에 대한 최신 뉴스 AstraZeneca (NASDAQ:AZN) 주식

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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지난주 카멀라 해리스가 2024년 미국 대선에서 패배하면서 다음 10개의 대형 주식이 가장 저조한 성과를 보였다. 

카멀라 해리스 대선 패배 주간(11월 4~8일) 대폭 하락한 대형주 10종목

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아스트라제네카(NASDAQ:AZN)는 2024년 3분기 실적을 화요일 아침에 발표할 예정이며, 이 회사의 2분기 실적은 종양학 및 심혈관 포트폴리오에 의해 촉진된 강력한 성장을 암시한다.

아스트라제네카 3분기 실적 미리보기: 암과 심장 치료약이 계속된 성장을 견인할까?

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화요일 존슨앤드존슨(NYSE:JNJ)은 선불금 6억 달러로 V-웨이브(V-Wave)를 인수하기로 합의했으며, 추가 규제 및 상업적 마일스톤 지불 가능성은 최대 약 11억 달러에 이른다.

존슨앤드존슨은 심부전 혁신업체 V-웨이브를 인수하기 위해 17억 달러 거래 체결

AstraZeneca PLC - American Depositary Shares

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AZN Capital Corp

The Institute for Clinical and Economic Review (ICER) has identified five prescription drugs whose price increases in 2023 lacked sufficient clinical evidence to justify the hikes.
Gilead Sciences Inc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GILD#NASDAQ">GILD</a>) Biktarvy, Johnson &amp; Johnson's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) Darzalex, Novartis AG's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Entresto, Exelixis Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/EXEL#NASDAQ">EXEL</a>) Cabometyx, and Pfizer Inc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) Xeljanz are among the five drugs flagged for unsupported price increases.
These five drugs' unsupported net price increases <a target="_blank" href="https://icer.org/news-insights/press-releases/icer-announces-most-significant-drug-price-hikes-unsupported-by-new-clinical-evidence-in-us/" rel="noreferrer noopener">produced</a> $815 million in incremental added costs to U.S. payers in 2023. These price increases contributed significantly to the overall spending surge.
ICER's analysis <a target="_blank" href="https://icer.org/wp-content/uploads/2024/12/UPI_2024_Report_121224.pdf" rel="noreferrer noopener">revealed</a> that the other five drugs on the list did demonstrate new clinical evidence to justify their increased costs.
Merck &amp; Co Inc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) Keytruda, AstraZeneca Plc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Imfinizi and Tagrisso, Bristol Myers Squibb &amp; Co's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Opdivo, and Amgen Inc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) Prolia
The findings are part of ICER's latest Unsupported Price Increases (UPI) report, which examines the top 10 drugs with significant net price increases in the past year.
ICER's Vice President of Research, Dr. Foluso Agboola, highlighted the impact of these price hikes, noting they exceed inflation rates and strain the healthcare system.
The ICER report highlighted that Gilead's Biktarvy saw its wholesale acquisition cost increase by 5.9%, with its hike costing U.S. payers $359 million in additional drug spending.
According to the ICER report, the Darzalex price before discounts increased by 7.6%, compared to 6.2% for Entresto, 7.5% for Cabometyx, and 6% for Xeljanz.
Those price increases added an additional $190 million, $108 million, $86 million, and $72 million to 2023 U.S. drug spending, respectively.
Methodology Behind ICER's Findings
<ul>
<li>ICER's evaluation followed a detailed protocol introduced in April 2024. The organization assessed drugs meeting criteria such as ranking among the top 250 by U.S. sales revenue and exceeding consumer price index growth plus 2% in their Wholesale Acquisition Cost.</li>
<li>The analysis focused on distinguishing price increases driven by value from those unrelated to new clinical evidence.</li>
<li>Manufacturers provided input, and ICER reviewed published studies for evidence of additional health benefits.</li>
</ul>
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Drug Price Hikes Unsupported By Evidence Cost US $815 Million: ICER Report

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"Weight-Loss Drug Craze Appears To Be Curbing U.S. Obesity Epidemic; Obesity Is Down In The U.S. For The First Time In A Decade. A New Study Suggests Weight-Loss Drugs May Explain Why" - Bloomberg News

