Latest news with #COVID-19-InfluenzaCombination
Business Insider
3 days ago
- Business
- Business Insider
Novavax Stock (NVAX) Gets a Boost from ‘Robust Immune Responses'
Novavax (NVAX) stock jumped on Wednesday after the vaccine maker released results from a Phase 3 clinical trial of its COVID-19-Influenza Combination (CIC) and stand-alone flu vaccine. The initial cohort results from this study included 'robust immune responses' for the CIC and flu vaccine that were comparable to licensed rivals Nuvaxovid and Fluzone HD. Confident Investing Starts Here: Additionally, Novavax noted that the two vaccines were well tolerated. Almost all of the adverse events, greater than 98%, that were experienced by patients were mild or moderate in severity. The trial includes roughly 2,000 patients aged 65 or older. Novavax stated that it will continue to seek partners to further the development of its CIC and stand-alone flu vaccines. The results from this study provide it with the data it needs for discussions with potential partners. NVAX Stock Movement Today While NVAX stock had soared more than 2% in pre-market trading, the company couldn't maintain those gains. As a result, the stock is only up 0.56% as of Wednesday morning. Investors will also note that shares are down 8.83% year-to-date and 54.6% over the past 12 months. The Phase 3 clinical trial data also failed to attract investor interest today. Trading volume was muted at 1.38 million shares, compared to a three-month daily average of roughly 11.29 million units. Is Novavax Stock a Buy, Sell, or Hold? Turning to Wall Street, the analysts' consensus rating for Novavax is Hold, based on one Buy, two Hold, and a single Sell rating over the past three months. With that comes an average NVAX stock price target of $11.25, representing a potential 55.39% upside for the shares. Spark, TipRanks' AI analyst, highlighted 'strong revenue growth and profitability improvements' but warned of 'negative equity and cash flow challenges.'
Yahoo
4 days ago
- Health
- Yahoo
Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Vaccine Candidates Showed Robust Immune Responses and Were Well Tolerated in Initial Cohort of a Phase 3 Trial
Both vaccine candidates induced robust immune responses across all antigens tested No new safety signals were observed and both vaccine candidates were well tolerated consistent with past trials Novavax continues to pursue partnering opportunities to advance further development of these programs GAITHERSBURG, Md., June 11, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced results of the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV) Phase 3 trial that showed both the CIC and flu vaccine candidates induced immune responses similar to licensed comparators Nuvaxovid® and Fluzone HD, respectively. This cohort was designed to provide descriptive data on three flu strains (H1N1, H3N2, B) and SARS-CoV-2 (COVID-19) to inform a future registrational Phase 3 program. "Both our combination and stand-alone flu vaccine candidates induced robust immune responses and were well tolerated," said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President and Head of Research and Development, Novavax. "This data set adds to findings from our Phase 2 trial and will help inform discussions with potential partners." Both stand-alone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains (2.4-5.7-fold over baseline). Both vaccine candidates were well tolerated and saw reactogenicity comparable to authorized comparators. Nearly all (>98%) solicited adverse events were mild or moderate in severity. This descriptive trial was designed to evaluate the safety and immunogenicity of the CIC and stand-alone flu vaccine candidates compared to Nuvaxovid and Fluzone HD in approximately 2,000 adults aged 65 and older. This trial was not adequately powered to demonstrate statistical significance. These results build on previous Phase 2 data. About NovavaxNovavax, Inc. (Nasdaq: NVAX) tackles some of the world's most pressing health challenges with its scientific expertise in vaccines and its proven technology platform, including protein-based nanoparticles and its Matrix-M® adjuvant. The Company's growth strategy seeks to optimize its existing partnerships and expand access to its proven technology platform via research and development innovation, organic portfolio expansion in infectious disease and beyond, and forging new partnerships and collaborations with other companies. Please visit and LinkedIn for more information. Forward-Looking Statements Statements herein relating to the future of Novavax, its operating plans and prospects, its partnerships, and the potential for its CIC and stand-alone influenza vaccine to be used with a partner in a registrational Phase 3 program, are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, challenges pursuing additional partnership opportunities; challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation and stability testing, necessary to satisfy applicable regulatory authorities; challenges or delays in conducting clinical trials or studies for its product candidates; challenges or delays in obtaining regulatory authorization for its product candidates, including for future COVID-19 variant strain changes, its CIC vaccine candidate, its stand-alone influenza vaccine candidate or other product candidates; manufacturing, distribution or export delays or challenges; Novavax's substantial dependence on Serum Institute of India Pvt. Ltd. and Serum Life Sciences Limited for co-formulation and filling Novavax's COVID-19 vaccine and the impact of any delays or disruptions in their operations; difficulty obtaining scarce raw materials and supplies including for its proprietary adjuvant; resource constraints, including human capital and manufacturing capacity; constraints on Novavax's ability to pursue planned regulatory pathways, alone or with partners; challenges in implementing its global restructuring and cost reduction plan; challenges in obtaining commercial adoption and market acceptance of its updated COVID-19 vaccine or any COVID-19 variant strain containing formulation, or for its CIC vaccine candidate and stand-alone influenza vaccine candidate or other product candidates; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities, including requirements to deliver doses that may require Novavax to refund portions of upfront and other payments previously received or result in reduced future payments pursuant to such agreements and challenges in amending or terminating such agreements; challenges related to the seasonality of vaccinations against COVID-19; challenges related to the demand for vaccinations against COVID-19 or influenza; challenges in identifying and successfully pursuing innovation expansion opportunities; Novavax's expectations as to expenses and cash needs may prove not to be correct for reasons such as changes in plans or actual events being different than its assumptions; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2024, and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our filings with the SEC, available at and for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Our business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties. Contacts: InvestorsLuis Sanay, CFA240-268-2022ir@ MediaGiovanna Chandler202-709-5563media@ View original content to download multimedia: SOURCE Novavax, Inc. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
02-04-2025
- Business
- Yahoo
Novavax (NasdaqGS:NVAX) Sees 21% Weekly Drop As Leadership Changes Shake Market
Novavax recently experienced a significant decline of 21% over the past week, coinciding with leadership changes, including the retirement of longtime Chairman James Young and the appointment of Margaret McGlynn as the new Chair. Despite Dr. Young's impactful tenure, marked by acquisitions and partnerships, the market's broader volatile conditions, driven by trade war concerns and tariff speculation, likely influenced this downturn. Consistently rising stocks like Amazon and Tesla amidst overall market volatility, which also saw a 3% drop, suggest investor jitters may have contributed to NVAX's recent performance. These events emphasize the uncertain environment surrounding the company's recent board transitions. We've discovered 2 risks for Novavax (1 doesn't sit too well with us!) that you should be aware of before investing here. We've found 21 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. Novavax's total shareholder return over the past year was 32.45%, significantly outperforming the broader US market's 7.5% and the US Biotechs industry's 11.7% decline. This impressive performance can be partly attributed to several key events. In December 2024, Novavax initiated a Phase 3 trial for its COVID-19-Influenza Combination vaccine, signaling potential growth opportunities. Additionally, the EU granted marketing authorization for an updated Nuvaxovid COVID-19 vaccine in October 2024, potentially expanding its market reach. Another important factor was the agreement announced in December 2024 to sell the Czech manufacturing facility to Novo Nordisk for US$200 million, aiming to reduce operating costs. Financially, the second quarter of 2024 was favorable, with Novavax reporting a net income increase to US$162.38 million from the previous year. These developments likely played a role in bolstering investor sentiment and contributing to Novavax's overall strong performance last year. Click here to discover the nuances of Novavax with our detailed analytical financial health report. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqGS:NVAX. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
