Últimas noticias sobre AstraZeneca (NASDAQ:AZN) Bolsa

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.

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El Ibex 35 y las bolsas europeas cotizan estables este martes. El Ibex sube un 0,07% a 11.280 puntos, tras las alzas del lunes en Europa y Wall Street.

Ibex 35 sube ligeramente mientras los mercados europeos se estabilizan este martes

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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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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.
Read Next:
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<li><a href="https://www.benzinga.com/news/large-cap/24/11/41887262/the-week-kamala-harris-lost-nov-4-8-these-large-cap-stocks-lost-big" target="_blank" rel="noreferrer noopener">The Week Kamala Harris Lost (Nov 4-8), These Large Cap Stocks Lost Big</a></li>
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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

<ul>
<li>Daiichi Sankyo and AstraZeneca's new application is based on the TROPION-Lung05 phase 2 trial and supported by data from additional trials including TROPION-Lung01</li>
<li>Previously submitted BLA based on TROPION-Lung01 phase 3 trial for patients with nonsquamous NSCLC has been voluntarily withdrawn</li>
</ul>

DSNKY

Daiichi Sankyo And AstraZeneca Submit New BLA For Datopotamab Deruxtecan, Targeting Accelerated Approval For EGFR-Mutated Lung Cancer Treatment

When Kamala Harris lost the 2024 U.S. election last week, these ten large-cap stocks were the worst performers.
<ol>
<li>Moderna, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MRNA#NASDAQ">MRNA</a>) shares dipped 12.53% last week despite a third-quarter earnings beat due to a weak vaccine demand slowdown. Several <a href="https://www.benzinga.com//node/41854205" target="_blank" rel="noreferrer noopener">analysts lowered their price forecast</a> on the stock.</li>
<li>Honda Motor Company, Ltd. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HMC#NYSE">HMC</a>) stock tumbled 11.46% on a decline in the first-half profit <a href="https://www.benzinga.com//node/41781952" target="_blank" rel="noreferrer noopener">and reduced annual profit forecast</a>.</li>
<li>Akamai Technologies, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AKAM#NASDAQ">AKAM</a>) shares declined 10.67% after the company <a href="https://www.benzinga.com//node/41823455" target="_blank" rel="noreferrer noopener">revised its FY24 guidance</a>.</li>
<li>Advanced Drainage Systems, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/WMS#NYSE">WMS</a>) stock fell 10.53% after it reported worse-than-expected second-quarter results and cut its FY25 <a href="https://www.benzinga.com//node/41839671" target="_blank" rel="noreferrer noopener">net sales outlook</a>.</li>
<li>AstraZeneca PLC (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) shares decreased 9.72% following a report suggesting that the company&#8217;s insurance fraud <a href="https://www.benzinga.com//node/41754167" target="_blank" rel="noreferrer noopener">involved senior executives in China</a>.</li>
<li>Pinterest, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PINS#NYSE">PINS</a>) stock was down 9.60% after the company reported third-quarter results, and several analysts cut <a href="https://www.benzinga.com//node/41850902" target="_blank" rel="noreferrer noopener">the price forecast on the stock</a>.</li>
<li>MercadoLibre, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MELI#NASDAQ">MELI</a>) shares fell 9.29% after it reported <a href="https://www.benzinga.com//node/41793254" target="_blank" rel="noreferrer noopener">third-quarter financial results</a>.</li>
<li>First Solar, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/FSLR#NASDAQ">FSLR</a>) stock declined 8.64%, probably due to Donald Trump&#8217;s presidential election victory. Investors may be assessing Trump&#8217;s policies<a href="https://www.benzinga.com//node/41778433" target="_blank" rel="noreferrer noopener"> regarding solar and renewable energy</a>.</li>
<li>POSCO HOLDINGS INC. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PKX#NYSE">PKX</a>) shares were down 8.42%.</li>
<li>Floor &amp; Decor Holdings, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FND#NYSE">FND</a>) stock fell 8.22%.</li>
</ol>
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The Week Kamala Harris Lost (Nov 4-8), These Large Cap Stocks Lost Big

