Dernières nouvelles pour AstraZeneca (NASDAQ:AZN) Stock

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.

AstraZeneca PLC - American Depositary Shares

AstraZeneca PLC

ASTRAZENECA ORD

AstraZeneca PLC ADRhedged AstraZeneca PLC ADRhedged

AZN Capital Corp

U.S. stocks traded lower toward the end of trading, with the Nasdaq Composite falling more than 150 points on Monday.
The Dow traded down 0.97% to 41,940.43 while the NASDAQ fell 0.89% to 17,976.85. The S&amp;P 500 also fell, dropping, 0.77% to 5,707.03.
Check This Out: <a href="https://www.benzinga.com/trading-ideas/long-ideas/24/10/41206375/jim-cramer-ast-spacemobile-is-just-too-hot-recommends-buying-this-tech-stock">Jim Cramer: AST SpaceMobile Is &#8216;Just Too Hot,&#8217; Recommends Buying This Tech Stock</a>
Leading and Lagging Sectors Energy shares jumped by 0.6% on Monday.
In trading on Monday, utilities shares dipped by 1.7%.
Top Headline
AstraZeneca plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) entered into an exclusive license agreement with Hong Kong-based CSPC Pharmaceutical Group Ltd to advance the development of an early-stage, novel small-molecule lipoprotein (a) (Lp(a)) disruptor that has the potential to offer additional benefits for patients with dyslipidemia.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Scholar Rock Holding Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRRK#NASDAQ">SRRK</a>) shares shot up 328% to $31.73 after the company announced topline results from the Phase 3 SAPPHIRE clinical trial evaluating the efficacy and safety of apitegromab in patients with SMA. The study achieved its primary endpoint.</li>
<li>Shares of Arcadium Lithium PLC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ALTM#NYSE">ALTM</a>) got a boost, surging 32% to $4.06 after the company announced that it has been approached by Rio Tinto regarding a potential acquisition.</li>
<li>Duckhorn Portfolio Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NAPA#NASDAQ">NAPA</a>) shares were also up, gaining 104% to $10.99 after the company reported better-than-expected fourth-quarter financial results. Also, the company announced it into a definitive agreement to be acquired by private equity funds managed by Butterfly Equity.</li>
</ul>
Equities Trading DOWN
<ul>
<li>Trevena, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TRVN#NASDAQ">TRVN</a>) shares dropped 46% to $2.50 after the company announced it received a Nasdaq delisting notification.</li>
<li>Shares of Heritage Insurance Holdings, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HRTG#NYSE">HRTG</a>) were down 25% to $9.09.</li>
<li>Universal Insurance Holdings, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UVE#NYSE">UVE</a>) was down, falling 19% to $17.12.</li>
</ul>
Commodities In commodity news, oil traded up 3.6% to $77.02 while gold traded down 0.1% at $2,666.10.
Silver traded down 1.1% to $32.035 on Monday, while copper fell 0.2% to $4.5635.
Euro zone
European shares closed mostly higher today. The eurozone's STOXX 600 rose 0.18%, Germany's DAX fell 0.09% and France's CAC 40 climbed 0.46%. Spain's IBEX 35 Index rose 0.50%, while London's FTSE 100 rose 0.28%.
Retail sales in the Eurozone rose 0.2% month-over-month in August compared to a revised flat reading in the previous month. The Halifax House Price Index in the UK rose 4.7% year-over-year in September compared to a 4.3% gain in August. Factory orders in Germany declined by 5.8% month-over-month in August.
Asia Pacific Markets
Asian markets closed mixed on Monday, with Japan's Nikkei 225 gaining 1.80%, Hong Kong's Hang Seng Index gaining 1.60% and India's BSE Sensex dipping 0.78%.
Foreign exchange reserves in Singapore fell to SGD 499.7 billion in September compared to SGD 501.3 billion a month ago. The index of leading economic indicators in Japan fell to 106.7 in August versus a final reading of 109.3 in the prior month, while index of coincident economic indicators declined to 113.5 in August compared to a final reading of 117.2 month ago.
Economics
Data on consumer credit for August will be released today.
Now Read This: 
<ul>
<li><a href="https://www.benzinga.com/news/earnings/24/10/41205686/how-to-earn-500-a-month-from-pepsico-stock-ahead-of-q3-earnings">How To Earn $500 A Month From PepsiCo Stock Ahead Of Q3 Earnings</a></li>
</ul>
<a href="https://www.benzinga.com/news/earnings/24/10/41205686/how-to-earn-500-a-month-from-pepsico-stock-ahead-of-q3-earnings">&nbsp;</a>

