最新ニュース Novavax (NASDAQ:NVAX) 株価情報

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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Novavax Inc

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 experienced a notable upswing this week, driven by President Donald Trump's announcement of a trade agreement with the United Kingdom. The deal includes reductions in tariffs on UK automobiles, steel, and aluminum, and grants the UK access to the U.S. beef market. This development spurred optimism for potential future trade agreements and contributed to a rally in equities, with the S&amp;P 500 and Nasdaq posting gains. Additionally, Bitcoin (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>) surpassed the $100,000 mark, reflecting increased investor confidence and a shift toward riskier assets.
Despite the positive market response, concerns about the broader economic outlook persist. The Federal Reserve opted to maintain current interest rates, citing uncertainties related to the new tariff policies and their potential impact on inflation and employment. Analysts warn of the risk of stagflation — a combination of stagnant economic growth and high inflation—especially as the effects of the tariffs become more pronounced.
Looking ahead, high-level trade discussions between U.S. and Chinese officials are scheduled, aiming to address ongoing tensions and possibly adjust existing tariffs. Investors are closely monitoring these developments, as outcomes could significantly influence market dynamics and economic forecasts in the coming months.
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/25/05/45259042/ibm-thinks-big-ai-delivers-bigger-why-bulls-are-charging-toward-300">"IBM Thinks Big, AI Delivers Bigger – Why Bulls Are Charging Toward $300"</a>, by Surbhi Jain, reports that International Business Machines Corp. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IBM#NYSE">IBM</a>) shares have climbed 48% over the past year and 13% year-to-date, driven by strong technical indicators and a bullish AI strategy, prompting Wedbush analyst Dan Ives to reiterate an Outperform rating with a $300 price target.
<a href="https://www.benzinga.com/25/05/45295534/novavax-reports-q1-profit-as-revenue-surges-to-over-600-million-and-lower-costs-raises-2025-forecasts">"Novavax reports Q1 profit as revenue surges to over $600 million and lower costs, raises 2025 forecasts"</a>, by Vandana Singh, reports that Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) posted a Q1 profit of $2.93 per share on $667 million in revenue — driven by $603 million from terminated advance purchase agreements — while raising its 2025 revenue forecast to $975 million-$1.025 billion and noting ongoing discussions with the FDA for full approval of its COVID-19 vaccine.
<a href="https://www.benzinga.com/25/05/45297555/hims-hers-stocks-100-surge-is-squeezing-shorts-and-it-might-just-be-getting-started">"Hims &amp; Hers stock's 100% surge is squeezing shorts—and it might just be getting started"</a>, by Surbhi Jain, reports that Hims &amp; Hers Health Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HIMS#NYSE">HIMS</a>) shares have doubled over the past month, fueled by strong Q1 earnings, a partnership with Novo Nordisk to offer Wegovy, and a high short interest of 33% of float, suggesting a classic short squeeze may be underway.
For additional bullish calls of the past week, check out the following:
<a href="https://www.benzinga.com/government/regulations/25/05/45298562/chipmakers-enter-bullish-seasonal-window-5-stocks-that-could-outperform">Chipmakers Enter Bullish Seasonal Window: 5 Stocks That Could Outperform</a>
<a href="https://www.benzinga.com/25/05/45291509/nvidia-broadcom-amd-surge-as-trump-reshapes-ai-chip-export-rules-to-ease-market-pressure">Nvidia, Broadcom, AMD Gain As Trump Reshapes AI Chip Export Rules To Ease Market Pressure</a>
<a href="https://www.benzinga.com/news/earnings/25/05/45268589/sunrun-stock-rallies-after-strong-q1-report-details">Sunrun Stock Rallies After Strong Q1 Report: Details</a>

