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CEL-SCI Corporation develops cancer immunotherapy programs centered on Multikine (Leukocyte Interleukin, Injection), an investigational neoadjuvant therapy for squamous cell carcinoma of the head and neck. Company news commonly covers Multikine regulatory interactions, FDA Orphan Drug designation for neoadjuvant use, confirmatory registration-study preparation, and the company's positioning of the therapy before surgery, radiation, and chemotherapy.
Updates also include financial results, public equity offerings used to fund Multikine development, investor presentations, and regional commercialization or regulatory-affairs agreements, including activity in Saudi Arabia. CEL-SCI's disclosures often connect clinical development with working-capital needs and potential international market access.
CEL-SCI Corporation (NYSE American: CVM) has issued a letter to shareholders emphasizing its investigational cancer immunotherapy, Multikine. The company aims to improve survival rates for head and neck cancer through early immune system activation before conventional treatments. It is finalizing results from a pivotal Phase 3 study, which has taken nearly a decade to complete. The letter highlights the complexity of the study, including past challenges with a CRO, and reassures stakeholders of ongoing FDA oversight and positive expectations for Multikine's efficacy.
CEL-SCI Corporation (CVM) reported its fiscal year 2020 results, highlighting key developments in its Phase 3 study of Multikine for head and neck cancer. The study reached a crucial milestone with 298 events, leading to data analysis. The company raised approximately $25.8 million in 2020 and an additional $14.7 million post-fiscal year. However, CEL-SCI recorded a net loss of $30.3 million, up from $22.1 million in 2019, primarily due to increased R&D and administrative expenses. The company is also advancing LEAPS immunotherapy for COVID-19 and rheumatoid arthritis.
CEL-SCI Corporation (NYSE American: CVM) announced its presentation at the 13th Annual LD Micro Main Event Conference on December 15, 2020, at 10:00 a.m. ET, featuring CEO Geert Kersten. The virtual presentation will include a 10-minute overview followed by a Q&A session. CEL-SCI's Phase 3 study of its investigational product, Multikine, aims to treat newly diagnosed advanced primary squamous cell carcinoma of the head and neck. It is noted as the largest Phase 3 study of its kind, fully enrolled with 928 patients. The study is currently in the statistical analysis phase.
CEL-SCI Corporation (NYSE American:CVM) announced its participation at the LD 500 investor conference on September 2, 2020, at 10:20 a.m. ET. CEO Geert Kersten will present to a virtual audience, with a live audio webcast available. CEL-SCI is conducting a Phase 3 study of Multikine for advanced primary squamous cell carcinoma of the head and neck, uniquely administering it before conventional therapies. The study has enrolled 928 patients, and data analysis is currently underway following 298 survival events in April 2020.