During 2000–2020, the U.K.'s National Health Service (NHS) faced significant trade-offs in prioritizing new drug treatments, as resources allocated to these medications often came at the expense of broader population health gains.
Lancet research revealed that while newly approved drugs directly benefit certain patients, the overall impact on population health was negative due to the high costs and resulting resource reallocation.
A retrospective analysis reviewed technology appraisals conducted by the National Institute for Health and Care Excellence (NICE) on 332 drugs.
Of these, 276 (83%) received positive recommendations, and most were appraised within five years of regulatory approval.
The study ultimately included 183 drugs after excluding ineligible cases. While these drugs generated an estimated 3.75 million quality-adjusted life years (QALYs) across 19.82 million patients, their cost to the NHS—totaling $94.93 billion (75.1 billion pounds)—led to an estimated net loss of 1.25 million QALYs.
For example, oncology drugs demonstrated a median cost-effectiveness ratio (ICER) of 30,000 pounds per QALY gained, significantly higher than the 6,478 pounds for anti-infective drugs.
Additionally, the ICER for new drug recommendations rose by 32% from 2000 to 2020, reflecting increased financial pressures on the NHS.
Despite potential long-term benefits from price reductions after patent expiration, these effects were limited. Only 19% of the studied drugs had generic or biosimilar alternatives by 2020.
For new drugs to contribute positively to population health, their initial costs would have required a median reduction of 42%.
The ongoing debate around NICE's cost-effectiveness threshold remains central to policy discussions.
A 2024 agreement retained the current threshold until 2029, but experts argue for alignment with the Department of Health and Social Care's estimate of health-opportunity costs.
Such an adjustment could ensure the NHS achieves better value for its investments in new drugs without compromising care quality in other areas.
Balancing innovation with equitable health outcomes requires nuanced policy solutions. The study <a target="_blank" href="https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(24)02352-3/fulltext" rel="noreferrer noopener">suggests</a> a lower cost-effectiveness threshold, closer to 15,000 pounds per QALY, could better align spending with health gains.
However, opposition from the pharmaceutical industry underscores the challenges of reforming pricing policies while fostering innovation.
This approach highlights how benefiting one group of patients may require deprioritizing others as existing NHS services and treatments are displaced to fund new drugs.
For instance, in 2010, NICE approved Roche Holding AG's (OTC:<a class="ticker" href="https://www.benzinga.com/stock/RHHBY#OTC">RHHBY</a>) Herceptin (trastuzumab) for metastatic gastric cancer, deeming an ICER of 43,206 pounds per QALY gained as cost-effective.
Framing this as 2.88 QALYs forgone for every QALY gained clarifies the value placed on patients receiving the treatment versus those who might lose out on care.
At a population level, using trastuzumab in this context resulted in an estimated 4,000 QALYs lost between 2010 and 2020.
However, adopting this perspective could pose challenges for policymakers due to the established 20,000–30,000 pounds per QALY threshold.
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United Kingdom's National Health Service Drug Spending Priorities Questioned in New Analysis

Tracer Biotechnologies Announces Multi-Year Project With AstraZeneca

AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) and Merck&nbsp;&amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), on Wednesday, announced long-term results from the <a target="_blank" href="https://www.benzinga.com/pressreleases/24/12/b42440199/lynparza-olaparib-demonstrated-clinically-meaningful-prolonged-survival-benefit-in-early-breast-ca" rel="noreferrer noopener">OlympiA Phase 3 trial</a>.
The trial showed Lynparza (olaparib) demonstrated sustained, clinically meaningful improvements in overall survival (OS), invasive disease-free survival (IDFS), and distant disease-free survival (DDFS) for people with germline BRCA-mutated (gBRCAm) HER2-negative high-risk early breast cancer.
Also Read: <a target="_blank" href="https://www.benzinga.com/24/12/42363652/soon-after-approval-for-lung-cancer-astrazenecas-cancer-drug-imfinzi-goes-under-fda-priority-review-for-bladder-cancer" rel="noreferrer noopener">After Lung Cancer Approval, AstraZeneca&#8217;s Imfinzi Goes Under FDA Priority Review For Bladder Cancer</a>
At a median follow-up of 6.1 years (maximum 9.6 years) in eligible patients, who had completed local treatment and standard neoadjuvant or adjuvant chemotherapy, Lynparza reduced the risk of death by 28% versus placebo.
In addition,&nbsp;87.5% of patients treated with&nbsp;Lynparza remained alive versus 83.2% of those on placebo.
Lynparza&nbsp;also demonstrated sustained and clinically meaningful improvements in the primary and secondary endpoints of IDFS and DDFS.
Lynparza reduced the risk of invasive breast cancer recurrence, second cancers, or death by 35% and reduced the risk of distant disease recurrence or death by 35% versus placebo.
The benefit with Lynparza was consistent across all key subgroups, including patients with high-risk, hormone-receptor-positive disease.
Recently, Merck&nbsp;announced topline data from the Phase 3&nbsp;KEYLYNK-001 trial of Keytruda (pembrolizumab) plus chemotherapy followed by maintenance with Lynparza, with or without bevacizumab, as a first-line treatment for BRCA non-mutated advanced epithelial ovarian cancer met its primary endpoint of <a target="_blank" href="https://www.benzinga.com/24/12/42393128/merck-reveals-mixed-data-from-keytrudalynparza-regime-in-ovarian-cancer" rel="noreferrer noopener">progression-free survival</a>.
The Keytruda plus Lynparza regimen demonstrated a statistically significant and clinically meaningful improvement in progression-free survival for these patients compared to chemotherapy alone.
The study did not reach its secondary endpoint of overall survival. The role of keytruda in the intention-to-treat population remains uncertain at this time.
Price Action: MRK stock is up 0.11% at $101.11, and AZN stock is up 0.47% at $67.50 at last check Wednesday.
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AstraZeneca-Merck Partnered Lynparza Shows Long-Term Survival With Reduced Death Risk Of 28% In Breast Cancer Patients