The Bears
<a href="https://www.benzinga.com/news/earnings/25/05/45268429/arm-holdings-stock-plunges-after-q4-results-heres-why">"Arm Holdings Stock Plunges After Q4 Results: Here's Why"</a>, by Erica Kollmann, reports that Arm Holdings plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARM#NASDAQ">ARM</a>) shares fell nearly 9% after the company beat Q4 expectations with $1.24 billion in revenue and $0.55 EPS but issued weaker-than-expected guidance for fiscal 2026, citing uncertainty in licensing deals and global trade tensions.
<a href="https://www.benzinga.com/25/05/45272331/super-micro-slides-as-ai-server-delays-nvidia-supply-limits-weigh-on-analyst-ratings">"Super Micro slides as AI server delays, Nvidia supply limits weigh on analyst ratings"</a>, by Anusuya Lahiri, reports that Super Micro Computer Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SMCI#NASDAQ">SMCI</a>) shares fell 5% after the company missed Q3 revenue and EPS expectations and issued a cautious Q4 outlook, attributing delays to customers awaiting NVIDIA Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVDA#NASDAQ">NVDA</a>) Blackwell GPUs and facing supply constraints, leading analysts to lower forecasts amid concerns over AI server demand and margin pressures.
<a href="https://www.benzinga.com/25/05/45261806/sarepta-therapeutics-stock-sinks-on-gloomy-forecast-analysts-cut-price-forecasts">"Sarepta Therapeutics stock sinks on gloomy forecast, analysts cut price forecasts"</a>, by Vandana Singh, reports that Sarepta Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>) shares fell after the company posted a deeper-than-expected Q1 loss and cut its 2025 forecast due to Elevidys rollout delays, despite beating revenue estimates.
For more bearish takes, be sure to see these posts:
<a href="https://www.benzinga.com/news/earnings/25/05/45239188/arista-networks-shares-fall-after-mixed-q1-results-eps-beat-revenues-miss-q2-guidance-below-estimates">Arista Networks Shares Fall After Mixed Q1 Results: EPS Beat, Revenues Miss, Q2 Guidance Below Estimates</a>
<a href="https://www.benzinga.com/news/earnings/25/05/45270996/cleveland-cliffs-stock-falls-on-q1-earnings-miss-steelmaker-idles-6-facilities-taking-decisive-action-to-streamline-our-operations">Cleveland-Cliffs Stock Falls On Q1 Earnings Miss, Steelmaker Idles 6 Facilities: ‘Taking Decisive Action To Streamline Our Operations'</a>
<a href="https://www.benzinga.com/news/earnings/25/05/45302422/coinbase-q1-earnings-highlights-revenue-eps-miss-2025">Coinbase Slips On Q1 Miss, Highlights SEC ‘Win' And Strategic Bitcoin Reserve Executive Order</a>

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Benzinga Bulls And Bears: IBM, Novavax, Arm Holdings — And UK Trade Deal Boosts Markets

JP Morgan analyst Eric Joseph maintains Novavax (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) with a Underweight and lowers the price target from $9 to $7.

