Ultime notizie per CEL-SCI (AMEX:CVM) Azioni

CEL-SCI

CEL-SCI Corp is a player in the biotechnology sector. It is engaged in the research and development at developing the treatment of cancer and other diseases by using the immune system. The Company's core capabilities that include are drug discovery, research, development and manufacturing of complex biological substances. It is focused on the development of Multikine (Leukocyte Interleukin, Injection), investigational immunotherapy under development for the treatment of certain head and neck cancers, and anal warts or cervical dysplasia.

CEL-SCI Corp

Morgan Stanley ETF Trust Calvert US Mid-Cap Core Responsible Index ETF

Sila Realty Trust Inc Ordinary Shares - Class A

Sila Realty Trust Inc Ordinary Shares - Class T

News

CEL-SCI And U.S. FDA Approve Use Of PD-L1 Biomarker To Select Head And Neck Cancer Patients For Multikine Registration Study, Targeting Low PD-L1 Expression Patients With 5-Year Survival Rates Of 73%; Study Set To Begin Q1 2025

<ul>
<li>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</li>
<li>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</li>
<li>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 <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.statista.com%2Fstatistics%2F973523%2Ftop-drugs-by-year-on-year-sales-increase%2F%23%3A%7E%3Atext%3DKeytruda%2520is%2520projected%2520to%2520be%2Cthan%252027%2520billion%2520U.S.%2520dollars.&amp;esheet=54139913&amp;newsitemid=20241021000924&amp;lan=en-US&amp;anchor=%2427+billion&amp;index=1&amp;md5=df83c0b582408bd76ecc1c7fee8d4c20">$27 billion</a> in 2024 sales</li>
<li>To the Company's knowledge, Multikine is the only neoadjuvant immunotherapy that has shown overall survival benefit in the low and negative PD-L1 head and neck cancer population</li>
</ul>
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fcel-sci.com%2F&amp;esheet=54139913&amp;newsitemid=20241021000924&amp;lan=en-US&amp;anchor=CEL-SCI+Corporation&amp;index=2&amp;md5=68ef23ce754be1ace196803245ed0a4a">CEL-SCI Corporation</a> (NYSE:<a href="https://www.benzinga.com/stock/CVM#NYSE">CVM</a>) today announced the potential positive impact on the clinical development of its immunotherapy Multikine&#xAE; (Leukocyte Interleukin, Injection)&#x2A; resulting from a recent U.S. Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.fda.gov%2Fadvisory-committees%2Fadvisory-committee-calendar%2Fseptember-26-2024-meeting-oncologic-drugs-advisory-committee-meeting-announcement-09262024&amp;esheet=54139913&amp;newsitemid=20241021000924&amp;lan=en-US&amp;anchor=meeting&amp;index=3&amp;md5=ae1bd361b36091a7bf7484e1dbf4a939">meeting</a>, a public forum.
FDA advisory committees provide independent expert advice to the FDA on the safety and effectiveness of new and marketed drugs and help the agency make sound and informed decisions. Advisory committees make non-binding recommendations to the FDA, which generally follows the recommendations but is not legally bound to do so.
The September 27, 2024 ODAC meeting evaluated the use of checkpoint inhibitors on patients with various cancers. PD-L1 is the biomarker most often used for patient selection for checkpoint inhibitors, the most successful class of cancer drugs including Keytruda and Opdivo. The FDA sought the ODAC's opinion on the following:
<ul>
<li>adequacy of PD-L1 expression as a predictive biomarker for patient selection in this patient population</li>
<li>differing risk-benefit assessments in different subpopulations defined by PD-L1 expression</li>
<li>adequacy of the cumulative data to restrict the approvals of immune checkpoint inhibitors based on PD-L1 expression</li>
</ul>
Following a thorough analysis of peer-reviewed published data, the panel of experts on the ODAC voted 10-2 and 11–1 against the risk-benefit profile for PD-L1 inhibitors in various cancers in two separate votes. Most ODAC members expressed concerns about the lack of benefit demonstrated for patients with low PD-L1 expression, while some members pointed to evidence that the use of the immune checkpoint inhibitors may add unnecessary toxicities for patients while also increasing financial burdens on patients.
Checkpoint inhibitors were an estimated $48 billion global market in 2023, with PD-L1 inhibitors representing 73% of the market. Current labeling for approved checkpoint inhibitors in the indications evaluated by the FDA's ODAC include broad approvals for all patients, regardless of PD-L1 expression.

