最新ニュース AstraZeneca (NASDAQ:AZN) 株価情報

AstraZeneca

A merger between Astra of Sweden and Zeneca Group of the United Kingdom formed AstraZeneca in 1999. The firm sells branded drugs across a number of major therapeutic areas, including gastrointestinal, diabetes, cardiovascular, respiratory, cancer, immunology and rare diseases. The majority of sales come from international markets with the United States representing close to one third of its sales.

AstraZeneca PLC - American Depositary Shares

AstraZeneca PLC

AstraZeneca PLC ADRhedged AstraZeneca PLC ADRhedged

AZN Capital Corp

On Thursday, the Cellular, Tissue, and Gene Therapies Advisory Committee will discuss AstraZeneca Plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) supplemental biologics license application for Andexxa (coagulation factor Xa (recombinant), inactivated -zhzo), for patients treated with rivaroxaban or apixaban when reversal of anticoagulation is needed due to life-threatening <a href="https://www.benzinga.com/general/health-care">or uncontrolled bleeding.</a>
The FDA initially granted accelerated approval of <a href="https://www.fda.gov/advisory-committees/advisory-committee-calendar/cellular-tissue-and-gene-therapies-advisory-committee-november-21-2024-meeting-announcement-11212024">Andexxa</a>, a recombinant modified human factor Xa (FXa) protein, in 2018 based on the change from baseline in anti-activated FXa (anti-FXa) activity, as a surrogate endpoint reasonably likely to predict clinical benefit as provided for in 21 CFR 601.41.
AstraZeneca was required to conduct a randomized controlled trial to verify and describe the clinical benefit of Andexxa, due to uncertainty as to the relation of the surrogate endpoint to clinical benefit and the observed clinical benefit to ultimate outcomes in the indicated population. In January 2024, the company submitted a supplemental Biologics Licensing Application for Andexxa with the results of the ANNEXA-I trial to fulfill this requirement.
Before the meeting, the FDA panel released <a target="_blank" href="https://www.fda.gov/media/183674/download" rel="noreferrer noopener">brief</a> documents highlighting some safety issues and other concerns.
"Although andexanet showed superiority of the primary efficacy endpoint over UC [usual care] within the PEP [primary efficacy population], the superior efficacy at 12 hours did not predict longer-term benefit," FDA said.
The major safety findings included a doubling of the rate of thromboses and thrombosis-related deaths at Day 30 in the andexanet arm compared with UC.
The major topics for discussion:
<ul>
<li>ANNEXA-I demonstrated an increased incidence of thrombosis (14.6% versus 6.9%) and thrombosis-related deaths at Day 30 (2.5% versus 0.9%) in the andexanet arm compared with the UC arm, respectively. These findings raise concerns regarding whether the serious risks of treatment with andexanet are acceptable in the indicated population.</li>
<li>While the primary efficacy endpoint in ANNEXA-I was met, the treatment difference across arms appears to be primarily driven by one of three components of the composite endpoint, namely the volume of hematoma at 12 hours, while other clinically meaningful endpoints were not different between the two arms. These findings raise the question as to whether the benefit demonstrated in ANNEXA-I outweighs the serious risks.</li>
</ul>
The document highlighted, &#8220;Treatment with andexanet demonstrated a statistically significant improvement in hemostasis compared to UC (andexanet: 65.7% versus UC: 53%). The observed treatment difference between arms appears to be primarily driven by hematoma volume, with more patients in the andexanet arm than UC arm experiencing a ≤35% increase from baseline in hematoma volume at 12 hours (74% versus 60%).&#8221;
Hematoma is a blood collection that pools outside blood vessels, usually caused by an injury or surgery.
Price Action: AZN stock is up 0.97% at $63.82 at last check Thursday.
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AstraZeneca's Andexxa Faces FDA Scrutiny Over Effectiveness, Safety Concerns

