Latest news with #Novavax
Yahoo
5 days ago
- Health
- Yahoo
Novavax's H5N1 Vaccine Candidate Demonstrates Immunogenicity in Preclinical Study
Peer-reviewed data shows Novavax's H5N1 vaccine candidate demonstrated immunogenicity against currently circulating variants following either single or two-dose administration Potential for single intranasal or intramuscular dose could differentiate Novavax's vaccine as part of pandemic emergency preparedness efforts GAITHERSBURG, Md., July 24, 2025 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX) today announced preclinical data demonstrating that Novavax's H5N1 avian pandemic influenza vaccine candidate, leveraging Novavax's recombinant, protein-based nanoparticle technology and Matrix-M® adjuvant, induced robust immune responses by either single or two-dose intranasal (IN) or intramuscular (IM) administration in nonhuman primates. Results were published in Nature Communications. "These preclinical results underscore the promise and potential of our pandemic influenza program as well as the strength of our technology platform and our ability to deliver against our corporate growth strategy," said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President and Head of Research and Development, Novavax. "Our R&D pipeline focuses on delivering assets ready for partnership and prioritizing areas of unmet medical need, including vaccines for avian pandemic influenza, where we see clear potential advantages for our technology compared with other vaccines that are licensed or in development." Results showed that a single dose administered by either IN or IM routes induced neutralizing antibody responses (IN: 1:54; IM: 1:1,160), at or above the 1:40 titer generally considered to be a protective antibody response. The data showed even higher levels of immunity after two doses. These data suggest that even a single IN dose has the potential to provide protective immunity in individuals previously exposed to seasonal influenza either by vaccination or infection. Further, data showed Novavax's H5N1 vaccine candidate elicited broad antibody responses, suggesting the potential to protect against forward-drift variants from currently circulating strains of the H5N1 virus. H5N1, a highly pathogenic and dynamic avian pandemic influenza virus, is of concern due to its potential to mutate into a strain adapted for sustained human-to-human transmission. To date, there have been 70 confirmed total reported human cases in the U.S., and one death associated with H5N1 avian pandemic influenza infection.1 As of July 2025, no reported cases in the U.S. have been proven to result from human-to-human transmission. As part of its corporate growth strategy, Novavax is making targeted investments in early-stage development programs to create value. Novavax intends to pursue funding, partnership and licensing opportunities for its H5N1 vaccine candidate. About Novavax Novavax, 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 (R&D) 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 a single intranasal or intramuscular dose differentiating Novavax's H5N1 vaccine, 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: Investors Luis Sanay, CFA 240-268-2022 ir@ Media Giovanna Chandler (844) 264-8571 media@ References U.S. Centers for Disease Control and Prevention. H5 Bird Flu: Current Situation. 2025. Available at: View original content to download multimedia: SOURCE Novavax, Inc.
CTV News
5 days ago
- Business
- CTV News
Five years after COVID, pharma shares languish in U.S. policy limbo
A vial of the Phase 3 Novavax coronavirus vaccine is prepared for a trial at St. George's University hospital in London on Oct. 7, 2020. (Alastair Grant / AP Photo) MILAN — Global healthcare stocks have not been this cheap in decades and fund inflows into the sector are picking up, yet the shares remain in the doldrums, highlighting uncertainty over drug pricing policies since Donald Trump returned to the White House. Pharma companies' earnings outlook is being obscured by concerns over revived 'most-favored-nation' drug pricing rules in the lucrative U.S. market and potential 200 per cent tariffs on pharma imports into the U.S. Money flooded into drugmakers' shares during the COVID-19 pandemic but more recently there has been an exodus as investors shifted into Big Tech, leaving the sector cheap but unloved. At 15.9 times forward earnings, healthcare trades 11 per cent below its long-term average and 20 per cent below global equities, its steepest discount in 16 years, just above a record discount in 2009, based on LSEG Datastream data. 'We've moved from cautious optimism to cautious pessimism,' said Stephanie Aliaga, global market strategist at J.P. Morgan Asset Management in New York. 'Valuations have gotten even cheaper, but for a reason,' she added, referring to intensifying U.S. policy risks. But some investors are starting to look past the Washington policy fog and at long-term positive drivers, such as aging populations, RNA-based therapeutics, and breakthroughs in weight-loss and diabetes drugs. 