Novavax (NASDAQ:NVAX) 주식

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.

Virus,Sample,For,H5n1,(avian,Influenza,Virus),Test,,Avian,Influenza

Large Cap

News

Health Care

General

CVAC

MRNA

NVAX

네바다의 한 낙농업자가 1월에 루이지애나 남자의 사망과 관련된 조류 독감 D1.1 변종에 양성 반응을 보였다고 CNN이 보도했다. 미국 질병통제예방센터(CDC)는 월요일에 초기 양성 반응을 확인하기 위해 작업 중이다.

네바다 남성에서 발견된 치명적인 조류 독감 변종: 주목해야 할 4가지 주식

Geneva,,Switzerland,,June,15,,2023:,Who,World,Health,Organization,Headquarters

Equities

Markets

IDNA

미국 질병통제예방센터(CDC)가 세계보건기구(WHO)와의 협력을 중단한 것으로 알려지면서 전 세계 보건 우려가 월요일 높아지는 가운데, 캘리포니아에서 희귀한 H5N9 조류 독감 변종이 발견되어 백신 회의론자 로버트 F. 케네디 주니어에 대한 상원 인준 청문회가 예정된 것과 동시에 이루어졌다.

CDC-WHO 협력 중단 및 조류 독감으로 모더나, 화이자 상승; RFK Jr. 후보 인준 청문회 예정

benzinga_deal_dispatch2

AMPS

BLCO

BTBT

FYBR

LBPH

LSPD

MSGM

PDCO

SNDR

TCEHY

UBSFF

USAP

새로이 등장한 블록 치과용품 제조업체인 패터슨 컴퍼니즈(NASDAQ:PDCO)가 주주 가치를 높이기 위해 매각 또는 합병을 포함한 전략적 옵션을 모색 중이라고 목요일 발표했다. 이 회사는 거래 과정을 2분기 재무 보고서의 일환으로 공개했다.

딜 디스패치: 유비소프트는 매각 협상 중, 패터슨은 매각 탐색 중, 프로마의 레카로 인수 등

Novavax Inc

WIIM

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

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

Biotech

"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:
<ul>
<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>
</ul>
Photo: Gorodenkoff/Shutterstock

Movers

Trading Ideas

BNTX

NAVX

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

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

Intraday Update

EWBC

GTLS

HCSG

HOOD

LITE

NVDA

PEGA

PONY

PSIX

SMCI

SMMT

SMTC

TSLA

Amphenol Posts Better-Than-Expected Results, Joins SAP, Tesla, Pegasystems And Other Big Stocks Moving Higher On Wednesday

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

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

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

DVAX

PCVX

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

Novavax, Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) on Tuesday released preliminary results from the SHIELD-Utah&nbsp;study investigating the effects of systemic and local reactogenicity of COVID-19 <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">vaccine doses in&nbsp;Utah</a>.
SHIELD-Utah&nbsp;was a prospective, interventional study conducted at the&nbsp;University of Utah&nbsp;Health.
The study showed Novavax&#8217;s COVID-19 Vaccine, Adjuvanted (2024-2025 Formula), targeting the JN.1 strain, resulted in fewer and less severe reactogenicity symptoms when compared with the Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>)-BioNTech SE&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/04/n44808832/shield-utah-study-shows-novavaxs-covid-19-vaccine-induces-lower-reactogenicity-symptoms-compared-t" rel="noreferrer noopener">mRNA 2024-2025 vaccine</a>.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/04/44634464/despite-headwinds-biotech-sell-off-could-offer-buying-opportunity-bofa" rel="noreferrer noopener">Despite Headwinds, Biotech Sell-Off Could Offer Buying Opportunity: Analyst</a>
This real-world study, conducted between September and&nbsp;December 2024, also showed that the impact of symptoms on daily activities, including work and family responsibilities, was lower in recipients of Novavax&#8217;s vaccine.
&#8220;The risk of side effects or reactogenicity has been shown to be a major decision factor for those opting to get vaccinated. Our findings of lower frequency and intensity of reactogenicity symptoms from the protein-based COVID-19 vaccine observed in SHIELD-Utah&nbsp;add valuable insights to the public debate weighing choice and value of COVID-19 vaccination,&#8221; said&nbsp;Sarang K. Yoon, DO, MOH, Principal Investigator,&nbsp;University of Utah&nbsp;Health.
As in previous studies, the SHIELD study found health care workers who received the Novavax vaccine reported significantly fewer reactogenicity events than Pfizer-BioNTech recipients.
On average, Novavax recipients experienced 1.7 symptoms versus 2.8 systemic symptoms in Pfizer-BioNTech recipients.
43.8% of Pfizer-BioNTech recipients experienced at least one symptom of Grade 2 or higher compared to 24.2% of Novavax recipients.
Local reactogenicity events also showed an absolute difference of 12.5% fewer in Novavax recipients versus Pfizer-BioNTech recipients.
The impact of symptoms on daily activities, including work, showed the hours of reduced activity were lower in Novavax recipients versus Pfizer-BioNTech recipients (mean=0.7 vs. 1.4h and mean=0.8 vs. 2.4h for missed work and less productivity, respectively).
Earlier this month, the regulators missed the deadline for deciding to grant full approval to <a target="_blank" href="https://www.benzinga.com/general/biotech/25/04/44613147/fda-delays-full-approval-decision-on-novavaxs-covid-19-vaccine" rel="noreferrer noopener">Novavax&#8217;s COVID-19 shot</a>.
Price Action: NVAX stock is down 3.60% at $6.18 at the last check Tuesday
Read Next:
<ul>
<li><a href="https://www.benzinga.com/news/global/25/04/44820082/global-electric-vehicle-sales-jump-in-march-what-country-leads-in-sales" target="_blank" rel="noreferrer noopener">Global Electric Vehicle Sales Jump In March: What Country Leads In Sales?</a></li>
</ul>
Image: Shutterstock

