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NOVAVAX INC

Novavax

Novavax Inc is a biotechnology company that develops vaccines. The company works in the clinical stage of development with a focus on delivering novel products that prevent a broad range of diseases. It works together with its wholly owned Swedish subsidiary to produce vaccine candidates to respond to both known and emerging disease threats. The company believes its vaccine technology has the potential to be applied broadly to a wide variety of human infectious diseases. The company manages its business as one operating segment, the development and commercialization of vaccines. The company generates maximum revenue from the United States.

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Un trabajador lechero en Nevada da positivo en gripe aviar H5N1. CDC investiga mientras la cepa se propaga en aves y ganado.

Gripe aviar en EE.UU.: trabajador lechero en Nevada da positivo

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IDNA

El brote de H5N9, la separación de la OMS y las audiencias de Kennedy generan incertidumbre en salud pública y mercados.

Acciones de Moderna (MRNA) y Pfizer (PFE) reaccionan al brote de H5N9 y la separación de los CDC de la OMS

Las acciones de Novavax caen a medida que las preocupaciones sobre la disminución de la demanda de vacunas afectan al sector.

Acciones de Novavax (NVAX) caen un 9,8% tras anuncio de Moderna

Novavax Inc

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On April 29, 2025, Novavax, Inc. (the "Company") entered into a collaboration and exclusive license agreement, as amended, (the "Amended Collaboration Agreement") with Takeda Pharmaceutical Company Limited ("Takeda") which amends and supersedes the collaboration and exclusive license agreement, dated February 24, 2021, (the "Original Agreement," together with the Amended Collaboration Agreement, the "Agreement").
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The Original Agreement, which granted Takeda an exclusive license to develop, manufacture, and commercialize NVX-CoV2373, the Company's vaccine candidate for the SARS-CoV-2 virus (the "Vaccine") in Japan, has been amended so that Takeda may develop and commercialize a strain for the Vaccine that is different from the strain that the Company selects for the year, provided such Takeda selected strain must be procured from the Company. Under the Amended Collaboration Agreement, Takeda will continue to purchase the Company's Matrix-M&#x2122; adjuvant to manufacture doses of finished Vaccine with updated adjuvant forecast and other supply terms.
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Under the Amended Collaboration Agreement, the Company will receive a non-refundable upfront payment of $19.5 million of which $5 million is creditable against royalties owed by Takeda for its fiscal year 2024. In addition, on an annual basis, (i) the Company will receive $2 million to compensate the Company for services provided by the Company under the Agreement, and (ii) the Company will receive an additional $8 million annual milestone payment of which $5 million is creditable against royalties owed by Takeda in its fiscal year 2025 or thereafter, if Takeda receives marketing approval of the Vaccine in that year or such approval is not necessary for such year. The parties have also updated the financial terms to replace the share of operating profits and, instead, provide the Company with a tiered royalty as a percentage of Takeda's, its affiliates' and sublicensees' total net sales in the mid to high-teen percentages (subject to certain capped royalty reductions), commencing on April 1, 2024 and will continue until the latest of (a) twenty years after April 29, 2025, (b) all the Company's know-how licensed under the Amended Collaboration Agreement has become publicly available through no fault of Takeda, and (c) the expiration of the last valid claim in the intellectual property rights licensed by the Company to Takeda under the Amended Collaboration Agreement covering the Vaccine in Japan.

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Novavax To Receive $19.5M Upfront Payment Under Amended Agreement With Takeda

