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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MRNA

U.S. CDC Advisory Panel Votes 5-1 In Favor Of Children 18 Years & Younger Receiving Seasonal Flu Vaccine Only In Single Dose Forms That Are Free From Thimerosal; Of Pregnant Women Receiving Seasonal Flu Vaccine Only In Single Dose Forms That Are Free From Thimerosal; Of All Adults Receiving Seasonal Flu Shot Only In Single Dose Forms That Are Free From Thimerosal

U.S. CDC Vaccine Advisory Panel Votes 7-0 In Favor Of Adding Preventive RSV Therapies To Vaccines For Children Resolution

<a href="https://www.youtube.com/watch?v=2PnYYb_xj3U">https://www.youtube.com/watch?v=2PnYYb_xj3U</a>
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Trump Nominee For U.S. CDC Director Monarez Tells Senate Panel She Has Not Seen A Causal Link Between Vaccines And Autism

Cidara Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CDTX#NASDAQ">CDTX</a>) stock is trading over 90% higher on Monday with a session volume of 3.2 million compared to the <a href="https://www.benzinga.com/pro/feature/newsfeed" target="_blank" rel="noreferrer noopener">average volume of 181.7K</a>.
On Monday, the company released topline results from its randomized, double-blind, placebo-controlled Phase 2b NAVIGATE trial evaluating CD388 for preventing seasonal influenza in healthy unvaccinated <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">adults aged 18 to 64</a>.
The study met its primary endpoint, demonstrating a statistically significant prevention efficacy (PE) for each of three dose groups in individuals who received a single dose of CD388 at the beginning of the flu season and were evaluated for laboratory and clinically confirmed <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/g46048318/cidara-therapeutics-announces-positive-topline-results-from-its-phase-2b-navigate-trial-evaluating" rel="noreferrer noopener">influenza over 24 weeks</a>.
The study also met all secondary endpoints, including efficacy at 37.8 and 37.2 degrees Celsius temperature thresholds and maintenance of PE for up to 28 weeks with statistical significance.
Over the same period, CD388 was well-tolerated at all doses, and no unexpected dose-limiting treatment-emergent adverse events were observed.
The highest dose group (450 mg) showed 76.1% prevention efficacy against laboratory and clinically confirmed influenza over 24 weeks, while the 300 mg and 150 mg doses demonstrated 61.3% and 57.7% efficacy, respectively.
All results were statistically significant compared to placebo.
Safety and tolerability data were similar in all arms ,but no safety signals were observed. No drug-related serious adverse events were observed, and treatment-emergent adverse events showed no dose-dependent pattern between CD388 and placebo groups.
Injection site reaction rates were similar across all CD388 dose groups and placebo.
Cidara expects to present additional results from the NAVIGATE trial at upcoming scientific conferences in 2025.
Cidara has submitted an end of Phase 2 meeting request to the FDA to review the Phase 2b results and further discuss the Phase 3 trial design and start time.
In June, Novavax Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) announced the results of the initial cohort of its COVID-19-Influenza Combination (CIC) and standalone trivalent hemagglutinin nanoparticle&nbsp;seasonal <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">influenza (tNIV) Phase 3 trial</a>.
The study showed that the CIC and flu vaccine candidates induced immune responses similar to those of licensed comparators Nuvaxovid and Sanofi SA's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) <a href="https://www.benzinga.com/news/health-care/25/06/45887132/novavaxs-experimental-covid-19-influenza-combo-shot-shows-immune-response-among-older-adults-in-phase-3-trial" target="_blank" rel="noreferrer noopener">Fluzone HD, respectively</a>.
Both standalone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains (2.4-5.7-fold over baseline).
Price Action: CDTX stock is up 90.7% at $40.08 at last check on Monday.
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</ul>
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CDTX

Why Is Cidara Therapeutics Stock Trading Higher On Monday?