Price Target

Analyst Ratings

JP Morgan Maintains Underweight on Novavax, Lowers Price Target to $7

On Thursday, Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) reported first-quarter 2025 sales of $667 million, compared to&nbsp;$94 million&nbsp;a year ago, beating the&nbsp;<a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">consensus of $343.85 million</a>.
Higher product sales for the first quarter of 2025 were primarily due to&nbsp;$603 million&nbsp;of revenue recognized with the termination of two Advance Purchase Agreements (APA) and related to cash received in prior years.&nbsp;
$45 million&nbsp;of Licensing, Royalties, &amp; Other Revenue in the first quarter of 2025 was higher than the prior year due to&nbsp;$40 million&nbsp;of Sanofi revenue associated with upfront payment, milestone amortization, <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/n45282885/novavax-reports-first-quarter-2025-financial-results-and-operational-highlights" rel="noreferrer noopener">and cost reimbursement</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/health-care/25/04/45059756/trump-era-fda-appointees-request-new-trials-for-novavax-covid-vaccine-reportedly-delaying-approval-timeline" rel="noreferrer noopener">Trump-Era FDA Appointees Request New Trials For Novavax COVID Vaccine, Reportedly Delaying Approval Timeline</a>
The COVID-19 vaccine maker reported an earnings per share of $2.93, a turnaround from a loss of $1.05, beating the Wall Street Estimate of 71 cents.
"I am pleased with the progress we have made in the first quarter on our corporate growth strategy," said&nbsp;John Jacobs, President and Chief Executive Officer, Novavax. "We remain focused on creating shareholder value as we advance our three priorities for the year – optimizing our partnership with Sanofi, advancing new and existing partnership opportunities and continuing the development of our early-stage organic pipeline."&nbsp;
Nuvaxovid sales reached $608 million, up from $82 million a year ago.
Cost of sales&nbsp;for the first quarter of 2025 was&nbsp;$14 million, compared to&nbsp;$59 million&nbsp;in the same period in 2024.
R&amp;D expenses&nbsp;were&nbsp;$89 million, compared to&nbsp;$93 million a year ago, primarily due to reductions in overall expenditures related to COVID-19 vaccine development.
SG&amp;A expenses&nbsp;reached $48 million, compared to&nbsp;$87 million&nbsp;a year ago, due to the completion of commercial activities and ongoing cost reduction efforts.
Cash and equivalents were $747 million as of March 31, 2025, compared to $938 million as of December 31, 2024.
Guidance: Beginning with the 2025-2026 vaccination season, Novavax transitioned lead commercial responsibility of Nuvaxovid to Sanofi for select markets.
Since Novavax relies on Sanofi SA's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) sales forecasts for certain revenue components, these are not included in the Full-Year 2025 Revenue Framework.
For 2025, Novavax expects to achieve adjusted total revenue between&nbsp;$975 million&nbsp;and&nbsp;$1.025 billion versus the consensus of $724.16 million and the prior <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">range of $300 million-$350 million</a>.
Nuvaxovid product sales for 2025 are expected to be $610 million, and adjusted supply sales of $20-$35 million.
According to a media report in early April, the regulators missed the deadline for deciding to grant full&nbsp;<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's shot</a>.
In an SEC filing, Novavax&nbsp;<a target="_blank" href="https://www.benzinga.com/secfilings/25/04/44946464/novavax-inc-general-corporate-statement-form8" rel="noreferrer noopener">said</a>, "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&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44966369/novavaxs-covid-19-vaccine-nears-fda-full-approval-stock-jumps" rel="noreferrer noopener">April 1 and through today</a>."
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.
Price Action: NVAX stock is up 16.10% at $6.91 at the last check on Thursday.
Read Next:
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<li><a href="https://www.benzinga.com/news/25/05/45285725/why-budweiser-parent-anheuser-busch-inbevs-stock-is-rising-today" target="_blank" rel="noreferrer noopener">Why Budweiser Parent Anheuser-Busch InBev's Stock Is Rising Today?</a></li>
</ul>
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COVID Vaccine Maker Novavax Stock Soars 16% - Here's Why