Novavax Covid Vaccine Shows Milder Side Effects Than Pfizer-BioNTech's Shot: Study

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

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

BCLI

BNGO

DHAI

KTTA

LUCD

NDRA

RSLS

STSS

VERO

12 Health Care Stocks Moving In Thursday's Intraday Session

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

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

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

Bank of America Securities <a href="https://www.benzinga.com/general/biotech">writes that SMid-cap biotech</a>, companies with small to mid-sized market capitalizations, had a rocky start to the year.
Many companies in the coverage are down 20-40% year-to-date (NBI: -2.35%).
Tariff concerns and the U.S. Food and Drug Administration (FDA) shakeup added further near-term uncertainty to an already challenging <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">already challenging outlook</a>.
Earlier this week, Peter Marks resigned from his role at the FDA&#8217;s Center for Biologics Evaluation and Research.
Marks was a top regulator at the FDA and played a key role in ensuring the quick approval of vaccines <a href="https://www.benzinga.com/25/03/44562368/moderna-novavax-shares-are-tumbling-monday-whats-going-on" target="_blank" rel="noreferrer noopener">during the COVID-19 pandemic</a>.
In March, the U.S. Department of Health and Human Services unveiled a sweeping restructuring plan on Thursday to cut costs, streamline operations and refocus priorities.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/health-care/25/04/44627279/ftc-pauses-lawsuit-against-cvs-cigna-unitedhealths-pbms-amid-commissioner-shortage" rel="noreferrer noopener">FTC Pauses Lawsuit Against CVS, Cigna, UnitedHealth&#8217;s PBMs Amid Commissioner Shortage</a>
The changes, aligned with President&nbsp;Donald Trump's&nbsp;executive order on government efficiency, will reduce the agency&#8217;s workforce, consolidate divisions, and emphasize efforts to <a target="_blank" href="https://www.benzinga.com/government/regulations/25/03/44519638/us-department-of-health-and-human-services-aligns-with-trumps-executive-order-to-cut-10k-jobs-save-18-billion" rel="noreferrer noopener">combat chronic illness</a>.
The analyst points out that public biotech companies raised only $4.7 billion, compared to $13.6 billion last year, highlighting ongoing challenges in the capital market.
&#8220;And while we see these macro headwinds as likely to continue over the course of 2025, <a href="https://www.benzinga.com/markets/25/04/44627820/trumps-reciprocal-tariffs-on-india-exempt-pharma-easing-mark-cubans-price-hike-concerns">drugs being exempt from reciprocal tariffs</a> should offer some much-needed near-term reprieve for the sector, in our view,&#8221; BofA analyst writes.
Novavax Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) is just one example of FDA. On Wednesday, the regulators missed the deadline for deciding to grant full approval to Novavax&#8217;s Covid-19 shot.
BofA expects more details on the delay in the coming weeks. The expected $125 million milestone payment from Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) will likely be pushed to the second half of 2025.
Despite small and mid-cap biotech stocks being among the worst performers this year, the sector may still present a strong opportunity. Most of these companies (80%) are pre-commercial and have minimal exposure to tariffs or FDA decisions, with only 2 out of 29 under BofA coverage awaiting FDA approval.
The bigger challenges are high interest rates and limited access to capital, but these risks are already factored into valuations. While negative headlines may continue to impact sentiment and investment flows, the recent broad sell-off could be an appealing entry point.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/news/contracts/25/04/44630746/serve-robotics-and-uber-eats-launch-self-driving-delivery-service-in-uptown-dallas" target="_blank" rel="noreferrer noopener">Serve Robotics and Uber Eats Launch Self-Driving Delivery Service in Uptown Dallas</a></li>
</ul>
Image: Shutterstock