Earnings

Equities

News

Eurozone

Commodities

Intraday Update

Markets

Trading Ideas

ALTM

HRTG

NAPA

SRRK

TRVN

Dow Tumbles Over 400 Points; Duckhorn Portfolio Shares Surge

U.S. stocks traded lower midway through trading, with the Dow Jones index falling more than 200 points on Monday.
The Dow traded down 0.49% to 42,146.78 while the NASDAQ fell 0.36% to 18,073.37. The S&amp;P 500 also fell, dropping, 0.32% to 5,732.84.
Check This Out: <a href="https://www.benzinga.com/trading-ideas/long-ideas/24/10/41206375/jim-cramer-ast-spacemobile-is-just-too-hot-recommends-buying-this-tech-stock">Jim Cramer: AST SpaceMobile Is &#8216;Just Too Hot,&#8217; Recommends Buying This Tech Stock</a>
Leading and Lagging Sectors Energy shares jumped by 0.5% on Monday.
In trading on Monday, consumer discretionary shares dipped by 1.3%.
Top Headline
AstraZeneca plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) entered into an exclusive license agreement with Hong Kong-based CSPC Pharmaceutical Group Ltd to advance the development of an early-stage, novel small-molecule lipoprotein (a) (Lp(a)) disruptor that has the potential to offer additional benefits for patients with dyslipidemia.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Scholar Rock Holding Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRRK#NASDAQ">SRRK</a>) shares shot up 310% to $30.44 after the company announced topline results from the Phase 3 SAPPHIRE clinical trial evaluating the efficacy and safety of apitegromab in patients with SMA. The study achieved its primary endpoint.</li>
<li>Shares of Arcadium Lithium PLC (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ALTM#NYSE">ALTM</a>) got a boost, surging 41% to $4.34 after the company announced that it has been approached by Rio Tinto regarding a potential acquisition.</li>
<li>Duckhorn Portfolio Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NAPA#NASDAQ">NAPA</a>) shares were also up, gaining 102% to $10.88 fter the company reported better-than-expected fourth-quarter financial results. Also, the company announced it into a definitive agreement to be acquired by private equity funds managed by Butterfly Equity.</li>
</ul>
Equities Trading DOWN
<ul>
<li>Trevena, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TRVN#NASDAQ">TRVN</a>) shares dropped 48% to $2.4192 after the company announced it received a Nasdaq delisting notification.</li>
<li>Shares of Heritage Insurance Holdings, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HRTG#NYSE">HRTG</a>) were down 21% to $9.65.</li>
<li>Universal Insurance Holdings, Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UVE#NYSE">UVE</a>) was down, falling 18% to $17.12.</li>
</ul>
Commodities In commodity news, oil traded up 3.4% to $76.99 while gold traded down 0.2% at $2,662.50.
Silver traded down 1.1% to $32.025 on Monday, while copper fell 0.5% to $4.5535.
Euro zone
European shares were mostly higher today. The eurozone's STOXX 600 rose 0.26%, Germany's DAX fell 0.09% and France's CAC 40 climbed 0.48%. Spain's IBEX 35 Index rose 0.80%, while London's FTSE 100 rose 0.46%.
Retail sales in the Eurozone rose 0.2% month-over-month in August compared to a revised flat reading in the previous month. The Halifax House Price Index in the UK rose 4.7% year-over-year in September compared to a 4.3% gain in August. Factory orders in Germany declined by 5.8% month-over-month in August.
Asia Pacific Markets
Asian markets closed mixed on Monday, with Japan's Nikkei 225 gaining 1.80%, Hong Kong's Hang Seng Index gaining 1.60% and India's BSE Sensex dipping 0.78%.
Foreign exchange reserves in Singapore fell to SGD 499.7 billion in September compared to SGD 501.3 billion a month ago. The index of leading economic indicators in Japan fell to 106.7 in August versus a final reading of 109.3 in the prior month, while index of coincident economic indicators declined to 113.5 in August compared to a final reading of 117.2 month ago.
Economics
Data on consumer credit for August will be released today.
Now Read This: 
<ul>
<li><a href="https://www.benzinga.com/news/earnings/24/10/41205686/how-to-earn-500-a-month-from-pepsico-stock-ahead-of-q3-earnings">How To Earn $500 A Month From PepsiCo Stock Ahead Of Q3 Earnings</a></li>
</ul>
<a href="https://www.benzinga.com/news/earnings/24/10/41205686/how-to-earn-500-a-month-from-pepsico-stock-ahead-of-q3-earnings">&nbsp;</a>