D-Wave Quantum Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/QBTS#NYSE">QBTS</a>), Asset Entities, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ASST#NASDAQ">ASST</a>), Alphabet, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOOG#NASDAQ">GOOG</a>) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOOGL#NASDAQ">GOOGL</a>), Novavax, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) and Carvana Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVNA#NYSE">CVNA</a>) are the top five trending tickers on Stocktwits <a href="https://www.benzinga.com/trading-ideas/movers/25/05/45274508/bitcoin-taps-98000-ethereum-dogecoin-steady-as-fed-chair-jerome-powell-raises-trump-tariff-induced-concerns-analyst-says-eth-holding-above-crucial-level-and-begins-its">Thursday.&nbsp;</a>
Here's a look at what is grabbing retail investors' attention.&nbsp;
QBTS: D-Wave Quantum shares are rallying after the company beat analysts' estimates and reported record <a href="https://www.benzinga.com/pressreleases/25/05/b45280859/d-wave-reports-first-quarter-2025-results">quarterly revenue</a> before the opening bell. While $15 million may not sound impressive, it is a 509% increase from the prior year's quarter and retail investors are piling in.&nbsp;
Read Next: <a href="https://www.benzinga.com/general/travel/25/05/45260938/disneys-new-abu-dhabi-theme-park-will-be-authentically-disney-and-distinctly-emirati-ceo-bob-iger-says?utm_source=articleShare">Disney&#8217;s New Abu Dhabi Theme Park Will Be &#8216;Authentically Disney And Distinctly Emirati,&#8217; CEO Bob Iger Says&nbsp;</a>
ASST: Asset Entities stock is volatile for the second day on Thursday following Wednesday's announcement that it <a href="https://www.benzinga.com/news/contracts/25/05/45260992/asset-entities-stock-rockets-higher-on-merger-deal-to-form-bitcoin-treasury-company">will merge</a> with Strive Asset Management to be the first publicly traded asset management Bitcoin (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>) treasury company. Trading has been halted multiple times for volatility and the stock is up over 100% at the time of publication.&nbsp;
GOOG: Alphabet suffered its worst <a href="https://www.benzinga.com/analyst-ratings/analyst-color/25/05/45288753/google-at-staggering-42-discount-to-sp-500-after-150-billion-value-dive">trading day</a> since 2023, shedding nearly $150 billion in market cap, on Wednesday after Apple revealed it has been talking to ChatGPT and Perplexity about potential search partnerships. The stock is attempting to recover some losses Thursday, but Google's future search dominance remains in question.&nbsp;&nbsp;
NVAX: Retail traders are celebrating Novavax's massive<a href="https://www.benzinga.com/pressreleases/25/05/n45282885/novavax-reports-first-quarter-2025-financial-results-and-operational-highlights"> first-quarter earnings</a> beat that was released before Thursday's opening bell. The company reported earnings of $2.93 per share which beat the Street estimate of 71 cents by a whopping 312%. Novavax also reported nearly double the consensus revenue estimate and issued guidance well-above analysts' estimates.&nbsp;
CVNA: Carvana shares are driving higher on its better-than-expected Q1 earnings, as well as a slew of analysts' price target raises. The company reported<a href="https://www.benzinga.com/news/earnings/25/05/45268560/carvana-q1-earnings-revenue-eps-beat-estimates-as-vehicles-sales-jump-46-company-remains-on-track-for-significant-growth-in-fy25"> first-quarter earnings</a> of $1.51 per share, smashing analyst estimates of 60 cents per share.
Read Next:&nbsp;
<ul>
<li><a href="https://www.benzinga.com/general/biotech/25/05/45239803/sarepta-therapeutics-stock-plummets-after-q1-results-heres-why?utm_source=articleShare">Sarepta Therapeutics Stock Plummets After Q1 Results: Here&#8217;s Why </a></li>
</ul>
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Thursday's Top 5 Trending Stocks: What's Going On With D-Wave, Novavax, Carvana?

WIIM

Novavax shares are trading higher after the company reported better-than-expected Q1 results and issued FY25 sales guidance above estimates.

<h3>Gainers</h3>
<ul>
<li>Cognition Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CGTX#NASDAQ">CGTX</a>) shares rose 22.9% to $0.44 during Thursday's pre-market session. The market value of their outstanding shares is at $27.0 million. As per the press release, Q1 earnings came out yesterday. </li>
<li>Emergent BioSolutions (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EBS#NYSE">EBS</a>) shares moved upwards by 18.55% to $5.62. The market value of their outstanding shares is at $305.3 million. The company's, Q1 earnings came out yesterday. </li>
<li>Mira Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MIRA#NASDAQ">MIRA</a>) stock rose 16.37% to $1.35. The market value of their outstanding shares is at $22.3 million. </li>
<li>Aveanna Healthcare Hldgs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVAH#NASDAQ">AVAH</a>) shares moved upwards by 16.18% to $5.6. The market value of their outstanding shares is at $1.0 billion. As per the press release, Q1 earnings came out today. </li>
<li>Novavax (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) stock moved upwards by 12.94% to $6.72. The company's market cap stands at $1.0 billion. As per the news, the Q1 earnings report came out today. </li>
<li>Akebia Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AKBA#NASDAQ">AKBA</a>) shares increased by 12.6% to $2.77. The company's market cap stands at $723.6 million. As per the press release, Q1 earnings came out today. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>NuCana (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NCNA#NASDAQ">NCNA</a>) stock declined by 63.4% to $0.11 during Thursday's pre-market session. </li>
<li>Accelerate Diagnostics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AXDX#NASDAQ">AXDX</a>) stock fell 29.2% to $0.33. The company's market cap stands at $8.2 million. </li>
<li>electroCore (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ECOR#NASDAQ">ECOR</a>) shares fell 14.69% to $5.81. The market value of their outstanding shares is at $41.7 million. As per the press release, Q1 earnings came out yesterday. </li>
<li>Exagen (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XGN#NASDAQ">XGN</a>) shares decreased by 13.47% to $5.91. The market value of their outstanding shares is at $106.3 million. The company's, Q1 earnings came out 3 days ago. </li>
<li>ZyVersa Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ZVSA#NASDAQ">ZVSA</a>) shares declined by 13.32% to $0.59. The market value of their outstanding shares is at $2.1 million. </li>
<li>LogicMark (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGMK#NASDAQ">LGMK</a>) stock decreased by 12.5% to $0.01. 
See Also: <a href="http://www.benzinga.com/money/best-healthcare-stocks/" title="www.benzinga.com/money/best-healthcare-stocks/">www.benzinga.com/money/best-healthcare-stocks/</a></li>
</ul>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

