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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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Las 5 acciones más populares del jueves: ¿Qué está pasando con D-Wave, Novavax, Carvana?

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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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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

Novavax Inc

The President Donald Trump administration terminated a <a href="https://www.benzinga.com/25/02/43999106/trumps-officials-to-re-consider-modernas-590-million-bird-flu-vaccine-funding-hhs-cites-biden-administrations-failed-oversight">nearly $600 million contract</a> to Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) for developing an mRNA-based bird flu vaccine, ending a key former President Joe Biden-era pandemic preparedness initiative.
What Happened: Health and Human Services officials canceled Moderna&#8217;s $590 million contract for bird flu vaccine development, the company announced on Wednesday.
Moderna CEO Stéphane Bancel stated: &#8220;While the termination of funding from HHS adds uncertainty, we are pleased by the robust immune response and safety profile observed in this interim analysis of the Phase 1/2 study of our H5 avian flu vaccine and we will explore alternative paths forward for the program.&#8221;
The company reported that clinical testing in approximately 300 adults showed participants achieved nearly 98% immunity within three weeks of the second vaccine dose, with the treatment being generally well-tolerated.
Trump administration officials had previously indicated they were reviewing all contracts from the prior administration. Robert F. Kennedy Jr.-led HHS criticized the review as necessary due to <a href="https://www.benzinga.com/25/02/43999106/trumps-officials-to-re-consider-modernas-590-million-bird-flu-vaccine-funding-hhs-cites-biden-administrations-failed-oversight">&#8220;four years of the Biden administration&#8217;s </a>failed oversight&#8221; of mRNA vaccine expenditures.
See Also: <a href="https://www.benzinga.com/markets/equities/25/05/45662786/boeing-ceo-kelly-ortberg-targets-year-end-certification-for-737-max-7-max-10-amid-faa-scrutiny-says-variants-are-very-important-to-customers-and-backlog">Boeing CEO Kelly Ortberg Targets Year-End Certification For 737 MAX-7, MAX-10 Amid FAA Scrutiny, Says Variants Are &#8216;Very Important&#8217; To Customers And Backlog</a>
Why It Matters: The contract termination threatens pandemic preparedness as H5N1 continues spreading. The Biomedical Advanced Research and Development Authority awarded the January funds to create defenses against strains circulating in livestock and birds. This followed an earlier $176 million bird flu vaccine development award granted in July.
 The CDC has confirmed <a href="https://www.benzinga.com/general/biotech/25/01/43046294/bird-flu-raising-red-flags-among-health-officials-cdc-urges-faster-testing?utm_source=chatgpt.com">67 human bird flu cases since 2024</a>, with the first U.S. death reported in Louisiana, highlighting the ongoing public health threat.
Other vaccine manufacturers are also developing bird flu vaccines, including Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) and CureVac N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVAC#NASDAQ">CVAC</a>), both with vaccines in clinical trials.
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Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo by pedro7merino via Shutterstock

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Trump Administration Terminates $590 Million Moderna Bird Flu Vaccine Deal, Dismantling Biden-Era Pandemic Preparedness Effort

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Novavax Eliminates Position Of COO And Terminates John Trizzino; Trizzino To Continue To Provide Consulting Services

<a href="https://nypost.com/2025/05/27/us-news/new-covid-19-strain-from-china-that-saw-massive-hospitalizations-spike-spreads-to-us/" title="https://nypost.com/2025/05/27/us-news/new-covid-19-strain-from-china-that-saw-massive-hospitalizations-spike-spreads-to-us/">https://nypost.com/2025/05/27/us-news/new-covid-19-strain-from-china-that-saw-massive-hospitalizations-spike-spreads-to-us/</a>

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'New COVID strain from China that led to massive spike in hospitalizations has spread to the US — including NYC' - NY Post