Crude Oil Gains Over 3%; Scholar Rock Shares Spike Higher

U.S. stocks traded lower this morning, with the Dow Jones falling more than 150 points on Monday.
Following the market opening Monday, the Dow traded down 0.38% to 42,192.55 while the NASDAQ fell 0.29% to 18,085.96. The S&amp;P 500 also fell, dropping, 0.32% to 5,732.58.
Check This Out: <a href="https://www.benzinga.com/trading-ideas/long-ideas/24/10/41206375/jim-cramer-ast-spacemobile-is-just-too-hot-recommends-buying-this-tech-stock">Jim Cramer: AST SpaceMobile Is &#8216;Just Too Hot,&#8217; Recommends Buying This Tech Stock</a>
Leading and Lagging Sectors Energy shares jumped by 0.5% on Monday.
In trading on Monday, consumer discretionary shares dipped by 1.2%.
Top Headline
AstraZeneca plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) entered into an exclusive license agreement with Hong Kong-based CSPC Pharmaceutical Group Ltd to advance the development of an early-stage, novel small-molecule lipoprotein (a) (Lp(a)) disruptor that has the potential to offer additional benefits for patients with dyslipidemia.
Equities Trading UP &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;
<ul>
<li>Scholar Rock Holding Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/SRRK#NASDAQ">SRRK</a>) shares shot up 264% to $27.23 after the company announced topline results from the Phase 3 SAPPHIRE clinical trial evaluating the efficacy and safety of apitegromab in patients with SMA. The study achieved its primary endpoint.</li>
<li>Shares of Algorhythm Holdings, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RIME#NASDAQ">RIME</a>) got a boost, surging 53% to $0.7174 after its subsidiary, SemiCab, secured a service contract with a $200 billion global consumer packaged goods company. Starting in mid-October 2024, SemiCab will provide AI-powered shipping services across major metro markets, with potential expansion after six months.</li>
<li>LogicMark, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LGMK#NASDAQ">LGMK</a>) shares were also up, gaining 47% to $0.1651.</li>
</ul>
Equities Trading DOWN
<ul>
<li>Trevena, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/TRVN#NASDAQ">TRVN</a>) shares dropped 44% to $2.64 after the company announced it received a Nasdaq delisting notification.</li>
<li>Shares of CNFinance Holdings Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CNF#NASDAQ">CNF</a>) were down 31% to $1.3601.</li>
<li>Laser Photonics Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/LASE#NASDAQ">LASE</a>) was down, falling 29% to $5.01.</li>
</ul>
Commodities In commodity news, oil traded up 1.4% to $75.40 while gold traded down 0.3% at $2,660.70.
Silver traded down 1.9% to $31.77 on Monday, while copper fell 0.7% to $4.5425.
Euro zone
European shares were mostly higher today. The eurozone's STOXX 600 rose 0.2%, Germany's DAX fell 0.1% and France's CAC 40 climbed 0.4%. Spain's IBEX 35 Index rose 0.9%, while London's FTSE 100 rose 0.4%.
Retail sales in the Eurozone rose 0.2% month-over-month in August compared to a revised flat reading in the previous month. The Halifax House Price Index in the UK rose 4.7% year-over-year in September compared to a 4.3% gain in August. Factory orders in Germany declined by 5.8% month-over-month in August.
Asia Pacific Markets
Asian markets closed mixed on Monday, with Japan's Nikkei 225 gaining 1.80%, Hong Kong's Hang Seng Index gaining 1.60% and India's BSE Sensex dipping 0.78%.
Foreign exchange reserves in Singapore fell to SGD 499.7 billion in September compared to SGD 501.3 billion a month ago. The index of leading economic indicators in Japan fell to 106.7 in August versus a final reading of 109.3 in the prior month, while index of coincident economic indicators declined to 113.5 in August compared to a final reading of 117.2 month ago.
Economics
Data on consumer credit for August will be released today.
Now Read This: 
<ul>
<li><a href="https://www.benzinga.com/news/earnings/24/10/41205686/how-to-earn-500-a-month-from-pepsico-stock-ahead-of-q3-earnings">How To Earn $500 A Month From PepsiCo Stock Ahead Of Q3 Earnings</a></li>
</ul>
<a href="https://www.benzinga.com/news/earnings/24/10/41205686/how-to-earn-500-a-month-from-pepsico-stock-ahead-of-q3-earnings">&nbsp;</a>