Lynparza Shows Significant Survival Benefit In Early Breast Cancer In OlympiA Phase III Trial; Reduces Risk Of Death By 28% And Recurrence By 35% At Six Years, Becoming First PARP Inhibitor To Improve Survival In Early Breast Cancer

Datopotamab deruxtecan (Dato-DXd) has been granted Breakthrough Therapy Designation (BTD) in the U.S. for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) with disease progression on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.
Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed by Daiichi Sankyo and AstraZeneca (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>).
The U.S. Food and Drug Administration (FDA) BTD is designed to accelerate the development and regulatory review of potential new medicines that are intended to treat serious conditions and address significant unmet medical needs. The medicine needs to have shown encouraging preliminary clinical results that demonstrate substantial improvement on a clinically significant endpoint over available medicines.
The FDA granted this BTD based on data from the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT04484142%3Fterm%3Dtropion-lung05%26rank%3D1&amp;esheet=54163228&amp;newsitemid=20241206314659&amp;lan=en-US&amp;anchor=TROPION-Lung05&amp;index=1&amp;md5=bfb7eb5703ca3e73e32cb6f616580ed8">TROPION-Lung05</a> phase 2 trial with supporting data from the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04656652&amp;esheet=54163228&amp;newsitemid=20241206314659&amp;lan=en-US&amp;anchor=TROPION-Lung01&amp;index=2&amp;md5=10ce6b41534181dc3781ed4177a115e8">TROPION-Lung01</a> phase 3 trial. Results from a pooled analysis of patients with previously treated EGFR-mutated NSCLC in these studies were <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.daiichisankyo.com%2Ffiles%2Fnews%2Fpressrelease%2Fpdf%2F202412%2F20241206_E.pdf&amp;esheet=54163228&amp;newsitemid=20241206314659&amp;lan=en-US&amp;anchor=presented&amp;index=3&amp;md5=6b0b3b2dfbe52c68b2743eeff561dd40">presented</a> this month at the European Society of Medical Oncology (ESMO) Asia 2024 Congress. This is the first BTD for datopotamab deruxtecan and the twelfth BTD across Daiichi Sankyo's oncology pipeline.

Regulations

Datopotamab Deruxtecan Receives FDA Breakthrough Therapy Designation for EGFR-Mutated Lung Cancer

Results from the AMPLIFY Phase III trial showed AstraZeneca's Calquence (acalabrutinib) in combination with venetoclax&nbsp;demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemoimmunotherapy in previously untreated adult patients with chronic lymphocytic leukaemia (CLL).
These results will be presented at the American Society of Hematology (ASH) 2024 Annual Meeting in San Diego, CA.
At a median follow up of 41 months, results showed Calquence plus venetoclax reduced the risk of disease progression or death by 35% compared to standard-of-care chemoimmunotherapy (hazard ratio [HR] 0.65; 95% confidence interval [CI] 0.49-0.87; p=0.0038). Calquence plus venetoclax with obinutuzumab demonstrated a 58% reduction in the risk of disease progression or death compared to standard-of-care chemoimmunotherapy (HR 0.42; 95% CI 0.30-0.59; p&lt;0.0001). Median PFS was not reached for either experimental arm versus median PFS of 47.6 months for chemoimmunotherapy.