'Armageddon scenario' Alberto Conca, CIO at Swiss wealth manager LFG+ZEST, has been adding exposure to pharma, biotech and medtech in recent weeks, drawn by strong cash-flow yields and the prospect of U.S. rate cuts boosting this rate-sensitive sector. Interest rate cuts typically support healthcare by lowering R&D funding costs and boosting the value of future cash flows. 'These are quality companies with good growth and defensive features being priced as if we're heading into an 'Armageddon scenario', which I believe is unlikely,' he said. UK-based M&G Investments has also been selectively adding to healthcare, according to its latest allocation report. Healthcare funds have seen net inflows since 2024, more than reversing the outflows from late 2022 through 2023, fund tracker EPFR data shows. Although year-to-date, inflows total US$7.2 billion, down 41 per cent from last year. Innovation is accelerating, pipelines are maturing and M&A is showing signs of picking up - yet stock prices are unmoved. Whether that represents a buying opportunity or a value trap hinges on how and when the policy uncertainty clears, investors said. Catalyst needed Historically, healthcare has traded at a modest premium to world stocks, thanks to its defensive profile and steady earnings. But that narrative has unraveled under political pressure from Washington and investors' love of Big Tech. Over the past three years, U.S. healthcare has underperformed the S&P 500 by more than 60 percentage points, making it the worst sectoral performer on Wall Street. Its valuation has deepened to a near-record 27 per cent discount, from parity to the S&P in 2023. 'Markets don't like uncertainty, and that shows up in valuations,' said Eddie Yoon, healthcare sector leader and portfolio manager at Fidelity Investments in Boston. 'Being cheap isn't necessarily a reason to buy. You need a catalyst.' For now, that catalyst is elusive. The policy uncertainty makes it difficult to forecast future earnings, he said, though he hopes for more clarity by year-end - potentially also paving the way for more M&A in the industry. Talks with the Trump administration have yet to clarify how and when drug prices will fall, executives from Eli Lilly and Merck said at a May industry conference. Yoon, who has typically been underweight Big Pharma due to patent expiry risks, notes smaller, innovative firms are becoming profitable. 'We're seeing companies go from unprofitable to very profitable,' he said, citing Alnylam and Penumbra as examples he owns. 'Historically, that's been a very good time to own healthcare stocks.' LFG+ZEST's Conca, who favors U.S. names like Abbott, Edwards Lifesciences, and AbbVie, along with Sanofi and Recordati in Europe, said interest rate cuts could be a major catalyst. Out of the woods? In Europe, healthcare is even cheaper than U.S. pharma, trading at 14.3 times forward earnings. A 55 per cent drop in shares of Novo Nordisk in the last year, related in part to concerns over competition in obesity drugs, along with tariff-driven production shifts to the U.S., has weighed on valuations. 'The sector will adapt,' wrote Arnaud Cadart, healthcare analyst at France's CIC Market Solutions. But that will come 'at the cost of rebalancing its revenues and probably transforming its organizations.' AstraZeneca, for example, has unveiled a US$50 billion U.S. investment. For now, the sector remains in limbo: cheap, but lacking enough visibility to trigger a broad re-rating. 'Healthcare has endured a lot of pain,' said J.P. Morgan's Aliaga. 'We're not sure if that pain is done, but the worst is likely over, given how extreme the exodus has been.' --- Reporting by Danilo Masoni; Editing by Amanda Cooper and Jane Merriman
Yahoo
15-07-2025
- Business
- Yahoo
Novavax (NVAX) Rises Higher Than Market: Key Facts
Novavax (NVAX) closed the most recent trading day at $6.97, moving +1.9% from the previous trading session. The stock's change was more than the S&P 500's daily gain of 0.14%. On the other hand, the Dow registered a gain of 0.2%, and the technology-centric Nasdaq increased by 0.27%. The vaccine maker's shares have seen a decrease of 1.44% over the last month, not keeping up with the Medical sector's loss of 1.34% and the S&P 500's gain of 3.97%. The upcoming earnings release of Novavax will be of great interest to investors. The company's upcoming EPS is projected at -$0.12, signifying a 112.12% drop compared to the same quarter of the previous year. In the meantime, our current consensus estimate forecasts the revenue to be $130.5 million, indicating a 68.59% decline compared to the corresponding quarter of the prior year. In terms of the entire fiscal year, the Zacks Consensus Estimates predict earnings of $2.65 per share and a revenue of $1.07 billion, indicating changes of +315.45% and +56.76%, respectively, from the former