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CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended June 30, 2023, along with key clinical and corporate developments. Health Canada advised CEL-SCI to request advance consideration for approval under a Notice of Compliance with Conditions (NOCC) policy, potentially leading to commercialization in 2024. Europe is a priority market for CEL-SCI, seeking conditional marketing authorization for Multikine. The FDA acknowledged the need for improved treatments for head and neck cancer, showing potential for close collaboration with CEL-SCI.
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CEL-SCI Corporation closes public offering, raising $5 million for cancer immunotherapy development
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CEL-SCI Corporation has announced the pricing of an underwritten public offering of 2,500,000 shares of its common stock at a price of $2.00 per share, resulting in gross proceeds of $5,000,000. The offering is expected to close on July 20, 2023, and the net proceeds will be used for the development of Multikine* and general corporate purposes.
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CEL-SCI Corporation plans to sell shares of its common stock in an underwritten public offering. The offering is subject to market conditions and the company intends to use the proceeds for the development of Multikine* and general corporate purposes.
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CEL-SCI announces productive meeting with FDA regarding path forward for Multikine immunotherapy for head and neck cancer treatment. FDA acknowledges need for improved treatments. CEL-SCI preparing additional information for next meeting with FDA. Scientific advice meetings planned with EMA and MHRA in fall 2023. Health Canada advises CEL-SCI to request advance consideration for approval. Geert Kersten, CEO of CEL-SCI, highlights positive results of Multikine treatment.
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CEL-SCI Corporation announced new data from a biomarker analysis of its Phase 3 study, showing that Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression. The data suggests that Multikine can be effective in extending life in patients who are generally not well served by checkpoint inhibitors. CEL-SCI has filed a patent for the use of Multikine in tumor expressing low levels of PD-L1.
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CEL-SCI Corporation presented the latest results from its Phase 3 study of Multikine at the ESTRO 2023 Congress. The study showed improved 5-year survival, progression-free survival, and local regional control in Multikine-treated subjects compared to control subjects. The tumor and tumor microenvironment changes induced by Multikine explain the positive outcomes seen. CEL-SCI plans to file for regulatory approval in the U.S., Canada, and Europe.
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CEL-SCI Corporation
NYSE:CVM
CVM Rankings
CVM Stock Data
68.55M
48.49M
3.2%
12.44%
12.69%
Biological Product (except Diagnostic) Manufacturing
Manufacturing
United States of America
VIENNA
About CVM
cel-sci corporation engages in the research and development of immunotherapy for the treatment of cancer and infectious diseases. the company's lead investigational immunotherapy is multikine, which is under phase iii clinical trial for the treatment of head and neck cancer. its ligand epitope antigen presentation system (leaps), a pre-clinical patented t-cell modulation process that stimulates the human immune system to fight bacterial, viral, and parasitic infections, as well as autoimmune diseases, allergies, transplantation rejections, and cancer. the company also develops leaps-h1n1-dc; cel-2000 and cel-4000 are product candidates for the treatment of rheumatoid arthritis; and leaps cov-19, a product candidate to treat covid-19 coronavirus. cel-sci corporation has a collaboration agreement with the university of georgia's center for vaccines and immunology to develop leaps covid-19 immunotherapy. the company was founded in 1983 and is headquartered in vienna, virginia.