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The Hindu
19 hours ago
- Business
- The Hindu
Novavax's COVID-flu combo vaccine shows strong immune response in trial
Novavax's experimental COVID-19-influenza combination and standalone influenza vaccines generated a strong immune response in adults aged 65 and older, similar to already approved shots against the viruses in a late-stage trial. Both the vaccine candidates were well tolerated with no new safety concerns, the biotech said on 11 June 2025. . Its shares rose 1.3% to $7.29 in premarket trading. The study, which involved about 2,000 participants, tested the safety and immune response of the COVID-influenza combination and standalone flu vaccines compared to its COVID-19 shot Nuvaxovid and Sanofi's flu shot Fluzone HD, respectively. Novavax said the study was not designed to show statistically significant results. The data will be used to design a future late-stage study, which can be submitted for regulatory approval, it said. The Maryland-based biotech, which is shifting its focus to commercialising its candidates through partnerships, said it continues to look for partners that can advance further development of these experimental vaccines. It had signed a licensing deal with Sanofi worth up to $1.2 billion last year to commercialize and further develop its COVID-19 vaccine, Nuvaxovid. Nuvaxovid gained the U.S. approval last month after the Food and Drug Administration missed an April 1 target to approve the shot. The approval, however, limited its use to older adults and at-risk individuals over the age of 12. The traditional protein-based shot offers an alternative to its messenger RNA-based rivals from Pfizer/BioNTech and Moderna. Earlier this week, health secretary Robert F. Kennedy Jr., a long-time vaccine skeptic, fired all members of a U.S. Centers for Disease Control and Prevention panel of vaccine experts — a move public health experts said could undermine confidence in currently available shots.
Business Insider
2 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
3 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