<a href="https://www.bloomberg.com/news/articles/2025-06-18/rfk-jr-weighs-review-of-dozens-of-shots-citing-aluminum-use" title="https://www.bloomberg.com/news/articles/2025-06-18/rfk-jr-weighs-review-of-dozens-of-shots-citing-aluminum-use">https://www.bloomberg.com/news/articles/2025-06-18/rfk-jr-weighs-review-of-dozens-of-shots-citing-aluminum-use</a>

'RFK Jr. Weighs Review of Dozens of Shots, Citing Aluminum Use' - Bloomberg News

<a href="https://www.statnews.com/2025/06/18/vinay-prasad-fda-cber-chief-medical-science-officer-advise-makary/#:~:text=Prasad%20will%20serve%20as%20the,have%20been%20two%20distinct%20roles" title="https://www.statnews.com/2025/06/18/vinay-prasad-fda-cber-chief-medical-science-officer-advise-makary/#:~:text=Prasad%20will%20serve%20as%20the,have%20been%20two%20distinct%20roles">https://www.statnews.com/2025/06/18/vinay-prasad-fda-cber-chief-medical-science-officer-advise-makary/#:~:text=Prasad%20will%20serve%20as%20the,have%20been%20two%20distinct%20roles</a>.

'Vinay Prasad Named Chief Medical And Science Officer At FDA' - STAT News

Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades, downgrades and initiations, please see our <a href="https://www.benzinga.com/analyst-stock-ratings">analyst ratings page</a>.
<ul class="wp-block-list">
<li>Canaccord Genuity analyst William Plovanic initiated coverage on Artivion, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/AORT#NYSE">AORT</a>) with a Buy rating and announced a price target of $35. Artivion shares closed at $28.73 on Monday. <a href="https://www.benzinga.com/quote/AORT/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Citigroup analyst Geoff Meacham initiated coverage on Novavax, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) with a Sell rating and announced a price target of $6. Novavax shares closed at $7.03 on Monday. <a href="https://www.benzinga.com/quote/NVAX/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>China Renaissance analyst Cindy Wang initiated coverage on Coinbase Global, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/COIN#NASDAQ">COIN</a>) with a Buy rating and announced a price target of $353.3. Coinbase shares closed at $261.57 on Monday. <a href="https://www.benzinga.com/quote/COIN/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Jones Trading analyst Debanjana Chatterjee initiated coverage on Theravance Biopharma, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TBPH#NASDAQ">TBPH</a>) with a Buy rating and announced a price target of $24. Theravance Biopharma shares closed at $10.75 on Monday. <a href="https://www.benzinga.com/quote/TBPH/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>Johnson Rice analyst Martin Malloy initiated coverage on Venture Global, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/VG#NYSE">VG</a>) with a Buy rating and announced a price target of $20. Venture Global shares closed at $17.40 on Monday. <a href="https://www.benzinga.com/quote/VG/analyst-ratings">See how other analysts view this stock.</a></li>
</ul>
Considering buying COIN stock? Here&#8217;s what analysts think: 
<figure class="wp-block-image size-large is-resized"><a href="https://www.benzinga.com/quote/COIN/analyst-ratings"><img loading="lazy" decoding="async" width="1024" height="593" src="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/17092339/image-264-1024x593.png" alt="" class="wp-image-952292" style="width:603px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/17092339/image-264-1024x593.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/17092339/image-264-300x174.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/17092339/image-264-768x444.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2025/06/17092339/image-264.png 1092w" sizes="(max-width: 1024px) 100vw, 1024px" /></a></figure>
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This Coinbase Global Analyst Begins Coverage On A Bullish Note; Here Are Top 5 Initiations For Tuesday

Citigroup analyst Geoff Meacham initiates coverage on Novavax (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) with a Sell rating and announces Price Target of $6.

Price Target

Citigroup Initiates Coverage On Novavax with Sell Rating, Announces Price Target of $6

