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VIENNA - CEL-SCI Corporation (NYSE American:CVM), a $52 million market cap biotechnology company, announced Wednesday that one of Saudi Arabia’s leading pharmaceutical companies has filed a Breakthrough Medicine Designation application with the Saudi Food and Drug Authority (SFDA) for Multikine, a cancer immunotherapy for head and neck cancer. According to InvestingPro data, the company’s stock has shown significant volatility, with a 78% decline over the past year, though recent analysis suggests the stock may be undervalued at current levels.
The company has signed a Memorandum of Understanding with the unnamed Saudi pharmaceutical firm for commercialization of Multikine in Saudi Arabia, with a final partnership agreement expected during the third quarter of 2025, according to a press release statement. With the company’s next earnings report due on August 19, InvestingPro subscribers have access to 10+ additional exclusive insights about CEL-SCI’s financial health and market performance.
Multikine is administered before surgery as a treatment for newly diagnosed head and neck cancer. In a Phase 3 study, the therapy reportedly increased the 5-year survival rate to 73% compared to 45% in patients treated with standard care alone.
If granted breakthrough designation, which typically takes about 60 days for SFDA review, Multikine would become immediately available for patient access and sale in Saudi Arabia.
"This MOU and the filing for Breakthrough Medicine Designation mark a significant advancement for Multikine’s global regulatory, patient access/sale and commercial roll out," said CEL-SCI CEO Geert Kersten in the press release.
Several Saudi investment funds have expressed interest in Multikine and potential joint ventures to serve the broader Middle East and North Africa market, the company stated. This development comes as CEL-SCI faces financial challenges, with InvestingPro data showing a current ratio of 0.55 and negative EBITDA of $23.94 million in the last twelve months, highlighting the strategic importance of potential partnerships for the company’s future growth.
To qualify for the SFDA’s Breakthrough Medicine Program, a treatment must target serious or life-threatening conditions with unmet medical needs, offer advantages over current methods, demonstrate a positive benefit-risk balance, and not be registered with any regulatory authority at the time of submission.
Multikine previously received Orphan Drug designation from the U.S. Food and Drug Administration for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck.
In other recent news, CEL-SCI Corporation has successfully raised approximately $5.7 million through a best-efforts offering of 1.5 million shares of common stock, priced at $3.82 per share. This transaction was facilitated by ThinkEquity, acting as the sole placement agent. In addition, CEL-SCI has entered a partnership with a leading Saudi Arabian pharmaceutical company to advance the regulatory approval and commercialization of its cancer immunotherapy, Multikine, in Saudi Arabia. The Saudi partner plans to submit a Breakthrough Medicine Designation application to the Saudi Food and Drug Authority, which could expedite patient access and commercialization if approved. Furthermore, CEL-SCI has expressed support for the FDA’s recent approval of Merck’s Keytruda for treating certain head and neck cancers. This approval followed a priority review and was based on interim results from a Phase 3 trial. These developments reflect CEL-SCI’s ongoing efforts in the cancer treatment landscape.
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