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Top Wall Street analysts changed their outlook on these top names. For a complete view of all analyst rating changes, including upgrades and downgrades, please see our <a href="https://www.benzinga.com/analyst-stock-ratings">analyst ratings page</a>.
<ul>
<li><a href="https://www.benzinga.com/analyst-stock-ratings/analyst/6054966d36622a00019eaa50/peter-low">Redburn Atlantic analyst Peter Low</a> upgraded the rating for Equinor ASA (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EQNR#NYSE">EQNR</a>) from Neutral to Buy. Equinor shares closed at $23.67 on Tuesday. <a href="https://www.benzinga.com/quote/EQNR/analyst-ratings">See how other analysts view this stock.</a></li>
<li>Jefferies analyst Greg Konrad upgraded AeroVironment, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AVAV#NASDAQ">AVAV</a>) from Hold to Buy but lowered the price target from $240 to $230. AeroVironment shares closed at $194.89 on Tuesday. <a href="https://www.benzinga.com/quote/AVAV/analyst-ratings">See how other analysts view this stock.</a></li>
<li><a href="https://www.benzinga.com/analyst-stock-ratings/analyst/5e5520feece4e60001201237/andrea-teixeira">JP Morgan analyst Andrea Teixeira</a> upgraded the rating for Energizer Holdings, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ENR#NYSE">ENR</a>) from Underweight to Neutral and raised the price target from $32 to $39. Energizer shares closed at $37.25 on Tuesday. <a href="https://www.benzinga.com/quote/ENR/analyst-ratings">See how other analysts view this stock</a>.</li>
<li>UBS analyst Matthew Weston upgraded the rating for AstraZeneca PLC (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) from Sell to Neutral. AstraZeneca shares closed at $63.80 on Tuesday. <a href="https://www.benzinga.com/quote/AZN/analyst-ratings">See how other analysts view this stock.</a></li>
<li>B of A Securities analyst Curtis Nagle upgraded Chewy, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CHWY#NYSE">CHWY</a>) from Underperform to Buy and raised the price target from $24 to $40. Chewy shares closed at $32.94 on Tuesday. <a href="https://www.benzinga.com/quote/chwy/analyst-ratings">See how other analysts view this stock.</a></li>
</ul>
Considering buying AZN stock? Here&#8217;s what analysts think: 
<figure class="wp-block-image size-large is-resized"><img loading="lazy" decoding="async" width="1024" height="572" src="https://editorial-assets.benzinga.com/wp-content/uploads/2024/11/20072541/image-206-1024x572.png" alt="" class="wp-image-656781" style="width:653px;height:auto" srcset="https://editorial-assets.benzinga.com/wp-content/uploads/2024/11/20072541/image-206-1024x572.png 1024w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/11/20072541/image-206-300x167.png 300w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/11/20072541/image-206-768x429.png 768w,https://editorial-assets.benzinga.com/wp-content/uploads/2024/11/20072541/image-206.png 1177w" sizes="(max-width: 1024px) 100vw, 1024px" /></figure>
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This AstraZeneca Analyst Is No Longer Bearish; Here Are Top 5 Upgrades For Wednesday

UBS analyst Matthew Weston upgrades AstraZeneca (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) from Sell to Neutral.

UBS Upgrades AstraZeneca to Neutral

GRAL

GRAIL Announces The First Patient Has Been Tested For Eligibility With Its Non-Small Cell Lung Cancer ctDNA Assay In The TROPION-Lung12 Phase 3 Study, Sponsored By AstraZeneca In Collaboration With Daiichi Sankyo

AstraZeneca's Tagrisso (Osimertinib) Has Been Recommended For Approval In The European Union For Adult Patients With Locally Advanced, Unresectable Non-small Cell Lung Cancer With Unresectable Epidermal Growth Factor Receptor-Mutated Lung Cancer