Biotech

General

CEL-SCI Announces The Potential Impact On The Clinical Development Of Its Immunotherapy Multikine Resulting From A Recent U.S. FDA Oncologic Drugs Advisory Committee Meeting; 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

Contracts

CEL-SCI Reveals Renewed Collaboration With Ergomed Clinical Research For Its Upcoming FDA Confirmatory Registration Study Of Multikine In Head And Neck Cancer

<ul>
<li>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</li>
<li>Data provide further evidence that the selection criteria for CEL-SCI's upcoming confirmatory Registration Study may yield improved clinical outcomes</li>
<li>Future advances in diagnostic technologies that improve patient selection, such as PET scans (which will be used in the confirmatory study), may further optimize patient selection and Multikine's already strong efficacy results from the current 5-year Overall Survival at 73% up into the 82% range</li>
<li>Clear unmet need: the 5-year survival rate remains below 50% in locally advanced resectable head and neck cancer patients who receive standard of care only</li>
</ul>

Health Care

CEL-SCI Reported New Data From Its Concluded Phase 3 Study Of Multikine (Leukocyte Interleukin, Injection) Presented At The European Society For Medical Oncology, Showing An Increased 5-year Survival Rate To 82.6% In Locally Advanced Resectable Head & Neck Cancer Patients

Events

CEL-SCI To Present Data for Multikine Head & Neck Cancer Immunotherapy At ESMO 2024 Congress

<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fcel-sci.com%2F&amp;esheet=54117012&amp;newsitemid=20240904760257&amp;lan=en-US&amp;anchor=CEL-SCI+Corporation&amp;index=1&amp;md5=bf2ea8e6dbdf9278cbb1ddd2f71b7426">CEL-SCI Corporation</a> (NYSE:<a href="https://www.benzinga.com/stock/CVM#NYSE">CVM</a>) today reported it has received a decision letter from the United Kingdom's Healthcare Products Regulatory Agency (MHRA) granting Multikine (Leukocyte Interleukin, Injection)&#x2A; 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.

Global

The UK's MHRA Grants CEL-SCI's Multikine A Product Specific Waiver For The Treatment Of Head And Neck Cancer In A Pediatric Population Of People Up To 18 Years Of Age

CEL-SCI (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/CVM#AMEX">CVM</a>) reported quarterly losses of $(0.14) per share which missed the analyst consensus estimate of $(0.11) by 27.27 percent.

