Welcome to our dedicated page for CEL-SCI news (Ticker: CVM), a resource for investors and traders seeking the latest updates and insights on CEL-SCI stock.
CEL-SCI Corporation (NYSE American: CVM) is a clinical stage cancer immunotherapy company whose news flow centers on the development, financing, and regulatory progress of its lead investigational product, Multikine (Leukocyte Interleukin, Injection). As a developer of biological products for head and neck cancer, CEL-SCI regularly issues updates on clinical plans, regulatory interactions, and capital markets activity that are relevant to investors and observers of the biotechnology sector.
News releases from CEL-SCI highlight key milestones for Multikine, including the completed Phase 3 study in head and neck cancer, the FDA’s concurrence on target patient selection criteria, and preparations for a 212-patient confirmatory Registration Study in newly diagnosed locally advanced head and neck cancer patients with specific PD-L1 and lymph node characteristics. The company also reports on efforts to seek early approval in the U.S. based on pre-surgical tumor response data and cites third-party scientific publications that support its development strategy.
CEL-SCI’s news coverage features international regulatory developments, particularly in the Kingdom of Saudi Arabia. The company has announced the filing of a Breakthrough Medicine Designation application for Multikine with the Saudi Food and Drug Authority through a local pharmaceutical partner, a Memorandum of Understanding for commercialization in Saudi Arabia, and growing interest from Saudi investment funds and potential joint ventures aligned with Saudi Arabia’s Vision 2030 and National Biotechnology Strategy.
In addition, CEL-SCI issues frequent updates on public offerings of common stock, including pricing and closing announcements, and related Form S-3 shelf registration usage. These items provide insight into how the company funds the continued development of Multikine, as well as its general corporate purposes and working capital. Visitors to this news page can review a chronological record of CEL-SCI’s clinical, regulatory, partnership, and financing announcements related to CVM.
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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
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.
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