Some large European and U.S. vaccine maker stocks have fallen in reaction to Robert F. Kennedy Jr.&#8217;s nomination to lead the&nbsp;Department of <a target="_blank" href="https://www.benzinga.com/government/regulations/24/11/41993115/trump-taps-rfk-jr-for-health-secretary-role-sends-5-vaccine-stocks-lower" rel="noreferrer noopener">Health and Human Services</a>.
Kennedy has been known to be against vaccines and has a track record of making false claims about vaccines, including the debunked idea that they cause autism. Scientific studies have <a target="_blank" href="https://www.benzinga.com/government/regulations/24/11/41993115/trump-taps-rfk-jr-for-health-secretary-role-sends-5-vaccine-stocks-lower" rel="noreferrer noopener">debunked this theory</a>.
Also, given his critical stance on mainstream medical practices and vaccines, U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) employees are worried about Kennedy <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/42009107/robert-kennedy-poised-to-lead-health-and-human-services-why-fda-nih-officials-are-nervous" rel="noreferrer noopener">being in charge</a>.
Kennedy, who received Trump&#8217;s blessing to &#8220;<a target="_blank" href="https://www.benzinga.com/markets/cannabis/24/11/41828359/could-trumps-go-wild-on-health-invite-to-rfk-jr-drive-changes-for-cannabis-and-psychedelics" rel="noreferrer noopener">go wild on health</a>,&#8221; has stated intentions to overhaul various aspects of the federal health agencies.
In a post on social media, Kennedy <a target="_blank" href="https://x.com/RobertKennedyJr/status/1857198805919138235" rel="noreferrer noopener">said</a>, &#8220;Together we will clean up corruption, stop the revolving door between industry and government, and return our health agencies to their rich tradition of gold-standard, evidence-based science. I will provide Americans with transparency and access to all the data so they can make informed choices for themselves and their families.&#8221;
On Friday, the World Health Organization also defended vaccines describing them as &#8220;absolutely critical&#8221; to global health, adding that many people alive today would not have survived <a href="https://www.benzinga.com/general/biotech/24/11/42006119/who-calls-vaccines-absolutely-critical-as-trumps-appointment-of-rfk-jr-pulls-pzifer-moderna-stocks-downhill" target="_blank" rel="noreferrer noopener">childhood without them</a>.
European vaccine player stocks declined, including&nbsp;GSK Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>), Valneva SE (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VALN#NASDAQ">VALN</a>), AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41715307/biontech-variant-adapted-covid-19-vaccines-do-well-in-q3" rel="noreferrer noopener">BioNTech SE</a> (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BNTX#NASDAQ">BNTX</a>), and Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>).
GSK stock fell after the company reported lower third-quarter sales, which was impacted by an 18% decline <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41624198/gsks-q3-earnings-hit-by-lower-than-expected-vaccine-sales-cautions-lower-revenue-for-2024" rel="noreferrer noopener">in vaccine sales</a>.
COVID-19 vaccine players <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41808252/moderna-q3-revenue-beats-on-updated-covid-19-vaccine-slashes-expenses-for-2024" rel="noreferrer noopener">Moderna Inc</a><a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41808252/moderna-q3-revenue-beats-on-updated-covid-19-vaccine-slashes-expenses-for-2024" rel="noreferrer noopener"> </a>(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>), <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41596761/pfizer-q3-earnings-revenue-and-profit-on-heightened-demand-for-paxlovid-expects-10-billion-in-202" rel="noreferrer noopener">Pfizer Inc</a> (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>), and BioNTech stock gained when the third quarter earnings surpassed estimates on increased vaccine demand.
Other vaccine players&#8217; stocks that are down include Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) and Inovio Pharmaceuticals, Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INO#NASDAQ">INO</a>).
Price Action: GSK stock is down 3.88% at $33.06, BNTX stock is down 5.18%, VALN stock is down 4.24%, AZN stock is down 2.08%, MRK stock is down 3.28%, INO stock is down 9.85% at last check Friday.
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Photo by Vladimka production via Shutterstock

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European And US Vaccine Stocks Are Under Pressure - Here's WHy