AstraZeneca Announced Fixed-duration Calquence Plus Venetoclax Demonstrated Superior PFS Vs. Standard Of Care In Previously Untreated CLL, With 77% Of Patients Progression Free At Three Years In AMPLIFY Phase III Trial At ASH Meeting

On Friday, Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) revealed topline results from the APPULSE-PNH Phase 3B study of Fabhalta&nbsp;(iptacopan) in adult patients with paroxysmal nocturnal hemoglobinuria (PNH) who were switched from anti-C5 therapies (Hb ≥10g/dL following treatment with eculizumab or ravulizumab).
Ultomiris (ravulizumab) and Soliris&nbsp;(eculizumab) are commonly used anti-C5 therapies, and they are made by AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>).
Also Read: <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/10/41634528/positive-outlook-for-novartis-as-company-capitalizes-on-growing-treatment-opportuni" rel="noreferrer noopener">Positive Outlook For Novartis As Company Capitalizes On Growing Treatment Opportunities, Analyst Highlights</a>
PNH is a rare complement-mediated blood disorder. People with PNH have an acquired mutation in some of their hematopoietic stem cells, which are located in the bone marrow and can grow and develop into red blood cells, white blood cells, and platelets.
This mutation <a target="_blank" href="https://www.novartis.com/news/media-releases/new-phase-iiib-data-shows-novartis-fabhalta-improved-hemoglobin-levels-adult-patients-paroxysmal-nocturnal-hemoglobinuria-who-switched-from-anti-c5-therapy" rel="noreferrer noopener">causes</a> them to produce RBCs that are susceptible to premature destruction by the complement system.
After 24 weeks of treatment with Fabhalta, the average hemoglobin (Hb) level improved compared to baseline. The study&#8217;s safety profile of Fabhalta monotherapy was consistent with previously reported data.
Data will be presented at an upcoming medical meeting in 2025.
The FDA recently granted accelerated approval for Fabhalta to reduce proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of rapid disease progression, and development is ongoing in multiple complement-mediated diseases.
Last month, Novartis raised its mid-term sales guidance, increasing its compound annual growth rate (CAGR) target to 6% from 5% <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/42115127/novartis-confident-in-growth-as-it-elevates-midterm-sales-forecast-ceo-narasimhan-highlights-robust-pipeline-supporting-long-term-strategy" rel="noreferrer noopener">for 2023-2028</a>.
The upgrade reflects performance from current growth drivers and anticipated launches, many of which are expected to retain U.S. exclusivity into the 2030s.
Earlier this week, PTC Therapeutics (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/PTCT#NASDAQ">PTCT</a>) signed an exclusive global license and collaboration agreement with&nbsp;Novartis for its PTC518 Huntington&#8217;s disease program, which&nbsp;<a target="_blank" href="https://www.benzinga.com/24/12/42272846/ptc-therapeutics-inks-licensing-pact-with-novartis-worth-3-billion-for-huntingtons-program" rel="noreferrer noopener">includes related molecules</a>.
Under the agreement, PTC will receive an upfront payment of $1.0 billion, up to $1.9 billion in development, regulatory and sales milestones, a profit share in the U.S., and double-digit tiered royalties on ex-U.S. sales.
<h2 class="wp-block-heading">Is Novartis A Good Stock To Buy?</h2>
Wall Street analysts view Novartis on the whole as a Neutral, given the history of coverage over the past three months. Graham Perry from B of A Securities in Novartis is the most bearish, expecting a 3.7% fall in the stock in the coming year.
But looking at how the market as a whole thinks of the stock, you can reference historical price action for views on whether investors feel strongly about the stock one way or another. In the past 3 months, Novartis fell 12.4%, which indicates that opinion soured on the business and how attractive it is to own based on either its stock price, or underlying fundamentals, like revenue, which rose 8.84% over the past year.
A complete overview of how Wall Street views individual stocks is available <a href="https://www.benzinga.com/analyst-stock-ratings">here</a>, while real time updates on the latest analyst actions will be delivered via <a href="https://pro.benzinga.com">Benzinga PRO</a>. Try it for free.
Price Action: At the last check on Friday, NVS stock was up 0.18% to $102.34.
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PTCT