Earnings

Earnings Misses

CEL-SCI Q3 2024 Adj EPS $(0.14) Misses $(0.11) Estimate

Shares of Saia, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SAIA#NASDAQ">SAIA</a>) fell sharply during Friday's session after the company reported worse-than-expected <a href="https://www.benzinga.com/quote/SAIA/earnings">second-quarter financial results</a>.
Saia reported quarterly earnings of $3.83 per share which missed the analyst consensus estimate of $4.00 per share. The company reported quarterly sales of $823.24 million which missed the analyst consensus estimate of $826.55 million, according to data from <a href="https://pro.benzinga.com/dashboard">Benzinga Pro</a>.
Saia shares dipped 18.6% to $398.01 on Friday.
Here are some other stocks moving in today&#8217;s mid-day session.
<h3 class="wp-block-heading">Gainers</h3>
<ul>
<li>BurgerFi International, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BFI#NASDAQ">BFI</a>) gained 117.4% to $0.4639 after the company announced it reached a legal settlement agreement with Lion Point Capital. The company agreed to pay $1,350,000 and issue Lion Point 300,000 of preferred stock.</li>
<li>Windtree Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/WINT#NASDAQ">WINT</a>) shares jumped 101.3% to $6.67 after the company filed a request for the withdrawal of its registration statement on a Form S-1.</li>
<li>Regencell Bioscience Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGC#NASDAQ">RGC</a>) gained 53% to $13.94.</li>
<li>Coursera, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/COUR#NYSE">COUR</a>) shares gained 46.2% to $10.83 after the company beat second-quarter earnings estimates.</li>
<li>Carbon Revolution Public Limited Company (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CREV#NASDAQ">CREV</a>) shares climbed 43.3% to $8.84. Carbon Revolution said it will supply the carbon fiber wheels available on the just-revealed Chevrolet Corvette ZR1.</li>
<li>Everi Holdings Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EVRI#NYSE">EVRI</a>) rose 41.1% to $12.93 after it entered an agreement to be acquired by funds managed by Apollo affiliates for $14.25 per share in cash.</li>
<li>Nauticus Robotics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KITT#NASDAQ">KITT</a>) gained 37% to $4.45.</li>
<li>Newell Brands Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NWL#NASDAQ">NWL</a>) jumped 36.6% to $8.66 on better-than-expected second-quarter earnings and raising FY24 outlook.</li>
<li>Sangamo Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SGMO#NASDAQ">SGMO</a>) gained 35% to $0.9043.</li>
<li>CEL-SCI Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVM#NYSE">CVM</a>) rose 28% to $1.55 after the company announced results from a bias analysis conducted for its concluded Phase 3 study of Multikine. Multikine cut the 5-year risk of death by half compared to control in its target population.</li>
<li>AudioEye, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AEYE#NASDAQ">AEYE</a>) rose 25% to $24.52 following second-quarter results.</li>
<li>Pineapple Financial Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PAPL#NYSE">PAPL</a>) gained 24.4% to $1.1760. Pineapple Financial CSO Christa Lillian Mitchell bought a total of 2,000 shares at an average price of $0.88.</li>
<li>Douglas Elliman Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DOUG#NYSE">DOUG</a>) climbed 23% to $1.66.</li>
<li>CareMax, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CMAX#NASDAQ">CMAX</a>) rose 19% to $6.71.</li>
<li>Liberty Broadband Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LBRDA#NASDAQ">LBRDA</a>) rose 17.6% to $65.16.</li>
<li>Charter Communications, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CHTR#NASDAQ">CHTR</a>) jumped 17% to $368.65 after the company reported better-than-expected second-quarter financial results.</li>
<li>Mohawk Industries, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MHK#NYSE">MHK</a>) gained 16.5% to $156.70 following mixed second-quarter earnings.</li>
<li>Karooooo Ltd (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KARO#NASDAQ">KARO</a>) gained 16% to $33.40. Karooooo announced termination of secondary public offering of ordinary shares due to market conditions.</li>
<li>3M Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MMM#NYSE">MMM</a>) climbed 15% to $118.99 after better-than-expected second-quarter financial results and FY24 EPS outlook raise.</li>
<li>International Game Technology PLC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IGT#NYSE">IGT</a>) gained 13.4% to $22.86 after the company entered an agreement for its Gaming &amp; Digital business to be acquired by funds managed by affiliates of Apollo.</li>
<li>Altice USA, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ATUS#NYSE">ATUS</a>) rose 12.1% to $1.76.</li>
<li>Stardust Power Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SDST#NASDAQ">SDST</a>) rose 11% to $15.06.</li>
<li>Avantor, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AVTR#NYSE">AVTR</a>) surged 11% to $25.32 after the company reported better-than-expected second-quarter earnings results.</li>
<li>Norfolk Southern Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NSC#NYSE">NSC</a>) gained 10.7% to $246.86 after the company reported better-than-expected second-quarter earnings results.</li>
<li>Selina Hospitality PLC (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLNA#NASDAQ">SLNA</a>) shares gained 10.4% to $0.0415 after falling over 17% on Thursday.</li>
<li>Viasat, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VSAT#NASDAQ">VSAT</a>) rose 9% to $20.58. Viasat announced new reporting segment structure.</li>