The President Donald Trump administration&#8217;s request for Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) to conduct new clinical trials for its COVID-19 vaccine.
What Happened: Novavax announced Monday that the Food and Drug Administration requested a new clinical trial before granting full approval for its protein-based COVID-19 shot, despite the company believing its vaccine remains &#8220;approvable.&#8221; 
The requirement came shortly after FDA Commissioner Marty Makary characterized the annually updated vaccine as &#8220;a new product&#8221; requiring new studies.
<figure class="wp-block-embed is-type-rich is-provider-twitter wp-block-embed-twitter"> 
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<blockquote class="twitter-tweet" data-width="500" data-dnt="true">To be clear, this is a new product that Novavax is trying to introduce to the market with a study of a different product from 2021. New products require new clinical studies. Under this administration, we are prioritizing the Gold Standard of Science&#8211;not what saves pharma… <a href="https://t.co/1f7NvJ9qEJ">pic.twitter.com/1f7NvJ9qEJ</a>
&mdash; Dr. Martin Makary (@DrMakaryFDA) <a href="https://twitter.com/DrMakaryFDA/status/1916253910039429309?ref_src=twsrc%5Etfw">April 26, 2025</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
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The situation developed following leadership changes at the FDA, including the departure of the agency&#8217;s longtime Vaccine Chief over disagreements with Health Secretary Robert F. Kennedy Jr. 
Industry experts note the FDA had been on track to approve Novavax&#8217;s application by April 1, but Trump appointees directed a pause, the Associated Press <a href="https://apnews.com/article/vaccine-novavax-fda-trump-covid-study-4b4465ad77cfb0554b27b7d59c40ae32">reported</a>, citing anonymous sources.
See Also: <a href="https://www.benzinga.com/general/entertainment/25/04/45059675/mrbeast-sparks-outrage-with-100-men-vs-gorilla-post-on-elon-musks-x-peta-claps-back-try-100-reasons-to-leave-animals">MrBeast Sparks Outrage With &#8216;100 Men Vs Gorilla&#8217; Post On Elon Musk&#8217;s X — PETA Claps Back: &#8216;Try 100 Reasons To Leave Animals&#8230;&#8217;</a>
Why It Matters: A United States Department of Health and Human Services spokesman suggested all COVID-19 vaccines could face stricter requirements, stating: &#8220;The urgency to rush approval of boosters without normal oversight no longer exists.&#8221;
Preliminary results from <a href="https://www.benzinga.com/general/biotech/25/04/44824383/novavax-covid-vaccine-shows-milder-side-effects-than-pfizer-biontechs-shot-study">the SHIELD-Utah study</a> showed Novavax&#8217;s 2024-2025 formula targeting the JN.1 strain produced fewer and less severe side effects compared to Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and BioNTech SE&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) mRNA shots.
Former Health Secretary Xavier Becerra defended the safety record of COVID-19 vaccines, noting: &#8220;We had put some 700 million COVID vaccines into the arms of Americans. That&#8217;s a pretty good size clinical trial.&#8221;
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

BNTX

Trump-Era FDA Appointees Request New Trials For Novavax COVID Vaccine, Reportedly Delaying Approval Timeline