BioNTech SE&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>) on Thursday agreed to acquire CureVac N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CVAC#NASDAQ">CVAC</a>) in an <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">all-stock transaction</a>.
According to the agreement, shareholders can exchange CureVac shares for around $5.46 in BioNTech ADSs. This equates, roughly, to an equity value of <a href="https://www.benzinga.com/pressreleases/25/06/g45900311/biontech-announces-strategic-transaction-to-acquire-curevac-in-public-exchange-offer" target="_blank" rel="noreferrer noopener">$1.25 billion</a>.
The consideration is subject to a collar mechanism. If the 10-day volume weighted average price of the BioNTech ADSs ending on the fifth business day before the offer&#8217;s closing exceeds $126.55, the exchange ratio would be 0.04318. If the VWAP is lower than $84.37, the exchange ratio would be 0.06476.
At closing, CureVac shareholders expect to own between 4% and 6% of BioNTech.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45853393/robert-kennedy-jr-axes-entire-cdc-vaccine-panel-to-restore-public-trust-pfizer-moderna-other-biotech-stocks-drop-in-after-hours-trading" rel="noreferrer noopener">Robert Kennedy Jr Axes Entire CDC Vaccine Panel To &#8216;Restore Public Trust&#8217; — Pfizer, Moderna, Other Biotech Stocks Drop In After-Hours Trading</a>
With the acquisition, BioNTech aims to strengthen the research, development, manufacturing, and commercialization of investigational mRNA-based cancer immunotherapy.
The strategic transaction will complement BioNTech&#8217;s capabilities and proprietary technologies in mRNA design, delivery formulations, and manufacturing.
For BioNTech, this transaction marks the next milestone in the execution of its oncology strategy which focuses on two pan-tumor programs, mRNA-based cancer immunotherapy candidates, and BNT327, a PD-L1xVEGF-A bispecific antibody candidate.
Following the transaction&#8217;s closing, CureVac&#8217;s operating subsidiary will become a wholly owned subsidiary of BioNTech. As part of this plan, BioNTech will integrate CureVac&#8217;s research and manufacturing site in Tübingen.
The transaction was unanimously approved by BioNTech&#8217;s and CureVac&#8217;s management and supervisory boards. The transaction is expected to close in 2025.
As of March 31, BioNTech had 15.9 billion euros in cash, cash equivalents, <a href="https://www.benzinga.com/25/05/45205736/biontech-appoints-novartis-executive-as-finance-chief-reaffirms-2025-guidance-focuses-on-oncology-expansion" target="_blank" rel="noreferrer noopener">and security investments</a>.
Earlier in June, BioNTech and&nbsp;Bristol Myers Squibb&nbsp;&amp; Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) entered into a co-development and <a target="_blank" href="https://www.benzinga.com/news/health-care/25/06/45723383/bristol-myers-inks-11-billion-licensing-pact-with-biontech-for-bispecific-cancer-drug" rel="noreferrer noopener">co-commercialization agreement</a>.
The pact focuses on BioNTech&#8217;s investigational bispecific antibody BNT327 across numerous solid tumor types.
Bristol Myers Squibb will pay BioNTech $1.5 billion upfront and $2 billion in non-contingent anniversary payments through 2028.
In addition, BioNTech will be eligible to receive up to $7.6 billion in additional development, regulatory and commercial milestones.
In March, CureVac said the European Patent Office (EPO) confirmed the validity of CureVac&#8217;s European patent EP 3 708 668 B1 subject to amendments to specify <a target="_blank" href="https://www.benzinga.com/25/03/44535393/european-patent-office-rules-vaccine-developer-curevacs-amended-patent-valid-stock-jumps" rel="noreferrer noopener">the scope of protection</a>.
The opposition division largely dismissed BioNTech&#8217;s original opposition filed in April 2023, challenging the patent&#8217;s validity and maintaining it in amended form.
Price Action: BNTX stock is up 1.22% at $106.75, and CVAC stock is up 33.2% at $5.42 during the premarket session at the last check on Thursday.
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<li><a href="https://www.benzinga.com/news/health-care/25/06/45887132/novavaxs-experimental-covid-19-influenza-combo-shot-shows-immune-response-among-older-adults-in-phase-3-trial" target="_blank" rel="noreferrer noopener">Novavax&#8217;s Experimental COVID-19-Influenza Combo Shot Shows Immune Response Among Older Adults In Phase 3 Trial</a></li>
</ul>
Image: Shutterstock

