CEL-SCI Corp Stock Price, News & Analysis

CEL-SCI Corporation (NYSE American: CVM) has successfully conducted a pre-submission meeting with Health Canada to discuss regulatory pathways for its investigational immunotherapy, Multikine. The company aims to secure marketing approval in Canada and other countries while preparing its Biologics License Application for the U.S. FDA. Health Canada advised CEL-SCI on pursuing a Notice of Compliance with Conditions policy, enabling earlier access for patients with serious conditions. Results from the Phase 3 IT-MATTERS study show Multikine's significant potential in improving survival rates for head and neck cancer patients.

CEL-SCI Corporation (CVM) recently presented pivotal Phase 3 study data at the 10th European Congress on Head & Neck Oncology. The study focused on its investigational therapy, Multikine, for newly diagnosed locally advanced squamous cell carcinoma of the head and neck. Key findings show that Multikine added to standard care significantly improves overall survival rates: 65.3% for treated patients versus 49.7% for controls after five years. The company plans to submit a Biologics License Application to the FDA for regulatory approval based on results involving 352 patients. The study highlights the potential of Multikine in enhancing treatment outcomes for this patient population.

CEL-SCI Corporation (NYSE American: CVM) announced that it will present new data from its pivotal Phase 3 study on March 8, 2023, at the 10th European Congress on Head & Neck Oncology in Lisbon, Portugal. The study, the largest ever for newly diagnosed locally advanced squamous cell carcinoma of the head and neck, involved 928 patients and aimed to assess the investigational product Multikine before standard treatments. Multikine, which received Orphan Drug designation from the FDA, seeks to harness the immune system's potential before conventional therapies. A summary of the findings will be published after the presentation.