Novartis Touts Encouraging Data From Late-Stage Study For Fabhalta In Rare Type Of Blood Disorder

On Friday, the FDA accepted and granted Priority Review AstraZeneca Plc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) supplemental Biologics License Application (sBLA) for&nbsp;Imfinzi&nbsp;(durvalumab) for patients with muscle-invasive bladder cancer (MIBC).
The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the second quarter of 2025.
The supplement application is <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-granted-priority-review-in-the-us-for-patients-with-muscle-invasive-bladder-cancer.html" rel="noreferrer noopener">based</a> on data from the NIAGARA Phase 3 trial.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42341810/fda-approves-astrazenecas-blockbuster-cancer-drug-imfinzi-for-aggressive-form-of-lung-cancer" rel="noreferrer noopener">FDA Approves AstraZeneca's Blockbuster Cancer Drug Imfinzi For Aggressive Form Of Lung Cancer</a>
In the trial, patients were treated with&nbsp;Imfinzi&nbsp;in combination with neoadjuvant chemotherapy before radical cystectomy, followed by&nbsp;Imfinzi&nbsp;as adjuvant monotherapy or neoadjuvant chemotherapy before radical cystectomy.
In a planned interim analysis, perioperative&nbsp;Imfinzi&nbsp;demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus neoadjuvant chemotherapy with radical cystectomy alone.
The estimated median event-free survival (EFS) for the&nbsp;Imfinzi&nbsp;arm has not yet been reached, versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the&nbsp;Imfinzi&nbsp;regimen were event-free at two years, compared to 59.8% in the comparator arm.
Results from the key secondary endpoint of overall survival (OS) showed that the&nbsp;Imfinzi&nbsp;perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy.
Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the&nbsp;Imfinzi&nbsp;regimen were alive at two years, compared to 75.2% in the comparator arm.
On Thursday, a&nbsp;pooled analysis of the&nbsp;TROPION-Lung05 phase 2 and the&nbsp;TROPION-Lung01 phase 3 trials <a target="_blank" href="https://www.businesswire.com/news/home/20241205215995/en/Datopotamab-Deruxtecan-Demonstrated-Meaningful-Clinical-Activity-in-Patients-with-Previously-Treated-Advanced-EGFR-Mutated-Non-Small-Cell-Lung-Cancer-in-TROPION-Lung05-and-TROPION-Lung01-Pooled-Analysis" rel="noreferrer noopener">showed</a> datopotamab deruxtecan (Dato-DXd) demonstrated clinically meaningful tumor response in patients with previously treated advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
These data and progression-free and overall survival results from the analysis&nbsp;were presented at the 2024 ESMO Asia Congress.
Daiichi Sankyo (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSKYF#OTC">DSKYF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>) and AstraZeneca's datopotamab deruxtecan showed a 42.7% objective response rate in previously treated patients.
Five (4.3%) complete responses, 45 (38.5%) partial responses, and 48 (41.0%) cases of stable disease were observed.
The median duration of response was 7.0 months, and the disease control rate was 86.3%. Median progression-free survival was 5.8 months, and median overall survival was 15.6 months.
Price Action: At last check on Friday, AZN stock was up 1.45% to $68.51 during the premarket session.
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After Lung Cancer Approval, AstraZeneca's Imfinzi Goes Under FDA Priority Review For Bladder Cancer

The FDA Has Accepted And Granted Priority Review To AstraZeneca's Supplemental Biologics License Application For Imfinzi (Durvalumab) For Muscle-invasive Bladder Cancer. The Prescription Drug User Fee Act Date Is Anticipated During The Second Quarter Of 2025

<ul>
<li>Daiichi Sankyo and AstraZeneca's datopotamab deruxtecan showed a 42.7% objective response rate in previously treated patients</li>
<li>Data support recent BLA submission in the U.S. for this patient population</li>
</ul>

Reported Earlier, Daiichi Sankyo And AstraZeneca's Datopotamab Deruxtecan Shows Meaningful Clinical Activity In Advanced EGFR-Mutated NSCLC In TROPION-Lung05 And TROPION-Lung01 Analysis