Large Cap

CVAC

BioNTech Expands mRNA Cancer Portfolio With CureVac $1.25 Billion All-Stock Deal

Health Secretary Robert F. Kennedy Jr. named eight new members to the CDC&#8217;s Advisory Committee on Immunization Practices on Wednesday, including several anti-vaccine proponents, after <a href="https://www.benzinga.com/news/health-care/25/06/45853393/robert-kennedy-jr-axes-entire-cdc-vaccine-panel-to-restore-public-trust-pfizer-moderna-other-biotech-stocks-drop-in-after-hours-trading">dismissing all 17 existing advisers</a>.
What Happened: The reconstituted panel includes Robert Malone, a prominent mRNA vaccine opponent aligned with Kennedy&#8217;s Make America Healthy Again movement, and Retsef Levi, who has called for the immediate withdrawal of mRNA vaccines, citing serious harm risks, according to a Reuters report.
The committee advises the CDC on immunization schedules after FDA approval, directly influencing insurance coverage and vaccine policy.
Kennedy justified the overhaul to &#8220;re-establish public confidence in vaccine science,&#8221; claiming prior Biden-appointed members had conflicts of interest without providing specific evidence. The new eight-member committee represents the minimum allowed under ACIP&#8217;s founding charter. See Also:<a href="https://www.benzinga.com/markets/equities/25/06/45897549/jim-cramer-says-america-wont-be-truly-liberated-until-it-strikes-rare-earth-deals-with-other-countries-us-doesnt-have-the-cards"> Jim Cramer Says America Won&#8217;t Be &#8216;Truly Liberated&#8217; Until It Strikes Rare-Earth Deals With Other Countries: US Doesn&#8217;t &#8216;Have The Cards&#8217;</a>
Why It Matters: Kennedy previously fired the entire 17-member panel Monday through a Wall Street Journal op-ed, arguing it had become a &#8220;rubber stamp for any vaccine.&#8221;
The Trump administration simultaneously terminated a $600 million Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) contract for mRNA bird flu vaccine development and removed COVID-19 vaccines from recommended schedules for <a href="https://www.benzinga.com/news/health-care/25/06/45810364/rfk-jr-champions-medical-freedom-while-curtailing-access-say-public-health-experts">healthy pregnant women and children</a>. Kennedy&#8217;s broader <a 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">healthcare restructuring eliminated</a> 10,000 HHS positions to save $1.8 billion annually.
Market reaction was mixed, with Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) and Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) shares declining marginally while Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) rose in after-hours trading. Earlier this year, <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">FDA&#8217;s top vaccine official</a>, Peter Marks, resigned after condemning Kennedy&#8217;s &#8220;misinformation and lies.&#8221;
The new panel will attend the June 25 ACIP meeting, originally scheduled to deliberate flu shots and 2025-26 COVID-19 booster recommendations. Critics argue Kennedy&#8217;s &#8220;medical freedom&#8221; messaging contradicts policies that restrict vaccine access. Read Next:
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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.
Photo courtesy: lev radin / Shutterstock.com

RFK Jr. Appoints Vaccine Critics To CDC Vaccine Panel After Firing Entire Advisory Committee: Report

Novavax, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) announced results Wednesday of the initial cohort of its COVID-19-Influenza Combination (CIC) and standalone trivalent hemagglutinin nanoparticle seasonal <a href="https://www.benzinga.com/general/health-care" target="_blank" rel="noreferrer noopener">influenza (tNIV) Phase 3 trial</a>.
The study showed that the CIC and flu vaccine candidates induced immune responses similar to those of licensed comparators Nuvaxovid&nbsp;and Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) <a target="_blank" href="https://www.benzinga.com/pressreleases/25/06/n45879363/novavaxs-covid-19-influenza-combination-and-stand-alone-influenza-vaccine-candidates-showed-robust" rel="noreferrer noopener">Fluzone HD, respectively</a>.
Both standalone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains (2.4-5.7-fold over baseline).
Also Read: <a target="_blank" href="https://www.benzinga.com/25/05/45624037/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-kids" rel="noreferrer noopener">Robert F. Kennedy Jr. Says CDC Drops COVID Vaccine For &#8216;Healthy&#8217; Pregnant Women, Children</a>
&#8220;Both our combination and standalone flu vaccine candidates induced robust immune responses and were well tolerated,&#8221; said Ruxandra Draghia-Akli, executive vice president and head of Research and Development at Novavax.
&#8220;This&nbsp;data set adds to&nbsp;findings from our Phase 2 trial and will help inform discussions with potential partners.&#8221;
Both vaccine candidates were well tolerated and saw reactogenicity comparable to authorized comparators.
Nearly all (&gt;98%) solicited adverse events were mild or moderate in severity.&nbsp;
The cohort was designed to provide descriptive data on three flu strains&nbsp;(H1N1, H3N2, B) and SARS-CoV-2 (COVID-19) to inform a future registrational Phase 3 program.
The descriptive trial evaluated the safety and immunogenicity of the CIC and standalone flu vaccine candidates&nbsp;compared to Nuvaxovid and Fluzone HD in approximately 2,000 adults&nbsp;aged 65 and older.
This trial was not adequately powered to demonstrate statistical significance.
In May 2023, Novavax unveiled data for its COVID-influenza combination vaccine and&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/05/32287464/novavax-eases-uncertainty-announces-job-cuts-encouraging-data-from-covidflu-combo-shot" rel="noreferrer noopener">two other shots</a>.
Data from a Phase 2 trial in adults aged 50-80 showed that the combination shot produced an immune response comparable to its protein-based COVID vaccine and already approved influenza shots.
The study found that all three of Novavax&#8217;s vaccine candidates—the COVID/flu combination shot, a standalone flu shot, and a higher dose of its COVID shot—were safe and well-tolerated.
In May, Novavax received limited approval from the U.S. Food and Drug Administration (FDA) for its COVID-19 vaccine, Nuvaxovid. This marked a regulatory milestone and unlocking a $175 million milestone payment <a href="https://www.benzinga.com/25/05/45496095/novavax-scores-key-fda-win-shares-jump-19-as-sanofi-milestone-unlock" target="_blank" rel="noreferrer noopener">from partner Sanofi</a>.
Earlier in June, the FDA approved&nbsp;Moderna, Inc.'s&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) mNexspike&nbsp;(mRNA-1283), a new vaccine against COVID-19, for all adults 65 and older and individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease&nbsp;<a target="_blank" href="https://www.benzinga.com/news/fda/25/06/45719840/modernas-new-covid-vaccine-secures-fda-clearance-for-seniors-at-risk-individuals" rel="noreferrer noopener">Control and Prevention (CDC)</a>.
Price Action: NVAX stock is up 0.56% at $7.24 at the last check on Wednesday.
Read Next:
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</ul>
Photo: Shutterstock

