansion across the Middle East and North Africa (MENA) region.
“We have been working closely with experts in Saudi Arabia, both directly and through our representatives at First Berlin and their local affiliates, to prepare the necessary regulatory filings,” said CEL-SCI CEO Geert Kersten.
Multikine is designed to be administered prior to surgery for patients newly diagnosed with head and neck cancer. In a global clinical trial spanning 20 countries, the therapy increased the five-year survival rate for its target population to 73%, up from 45% with standard care, effectively cutting the five-year mortality risk from 55% to 27%.
CEL-SCI expects to finalize a formal agreement with its Saudi partner soon. The two companies will then jointly develop a go-to-market strategy that leverages the partner’s expertise in navigating the local healthcare system.
CEL-SCI Corporation stock price
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