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 several major therapeutic classes, 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.

Biotech

Large Cap

News

Health Care

General

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

Earnings

Pre-Market Outlook

Markets

Trading Ideas

목요일 아침 (현지 시간 기준) 미국 주식 선물이 더 높게 거래되면서 오늘 투자자의 관심을 끌 수 있는 일부 주식은 다음과 같다: 월스트리트는 허니웰 인터내셔널(NASDAQ:HON)가 개장 전에 94억 1천만 달러의 매출과 94억 1천만 달러의 분기 이익을 주당 2.42달러로 보고할 것으로 예상하고 있다. Benzinga Pro의 데이터에 따르면 허니웰의 주식은 시간외 거래에서 0.5% 상승한 214.80달러를 기록했다.

목요일 주목해야 할 주식: 아메리칸 항공, 아스트라제네카 그리고 3종목

Equities

Previews

Tech

ABBV

AGYS

ASML

BJRI

CHKP

CHTR

CMCSA

DECK

GATX

GOOG

GOOGL

JNPR

NFLX

NXPI

ODFL

ORLY

SKYW

SPOT

TSLA

VRSN

S&amp;P 500 기업들 중 약 14%가 6월 분기 실적을 발표했으며, 더 넓은 지수를 구성하는 기업들의 혼합 실적 성장률은 여전히 ​​양호하다. 이번 주에는 기술 보고 시즌이 공식적으로 시작될 것이며, 이는 최근 주에 가파른 하락세를 보인 시장의 향방을 잠재적으로 결정할 수 있다.

테슬라, 알파벳, GM 및 포드가 이번 주 실적 발표 주도하며 상승세 유지 위해 고군분투

AstraZeneca PLC - American Depositary Shares

AstraZeneca PLC

ASTRAZENECA ORD

AZN Capital Corp

Thermo Fisher Scientific&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TMO#NYSE">TMO</a>) one of the largest contract drug manufacturing sites in the U.S., has repeatedly been flagged for regulatory violations.
Thermo Fisher&#8217;s Greenville facility manufactures around 40 medicines, including Novo Nordisk A/S&#8217; (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) weight-loss <a target="_blank" href="https://www.benzinga.com/general/biotech/23/10/35142181/weight-loss-drug-boom-has-another-ripple-effect-rapid-growth-expected-in-fill-finish-market" rel="noreferrer noopener">drug Wegovy (semaglutide)</a>.
Recently, Stephen&#8217;s analyst said that Thermo Fisher&#8217;s pharma services assets, especially its contract development and manufacturing organization (CDMO), are well positioned. The company is set to capitalize on growth opportunities in the injectables sector, driven by GLP-1 demand and biologics <a target="_blank" href="https://www.benzinga.com/analyst-ratings/analyst-color/24/10/41127566/industry-leader-thermo-fishers-contract-services-positioned-for-growth-amid-popular" rel="noreferrer noopener">drug substance production</a>.
Over the past decade, the Greenville plant has been cited for issues related to contamination prevention, including two incidents earlier this year, Reuters noted, citing FDA documents.
Also Read: <a target="_blank" href="https://www.benzinga.com/news/earnings/24/07/39930516/thermo-fisher-q2-earnings-marginal-revenue-dip-completes-olink-acquisition-lifts-annual-profit-outl" rel="noreferrer noopener">Thermo Fisher Q2 Earnings: Marginal Revenue Dip, Completes Olink Acquisition, Lifts Annual Profit Outlook</a>.
Despite these concerns, the FDA did not take regulatory action, stating that the issues had been resolved to its satisfaction and that there was no evidence that patients had been harmed as a result.
During a recent inspection in May, the FDA identified manufacturing problems with Sanofi SA (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SNY#NASDAQ">SNY</a>) and AstraZeneca Plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Beyfortus. The respiratory syncytial virus (RSV) preventive drug for infants and toddlers scored <a target="_blank" href="https://www.benzinga.com/general/biotech/23/07/33262341/astrazeneca-sanofis-respiratory-syncytial-virus-treatment-scores-fda-approval-to-prevent-infectio" rel="noreferrer noopener">FDA approval in 2023</a>.
The Reuters report highlighted that the FDA identified 17 deficiencies during the Beyfortus audit, including insufficient visual inspections for particulate matter in injectable drugs and issues with staff handling of sterile components.
The agency noted that Thermo Fisher&#8217;s equipment sterilization procedures were inadequate, and visual inspections for injectable drug contaminants failed.
Thermo Fisher has since addressed these issues, providing the FDA with the necessary data on drug safety, including control over bubble size in injectable medications. However, experts remain concerned about the plant&#8217;s approach to quality control.
In July, Merck &amp; Co Inc&#8217;s&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) Phase 2b/3 trial (MK-1654-004) of&nbsp;clesrovimab (MK-1654) to protect infants from respiratory syncytial virus (RSV) disease met its primary safety <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39916077/merck-competes-with-sanofiastrazeneca-as-its-rsv-treatment-drug-meets-primary-goal-in-late-stage-" rel="noreferrer noopener">and efficacy endpoints</a>.
Price Action: TMO stock is down 0.39% at $598.59 during the premarket session at last check Friday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/markets/equities/24/10/41182921/rivians-production-forecast-hits-bump-supply-shortage-sends-shares-tumbling" target="_blank" rel="noreferrer noopener">Rivian&#8217;s Production Forecast Hits Bump, Supply Shortage Sends Shares Tumbling</a></li>
</ul>
Photo via Shutterstock

Novo Nordisk/AstraZeneca's Manufacturing Partner Thermo Fisher Questioned Over Manufacturing Lapses