<li>Deckers Outdoor Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DECK#NYSE">DECK</a>) shares gained 8.7% to $914.71 as the company reported better-than-expected results for the first quarter. The company said it still expects net sales to increase approximately 10% year-over-year in fiscal year 2025 to $4.7 billion.</li>
<li>Bristol-Myers Squibb Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) climbed 7.6% to $48.69 following strong second-quarter earnings and increased 2024 guidance.</li>
<li>Centene Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CNC#NYSE">CNC</a>) climbed 7.6% to $72.55 following better-than-expected second-quarter financial results and increased 2024 guidance.</li>
<li>Columbia Banking System, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/COLB#NASDAQ">COLB</a>) rose 7.4% to $25.98 after the company reported better-than-expected quarterly earnings results. Also, multiple firms raised their respective price targets on its stock.</li>
<li>Aon plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AON#NYSE">AON</a>) gained 6.8% to $319.30 after the company reported better-than-expected quarterly revenue results.</li>
<li>Ultra Clean Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/UCTT#NASDAQ">UCTT</a>) shares gained 4.7% to $47.26 following better-than-expected quarterly results.</li>
</ul>
<h3 class="wp-block-heading">Losers</h3>
<ul>
<li>NovaBay Pharmaceuticals, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NBY#NYSE">NBY</a>) shares dipped 59.6% to $0.7830 after the company reported pricing of $3.5 million underwritten public offering.</li>
<li>Tantech Holdings Ltd (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TANH#NASDAQ">TANH</a>) fell 46.9% to $0.2603.</li>
<li>Nature&#8217;s Miracle Holding Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NMHI#NASDAQ">NMHI</a>) fell 46.4% to $0.2099 after the company announced pricing of $1.2 million public offering.</li>
<li>DexCom, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DXCM#NASDAQ">DXCM</a>) shares declined 40.7% to $63.97 after the company reported worse-than-expected second-quarter revenue results and issued weak FY24 revenue guidance.</li>
<li>Predictive Oncology Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/POAI#NASDAQ">POAI</a>) fell 29.6% to $1.3150. Predictive Oncology announced exercise of warrants for $1.26 million gross proceeds.</li>
<li>ProMIS Neurosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PMN#NASDAQ">PMN</a>) declined 29.2% to $1.5006 as the company reported top-line data from its Phase 1a Alzheimer&#8217;s trial and announced up to $122.7 million private placement financing.</li>
<li>PS International Group Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PSIG#NASDAQ">PSIG</a>) dipped 26.1% to $1.53</li>
<li>Grom Social Enterprises, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GROM#NASDAQ">GROM</a>) fell 23.8% to $0.2751.</li>
<li>Ocean Power Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/OPTT#NASDAQ">OPTT</a>) shares declined 23.2% to $0.3188 after reporting fourth-quarter results.</li>
<li>Avinger, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVGR#NASDAQ">AVGR</a>) fell 20.2% to $1.30.</li>
<li>Next Technology Holding Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NXTT#NASDAQ">NXTT</a>) declined 20.1% to $1.6299.</li>
<li>Zynex, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZYXI#NASDAQ">ZYXI</a>) shares fell 18.9% to $8.27 after the company reported worse-than-expected second-quarter financial results.</li>
<li>2U, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TWOU#NASDAQ">TWOU</a>) declined 17.6% to $1.24.</li>
<li>Ur-Energy Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/URG#NYSE">URG</a>) shares dipped 13.4% to $1.1250 after the company announced a proposed public offering of common shares.</li>
<li>BJ&#8217;s Restaurants, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BJRI#NASDAQ">BJRI</a>) fell 12.6% to $32.53 following quarterly results.</li>
<li>Booz Allen Hamilton Holding Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BAH#NYSE">BAH</a>) declined 11.8% to $135.36 following a first-quarter earnings miss and soft EPS guidance.</li>
<li>Advent Technologies Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ADN#NASDAQ">ADN</a>) shares fell 11.2% to $4.40 after gaining 3% on Thursday.</li>
<li>Tarsus Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TARS#NASDAQ">TARS</a>) fell 9.1% to $25.67.</li>
<li>World Acceptance Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/WRLD#NASDAQ">WRLD</a>) dipped 7.8% to $134.62 following weak quarterly sales.</li>
<li>Forward Air Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FWRD#NASDAQ">FWRD</a>) fell 7.4% to $25.61.</li>
<li>Olin Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/OLN#NYSE">OLN</a>) shares declined 7.2% to $44.56 following a second-quarter earnings miss.</li>
<li>Carter&#8217;s, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CRI#NYSE">CRI</a>) shares fell 6.6% to $55.87 following weak quarterly sales.</li>
<li>Biogen Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BIIB#NASDAQ">BIIB</a>) declined 6.3% to $213.01 after the European Medicines Agency adopted a negative opinion on the Marketing Authorization Approval for lecanemab.</li>
<li>Tandem Diabetes Care, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNDM#NASDAQ">TNDM</a>) shares fell 6% to $38.18. Tandem Diabetes Care will release its second quarter results after the closing bell on Thursday, Aug. 1.</li>
<li>L3Harris Technologies, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LHX#NYSE">LHX</a>) declined 4.6% to $232.05 following second-quarter results.</li>
</ul>
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Intraday Update