The U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced Tuesday that the COVID-19 vaccine will no longer be among the recommended vaccines for pregnant women and healthy children on the US Centers for Disease Control and Prevention&#8217;s <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">immunization schedule</a>.
Kennedy announced the change in a&nbsp;video&nbsp;<a target="_blank" href="https://x.com/seckennedy/status/1927368440811008138?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg" rel="noreferrer noopener">posted</a> to the social media platform X.
&#8220;As of today, the Covid vaccine for healthy children and healthy pregnant women has been removed from the CDC recommended immunization schedule,&#8221; Kennedy said. &#8220;Last year, the Biden administration urged healthy children to get yet another COVID shot, despite the lack of any clinical data to support the repeat booster strategy in children.&#8221;
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/05/45254051/vinay-prasads-appointment-to-fdas-cber-triggers-questions-over-future-of-cell-and-gene-therapy-regulation" rel="noreferrer noopener">Vinay Prasad&#8217;s Appointment To FDA&#8217;s CBER Triggers Questions Over Future Of Cell And Gene Therapy Regulation</a>
He was joined by the U.S. Food and Drug Administration Commissioner Dr. Marty Makary and National Institutes of Health Director Dr. Jay Bhattacharya.
As of Tuesday morning, the immunization schedule posted online had not yet been changed.
In 2021, Kennedy <a target="_blank" href="https://www.regulationsa.gov/document/FDA-2021-P-0460-0001" rel="noreferrer noopener">filed</a> a citizen petition&nbsp;requesting the FDA to revoke Emergency Use Authorizations for existing COVID-19 vaccines and refrain from approving and licensing them.
The update follows the FDA&#8217;s changes to COVID-19 vaccine requirements, limiting annual booster approvals to older and high-risk Americans while implementing stricter clinical trial <a target="_blank" href="https://www.benzinga.com/government/regulations/25/05/45537919/fda-limits-annual-covid-19-boosters-to-high-risk-americans-demands-new-trials-for-healthy-adults-in-policy-shift-under-rfk-jr" rel="noreferrer noopener">requirements for healthy adults</a>.
The FDA will now require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively restricting their availability to older adults and those at risk of severe illness, according to FDA Commissioner&nbsp;Marty Makary&nbsp;and top U.S. vaccines regulator&nbsp;Vinay Prasad&nbsp;in the New England Journal of Medicine, reported Reuters.
Last week, the FDA&#8217;s Vaccines and Related Biological Products Advisory Committee (VRBPAC) <a target="_blank" href="https://www.fda.gov/vaccines-blood-biologics/industry-biologics/covid-19-vaccines-2025-2026-formula-use-united-states-beginning-fall-2025" rel="noreferrer noopener">voted</a> to recommend a monovalent JN.1-lineage vaccine composition.
Based on the totality of the evidence, the FDA has advised the manufacturers of the approved COVID-19 vaccines that to more closely match currently circulating SARS-CoV-2 viruses, the COVID-19 vaccines for use in the United States beginning in fall 2025 should be monovalent JN.1-lineage-based COVID-19 vaccines (2025-2026 Formula), preferentially using the LP.8.1 strain.&nbsp;
On Friday, Moderna Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) submitted an application to the FDA to review its Spikevax 2025-2026 formula, targeting the SARS-<a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/ac45595488/moderna-files-fda-application-for-the-lp-8-1-targeting-covid-19-vaccine" rel="noreferrer noopener">CoV-2 variant LP.8.1</a>.
Also, Novavax Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) received limited FDA approval for its COVID-19 vaccine, Nuvaxovid, marking a regulatory milestone and unlocking a&nbsp;$175 million milestone payment&nbsp;from partner&nbsp;Sanofi SA&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>)
The approval came after a six-week delay as regulators <a target="_blank" 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" rel="noreferrer noopener">sought additional data</a>.
The vaccine is now authorized for people aged 65 and older and for individuals 12 and up with underlying medical conditions that increase the <a target="_blank" href="https://www.benzinga.com/25/05/45496095/novavax-scores-key-fda-win-shares-jump-19-as-sanofi-milestone-unlock" rel="noreferrer noopener">risk of severe COVID-19</a>.
Price Action: MRNA stock is down 2.86% at $27.01 at the last check Tuesday.
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Photo: Shutterstock

Trading Ideas

Robert F. Kennedy Jr. Says CDC Drops COVID Vaccine For 'Healthy' Pregnant Women, Children

<a href="https://x.com/seckennedy/status/1927368440811008138?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg">https://x.com/seckennedy/status/1927368440811008138?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg</a>

US Health Secretary Kennedy Posts On X "Today, the COVID vaccine for healthy children and healthy pregnant women has been removed from @CDCgov recommended immunization schedule. Bottom line: it's common sense and it's good science. We are now one step closer to realizing @POTUS's promise to Make America Healthy Again."

<a href="https://endpts.com/fda-vaccine-advisors-update-covid-strain-guidance-following-new-framework/#:~:text=Committee%20members%20voted%20unanimously%20to,was%20the%20KP.2%20strain" title="https://endpts.com/fda-vaccine-advisors-update-covid-strain-guidance-following-new-framework/#:~:text=Committee%20members%20voted%20unanimously%20to,was%20the%20KP.2%20strain">https://endpts.com/fda-vaccine-advisors-update-covid-strain-guidance-following-new-framework/#:~:text=Committee%20members%20voted%20unanimously%20to,was%20the%20KP.2%20strain</a>.

'All FDA Committee Members Voted Unanimously To Recommend A Monovalent JN.1-lineage Covid-19 Vaccine For The Upcoming Season, The Same Recommendation Made Last Year; The FDA Ultimately Told Vaccine Manufacturers That The Preferred Strain Within That Lineage Was The KP.2 Strain' - STAT News

<a href="https://www.wsj.com/politics/policy/rfk-jr-maha-commission-report-5c13696d">https://www.wsj.com/politics/policy/rfk-jr-maha-commission-report-5c13696d</a>

'What's Inside RFK Jr.'s MAHA Report'- Wall Street Journal

Novavax's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NYSE">NVAX</a>) short percent of float has fallen 17.46% since its last report. The company recently reported that it has 42.33 million shares sold short, which is 26.23% of all regular shares that are available for trading. Based on its trading volume, it would take traders 6.4 days to cover their short positions on average.
<h3>Why Short Interest Matters</h3>
Short interest is the number of shares that have been sold short but have not yet been covered or closed out. <a href="https://www.benzinga.com/money/how-to-short-a-stock?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">Short selling</a> is when a trader sells shares of a company they do not own, with the hope that the price will fall. Traders make money from short selling if the price of the stock falls and they lose if it rises.
Short interest is important to track because it can act as an indicator of market sentiment towards a particular stock. An increase in short interest can signal that investors have become more bearish, while a decrease in short interest can signal they have become more bullish.
See Also: <a href="https://www.benzinga.com/short-interest?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">List of the most shorted stocks</a>
<h3>Novavax Short Interest Graph (3 Months)</h3>
<img src="https://www.benzinga.com/files/images/story/2025/1747843220_0.png" alt="short_fig" />
As you can see from the chart above the percentage of shares that are sold short for Novavax has declined since its last report. This does not mean that the stock is going to rise in the near-term but traders should be aware that less shares are being shorted.
<h3>Comparing Novavax's Short Interest Against Its Peers</h3>
Peer comparison is a popular technique amongst analysts and investors for gauging how well a company is performing. A company's peer is another company that has similar characteristics to it, such as industry, size, age, and financial structure. You can find a company's peer group by reading its 10-K, proxy filing, or by doing your own similarity analysis.
According to <a href="https://www.benzinga.com/pro/">Benzinga Pro</a>, Novavax's peer group average for short interest as a percentage of float is 16.62%, which means the company has more short interest than most of its peers.
Did you know that increasing short interest can actually be bullish for a stock? <a href="https://www.benzinga.com/money/how-to-make-money-on-a-short-squeeze?adType=benzinga-insights&amp;ad=short-interest&amp;campaign=wallstreetadvantage">This post by Benzinga Money explains how you can profit from it.</a>
This article was generated by Benzinga's automated content engine and was reviewed by an editor.