Benzinga examined the prospects for <a href="http://www.benzinga.com/trading-ideas" target="_blank" rel="noreferrer noopener">many investors' favorite stocks</a> over the last week — here's a look at some of our top stories.
U.S. markets rebounded this week as President Donald Trump softened his stance on trade and monetary policy. He indicated that tariffs on Chinese imports could decrease from the current 145% and affirmed his support for Federal Reserve Chair Jerome Powell, alleviating investor concerns about central bank independence.
The S&amp;P 500 regained nearly 80% of its post-April 2 losses, with notable gains in technology stocks. ServiceNow (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NOW#NYSE">NOW</a>) led with a 20% weekly increase, while Tesla (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NYSE">TSLA</a>) surged 9.9% after CEO Elon Musk announced a reduced focus on the Department of Government Efficiency (DOGE).
Despite the rally, economic indicators signaled caution. U.S. private sector growth slowed to a 16-month low, and consumer sentiment declined sharply. Inflation expectations rose, with one-year forecasts reaching 6.5%, the highest since 1981, suggesting persistent economic uncertainty.
Benzinga provides daily reports on the stocks most popular with investors. Here are a few of this past week's most bullish and bearish posts that are worth another look.
The Bulls
<a href="https://www.benzinga.com/analyst-ratings/analyst-color/25/04/44935008/netflix-stock-nears-all-time-high-whats-going-on">"Netflix stock nears all-time high: What's going on?"</a>, by Adam Eckert, reports that Netflix Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NFLX#NASDAQ">NFLX</a>) shares approached record highs following strong Q1 earnings—$10.54 billion in revenue and $6.61 EPS—driven by robust subscription and advertising growth, with analysts raising price targets up to $1,514 and highlighting the company's insulation from global tariffs due to its digital-only business model.
<a href="https://www.benzinga.com/general/biotech/25/04/44963467/why-is-summit-therapeutics-stock-soaring-on-wednesday">"Why Is Summit Therapeutics Stock Soaring On Wednesday?"</a>, by Vandana Singh, reports that Summit Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SMMT#NASDAQ">SMMT</a>) shares surged after partner Akeso, Inc. announced that their Phase 3 HARMONi-6 trial met its primary endpoint, with ivonescimab plus chemotherapy showing a statistically significant improvement in progression-free survival over BeiGene Ltd.'s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ONC#NASDAQ">ONC</a>) tislelizumab combo in patients with advanced squamous non-small cell lung cancer.
<a href="https://www.benzinga.com/general/biotech/25/04/44966369/novavaxs-covid-19-vaccine-nears-fda-full-approval-stock-jumps">"Novavax's COVID-19 Vaccine Nears FDA Full Approval, Stock Jumps"</a>, by Vandana Singh, reports that Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) shares rose after the company stated its Biologics License Application is approvable and awaits FDA response following a post-marketing data request.
For additional bullish calls of the past week, check out the following:
<a href="https://www.benzinga.com/news/earnings/25/04/44998075/celestica-beats-q1-estimates-raises-fy-outlook-on-strengthening-demand-shares-slide">Celestica Beats Q1 Estimates, Raises FY Outlook On ‘Strengthening Demand,' Shares Slide</a>
<a href="https://www.benzinga.com/25/04/44927300/this-nvidia-backed-ai-upstart-boasts-extremely-rapid-revenue-growth-analyst-initiates-overweight">Nvidia-Backed AI Startup Boasts ‘Extremely Rapid Revenue Growth' &#8211; JPMorgan Initiates With Overweight</a>
<a href="https://www.benzinga.com/trading-ideas/movers/25/04/44995270/why-is-rocket-lab-stock-trading-higher-on-thursday">Why Is Rocket Lab Stock Trading Higher On Thursday?</a>
The Bears
<a href="https://www.benzinga.com/news/earnings/25/04/44996628/intel-q1-earnings-revenue-beat-eps-beat-shares-tumble-on-weak-guidance-chipmaker-plans-swift-actions-to-drive-efficiency">"Intel Q1 earnings: Revenue beat, EPS beat, shares tumble on weak guidance, chipmaker plans ‘swift actions' to drive efficiency"</a>, by Adam Eckert, reports that Intel Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INTC#NASDAQ">INTC</a>) shares fell after the company reported first-quarter revenue of $12.67 billion and adjusted earnings of 13 cents per share, both surpassing analyst expectations, but issued a disappointing second-quarter revenue forecast of $11.2–$12.4 billion, prompting CEO Lip-Bu Tan to announce organizational streamlining and cost-cutting measures to enhance efficiency.
<a href="https://www.benzinga.com/25/04/44903087/amazon-stock-downgraded-price-target-slashed-as-tariffs-create-uncertainty">"Amazon stock downgraded, price target slashed as tariffs create uncertainty"</a>, by Erica Kollmann, reports that Amazon.com Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMZN#NASDAQ">AMZN</a>) shares fell after Raymond James analyst Josh Beck downgraded the stock from Strong Buy to Outperform and cut the price target from $275 to $195, citing underestimated EBIT pressures from tariffs and macroeconomic headwinds.
<a href="https://www.benzinga.com/news/earnings/25/04/44966124/ibm-shares-slide-despite-better-than-expected-q1-details">"IBM Shares Slide Despite Better-Than-Expected Q1: Details"</a>, by Erica Kollmann, reports that International Business Machines Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IBM#NYSE">IBM</a>) shares fell despite beating Q1 expectations with $1.60 EPS and $14.54 billion in revenue, as investors reacted to CEO Arvind Krishna's warning that economic uncertainty may cause clients to pause spending.
For more bearish takes, be sure to see these posts:
<a href="https://www.benzinga.com/analyst-ratings/price-target/25/04/44962797/enphase-energy-stock-is-tumbling-wednesday-why-investors-are-selling-shares">Enphase Energy Stock Is Tumbling Wednesday: Why Investors Are Selling Shares</a>
<a href="https://www.benzinga.com/analyst-ratings/reiteration/25/04/44965222/metas-fundamentals-look-fragile-heading-into-q1-report-analyst-warns">Meta's Fundamentals Look Fragile Heading Into Q1 Report, Analyst Warns</a>
<a href="https://www.benzinga.com/news/earnings/25/04/44995935/t-mobile-shares-drop-despite-better-than-expected-q1-report-details">T-Mobile Shares Drop Despite Better-Than-Expected Q1 Report: Details</a>
Keep up with all the latest breaking news and trading ideas by following <a href="https://twitter.com/Benzinga" target="_blank" rel="noreferrer noopener">Benzinga</a><a href="http://twitter.com/Benzinga" target="_blank" rel="noreferrer noopener"> on X</a>.
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Benzinga Bulls And Bears: Netflix, Novavax, Intel — And The Market Begins To Bounce Back

WIIM

Novavax shares are trading lower following a WSJ report indicating the FDA asked the company to complete a new trial for its Covid-19 vaccine.

<a href="https://www.wsj.com/health/healthcare/novavax-covid-19-vaccine-clinical-trial-fda-de5d3bb3" title="https://www.wsj.com/health/healthcare/novavax-covid-19-vaccine-clinical-trial-fda-de5d3bb3">https://www.wsj.com/health/healthcare/novavax-covid-19-vaccine-clinical-trial-fda-de5d3bb3</a>

"FDA Asks Vaccine Maker To Complete New Clinical Trial For Delayed Covid-19 Shot; A New Randomized Study Could Cost Novavax Tens Of Millions Of Dollars, Vaccine Experts Say" - WSJ