On Thursday, the FDA approved AstraZeneca Plc's&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Imfinzi&nbsp;(durvalumab) for adult patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following concurrent platinum-based chemotherapy and radiation therapy.
SCLC is a highly aggressive form of lung cancer.
The FDA <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-approved-in-us-for-limited-stage-sclc.html" rel="noreferrer noopener">approval</a> was based on results from the ADRIATIC Phase 3 trial, presented during the Plenary Session of the 2024 American Society of Clinical Oncology Annual Meeting. It was subsequently published in the&nbsp;<a target="_blank" href="https://www.nejm.org/" rel="noreferrer noopener">New England Journal of Medicine</a>.
In the trial,&nbsp;Imfinzi&nbsp;reduced the risk of death by 27% versus placebo. The estimated median overall survival was 55.9 months for&nbsp;Imfinzi&nbsp;versus 33.4 months for placebo.
An estimated 57% of patients treated with&nbsp;Imfinzi&nbsp;were alive at three years compared to 48% for placebo.
Imfinzi&nbsp;also reduced the risk of disease progression or death by 24% versus placebo. The median progression-free survival (PFS) was 16.6 months for&nbsp;Imfinzi&nbsp;versus 9.2 months for placebo.
An estimated 46% of patients treated with&nbsp;Imfinzi&nbsp;had not experienced disease progression at two years compared to 34% for placebo.
Based on the ADRIATIC results, Imfinzi&nbsp;has also been approved in Switzerland in this setting.
In August, the FDA approved&nbsp;Imfinzi&nbsp;(durvalumab) in combination with chemotherapy for adult patients with resectable early-stage non-small cell lung cancer (NSCLC) and no known epidermal growth factor receptor mutations or anaplastic&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40416174/fda-approves-astrazenecas-blockbuster-cancer-drug-imfinzi-in-combination-with-chemo-for-non-small" rel="noreferrer noopener">lymphoma kinase rearrangements</a>.
In this regimen, patients are treated with&nbsp;Imfinzi&nbsp;in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery.
Earlier this year, topline data from the ADJUVANT BR.31 Phase 3 trial showed&nbsp;that Imfinzi&nbsp;did not achieve statistical significance for the primary endpoint of disease-free survival versus placebo in early-stage NSCLC after complete tumor resection in patients whose tumors express PD-L1 on <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39480495/astrazenecas-blockbuster-cancer-drug-imfinzi-flunks-as-follow-up-in-type-of-early-stage-lung-canc" rel="noreferrer noopener">25% or more tumor cells</a>.
AstraZeneca also&nbsp;shared&nbsp;high-level results from the NIAGARA Phase 3 trial showing Imfinzi&nbsp;in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in&nbsp;the primary endpoint of&nbsp;event-free survival and the key secondary endpoint of overall survival versus neoadjuvant chemotherapy for&nbsp;muscle-invasive bladder cancer.
Price Action: At last check Thursday, AZN stock was up 1.31% at $67.66.
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FDA Approves AstraZeneca's Blockbuster Cancer Drug Imfinzi For Aggressive Form Of Lung Cancer

FDA Approves Durvalumab For Limited-Stage Small Cell Lung Cancer; Recommended Durvalumab Dose Is 1,500 MG Every 4 Weeks For Patients With A Body Weight Of ≥30 KG; Approved Astrazeneca's Imfinzi For Adults With LS-SCLC Whose Disease Has Not Progressed Post Platinum-Based Chemotherapy & Radiation Therapy

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'ADA Advises Against Using Compounded GLP-1 RA Medications' - Medscape

On CNBC's &#8220;<a href="https://www.benzinga.com/topic/mad-money-lightning-round">Mad Money Lightning Round</a>,&#8221; Jim Cramer said United Parcel Service, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UPS#NYSE">UPS</a>) has &#8220;screwed up a lot of holiday seasons.&#8221; He prefers FedEx Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FDX#NYSE">FDX</a>) over UPS.
On Oct. 24, United Parcel Service reported better-than-expected third-quarter financial results.
It's time to take profits in Omeros Corporation (NASDAQ:<a href="https://www.benzinga.com/quote/OMER/earnings"> OMER</a>), Cramer said. 
On Nov. 13, Omeros reported better-than-expected third-quarter earnings results.
When asked about Lockheed Martin Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LMT#NYSE">LMT</a>), he said, &#8220;I would not touch this thing until it broke 500. But it's run by Jim Taiclet [CEO of Lockheed Martin], and he's really fabulous.&#8221;
On Oct. 22, the company reported net sales growth of 1.3% year-over-year to $17.104 billion, missing the consensus of $17.351 billion. Adjusted EPS of $6.84, up from $6.77 in the prior year, topped the consensus of $6.50.
&#8220;I actually think these stocks have over-heated, and I am worried about a strong unemployment number on Friday,&#8221; Cramer said when asked about Archer Aviation Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ACHR#NYSE">ACHR</a>).
On Nov. 7, Archer Aviation reported better-than-expected third-quarter earnings results.
The &#8220;Mad Money&#8221; host recommended taking a pass on AstraZeneca PLC (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>). &#8220;There's just been a series of disappointments. I don't know what to make of it,&#8221; he added.
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. The company's adjusted EPADS reached $1.04, beating the consensus of $1.03. The adjusted EPS was $2.08 (1 ADR = 2 Common Shares).
Price Action:
<ul>
<li>Lockheed Martin Corporation shares fell 1.1% to settle at $520.34 on Monday.</li>
<li>UPS shares fell 1.3% to close at $134.02.</li>
<li>Omeros shares gained 5.3% to close at $11.95 on Monday.</li>
<li>Archer Aviation shares dipped 23.7% to close at $7.30.</li>
<li>AstraZeneca shares fell 0.9% to settle at $67.04 on Monday.</li>
</ul>
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</ul>
Image: Shutterstock