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What's Driving the Market Sentiment Around Novavax?

The U.S. Food and Drug Administration has announced significant changes to COVID-19 vaccine requirements, limiting annual booster approvals to older and high-risk Americans while implementing stricter clinical trial requirements for healthy adults.
What Happened: The FDA will now require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under age 65, effectively restricting their availability to older adults and those at risk of severe illness, according to FDA Commissioner Marty Makary and top U.S. vaccines regulator Vinay Prasad in the New England Journal of Medicine, reported Reuters.
&#8220;At-risk Americans can be reassured that they will be covered by such approvals. At the same time, we want more evidence at the U.S. Food and Drug Administration,&#8221; Prasad told FDA scientists during a live-streamed presentation on Tuesday. &#8220;We want to know more about what these products are doing, especially as we enter the seventh, eighth and ninth dose.&#8221;
See Also: <a href="https://www.benzinga.com/markets/25/05/45537306/google-unveils-total-reimagining-of-search-with-chatbot-style-feature-to-compete-with-openai">Google Unveils &#8216;Total Reimagining Of Search&#8217; With Chatbot-Style Feature To Compete With OpenAI</a> Why It Matters: This policy shift represents a significant departure from previous U.S. vaccination strategy, with Makary and Prasad noting that America has been more aggressive than other high-income nations in recommending yearly shots for healthy adults.
The decision comes amid shifting political priorities at the FDA under Health Secretary Robert F. Kennedy Jr., who has been remaking the U.S. health system to align with President Donald Trump&#8216;s goal of dramatically <a href="https://www.benzinga.com/government/regulations/25/05/45488265/novavax-wins-limited-fda-nod-for-covid-shot-cleared-only-for-seniors-high-risk-groups-amid-safety-scrutiny">shrinking the federal government</a>. 
This follows a pattern of increased scrutiny of vaccines, as evidenced by the FDA&#8217;s recent limited approval of Novavax Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) COVID-19 vaccine only for <a href="https://www.benzinga.com/government/regulations/25/05/45488265/novavax-wins-limited-fda-nod-for-covid-shot-cleared-only-for-seniors-high-risk-groups-amid-safety-scrutiny">people 65 and older and those 12</a> and up with underlying health conditions.
Despite the policy change, investors appeared reassured that vaccine policies for older and high-risk Americans remain unchanged. Shares of COVID-19 vaccine makers rose following the announcement, with Moderna (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) up 6.06%, Pfizer (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) rising 2.22%, BioNTech&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) U.S. ADRs up 4.1%, and Novavax gaining 1.5%.
Image Via Shutterstock 
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Disclaimer:&nbsp;This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.

FDA Limits Annual COVID-19 Boosters To High-Risk Americans, Demands New Trials For Healthy Adults In Policy Shift Under RFK Jr.

<a href="https://x.com/US_FDA/status/1924871996216951112">https://x.com/US_FDA/status/1924871996216951112</a>
&nbsp;

Macro Economic Events

Economics

PCVX

FDA's Vinayak Prasad Says No High-Quality Evidence For Benefit Of Vaccinating People Around Immunocompromised People With Covid Shots; I Don't Envision Randomized Trials Every Year For Covid Vaccines But Rather When There's Major Antigenic Shift

WIIM

Shares of vaccine stocks are trading higher following a report indicating FDA advisers will consider if COVID-19 vaccines should target the LP.8.1 subvariant for 2025-2026.

<a href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-advisers-consider-if-new-covid-shots-should-target-lp81-subvariant-2025-05-20/" title="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-advisers-consider-if-new-covid-shots-should-target-lp81-subvariant-2025-05-20/">https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-advisers-consider-if-new-covid-shots-should-target-lp81-subvariant-2025-05-20/</a>

'US FDA Advisers To Consider If New COVID Shots Should Target LP.8.1 Subvariant' - Reuters News

<a href="https://www.reuters.com/business/healthcare-pharmaceuticals/fda-sets-new-covid-booster-guidelines-requiring-trials-approvals-healthy-adults-2025-05-20/" title="https://www.reuters.com/business/healthcare-pharmaceuticals/fda-sets-new-covid-booster-guidelines-requiring-trials-approvals-healthy-adults-2025-05-20/">https://www.reuters.com/business/healthcare-pharmaceuticals/fda-sets-new-covid-booster-guidelines-requiring-trials-approvals-healthy-adults-2025-05-20/</a>

'FDA Sets New COVID Booster Guidelines Requiring Trials For Approvals For Healthy Adults' - Reuters News