Deep-pocketed investors have adopted a bullish approach towards AstraZeneca (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), and it's something market players shouldn't ignore. Our tracking of public options records at Benzinga unveiled this significant move today. The identity of these investors remains unknown, but such a substantial move in AZN usually suggests something big is about to happen.
We gleaned this information from our observations today when Benzinga's options scanner highlighted 10 extraordinary options activities for AstraZeneca. This level of activity is out of the ordinary.
The general mood among these heavyweight investors is divided, with 80% leaning bullish and 20% bearish. Among these notable options, 4 are puts, totaling $172,930, and 6 are calls, amounting to $551,032.
<h3>What's The Price Target?</h3>
After evaluating the trading volumes and Open Interest, it's evident that the major market movers are focusing on a price band between $60.0 and $85.0 for AstraZeneca, spanning the last three months.
<h3>Volume &amp; Open Interest Development</h3>
Looking at the volume and open interest is a powerful move while trading options. This data can help you track the liquidity and interest for AstraZeneca's options for a given strike price. Below, we can observe the evolution of the volume and open interest of calls and puts, respectively, for all of AstraZeneca's whale trades within a strike price range from $60.0 to $85.0 in the last 30 days. 
<h3>AstraZeneca Call and Put Volume: 30-Day Overview</h3>
<img src="https://www.benzinga.com/files/images/story/2024/1731353433_0.png" alt="Options Call Chart" />
<h3>Biggest Options Spotted:</h3>

<table>
<thead>
<tr>
<th>Symbol</th>
<th>PUT/CALL</th>
<th>Trade Type</th>
<th>Sentiment</th>
<th>Exp. Date</th>
<th>Ask</th>
<th>Bid</th>
<th>Price</th>
<th>Strike Price</th>
<th>Total Trade Price</th>
<th align="right">Open Interest</th>
<th>Volume</th>
</tr>
</thead>
<tbody>
<tr>
<td>AZN</td>
<td>CALL</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>11/22/24</td>
<td>$1.47</td>
<td>$1.37</td>
<td>$1.45</td>
<td>$66.00</td>
<td>$145.0K</td>
<td align="right">11</td>
<td>1.1K</td>
</tr>
<tr>
<td>AZN</td>
<td>CALL</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>11/22/24</td>
<td>$1.47</td>
<td>$1.37</td>
<td>$1.45</td>
<td>$66.00</td>
<td>$130.5K</td>
<td align="right">11</td>
<td>1.0K</td>
</tr>
<tr>
<td>AZN</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>12/06/24</td>
<td>$2.88</td>
<td>$2.66</td>
<td>$2.88</td>
<td>$64.00</td>
<td>$114.9K</td>
<td align="right">402</td>
<td>400</td>
</tr>
<tr>
<td>AZN</td>
<td>CALL</td>
<td>SWEEP</td>
<td>BULLISH</td>
<td>11/29/24</td>
<td>$2.14</td>
<td>$1.91</td>
<td>$2.14</td>
<td>$65.00</td>
<td>$64.2K</td>
<td align="right">57</td>
<td>594</td>
</tr>
<tr>
<td>AZN</td>
<td>PUT</td>
<td>TRADE</td>
<td>BULLISH</td>
<td>01/15/27</td>
<td>$21.65</td>
<td>$21.25</td>
<td>$21.3</td>
<td>$85.00</td>
<td>$63.9K</td>
<td align="right">11</td>
<td>30</td>
</tr>
</tbody>
</table>

<h3>About AstraZeneca</h3>
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.
In light of the recent options history for AstraZeneca, it's now appropriate to focus on the company itself. We aim to explore its current performance.
<h3>Current Position of AstraZeneca</h3>
<ul>
<li>Trading volume stands at 6,291,293, with AZN's price up by 0.41%, positioned at $64.75.</li>
<li>RSI indicators show the stock to be may be oversold.</li>
<li>Earnings announcement expected in 1 days.</li>
</ul>
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A Closer Look at AstraZeneca's Options Market Dynamics

