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.
CEL-SCI (NYSE American: CVM), a cancer immunotherapy company, has closed a $10.8 million offering of 10,845,000 shares of common stock (or pre-funded warrants) at $1.00 per share. The company plans to use the net proceeds to fund the development of Multikine, its lead investigational therapy, as well as for general corporate purposes and working capital. ThinkEquity acted as the sole placement agent for this best-efforts offering. CEL-SCI is preparing to commence a confirmatory trial for Multikine, with enrollment expected to begin in Q4 2024. The company's focus remains on activating the immune system to fight cancer and infectious diseases.
CEL-SCI (NYSE American: CVM), a cancer immunotherapy company, has announced the pricing of a $10.8 million offering of 10,845,000 shares of common stock (or pre-funded warrants) at $1.00 per share. The offering, expected to close on July 29, 2024, aims to fund the development of Multikine, their lead investigational therapy, and general corporate purposes. ThinkEquity is acting as the sole placement agent for this best-efforts offering. CEL-SCI's Multikine has completed a pivotal Phase 3 clinical trial for head and neck cancer and received Orphan Drug Status from the FDA. The company plans to commence a confirmatory trial for Multikine, with enrollment expected to begin in Q4 2024.
CEL-SCI (NYSE American: CVM) reported positive results from a bias analysis for its Phase 3 study of Multikine in head and neck cancer treatment. The analysis showed no bias in the study, with comparable demographics and baseline characteristics between Multikine-treated and control arms. This supports the reliability of the study data, which demonstrated Multikine's efficacy in extending patient life.
Key findings include:
- 5-year survival rate of 73% in Multikine-treated patients vs. 45% in control group for the target population
- Hazard ratio of 0.35 with an upper limit of 0.66, suggesting a high chance of repeating the survival benefit
- No confounding baseline parameters detected
CEL-SCI is preparing to submit data to regulators for a 212-patient confirmatory registration study, agreed upon with the FDA.
CEL-SCI (NYSE American: CVM) has appointed Robert Watson as Chairperson of the Board. Watson, who joined the board in 2017, has an extensive background in the healthcare sector, particularly in capital formation and partnerships. He has facilitated over $750 million in transactions throughout his career.
Watson's appointment comes at a pivotal moment for CEL-SCI, as the company prepares for a confirmatory Registration Study for its immunotherapy drug, Multikine. The FDA approved this study based on positive efficacy and safety data from over 750 patients. Multikine showed a 73% survival rate compared to 45% in the control group at five years post-treatment.
The forthcoming study will enroll 212 patients with advanced primary head and neck cancer, a condition impacting an estimated 100,000 patients annually. Watson expressed confidence in confirming the drug’s efficacy and safety, emphasizing his commitment to CEL-SCI’s mission.
CEL-SCI announced promising data for its investigational drug Multikine at the IDDST Annual Congress in Budapest. Dr. Eyal Talor presented findings showing that Multikine significantly improves overall survival in head and neck cancer patients with low PD-L1 expression levels. Specifically, the 5-year survival rate for Multikine-treated patients was 73%, compared to 45% in the control group. The hazard ratio was 0.35, indicating a 5-year death risk reduction from 55% to 27%. The company is planning a confirmatory FDA registration study.
CEL-SCI announced that Dr. Giovanni Selvaggi, a renowned oncology expert, has joined as a Clinical Advisor. Dr. Selvaggi has been pivotal in the approval of lung cancer drugs such as Zykadia and Opdivo. CEL-SCI's Multikine immunotherapy has shown significant efficacy in head and neck cancer, improving 5-year survival to 73% compared to 45% in controls. The FDA has approved a confirmatory Registration Study for Multikine. Dr. Selvaggi will support CEL-SCI in navigating this trial, aiming for regulatory approval.
CEL-SCI (NYSE American: CVM) reported its Q2 fiscal 2024 financial results. Key clinical and corporate developments included FDA approval for a confirmatory Registration Study of Multikine in head and neck cancer, following strong Phase 3 results with a 28% survival benefit at 5 years. The new study will enroll 212 patients.
Financial highlights for the period ending March 31, 2024: R&D expenses decreased by $2.5M to $9M, G&A expenses increased slightly to $4.6M, and net loss narrowed by $2.2M to $14M. CEL-SCI also raised $7.75M through a public stock offering. Other notable developments: completion of a state-of-the-art manufacturing facility and a key waiver from the European Medicines Agency for Multikine's commercialization in Europe.
CEL-SCI has received FDA approval for a confirmatory study of its cancer immunotherapy Multikine for head and neck cancer patients, based on strong Phase 3 data showing a 73% survival rate with Multikine. The study will enroll 212 patients and aims to confirm the results of the Phase 3 trial, paving the way for potential approval. The FDA acknowledged the unmet need for improved therapies in this patient population, supporting approval for Multikine.
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