year. It's also important for investors to be aware of any recent modifications to analyst estimates for Novavax. These revisions help to show the ever-changing nature of near-term business trends. With this in mind, we can consider positive estimate revisions a sign of optimism about the business outlook. Research indicates that these estimate revisions are directly correlated with near-term share price momentum. To exploit this, we've formed the Zacks Rank, a quantitative model that includes these estimate changes and presents a viable rating system. The Zacks Rank system, which varies between #1 (Strong Buy) and #5 (Strong Sell), carries an impressive track record of exceeding expectations, confirmed by external audits, with stocks at #1 delivering an average annual return of +25% since 1988. Over the last 30 days, the Zacks Consensus EPS estimate has remained unchanged. At present, Novavax boasts a Zacks Rank of #3 (Hold). Valuation is also important, so investors should note that Novavax has a Forward P/E ratio of 2.58 right now. This represents a discount compared to its industry average Forward P/E of 18.51. Also, we should mention that NVAX has a PEG ratio of 0.06. This metric is used similarly to the famous P/E ratio, but the PEG ratio also takes into account the stock's expected earnings growth rate. The average PEG ratio for the Medical - Biomedical and Genetics industry stood at 1.54 at the close of the market yesterday. The Medical - Biomedical and Genetics industry is part of the Medical sector. This group has a Zacks Industry Rank of 74, putting it in the top 30% of all 250+ industries. The Zacks Industry Rank gauges the strength of our individual industry groups by measuring the average Zacks Rank of the individual stocks within the groups. Our research shows that the top 50% rated industries outperform the bottom half by a factor of 2 to 1. Remember to apply to follow these and more stock-moving metrics during the upcoming trading sessions. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Novavax, Inc. (NVAX) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
13-07-2025
- Business
- Yahoo
BTIG Maintains a Buy Rating on Novavax (NVAX), Sets a $19 PT
Novavax Inc. (NASDAQ:NVAX) is one of the best cheap stocks with huge upside potential. On June 11, BTIG maintained a Buy rating on Novavax Inc. (NASDAQ:NVAX) with a $19 price target. A closeup of a vial of the biotechnology company's vaccines. BTIG analyst Thomas Shrader told investors following the company's announcement of the results of the initial cohort of its COVID-19-Influenza Combination and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza Phase 3 trial that the primary goal was to exhibit that the immunogenicity of both the COVID-19 and Influenza vaccines was within the protective range with 'interference' not being a strong factor. He stated that the first CIC data 'looks unremarkable – exactly what we hoped for,' adding that the 'most positive signs from today's data' were stronger immunogenicity for the Novavax flu vaccine for some antigens compared to the 'gold-standard' flu vaccine FLUZONE-HD. Novavax Inc. (NASDAQ:NVAX) is a biotechnology company that discovers, develops, and commercializes recombinant vaccines. While we acknowledge the potential of NVAX as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. This article is originally published at Insider Monkey. 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
12-07-2025
- Business
- Yahoo
2 Beaten-Down Stocks That Haven't Hit Rock Bottom Yet
Canopy Growth seems unable to overcome the industrywide challenges it faces. Novavax's recent quarterly update, though strong, says little about its prospects. 10 stocks we like better than Canopy Growth › Buying shares of beaten-down companies only makes sense if there are good reasons to expect them to bounce back. If that's not the case, stocks that may look cheap and attractive aren't actually so. You should be careful to avoid catching falling knives. Let's consider two stocks that have significantly lagged the market in recent years but could still fall further: Canopy Growth (NASDAQ: CGC) and Novavax (NASDAQ: NVAX). Canopy Growth emerged as a leader in the cannabis industry toward the end of the past decade. The company has significant operations in Canada, the U.S., and various countries worldwide, including Germany. Despite its position in these markets, Canopy Growth has been a profoundly disappointing investment over the past five years. Its latest results provided another example as to why. During the fourth quarter of its fiscal 2025, which ended March 31, Canopy Growth's net revenue declined by 11% year over year to 65 million Canadian dollars ($47.6 million). The company's loss per share for the period was CA$1.43 ($1.05), worse than the CA$1.03 ($0.75) it reported in the prior-year quarter. In fairness, Canopy Growth's troubles aren't entirely its fault. The cannabis industry has been a mess due to