Novavax's Experimental COVID-19-Influenza Combo Shot Shows Immune Response Among Older Adults In Phase 3 Trial

<ul>
<li>Both vaccine candidates induced robust immune responses across all antigens tested</li>
<li>No new safety signals were observed and both vaccine candidates were well tolerated consistent with past trials</li>
<li>Novavax continues to pursue partnering opportunities to advance further development of these programs</li>
</ul>
GAITHERSBURG, Md., June 11, 2025 /PRNewswire/ --&nbsp;Novavax, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) today announced results of the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alone&nbsp;trivalent hemagglutinin nanoparticle&nbsp;seasonal influenza (tNIV) Phase 3 trial that showed both the CIC and flu vaccine candidates induced immune responses similar to licensed comparators Nuvaxovid&#xAE; and Fluzone HD, respectively. This cohort was designed to provide descriptive data on three flu strains&nbsp;(H1N1, H3N2, B) and SARS-CoV-2 (COVID-19) to inform a future registrational Phase 3 program.
Both stand-alone flu and CIC vaccine candidates induced robust immune responses to the vaccine strains (2.4-5.7-fold over baseline). Both vaccine candidates were well tolerated and saw reactogenicity comparable to authorized comparators. Nearly all (&gt;98%) solicited adverse events were mild or moderate in severity.&nbsp;
This descriptive trial was designed to evaluate the safety and immunogenicity of the CIC and stand-alone flu vaccine candidates compared to Nuvaxovid and Fluzone HD in approximately 2,000 adults aged 65 and older. This trial was not adequately powered to demonstrate statistical significance. These results build on previous Phase 2 data.

Novavax Says Results Of Initial Cohort Of COVID-19-Influenza Combination And tNIV Phase 3 Trial Shows Both Vaccine Candidates Induced Immune Responses Similar To Licensed Comparators Nuvaxovid And Fluzone HD, Respectively

The American Pharmacists Association announced Monday it will withhold endorsement of the Centers for Disease Control and Prevention&#8217;s updated immunization schedule that removed COVID-19 vaccine recommendations for pregnant women and healthy children.
What Happened: The CDC modified its guidance last month, stating COVID-19 vaccines remain optional for healthy children when parents and physicians determine necessity, reported Reuters. Health Secretary Robert F. Kennedy Jr., who oversees the CDC, Food and Drug Administration and National Institutes of Health, announced the policy changes before official website updates.
&#8220;COVID-19 vaccination during pregnancy has been proven safe and effective. Additionally, this vaccine is not associated with any fertility issues in either women or men,&#8221; the pharmacists&#8217; association stated. The group emphasized that pregnancy represents a high-risk condition requiring COVID-19 vaccination recommendations.
Kennedy&#8217;s <a href="https://www.benzinga.com/government/regulations/25/05/45688464/rfk-jr-drops-covid-vaccine-recommendation-for-healthy-kids-but-experts-warn-of-major-risks">announcement bypassed the traditional CDC Advisory Committee</a> for Immunization Practices review processes. The policy shift follows FDA changes<a href="https://www.benzinga.com/news/25/05/45661031/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-children"> limiting annual boosters to Americans over 65</a> and high-risk populations while requiring new clinical trials for healthy adults under 65.
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Why It Matters: The FDA recently advised vaccine manufacturers that fall 2025 formulations should target monovalent JN.1-lineage variants, preferentially using the LP.8.1 strain. Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) submitted its Spikevax 2025-2026 formula application targeting the LP.8.1 variant Friday.
Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) received limited FDA approval for its Nuvaxovid vaccine, authorized for individuals 65 and older and those 12 and up with underlying medical conditions. The approval triggered a $175 million milestone payment from partner Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>).
The policy changes create uncertainty for vaccine manufacturers and healthcare investors as the <a 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">administration implements stricter clinical trial</a> requirements. Previous guidance under the Biden administration recommended additional COVID-19 boosters for healthy children despite limited clinical data supporting repeat booster strategies in pediatric populations.
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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.
Photo courtesy: JHVEPhoto / Shutterstock.com