On Thursday, the FDA accepted and granted Priority Review to AstraZeneca Plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) supplemental marketing application for Calquence (acalabrutinib) for adult patients with previously untreated <a target="_blank" href="https://www.benzinga.com/pressreleases/24/10/b41160742/calquence-acalabrutinib-granted-priority-review-in-the-us-for-patients-with-untreated-mantle-cell-" rel="noreferrer noopener">mantle cell lymphoma (MCL)</a>.
The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the first quarter of 2025.
MCL is a rare and typically aggressive form of non-Hodgkin lymphoma (NHL), resulting when B-lymphocytes mutate into malignant cells within a region of the lymph node known as the mantle zone.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/41050339/astrazenecas-top-selling-cancer-drug-tagrisso-receives-fda-green-light-for-another-lung-cancer-in" rel="noreferrer noopener">AstraZeneca&#8217;s Top-Selling Cancer Drug Tagrisso Receives FDA Green Light For Another Lung Cancer Indication</a>.
It is estimated that more than 27,500 people are living with MCL worldwide.
Results from the <a target="_blank" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.astrazeneca-us.com%2Fmedia%2Fpress-releases%2F2024%2Fcalquence-acalabrutinib-plus-chemoimmunotherapy-reduced-the-risk-of-disease-progression-or-death-by-27-percentage-vs-standard-of-care-in-patients-with-untreated-mantle-cell-lymphoma-in-echo-phase-iii-trial.html&amp;esheet=54130935&amp;newsitemid=20241003958806&amp;lan=en-US&amp;anchor=ECHO+Phase+III+trial&amp;index=1&amp;md5=3837bcbd9ded15f0ec3b2c2476b8d102" rel="noreferrer noopener">ECHO Phase III trial</a> recently were presented during the late-breaking oral session at the European Hematology Association (EHA) 2024 Hybrid Congress.
In the trial, Calquence plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care (SoC) chemoimmunotherapy.
Adding Calquence to SoC provided almost 1.5 years of additional median progression-free survival (mPFS) with mPFS of 66.4 months for patients treated with the Calquence combination versus 49.6 months with SoC.
Overall survival (OS) showed a favorable trend for the Calquence combination compared to SoC chemoimmunotherapy.
The OS data were not mature during this analysis, and the trial will continue to assess OS as a key secondary endpoint.
The ECHO trial was conducted during the COVID-19 pandemic. After censoring COVID-19 deaths, the PFS was further improved in both arms, with the CALQUENCE combination reducing the risk of disease progression or death by 36%. A favorable trend was seen for OS in this analysis for the Calquence combination, but OS data were not mature.
Price Action: AZN stock is down 1.73% at $78.21 at last check Thursday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/markets/equities/24/10/41170239/american-tower-boosts-data-power-new-400g-aws-connections-to-fuel-ai-and-big-data-at-key-us-data" target="_blank" rel="noreferrer noopener">American Tower Boosts Data Power: New 400G AWS Connections To Fuel AI And Big Data At Key US Data Centers</a>.</li>
</ul>

AstraZeneca Seeks Expanded Use For Blood Cancer Drug Calquence, FDA Grants Priority Review

The FDA Has Accepted And Granted Priority Review AstraZeneca's Supplemental New Drug Application For Calquence (Acalabrutinib) For Previously Untreated Mantle Cell Lymphoma, The FDA Action Date Is Anticipated During Q1 Of 2025

RCUS

Arcus Biosciences Announces Clinical Trial Collaboration Agreement With AstraZeneca To Evaluate Casdatifan In Combination With Volrustomig In Renal Cell Carcinoma

Monday, the U.S. Department of Health and Human Services (HHS) announced that Medicare enrollees will benefit from reduced prices on 54 drugs through Medicare Part B, effective from October 1, 2024, to December 31, 2024.
The <a target="_blank" href="https://www.hhs.gov/about/news/2024/09/30/hhs-announces-cost-savings-for-prescription-drugs-thanks-to-medicare-inflation-rebate-program.html" rel="noreferrer noopener">program</a> aims to counter drug price hikes that exceed inflation, providing financial relief for over 822,000 Medicare beneficiaries who rely on these medications to treat conditions like cancer, osteoporosis, and pneumonia.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40422798/doctors-struggle-to-secure-medicare-coverage-for-heart-patients-on-novo-nordisks-wegovy" rel="noreferrer noopener">Doctors Struggle to Secure Medicare Coverage for Heart Patients on Novo Nordisk&#8217;s Wegovy</a>
HHS Secretary Xavier Becerra emphasized that the Biden administration&#8217;s prescription drug policies are making a tangible impact on seniors and people with disabilities by reducing out-of-pocket costs.
According to Chiquita Brooks-LaSure, CMS Administrator, some Medicare beneficiaries could see daily savings ranging from $1 to as much as $3,854 on drugs included in the rebate program.
For example, a cancer patient using Novartis&#8217; AGs (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) Kymriah could save up to $3,000.
Brooks-LaSure also noted that the law disincentivizes drug companies from raising prices faster than inflation, which helps protect Medicare beneficiaries from sharp price increases.
The Inflation Reduction Act&#8217;s initiatives extend beyond 2024. In August, the administration reached new agreements to reduce prices for ten additional high-cost drugs.
Once these prices take effect in 2026, Medicare is projected to save an estimated $6 billion, while beneficiaries could see a reduction of $1.5 billion in <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40397706/biden-administration-targets-6b-savings-through-medicare-drug-price-negotiations" rel="noreferrer noopener">out-of-pocket expenses</a>.
Starting in 2025, Medicare Part D enrollees will further benefit from a $2,000 annual cap on prescription drug costs, down from the current cap of $3,500 for those with high expenses.
According to some analysts,&nbsp;Novo Nordisk A/S&#8217; (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>)&nbsp;blockbuster diabetes drug&nbsp;Ozempic might be included, along with several other well-known medications, in the next round of negotiations, which <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40534249/novo-nordisks-ozempic-might-be-among-2027-medicare-price-negotiation-targets" rel="noreferrer noopener">is set for 2027</a>.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/markets/equities/24/10/41124151/tpg-gic-agree-to-buy-techem-for-7-5b-look-to-expand-across-europe-and-beyond" target="_blank" rel="noreferrer noopener">TPG, GIC Agree To Buy Techem For $7.5B: Look To Expand &#8216;Across Europe And Beyond&#8217;</a></li>
</ul>
Photo via Shutterstock