Analyst Color

Analyst Ratings

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

Editor&#8217;s Note: The story has been updated with comments from Novavax
In September 2024, the U.S. Food And Drug Administration (FDA) granted Emergency Use Authorization to Novavax Inc.'s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) COVID-19 Vaccine, Adjuvanted (2024-2025 Formula) (NVX-CoV2705) for active immunization to prevent COVID-19 in <a href="https://www.benzinga.com/general/biotech/24/09/40688052/fda-approves-novavaxs-updated-covid-vaccine-targeting-currently-circulating-variants" target="_blank" rel="noreferrer noopener">individuals aged 12 and older</a>.
Novavax's vaccine was included in the recommendations issued by the U.S. Centers for Disease Control and Prevention (CDC) on&nbsp;June 27, 2024.
Also Read: <a target="_blank" href="https://www.benzinga.com/24/12/42323263/wegovy-maker-novo-nordisk-to-buy-novavaxs-czech-republic-manufacturing-facility-for-200-million" rel="noreferrer noopener">Wegovy Maker Novo Nordisk To Buy Novavax&#8217;s Czech Republic Manufacturing Facility For $200 Million</a>
According to a media report on Wednesday, the regulators missed the deadline for deciding to grant full approval to Novavax's shot.
In an emailed statement to Benzinga, Novavax said, &#8220;Novavax can confirm that April 1, 2025, was the U.S. Food and Drug Administration (FDA)'s Prescription Drug User Fee Act date for our Biologics License Application (BLA) seeking the approval of our COVID-19 Vaccine. As of Tuesday, April 1, we had responded to all of the FDA's information requests and we believe that our BLA is ready for approval. 
As of today, we continue to wait on action from the agency and have not yet received an official decision from the U.S. FDA. Our application included robust Phase 3 clinical trial data that showed our vaccine is safe and effective for the prevention of COVID-19. We are confident our well-tolerated vaccine represents an important alternative to mRNA COVID-19 vaccines for the U.S.&#8221;
Earlier this week, Peter Marks&nbsp;resigned from his role at the FDA's Center for Biologics Evaluation and Research.
Marks was a top regulator at the FDA and played a key role in pushing quick approvals of vaccines <a href="https://www.benzinga.com/25/03/44562368/moderna-novavax-shares-are-tumbling-monday-whats-going-on" target="_blank" rel="noreferrer noopener">during the COVID-19 pandemic</a>.
The Wall Street Journal <a href="https://www.wsj.com/health/healthcare/fda-novavax-covid-19-vaccine-deadline-c160454b" target="_blank" rel="noreferrer noopener">writes</a> that the agency is now delaying the decision and has reportedly asked for more data and that the application isn't likely to be approved soon, according to sources.
The FDA set an April 1 deadline for a decision.
Novavax reported fourth-quarter 2024 sales of $88.31 million, compared to&nbsp;$291 million&nbsp;a year, beating the&nbsp;consensus of $84.35 million. The decrease was due to lower product sales <a target="_blank" href="https://www.benzinga.com/general/biotech/25/02/44013531/novavax-reports-smaller-q4-loss-shifts-focus-from-commercializing-covid-19-vaccine-to-maximize-value" rel="noreferrer noopener">under APA agreements</a>.
The COVID-19 vaccine maker reported an earning loss of 51 cents per share, down from $1.44 a year ago, in line&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/25/02/n44004179/novavax-reports-fourth-quarter-and-full-year-2024-financial-results-and-operational-highlights" rel="noreferrer noopener">with the Wall Street Estimate</a>.
The news comes after vaccine stocks came under pressure last week following reports that the Trump administration plans to end financial support for vaccine alliance Gavi, which helps buy vaccines for children in developing countries. The Trump administration reportedly plans to cut billions in global health initiatives.
Price Action: NVAX stock is up 1.25% at $6.09 at the last check on Wednesday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/general/biotech/25/04/44610702/edgewise-therapeutics-sees-meaningful-hcm-treatment-gains-with-edg-7500-in-phase-2-study" target="_blank" rel="noreferrer noopener">Edgewise Therapeutics Sees Meaningful HCM Treatment Gains With EDG-7500 In Phase 2 Study</a></li>
</ul>
Photo: Shutterstock

Rumors

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

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

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

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

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

Politics

Trump Administration Health Agency Firings Include Staff Overseeing Bird Flu Response