American Pharmacists Association Withholds Endorsement Of CDC's Revised COVID-19 Vaccine Guidance

U.S. Health Secretary Robert F. Kennedy Jr. has championed &#8220;medical freedom&#8221; while simultaneously limiting access to COVID-19 vaccines and restricting food stamp purchases, creating what public health experts call a dichotomy in his approach to healthcare policy.
What Happened: Kennedy announced last week that the Centers for Disease Control and Prevention would remove COVID-19 vaccines from <a href="https://www.benzinga.com/news/25/05/45661031/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-children">recommended </a>immunization schedules for healthy children and pregnant women.
The decision bypassed traditional advisory committee processes and shifted coverage from routine recommendations to shared clinical decision-making between doctors and patients.
&#8220;Regarding the vaccines, HHS is restoring the doctor-patient relationship,&#8221; HHS spokesperson Andrew Nixon said in a <a href="https://abcnews.go.com/Health/rfk-jr-promoted-freedom-choice-limiting-vaccines-food/story?id=122526364">statement</a> to ABC News. &#8220;We are encouraging those groups to consult with their health care provider to help them make an informed decision.&#8221;
Kennedy has also pushed to ban Supplemental Nutrition Assistance Program recipients from purchasing candy and soda with food stamps. Ten state governors have submitted waivers to the Agriculture Department requesting permission for such restrictions, according to Kennedy&#8217;s statements at a Make America Healthy Again event in May.
The Food and Drug Administration began <a href="https://www.benzinga.com/government/regulations/25/05/45399804/robert-kennedy-jr-cheers-fda-plan-to-ban-fluoride-supplements-for-children-calls-move-long-overdue">removing fluoride supplements for children </a>from the market, earning Kennedy&#8217;s praise as &#8220;long overdue.&#8221; The agency cited a lack of FDA approval and evidence that these products alter gut microbiomes.
Kennedy&#8217;s broader MAHA initiative has influenced restaurant chains to eliminate seed oils. Biglari Holdings Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BH#NYSE">BH</a>) subsidiary Steak &#8216;n Shake switched to beef tallow for French fries, while Sweetgreen Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SG#NYSE">SG</a>), Bloomin&#8217; Brands Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BLMN#NASDAQ">BLMN</a>), and Restaurant Brands International Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/QSR#NYSE">QSR</a>) have initiated similar transitions.
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Why It Matters: Critics argue Kennedy&#8217;s policies contradict his &#8220;medical freedom&#8221; messaging by limiting choices. Removing COVID vaccines from CDC schedules restricts access while claiming to promote freedom.
&#8220;If you restrict access, you necessarily restrict choice,&#8221; Dr. Matthew Ferrari of Pennsylvania State University told ABC News. Public health experts warn Kennedy&#8217;s approach individualizes community health decisions. &#8220;We&#8217;re losing a lot of that underpinning, which has led to a lot of the gains in public health,&#8221; Dr. Craig Spencer of Brown University told ABC News.
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Image Via Shutterstock

BLMN

RFK Jr. Champions 'Medical Freedom' While Curtailing Access, Say Public Health Experts

<a href="https://x.com/seckennedy/status/1930012848056365294?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg">https://x.com/seckennedy/status/1930012848056365294?s=46&amp;t=dtUiyC3dUs5yGRgT9qYHWg</a>

US Health Secretary Kennedy Posts On X "I want to address those of you who have anxieties about @US_FDA's limited approval of a new mRNA COVID vaccine for high-risk populations. Moderna has agreed to a true placebo-controlled trial of the new vaccine....."

