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

AstraZeneca PLC - American Depositary Shares

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AZN Capital Corp

Achilles Therapeutics plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACHL#NASDAQ">ACHL</a>) shares are trading higher on Tuesday after the company announced a $12 million deal with AstraZeneca PLC (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) <a target="_blank" href="https://www.benzinga.com/pressreleases/24/12/g42669546/achilles-therapeutics-announces-sale-of-technology-assets-to-astrazeneca" rel="noreferrer noopener">and plans to cut jobs.</a>
The agreement involves the transfer of the commercial license for data and tumor samples from Achilles&#8217; TRACERx Non-Small Cell Lung Cancer (NSCLC) study to AstraZeneca.
The million deal signals the conclusion of Achilles&#8217; strategic review, which was announced in September 2024.
In the wake of the deal&#8217;s completion, Achilles also rvealed plans to reduce its employee headcount and trim its Board of Directors, while staying compliant with Nasdaq and SEC requirements.
&#8220;Achilles now plans to undertake additional measures, including a further reduction in employee headcount and a decrease in the size of its Board of Directors, while remaining compliant with Nasdaq and SEC requirements,&#8221; the company noted.
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TRACERx, a study led by Professor Charles Swanton at University College London (UCL), has collected extensive genetic data from over 3,200 tumor samples from more than 800 lung cancer patients.
This multi-region, multi-time-point sequencing offers deep insights into cancer evolution and treatment responses.
As part of the deal, AstraZeneca will also take over Achilles&#8217; Material Acquisition Platform (MAP), which houses tumor samples and data collected from nearly 300 cancer patients across various solid tumor indications such as lung, melanoma and breast cancer.
&#8220;We are pleased that as a leader in Oncology, AstraZeneca recognizes the scientific value of our TRACERx and MAP assets,&#8221; said Dr. Iraj Ali, CEO of Achilles Therapeutics.
The company believes these assets have significant potential to aid in developing improved cancer therapies.
Price Action: ACHL shares are trading higher by 7.01% to $1.050 at last check Tuesday.
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Achilles Therapeutics Announces $12M AstraZeneca Deal, Plans Job Cuts

Asset Sales

Achilles Therapeutics Sells TRACERx And MAP Assets To AstraZeneca For $12M, Transferring Tumor Data And Samples; Concludes Strategic Review With Plans For Workforce And Board Reductions

Biotech

Alexion, AstraZeneca Rare Disease Announces Agreement With Pan-Canadian Pharmaceutical Alliance For Koselugo In Treatment Of Paediatric Patients With Neurofibromatosis Type 1 Who Have Symptomatic, Inoperable Plexiform Neurofibromas

On Monday, the U.S. Food and Drug Administration issued a complete response letter (CRL) to Johnson &amp; Johnson&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) Biologics License Application for a fixed combination of amivantamab and recombinant human hyaluronidase for subcutaneous administration (SC amivantamab) in patients with non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) mutations.
The CRL is <a target="_blank" href="https://www.jnj.com/media-center/press-releases/update-on-u-s-regulatory-review-of-subcutaneous-amivantamab" rel="noreferrer noopener">related</a> to observations as part of a standard pre-approval inspection at a manufacturing facility.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41941391/johnson-johnson-challenges-government-drug-pricing-dispute-over-two-drugs" rel="noreferrer noopener">Johnson &amp; Johnson Challenges Government Drug Pricing Dispute Over Two Drugs</a>
The CRL is unrelated to the product formulation or the efficacy and safety data submitted in the regulatory application, and the FDA has not requested any additional clinical studies.
The CRL does not impact the currently approved intravenous (IV) formulation of Rybrevant&nbsp;(amivantamab-vmjw).
&#8220;We&#8217;re working closely with the FDA to bring SC amivantamab to patients as quickly as possible and are confident in our path to resolution,&#8221; said Yusri Elsayed, Global Therapeutic Area Head, Oncology, Innovative Medicine,&nbsp;Johnson &amp; Johnson.
&#8220;Backed by interim overall survival data showing a strong favorable trend compared to osimertinib, we believe strongly in the robust efficacy and safety of RYBREVANT — both as a standalone treatment and in combination with LAZCLUZE — for EGFR-mutated advanced lung cancer,&#8221; Elsayed added.
AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) sells osimertinib under the Tagrisso name.
The BLA is based on the Phase 3 PALOMA-3 study results, presented at the 2024 American Society of Clinical Oncology Annual Meeting and published in the&nbsp;<a href="https://ascopubs.org/doi/10.1200/JCO.24.01001" target="_blank" rel="noreferrer noopener">Journal of Clinical Oncology</a>.
In August 2024, the FDA granted a Priority Review for the BLA for SC amivantamab as a treatment for patients with NSCLC with EGFR exon 19 deletions or L858R substitution mutations. RYBREVANT is currently approved in over 60 countries worldwide.
JNJ Price Action: Johnson &amp; Johnson stock is up 1.26% at $145.64&nbsp;at last check Tuesday.
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FDA Rejects Johnson & Johnson's Injectable Version Of Approved Drug For Lung Cancer

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>).
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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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Photo by Taljat David via Shutterstock

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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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Image by Robert Way via Shutterstock

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

<a href="https://www.medscape.com/viewarticle/ada-advises-against-using-compounded-glp-1-ra-medications-2024a1000m0u?form=fpf" title="https://www.medscape.com/viewarticle/ada-advises-against-using-compounded-glp-1-ra-medications-2024a1000m0u?form=fpf">https://www.medscape.com/viewarticle/ada-advises-against-using-compounded-glp-1-ra-medications-2024a1000m0u?form=fpf</a>

'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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Image: Shutterstock

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AstraZeneca PLC Investors: Please contact the Portnoy Law Firm to recover your losses; February 21, 2025 Deadline to file Lead Plaintiff Motion

Achilles Therapeutics Announces Sale of Technology Assets to AstraZeneca

Gainey McKenna & Egleston Announces a Class Action Lawsuit Has Been Filed Against AstraZeneca PLC (AZN)

Rosen Law Firm Encourages AstraZeneca PLC Investors to Inquire About Securities Class Action Investigation - AZN

AZN INVESTOR ALERT: Bronstein, Gewirtz & Grossman LLC Announces that AstraZeneca PLC Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit

ROSEN, TOP-RANKED INVESTOR COUNSEL, Encourages AstraZeneca PLC Investors to Secure Counsel Before Important Deadline in Securities Class Action First Filed by the Firm – AZN

AZN INVESTOR DEADLINE: AstraZeneca PLC Investors with Substantial Losses Have Opportunity to Lead Class Action Lawsuit

Achievements and Progress Heading into 2025 for Oncology Treatments and Therapies Fuel an Optimistic Outlook

ASTRAZENECA SHAREHOLDER ALERT by Former Louisiana Attorney General: Kahn Swick & Foti, LLC Reminds Investors With Losses in Excess of $100,000 of Lead Plaintiff Deadline in Class Action Lawsuit Against AstraZeneca PLC - AZN

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