Government

Regulations

US HHS Reveal Cost Savings For 54 Prescription Drugs Including Novartis' Cancer Drug, Ozempic Could be Next

Daiichi Sankyo (TSE: 4568) and AstraZeneca's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) supplemental Biologics License Application (sBLA) for ENHERTU&#xAE; (fam-trastuzumab deruxtecan-nxki) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with unresectable or metastatic HER2 low (IHC 1+ or IHC 2+/ISH-) or HER2 ultralow (IHC 0 with membrane staining) breast cancer who have received at least one endocrine therapy in the metastatic setting.
ENHERTU is a specifically engineered HER2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
The U.S. Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available treatment options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance. The Prescription Drug User Fee Act (PDUFA) date, the FDA action date for their regulatory decision, is February 1, 2025. The Priority Review follows receipt of Breakthrough Therapy Designation <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.daiichisankyo.com%2Ffiles%2Fnews%2Fpressrelease%2Fpdf%2F202408%2F20240819_E1.pdf&amp;esheet=54129231&amp;newsitemid=20240930807595&amp;lan=en-US&amp;anchor=granted&amp;index=1&amp;md5=c82129aaf52e5fdfcdcfd5c5d0f72567">granted</a> by the FDA for ENHERTU based on data from the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04494425&amp;esheet=54129231&amp;newsitemid=20240930807595&amp;lan=en-US&amp;anchor=DESTINY-Breast06&amp;index=2&amp;md5=ecfc5698cd40f1242f214ba893845e59">DESTINY-Breast06</a> phase 3 trial in August 2024.
Hormone receptor (HR) positive, HER2 negative is the most common breast cancer subtype, accounting for approximately 70% of all breast cancers.1 Despite being classified as HER2 negative, many of these tumors still carry some level of HER2 expression.2 It is estimated that up to 85% to 90% of tumors historically classified as HR positive, HER2 negative, may be HER2 low or HER2 ultralow.3,4
The sBLA is based on data from DESTINY-Breast06 <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.daiichisankyo.com%2Ffiles%2Fnews%2Fpressrelease%2Fpdf%2F202406%2F20240602_E2.pdf&amp;esheet=54129231&amp;newsitemid=20240930807595&amp;lan=en-US&amp;anchor=presented&amp;index=3&amp;md5=60d743b75d92125e38563f950191d661">presented</a> as a late-breaking oral session at the 2024 American Society of Clinical Oncology (#ASCO24) Annual Meeting and recently published in <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=http%3A%2F%2Fwww.nejm.org&amp;esheet=54129231&amp;newsitemid=20240930807595&amp;lan=en-US&amp;anchor=The+New+England+Journal+of+Medicine&amp;index=4&amp;md5=1e3a45484df713407df2ad6cdbca0eba">The New England Journal of Medicine</a>. In the overall trial population, ENHERTU reduced the risk of disease progression or death by 37% by blinded independent central review (BICR) versus chemotherapy (hazard ratio [HR] 0.63; 95% confidence interval [CI]: 0.53-0.75; p&lt;0.0001). Median progression-free survival (PFS) was 13.2 months with ENHERTU compared to 8.1 months with chemotherapy.
Results were consistent in patients with HER2 low expression and HER2 ultralow expression. In the primary endpoint analysis of patients with HR positive, HER2 low metastatic breast cancer, median PFS was 13.2 months in the ENHERTU arm compared to 8.1 months in the chemotherapy arm (HR 0.62; 95% CI: 0.51-0.74; p&lt;0.0001), as assessed by BICR. In a prespecified exploratory analysis of patients with HER2 ultralow expression, ENHERTU showed a median PFS of 13.2 months versus 8.3 months, respectively (HR 0.78; 95% CI: 0.50-1.21).
The safety profile of ENHERTU in DESTINY-Breast06 was consistent with previous breast cancer clinical trials with no new safety concerns identified. The most common grade 3 or higher treatment related treatment emergent adverse events (TEAEs) occurring in 5% or more of patients treated with ENHERTU were neutropenia (20.7%), leukopenia (6.9%) and anemia (5.8%). Interstitial lung disease (ILD) or pneumonitis occurred in 11.3% of patients treated with ENHERTU. The majority of ILD or pneumonitis events were low grade (grade 1 [n=7; 1.6%] or grade 2 [n=36; 8.3%]). There were three grade 3 ILD events (0.7%), zero grade 4 events and three grade 5 events (0.7%) as determined by an independent adjudication committee.
"This Priority Review highlights the potential to expand the existing indication of ENHERTU in HER2 low metastatic breast cancer to include use in an earlier disease setting as well as in a broader patient population that includes HER2 ultralow," said Ken Takeshita, MD, Global Head, R&amp;D, Daiichi Sankyo. "We look forward to working closely with the FDA with the goal of bringing ENHERTU to more patients as quickly as possible."
"While endocrine therapies are widely used in the initial treatment of HR positive metastatic breast cancer, most patients see limited benefit with additional lines of treatment and subsequent chemotherapy is associated with poor response rates and outcomes," said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&amp;D, AstraZeneca. "The results from DESTINY-Breast06 show that ENHERTU has the potential to evolve the current HR positive treatment landscape and become the first targeted treatment for patients with HER2 low or HER2 ultralow expression following endocrine therapy."