U.S. stock futures were slightly lower on Tuesday after ending largely flat on Monday. Futures of major benchmark indices were trading lower in premarket.
The S&amp;P 500 index recorded its <a href="https://www.benzinga.com/25/05/45511478/dow-surges-over-100-points-despite-moodys-us-downgrade-investor-sentiment-decreases-fear-greed-index-remains-in-greed-zone">sixth session of advance</a> by ending marginally higher, shrugging off the <a href="https://www.benzinga.com/news/econ-s/25/05/45479078/moodys-downgrades-us-credit-rating-over-debt-deficit-concerns">Moody&#8217;s downgrade</a> from the weekend.
Experts were assessing the impact of President Donald Trump&#8216;s tax cuts via the proposed &#8216;<a href="https://www.benzinga.com/government/regulations/25/05/45506863/trumps-big-beautiful-bill-advances-heres-who-wins-and-loses">Big, Beautiful Bill</a>,&#8217; as Moody&#8217;s also highlighted the impact of the tax cuts from 2017, and underscored it as a key reason for its decision to downgrade the U.S. credit rating from Aaa to Aa1 on May 16, 2025.
Meanwhile, the 10-year Treasury bond yielded 4.45% and the two-year bond was at 3.96%. The CME Group's FedWatch <a href="https://www.cmegroup.com/markets/interest-rates/cme-fedwatch-tool.html">tool</a>&#8216;s projections show markets pricing a 91.4% likelihood of the Federal Reserve keeping the current interest rates unchanged in its June meeting. 
<figure class="wp-block-table is-style-stripes"> 
<table class="has-fixed-layout">
<tbody>
<tr>
<td>Futures</td>
<td>Change (+/-)</td>
</tr>
<tr>
<td>Dow Jones</td>
<td>-0.20%</td>
</tr>
<tr>
<td>S&amp;P 500</td>
<td>-0.37%</td>
</tr>
<tr>
<td>Nasdaq 100</td>
<td>-0.45%</td>
</tr>
<tr>
<td>Russell 2000</td>
<td>-0.36%</td>
</tr>
</tbody>
</table>
</figure>
The SPDR S&amp;P 500 ETF Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>) and Invesco QQQ Trust ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QQQ#NASDAQ">QQQ</a>), which track the S&amp;P 500 index and Nasdaq 100 index, respectively, fell in premarket on Tuesday. The SPY was down 0.29% to $593.14, while the QQQ declined 0.39% to $519.99, according to <a href="https://pro.benzinga.com/dashboard">Benzinga Pro </a>data.
Cues From Last Session:
Healthcare, consumer staples, and industrials led the S&amp;P 500&#8217;s Monday gains as U.S. stocks mostly climbed, with the Dow Jones adding over 100 points.
However, energy and consumer discretionary stocks bucked the upward trend, closing lower.
This positive momentum followed a strong prior week where the S&amp;P 500 rose 5.3%, the Dow increased 3.4%, and the Nasdaq Composite surged 7.2%.
Despite Moody&#8217;s downgrading U.S. sovereign credit from Aaa to Aa1, investors showed limited concern. Notably, UnitedHealth Group Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNH#NYSE">UNH</a>) shares jumped over 8% on Monday, extending Friday&#8217;s 6% surge, after executives purchased shares during a recent dip.
Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) also soared 15% following FDA approval for its Nuvaxovid COVID-19 vaccine for high-risk individuals.
On the economic front, the CB Leading Index saw a 1% monthly decline in April.
<figure class="wp-block-table is-style-stripes"> 
<table class="has-fixed-layout">
<tbody>
<tr>
<td>Index</td>
<td>Performance (+/-)</td>
<td>Value</td>
</tr>
<tr>
<td>Nasdaq Composite</td>
<td>0.023%</td>
<td>19,215.46</td>
</tr>
<tr>
<td>S&amp;P 500</td>
<td>0.088%</td>
<td>5,963.60</td>
</tr>
<tr>
<td>Dow Jones</td>
<td>0.32%</td>
<td>42,792.07</td>
</tr>
<tr>
<td>Russell 2000</td>
<td>-0.42%</td>
<td>2,104.43</td>
</tr>
</tbody>
</table>
</figure>
Insights From Analysts:
As the S&amp;P 500 index recovered and it was just 2.99% lower than its all-time high of 6,147.43 points, Subu Trade shares data in an X post suggesting that the index tends to rally for 2-12 months after notching such &#8220;quick recoveries.&#8221;
Last time the S&amp;P 500 recovered from -18% to -3% within 50 days, it returned 20.43% on average after one year and 4.86% after three months.
Also, the data shows that the index was higher than 100% of the time after nine months and a year.
&#8220;These quick recoveries tend to see stocks rally more over the next 3-12 months. Momentum is strong,&#8221; the X post stated.
<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">The S&amp;P 500 is now -3% below its all-time high. Last month it was -18% below its all-time high. These quick recoveries tend to see stocks rally more over the next 3-12 months. Momentum is strong. <a href="https://t.co/rYzFp9IhSQ">pic.twitter.com/rYzFp9IhSQ</a>
&mdash; Subu Trade (@SubuTrade) <a href="https://twitter.com/SubuTrade/status/1924556261581787515?ref_src=twsrc%5Etfw">May 19, 2025</a></blockquote>
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Meanwhile, analysts at BlackRock <a href="https://www.benzinga.com/general/market-summary/25/05/45512310/blackrock-bets-on-inflation-goes-overweight-inflation-linked-bonds-amid-us-fiscal-sustainability-challenge-heres-a-list-of-etfs-investors-can-consider">bet on rising inflation</a> by being "overweight" on the inflation-linked bonds. 
