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VIENNA - CEL-SCI Corporation (NYSE American: CVM), a small-cap biotech company with a market capitalization of approximately $12 million, on Wednesday welcomed the FDA’s approval of Merck’s Keytruda for treating adult patients with resectable locally advanced head and neck squamous cell carcinoma whose tumors express PD-L1. The company’s stock, which InvestingPro data shows has declined over 93% in the past year, is currently trading near its 52-week low.
The FDA granted Merck’s application priority review on February 25, 2025, with approval following on June 13, 2025, based on interim results from Keytruda’s Phase 3 KEYNOTE-689 trial.
According to the press release, Keytruda reduced the risk of recurrence and progression by 30% compared to standard care in patients with PD-L1 expression, though it did not demonstrate improvement in overall survival. The treatment benefits patients whose tumors express PD-L1 at a positive level, but not those with low to zero levels.
In contrast, CEL-SCI reported that its Multikine treatment showed a 66% reduction in death risk for patients with low to zero PD-L1 expression in its own Phase 3 study, extending 5-year overall survival to 73% compared to 45% with standard care. The company noted that approximately 70% of patients in their study had low to zero PD-L1 levels.
CEL-SCI CEO Geert Kersten stated that Keytruda’s approval based on pre-specified interim results suggests potential for accelerated regulatory approval for Multikine. The FDA has authorized CEL-SCI to conduct a confirmatory Registration Study with 212 patients based on results from their completed Phase 3 study. According to InvestingPro analysis, while the company faces challenges with cash burn and weak financial health scores, analysts maintain notably optimistic price targets, suggesting significant potential upside if the treatment succeeds. InvestingPro subscribers can access 15 additional key insights about CEL-SCI’s financial position and market performance.
Multikine, administered after diagnosis but before surgery, has received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma of the head and neck. Despite current financial challenges, including a current ratio of 0.55 indicating liquidity concerns, InvestingPro’s Fair Value analysis suggests the stock may be undervalued at current levels.
The information in this article is based on a press release from CEL-SCI Corporation.
In other recent news, CEL-SCI Corporation has announced an underwritten public offering of its common stock, with proceeds aimed at supporting the development of its Multikine therapy. The offering’s completion and terms are subject to market conditions, with ThinkEquity serving as the sole book-running manager. Additionally, CEL-SCI is seeking Breakthrough Medicine Designation for Multikine with the Saudi Food and Drug Authority (SFDA) to expedite patient access in Saudi Arabia. The company is also preparing a regulatory filing for Conditional Approval of Multikine in Saudi Arabia, following positive Phase 3 study results.
Moreover, CEL-SCI’s Board of Directors has approved a 1-for-30 stock combination, converting every 30 shares into one, to potentially increase investment interest. The company is preparing for a confirmatory Registration Study, with the aim to enroll 212 patients with resectable head and neck cancer. These developments come as CEL-SCI explores local manufacturing and distribution partnerships in the Middle East and North Africa region. Multikine has been administered to over 740 patients and holds Orphan Drug designation from the FDA.
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