AstraZeneca plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) is set to report its third-quarter 2024 earnings <a href="https://www.benzinga.com/quote/AZN/earnings">Tuesday morning</a>, and the company's second-quarter performance hints at robust growth fueled by its oncology and cardiovascular portfolios.
What To Know: In the second quarter, AstraZeneca reported <a 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">$12.94 billion in revenue</a>, marking a 13% year-over-year increase (17% at constant currency), surpassing analysts' expectations of $12.75 billion. 
This was bolstered by steady demand across its core therapeutic areas and an impressive array of high-performing drugs. Adjusted earnings per ADR (equivalent to two common shares) came in at 99 cents, in line with consensus, while adjusted EPS reached $1.98.
AstraZeneca's oncology division, which remains the largest revenue driver, saw a 15% boost in sales to $5.33 billion. Key contributors were the cancer treatments Tagrisso, Imfinzi and Calquence, generating $1.61 billion, $1.15 billion and $790 million, respectively.
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Tagrisso's popularity continues to rise globally, reflected in an 8% sales increase (12% at constant currency). Calquence, a leading therapy for first-line chronic lymphocytic leukemia (CLL), jumped 21% in revenue. 
Enhertu, developed in collaboration with Daiichi Sankyo, showed exceptional growth at 46%, indicating the strong market reception of AstraZeneca's innovative oncology pipeline.
What Else: The Cardiovascular, Renal and Metabolism (CVRM) segment performed similarly well in the second quarter, with sales up 18% (22% at CER) to $3.16 billion. Farxiga, AstraZeneca's standout diabetes and heart failure treatment, contributed $1.95 billion, reflecting a 29% sales increase. 
Respiratory &amp; Immunology (R&amp;I) saw significant gains, too, with Breztri revenue up 44% and sales for the asthma drug Tezspire nearly doubling. Rare disease treatments also contributed positively, with Ultomiris leading this segment's 10% growth, counterbalancing the decline of older drug Soliris.
For the full fiscal year, AstraZeneca anticipates mid-teens percentage growth in both revenue and core EPS, driven by its established treatments and expansion into new indications. As the company pivots away from COVID-19 vaccine revenues, it leans into its robust portfolio, led by oncology and CVRM.
According to data from <a href="https://benzinga.grsm.io/register174">Benzinga Pro</a>, AZN has a 52-week high of $87.67 and a 52-week low of $60.48.
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Previews

AstraZeneca Q3 Earnings Preview: Will Cancer, Heart Drugs Fuel Continued Growth?

AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) and Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) released topline data from the Phase 3 WAYPOINT trial of Tezspire (tezepelumab) in patients with chronic rhinosinusitis with nasal polyps (CRSwNP [nasal polyps])
The data <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/tezspire-nasal-polyps-trial-met-primary-endpoints.html" rel="noreferrer noopener">showed</a> that Tezspire&nbsp;demonstrated a statistically significant and clinically meaningful reduction in the size of nasal polyps and reduced nasal congestion compared to placebo.
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/04/38299995/amgenastrazenecas-asthma-drug-tezspire-vs-sanofiregenerons-blockbuster-dupixent-ana" rel="noreferrer noopener">Amgen/AstraZeneca&#8217;s Asthma Drug Tezspire Vs. Sanofi/Regeneron&#8217;s Blockbuster Dupixent &#8211; Analyst Gives His Pick</a>
WAYPOINT is a randomized, double-blind trial that evaluated the efficacy and safety of&nbsp;Tezspire&nbsp;administered subcutaneously compared to placebo in adults with severe CRSwNP.
Participants in the trial were symptomatic despite treatment with standard of care (intranasal corticosteroids [INCS]).
Chronic rhinosinusitis with nasal polyps is&nbsp;a condition that can cause symptoms from sinus pain and nose stuffiness to loss of smell. Nasal polyps are growths in the nose or sinuses.
The safety profile and tolerability of&nbsp;Tezspire in this trial were consistent with the known profile of the medicine.
Full results will be shared with regulatory authorities and the scientific community at an upcoming medical meeting.
Tezspire&nbsp;is currently approved for severe asthma in the US, EU, Japan, and nearly 60 countries.
It is approved as a single-use pre-filled syringe and auto-injector for self-administration in the US and EU.
In May, the companies announced the results of the Phase 2a COURSE trial of Tezspire for severe chronic obstructive pulmonary disease (COPD) with a broad range of baseline blood eosinophil counts (BEC) irrespective of emphysema, chronic&nbsp;bronchitis, <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38924821/amgenastrazeneca-say-asthma-drug-shows-activity-in-another-lung-disease-across-broad-patient-popu" rel="noreferrer noopener">or smoking status</a>.&nbsp;
The primary results showed that treatment with Tezspire led to a 17% numerical reduction in the annual rate of moderate or severe COPD exacerbations compared to placebo at week 52, which was not statistically significant.
Price Action: AMGN stock closed at $321.91 on Thursday, and AZN stock is up 0.11% at $64.76 during the premarket session at the last check on Friday.
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Photo: Shutterstock

AMGN

AstraZeneca/Amgen's Asthma Drug Aces Late-Stage Study In Patients With Chronic Rhinosinusitis

Astrazeneca Says TEZSPIRE Met Both Co-primary Endpoints In The Phase III Waypoint Trial In Patients With Chronic Rhinosinusitis With Nasal Polyps

&nbsp;"The top-line results from our Phase 3 WAYPOINT study represent a significant step forward in our commitment to enhancing the lives of those affected by chronic rhinosinusitis with nasal polyps," said&nbsp;Jay Bradner, M.D., executive vice president of Research and Development and chief scientific officer at&nbsp;Amgen. "The data highlight tezepelumab's unique capacity to target multiple inflammatory pathways by acting directly at the epithelium, resulting in meaningful symptom relief that can improve patients' daily experiences."