Markets

Movers

Trading Ideas

AEYE

ATUS

AVGR

AVTR

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BJRI

CHTR

CMAX

COLB

COUR

CREV

DECK

DOUG

DXCM

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FWRD

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KARO

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LBRDA

NMHI

Next Technology Holding Inc. - Ordinary Shares

NXTT

OPTT

PAPL

POAI

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SDST

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TANH

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TNDM

TWOU

UCTT

VSAT

WINT

WRLD

ZYXI

Why Saia Shares Are Trading Lower? Here Are Other Stocks Moving In Friday's Mid-Day Session

CEL-SCI Shares Resume Trade

CEL-SCI Shares Halted On Code News Pending

CEL-SCI Corporation (&quot;CEL-SCI&quot; or the &quot;Company&quot;) (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/cvm#NYSE">CVM</a>), 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 (&quot;Pre-Funded Warrants&quot;) 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&#39;s fees and other offering expenses, are expected to be $10,845,000. The offering is expected to close on July 29, 2024, subject to satisfaction of customary closing conditions.
The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital.
ThinkEquity is acting as sole placement agent for the offering.

Penny Stocks

Offerings

CEL-SCI Prices $10.845M Best-Efforts Offering Of 10.845M Shares And Pre-Funded Warrants At A Price Of $1/Share

CEL-SCI shares are trading higher after the company announced results from a bias analysis conducted for its concluded Phase 3 study of Multikine. Multikine cut the 5-year risk of death by half compared to control in its target population.

<ul>
<li>Multikine, a true first-line cancer immunotherapy, cut the 5-year risk of death by half compared to control in its target population</li>
<li>Bias analysis conducted in preparation for submission of data to regulatory agencies including the FDA for confirmatory registration study</li>
<li>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</li>
</ul>
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fcel-sci.com%2F&amp;esheet=54100013&amp;newsitemid=20240726306579&amp;lan=en-US&amp;anchor=CEL-SCI+Corporation&amp;index=1&amp;md5=82d04ea8b620a5747c364cfd27dacc10">CEL-SCI Corporation</a> (NYSE:<a href="https://www.benzinga.com/stock/CVM#NYSE">CVM</a>) today reported positive results from a bias analysis conducted for its concluded Phase 3 study of Multikine (Leukocyte Interleukin, Injection)&#x2A; in the treatment of head and neck cancer. Conducting a bias analysis is a standard process used to identify, assess, and address potential sources of bias that could influence the outcomes and interpretations of study results. The goal of a bias analysis is to ensure that the trial's findings are reliable, the conclusions are valid, and to minimize the risk that bias has distorted the results.

CEL-SCI's Phase 3 Population Analysis For Confirmatory Registration Study In Head & Neck Cancer Demonstrates Well Balanced Patient Population, Confidence In Clinical Results; Multikine, A Cancer Immunotherapy, Cut The 5-Year Risk Of Death By Half Compared To Control In Its Target Population

<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fcel-sci.com%2F&amp;esheet=54091181&amp;newsitemid=20240708501317&amp;lan=en-US&amp;anchor=CEL-SCI+Corporation&amp;index=1&amp;md5=dc7dd6443ebdfd6e4e442edcf9ea0f83">CEL-SCI Corporation</a> (NYSE:<a href="https://www.benzinga.com/stock/CVM#NYSE">CVM</a>) 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 instruments.