ACHR

OMER

Jim Cramer Prefers FedEx Over This Delivery Giant That 'Screwed Up A Lot Of Holiday Seasons'

Positive high-level results from the CAPItello-281 Phase III trial showed that AstraZeneca's Truqap (capivasertib) in combination with abiraterone and androgen deprivation therapy (ADT) demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of radiographic progression-free survival (rPFS) versus abiraterone and ADT with placebo in patients with PTEN-deficient de novo metastatic hormone-sensitive prostate cancer (mHSPC).
Overall survival (OS) data were immature at the time of this analysis; however, the Truqap combination showed an early trend towards an OS improvement versus abiraterone and ADT with placebo. The trial will continue as planned to further assess OS as a key secondary endpoint.
Prostate cancer is the second most prevalent cancer in men and the fifth leading cause of male cancer death globally.1 Only one third of patients with metastatic prostate cancer survive five years after diagnosis.2 Newly diagnosed mHSPC is an aggressive form of the disease associated with poor outcomes and survival.3,4 Approximately 200,000 patients are diagnosed with mHSPC each year, and one in four have PTEN-deficient tumours.5 Patients with a tumour biomarker of PTEN deficiency have a particularly poor prognosis.6
Karim Fizazi, MD, PhD, Institut Gustave Roussy, and University of Paris Saclay in Villejuif, France, and principal investigator for the trial said: "Patients with this aggressive form of prostate cancer with tumour PTEN deficiency currently face a particularly poor prognosis, and there is an urgent need for new treatments that improve upon current therapies. The results seen with capivasertib in combination with abiraterone-prednisone and androgen deprivation therapy in the CAPItello-281 trial represent a step forward for these patients."
Susan Galbraith, Executive Vice President, Oncology R&amp;D, AstraZeneca, said: "These results show for the first time, that adding an AKT inhibitor to a standard-of-care therapy can provide benefit to patients with a biomarker of PTEN-deficient metastatic hormone-sensitive prostate cancer. By targeting a key driver of the disease, we have been able to improve upon current therapies and demonstrate the potential role of this combination in an area of critical unmet need. It will be important to see greater maturity in key secondary endpoints including overall survival."
The safety profile of&nbsp;Truqap&nbsp;in combination with abiraterone and ADT in CAPItello-281 was broadly consistent with the known profile of each medicine.
Data will be presented at a forthcoming medical meeting and shared with global regulatory authorities.
Notes
Prostate cancer Prostate cancer is the second most prevalent cancer in men and the fifth leading cause of male cancer death globally, with an incidence of more than 1.4 million and approximately 397,000 deaths in 2022.1
Metastatic prostate cancer is associated with a significant mortality rate, with only one third of patients surviving five years after diagnosis.2 Development of prostate cancer is often driven by male sex hormones called androgens, including testosterone.7
Metastatic hormone-sensitive prostate cancer In patients with mHSPC, also known as metastatic castration-sensitive prostate cancer (mCSPC), prostate cancer cells need high levels of androgens to drive cancer growth.4,7 Hormone therapies, such as ADT, are widely used to block the action of male sex hormones and lower the levels of androgens in the body.4,8 However, resistance to these therapies is common and there is a need to extend their use to delay disease progression and castration resistance, where the prostate cancer grows and spreads to other parts of the body despite the use of these therapies.3,4,8
In patients with de novo mHSPC, the cancer has spread to distant parts of the body at the time of first diagnosis.9
PTEN-loss or deficiency fuels the growth of cancer cells, leading to dysregulation of the PI3K/AKT pathway, and is associated with poor outcomes in patients with prostate cancer.6,10
CAPItello-281 CAPItello-281 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of Truqap in combination with abiraterone and ADT versus abiraterone and ADT in combination with placebo in the treatment of patients with PTEN-deficient de novo mHSPC.
The global trial enrolled 1,012 adult patients with histologically confirmed de novo hormone-sensitive prostate adenocarcinoma and PTEN deficiency as confirmed by central testing. The primary endpoint of the CAPItello-281 trial is rPFS as assessed by investigator, with OS as a secondary endpoint.
Truqap Truqap is a first-in-class, potent, adenosine triphosphate (ATP)-competitive inhibitor of all three AKT isoforms (AKT1/2/3). Truqap 400mg is administered twice daily according to an intermittent dosing schedule of four days on and three days off. This was chosen in early phase trials based on tolerability and the degree of target inhibition.
Truqap is approved in the US, EU, Japan and several other countries for the treatment of adult patients with HR-positive (or ER-positive), HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN) following recurrence or progression on or after an endocrine-based regimen based on the results from the CAPItello-291 trial. Truqap is also approved in Australia for the treatment of adult patients with HR-positive, HER2-negative locally advanced or metastatic breast cancer following recurrence or progression on or after an endocrine based regimen based on these trial results.
Truqap is currently being evaluated in Phase III trials for the treatment of breast cancer (CAPItello-292) and prostate cancer (CAPItello-280 and CAPItello-281) in combination with established treatments.
Truqap was discovered by AstraZeneca subsequent to a collaboration with Astex Therapeutics (and its collaboration with the Institute of Cancer Research and Cancer Research Technology Limited).
AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients.
The Company's focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca's Truqap Demonstrates Progress in Advanced Prostate Cancer Treatment