This strategic shift is to mitigate risks stemming from "persistent inflation pressure" and growing concerns over the sustainability of U.S. government finances.
The note also highlighted how the U.S. debt sustainability relies on large and steady funding by foreign investors.
"The downgrade reinforces the U.S. fiscal sustainability challenge that we've long flagged, especially persistent U.S. budget deficits at a time when higher interest rates are boosting debt servicing costs. If these dynamics dent the confidence of foreign bond holders, rising term premium could push up bond yields and debt servicing costs even more," explained BlackRock in its note.
As a result, BlackRock&#8217;s current strategy now anticipates higher term premiums for U.S. Treasuries and ongoing inflation.
"That&#8217;s why our starting point also includes our expectation of rising term premium for U.S. Treasuries and persistent inflation pressure. We go overweight inflation-linked bonds and neutral global investment grade credit given wider spreads," the note stated.
Even though U.S. assets are still core to their portfolios, BlackRock&#8217;s shift into inflation-linked bonds highlights their proactive approach to counter looming fiscal and inflationary challenges.
See Also:<a href="https://www.benzinga.com/money/how-to-trade-futures"> How to Trade Futures</a>
Upcoming Economic Data
Here&#8217;s what investors will keep an eye on Tuesday:
<ul class="wp-block-list">
<li>Richmond Fed President Tom Barkin will speak at 9:00 a.m. ET.</li>
<li>Boston Fed President Susan Collins will participate in the &#8216;Fed Listens&#8217; event at 9:30 a.m. ET.</li>
<li>St. Louis Fed President Alberto Musalem will speak at 1:00 p.m., and Federal Reserve Governor Adriana Kugler will speak at 5:00 p.m. ET.</li>
</ul>
Stocks In Focus:
<ul class="wp-block-list">
<li>Home Depot Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HD#NYSE">HD</a>) was 0.36% higher in premarket on Tuesday as analysts expect it to report quarterly earnings of $3.60 per share on revenue of $39.33, before the opening bell.</li>
<li>Toll Brothers Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TOL#NYSE">TOL</a>) was up 0.75% as Wall Street expects it to report earnings after the closing bell. It is expected to post earnings of $2.83 per share on revenue of $2.48 billion.</li>
<li>Palo Alto Networks Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PANW#NASDAQ">PANW</a>) was 0.026% above the flatline as analysts expect it to report quarterly earnings of 77 cents per share on revenue of $2.28 billion, after the closing bell.</li>
<li>Ekso Bionics Holdings Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EKSO#NASDAQ">EKSO</a>) dropped 19.34% after announcing a 1-for-15 reverse stock split.</li>
<li>8&#215;8 Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EGHT#NASDAQ">EGHT</a>) jumped 5% and posted in-line earnings for the fourth quarter on Monday.</li>
<li>DigiAsia Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FAAS#NASDAQ">FAAS</a>) fell 15.56% after announcing that it will allocate up to 50% of net profits for Bitcoin (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>) acquisition as part of a new strategic treasury reserve. The company also aims to raise upto $100 million to establish its initial BTC holdings and plans to generate yield through regulated institutional lending and staking.</li>
<li>Lyra Therapeutics Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LYRA#NASDAQ">LYRA</a>) dropped 20.21% after announcing a reverse stock split, at 1-for-50, effective from May 27, 2025.</li>
<li>Yalla Group Ltd. ADR (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/YALA#NYSE">YALA</a>) slumped 9.08% after the first quarter showed an 8% year-over-year decline in paying users to 11.8 million.</li>
<li>ASP Isotopes Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ASPI#NASDAQ">ASPI</a>) zoomed 14.49% after announcing multiple deals with TerraPower involving financial support and future HALEU supply.</li>
</ul>
Commodities, Gold, And Global Equity Markets:
Crude oil futures were trading lower in the early New York session by 0.19% to hover around $62.02 per barrel.
Gold Spot US Dollar rose 0.24% to hover around $3,238.07 per ounce. Its last record high stood at $3,500.33 per ounce. The U.S. Dollar Index spot was lower by 0.22% at the 100.2010 level.
Asian markets ended higher on Tuesday except South Korea's Kospi and India's S&amp;P BSE Sensex index. Australia's ASX 200, Japan's Nikkei 225, Hong Kong's Hang Seng, and China&#8217;s CSI 300 indices advanced. European markets were higher in early trade.
Read Next:
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/25/05/45510990/federal-reserve-should-do-nothing-at-all-about-the-rising-yields-says-craig-shapiro-let-the-bond-vigilantes-eat">Federal Reserve Should Do &#8216;Nothing At All&#8217; About The Rising Yields, Says Craig Shapiro: &#8216;Let The Bond Vigilantes Eat&#8217; </a></li>
</ul>
Photo courtesy: Shutterstock