Management

CEL-SCI Appoints Robert Watson As Chairperson Of The Board

<ul>
<li>Multikine significantly increases overall survival in patients with low levels of tumor cell PD-L1 expression in contrast to approved checkpoint inhibitors</li>
<li>73% survival for Multikine vs 45% in the control arm at 5 years</li>
<li>Statistically significant log rank p = 0.0015</li>
<li>5-year risk of death cut in half from 55% to 27%</li>
<li>Hazard ratio = 0.35 (95% CIs [0.19, 0.66])</li>
<li>Working to commence FDA confirmatory Registration Study for Multikine</li>
</ul>
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fcel-sci.com%2F&amp;esheet=54071016&amp;newsitemid=20240618624058&amp;lan=en-US&amp;anchor=CEL-SCI+Corporation&amp;index=1&amp;md5=85dbdf3ae883fba978da1da04df30e2b">CEL-SCI Corporation</a> (NYSE:<a href="https://www.benzinga.com/stock/CVM#NYSE">CVM</a>) 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 &amp; Technology (IDDST) 20th Annual Congress in Budapest, Hungary on Tuesday, June 18, 2024. Dr. Talor presented during the Cancers/Tumors session which he Chaired along with Dr. Elizabeth Tran of Purdue University.

CEL-SCI Presents Head & Neck Cancer Data At IDDST Annual Congress In Budapest: Risk Of Death Cut In Half For Patients Treated With Multikine In The Target Population

CEL-SCI (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/CVM#AMEX">CVM</a>) reported quarterly losses of $(0.28) per share which missed the analyst consensus estimate of $(0.14) by 100 percent.

CEL-SCI Q2 2024 GAAP EPS $(0.28) Misses $(0.14) Estimate

<h3>Gainers</h3>
<ul>
<li>Zai Lab (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZLAB#NASDAQ">ZLAB</a>) 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. </li>
<li>ZimVie (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZIMV#NASDAQ">ZIMV</a>) 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. </li>
<li>Aadi Bioscience (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AADI#NASDAQ">AADI</a>) 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. </li>
<li>CEL-SCI (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/CVM#AMEX">CVM</a>) shares moved upwards by 14.38% to $1.59. The company's market cap stands at $85.8 million. </li>
<li>Tarsus Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TARS#NASDAQ">TARS</a>) shares moved upwards by 13.94% to $42.56. The market value of their outstanding shares is at $1.6 billion. As per the press release, Q1 earnings came out yesterday. </li>
<li>Embecta (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EMBC#NASDAQ">EMBC</a>) shares rose 13.33% to $11.64. The company's market cap stands at $670.2 million. The company's, Q2 earnings came out today. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Tivic Health Systems (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TIVC#NASDAQ">TIVC</a>) shares declined by 35.8% to $0.86 during Thursday's pre-market session. The company's market cap stands at $1.2 million. </li>
<li>CytomX Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CTMX#NASDAQ">CTMX</a>) shares declined by 30.32% to $2.92. The market value of their outstanding shares is at $198.9 million. As per the press release, Q1 earnings came out yesterday. </li>
<li>CNS Pharma (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CNSP#NASDAQ">CNSP</a>) shares fell 13.84% to $0.21. The market value of their outstanding shares is at $2.1 million. </li>
<li>Ironwood Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IRWD#NASDAQ">IRWD</a>) shares decreased by 12.44% to $7.11. The market value of their outstanding shares is at $1.1 billion. As per the news, the Q1 earnings report came out today. </li>
<li>Syra Health (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SYRA#NASDAQ">SYRA</a>) stock declined by 11.22% to $1.9. The company's market cap stands at $12.5 million. The company's, Q1 earnings came out today. </li>
<li>Exact Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EXAS#NASDAQ">EXAS</a>) stock fell 10.56% to $53.2. The market value of their outstanding shares is at $9.7 billion. As per the news, the Q1 earnings report came out yesterday. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