FDA Grants Priority Review for Daiichi Sankyo and AstraZeneca's ENHERTU in Breast Cancer Treatment

Thursday, the FDA approved AstraZeneca Plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Tagrisso&nbsp;(osimertinib)​ for adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT).&nbsp;
Tagrisso&nbsp;is indicated for patients with exon 19 deletions or exon 21 (L858R) mutations.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40977596/latest-trial-setback-for-astrazenecas-dato-dxd-the-drug-fails-to-extend-lives-of-pretreated-breas" rel="noreferrer noopener">Latest Trial Setback For AstraZeneca&#8217;s Dato-DXd, The Drug Fails To Extend Lives Of Pretreated Breast Cancer Patients</a>.
Tagrisso is AstraZeneca&#8217;s top-selling cancer drug, and in the second quarter of 2024, it generated around <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">$1.6 billion in sales</a>.
The <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/tagrisso-us-approval-in-unresectable-lung-cancer.html" rel="noreferrer noopener">approval</a> follows the FDA&#8217;s&nbsp;Priority Review based on results from the LAURA Phase 3 trial.
Tagrisso&nbsp;reduced the risk of disease progression or death by 84% compared to placebo.
Median progression-free survival (PFS) was 39.1 months in patients treated with&nbsp;Tagrisso&nbsp;versus 5.6 months for placebo.&nbsp;
Overall survival (OS) results remain immature at this current analysis. The trial continues to assess OS as a secondary endpoint.
Each year in the US, there are more than 200,000 people diagnosed with lung cancer, and 80-85% of these patients are diagnosed with NSCLC, the most common form of lung cancer.
Approximately 15% of NSCLC patients in the US have EGFR mutations. Nearly one in five people diagnosed with NSCLC has an unresectable tumor.
The safety and tolerability of&nbsp;Tagrisso&nbsp;in the LAURA trial was consistent with its established profile and no new safety concerns were identified.
Tagrisso is approved for patients with EGFR mutations in the first-line metastatic setting as monotherapy, in combination with chemotherapy, and as an adjuvant treatment for early-stage disease.&nbsp;
Last week, the FDA approved&nbsp;AstraZeneca&#8217;s Fasenra&nbsp;(bevacizumab) for eosinophilic granulomatosis with polyangiitis (EGPA), a rare, immune-mediated vasculitis (inflammation of the blood vessels) that can damage<a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40923602/astrazenecas-asthma-drug-gets-fda-approval-for-rare-disease-of-blood-vessel-inflammation" rel="noreferrer noopener"> multiple organs</a>.
Price Action: AZN stock is up 0.94% at $78.27 at the last check Thursday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/markets/equities/24/09/41048659/blackstone-to-invest-13-3b-in-ai-data-center-in-uk-projects-4-000-new-jobs" target="_blank" rel="noreferrer noopener">Blackstone To Invest $13.3B In AI Data Center In UK, Projects 4,000 New Jobs</a>.</li>
</ul>
Image by Robert Way via Shutterstock

AstraZeneca's Top-Selling Cancer Drug Tagrisso Receives FDA Green Light For Another Lung Cancer Indication

FDA Approves Osimertinib For Locally Advanced, Unresectable Stage III Non-Small Cell Lung Cancer After Chemoradiation Therapy; Recommended Dose Is 80mg Daily Until Disease Progression Or Unacceptable Toxicity

Monday, Black Diamond Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BDTX#NASDAQ">BDTX</a>) reported initial Phase 2 <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/g40976802/black-diamond-therapeutics-announces-initial-phase-2-data-demonstrating-robust-anti-tumor-activity" rel="noreferrer noopener">data of BDTX-1535</a>.
The data demonstrated encouraging clinical responses and durability of BDTX-1535 in patients with relapsed/refractory epidermal growth factor receptor (EGFR)-mutant (EGFRm) non-small cell lung cancer (NSCLC).
&#8220;Patients often become resistant to osimertinib with the emergence of on-target resistance EGFR mutations,&#8221; said Sergey Yurasov, Chief Medical Officer of Black Diamond Therapeutics. &#8220;Our preliminary Phase 2 data demonstrate the potential of BDTX-1535 to deliver durable responses for these patients.&#8221;
AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) markets osimertinib as&nbsp;Tagrisso.
Preliminary response rate and durability were assessed in 27 patients at 200 mg with an August 17, 2024, data cutoff, including 22 response-evaluable patients who met protocol eligibility criteria.
The preliminary objective response rate (ORR) for the 22 response-evaluable patients was 36%. Nineteen of these 22 patients expressed known osimertinib resistance mutations.
Of these 19 patients, 8 achieved a response (42%): 5 with a confirmed partial response (PR), including one patient who converted from a PR to an unconfirmed complete response (CR) at 8 months (and awaits confirmatory scan); and 3 with an unconfirmed PR at first scan and awaiting a confirmatory scan. An additional 9 patients experienced stable disease.
Encouraging durability was observed, with a duration of response (DOR) of approximately 8 months or more for the first three patients with PR; 14 of 19 remain on therapy.&nbsp;Mean follow-up time is 4.7 months.
Most adverse events were mild or moderate, and no new safety signals were observed.
200 mg daily selected for pivotal clinical development.&nbsp;
Black Diamond continues to enroll patients in the second—and third-line cohorts and in the first-line setting for patients with non-classical EGFR mutations.
In Q1 2025, the company expects to disclose initial results from the first-line cohort and outline potential registrational paths in the recurrent setting based on FDA feedback.
Price Action: BDTX stock is up 2.21% at $4.86 at the last check on Monday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/general/biotech/24/09/40979253/sanofis-sarclisa-secures-fda-approval-for-first-line-multiple-myeloma-marking-its-third-us-approv" target="_blank" rel="noreferrer noopener">Sanofi&#8217;s Sarclisa Secures FDA Approval For First-Line Multiple Myeloma, Marking Its Third US Approval</a>.</li>
</ul>

Movers

BDTX

Black Diamond Therapeutics' Lead Drug Candidate Shows Initial Anti-tumor Activity In Certain Type Of Lung Cancer Resistant To AstraZeneca's Drug