Market Summary

Futures

Pre-Market Outlook

Analyst Ratings

ASPI

EGHT

EKSO

FAAS

LYRA

PANW

YALA

US Stocks Likely To Open Lower After S&P 500's Six-Day Streak: 'Quick Recoveries Tend To See Stocks Rally More Over The Next 3-12 Months,' Says Expert

The CNN Money Fear and Greed index showed some decline in the overall market sentiment, while the index remained in the &#8220;Greed&#8221; zone on Monday.
U.S. stocks settled mostly higher on Monday, with the Dow Jones index gaining more than 100 points during the session. Major indices recorded gains last week. For the week, the S&amp;P 500 gained 5.3%, while the Dow added 3.4%. The Nasdaq Composite was the standout performer, surging 7.2% last week.
Investors showed limited concern after <a href="https://www.benzinga.com/news/econ-s/25/05/45479078/moodys-downgrades-us-credit-rating-over-debt-deficit-concerns">Moody&#8217;s downgraded U.S. sovereign credit</a> from Aaa to Aa1, effectively stripping the world&#8217;s largest economy of its last top-tier credit rating.
UnitedHealth Group Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNH#NYSE">UNH</a>) shares jumped more than 8% on Monday, extending Friday&#8217;s 6% surge, after several company executives bought shares during the recent selloff. Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) surged 15% after the FDA approved its Nuvaxovid COVID-19 vaccine for high-risk individuals, including seniors over 65 and those aged 12–64 with underlying health conditions.
On the economic data front, the CB Leading Index fell 1% month-over-month in April.
Most sectors on the S&amp;P 500 closed on a positive note, with health care, consumer staples, and industrials stocks recording the biggest gains on Monday. However, energy and consumer discretionary stocks bucked the overall market trend, closing the session lower.
The Dow Jones closed higher by around 137 points to 42,792.07 on Monday. The S&amp;P 500 gained 0.09% to 5,963.60, while the Nasdaq Composite rose 0.02% to 19,215.46 during Monday's session.
Investors are awaiting earnings results from The Home Depot, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HD#NYSE">HD</a>), Toll Brothers Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TOL#NYSE">TOL</a>), and Palo Alto Networks Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PANW#NASDAQ">PANW</a>) today.
What is CNN Business Fear &amp; Greed Index?
At a current reading of 69.6, the index remained in the &#8220;Greed&#8221; zone on Monday, versus a prior reading of 70.4.
The Fear &amp; Greed Index is a measure of the current market sentiment. It is based on the premise that higher fear exerts pressure on stock prices, while higher greed has the opposite effect. The index is calculated based on seven equal-weighted indicators. The index ranges from 0 to 100, where 0 represents maximum fear and 100 signals maximum greediness.
Read Next:<a href="https://www.benzinga.com/tech/25/05/45492092/jim-cramer-was-skeptical-of-rocket-lab-now-says-its-actually-a-decent-story"> </a>
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/tech/25/05/45492092/jim-cramer-was-skeptical-of-rocket-lab-now-says-its-actually-a-decent-story">Jim Cramer Was &#8216;Skeptical&#8217; Of Rocket Lab, Now Says &#8216;It&#8217;s Actually A Decent Story&#8217;</a></li>
</ul>
Photo courtesy: Shutterstock

Dow Surges Over 100 Points Despite Moody's US Downgrade: Fear Index Remains In 'Greed' Zone

U.S. stocks trimmed early-session losses by midday Monday, as investors showed limited concern after Moody's downgraded U.S. sovereign credit from Aaa to Aa1, effectively stripping the world's largest economy of its last <a href="https://www.benzinga.com/25/05/45492889/americas-credit-strength-just-got-cut-again-should-you-panic">top-tier credit rating. </a>
The S&amp;P 500 index hovered near Friday's close. A green end to the session would mark the sixth consecutive daily gain. The Nasdaq 100 also traded flat, while the Dow Jones Industrial Average outperformed, and small caps lagged. 
Bond markets initially reacted sharply, with 30-year Treasury yields spiking above 5% following the downgrade. Yet, buying interest emerged during the session, pulling yields back to 4.95%. The iShares 20+ Year Treasury Bond ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TLT#NASDAQ">TLT</a>) still was down 0.6% on the day. 
The U.S. dollar index (DXY) weakened 0.6% to 100.40, reflecting moderate selling pressure on the greenback. Sector performance was muted overall, except for energy, which fell 1.5%. Crude oil slipped 0.4%, while natural gas dropped 6% amid oversupply concerns. 
Gold rose 1% to $3,235 per ounce, supported by safe-haven flows. Bitcoin (CRYPTO: <a class="ticker" href="https://www.benzinga.com/quote/btc/usd">BTC</a>) rallied 2%, climbing above the $105,000 mark.
<h3 class="wp-block-heading">Monday&#8217;s Performance In Major US Indices, ETFs</h3>
<figure class="wp-block-table is-style-stripes"> 
<table class="has-fixed-layout">
<tbody>
<tr>
<td>Major Indices</td>
<td>Price</td>
<td>1-day %chg</td>
</tr>
<tr>
<td>Dow Jones</td>
<td>42,824.92</td>
<td>0.4%</td>
</tr>
<tr>
<td>Nasdaq 100</td>
<td>21,456.60</td>
<td>0.1 %</td>
</tr>
<tr>
<td>S&amp;P 500</td>
<td>5,965.78</td>
<td>0.1 %</td>
</tr>
<tr>
<td>Russell 2000</td>
<td>2,102.02</td>
<td>-0.5%</td>
</tr>
</tbody>
</table>
<figcaption class="wp-element-caption">Updated by 1:05 p.m. ET</figcaption></figure>
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/analyst-ratings/analyst-color/25/05/45497403/is-the-dollars-global-reserve-role-at-risk-after-moodys-downgrade">Is The Dollar&#8217;s Global Reserve Role At Risk After Moody&#8217;s Downgrade?</a></li>
</ul>
According to&nbsp;<a href="https://www.benzinga.com/pro/?utm_source=BZprocontent&amp;t=be2bearmibe3na1">Benzinga Pro</a>&nbsp;data:
<ul class="wp-block-list">
<li>The&nbsp;SPDR S&amp;P 500 ETF Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SPY#NYSE">SPY</a>) inched 0.1% up to $594.91.</li>
<li>The&nbsp;SPDR Dow Jones Industrial Average&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DIA#NYSE">DIA</a>) rose 0.4% to $428.18.</li>
<li>The tech-heavy&nbsp;Invesco QQQ Trust Series&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QQQ#NASDAQ">QQQ</a>)&nbsp;edged 0.1% higher to $522.01.</li>
<li>The&nbsp;iShares Russell 2000 ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IWM#NYSE">IWM</a>) fell 0.5% to $208.80.</li>
<li>The&nbsp;Health Care&nbsp;Select Sector SPDR Fund (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XLV#NYSE">XLV</a>) outperformed, up 0.7%; the&nbsp;Energy&nbsp;Select Sector SPDR Fund&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XLE#NYSE">XLE</a>) lagged, down 1.5%.</li>
</ul>
<h3 class="wp-block-heading">Monday&#8217;s Stock Movers</h3>
<ul class="wp-block-list">
<li>UnitedHealth Group Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNH#NYSE">UNH</a>) jumped 8%, extending Friday's 6% surge, after several company executives bought shares <a href="https://www.benzinga.com/25/05/45493652/700m-asset-manager-exits-unitedhealth-stock-says-medicare-advantage-is-facing-a-perfect-storm">during the recent selloff</a>.</li>
<li>New Fortress Energy Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NFE#NASDAQ">NFE</a>) rallied 21%, following a nearly 60% decline last week amid lower-than-expected earnings. </li>
<li>Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) surged 18% after the FDA approved its Nuvaxovid COVID-19 vaccine <a href="https://www.benzinga.com/government/regulations/25/05/45488265/novavax-wins-limited-fda-nod-for-covid-shot-cleared-only-for-seniors-high-risk-groups-amid-safety-scrutiny">for high-risk individuals</a>, including seniors over 65 and those aged 12–64 with underlying health conditions. Shares of Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) rose 6.4%.</li>
</ul>
Now Read: 
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/analyst-ratings/analyst-color/25/05/45497403/is-the-dollars-global-reserve-role-at-risk-after-moodys-downgrade">Is The Dollar&#8217;s Global Reserve Role At Risk After Moody&#8217;s Downgrade?</a></li>
</ul>
Image: Shutterstock

