Biomarker used to select patients who are more likely have favorable outcomes, supporting a successful confirmatory Registration Study Patients with low PD-L1 expression treated with Multikine in the target population had a 5-year survival of 73% vs. 45% in the control group in the prior randomized controlled Phase 3 study CEL-SCI Corporation (NYSE:CVM) today announced that in a recent meeting the U.S. Food and Drug Administration (FDA) concurred with the Company's approach to patient selection using low PD-L1 tumor expression in its confirmatory Registration Study for Multikine® (Leukocyte Interleukin, Injection)*. This study will focus on the treatment of newly diagnosed locally adva

Oncologic Drugs Advisory Committee (ODAC) determines risks outweigh benefits in some cancers for frontline immune checkpoint inhibitors, including blockbuster drugs such as Keytruda and Opdivo, in patients with low PD-L1 expression Multikine has shown survival benefit and favorable safety profile in a randomized controlled Phase 3 study of treatment naïve resectable locally advanced head and neck cancer patients with low PD-L1 expression Multikine has potential as a combination drug with current checkpoint inhibitors such as Keytruda which is projected to be the top selling drug in the world with $27 billion in 2024 sales To the Company's knowledge, Multikine is the only neoadjuvant

As a clinical research organization (CRO) Ergomed has a strong track record with CEL-SCI in fast enrolment and high quality study delivery CEL-SCI Corporation (NYSE:CVM) today announced its renewed collaboration with Ergomed Clinical Research for its upcoming U.S. Food and Drug Administration (FDA) confirmatory Registration Study of Multikine® (Leukocyte Interleukin, Injection) in head and neck cancer. Ergomed will provide global comprehensive clinical operations support to ensure the timely and efficient execution of the trial, supporting CEL-SCI in bringing a new treatment option for patients with locally advanced primary head and neck cancer to the market. This partnership marks a con

5-year survival rate of 82.6% and 73% reduction in overall risk of death (hazard ratio of 0.27) are the strongest Multikine efficacy results reported to date, reflecting results in patients who met the CEL-SCI confirmatory Registration Study target population criteria and were deemed at low risk for recurrence, therefore not recommended per NCCN guidelines to receive chemotherapy post-surgery Data provide further evidence that the selection criteria for CEL-SCI's upcoming confirmatory Registration Study may yield improved clinical outcomes Future advances in diagnostic technologies that improve patient selection, such as PET scans (which will be used in the confirmatory study), may fur

Data to be presented on Saturday, September 14 and published via a press release before the open of market on Monday, September 16 CEL-SCI Corporation (NYSE:CVM) today reported it will report new data from its Phase 3 study of Multikine (Leukocyte Interleukin, Injection)* at the European Society for Medical Oncology (ESMO) 2024 Congress which takes place from September 13 – 17, 2024 in Barcelona, Spain. A poster titled "Prognostic significance of diagnostic staging in treatment naïve, resectable locally advanced primary oral cavity squamous cell carcinoma for neoadjuvant Leukocyte Interleukin Injection immunotherapy" will be presented by the study's co-author József Tímár MD, PhD, DSc, a p

CEL-SCI Corporation (NYSE:CVM) today reported it has received a decision letter from the United Kingdom's Healthcare Products Regulatory Agency (MHRA) granting Multikine (Leukocyte Interleukin, Injection)* a product specific waiver for the treatment of head and neck cancer in a pediatric population of people up to 18 years of age. As a result, CEL-SCI will not be required to evaluate Multikine in a pediatric population as part of license and marketing clearance review in the UK. "While we prepare to commence our confirmatory FDA Registration Study of Multikine here in the U.S., and elsewhere, we are very pleased to receive continued positive responses from the UK's healthcare regulatory a

CEL-SCI Corporation (NYSE:CVM) today reported financial results for the quarter ended June 30, 2024, as well as key recent clinical and corporate developments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20240815767286/en/The table includes detailed results from the bias analysis. (Graphic: Business Wire) Clinical and Corporate Developments include: In July 2024, following the end of the third fiscal quarter, CEL-SCI reported the results of a bias analysis. The bias analysis, a standard process to ensure a trial's findings are reliable, was conducted in preparation for CEL-SCI's upcoming confirmatory Registration Study. This

CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE:CVM), a cancer immunotherapy company, today announced the closing of its previously announced best-efforts offering of 10,845,000 shares of its common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof). Each share of common stock (or Pre-Funded Warrant) was sold at an offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price), for gross proceeds of $10,845,000, before deducting placement agent fees and other offering expenses. All the shares and Pre-Funded Warrants in the offering were offered by the Company. The Company intends to use the net proceeds from the offering to fund the conti

CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE:CVM), a cancer immunotherapy company, today announced the pricing of a best-efforts offering of 10,845,000 shares of its common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof). Each share of common stock (or Pre-Funded Warrant) is being sold at an offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price). All of the shares and Pre-Funded Warrants in the offering are being offered by the Company. Total gross proceeds from the offering, before deducting the placement agent's fees and other offering expenses, are expected to be $10,845,000. The offering is expected to close on July 29, 20