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

Novavax (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) sees FY2025 sales of $975.000 million-$1.025 billion vs $724.16 million analyst estimate.

Novavax Sees FY2025 Sales $975.000M-$1.025B vs $724.16M Est

Novavax (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) reported quarterly earnings of $2.93 per share which beat the analyst consensus estimate of $0.71 by 312.68 percent. This is a 379.05 percent increase over losses of $(1.05) per share from the same period last year. The company reported quarterly sales of $666.65 million which beat the analyst consensus estimate of $343.85 million by 93.88 percent. This is a 610.30 percent increase over sales of $93.86 million the same period last year.

Earnings Beats

Novavax Q1 EPS $2.93 Beats $0.71 Estimate, Sales $666.65M Beat $343.85M Estimate

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Earnings Scheduled For May 8, 2025

Novavax (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) is gearing up to announce its quarterly earnings on Thursday, 2025-05-08. Here's a quick overview of what investors should know before the release.
Analysts are estimating that Novavax will report an earnings per share (EPS) of $0.19.
The market awaits Novavax's announcement, with hopes high for news of surpassing estimates and providing upbeat guidance for the next quarter.
It's important for new investors to understand that guidance can be a significant driver of stock prices.
<h3>Overview of Past Earnings</h3>
During the last quarter, the company reported an EPS missed by $0.00, leading to a 17.99% increase in the share price on the subsequent day.
Here's a look at Novavax's past performance and the resulting price change:

<table>
<thead>
<tr>
<th>Quarter</th>
<th>Q4 2024</th>
<th>Q3 2024</th>
<th>Q2 2024</th>
<th>Q1 2024</th>
</tr>
</thead>
<tbody>
<tr>
<td>EPS Estimate</td>
<td>-0.51</td>
<td>-0.83</td>
<td>1.36</td>
<td>-1.06</td>
</tr>
<tr>
<td>EPS Actual</td>
<td>-0.51</td>
<td>-0.76</td>
<td>0.99</td>
<td>-1.05</td>
</tr>
<tr>
<td>Price Change %</td>
<td>18.0%</td>
<td>-8.0%</td>
<td>-1.0%</td>
<td>99.0%</td>
</tr>
</tbody>
</table>

<img src="https://www.benzinga.com/files/images/story/2025/1746630170_0.png" alt="eps graph" />
<h3>Market Performance of Novavax's Stock</h3>
Shares of Novavax were trading at $6.07 as of May 06. Over the last 52-week period, shares are up 35.01%. Given that these returns are generally positive, long-term shareholders should be satisfied going into this earnings release. 
<a href="https://www.benzinga.com/quote/NVAX/earnings">To track all earnings releases for Novavax visit their earnings calendar on our site.</a>
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Uncovering Potential: Novavax's Earnings Preview