Novavax, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NAVX#NASDAQ">NAVX</a>) stock traded higher on Wednesday.
In an SEC filing, Novavax <a target="_blank" href="https://www.benzinga.com/secfilings/25/04/44946464/novavax-inc-general-corporate-statement-form8" rel="noreferrer noopener">said</a>, &#8220;We believe that our Biologics License Application (BLA) is approvable based on conversations with U.S. Food and Drug Administration (FDA), as of our Prescription Drug User Fee Act date on <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">April 1 and through today</a>.&#8221;
The company said that it received formal communication from the FDA in the form of an information request for a post-marketing commitment to generate additional clinical data.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44634464/despite-headwinds-biotech-sell-off-could-offer-buying-opportunity-bofa" rel="noreferrer noopener">Despite Headwinds, Biotech Sell-Off Could Offer Buying Opportunity: Analyst</a>
&#8220;We look forward to engaging with the FDA expeditiously to address the PMC request and move to approval as soon as possible,&#8221; the company <a target="_blank" href="https://www.benzinga.com/secfilings/25/04/44946464/novavax-inc-general-corporate-statement-form8" rel="noreferrer noopener">said</a> in the SEC filing on Wednesday.&nbsp;&nbsp;
According to a media report in early April, the regulators missed the deadline for deciding to grant full <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44613147/fda-delays-full-approval-decision-on-novavaxs-covid-19-vaccine" rel="noreferrer noopener">approval to Novavax&#8217;s shot</a>.
The Wall Street Journal reports that the agency is now delaying the decision and has reportedly requested more data, making it unlikely that the application will be approved soon, according to sources.
In April, Novavax released preliminary results from the SHIELD-Utah&nbsp;study investigating the effects of systemic and local reactogenicity of COVID-19&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44824383/novavax-covid-vaccine-shows-milder-side-effects-than-pfizer-biontechs-shot-study" rel="noreferrer noopener">vaccine doses in&nbsp;Utah</a>.
SHIELD-Utah&nbsp;was a prospective, interventional study conducted at the&nbsp;University of Utah&nbsp;Health.
The study showed Novavax's COVID-19 Vaccine, Adjuvanted (2024-2025 Formula), targeting the JN.1 strain, resulted in fewer and less severe reactogenicity symptoms when compared with the&nbsp;Pfizer Inc&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>)-BioNTech SE's&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>)&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/n44808832/shield-utah-study-shows-novavaxs-covid-19-vaccine-induces-lower-reactogenicity-symptoms-compared-t" rel="noreferrer noopener">mRNA 2024-2025 vaccine</a>.
In September 2024, the U.S. Food And Drug Administration (FDA) granted Emergency Use Authorization to&nbsp;Novavax COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) for active immunization to prevent COVID-19 in&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40688052/fda-approves-novavaxs-updated-covid-vaccine-targeting-currently-circulating-variants" rel="noreferrer noopener">individuals aged 12 and older</a>.
Novavax&#8217;s vaccine was included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on&nbsp;June 27, 2024.
<h2 class="wp-block-heading">Novavax Stock Prediction For 2025</h2>
Equity research analysts, both on and off Wall Street, typically use earnings growth and fundamental research as a form of valuation and forecasting. But many in trading turn to technical analysis as a way to form predictive models for share price trajectory.
Some investors look to trends to help forecast where they believe a stock could trade at a certain point in the future. Looking at Novavax, an investor could make an assessment about a stock's long term prospects using a moving average and trend line. If they believe a stock will remain above the moving average, which many believe is a bullish signal, they can extrapolate that trend into the future using a trend line. 
For Novavax, the 200-day moving average sits at $9.94, according to <a href="https://pro.benzinga.com/">Benzinga Pro</a>, which is above the current price of $7.33. For more on charts and trend lines, <a href="https://pro.benzinga.com/">see a description here.</a>
Traders believe that when a stock is above its moving average, it is a generally bullish signal, and when it crosses below, it is a more negative signal. Investors could use trend lines to make an educated guess about where a stock could trade at a later date if conditions remain stable.
Price Action: NVAX stock was up 19.5% at $7.47 on Wednesday.
Read Next:
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<li><a href="https://www.benzinga.com/general/biotech/25/04/44934942/roche-plans-50-billion-us-investment-over-5-years-with-12000-new-jobs" target="_blank" rel="noreferrer noopener">Roche Plans $50 Billion US Investment Over 5 Years With 12,000 New Jobs</a></li>
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Movers