Multikine, a true first-line cancer immunotherapy, cut the 5-year risk of death by half compared to control in its target population Bias analysis conducted in preparation for submission of data to regulatory agencies including the FDA for confirmatory registration study Detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrate balance between the treatment and control arms, no bias found, supporting confidence in Multikine's efficacy results CEL-SCI Corporation (NYSE:CVM) today reported positive results from a bias analysis conducted for its concluded Phase 3 study of Multikine (Leukocyte Interleukin, Injection)* in the treatment of he

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CEL-SCI Corporation (NYSE:CVM) today announced that Robert ("Bob") Watson, who has served as a Director of the Company since 2017, has been appointed Chairperson of the Board.Bob is an accomplished business leader who began his career as an investment banker. With over four decades of experience across various healthcare markets, Bob brings extensive expertise in capital formation strategies and partnerships to drive an efficient capital structure. During his career as CEO or President of private and publicly traded companies in the healthcare sector, Bob negotiated over a half dozen exits and more than $750 million in capital transactions including IPOs, secondary offerings, and debt instru

Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression in contrast to approved checkpoint inhibitors73% survival for Multikine vs 45% in the control arm at 5 yearsStatistically significant log rank p = 0.00155-year risk of death cut in half from 55% to 27%Hazard ratio = 0.35 (95% CIs [0.19, 0.66])Working to commence FDA confirmatory Registration Study for MultikineCEL-SCI Corporation (NYSE:CVM) today announced the Company's Chief Scientific Officer, Dr. Eyal Talor, delivered a presentation titled "Neoadjuvant Immunotherapy for Head and Neck Cancer: Low Tumor PD-L1 Expression - IT-MATTERS – RCT" at the International Drug Discovery Science

CEL-SCI (AMEX:CVM) reported quarterly losses of $(0.28) per share which missed the analyst consensus estimate of $(0.14) by 100 percent.

Gainers Zai Lab (NASDAQ:ZLAB) stock increased by 21.5% to $20.14 during Thursday's pre-market session. The market value of their outstanding shares is at $1.9 billion. As per the news, the Q1 earnings report came out yesterday. ZimVie (NASDAQ:ZIMV) shares moved upwards by 20.28% to $18.5. The market value of their outstanding shares is at $503.5 million. The company's, Q1 earnings came out yesterday. Aadi Bioscience (NASDAQ:AADI) shares moved upwards by 16.84% to $2.15. The company's market cap stands at $52.7 million. As per the press release, Q1 earnings came out yesterday. CEL-SCI (AMEX:CVM) shares moved upwards by 14.38% to $1.59. The company's market cap stands at $85.8 million. Ta

CEL-SCI Corp (NASDAQ:CVM) shares are trading higher by 18.6% to $1.98 during Wednesday’s session after the company received positive feedback from the FDA regarding their cancer immunotherapy, Multikine, for treating newly diagnosed advanced primary head and neck cancer patients. Based on strong safety and efficacy data from a Phase 3 study, the FDA agreed to a confirmatory Registration Study with only 212 participants. Multikine-treated patients in the prior study showed a significant 5-year survival benefit compared to the control group. The FDA accepted pre-surgical patient selection criteria and study design, recognizing the high unmet need for improved therapies in this populati

Critical milestone achieved—the FDA accepted CEL-SCI's selection criteria defining the Multikine target population before surgerySelected patient population had 73% survival with Multikine vs. 45% without Multikine based on analysis of completed 928-patient Phase 3 randomized controlled trial212-patient confirmatory study is de-risked, backed by robust efficacy and safety data from completed Phase 3 trial, the largest in advanced primary head and neck cancerView CEL-SCI's comprehensive report regarding the FDA's go-ahead and the Company's value proposition for investors here: https://cel-sci.com/wp-content/uploads/2024/05/CEL_SCI-Report-on-FDA-Path-Forward-May-2024-FINAL.pdfCEL-SCI Corporati

Gainers Repare Therapeutics (NASDAQ:RPTX) shares rose 34.1% to $4.4 during Wednesday's pre-market session. The company's market cap stands at $186.7 million. The company's, Q1 earnings came out yesterday. Enveric Biosciences (NASDAQ:ENVB) shares increased by 16.85% to $1.04. The company's market cap stands at $7.5 million. Clover Health Investments (NASDAQ:CLOV) stock increased by 16.21% to $0.86. The company's market cap stands at $426.3 million. As per the press release, Q1 earnings came out yesterday. Envoy Medical (NASDAQ:COCH) stock rose 13.88% to $3.28. The company's market cap stands at $64.2 million. Myriad Genetics (NASDAQ:MYGN) stock moved upwards by 13.75% to $22.5. The marke

CEL-SCI Corporation (NYSE:CVM) today issued a letter to its shareholders. This letter will be sent to the Company's shareholders along with the proxy to the upcoming annual meeting.Dear CEL-SCI Shareholders:Last year we successfully moved our investigational Multikine® (Leukocyte Interleukin, Injection)* cancer therapy forward on the clinical, manufacturing, and regulatory fronts by overcoming several challenges as the biotechnology sector went through very difficult times. The results from our Phase 3 trial presented us with a conundrum in that we had great survival data with Multikine as a pre-surgical treatment in head and neck cancer when followed by surgery and radiotherapy only, but no

CEL-SCI (AMEX:CVM) reported quarterly losses of $(0.14) per share. This is a 22.22 percent increase over losses of $(0.18) per share from the same period last year.