FDA Commissioner Marty Makary on Tuesday named Vinay Prasad the next director of the U.S. Food and Drug Administration&#8217;s (FDA) Center of Biologics Evaluation and Research (CBER).
Dr. Prasad has openly criticized the biopharma industry and the FDA for using accelerated approvals broadly based on surrogate endpoints.
&#8220;We are surprised by the announcement because it seems to be in stark contrast to themes and initiatives that have been laid out by Dr. Makary, and it comes on the heels of large personnel departures across the FDA, raising questions on the ability to meet review timelines,&#8221; writes <a href="https://www.benzinga.com/topic/william-blair">William Blair </a>of Blue Matrix.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/05/45234032/fda-expands-surprise-inspections-at-foreign-drug-and-food-facilities-targets-double-standards-in-overseas-manufac" rel="noreferrer noopener">FDA Expands Surprise Inspections At Foreign Drug And Food Facilities, Targets Double Standards In Overseas Manufacturing Oversight</a>
Analyst Matt Phipps adds that there are many questions about how Prasad will shape regulatory decisions as the new head of CBER. Investors also seem confused about what CBER regulates compared to the Center of Drug Evaluation and Research (CDER).
Generally, drugs like antibodies, bispecifics and antibody-drug conjugates (ADCs) are reviewed by CDER, even though they use biologics license applications (BLAs).
CBER, on the other hand, oversees gene and cell therapies, vaccines and some other biological products. CDER typically handles therapeutic antibodies, proteins, cytokines and enzymes.
Blair wrote on Tuesday that for cell and gene therapies stocks that have reacted negatively, there are outstanding questions and increased uncertainty now as the analyst waits to see whether Makary or Prasad will have more impact on the guidelines and regulatory development requirements for these novel therapies, particularly in rare diseases.
Since being confirmed as commissioner, Makary has advocated for more accelerated approval opportunities for ultrarare diseases or therapies with overwhelming efficacy.
The vaccine space continues to face negative sentiment from HHS Secretary Robert F. Kennedy Jr., who requested placebo-controlled studies for new vaccine approvals.
Prasad&#8217;s appointment at CBER will likely continue to pressure this sector.
&#8220;Under Secretary Kennedy&#8217;s leadership, all new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices,&#8221; HHS <a target="_blank" href="https://edition.cnn.com/2025/04/30/health/hhs-vaccine-placebo-testing" rel="noreferrer noopener">told</a> CNN in a statement Wednesday.
Blair writes that from the coverage list, Moderna Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) has seen a sharp sell-off and remains in a difficult position with a politically out-of-favor mRNA vaccine technology and a potentially more restrictive CBER head and review process for new vaccine products.
In contrast, Dynavax Technologies Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/DVAX#NASDAQ">DVAX</a>) remains largely insulated given that Heplisav is approved and the analyst sees less scrutiny on adult vaccines that are not being pushed as mandatory.
Taysha Gene Therapies (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TSHA#NASDAQ">TSHA</a>) fell 18%, Solid Biosciences Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SLDB#NASDAQ">SLDB</a>) closed 20.3% lower, Capricor Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CAPR#NASDAQ">CAPR</a>) stock closed 29% lower, Crispr Therapeutics AG (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CRSP#NASDAQ">CRSP</a>) stock closed 12% lower, Sarepta Therapeutics Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>) stock closed 27% lower, Moderna fell 12%, Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) fell 4.2%, and Novavax Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) closed 3.2% on Tuesday. Virtus LifeSci Biotech Clinical Trials ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BBC#NYSE">BBC</a>) closed 9.74% lower at $17.15 and SPDR Series Trust SPDR S&amp;P Biotech ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XBI#NYSE">XBI</a>) fell 6.63% to $77.17 on Tuesday.
Read Next:
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<li><a href="https://www.benzinga.com/25/05/45237060/despite-nikes-executive-overhaul-ongoing-challenges-persist-says-analyst" target="_blank" rel="noreferrer noopener">Nike Revamps C-Suite, &#8216;Win Now&#8217; Strategy Faces Profit Pressure: Analyst</a></li>
</ul>
Photo: Shutterstock

Analyst Color

CAPR

CRSP

DVAX

MRNA

SLDB

TSHA

Vinay Prasad's Appointment To FDA's CBER Triggers Questions Over Future Of Cell And Gene Therapy Regulation

BHVN

MARA

XNCR

Shares of vaccine and gene therapy stocks are trading lower after FDA Commissioner Marty Makary reportedly named Vinay Prasad as director of the Center for Biologics and Research.