Amgen And AstraZeneca Report Phase 3 Results: Tezspire Meets Both Primary Endpoints In Chronic Rhinosinusitis With Nasal Polyps Study

Says Medical Insurance Probe Is "Historic", In Past, Not Involving Any Current Executives; Medical Insurance Probe Began Three Years Ago, Initially Involved Small Number Of Employees; Now 100 Former Employees Have Been Sentenced To Jail Time
-Investor Call

AstraZeneca Says Arrests Of Current And Former Staff Mentioned By CEO In September To Bloomberg Are A Third Issue, Unrelated To Medical Insurance And Wang Investigations; Sought To Quell Concerns About China Business After Report Of Broader Probe Into Potential Insurance Fraud; China Exec. Leon Wang Is Detained By Chinese Authorities As Part Of The Investigation; To The Company's Knowledge; Medical Insurance Probe Reported By Yicai Is Separate From The Leon Wang Investigation

Just two weeks ago, Upstream Bio, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/UPB#NASDAQ">UPB</a>) closed its upsized initial public offering (IPO) of 17.25 million shares at $17 per share, with gross proceeds of <a href="https://www.benzinga.com/pressreleases/24/10/g41344387/upstream-bio-announces-closing-of-293-million-upsized-initial-public-offering-including-full-exerc" target="_blank" rel="noreferrer noopener">approximately $293 million</a>.
Upstream Bio is a clinical-stage biotechnology company developing treatments for inflammatory diseases with an initial focus on severe respiratory disorders.
<ul>
<li>Piper Sandler initiated coverage on Upstream Bio with an Overweight rating and a <a href="https://www.benzinga.com/quote/UPB/analyst-ratings" target="_blank" rel="noreferrer noopener">price target of $75</a>.</li>
<li>William Blair has also initiated coverage of Upstream Bio with an Outperform rating </li>
</ul>
Piper Sandler noted the company&#8217;s lead program, verekitug, has a differentiated mechanism of action that targets the TSLP receptor vs. ligand.
The TSLP ligand has been de-risked by AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) / Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) Tezspire&#8217;s 2021 approval in severe asthma, the analyst says. It represents a rapidly growing biologic market opportunity of over $7.5 billion.
Piper analyst writes, &#8220;verekitug&#8217;s key advantage is its durability given its high potency, enabling Q12W dosing and potentially up to Q24W dosing, which is significantly lower compared to other biologics such as Tezspire (Q4W dosing) and Regeneron Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>) / Sanofi SA&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) Dupixent (Q2W dosing).
William Blair also based its rating on the blockbuster potential of verekitug in large indications, including asthma and chronic obstructive pulmonary disease (COPD).
&#8220;The analyst writes that &#8220;Verekitug has the potential to deliver differentiated efficacy and longer dosing intervals than currently approved biologics for the treatment of asthma, most notably the TSLP antibody Tezspire, which targets the ligand.
William Blair writes that demonstrating clinical efficacy at least comparable to Tezspire, with dosing intervals of every three to six months, could position the therapy as a blockbuster, aligning with patient preferences for fewer doses.
However, early preclinical and clinical data for verekitug indicate a potential for even greater efficacy than Tezspire, which could exceed current baseline expectations.
Price Action: Upstream Bio stock is up 12.5% at $28.30 at last check Tuesday.
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Analyst Color

Initiation

Analyst Ratings

Upstream Bio Is New On NASDAQ, Can Potentially Beat AstraZeneca's Asthma Drug On Efficacy, Analysts Say