Trading Ideas

NAVX

Novavax's COVID-19 Vaccine Nears FDA Full Approval, Stock Jumps

U.S. stocks were higher, with the Dow Jones index gaining around 1,000 points on Wednesday.
Shares of Amphenol Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/APH#NYSE">APH</a>) rose sharply during Wednesday's session after the company reported better-than-expected first-quarter financial results and issued second-quarter <a href="https://in.benzinga.com/news/earnings/25/04/44950358/amphenol-q1-earnings-48-topline-growth-driven-by-it-mobile-defense-sectors">guidance above estimates</a>.
The quarterly sales increased by 48% year-on-year to $4.81 billion, topping the analyst consensus estimate of $4.23 billion, driven by excellent organic growth in the IT datacom market as well as robust organic growth in the mobile devices, defense, and communications networks markets, together with contributions from the company's acquisition program.
Amphenol shares jumped 11.7% to $73.46 on Wednesday.
Here are some other big stocks recording gains in today's session.
<ul>
<li>Pony AI Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PONY#NASDAQ">PONY</a>) shares jumped 33.4% to $5.55 after the company showcased its 7th-gen autonomous system and robotaxi fleet.</li>
<li>Pegasystems Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PEGA#NASDAQ">PEGA</a>) gained 31.1% to $90.16 after the company reported better-than-expected first-quarter financial results.</li>
<li>Healthcare Services Group, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HCSG#NASDAQ">HCSG</a>) jumped 25.5% to $11.81 after the company reported better-than-expected quarterly financial results.</li>
<li>Novavax, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) gained 23.6% to $7.73 after the company said it believes its Biologics License Application is approvable based on recent conversations with the FDA.</li>
<li>Power Solutions International, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PSIX#NASDAQ">PSIX</a>) gained 20.9% to $25.41.</li>
<li>Summit Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SMMT#NASDAQ">SMMT</a>) rose 17.2% to $32.06 after the company provided updates on its Phase 3 trial of Ivonescimab and announced it met its primary endpoint.</li>
<li>Tempus AI, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TEM#NASDAQ">TEM</a>) gained 15.1% to $49.77 after the company announced a multi-year collaboration with several firms, including AstraZeneca, to develop the largest multimodal foundation model in oncology.</li>
<li>BioNTech SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) jumped 13.9% to $119.23.</li>
<li>Chart Industries, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GTLS#NASDAQ">GTLS</a>) rose 13% to $136.79.</li>
<li>Semtech Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SMTC#NASDAQ">SMTC</a>) jumped 12.7% to $27.83.</li>
<li>Super Micro Computer, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SMCI#NASDAQ">SMCI</a>) rose 12.7% to $34.51.</li>
<li>Lumentum Holdings Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LITE#NASDAQ">LITE</a>) gained 12.5% to $58.12.</li>
<li>Amer Sports, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AS#NYSE">AS</a>) rose 12.2% to $24.95.</li>
<li>East West Bancorp, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EWBC#NASDAQ">EWBC</a>) gained 12.1% to $88.79 after Barclays raised its price target on the stock from $105 to $110 and maintained an Overweight rating.</li>
<li>Vertiv Holdings Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/VRT#NYSE">VRT</a>) rose 12% to $80.41 after the company reported better-than-expected quarterly financial results and raised its full-year sales guidance.</li>
<li>Robinhood Markets, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HOOD#NASDAQ">HOOD</a>) gained 11% to $46.74.</li>
<li>SAP SE (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SAP#NYSE">SAP</a>) gained 9.2% to $275.61 after the company reported better-than-expected quarterly financial results.</li>
<li>Tesla, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSLA#NASDAQ">TSLA</a>) rose 7.5% to $255.71 after the company reported first-quarter results and CEO Elon Musk indicated his time allocation to DOGE would drop. Additionally, Wedbush raised its price target from $315 to $350.</li>
<li>NVIDIA Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVDA#NASDAQ">NVDA</a>) gained 5.7% to $104.51.</li>
</ul>
Now Read This: 
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<li><a href="https://www.benzinga.com/25/04/44947241/wall-streets-most-accurate-analysts-give-their-take-on-3-tech-stocks-with-over-4-dividend-yields">Wall Street&#8217;s Most Accurate Analysts Give Their Take On 3 Tech Stocks With Over 4% Dividend Yields</a> </li>
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Amphenol Posts Better-Than-Expected Results, Joins SAP, Tesla, Pegasystems And Other Big Stocks Moving Higher On Wednesday

Novavax shares are trading higher after the company said it believes its Biologics License Application is approvable based on recent conversations with the FDA.

On April 23, 2025, Novavax, Inc. (the "Company") issued the following statement:
&nbsp;
We believe that our Biologics License Application ("BLA") is approvable based on conversations with U.S. Food and Drug Administration ("FDA"), as of our Prescription Drug User Fee Act date on April 1 and through today.
&nbsp;
We have recently received formal communication from the FDA in the form of an information request for a post marketing commitment ("PMC") to generate additional clinical data. We look forward to engaging with the FDA expeditiously to address the PMC request and move to approval as soon as possible.&nbsp;&nbsp;

Novavax Believes Its Biologics License Application Is Approvable Based On Conversations With FDA As Of PDUFA Date On Apr. 1 And Through Today

DVAX

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Shares of vaccine stocks are trading lower after CDC advisers begins a review of vaccine guidelines and discussed a more narrow use of COVID-19 booster shots.