<a href="https://news.bloomberglaw.com/health-law-and-business/fda-names-vinay-prasad-as-new-head-of-vaccines-biologics" title="https://news.bloomberglaw.com/health-law-and-business/fda-names-vinay-prasad-as-new-head-of-vaccines-biologics">https://news.bloomberglaw.com/health-law-and-business/fda-names-vinay-prasad-as-new-head-of-vaccines-biologics</a>

DSGN

PTCT

'FDA Names Vinay Prasad as New Head of Vaccines, Biologics'- Bloomberg Law

This whale alert can help traders discover the next big trading opportunities.
Whales are entities with large sums of money and we track their transactions here at Benzinga on our options activity scanner.
Traders will search for circumstances when the market estimation of an option diverges heavily from its normal worth. High amounts of trading activity could push option prices to exaggerated or underestimated levels. 
Below are some instances of options activity happening in the Health Care sector: 
<table>
<thead>
<tr>
<th>Symbol</th>
<th>PUT/CALL</th>
<th>Trade Type</th>
<th>Sentiment</th>
<th>Exp. Date</th>
<th>Strike Price</th>
<th>Total Trade Price</th>
<th>Open Interest</th>
<th>Volume</th>
</tr>
</thead>
<tbody>
<tr>
<td>UNH</td>
<td>CALL</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>05/09/25</td>
<td>$400.00</td>
<td>$51.3K</td>
<td>1.2K</td>
<td>2.2K</td>
</tr>
<tr>
<td>NVAX</td>
<td>PUT</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>01/16/26</td>
<td>$12.50</td>
<td>$50.3K</td>
<td>9.5K</td>
<td>1.4K</td>
</tr>
<tr>
<td>MRNA</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>06/20/25</td>
<td>$20.00</td>
<td>$33.2K</td>
<td>3.0K</td>
<td>578</td>
</tr>
<tr>
<td>HIMS</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>01/16/26</td>
<td>$50.00</td>
<td>$137.0K</td>
<td>3.2K</td>
<td>466</td>
</tr>
<tr>
<td>MRK</td>
<td>PUT</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>05/30/25</td>
<td>$84.00</td>
<td>$49.2K</td>
<td>684</td>
<td>443</td>
</tr>
<tr>
<td>SRPT</td>
<td>PUT</td>
<td>TRADE</td>
<td>BEARISH</td>
<td>05/16/25</td>
<td>$55.00</td>
<td>$30.7K</td>
<td>660</td>
<td>405</td>
</tr>
<tr>
<td>VERA</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>06/20/25</td>
<td>$25.00</td>
<td>$165.0K</td>
<td>1.9K</td>
<td>306</td>
</tr>
<tr>
<td>CAPR</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>09/19/25</td>
<td>$15.00</td>
<td>$48.0K</td>
<td>2.8K</td>
<td>274</td>
</tr>
<tr>
<td>BIO</td>
<td>PUT</td>
<td>TRADE</td>
<td>NEUTRAL</td>
<td>05/16/25</td>
<td>$210.00</td>
<td>$60.0K</td>
<td>401</td>
<td>250</td>
</tr>
<tr>
<td>PFE</td>
<td>PUT</td>
<td>TRADE</td>
<td>NEUTRAL</td>
<td>05/16/25</td>
<td>$30.00</td>
<td>$36.2K</td>
<td>1.0K</td>
<td>150</td>
</tr>
</tbody>
</table>