On CNBC's &#8220;<a href="https://www.benzinga.com/topic/mad-money-lightning-round">Mad Money Lightning Round</a>,&#8221; Jim Cramer said Altria Group, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MO#NYSE">MO</a>) is &#8220;undervalued,&#8221; but he is not going to <a href="https://www.benzinga.com/quote/MO/guidance">recommend tobacco stocks</a>.
On Oct. 31, the company reported third-quarter adjusted earnings per share of $1.38. It beat the street view of $1.35. Quarterly sales of $5.334 billion (+1.3%) beat the analyst consensus estimate of $5.326 billion.
Cramer recommended selling Super Micro Computer, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SMCI#NASDAQ">SMCI</a>).
Super Micro Computer filed a FormNT 10-Q with the Securities and Exchange Commission, indicating that it's unable to file its 2025 fiscal-year first-quarter earnings on time.
When asked about The Boeing Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BA#NYSE">BA</a>), he said, &#8220;I prefer not to be in a stock that is going to lose a lot of money for a long time.&#8221;
According to Reuters, the company reportedly begins issuing layoff notices to employees affected by a major restructuring plan. The plan, which aims to reduce Boeing's global workforce by 17,000 jobs—approximately 10% of its total—comes as the heavily indebted aerospace <a href="https://www.benzinga.com/trading-ideas/movers/24/11/41950702/boeing-reportedly-plans-furloughs-whats-going-on">giant seeks to cut costs</a>.
Becton, Dickinson and Company (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BDX#NYSE">BDX</a>) has &#8220;broken down severely,&#8221; Cramer said. &#8220;If Robert F. Kennedy Jr. is going to be the head of HHS, then it's going to hurt a lot of vaccines, it could hurt a lot of their business.&#8221;
On Nov. 7, the company posted better-than-expected results for its fourth quarter.
&#8220;They have a lot of phase one stuff, and phase one is might early. Too early for me to bet on,&#8221; Cramer said when asked about IDEAYA Biosciences, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/IDYA#NASDAQ">IDYA</a>).
On Nov. 4, IDEAYA Biosciences reported a quarterly loss of 60 cents per share, compared to consensus estimates of a loss of 64 cents per share.
&#8220;I just don't know what is wrong,&#8221; Cramer said about AstraZeneca PLC (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>). &#8220;My god is this thing going lower.&#8221;
On Nov. 12, AstraZeneca reported third-quarter sales of $13.57 billion, up 18% year over year (+21% at constant currency), beating the consensus of $13.09 billion.
Price Action:
<ul>
<li>Altria shares rose 0.3% to settle at $55.39 on Thursday.</li>
<li>Super Micro Computer shares dipped 11.4% to close at $18.01.</li>
<li>Boeing shares fell 1.3% to settle at $138.14 during the session.</li>
<li>Becton Dickinson shares fell 1.8% to close at $227.17 on Thursday.</li>
<li>IDEAYA Biosciences shares fell 3.4% to settle at $29.47 during the session.</li>
<li>AstraZeneca shares fell 0.4% to close at $65.04 on Thursday.</li>
</ul>
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The World Health Organization (WHO) on Friday described vaccines as &#8220;absolutely critical&#8221; to global health, adding that many people alive today would not have survived childhood without them. This comes at after Donald Trump&#8216;s announcement of Robert F. Kennedy Jr. as Health Secretary.
What Happened: As per <a href="https://pro.benzinga.com">Benzinga Pro</a> on Friday, health stocks declined further during pre-market hours. Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) saw a 0.58% drop after closing 2.62% lower at $26.02. Moderna Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) was down by 1.56% while AstraZeneca plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) fell by 1.41%, and Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) decreased by 1.39%, having already dropped 7.02% to $7.22.
While the spokesperson for WHO did not comment on Kennedy Jr&#8217;s appointment directly, she mentioned that the U.S. is an important United Nations member and hoped the &#8220;fantastic work&#8221;&nbsp; would continue, <a href="https://www.bbc.com/news/live/c0lp93494g9t?post=asset%3Afdf8e84f-8eb1-45b0-9e05-4ad5adad709b#post">as</a> per BBC news.
Trump&#8217;s decision to appoint Kennedy, known for his vaccine skepticism and conspiracy theories has sparked significant attention. The move aligns with Kennedy&#8217;s recent endorsement of Trump after ending his presidential bid.
<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">Thank you <a href="https://twitter.com/realDonaldTrump?ref_src=twsrc%5Etfw">@realDonaldTrump</a> for your leadership and courage. I&#39;m committed to advancing your vision to Make America Healthy Again. We have a generational opportunity to bring together the greatest minds in science, medicine, industry, and government to put an end to the chronic…
&mdash; Robert F. Kennedy Jr (@RobertKennedyJr) <a href="https://twitter.com/RobertKennedyJr/status/1857198805919138235?ref_src=twsrc%5Etfw">November 14, 2024</a></blockquote>
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8"></script></div>
</figure>
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Why It Matters: The appointment of Kennedy, a prominent critic of vaccines, as Health Secretary could signal a shift in national health policies. Trump&#8217;s choice has <a href="https://www.benzinga.com/government/regulations/24/11/41993115/trump-taps-rfk-jr-for-health-secretary-role-sends-5-vaccine-stocks-lower">elicited mixed reactions</a>, particularly among public health experts. Kennedy&#8217;s stance on vaccines may influence future health regulations and policies.
Kennedy&#8217;s views on vaccines <a href="https://www.benzinga.com/government/regulations/24/11/41993115/trump-taps-rfk-jr-for-health-secretary-role-sends-5-vaccine-stocks-lower">and health agencies diverge sharply</a> from mainstream medical consensus. He has consistently propagated debunked claims, including the false assertion that vaccines cause autism—a theory discredited by extensive scientific research. His nomination for HHS secretary comes amid declining vaccination rates, which have contributed to public health challenges such as 13 measles outbreaks reported in the U.S. this year.
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WHO Calls Vaccines 'Absolutely Critical' As Trump's Appointment Of RFK Jr Pulls Pzifer, Moderna Stocks Downhill

