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.

CEL-SCI Corporation (AMEX: CVM) announced its financial results for the quarter ending December 31, 2022. Key highlights include successful clinical outcomes for Multikine, with five patients achieving complete cancer clearance and 40 demonstrating significant tumor reduction. The company prepares to submit a Biologic License Application (BLA) to the FDA, as its Phase 3 study shows a median overall survival improvement of 46.5 months for Multikine patients. Financially, CEL-SCI reported a net operating loss of $7.7 million and $18 million in cash reserves.

CEL-SCI Corporation (NYSE American: CVM) reported fiscal year 2022 results, focusing on the submission of a Biologics License Application for its product, Multikine, targeting advanced primary head and neck cancer. The Phase 3 trial showed significant survival benefits, with a median overall survival improvement of 46.5 months. Financially, the company had a net operating loss of $36.1 million. As of September 30, 2022, CEL-SCI was holding $22.7 million in cash. Despite challenges, the company aims to expedite its regulatory submission and leverage positive trial outcomes.

CEL-SCI Corporation (NYSE American: CVM) announced significant progress regarding its investigational drug Multikine for treating locally advanced primary squamous cell carcinoma of the head and neck. The Phase 3 trial showed a median overall survival improvement of 46.5 months, with 62.7% of patients alive after five years. Multikine is positioned as a neoadjuvant therapy, unlike competitors’ treatments, which are for recurrent tumors. Despite challenges due to limited resources compared to larger firms, the company remains committed to advancing Multikine’s approval for patient benefit.