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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Upgrades

Pre-Market Outlook

Markets

Analyst Ratings

ACNB

AVAV

CHWY

EQNR

This AstraZeneca Analyst Is No Longer Bearish; Here Are Top 5 Upgrades For Wednesday

Updated results from the OlympiA Phase 3 trial showed AstraZeneca (AZN) and Merck's (MRK) Lynparza demonstrated sustained, clinically meaningful im...

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In a report released today, Steve Scala from TD Cowen maintained a Buy rating on AstraZeneca (AZN – Research Report), with a price target of $95.00...

TD Cowen Keeps Their Buy Rating on AstraZeneca (AZN)

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3 Best Stocks to Buy Now, 12/12/2024, According to Top Analysts

In a report released on December 11, David Evans from Kepler Capital maintained a Hold rating on AstraZeneca (AZN – Research Report), with a price ...

AstraZeneca (AZN) Gets a Hold from Kepler Capital

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Screenshot 2024-09-30 at 9.13.36 PM

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GNPX

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Press Releases

INVESTOR ALERT: Law Offices of Howard G. Smith Announces Investigation of AstraZeneca PLC (AZN) on Behalf of Investors

IMFINZI® (durvalumab) approved in the US as first and only immunotherapy regimen for patients with limited-stage small cell lung cancer

Datopotamab Deruxtecan Demonstrated Meaningful Clinical Activity in Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer in TROPION-Lung05 and TROPION-Lung01 Pooled Analysis

IMFINZI® (durvalumab) granted Priority Review in the US ​for patients with muscle-invasive bladder cancer

Fixed-duration CALQUENCE plus venetoclax demonstrated superior PFS vs. standard of care in previously untreated CLL, with 77% of patients progression free at three years in AMPLIFY Phase III trial

Datopotamab Deruxtecan Granted Breakthrough Therapy Designation in U.S. for Patients with Previously Treated Advanced EGFR-Mutated Non-Small Cell Lung Cancer

Datopotamab deruxtecan granted breakthrough therapy designation in US for patients with previously treated advanced EGFR-mutated non-small cell lung cancer

Comments

AstraZeneca

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에 대한 최신 뉴스 AstraZeneca (NASDAQ:AZN) 주식

월요일, 11월 11, 2024

화요일, 8월 20, 2024

목요일, 7월 25, 2024

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일요일, 4월 07, 2024

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