Vaccine stocks are trading lower Monday following a shakeup at the <a href="https://www.benzinga.com/markets/25/03/44550801/rfk-jr-spreading-misinformation-and-lies-fdas-top-vaccine-official-walks-out-sparking-debate-on-safety-and-public-trust">U.S. Food and Drug Administration</a>.
What Happened: Peter Marks has resigned from his role at the FDA&#8217;s Center for Biologics Evaluation and Research. According to a Bloomberg<a href="https://www.bloomberg.com/news/articles/2025-03-31/vaccine-makers-plunge-after-fda-biologics-head-marks-steps-down?srnd=homepage-uk&amp;embedded-checkout=true"> report</a>, Marks was a top regulator at the FDA and played a key role in pushing quick approvals of vaccines during the Covid pandemic. 
Moderna Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) shares were down 13.5% at $26.88 and Novavax Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) shares were down 9.6% at $6.30 at last check. The SPDR S&amp;P Biotech ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XBI#NYSE">XBI</a>) was down about 5.76% at publication time, according to <a href="http://pro.benzinga.com">Benzinga Pro</a>.
The report indicates that Marks was also responsible for the FDA&#8217;s evaluation of cutting-edge treatments like cell therapies and gene therapies. He reportedly cited some issues with Health and Human Services Secretary Robert F. Kennedy Jr. in his resignation letter.
"I was willing to work to address the Secretary's concerns regarding vaccine safety and transparency," Marks reportedly said in the letter. 
"However it has become clear that truth and transparency are not desired by the Secretary, but rather he wishes subservient confirmation of his misinformation and lies."
Check This Out: <a href="https://www.benzinga.com/25/03/44560524/auto-stocks-skid-after-trump-shrugs-off-higher-prices-should-you-buy-the-dip">Auto Stocks Skid After Trump Shrugs Off Higher Prices &#8211; Should You Buy The Dip?</a>
The news comes after vaccine stocks came under pressure last week following reports The Trump administration plans to end financial support for vaccine alliance Gavi, which helps buy vaccines for children in developing countries. The Trump administration reportedly plans to cut billions in global health initiatives. 
Moderna was awarded $590 million by the U.S. Department of Health and Human Services (HHS) in January to continue developing a vaccine to protect against bird flu. The Trump administration was reportedly&nbsp;<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" target="_blank" rel="noreferrer noopener">reconsidering that funding</a>&nbsp;as of last month.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/insights/options/25/03/44518123/modernas-options-frenzy-what-you-need-to-know">Moderna&#8217;s Options Frenzy: What You Need to Know</a></li>
</ul>
Photo: Shutterstock.

Moderna, Novavax Shares Are Tumbling Monday: What's Going On?

Vaccine makers Moderna Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) and Novavax Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) are facing selling pressure on Wednesday following reports suggesting the Trump administration will <a href="https://www.benzinga.com/economics/macro-economic-events/25/03/44495713/the-trump-administration-intends-to-terminate-u-s-financial-support-for-gavi-and-">end support for Gavi</a>.
What To Know: According to a New York Times <a href="https://www.nytimes.com/2025/03/26/health/usaid-cuts-gavi-bird-flu.html">report</a>, The Trump administration plans to cease financial support for vaccine alliance Gavi, which helps buy vaccines for children in developing countries. 
The Trump administration is also planning to &#8220;significantly scale back&#8221; support for efforts to combat malaria, the report states, citing a document from the United States Agency for International Development.
Meanwhile, the administration will continue to provide some grants for H.I.V. and tuberculosis medications, as well as food aid for countries in civil wars or facing natural disasters. In total, the Trump administration has reportedly decided to end 5,341 previously granted awards and continue with 898 of them. 
See Also: <a href="https://www.benzinga.com/insights/options/25/03/44422820/modernas-options-a-look-at-what-the-big-money-is-thinking">Moderna&#8217;s Options: A Look at What the Big Money is Thinking</a>
Funding for the United Nations Food and Agriculture Organization is also being terminated. The report indicates that the organization conducts surveillance for diseases that can be transmitted from animals to humans, including the bird flu. 
Moderna was awarded $590 million by the U.S. Department of Health and Human Services (HHS) in January to continue developing a vaccine to protect against bird flu. The Trump administration was reportedly <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">reconsidering that funding</a> as of last month. 
MRNA, NVAX Price Action: At the time of publication, Moderna shares were down 5.70% at $31.91 and Novavax shares were down 3.37% at $7.30, according to <a href="http://pro.benzinga.com">Benzinga Pro</a>.
Photo: Shutterstock.

Global

Moderna, Novavax Shares Are Sliding Wednesday: What's Going On?

Shares of vaccine stocks are trading lower on reports suggesting the Trump Administration will end support for vaccine alliance, Gavi.

Press Releases

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Novavax, Inc. - NVAX

Novavax Announces Sale of Czech Republic Manufacturing Site to Novo Nordisk for $200 Million

Novavax Initiates Phase 3 Trial for COVID-19-Influenza Combination and Stand-Alone Influenza

Contracts

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

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

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

Earnings

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

Novavax to Participate in Upcoming March Investor Conferences

Novavax Announces Changes to Board of Directors

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

Comments

Novavax

뉴스

파트너 / 기고자

벤징가 글로벌