Monday, AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) released high-level results from the TROPION-Breast01 Phase 3 trial of datopotamab deruxtecan (Dato-DXd) compared to the investigator&#8217;s choice of chemotherapy.
The <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/datopotamab-deruxtecan-final-overall-survival-results-reported-in-patients-with-metastatic-hr-positive-her2-low-or-negative-breast-cancer-in-tropion-breast01-phase-iii-trial.html" rel="noreferrer noopener">study</a> did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.
The study previously met the dual primary endpoint of progression-free survival.
Also Read: <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">AstraZeneca CEO Pascal Soriot Updates On Chinese Compliance Probe And Lung Cancer Drug Trial Results</a>.
An improvement in patient-reported outcomes was also seen.
The safety profile of datopotamab deruxtecan was consistent with that observed in the previous analysis, including lower rates of Grade 3 or higher treatment-related adverse events compared to chemotherapy, and no new safety concerns were identified.
All-grade interstitial lung disease (ILD) rates remained low, and no new Grade 3 or higher ILD events were observed.
With multiple antibody-drug conjugates (ADCs) approved during the trial, including&nbsp;Enhertu (trastuzumab deruxtecan), subsequent treatment following patients&#8217; disease progression or treatment discontinuation is likely to have affected survival results.
Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd ADC discovered by Daiichi Sankyo Ltd&nbsp;(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 being jointly developed by AstraZeneca and Daiichi Sankyo.
Earlier this month, AstraZeneca&nbsp;shared detailed results from the TROPION-Lung01 Phase 3 of datopotamab deruxtecan (Dato-DXd) compared to docetaxel, the current standard of care chemotherapy for locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) treated with at least&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40791315/astrazenecas-investigational-cancer-drug-disappoints-in-late-stage-lung-cancer-trial" rel="noreferrer noopener">one prior line of therapy</a>.
In the overall trial population, OS results numerically favored datopotamab deruxtecan compared to docetaxel (12.9 vs. 11.8 months) but did not reach statistical significance.
Friday, the FDA <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/flumist-approved-for-self-administration-in-the-us.html" rel="noreferrer noopener">approved</a> AstraZeneca&#8217;s FluMist as the only self-administered influenza vaccine.&nbsp;
FluMist, a needle-free nasal spray, was approved for self-administration by adults up to 49 years of age or for parent/caregiver administration to individuals 2-17 years of age.
Once available, individuals 18 and older can have FluMist delivered directly to their homes via FluMist Home.
Price Action: AZN stock is down 1.86% at $76.92 during the premarket session at last check Monday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/news/large-cap/24/09/40964870/us-federal-trade-commission-sues-cvs-health-cigna-unitedhealths-pharmacy-benefit-managers-for-infl" target="_blank" rel="noreferrer noopener">US Federal Trade Commission Sues CVS Health, Cigna, UnitedHealth&#8217;s Pharmacy Benefit Managers For Inflating Insulin Prices</a>.</li>
</ul>
Image by Robert Way via Shutterstock

DSKYF

DSNKY

Latest Trial Setback For AstraZeneca's Dato-DXd, The Drug Fails To Extend Lives Of Pretreated Breast Cancer Patients

The&nbsp;Committee for Medicinal Products for Human Use (CHMP)&nbsp;of the European Medicines Agency based its positive opinion on results from the MANDARA Phase III trial published in&nbsp;The New England Journal of Medicine, which compared the efficacy and safety of&nbsp;Fasenra&nbsp;to the only approved EGPA treatment, mepolizumab, in patients with relapsing or refractory EGPA.
MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA. Patients were randomized to receive either a single 30 mg subcutaneous injection of&nbsp;Fasenra, or three separate 100 mg subcutaneous injections of mepolizumab every four weeks.

AstraZeneca's Fasenra (Benralizumab) Has Been Recommended For Approval In The European Union As An Add-on Treatment For Adult Patients With Relapsing Or Refractory Eosinophilic Granulomatosis With Polyangiitis

Topline results from the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05104866&amp;esheet=54125378&amp;newsitemid=20240921214470&amp;lan=en-US&amp;anchor=TROPION-Breast01&amp;index=1&amp;md5=38bfe55b682fc21bfb63c9c96538d6dd">TROPION-Breast01</a> phase 3 trial of datopotamab deruxtecan (Dato-DXd) compared to investigator's choice of chemotherapy, which previously met the dual primary endpoint of progression-free survival (PFS), did not achieve statistical significance in the final overall survival (OS) analysis in patients with inoperable or metastatic hormone receptor (HR) positive, HER2 low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.
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>).
This analysis follows the positive PFS results <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.daiichisankyo.com%2Ffiles%2Fnews%2Fpressrelease%2Fpdf%2F202310%2F20231023_E2.pdf&amp;esheet=54125378&amp;newsitemid=20240921214470&amp;lan=en-US&amp;anchor=presented&amp;index=2&amp;md5=cff8252e7446c8d69a1c27fc9fce80e2">presented</a> at the 2023 European Society for Medical Oncology Congress which showed datopotamab deruxtecan demonstrated a statistically significant and clinically meaningful improvement in PFS. An improvement in patient-reported outcomes was also seen.1 The PFS data and additional results for key secondary endpoints were published this month in the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fascopubs.org%2Fdoi%2F10.1200%2FJCO.24.00920&amp;esheet=54125378&amp;newsitemid=20240921214470&amp;lan=en-US&amp;anchor=Journal+of+Clinical+Oncology&amp;index=3&amp;md5=e7ed20db0874315d5367f7b02d51353a">Journal of Clinical Oncology</a>.
The safety profile of datopotamab deruxtecan was consistent with that observed in the previous analysis, including lower rates of grade 3 or higher treatment-related adverse events compared to chemotherapy, and no new safety concerns identified. All grade interstitial lung disease (ILD) rates remained low with no new grade 3 or higher ILD events observed.
With ADCs approved during the course of the trial, including ENHERTU&#xAE; (trastuzumab deruxtecan), subsequent treatment following patients' disease progression or treatment discontinuation is likely to have affected survival results.
"Datopotamab deruxtecan has previously shown a statistically significant progression-free survival benefit in TROPION-Breast01, a result supported by multiple meaningful secondary measures including patient-reported outcomes," said Ken Takeshita, MD, Global Head, R&amp;D, Daiichi Sankyo. "We are proud to have brought forth a new standard of care for patients with metastatic breast cancer with ENHERTU and we remain committed to making datopotamab deruxtecan another potential option for patients who can benefit."
"The metastatic HR positive breast cancer treatment landscape has advanced remarkably in the last several years to the benefit of patients," said Susan Galbraith, MBBChir, PhD, Executive Vice President, Oncology R&amp;D, AstraZeneca. "Based on the TROPION-Breast01 results, there is evidence of the clinical value of datopotamab deruxtecan in this setting. We will continue discussions with regulatory authorities and apply insights from these results to our clinical development program for datopotamab deruxtecan in breast cancer."
The data will be presented at an upcoming medical meeting and shared with regulatory authorities currently reviewing applications for this indication.
In addition to TROPION-Breast01, Daiichi Sankyo and AstraZeneca are evaluating datopotamab deruxtecan alone and with immunotherapy as treatment for patients with triple negative or HR low, HER2 negative breast cancers in the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT05374512&amp;esheet=54125378&amp;newsitemid=20240921214470&amp;lan=en-US&amp;anchor=TROPION-Breast02&amp;index=4&amp;md5=01feaaff425affd80759eb06d8c92034">TROPION-Breast02</a>, <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05629585&amp;esheet=54125378&amp;newsitemid=20240921214470&amp;lan=en-US&amp;anchor=TROPION-Breast03&amp;index=5&amp;md5=bb5bdbad13d3fdfbaf1635f870880f2a">TROPION-Breast03</a>, <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06112379&amp;esheet=54125378&amp;newsitemid=20240921214470&amp;lan=en-US&amp;anchor=TROPION-Breast04&amp;index=6&amp;md5=191cffef0ab77f965d8b58af4ebbca39">TROPION-Breast04</a> and <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT06103864&amp;esheet=54125378&amp;newsitemid=20240921214470&amp;lan=en-US&amp;anchor=TROPION-Breast05&amp;index=7&amp;md5=0f12d2808ec2428fa29d6d8aabb36d6e">TROPION-Breast05</a> phase 3 trials.