Novavax, Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) on Tuesday released preliminary results from the SHIELD-Utah&nbsp;study investigating the effects of systemic and local reactogenicity of COVID-19 <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">vaccine doses in&nbsp;Utah</a>.
SHIELD-Utah&nbsp;was a prospective, interventional study conducted at the&nbsp;University of Utah&nbsp;Health.
The study showed Novavax&#8217;s COVID-19 Vaccine, Adjuvanted (2024-2025 Formula), targeting the JN.1 strain, resulted in fewer and less severe reactogenicity symptoms when compared with the Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>)-BioNTech SE&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/n44808832/shield-utah-study-shows-novavaxs-covid-19-vaccine-induces-lower-reactogenicity-symptoms-compared-t" rel="noreferrer noopener">mRNA 2024-2025 vaccine</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44634464/despite-headwinds-biotech-sell-off-could-offer-buying-opportunity-bofa" rel="noreferrer noopener">Despite Headwinds, Biotech Sell-Off Could Offer Buying Opportunity: Analyst</a>
This real-world study, conducted between September and&nbsp;December 2024, also showed that the impact of symptoms on daily activities, including work and family responsibilities, was lower in recipients of Novavax&#8217;s vaccine.
&#8220;The risk of side effects or reactogenicity has been shown to be a major decision factor for those opting to get vaccinated. Our findings of lower frequency and intensity of reactogenicity symptoms from the protein-based COVID-19 vaccine observed in SHIELD-Utah&nbsp;add valuable insights to the public debate weighing choice and value of COVID-19 vaccination,&#8221; said&nbsp;Sarang K. Yoon, DO, MOH, Principal Investigator,&nbsp;University of Utah&nbsp;Health.
As in previous studies, the SHIELD study found health care workers who received the Novavax vaccine reported significantly fewer reactogenicity events than Pfizer-BioNTech recipients.
On average, Novavax recipients experienced 1.7 symptoms versus 2.8 systemic symptoms in Pfizer-BioNTech recipients.
43.8% of Pfizer-BioNTech recipients experienced at least one symptom of Grade 2 or higher compared to 24.2% of Novavax recipients.
Local reactogenicity events also showed an absolute difference of 12.5% fewer in Novavax recipients versus Pfizer-BioNTech recipients.
The impact of symptoms on daily activities, including work, showed the hours of reduced activity were lower in Novavax recipients versus Pfizer-BioNTech recipients (mean=0.7 vs. 1.4h and mean=0.8 vs. 2.4h for missed work and less productivity, respectively).
Earlier this month, the regulators missed the deadline for deciding to grant full approval to <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44613147/fda-delays-full-approval-decision-on-novavaxs-covid-19-vaccine" rel="noreferrer noopener">Novavax&#8217;s COVID-19 shot</a>.
Price Action: NVAX stock is down 3.60% at $6.18 at the last check Tuesday
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Novavax Covid Vaccine Shows Milder Side Effects Than Pfizer-BioNTech's Shot: Study

Novavax Announces Prelim. Results From SHIELD-Utah Study Showing Co.'s Vaccine, Adjuvanted (2024-2025 Formula) Resulted In Fewer And Less Severe Reactogenicity Symptoms vs Pfizer-BioNTech mRNA 2024-2025 Vaccine

<h3>Gainers</h3>
<ul>
<li>Reshape Lifesciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RSLS#NASDAQ">RSLS</a>) stock moved upwards by 81.6% to $0.62 during Thursday's regular session. The market value of their outstanding shares is at $2.0 million. As per the news, the Q4 earnings report came out 4 days ago. </li>
<li>Sharps Technology (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/STSS#NASDAQ">STSS</a>) shares rose 66.42% to $0.02. </li>
<li>Conduit Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDT#NASDAQ">CDT</a>) stock rose 50.58% to $0.93. The market value of their outstanding shares is at $8.9 million. </li>
<li>Bio-Rad Laboratories (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BIO#NYSE">BIO</a>) stock increased by 38.04% to $311.01. The market value of their outstanding shares is at $8.7 billion. </li>
<li>Pasithea Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/KTTA#NASDAQ">KTTA</a>) stock moved upwards by 33.99% to $1.46. The market value of their outstanding shares is at $3.9 million. </li>
<li>Bionano Genomics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNGO#NASDAQ">BNGO</a>) stock increased by 27.67% to $3.93. The market value of their outstanding shares is at $10.7 million. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Venus Concept (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VERO#NASDAQ">VERO</a>) shares fell 52.8% to $4.22 during Thursday's regular session. The company's market cap stands at $2.7 million. </li>
<li>Lucid Diagnostics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LUCD#NASDAQ">LUCD</a>) stock declined by 24.78% to $1.24. The company's market cap stands at $112.6 million. </li>
<li>Brainstorm Cell (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BCLI#NASDAQ">BCLI</a>) shares declined by 21.76% to $0.87. The company's market cap stands at $4.9 million. </li>
<li>Novavax (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) shares decreased by 21.2% to $5.32. The market value of their outstanding shares is at $855.5 million. </li>
<li>DIH Holding US (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DHAI#NASDAQ">DHAI</a>) stock declined by 21.12% to $0.13. The market value of their outstanding shares is at $6.0 million. </li>
<li>ENDRA Life Sciences (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NDRA#NASDAQ">NDRA</a>) shares declined by 19.59% to $4.08. The company's market cap stands at $2.1 million. 
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</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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12 Health Care Stocks Moving In Thursday's Intraday Session

Novavax shares are trading lower following comments by RFK Jr. on the company's COVID-19 vaccine in an interview.