AADI

CNSP

CTMX

EMBC

EXAS

IRWD

SYRA

TIVC

ZIMV

ZLAB

12 Health Care Stocks Moving In Thursday's Pre-Market Session

CEL-SCI Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVM#NASDAQ">CVM</a>) shares are trading higher by 18.6% to $1.98 during Wednesday&#8217;s session after the company received positive feedback from the FDA regarding their cancer immunotherapy, Multikine, for treating newly diagnosed advanced primary <a href="https://www.benzinga.com/pressreleases/24/05/b38700268/cel-sci-receives-fda-go-ahead-for-its-confirmatory-study-of-multikine-in-the-treatment-of-head-nec">head and neck cancer patients</a>. 
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 population. With a de-risked value proposition, CEL-SCI aims to confirm the positive results in a smaller study and potentially add Multikine to the standard of care for this target population.
See Also: <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/05/38701300/apples-new-m4-ipads-more-powerful-than-any-ai-pc-today-set-to-boost-sales">Apple&#8217;s New M4 iPads: &#8216;More Powerful Than Any AI PC&#8217; Today, Set To Boost Sales</a>
<h2 class="wp-block-heading">How To Buy CVM Stock</h2>
By now you're likely curious about how to participate in the market for CEL-SCI &#8211; be it to purchase shares, or even attempt to bet against the company.
Buying shares is typically done through a brokerage account. You can find a list of <a href="https://www.benzinga.com/money/best-stock-trading-platforms">possible trading platforms here.</a> Many will allow you to buy ‘fractional shares,' which allows you to own portions of stock without buying an entire share. For example, some stock, like Berkshire Hathaway, or Amazon.com, can cost thousands of dollars to own just one share. However, if you only want to invest a fraction of that, brokerages will allow you to do so. 
In the the case of CEL-SCI, which is trading at $2.12 as of publishing time, $100 would buy you 47.17 shares of stock.
If you're looking to bet against a company, the process is more complex. You'll need access to an options trading platform, or a broker who will allow you to ‘go short' a share of stock by lending you the shares to sell. The process of shorting a <a href="https://www.benzinga.com/money/how-to-short-a-stock">stock can be found at this resource.</a> Otherwise, if your broker allows you to trade options, you can either buy a put option, or sell a call option at a strike price above where shares are currently trading &#8211; either way it allows you to profit off of the share price decline.
According to data from <a href="https://benzinga.grsm.io/register174">Benzinga Pro</a>, CVM has a 52-week high of $3.23 and a 52-week low of $1.04.

Why CEL-SCI (CVM) Shares Are Trading Higher

CEL-SCI shares are trading higher after the company announced it received FDA approval for its confirmatory study of Multikine for the treatment of head & neck cancer.