<h2>Explanation</h2>
These bullet-by-bullet explanations have been constructed using the accompanying table. 
• For UNH (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNH#NYSE">UNH</a>), we notice a call option trade that happens to be bearish, expiring in 3 day(s) on May 9, 2025. This event was a transfer of 137 contract(s) at a $400.00 strike. The total cost received by the writing party (or parties) was $51.3K, with a price of $375.0 per contract. There were 1204 open contracts at this strike prior to today, and today 2200 contract(s) were bought and sold. 
• Regarding NVAX (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>), we observe a put option trade with bearish sentiment. It expires in 255 day(s) on January 16, 2026. Parties traded 74 contract(s) at a $12.50 strike. The total cost received by the writing party (or parties) was $50.3K, with a price of $680.0 per contract. There were 9573 open contracts at this strike prior to today, and today 1429 contract(s) were bought and sold. 
• Regarding MRNA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>), we observe a put option sweep with bullish sentiment. It expires in 45 day(s) on June 20, 2025. Parties traded 537 contract(s) at a $20.00 strike. This particular put needed to be split into 24 different trades to become filled. The total cost received by the writing party (or parties) was $33.2K, with a price of $62.0 per contract. There were 3002 open contracts at this strike prior to today, and today 578 contract(s) were bought and sold. 
• For HIMS (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HIMS#NYSE">HIMS</a>), we notice a call option sweep that happens to be bullish, expiring in 255 day(s) on January 16, 2026. This event was a transfer of 100 contract(s) at a $50.00 strike. This particular call needed to be split into 10 different trades to become filled. The total cost received by the writing party (or parties) was $137.0K, with a price of $1370.0 per contract. There were 3252 open contracts at this strike prior to today, and today 466 contract(s) were bought and sold. 
• Regarding MRK (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), we observe a put option sweep with bullish sentiment. It expires in 24 day(s) on May 30, 2025. Parties traded 88 contract(s) at a $84.00 strike. This particular put needed to be split into 7 different trades to become filled. The total cost received by the writing party (or parties) was $49.2K, with a price of $560.0 per contract. There were 684 open contracts at this strike prior to today, and today 443 contract(s) were bought and sold. 
• For SRPT (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRPT#NASDAQ">SRPT</a>), we notice a put option trade that happens to be bearish, expiring in 10 day(s) on May 16, 2025. This event was a transfer of 83 contract(s) at a $55.00 strike. The total cost received by the writing party (or parties) was $30.7K, with a price of $370.0 per contract. There were 660 open contracts at this strike prior to today, and today 405 contract(s) were bought and sold. 
• For VERA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VERA#NASDAQ">VERA</a>), we notice a call option sweep that happens to be bullish, expiring in 45 day(s) on June 20, 2025. This event was a transfer of 300 contract(s) at a $25.00 strike. This particular call needed to be split into 6 different trades to become filled. The total cost received by the writing party (or parties) was $165.0K, with a price of $550.0 per contract. There were 1903 open contracts at this strike prior to today, and today 306 contract(s) were bought and sold. 
• For CAPR (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CAPR#NASDAQ">CAPR</a>), we notice a call option sweep that happens to be bullish, expiring in 136 day(s) on September 19, 2025. This event was a transfer of 200 contract(s) at a $15.00 strike. This particular call needed to be split into 14 different trades to become filled. The total cost received by the writing party (or parties) was $48.0K, with a price of $240.0 per contract. There were 2857 open contracts at this strike prior to today, and today 274 contract(s) were bought and sold. 
• For BIO (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BIO#NYSE">BIO</a>), we notice a put option trade that happens to be neutral, expiring in 10 day(s) on May 16, 2025. This event was a transfer of 250 contract(s) at a $210.00 strike. The total cost received by the writing party (or parties) was $60.0K, with a price of $240.0 per contract. There were 401 open contracts at this strike prior to today, and today 250 contract(s) were bought and sold. 
• Regarding PFE (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), we observe a put option trade with neutral sentiment. It expires in 10 day(s) on May 16, 2025. Parties traded 50 contract(s) at a $30.00 strike. The total cost received by the writing party (or parties) was $36.2K, with a price of $725.0 per contract. There were 1013 open contracts at this strike prior to today, and today 150 contract(s) were bought and sold. 
Options Alert Terminology 
 - Call Contracts: The right to buy shares as indicated in the contract. 
 - Put Contracts: The right to sell shares as indicated in the contract. 
 - Expiration Date: When the contract expires. One must act on the contract by this date if one wants to use it. 
 - Premium/Option Price: The price of the contract. 
For more information, visit our <a href="https://pro.benzinga.com/blog/how-to-understand-option-alerts/">Guide to Understanding Options Alerts</a> or read <a href="https://www.benzinga.com/markets/options">more about unusual options activity</a>. 
This article was generated by Benzinga's automated content engine and reviewed by an editor.

Options

VERA

10 Health Care Stocks With Whale Alerts In Today's Session

&nbsp;
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").
&nbsp;
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.
&nbsp;
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.

Contracts

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"> 
<div class="wp-block-embed__wrapper">
<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>
</figure>
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;
Read Next: 
<ul>
<li><a href="https://www.benzinga.com/news/insider-trades/25/04/45059696/airbnb-billionaire-joe-gebbia-buys-over-1-million-worth-of-tsla-stock-ahead-of-elon-musks-robotaxi-launch-in-june">Airbnb Billionaire Joe Gebbia Buys Over $1 Million Worth Of TSLA Stock Ahead Of Elon Musk&#8217;s Robotaxi Launch In June</a></li>
</ul>
Image Via Shutterstock
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

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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Photo: Gorodenkoff/Shutterstock

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