Sector ETFs

Bonds

Broad U.S. Equity ETFs

Treasuries

Econ #s

Tech

ETFs

SPDR Dow Jones Industrial Average ETF Trust

iShares Trust Barclays 20+ Year Treasury Bond Fund

Select Sector SPDR-Consumer Discretionary

Stocks Mixed, Treasury Bonds Slip On Moody's US Downgrade: What's Driving Markets Monday?

U.S. stocks traded higher midway through trading, with the Dow Jones index gaining more than 150 points on Monday.
The Dow traded up 0.40% to 42,825.71 while the NASDAQ rose 0.02% to 19,215.06. The S&amp;P 500 also rose, gaining, 0.13% to 5,965.84.
Check This Out: <a href="https://www.benzinga.com/25/05/45489465/top-3-tech-and-telecom-stocks-that-may-rocket-higher-this-month">Top 3 Tech And Telecom Stocks That May Rocket Higher This Month</a>
Leading and Lagging Sectors Consumer staples shares rose by 0.1% on Monday.
In trading on Monday, energy stocks dipped by 1.5%.
Top Headline
Global Ship Lease, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSL#NYSE">GSL</a>) reported upbeat results for the first quarter on Monday.
The company posted quarterly earnings of $2.65 per share which beat the analyst consensus estimate of $2.31 per share. The company reported quarterly sales of $190.97 million which beat the analyst consensus estimate of $175.23 million.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul class="wp-block-list">
<li>DigiAsia Corp. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FAAS#NASDAQ">FAAS</a>) shares shot up 188% to $0.5351 after the company announced the launch of Bitcoin treasury reserve strategy. The company said it is exploring up to $100 million capital raise to acquire Bitcoin.</li>
<li>Shares of Protagenic Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTIX#NASDAQ">PTIX</a>) got a boost, surging 163% to $7.96 after the company entered a business combination with Phytanix</li>
<li>Novavax, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) shares were also up, gaining 8% to $7.29 after the company provided FY25, 2026, and 2027 R&amp;D and SG&amp;A expense guidance. The FDA gave its conditional approval to its COVID-19 vaccine, targeting specific populations under particular conditions.</li>
</ul>
Equities Trading DOWN
<ul class="wp-block-list">
<li>Gilat Satellite Networks Ltd. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILT#NASDAQ">GILT</a>) shares dropped 9% to $6.08 after the company reported a first-quarter revenue miss.</li>
<li>Shares of Quantum Computing Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/QUBT#NASDAQ">QUBT</a>) were down 10% to $11.64. Quantum Computing, last week, reported better-than-expected first-quarter EPS results.</li>
<li>Archer Aviation Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ACHR#NYSE">ACHR</a>) was down, falling 10% to $12.01.</li>
</ul>
Commodities In commodity news, oil traded up 0.1% to $62.51 while gold traded up 1.4% at $3,233.
Silver traded up 0.2% to $32.410 on Monday, while copper rose 1% to $4.6390.
Euro zone
European shares were mixed today. The eurozone's STOXX 600 fell 0.20%, while Spain's IBEX 35 Index rose 0.06%. London's FTSE 100 fell 0.14%, Germany's DAX 40 gained 0.28% and France's CAC 40 slipped 0.30% during the session.
Asia Pacific Markets
Asian markets closed mostly lower on Monday, with Japan's Nikkei falling 0.68%, Hong Kong's Hang Seng Index declining 0.05%, China's Shanghai Composite Index falling 0.004% and India's BSE Sensex declining 0.33%.
Economics
The CB Leading Index fell 1% month-over-month in April.
Now Read This: 
<ul class="wp-block-list">
<li><a href="https://www.benzinga.com/analyst-ratings/price-target/25/05/45490061/5-stock-picks-last-week-from-wall-streets-most-accurate-analysts-6">5 Stock Picks Last Week From Wall Street&#8217;s Most Accurate Analysts</a> </li>
</ul>
Photo via Shutterstock