President-elect Donald Trump picked Robert F. Kennedy Jr., known for his vaccine skepticism, as his nominee Thursday to lead the <a href="https://www.benzinga.com/general/biotech/24/10/41127143/us-hhs-reveal-cost-savings-for-54-prescription-drugs-including-novartis-cancer-drug-ozempic-could">Department of Health and Human Services. </a>
This move, which comes after Kennedy ended his presidential campaign and endorsed Trump, positions the environmental activist to potentially reshape national health policies. The selection has stirred mixed reactions, particularly from public health experts, <a href="https://www.politico.com/news/2024/11/14/robert-f-kennedy-jr-trump-hhs-secretary-pick-00188617">Politico</a> reports.
&#8220;For too long, Americans have been crushed by the industrial food complex and drug companies who have engaged in deception, misinformation, and disinformation when it comes to Public Health,&#8221; Trump said in a tweet announcing the decision. 
As Benzinga reported earlier this month, Kennedy has a history of spreading falsehoods about vaccines, including that they cause autism, a theory disproven by scientific studies. His selection as the nominee for HHS secretary comes against a backdrop of falling vaccination rates, which coincide with, in one example, 13 measles outbreaks in the U.S. so far this year. 
What Happened: Trump's decision is part of a broader promise to "let Kennedy go wild" with health and food policies, aiming to overhaul the HHS. Kennedy has expressed sharp criticisms of several health agencies.
Kennedy had hinted at the potential role of "health czar" in Trump&#8217;s administration. If he is confirmed, Kennedy's appointment could influence vaccine policy and the <a href="https://www.benzinga.com/general/biotech/24/11/41822473/trumps-potential-health-czar-robert-f-kennedy-jr-rattles-vaccine-stocks-shoot-first-reaction">direction of the CDC, FDA, and NIH.</a>
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Kennedy's prospective role has already affected vaccine manufacturer stocks. Major vaccine-related companies saw declines in stock prices on Thursday due to the uncertainty surrounding Kennedy&#8217;s influence on health policy.
Key companies impacted include:
<ul>
<li>Moderna Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) down 5.62% to $39.77.</li>
<li>Pfizer Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) down 2.62% to $26.02.</li>
<li>Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) down 0.89% to $151.87.</li>
<li>AstraZeneca plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) down 0.38% to $65.04.</li>
<li>Novavax Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVAX#NASDAQ">NVAX</a>) down 7.02% to $7.22.</li>
</ul>
Why It Matters: Kennedy's views on vaccines and health oversight agencies stand in stark contrast to established medical consensus. His appointment could alter public health directives, with some analysts predicting potential shifts in FDA regulatory independence and vaccine guidelines. 
The impact may extend beyond policy, shaping public trust in health systems amid ongoing debates over vaccine safety.
Kennedy, while indicating he has no plans to "take away anybody's vaccines," continues to be a polarizing figure. Vaccine-related stocks may experience ongoing volatility as the Trump administration finalizes its health policy agenda.
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Photo: Shutterstock.