LASE

LGMK

RIME

US Stocks Open Lower; Dow Tumbles Over 150 Points

On Monday, AstraZeneca plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) entered into an exclusive license agreement with Hong Kong-based CSPC Pharmaceutical Group Ltd to advance the development of an early-stage, novel small-molecule lipoprotein (a) (Lp(a)) disruptor that has the potential to offer additional benefits for <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/airsupra-positive-results-phase-iii-batura-trial.html" rel="noreferrer noopener">patients with dyslipidemia</a>.
Dyslipidemia is&nbsp;a metabolic disorder that occurs when there are abnormal levels of lipids or fats, such as cholesterol and triglycerides, in the blood.&nbsp;
Under the terms of the agreement, AstraZeneca will <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/astrazeneca-licenses-lipid-lowering-lpa-asset.html" rel="noreferrer noopener">receive</a> access to CSPC's pre-clinical candidate small molecule, YS2302018, an oral Lp(a) disruptor, to develop the lipid-lowering therapy with potential in a range of cardiovascular disease indications alone or in combination, including with the oral small molecule PCSK9 inhibitor, AZD0780.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41171850/astrazeneca-seeks-expanded-use-for-blood-cancer-drug-calquence-fda-grants-priority-review" rel="noreferrer noopener">AstraZeneca Seeks Expanded Use For Blood Cancer Drug Calquence, FDA Grants Priority Review</a>.
YS2302018 was discovered by CSPC and has been shown to prevent the formation of Lp(a).
Lp(a) is a form of low-density lipoprotein (LDL) that plays a key role in cholesterol transport in the bloodstream.
Elevated levels of Lp(a) and elevated LDL cholesterol are known risk factors for cardiovascular disease.
CSPC will receive an upfront payment of $100 million from AstraZeneca and is eligible to receive up to $1.92 billion for further development and commercialization milestones, plus tiered royalties.
On Monday, AstraZeneca released topline data from BATURA Phase 3b trial of&nbsp;inhaled Airsupra&nbsp;(albuterol/budesonide) as an as-needed rescue medication in response to symptoms compared to as-needed albuterol.
The study met the primary endpoint, demonstrating a statistically significant and clinically meaningful reduction in the risk of severe exacerbation.&nbsp;
The trial included patients with intermittent or mild persistent asthma.
Asthma affects as many as 262 million people worldwide, including over 25 million in the U.S.
Patients with mild asthma comprise at least 50% of the U.S. asthma population and are at risk of severe exacerbations.
Airsupra&nbsp;is the first and only anti-inflammatory rescue medication approved in the U.S. for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma <a target="_blank" href="https://www.benzinga.com/general/biotech/23/01/30375883/astrazenecas-new-asthma-treatment-for-adults-gets-green-light-from-fda" rel="noreferrer noopener">aged 18 years and older</a>.
The&nbsp;US approval&nbsp;was based on&nbsp;MANDALA and DENALI Phase 3 trial results.
Airsupra&nbsp;is also being studied in adolescents with asthma in the ACADIA Phase 3 trial and in patients in China in the BAIYUN Phase 3 trial.
Price Action: AZN stock is down 0.68% at $76.94 during the premarket session at last check Monday.
Read Next:
<ul>
<li><a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/10/41190957/warner-music-hit-by-streaming-volatility-and-execution-risks-analyst" target="_blank" rel="noreferrer noopener">Warner Music Hit By Streaming Volatility And Execution Risks: Analyst</a>.</li>
</ul>
Image by Robert Way via Shutterstock