Daiichi Sankyo and AstraZeneca's Datopotamab Deruxtecan Falls Short on Survival in Breast Cancer Trial

FLUMIST Receives Approval For Self-Administration In U.S.

<a href="https://www.astrazeneca-us.com/media/press-releases/2024/astrazeneca-announces-start-of-recruitment-in-2-new-phase-iii-trials-evaluating-saphnelo-in-cle-and-in-iim.html" title="https://www.astrazeneca-us.com/media/press-releases/2024/astrazeneca-announces-start-of-recruitment-in-2-new-phase-iii-trials-evaluating-saphnelo-in-cle-and-in-iim.html">https://www.astrazeneca-us.com/media/press-releases/2024/astrazeneca-announces-start-of-recruitment-in-2-new-phase-iii-trials-evaluating-saphnelo-in-cle-and-in-iim.html</a>

AstraZeneca Initiates Recruitment For Two New Phase III Trials Investigating SAPHNELO In Cutaneous Lupus Erythematosus (LAVENDER) And Idiopathic Inflammatory Myopathies (JASMINE)

JMP Securities initiated coverage on BeiGene Ltd (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BGNE#NASDAQ">BGNE</a>), noting the Chinese biotech firm as a &#8216;unique <a target="_blank" href="https://www.benzinga.com/quote/bgne" rel="noreferrer noopener">investment opportunity</a>.&#8217;
The company&#8217;s flagship drug, Brukinsa (zanubrutinib), is among the more recent BTK inhibitors to break into a global market projected to hit $12.2 billion by 2031. Three major players dominate this sector, with Johnson &amp; Johnson&#8216;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) Imbruvica leading the charge, peaking at $8.7 billion in sales in 2021.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40534057/cancer-medicines-from-merck-bristol-myers-and-beigene-in-question-as-fda-committee-to-discuss-lim" rel="noreferrer noopener">Cancer Medicines From Merck, Bristol Myers And BeiGene In Question, As FDA Committee To Discuss Limiting PD-1 Drugs For Stomach Cancer</a>.
However, competition intensified when AstraZeneca Plc&#8216;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Calquence and Brukinsa entered the market in 2017 and 2019, respectively.
Analyst Reni Benjamin&#8217;s confidence in Brukinsa emerging as a market leader is bolstered by an exclusive survey of 37 doctors, indicating that 80% plan to boost their use of Brukinsa due to its perceived safety and long-term <a href="https://www.benzinga.com/general/biotech/24/03/37560438/fda-conditionally-approves-expanded-use-of-beigenes-combination-drug-for-certain-type-of-blood-ca" target="_blank" rel="noreferrer noopener">effectiveness advantages</a>.
As Imbruvica&#8217;s popularity declines, Calquence and Brukinsa will capture a larger market share. By 2031, Brukinsa is expected to command 55% of the market, potentially generating global sales of $5.4 billion, the analyst adds.
Benjamin says Brukinsa is on track to generate over $2 billion for the company in 2024, with total revenues to reach $3.7 billion.
The analyst has initiated the coverage with a Market Perform rating and a <a target="_blank" href="https://www.benzinga.com/quote/BGNE/analyst-ratings" rel="noreferrer noopener">price target of $288</a>.
China ranks as the third-largest healthcare market globally, behind the U.S. and the EU, with expenditures reaching $1.2 trillion.
BeiGene, which offers 14 products in China through various U.S. partners, holds a significant position in this market. Despite limited visibility into China&#8217;s regulatory and commercial environment, BeiGene&#8217;s sales force has driven annual revenues from China to $1.1 billion.
However, JMP writes that the numbers can drop to $178 million by 2031 due to patent expirations unless additional therapeutics are licensed.
Price Action: BGNE stock is up 1.05% at $199.59 at last check Wednesday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/markets/equities/24/09/40924917/veea-partners-with-iot-platform-crowdkeep-whats-the-benefit" target="_blank" rel="noreferrer noopener">Veea Partners With IoT Platform Crowdkeep &#8211; What&#8217;s The Benefit?</a></li>
</ul>
Photo: Shutterstock