The U.S. Food and Drug Administration (FDA) on Saturday approved Moderna, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) mNexspike&nbsp;(mRNA-1283), a new vaccine against COVID-19, for all adults 65 and older and individuals aged 12-64 years with at least one or more underlying risk factor as defined by the Centers for Disease <a target="_blank" href="https://www.benzinga.com/general/health-care" rel="noreferrer noopener">Control and Prevention (CDC)</a>.
&#8220;The FDA approval of our third product, mNEXSPIKE&#8230;,&#8221; said Stéphane Bancel, Chief <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/ac45708511/moderna-receives-u-s-fda-approval-for-covid-19-vaccine-mnexspike" rel="noreferrer noopener">Executive Officer of Moderna</a>.
The FDA&#8217;s approval of mNEXSPIKE is based on results from a randomized, observer-blind, active-controlled Phase 3 trial, which enrolled approximately 11,400 participants aged 12 years and older.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/05/45624037/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-kids" rel="noreferrer noopener">Robert F. Kennedy Jr. Says CDC Drops COVID Vaccine For &#8216;Healthy&#8217; Pregnant Women, Children</a>
The primary efficacy objective was to demonstrate the non-inferior vaccine efficacy against COVID-19 starting 14 days after mNexspike compared to that after the comparator vaccine, mRNA-1273 (Spikevax), Moderna&#8217;s original COVID-19 vaccine.
Participants received either a 10 μg dose of mRNA-1283 or a 50 μg dose of mRNA-1273.
mRNA-1283 showed a 9.3% higher relative vaccine efficacy (rVE) compared to mRNA-1273 in individuals aged 12 years and older, and in a descriptive sub-group analysis, a 13.5% higher rVE in adults aged 65 and older.
In the Phase 3 trial, mRNA-1283 was found to have a similar safety profile to mRNA-1273, with fewer local reactions and comparable systemic reactions.
The most commonly solicited side effects were injection site pain, fatigue, headache and myalgia.
Moderna expects to have mNexspike available for eligible populations in the U.S. for the 2025-2026 respiratory virus season, alongside Spikevax and mRESVIA, the company&#8217;s approved respiratory syncytial virus (RSV) vaccine.
William Blair writes, &#8220;Approval of mRNA-1283 is an incremental win for Moderna, especially considering HHS Secretary Robert F. Kennedy Jr.&#8217;s negative public opinion on mRNA COVID-19 vaccines, and we continue to see autonomy and data-driven decisions at the FDA.&#8221;
&#8220;We do not see approval of mRNA-1283 as a massive boost to Moderna&#8217;s COVID-19 vaccine sales, which we believe are primarily driven by sentiment surrounding the vaccination market in general, but this is a critical step in the regulatory path for the combo flu/COVID vaccine product, mRNA-1083, which uses mRNA-1283 as the COVID-19 component of its formulation,&#8221; analyst Myles Minter writes.
Analyst Minter says Moderna is still facing challenges from new government policies, including <a target="_blank" href="https://www.benzinga.com/government/regulations/25/05/45663794/hhs-cancels-590m-moderna-bird-flu-vaccine-deal-casting-uncertainty-over-pandemic-preparedness-effort" rel="noreferrer noopener">losing about $700 million</a> in funding from the Department of Health and Human Services for its bird flu vaccine project.
In addition, William Blair writes that the company&#8217;s goal to break even by 2028 is overly optimistic since it would need to more than double its revenue—based on cash costs—to reach that target.
In May, the FDA approved Novavax, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) Nuvaxovid for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adults 65 years and older and individuals 12 through 64 years who have at least one underlying condition that puts them at high risk for severe outcomes from COVID-19 (e.g. asthma, cancer, <a target="_blank" href="https://www.benzinga.com/pressreleases/25/05/n45489838/u-s-fda-approves-bla-for-novavaxs-covid-19-vaccine" rel="noreferrer noopener">diabetes, obesity, smoking)</a>.
Achievement of the U.S. license approval has triggered a&nbsp;$175 million&nbsp;milestone payment from Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>).
Price Action: MRNA stock is up 4.82% at $27.84 during the premarket session at the last check on Monday.
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Photo by Wolfilser via Shutterstock

