CVM - Why CEL-SCI (CVM) Shares Are Trading Higher | Benzinga

CEL-SCI Corp (NASDAQ:CVM) shares are trading higher by 18.6% to $1.98 during Wednesday’s session after the company received positive feedback from the FDA regarding their cancer immunotherapy, Multikine, for treating newly diagnosed advanced primary head and neck cancer patients.

Based on strong safety and efficacy data from a Phase 3 study, the FDA agreed to a confirmatory Registration Study with only 212 participants. Multikine-treated patients in the prior study showed a significant 5-year survival benefit compared to the control group.

The FDA accepted pre-surgical patient selection criteria and study design, recognizing the high unmet need for improved therapies in this population. With a de-risked value proposition, CEL-SCI aims to confirm the positive results in a smaller study and potentially add ...

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