In September, Chinese authorities detained five current and former employees of&nbsp;AstraZeneca Plc&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) as part of a broader investigation into alleged illegal activities&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40737381/astrazeneca-in-trouble-for-employee-detentions-in-china-over-illegal-activities" rel="noreferrer noopener">in the pharmaceutical sector</a>.
The investigation focuses on potential breaches of data privacy laws and the importation of unlicensed cancer medications.
CEO Pascal Soriot said AstraZeneca complies with Chinese policies and works closely with authorities <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40793946/astrazeneca-ceo-pascal-soriot-updates-on-chinese-compliance-probe-and-lung-cancer-drug-trial-resu" rel="noreferrer noopener">following the detention</a>.
As per a financial media company Yicai report, senior executives at AstraZeneca China are embroiled in a significant insurance fraud case, marking one of the most extensive scandals in China&#8217;s pharmaceutical industry in recent years.
Also Read:<a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41723132/astrazeneca-unveils-early-data-from-chinese-firm-partnered-oral-weight-loss-drug" rel="noreferrer noopener"> AstraZeneca Unveils Early Data From Chinese-Firm Partnered Oral Weight Loss Drug</a>
Citing sources, the report adds that Leon Wang, President of AstraZeneca China, is cooperating with authorities in a rapidly expanding investigation that now involves multiple government bodies, including the public security bureau and the supervisory commission.
In October, the company <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/astrazeneca-china-president-currently-under-investigation.html" rel="noreferrer noopener">disclosed</a> that Leon Wang is cooperating with an ongoing investigation by Chinese authorities. AstraZeneca also added that China operations continue under the leadership of the current General Manager of AstraZeneca China.
The ongoing probe has exposed fraudulent practices tied to the sale of Tagrisso, a lung cancer treatment.
The case gained initial traction in 2021 when an AstraZeneca medical representative in Yibin, Sichuan province, was found to have forged prescriptions, enabling patients to purchase Tagrisso through insurance coverage.
Tagrisso is AstraZeneca&#8217;s top-selling cancer drug, generating <a target="_blank" href="https://www.astrazeneca.com/content/dam/az/PDF/2023/fy/Full-year-and-Q4-2023-results-announcement.pdf" rel="noreferrer noopener">around</a> $5.8 billion in 2023 sales.
The report <a target="_blank" href="https://www.yicaiglobal.com/news/astrazenecas-insurance-fraud-is-said-to-touch-dozens-of-china-senior-execs" rel="noreferrer noopener">added</a> that some staff members reportedly faked genetic testing results to qualify patients for insurance-covered Tagrisso treatments.
Over the past three years, additional insurance fraud cases have emerged involving AstraZeneca employees in various Chinese regions.
In these instances, regional and district managers and even senior executives were reportedly complicit in directing employees to use unethical practices to meet sales quotas.
AstraZeneca issued a <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/azn-share-price-movement.html" rel="noreferrer noopener">statement saying</a>, &#8221; We do not comment on speculative media reports, including those related to ongoing investigations in China.&#8221;
&#8220;If requested,&nbsp;we will fully cooperate with the Chinese authorities,&#8221; the company added.
Price Action: AZN stock is down 6.75% at $66.61 at last check Tuesday.
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Image by Robert Way via Shutterstock

Emerging Markets

Legal

Why Is AstraZeneca Stock Sinking On Tuesday?

Management

Global

AstraZeneca Comments On Share Price Movement; Says "As A Matter Of Policy, We Do Not Comment On Speculative Media Reports Including Those Related To Ongoing Investigations In China. If Requested, We Will Fully Cooperate With The Chinese Authorities. We Continue To Deliver Our Life Changing Medicines To Patients In China And Our Operations Are Ongoing."

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In a report released today, Emmanuel Papadakis from Deutsche Bank maintained a Hold rating on AstraZeneca (AZN – Research Report), with a price tar...

Deutsche Bank  Keeps Their Hold Rating on AstraZeneca (AZN)

DZ BANK AG analyst Elmar Kraus maintained a Hold rating on AstraZeneca (AZN – Research Report) today. The company's shares opened today at p10,230....

DZ BANK AG Keeps Their Hold Rating on AstraZeneca (AZN)

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AstraZeneca: Strong Growth Potential And Market Volatility Offer Opportunity

In a report released on November 12, David Evans from Kepler Capital maintained a Hold rating on AstraZeneca (AZN – Research Report), with a price ...

Kepler Capital  Remains a Hold on AstraZeneca (AZN)

Bernstein analyst Justin Smith maintained a Buy rating on AstraZeneca (AZN – Research Report) today and set a price target of p18,000.00. Justin Sm...

AstraZeneca: Overcoming Short-term Challenges with Robust Long-term Potential

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