<a href="https://www.bloomberg.com/news/articles/2025-04-10/novavax-shares-plunge-after-rfk-jr-questions-its-covid-vaccine" title="https://www.bloomberg.com/news/articles/2025-04-10/novavax-shares-plunge-after-rfk-jr-questions-its-covid-vaccine">https://www.bloomberg.com/news/articles/2025-04-10/novavax-shares-plunge-after-rfk-jr-questions-its-covid-vaccine</a>

'Novavax Shares Plunge After RFK Jr. Questions Its Covid Vaccine' - Bloomberg News

Bank of America Securities <a href="https://www.benzinga.com/general/biotech">writes that SMid-cap biotech</a>, companies with small to mid-sized market capitalizations, had a rocky start to the year.
Many companies in the coverage are down 20-40% year-to-date (NBI: -2.35%).
Tariff concerns and the U.S. Food and Drug Administration (FDA) shakeup added further near-term uncertainty to an already challenging <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">already challenging outlook</a>.
Earlier this week, Peter Marks resigned from his role at the FDA&#8217;s Center for Biologics Evaluation and Research.
Marks was a top regulator at the FDA and played a key role in ensuring the quick approval of vaccines <a href="https://www.benzinga.com/25/03/44562368/moderna-novavax-shares-are-tumbling-monday-whats-going-on" target="_blank" rel="noreferrer noopener">during the COVID-19 pandemic</a>.
In March, the U.S. Department of Health and Human Services unveiled a sweeping restructuring plan on Thursday to cut costs, streamline operations and refocus priorities.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/health-care/25/04/44627279/ftc-pauses-lawsuit-against-cvs-cigna-unitedhealths-pbms-amid-commissioner-shortage" rel="noreferrer noopener">FTC Pauses Lawsuit Against CVS, Cigna, UnitedHealth&#8217;s PBMs Amid Commissioner Shortage</a>
The changes, aligned with President&nbsp;Donald Trump's&nbsp;executive order on government efficiency, will reduce the agency&#8217;s workforce, consolidate divisions, and emphasize efforts to <a target="_blank" href="https://www.benzinga.com/government/regulations/25/03/44519638/us-department-of-health-and-human-services-aligns-with-trumps-executive-order-to-cut-10k-jobs-save-18-billion" rel="noreferrer noopener">combat chronic illness</a>.
The analyst points out that public biotech companies raised only $4.7 billion, compared to $13.6 billion last year, highlighting ongoing challenges in the capital market.
&#8220;And while we see these macro headwinds as likely to continue over the course of 2025, <a href="https://www.benzinga.com/markets/25/04/44627820/trumps-reciprocal-tariffs-on-india-exempt-pharma-easing-mark-cubans-price-hike-concerns">drugs being exempt from reciprocal tariffs</a> should offer some much-needed near-term reprieve for the sector, in our view,&#8221; BofA analyst writes.
Novavax Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) is just one example of FDA. On Wednesday, the regulators missed the deadline for deciding to grant full approval to Novavax&#8217;s Covid-19 shot.
BofA expects more details on the delay in the coming weeks. The expected $125 million milestone payment from Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) will likely be pushed to the second half of 2025.
Despite small and mid-cap biotech stocks being among the worst performers this year, the sector may still present a strong opportunity. Most of these companies (80%) are pre-commercial and have minimal exposure to tariffs or FDA decisions, with only 2 out of 29 under BofA coverage awaiting FDA approval.
The bigger challenges are high interest rates and limited access to capital, but these risks are already factored into valuations. While negative headlines may continue to impact sentiment and investment flows, the recent broad sell-off could be an appealing entry point.
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Analyst Color