Eurozone

Intraday Update

ACHR

GILT

PTIX

QUBT

Gold Gains Over 1%; Protagenic Therapeutics Shares Spike Higher

<h3>Gainers</h3>
<ul>
<li>Protagenic Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTIX#NASDAQ">PTIX</a>) shares rose 286.8% to $11.72 during Monday's regular session. The company's market cap stands at $6.3 million. The company's, Q1 earnings came out 4 days ago. </li>
<li>Healthcare Triangle (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HCTI#NASDAQ">HCTI</a>) stock increased by 56.96% to $0.01. </li>
<li>China SXT Pharmaceuticals (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SXTC#NASDAQ">SXTC</a>) shares increased by 30.83% to $1.57. The market value of their outstanding shares is at $21.6 million. </li>
<li>Abpro Hldgs (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABP#NASDAQ">ABP</a>) shares rose 27.17% to $0.29. The market value of their outstanding shares is at $15.2 million. </li>
<li>Tango Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TNGX#NASDAQ">TNGX</a>) shares increased by 23.2% to $1.85. The company's market cap stands at $200.3 million. </li>
<li>Novavax (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) stock moved upwards by 20.8% to $8.13. The market value of their outstanding shares is at $1.3 billion. </li>
</ul>
<h3>Losers</h3>
<ul>
<li>Prime Medicine (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PRME#NASDAQ">PRME</a>) stock fell 19.2% to $1.28 during Monday's regular session. The company's market cap stands at $168.7 million. </li>
<li>Plus Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PSTV#NASDAQ">PSTV</a>) shares fell 16.67% to $0.35. The company's market cap stands at $2.0 million. </li>
<li>Applied Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/APLT#NASDAQ">APLT</a>) stock fell 15.4% to $0.51. The market value of their outstanding shares is at $72.2 million. The company's, Q1 earnings came out 4 days ago. </li>
<li>Matinas BioPharma Hldgs (AMEX:<a class="ticker" href="https://www.benzinga.com/stock/MTNB#AMEX">MTNB</a>) shares decreased by 13.53% to $0.75. The market value of their outstanding shares is at $3.8 million. </li>
<li>Regencell Bioscience (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RGC#NASDAQ">RGC</a>) shares decreased by 12.81% to $342.68. The market value of their outstanding shares is at $4.4 billion. </li>
<li>Liquidia (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LQDA#NASDAQ">LQDA</a>) stock declined by 11.1% to $16.79. The market value of their outstanding shares is at $1.4 billion. 
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.

APLT

HCTI

LQDA

MTNB

PRME

PSTV

SXTC

TNGX

12 Health Care Stocks Moving In Monday's Intraday Session

Moderna shares are trading higher after the company announced it received approval from the FDA for its COVID-19 vaccine and unlocked a milestone $175 million payment from Sanofi SA.

Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) has received limited approval from the U.S. Food and Drug Administration for its COVID-19 vaccine, Nuvaxovid, marking a regulatory milestone and unlocking a <a href="https://www.benzinga.com/pressreleases/25/05/n45489838/u-s-fda-approves-bla-for-novavaxs-covid-19-vaccine" target="_blank" rel="noreferrer noopener">$175 million milestone payment</a> from partner Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>).
The protein-based vaccine, distinct from mRNA options by Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) and BioNTech SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>), is now authorized for people aged 65 and older and for individuals 12 and up with underlying medical conditions that increase the risk of severe COVID-19. 
The approval came after a six-week delay as regulators sought additional data.
Related: <a href="https://www.benzinga.com/government/regulations/25/05/45488265/novavax-wins-limited-fda-nod-for-covid-shot-cleared-only-for-seniors-high-risk-groups-amid-safety-scrutiny" target="_blank" rel="noreferrer noopener">Novavax Wins Limited FDA Nod For COVID Shot—Cleared Only For Seniors, High-Risk Groups Amid Safety Scrutiny</a>         
Novavax CEO John C. Jacobs called the decision "a significant milestone" and emphasized the company's commitment to vulnerable populations. The CDC has noted that these groups will most likely seek seasonal COVID vaccinations.
The approval comes as CDC advisers weigh adjustments to annual COVID shot guidance, potentially narrowing recommendations to older adults and high-risk groups.
Novavax plans to begin commercial distribution of its 2025–2026 formula this fall, pending strain selection at the FDA advisory committee meeting on May 22. The company is also working with Sanofi to fund a Phase 4 study in adults 50–64 without high-risk conditions, as requested by the FDA.
Financially, Novavax reaffirmed its 2025 forecast for R&amp;D and SG&amp;A expenses between $475 million and $525 million. It plans to cut these to around $350 million in 2026 and $250 million by 2027, according to BZ Pro.
Related ETFs: iShares Biotechnology ETF (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IBB#NASDAQ">IBB</a>), SPDR S&amp;P Biotech ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XBI#NYSE">XBI</a>)
Price Action: NVAX shares are trading higher by 19.0% at $8.01 premarket at the last check on Monday.&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
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