Moderna's New COVID Vaccine Secures FDA-Clearance For Seniors, At-Risk Individuals

<a href="https://www.washingtonpost.com/health/2025/05/30/covid-vaccines-children-pregnant-women/" title="https://www.washingtonpost.com/health/2025/05/30/covid-vaccines-children-pregnant-women/">https://www.washingtonpost.com/health/2025/05/30/covid-vaccines-children-pregnant-women/</a>

'Contradicting RFK Jr., CDC keeps recommending covid vaccine for kids' - Washington Post

The U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced that the Centers for Disease Control and Prevention will no longer recommend COVID-19 vaccines for healthy children and pregnant women, sparking criticism from public health experts who cite ongoing risks.
What Happened: Kennedy <a href="https://www.benzinga.com/news/25/05/45661031/robert-f-kennedy-jr-says-cdc-drops-covid-vaccine-for-healthy-pregnant-women-children">announced</a> the policy change in a video posted on X, joined by FDA Commissioner Dr. Marty Makary and NIH Director Jay Bhattacharya. &#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 stated. Makary said there is no evidence that healthy children &#8220;need&#8221; the vaccine.
The decision bypassed the traditional CDC Advisory Committee for Immunization Practices review process. Dr. Paul Offit, director of the Vaccine Education Center at Children&#8217;s Hospital of Philadelphia, said, &#8220;152 children died last year of COVID. 40% of those children were perfectly healthy,&#8221; challenging Kennedy&#8217;s rationale, <a href="https://abcnews.go.com/Health/healthy-children-vaccination-rfk-jr-cuts-covid-shot/story?id=122303993">reported</a> ABC News.
The policy follows FDA changes <a 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">limiting annual boosters to Americans</a> over 65 and high-risk groups while requiring new clinical trials for healthy adults under 65.
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Why It Matters: The announcement creates uncertainty for vaccine manufacturers and healthcare investors. Previous FDA policy shifts under the Trump administration have already <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">impacted vaccine approvals</a>, with Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) receiving only limited approval for seniors and high-risk groups after regulatory delays.
Dr. Gregory Poland from the Atria Research Institute noted that over one million U.S. children may have experienced long COVID, with vaccination reducing emergency room visits and hospitalizations by approximately 40%.
Image via Shutterstock
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Regulations

RFK Jr. Drops COVID Vaccine Recommendation For Healthy Kids, But Experts Warn Of Major Risks

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.
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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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Equities

Government

Politics

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

Management

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

Press Releases

Novavax Announces Changes to Board of Directors

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

Novavax Appoints Charles Newton to Board of Directors

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

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

Novavax to Participate in BofA Securities 2025 Health Care Conference

Earnings

Novavax Reports First Quarter 2025 Financial Results and Operational Highlights

U.S. FDA Approves BLA for Novavax's COVID-19 Vaccine

Novavax to Participate in Upcoming Investor Conferences

Novavax's COVID-19-Influenza Combination and Stand-alone Influenza Vaccine Candidates Showed Robust Immune Responses and Were Well Tolerated in Initial Cohort of a Phase 3 Trial

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<li>Smartsheet Inc。（NYSE:<a class="ticker" href="https://www.benzinga.com/stock/SMAR#NYSE">SMAR</a>）の株価は、同社が予想を上回るQ1業績を発表し、<a href="https://www.benzinga.com//node/39195040" target="_blank" rel="noreferrer noopener">初めての1億5000万ドルの株買い戻しプログラムを発表した</a>ことで18.01％上昇しました。 これを受け、多くのアナリストが<a href="https://www.benzinga.com//node/39206468" target="_blank" rel="noreferrer noopener">株価ターゲットを変更しました</a>。</li>
<li>Halozyme Therapeutics, Inc。（NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HALO#NASDAQ">HALO</a>）の株価は14.03％急伸し、同社が<a href="https://www.benzinga.com//node/39211537" target="_blank" rel="noreferrer noopener">FY24業績見通しを引き上げた</a>ことが要因です。</li>
<li>Legend Biotech Corporation（NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LEGN#NASDAQ">LEGN</a>）の<a href="https://www.benzinga.com/quote/legn/analyst-ratings" target="_blank" rel="noreferrer noopener">株価が13.93％上昇しました</a>。</li>
<li>Liberty Global Ltd。（NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LBTYB#NASDAQ">LBTYB</a>）の株価は12.48％上昇しました。</li>
</ol>

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月曜日, 6 10, 2024

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