Analyst Ratings

Despite Headwinds, Biotech Sell-Off Could Offer Buying Opportunity: Analyst

Editor&#8217;s Note: The story has been updated with comments from Novavax
In September 2024, the U.S. Food And Drug Administration (FDA) granted Emergency Use Authorization to Novavax Inc.'s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) for active immunization to prevent COVID-19 in <a href="https://www.benzinga.com/general/biotech/24/09/40688052/fda-approves-novavaxs-updated-covid-vaccine-targeting-currently-circulating-variants" target="_blank" rel="noreferrer noopener">individuals aged 12 and older</a>.
Novavax's vaccine was included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on&nbsp;June 27, 2024.
Also Read: <a target="_blank" href="https://www.benzinga.com/24/12/42323263/wegovy-maker-novo-nordisk-to-buy-novavaxs-czech-republic-manufacturing-facility-for-200-million" rel="noreferrer noopener">Wegovy Maker Novo Nordisk To Buy Novavax&#8217;s Czech Republic Manufacturing Facility For $200 Million</a>
According to a media report on Wednesday, the regulators missed the deadline for deciding to grant full approval to Novavax's shot.
In an emailed statement to Benzinga, Novavax said, &#8220;Novavax can confirm that April 1, 2025, was the U.S. Food and Drug Administration (FDA)'s Prescription Drug User Fee Act date for our Biologics License Application (BLA) seeking the approval of our COVID-19 Vaccine. As of Tuesday, April 1, we had responded to all of the FDA's information requests and we believe that our BLA is ready for approval. 
As of today, we continue to wait on action from the agency and have not yet received an official decision from the U.S. FDA. Our application included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of COVID-19. We are confident our well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S.&#8221;
Earlier this week, Peter Marks&nbsp;resigned from his role at the FDA's Center for Biologics Evaluation and Research.
Marks was a top regulator at the FDA and played a key role in pushing quick approvals of vaccines <a href="https://www.benzinga.com/25/03/44562368/moderna-novavax-shares-are-tumbling-monday-whats-going-on" target="_blank" rel="noreferrer noopener">during the COVID-19 pandemic</a>.
The Wall Street Journal <a href="https://www.wsj.com/health/healthcare/fda-novavax-covid-19-vaccine-deadline-c160454b" target="_blank" rel="noreferrer noopener">writes</a> that the agency is now delaying the decision and has reportedly asked for more data and that the application isn't likely to be approved soon, according to sources.
The FDA set an April 1 deadline for a decision.
Novavax reported fourth-quarter 2024 sales of $88.31 million, compared to&nbsp;$291 million&nbsp;a year, beating the&nbsp;consensus of $84.35 million. The decrease was due to lower product sales <a target="_blank" href="https://www.benzinga.com/general/biotech/25/02/44013531/novavax-reports-smaller-q4-loss-shifts-focus-from-commercializing-covid-19-vaccine-to-maximize-value" rel="noreferrer noopener">under APA agreements</a>.
The COVID-19 vaccine maker reported an earning loss of 51 cents per share, down from $1.44 a year ago, in line&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/25/02/n44004179/novavax-reports-fourth-quarter-and-full-year-2024-financial-results-and-operational-highlights" rel="noreferrer noopener">with the Wall Street Estimate</a>.
The news comes after vaccine stocks came under pressure last week following reports that the Trump administration plans to end financial support for vaccine alliance Gavi, which helps buy vaccines for children in developing countries. The Trump administration reportedly plans to cut billions in global health initiatives.
Price Action: NVAX stock is up 1.25% at $6.09 at the last check on Wednesday.
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Rumors

FDA Delays Full Approval Decision On Novavax's COVID-19 Vaccine (UPDATED)

<a href="https://ir.novavax.com/press-releases/Update-on-U-S-FDA-BLA-for-Novavaxs-COVID-19-Vaccine" title="https://ir.novavax.com/press-releases/Update-on-U-S-FDA-BLA-for-Novavaxs-COVID-19-Vaccine">https://ir.novavax.com/press-releases/Update-on-U-S-FDA-BLA-for-Novavaxs-COVID-19-Vaccine</a>

Novavax Confirms That April 1, 2025, Was The U.S. FDA's Prescription Drug User Fee Act Date For It's Biologics License Application Seeking The Approval Its COVID-19 Vaccine

<a href="https://www.wsj.com/health/healthcare/fda-novavax-covid-19-vaccine-deadline-c160454b" title="https://www.wsj.com/health/healthcare/fda-novavax-covid-19-vaccine-deadline-c160454b">https://www.wsj.com/health/healthcare/fda-novavax-covid-19-vaccine-deadline-c160454b</a>

'FDA Misses Deadline For Covid-19 Vaccine Decision' - Wall Street Journal

Politics

Trump Administration Health Agency Firings Include Staff Overseeing Bird Flu Response

Press Releases

Novavax Advances Corporate Growth Strategy Through Sanofi Partnership, Including Achievement of First $50 Million Milestone

Brian Rosen, Commercial Strategy Senior Executive, Appointed as Director of Capstone Companies, Inc.

Novavax to Host Conference Call to Discuss Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights on February 27, 2025

Earnings

Novavax Reports Fourth Quarter and Full Year 2024 Financial Results and Operational Highlights

Novavax to Participate in Upcoming March Investor Conferences

Novavax Announces Changes to Board of Directors

SHIELD-Utah Study Shows Novavax's COVID-19 Vaccine Induces Lower Reactogenicity Symptoms Compared to mRNA

Novavax Appoints Charles Newton to Board of Directors

Novavax to Report First Quarter 2025 Financial Results on May 8, 2025

Novavax Announces Significantly Improved Terms for Collaboration and License Agreement with Takeda for Nuvaxovid® in Japan

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