Retail Buzz Builds Around Cel-Sci Stock Ahead Of Saudi Ruling On Cancer Drug Multikine

Retail chatter picked up on Cel-Sci Corporation on Wednesday as investors awaited a key decision from the Saudi Food and Drug Authority (SFDA) on the company’s application for Breakthrough Medicine Designation for its cancer immunotherapy, Multikine. 

The ruling could come soon, as the SFDA’s 60-day review window is nearing its close.

In August, Cel-Sci signed a Memorandum of Understanding with a leading Saudi pharmaceutical company, which submitted the application to the SFDA. A final commercialization agreement between the two partners is expected in the third quarter of 2025. The Saudi partner is also expected to facilitate reimbursement and accelerate Multikine’s sale and patient access in the Kingdom.

The move has drawn growing interest from Saudi investment funds looking to back Multikine and Cel-Sci’s expansion across the Middle East and North Africa region.

Multikine is designed to strengthen a patient’s immune system before surgery for newly diagnosed, untreated head and neck cancer. In a global Phase 3 study, the largest of its kind, the therapy improved five-year survival rates to 73% from 45% among patients receiving standard care alone, cutting the risk of death by half.

If approved, Multikine would qualify for accelerated patient access and reimbursement under Saudi Arabia’s Breakthrough Medicine Program, which aims to fast-track treatments for serious or life-threatening diseases that meet unmet medical needs.

On Stocktwits, retail sentiment was ‘extremely bullish’ amid ‘high’ message volume.

One user noted that Cel-Sci’s April update indicated the company was encouraged to seek conditional approval under the Breakthrough Therapy Designation. The filing was made around mid-August, suggesting a decision could be imminent.

Another user expressed anticipation for an update from CEO Geert Kersten, while a third observed that the stock might remain subdued until the SFDA announcement.

CEL-SCI Corporation’s stock has declined 18% so far in 2025.

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