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CEL-SCI Corporation (CVM) on Friday announced it has reached an agreement with one of Saudi Arabia’s premier pharmaceutical companies for a partnership that spans regulatory and commercial activities for Multikine in the Kingdom of Saudi Arabia.
CEL-SCI’s shares were trading 33% higher at the time of writing.
The formal agreement is expected to be signed with the Saudi pharmaceutical partner in the coming weeks, the company said. The partner will then file a Breakthrough Medicine Designation application for Multikine with the Saudi Food and Drug Authority (SFDA).
Multikine is a cancer drug administered before surgery as a treatment for newly diagnosed and previously untreated head and neck cancer.
If granted Breakthrough Medicine Designation, Multikine would immediately become available for patient access, reimbursement, or sale in Saudi Arabia. CEL-SCI said that it believes Multikine meets all requirements for Breakthrough Medicine Designation as published by the SFDA and is now developing a comprehensive commercialization plan with its Saudi pharma partner.
In a study spanning 20 countries, Multikine increased the 5-year survival rate of the target patient population to 73% versus 45% in patients treated with standard of care alone. The 5-year risk of death was halved from 55% to 27%.
The drug, given right after diagnosis and before surgery, has been dosed in over 740 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
CEL-SCI also said on Friday that several Saudi funds have expressed interest in investing in Multikine, CEL-SCI, and/or a potential joint venture to serve the wider Middle East and North Africa (MENA) market.
On Stocktwits, retail sentiment around CVM jumped from ‘bearish’ to ‘extremely bullish’ over the past 24 hours while message volume rose from ‘high’ to ‘extremely high’ levels.
CVM stock is down by 58% this year and by over 86% over the past 12 months.
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