Equities

Government

Regulations

Politics

Trump Taps RFK Jr. For Health Secretary Role, Sends 5 Vaccine Stocks Lower

LBRDA

MCHP

Soros Fund Management 13F Shows Added Put Position In SPDR S&P 500 ETF With 2,123,000 Shares; Added Stake In Smurfit Westrock With 6,896,971 Shares; Added Put Position In Ishares Russell 2000 ETF With 800,000 Shares; Added Stake In Microchip Technology Convertible Notes With $130.3M In Principal;  Added Stake In Liberty Broadband Corp With 1,119,893 Shares; Added Stake In AstraZeneca With 2,652,771 Shares

After years of limited advancements in chronic obstructive pulmonary disease (COPD) treatment, patients now have new options.
Regeneron Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) and Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Dupixent recently gained FDA approval for COPD, marking its sixth U.S. indication since its first use for atopic dermatitis <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/41069388/fda-approves-regeneronsanofis-blockbuster-dupixent-for-smokers-lung-disease" rel="noreferrer noopener">seven years ago</a>.
This expansion positions Dupixent as the first targeted therapy for COPD, a significant leap in treating this progressive lung condition that impedes breathing due to obstructed airflow.
COPD often manifests as chronic bronchitis and emphysema, typically developing from prolonged exposure to irritants like cigarette smoke, air pollution, or occupational dust.
Also Read: <a target="_blank" href="https://www.benzinga.com/markets/equities/24/06/39312759/regenerons-dupixent-copd-sales-to-reach-20b-by-2026-analyst-sees-larger-addressable-market" rel="noreferrer noopener">Regeneron&#8217;s Dupixent COPD Sales To Reach $20B By 2026, Analyst Sees Larger Addressable Market</a>
The condition impacts millions globally, with a 2023 analysis by DelveInsight <a target="_blank" href="https://www.prnewswire.com/news-releases/sanofiregeneron-pharmaceuticals-dupixent-approval-marks-a-significant-shift-in-chronic-obstructive-pulmonary-disease-treatment-landscape--delveinsight-302302232.html" rel="noreferrer noopener">reporting</a> around 44 million diagnosed cases across seven major markets, with projections of continued growth at a 1.4% CAGR through 2034.
COPD management typically involves medications like bronchodilators, which ease breathing by relaxing airway muscles.
These drugs, often used in inhalers, can include steroids to reduce inflammation in severe cases. Common options include short—and long-acting bronchodilators like Albuterol, Ipratropium, and Aclidinium. LABAs and LAMAs are also prevalent, with combinations such as LABA+ICS (e.g., AstraZeneca Plc&#8217;s (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/azn#NASDAQ">AZN</a>) Symbicort, GSK Plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Advair) and LABA+LAMA (e.g., GSK&#8217;s Anoro Ellipta, Boehringer Ingelheim&#8217;s Stiolto Respimat) available for comprehensive treatment.
The introduction of Dupixent changes the treatment landscape by specifically targeting type 2 inflammation pathways (IL-4 and IL-13), which play a role in COPD patients with elevated eosinophils prone to frequent exacerbations.
The Phase 3 BOREAS trial demonstrated that DUPIXENT reduced moderate-to-severe exacerbations by 30% over 52 weeks and improved lung function, with prebronchodilator FEV1 increasing by 160 mL compared to 77 mL in the placebo group.
The drug also had a favorable safety profile, indicating its potential as a game-changer for those with type 2 inflammation.
Further boosting the pipeline, mid-stage drugs like Sanofi/Regeneron&#8217;s itepekimab, AstraZeneca&#8217;s benralizumab, Amgen Inc NASDAQ: AMGN/AstraZeneca&#8217;s tezepelumab, and GSK&#8217;s mepolizumab are in development, promising more options to transform COPD management.
On Wednesday, Regeneron announced that new and updated data from its hematology pipeline will be presented in 23 abstracts at the American Society of Hematology <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/g41934824/regeneron-to-highlight-pioneering-pipeline-progress-across-multiple-modalities-spanning-10-types-o" rel="noreferrer noopener">2024 Annual Meeting</a>.
Price Action: REGN stock traded lower by 0.98% to $812.92 at the last check on Wednesday.
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Photo by Minerva Studio via Shutterstock

REGN

Regeneron/Sanofi's Dupixent Approval Signals Major Treatment Breakthrough For Smokers' Lung Disease

AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) reported third-quarter sales of $13.57 billion, up 18% year over year (+21% at constant currency), beating the <a target="_blank" href="https://www.benzinga.com/calendars/earnings" rel="noreferrer noopener">consensus of $13.09 billion</a>.&nbsp;
The company&#8217;s adjusted EPADS&nbsp;reached&nbsp;$1.04, beating the consensus of $1.03. The adjusted EPS was $2.08 (1 ADR = 2 Common Shares).
AstraZeneca&#8217;s top business, oncology, <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/9m-and-q3-2024-results.html" rel="noreferrer noopener">increased</a> 19% (up 22% on constant currency) to $5.57 billion.
<ul>
<li>Tagrisso sales were up 14% to $1.67 billion (17% at CER), Calquence sales increased 24% (25% at CER) to $8.13 million, and Enhertu revenue was up 50% (55% at CER) to $510 million.</li>
</ul>
Cardiovascular, Renal, and Metabolism (CVRM) sales increased 18% (up 20 at CER)% to&nbsp;$3.16 billion.
<ul>
<li>Farxiga sales were up 25% (27% at CER) to $1.94 billion, and Lokelma sales increased 40% (42% at CER) to $143 million.</li>
</ul>
R&amp;I Respiratory &amp; Immunology sales increased 26% (29% CER) to $1.96 billion.
Rare Disease drug sales increased by 9% (+11% at CER) to&nbsp;$2.15 billion.
Guidance:&nbsp;For fiscal year 2024, AstraZeneca forecasts total revenue and core EPS to increase by a high-teens percentage, compared to prior guidance of a <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39958623/astrazeneca-posts-mixed-q2-earnings-still-raises-annual-guidance-on-strong-demand-for-cancer-rare" rel="noreferrer noopener">mid-teens percentage</a>.
AstraZeneca also said that, along with its partner Daiichi Sankyo Ltd (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSKNY#OTC">DSKNY</a>), it has <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/dato-dxd-new-bla-submitted-nsq-bla-withdrawn.html" rel="noreferrer noopener">submitted</a> a new biologics license application for accelerated approval of datopotamab deruxtecan (Dato-DXd) for locally advanced or metastatic epidermal growth factor receptor-mutated non-small cell lung cancer patients who have received prior systemic therapies.
&#8220;We take the matters in China very seriously. If requested, we will fully cooperate with the authorities. We remain committed to delivering innovative life-changing medicines to patients in China,&#8221; the company said.
AstraZeneca&#8217;s third-quarter revenue in China was $1.7 billion, representing a 15% growth at constant exchange rates.
As per a financial media company Yicai report last week, senior executives at&nbsp;AstraZeneca China&nbsp;are embroiled in a significant insurance fraud case, marking one of the most extensive scandals in China&#8217;s pharmaceutical <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41754167/why-is-astrazeneca-stock-sinking-on-tuesday" rel="noreferrer noopener">industry in recent years</a>.
The company has not received any notification that it is itself under investigation. If requested, AstraZeneca will fully cooperate with the Chinese authorities.
On Tuesday, the European pharma giant <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/astrazeneca-invests-3bn-500mn-in-us.html" rel="noreferrer noopener">announced</a> $3.5 billion of capital investment in the U.S., which will be used to expand the company&#8217;s research and manufacturing footprint by the end of 2026.
This includes $2 billion of new investment in new spending on research and development and on plants that manufacture biologics medicines and cell therapies.
The new investments will expand manufacturing sites in Maryland, Texas, and California and create 1,000 high-skilled jobs.
&#8220;Our multibillion-dollar investment reflects the attractiveness of the business environment together with the quality of talent and innovation capabilities here in the United States,&#8221; CEO Pascal Soriot said.
AstraZeneca also <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/komet-phase-iii-trial-met-primary-endpoint.html" rel="noreferrer noopener">released</a> high-level results from the KOMET Phase 3 trial of Koselugo&nbsp;(selumetinib) in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable plexiform neurofibromas.
The data showed that Koselugo met its primary endpoint, demonstrating a statistically significant and clinically meaningful objective response rate versus placebo.
Price Action: AZN stock is down 0.89% at $64.22 at the last check on Tuesday.
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</ul>
Image by Robert Way via Shutterstock

Earnings

Guidance

DSKNY

AstraZeneca Lifts 2024 Forecast On Better Than Expected Q3 Performance, Says It Takes China Investigations 'Very Seriously'

AstraZeneca CEO Says Too Early To Judge Whether Wang Probe Will Have Short Or Long Term Impact On China Outlook

AstraZeneca Commits $3.5B Investment To Expand R&D And Manufacturing In The U.S., Creating Over 1,000 High-Skilled Jobs; New Facilities Planned Across Multiple States To Support Growth Ambition