Price Target

Initiation

Analyst Ratings

BGNE

Chinese Biotech BeiGene Labeled 'Unique Investment' As Analyst Confident In Lead Cancer Drug

The FDA approved on Wednesday AstraZeneca Plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Fasenra&nbsp;(benralizumab) for eosinophilic granulomatosis with polyangiitis (EGPA), a rare, immune-mediated vasculitis (inflammation of the blood vessels) that can result in damage to multiple organs.
The <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/fasenra-approved-in-the-us-for-eosinophilic-granulomatosis-with-polyangiitis.html" rel="noreferrer noopener">approval</a> was based on data from the MANDARA Phase 3 trial published in&nbsp;The New England Journal of Medicine, which compared the efficacy and safety of&nbsp;Fasenra&nbsp;to the only approved EGPA treatment, GSK Plc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Nucala (mepolizumab).
Also Read: <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">AstraZeneca CEO Pascal Soriot Updates On Chinese Compliance Probe And Lung Cancer Drug Trial Results</a>
MANDARA was the first head-to-head non-inferiority trial of biologics in patients with EGPA.
In the trial, nearly 60% of&nbsp;Fasenra-treated patients achieved remission, comparable to mepolizumab-treated patients.
Data also showed 41% of&nbsp;Fasenra-treated patients fully tapered off oral corticosteroids (OCS) (vs. 26% in the mepolizumab arm).
The safety and tolerability profile for&nbsp;Fasenra&nbsp;in the MANDARA trial was consistent with the known profile of the medicine.
Approximately half of patients with EGPA have adult-onset severe eosinophilic asthma and often have sinus and nasal symptoms. Fasenra&nbsp;is the second biologic approved to treat this disease.
Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in over 80 countries.
It is also approved in children and adolescents ages six and above in the U.S. and Japan.
Last month, the FDA approved&nbsp;AstraZeneca&#8217;s 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/24/07/39958623/astrazeneca-posts-mixed-q2-earnings-still-raises-annual-guidance-on-strong-demand-for-cancer-rare" rel="noreferrer noopener">lymphoma kinase rearrangements</a>.
AZN Price Action: AstraZeneca stock is down 0.16% at $78.41 at publication Wednesday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/government/24/09/40921024/lenovo-expands-ai-server-production-in-india-targets-major-exports-to-asia-pacific" target="_blank" rel="noreferrer noopener">Lenovo Expands AI Server Production in India, Targets Major Exports to Asia-Pacific</a>.</li>
</ul>
Photo: Shutterstock

AstraZeneca's Asthma Drug Gets FDA Approval For Rare Disease Of Blood Vessel Inflammation

The FDA Approves AstraZeneca's Fasenra (benralizumab) For Eosinophilic Granulomatosis With Polyangiitis

Updated results from the HIMALAYA Phase III trial showed AstraZeneca's IMFINZI&#xAE; (durvalumab) plus IMJUDO&#xAE;(tremelimumab-actl) demonstrated a sustained, clinically meaningful overall survival (OS) benefit at five years for patients with unresectable hepatocellular carcinoma (HCC) who had not received prior systemic therapy and were not eligible for localized treatment.
These results from HIMALAYA will be presented today at the European Society for Medical Oncology (ESMO) Congress 2024 in Barcelona, Spain (presentation 947MO).
At five years of follow-up, this latest exploratory analysis showed that a single priming dose of IMJUDO added toIMFINZI, called the STRIDE regimen (Single Tremelimumab-actl Regular Interval Durvalumab), reduced the risk of death by 24% compared to sorafenib (based on a hazard ratio [HR] of 0.76; 95% confidence interval [CI] 0.65-0.89). An estimated 19.6% of patients treated with the STRIDE regimen were alive at five years versus 9.4% for those treated with sorafenib.
In a subgroup analysis of patients in the trial who achieved disease control, defined as complete or partial response or stable disease, 28.7% of those treated with the STRIDE regimen were alive at five years versus 12.7% of patients treated with sorafenib. In addition, an exploratory analysis of depth of response (DpR) showed that more patients treated with the STRIDE regimen experienced deep responses leading to longer survival compared to sorafenib.
Lorenza Rimassa, MD, Associate Professor of Medical Oncology, Humanitas University and IRCCS Humanitas Research Hospital, Milan, Italy and a lead investigator in the HIMALAYA trial, said: "Treatment with durvalumab plus tremelimumab-actl for patients with advanced liver cancer doubled the overall survival rate at five years, a significant survival advantage over sorafenib that has also become even more pronounced over time. These data reinforce the use of this novel dual immunotherapy regimen and are an important milestone for patients with this devastating disease."
Sarah Manes, Liver Cancers Program Director at Global Liver Institute, said: "Reaching the five-year survival milestone is both clinically significant and emotionally meaningful for people with advanced liver cancer and their families. We are thrilled to see this progress in improving outcomes with new treatment options, bringing new hope for long-term survivorship to patients in our community."
Susan Galbraith, Executive Vice President, Oncology R&amp;D, AstraZeneca, said: "It is remarkable to see nearly 20 percent of patients with advanced liver cancer treated with the STRIDE regimen alive at five years compared to only about seven percent of patients living that long historically. This is a major step forward, setting a new survival benchmark. This underscores our commitment to following patients for the long term to help us better characterize the enduring clinical benefits of this innovative priming approach with an anti-CTLA-4 antibody added to PD-L1 blockade."

AstraZeneca's HIMALAYA Trial Highlights 5-Year Outcomes for AstraZeneca's Dual Therapy in Liver Cancer

First immunotherapy regimen before and after surgery to demonstrate statistically significant and clinically meaningful overall survival improvement in this setting
Positive results from the NIAGARA Phase III trial showed AstraZeneca&#39;s IMFINZI&reg;&nbsp;(durvalumab)in combination with chemotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of event-free survival (EFS) and the key secondary endpoint of overall survival (OS) versus neoadjuvant chemotherapy for patients with muscle-invasive bladder cancer (MIBC). Patients were treated with IMFINZIin combination with neoadjuvant chemotherapy before radical cystectomy (surgery to remove the bladder) followed by IMFINZIas adjuvant monotherapy.