legal and regulatory challenges; competition from illicit channels, sometimes even where the product is legal; and oversupply, particularly in Canada, which legalized recreational use of cannabis for adults in 2018. Hardly any pot company has found consistent success over the past five years, despite different focuses, strategies, and executions across the industry. That may suggest the problem is not exclusive to specific companies. No matter whose fault it is, though, Canopy Growth's business is in shambles, and things are not about to get better. True, the company is engaged in cost-cutting efforts while refocusing its portfolio in Canada on in-demand items, such as vapes and pre-rolls. Management predicts that it will achieve positive adjusted earnings before interest, taxes, depreciation, and amortization (EBITDA) in "the near-term." Yet, even if Canopy Growth gets there, positive EBITDA would only be a step toward profitability. The company's efforts to reduce expenses may help boost margins in the short term. But it's challenging to envision a path for it to perform well in the long run, given the industry challenges that have led to inconsistent financial results over the past half-decade. Are investors to believe that, after all this time and countless failures across the industry -- both those of Canopy Growth and of others -- the company has finally cracked the code? Convincing the market that that's the case will require more than just positive adjusted EBITDA. I see little reason to expect the pot grower to perform well over the next five years. In fact, I'd expect the stock to sink even further -- and advise investors to stay far away. Examining Novavax's financial results and recent progress may suggest that the stock is a compelling investment opportunity. In the first quarter, the company's revenue was $666.7 million, compared to just $93.9 million for the comparable period of the previous fiscal year. Net income was $518.6 million, compared to a net loss of $147.6 million in the first quarter of 2024. Furthermore, Novavax recently reported positive results from phase 3 studies for its stand-alone influenza vaccine and combination COVID-19/flu vaccine. That's to say nothing of the partnerships it's signed with companies like Sanofi and Takeda Pharmaceuticals, which have paid Novavax for the rights to its COVID vaccines in various countries. But can the company sustain its performance over the long run? Probably not, and here's why. First, the coronavirus vaccine market has been inconsistent and hard to predict. Recent regulatory guidance in the U.S. may further complicate matters, with the Department of Health and Human Services no longer recommending the vaccine for certain populations, including pregnant women and healthy children. It's also worth noting that Novavax has generally played second fiddle to the leaders in this space, Moderna and Pfizer. Novavax's strong financial results in the first quarter are not at all indicative of how it will perform year in and year out. Second, the company's phase 3 wins for its two leading vaccines were not significant achievements. Although they induced strong immune responses in participants, Novavax itself states that these trials were not designed to demonstrate statistical significance. In other words, these results won't support approval. And while they're a good stepping stone to phase 3 studies that would, Novavax is waiting for a partner with big pockets to run these trials. That means it either doesn't have the funds to go at it alone, or management doesn't think doing so without a partner will be worth the investment -- or both. Even if it does find a partner, other companies (including Moderna) have made significant strides in developing competing vaccines. Lastly, the infusion of cash it received from its partnership with Sanofi will eventually run out. The company's business will likely have little to show for itself after that point. All these factors make Novavax unattractive to long-term investors, as the stock could fall much further than it has in the past five years. Before you buy stock in Canopy Growth, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the for investors to buy now… and Canopy Growth wasn't one of them. The 10 stocks that made the cut could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you'd have $694,758!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you'd have $998,376!* Now, it's worth noting Stock Advisor's total average return is 1,058% — a market-crushing outperformance compared to 180% for the S&P 500. Don't miss out on the latest top 10 list, available when you join . See the 10 stocks » *Stock Advisor returns as of July 7, 2025 Prosper Junior Bakiny has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Pfizer. The Motley Fool recommends Moderna. The Motley Fool has a disclosure policy. 2 Beaten-Down Stocks That Haven't Hit Rock Bottom Yet was originally published by The Motley Fool