Biotech

Large Cap

Health Care

Contracts

General

AstraZeneca Inks $1.92B License Pact With Hong Kong-Based Firm To Boost Cardiovascular Pipeline

AstraZeneca Says High-level Results From BATURA Phase 3b Trial Showed Airsupra (Albuterol/Budesonide) Met The Primary Endpoint, Demonstrating A Statistically Significant And Clinically Meaningful Reduction In The Risk Of A Severe Exacerbation When Used As An As-needed Rescue Medication In Response To Symptoms Compared To As-needed Albuterol

AstraZeneca has entered into an exclusive license agreement with CSPC Pharmaceutical Group Ltd (CSPC) to advance the development of an early stage, novel small molecule Lipoprotein (a) (Lp(a)) disruptor that has the potential to offer additional benefits for patients with dyslipidaemia. This asset further strengthens the company's cardiovascular portfolio to help address the major risk factors driving chronic cardiovascular disease. &nbsp;
Under the terms of the agreement, AstraZeneca will receive access to CSPC's pre-clinical candidate small molecule, YS2302018, an oral Lp(a) disruptor, with the aim of developing this as a novel lipid-lowering therapy with potential in a range of cardiovascular disease indications alone or in combination, including with the oral small molecule PCSK9 inhibitor, AZD0780.

Astrazeneca Entered Into An Exclusive License Agreement With CSPC Pharmaceutical Group To Advance The Development Of An Early Stage, Novel Small Molecule Lipoprotein (A) (LP(A)) Disruptor

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)

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

AstraZeneca looks to boost cardiovascular pipeline with $2B license deal

AstraZeneca reports positive results for Airsupra v. albuterol study

ABBV

ABSI

AMGN

ARGX

ATEYY

AZNCF

BKAG

BKCI

BKEM

BKGI

BKHY

BKIE

BKLC

BKMC

BKSE

BKUI

CNVVF

CTLT

DNTH

EXPGF

LVMHF

LZAGF

LZAGY

NSRGY

NVDA

RCRRF

RHHBF

RHHBY

RHHVF

SIEGY

SNYNF

SZCRF

TCCPY

TEVA

TEVJF

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

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

AIRSUPRA® (albuterol/budesonide) demonstrated statistically significant and clinically meaningful reduction in the risk of severe exacerbations in patients with intermittent or mild persistent asthma in BATURA Phase III trial

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)

Comments

AstraZeneca

Actualités

Dernières nouvelles pour AstraZeneca (NASDAQ:AZN) Stock

Les gens regardent aussi

Notizie

PARTENAIRE / CONTRIBUTEUR

BENZINGA MONDIAL