This includes $2 billion of new investment creating more than a thousand new, high-skilled jobs contributing to the growth of the US economy.
AstraZeneca's expanding footprint in the US includes, among others:
<ul>
<li>A state-of-the-art R&amp;D centre in Kendall Square, Cambridge, Massachusetts</li>
<li>A next generation manufacturing facility for biologics in Maryland</li>
<li>Cell therapy manufacturing capacity on the West and East Coasts</li>
<li>Specialty manufacturing in Texas</li>
</ul>
These US investments are the first of a series of important steps to help deliver AstraZeneca's ambition to achieve $80 billion in Total Revenue by 2030 as set out in <a href="https://www.astrazeneca.com/investor-relations/astrazeneca-investor-day.html">May this year</a>. A key element of our strategy is accelerating the Company's development in the United States. The US is AstraZeneca's largest market, generating 44% of its Total Revenue.1
 &nbsp;

AstraZeneca Announces $3.5B Of Capital Investment In The Us Focused On Expanding The Company's Research And Manufacturing Footprint By The End Of 2026

Results demonstrated reduction in tumour volume, building on established safety and efficacy profile of Koselugo in children and supporting expanded use in adults&nbsp;
Results demonstrated reduction in tumour volume, building on established safety and efficacy profile of Koselugo in children and supporting expanded use in adults &nbsp;

AstraZeneca's High-Level Results From KOMET Phase 3 Trial In Adults With Neurofibromatosis Type 1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas Showed That Koselugo (Selumetinib) Met Its Primary Endpoint, Demonstrating A Statistically Significant And Clinically Meaningful Objective Response Rate Versus Placebo

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Avadel Pharmaceuticals plc - American Depositary Shares each representing one Ordinary Share

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The Beachbody Company, Inc. Class A Common Stock

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Earnings Scheduled For November 12, 2024

Guidance Given the strength of underlying Product Sales and Alliance Revenue, as well as increased confidence in achieving certain sales-based milestones, the&nbsp;

AstraZeneca Raised Its 2024 Guidance: Now Expects Total Revenue And Core EPS To Increase By High Teens Percentage (Previously Anticipated To Rise By Mid-Teens Percentage)

AstraZeneca (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) reported quarterly earnings of $1.04 per share which beat the analyst consensus estimate of $1.03 by 0.97 percent. The company reported quarterly sales of $13.565 billion which beat the analyst consensus estimate of $13.088 billion by 3.65 percent. This is a 18.04 percent increase over sales of $11.492 billion the same period last year.

Earnings Beats

AstraZeneca Q3 2024 Adj. EPADS $1.04 Beats $1.03 Estimate, Sales $13.565B Beat $13.088B Estimate

Optimism over global healthcare sector rises: Jefferies

IonQ Inc. ($IONQ) has seen its stock price double over the last month, with shares rising more than 50% in the two days following the release of it...

IonQ (IONQ) Stock Lacks Needed Catalysts

Eli Lilly Stock: Unexpected Developments (Rating Downgrade)

Amneal gets FDA approval for generic Byetta, resubmits DHE NDA

Barclays analyst Emily Field maintained a Buy rating on AstraZeneca (AZN – Research Report) today and set a price target of £140.00. The company's ...

AstraZeneca (AZN) Receives a Buy from Barclays

In a report released today, James Gordon from J.P. Morgan reiterated a Buy rating on AstraZeneca (AZN – Research Report), with a price target of p1...

J.P. Morgan Remains a Buy on AstraZeneca (AZN)

Franklin Growth Fund Q3 2024 Commentary

Trump picks surgeon Marty Makary to head FDA, Rep. Dave Weldon to lead CDC

Pfizer meets amyloidosis rival as BridgeBio wins FDA nod for Attruby

Notable analyst calls this week: Roku, Nvidia and Biogen among top picks

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Screenshot 2024-09-30 at 9.13.36 PM

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The Rush For Non-Addictive Painkillers To Counter The Opioid Crisis Puts Two Companies Closer To FDA Decisions

Screenshot 2024-09-30 at 5.38.54 PM

Movers & Shakers

How Cosmos Health&#39;s Acquisition Of Almost 100-Year-Old Company, Adding To Capabilities Like Contract Manufacturing, Could Generate Over $10 Million In Annual Gross Profit

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