<ul>
<li>Critical milestone achieved—the FDA accepted CEL-SCI's selection criteria defining the Multikine target population before surgery</li>
<li>Selected patient population had 73% survival with Multikine vs. 45% without Multikine based on analysis of completed 928-patient Phase 3 randomized controlled trial</li>
<li>212-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 cancer</li>
<li>View CEL-SCI's comprehensive report regarding the FDA's go-ahead and the Company's value proposition for investors here: <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fcel-sci.com%2Fwp-content%2Fuploads%2F2024%2F05%2FCEL_SCI-Report-on-FDA-Path-Forward-May-2024-FINAL.pdf&amp;esheet=53978765&amp;newsitemid=20240508140076&amp;lan=en-US&amp;anchor=https%3A%2F%2Fcel-sci.com%2Fwp-content%2Fuploads%2F2024%2F05%2FCEL_SCI-Report-on-FDA-Path-Forward-May-2024-FINAL.pdf&amp;index=1&amp;md5=290b7f8e3cbe711686f76bb676e21f69">https://cel-sci.com/wp-content/uploads/2024/05/CEL_SCI-Report-on-FDA-Path-Forward-May-2024-FINAL.pdf</a></li>
</ul>
<a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fcel-sci.com%2F&amp;esheet=53978765&amp;newsitemid=20240508140076&amp;lan=en-US&amp;anchor=CEL-SCI+Corporation&amp;index=2&amp;md5=d695c9571f281d7708d8c117077137c9">CEL-SCI Corporation</a> (NYSE:<a href="https://www.benzinga.com/stock/CVM#NYSE">CVM</a>) today announced a significantly positive outcome from its recent meeting with the U.S. Food and Drug Administration (FDA) regarding the path to approval for its first-line investigational cancer immunotherapy Multikine&#x2A; (Leukocyte Interleukin, Injection). Based on strong safety and efficacy data from CEL-SCI's completed Phase 3 head and neck cancer study, the FDA indicated CEL-SCI may move forward with a confirmatory Registration Study of Multikine in newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy).
"Through this discussion and agreement with the FDA, we have achieved a tremendous milestone for people who are newly diagnosed with head and neck cancer. The survival benefit was so strong and clear in the target patient population that our confirmatory study needs to enroll only 212 people to confirm what was already achieved in the Phase 3 study. This gives us a clear path forward," stated CEL-SCI CEO, Geert Kersten. "We are eager to begin the study as soon as possible."
CEL-SCI published a report on the FDA's agreement and Multikine's path forward. Please click on this link <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fcel-sci.com%2Fwp-content%2Fuploads%2F2024%2F05%2FCEL_SCI-Report-on-FDA-Path-Forward-May-2024-FINAL.pdf&amp;esheet=53978765&amp;newsitemid=20240508140076&amp;lan=en-US&amp;anchor=https%3A%2F%2Fcel-sci.com%2Fwp-content%2Fuploads%2F2024%2F05%2FCEL_SCI-Report-on-FDA-Path-Forward-May-2024-FINAL.pdf&amp;index=3&amp;md5=67893699e8ce7d9fae30dcb95228f745">https://cel-sci.com/wp-content/uploads/2024/05/CEL_SCI-Report-on-FDA-Path-Forward-May-2024-FINAL.pdf</a> to read the full report. Highlights include:

CEL-SCI Receives FDA Approval For Its Confirmatory Study Of Multikine For The Treatment Of Head & Neck Cancer

Cel-Sci GAAP EPS of -$0.28 misses by $0.15

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	The post <a href="https://investorplace.com/earning-results/2024/05/cvm-stock-earnings-cel-sci-for-q2-of-2024/">CVM Stock Earnings: CEL-SCI Reported Results for Q2 2024</a> appeared first on <a href="https://investorplace.com">InvestorPlace</a>.

CVM Stock Earnings: CEL-SCI Reported Results for Q2 2024

CEL-SCI names Robert Watson as chair

CEL-SCI stock rallies 40% on Multikine study analysis results

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Cel-Sci GAAP EPS of -$0.42 misses by $0.31

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Press Releases

CEL-SCI's Phase 3 Population Analysis for Upcoming Confirmatory Registration Study in Head & Neck Cancer Demonstrates Well Balanced Patient Population, Confidence in Clinical Results

CEL-SCI Announces Pricing of $10.8 Million Offering

CEL-SCI Announces Closing of $10.8 Million Offering

CEL-SCI Corporation Reports Third Quarter Fiscal 2024 Financial Results

The UK's Medicines & Healthcare Products Regulatory Agency Grants CEL-SCI a Pediatric Waiver, Bringing Multikine® One Step Closer to Future Marketing Clearance

CEL-SCI to Present New Data for Multikine® Head & Neck Cancer Immunotherapy at the European Society for Medical Oncology 2024 Congress

CEL-SCI's Multikine® Increased 5-Year Survival Rate to 82.6% in Locally Advanced Resectable Head & Neck Cancer Patients Who Were Deemed to be in the Treatment Group for Surgery and Radiation

CEL-SCI Selects Ergomed as CRO as it Gears Up for Confirmatory FDA Registration Study of Multikine® in Head and Neck Cancer

FDA's Oncologic Drugs Advisory Committee Decision on Checkpoint Inhibitors Substantiates Potential of CEL-SCI's Multikine® to Address Major Treatment Gap for PD-L1 Negative Cancer Patients

U.S. FDA and CEL-SCI Agree on Use of PD-L1 Biomarker to Select Head and Neck Cancer Patients for Marketing Registration Study to Commence Q1 2025

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