Reported Sunday, AstraZeneca's IMFINZI Perioperative Regimen Reduced Recurrence Risk By 32% And Death Risk By 25% Versus Chemotherapy Alone In Bladder Cancer, Per NIAGARA Phase III Trial

<ul>
<li>Daiichi Sankyo and AstraZeneca's ENHERTU achieved a 61.6% progression-free survival rate at one year in patients with active or stable brain metastases in DESTINY-Breast12</li>
<li>Largest prospective trial of ENHERTU in this patient population</li>
</ul>

AstraZeneca And Daiichi Sankyo To Present Findings Of ENHERTU Showing Clinical Activity In Patients With HER2 Positive Metastatic Breast Cancer And Brain Metastases

AstraZeneca's Enhertu application accepted by FDA with priority review

Lilly looking to test Zepbound as health maintenance drug: report

Bank of America Securities analyst Sachin Jain has reiterated their bullish stance on AZN stock, giving a Buy rating on September 30. Sachin Jain h...

AstraZeneca: Strong Sales and Robust Pipeline Underpin Buy Rating

Jefferies analyst Peter Welford maintained a Hold rating on AstraZeneca (AZN – Research Report) today and set a price target of £114.00. The compan...

AstraZeneca (AZN) Receives a Hold from Jefferies

U.S. tweaks 2025 Medicare price negotiation process

AstraZeneca supplemental NDA for Calquence accepted by FDA

BNY Mellon International Equity Fund Q2 2024 Commentary

Dianthus started at outperform by Oppenheimer on DNTH103 opportunity

Absci: AI-Driven Platform Could Establish Best-In-Class TL1A Drug Targeting Profile

Thermo Fisher plant making Astra/ Sanofi RSV drug reportedly breached FDA rules

ABSI

AMGN

ARGX

ATEYY

AZNCF

BKAG

BKCI

BKEM

BKGI

BKHY

BKIE

BKLC

BKMC

BKSE

BKUI

CNVVF

CTLT

DNTH

EXPGF

GPCR

LVMHF

LZAGF

LZAGY

NSRGY

NVDA

RCRRF

RHHBF

RHHBY

RHHVF

SIEGY

SNYNF

SZCRF

TCCPY

TEVA

TEVJF

VKTX

Screenshot 2024-09-30 at 9.13.36 PM

TNXP

VRTX

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

Screenshot 2024-09-30 at 5.38.54 PM

Movers & Shakers

COSM

Nestle Sponsored representing Registered Shares Series B

VTRS

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

Screenshot 2024-03-13 at 5.45.52 PM

FDXTF

MRNA

SHTDY

Nanotechnology&#39;s Promising Role In Fighting Infectious Diseases: Protecting Surfaces With FendX&#39;s Nanotechnology

Screenshot 2023-07-10 at 5.56.06 PM

GNPX

Gene Therapy Company Genprex, Inc. (NASDAQ: GNPX) Receives Fast Track Designation From The FDA For Its Small Cell Lung Cancer Drug Candidate

Press Releases

FLUMIST approved for self-administration in the US

Datopotamab Deruxtecan Final Overall Survival Results Reported in Patients with Metastatic HR Positive, HER2 Low or Negative Breast Cancer in TROPION-Breast01 Phase 3 Trial

Datopotamab deruxtecan final overall survival results reported in patients with metastatic HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial

TAGRISSO® (osimertinib) approved in the US for patients with unresectable, Stage III EGFR-mutated lung cancer

ENHERTU® Granted Priority Review in the U.S. for Patients with HER2 Low or HER2 Ultralow Metastatic Breast Cancer Who Have Received at Least One Line of Endocrine Therapy

ENHERTU® (fam-trastuzumab deruxtecan-nxki) granted Priority Review in the US for patients with HER2-low or HER2-ultralow metastatic breast cancer who have received at least one line of endocrine therapy

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

Arcus Biosciences Announces Clinical Trial Collaboration Agreement to Evaluate Casdatifan in Combination with Volrustomig in Renal Cell Carcinoma

CALQUENCE® (acalabrutinib) granted Priority Review in the US for patients with untreated mantle cell lymphoma

TYO:4568

Amneal Pharmaceuticals, Inc. - Class A Common Stock

Amneal Pharmaceuticals

Axsome Therapeutics

Bristol-Myers Squibb Company Common Stock

Bristol-Myers Squibb

Corcept Therapeutics Incorporated - Common Stock

Corcept Therapeutics

Catalent

Elanco Animal Health Incorporated Common Stock

Elanco Animal Health

GSK plc American Depositary Shares (Each representing two Ordinary Shares)

HUTCHMED (China) Limited - American Depositary Shares

HUTCHMED (China)

Intra-Cellular Therapies Inc. - Common Stock

Intra-Cellular Therapies

Jazz Pharmaceuticals plc - Ordinary Shares

Jazz Pharmaceuticals

Johnson & Johnson

Eli Lilly

Merck & Co

Novo Nordisk

Novartis

Organon

Prestige Consumer Healthcare Inc. Common Stock

Prestige Consumer

Pfizer

Dr. Reddy's Laboratories Ltd Common Stock

Dr Reddy's Laboratories

Royalty Pharma plc - Class A Ordinary Shares

Royalty Pharma

Sanofi

Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of Common Stock)

Takeda Pharmaceutical

Comments

AstraZeneca

뉴스

에 대한 최신 뉴스 AstraZeneca (NASDAQ:AZN) 주식

화요일, 8월 20, 2024

목요일, 7월 25, 2024

일요일, 7월 21, 2024

일요일, 4월 07, 2024

사람들이 또한 지켜본다

뉴스

파트너 / 기고자

벤징가 글로벌