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AstraZeneca

A merger between Astra of Sweden and Zeneca Group of the United Kingdom formed AstraZeneca in 1999. The firm sells branded drugs across a number of major therapeutic areas, including gastrointestinal, diabetes, cardiovascular, respiratory, cancer, immunology and rare diseases. The majority of sales come from international markets with the United States representing close to one third of its sales.

Duluth,,Georgia,,October,23,,2024.,Robert,F.,Kennedy,Jr,And

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Kennedy seeks to be Secretary of Health and Human Services — a position that would put him in charge of the health of the American people.

RFK Jr. And Big Pharma: Health Secretary Hopeful Answers Pointed Questions On Drugs, Insurance, Trump Exec Orders

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FDA approves Enhertu for metastatic breast cancer with HER2-low or HER2-ultralow expression after showing significant efficacy in the DESTINY-Breast06 trial.

FDA Approves AstraZeneca, Daiichi Sankyo&#39;s Enhertu For Certain Type Of Breast Cancer Patients

AstraZeneca invests $570 million in Canada, expands facilities, and boosts R&amp;D efforts, aiming to deliver 20 new medicines globally by 2030.

AstraZeneca To Pump $570 Million Into Canada, Driving Expansion, Job Growth

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Cytokinetics receives a Buy rating from Stifel, with a promising outlook for aficamten in the $3 billion U.S. oHCM market, despite investor concerns over M&amp;A and deals.

Cytokinetics Heart Drug&#39;s Future Sparks Optimism Despite M&amp;A Hurdles and Royalty Deal Concerns: Analyst

ABSI

Needham initiated a Buy rating for Absci (ABSI), noting its AI-powered drug discovery platforms, strategic partnerships, and $9 price target.

Analyst Praises AMD-Partner Absci&#39;s Practical Approach, Sees 118% Stock Upside

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AstraZeneca&#39;s Datroway gains FDA approval for HR-positive, HER2-negative breast cancer after prior therapies, based on Phase 3 trial data.

FDA Approves AstraZeneca&#39;s Datroway For Pretreated Breast Cancer Patients

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Just when you may have finally gotten your head around the opportunity in artificial intelligence (AI), a new investment opportunity has popped up. Quantum computing is the latest “new thing” among

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AstraZeneca PLC - American Depositary Shares

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AZN Capital Corp

DATROWAY is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo (TSE: 4568) and being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>).
Standard treatment for stage 1 NSCLC is tumor resection, but up to 40% of patients may experience disease recurrence.1,2,3 Tumor resection is typically followed by observation but adjuvant chemotherapy and/or immunotherapy may be offered to patients with stage 1b disease who are identified to be at high risk of relapse.4 However, novel strategies to identify high risk patients are needed as well as additional treatment options in the adjuvant setting. Research suggests that ctDNA screening may help identify high risk patients who are most likely to benefit from adjuvant therapy.5,6

Reported Earlier, Daiichi Sankyo And AstraZeneca Initiate TROPION-Lung12 Phase 3 Trial To Evaluate DATROWAY In Adjuvant Treatment for High-Risk Early-Stage NSCLC

Robert F. Kennedy Jr., President Donald Trump's pick for health secretary, addressed a wide range of medical-related topics on Wednesday during a confirmation hearing with <a href="https://www.benzinga.com/25/01/43306674/trumps-hhs-pick-robert-kennedy-jr-begins-senate-confirmation-hearings">the Senate Finance Committee.</a>
While Kennedy&#8217;s tone in each back-and-forth varied, depending on the senator, it was evident that Kennedy&#8217;s role in the new administration would have a tremendous impact on both pharma and insurance stocks.
<h3 class="wp-block-heading">Drug Price Negotiation</h3>
During one exchange about the high cost of drugs with Senator Catherine Cortez Masto (D-NV), Kennedy said: "Senator, my understanding is that the White House issued an executive order, I believe today, supporting the drug negotiations under the I.R.A. President Trump was very aggressive during his first term about negotiating drug prices."
In reality, Trump has not signed an executive order on the topic since he was sworn into office. A Wednesday news <a href="https://www.cms.gov/newsroom/press-releases/cms-statement-lowering-cost-prescription-drugs" target="_blank" rel="noreferrer noopener">release</a> from the Centers for Medicare and Medicaid Services said that lowering the cost of prescription drugs for Americans &#8220;a top priority&#8221; for the Trump administration and that he would work to improve the transparency of the negotiation process.
Perhaps Kennedy was recalling Trump&#8217;s first term. In 2020, then-45th President Trump <a href="https://www.benzinga.com/general/biotech/20/09/17482940/trump-signs-executive-order-to-lower-us-drug-prices-after-negotiations-with-drugmakers-fail">signed an executive order</a> on U.S. Medicare drug prices intending to reduce costs. Industry leaders, including Pfizer (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) CEO Albert Bourla, criticized the move. Pfizer was seeking regulatory approval to expand its late-stage vaccine trial at the time.
If Trump signs such an order, it would be a rare show of support from his camp for a Biden-era initiative. In addition to Pfizer, it would also impact major companies like Bristol Myers Squibb, Eli Lilly (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/LLY#NYSE">LLY</a>), Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>), Merck &amp; Co. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), AstraZeneca (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), Novartis (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) and AbbVie (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>).
Last month, the Biden administration <a href="https://www.benzinga.com/25/01/43062779/popular-ozempic-wegovy-selected-for-next-round-of-medicare-drug-price-negotiations">identified the next 15 drugs</a> as subject to negotiation. The list included Ozempic and Wegovy — two expensive drugs for diabetes and obesity owned by Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>).
See Also: <a href="https://www.benzinga.com/25/01/43306674/trumps-hhs-pick-robert-kennedy-jr-begins-senate-confirmation-hearings">RFK Jr. Is A &#8216;Predator&#8217; Unfit For Office, Caroline Kennedy Says </a>
<h3 class="wp-block-heading">Insurance Providers</h3>
According to the <a href="https://www.nytimes.com/live/2025/01/29/us/rfk-jr-health-senate-hearing">New York Times</a>, Kennedy wasn&#8217;t exactly familiar with Medicare and Medicaid, but expressed support for Medicare Advantage, where private insurers provide coverage for elderly Americans.
Kennedy also called out what he considered to be &#8220;rapacious behavior by insurance companies." He even suggested he would support some of the efforts undertaken during the Biden administration to crack down on abusive tactics like denying care and overcharging the government.
Traders would be wise to keep an eye on how insurance stocks — especially those tied to Medicaid and Medicare providers — react if Kennedy is sworn in. The major players in this space include: 
UnitedHealth Group (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNH#NYSE">UNH</a>), the largest Medicare Advantage insurer in the U.S.; Centene Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CNC#NYSE">CNC</a>); Elevance Health (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ELV#NYSE">ELV</a>), one of the largest Medicaid managed care organizations; Humana (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/HUM#NYSE">HUM</a>); CVS Health (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CVS#NYSE">CVS</a>); Molina Healthcare (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MOH#NYSE">MOH</a>); and Cigna (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/CI#NYSE">CI</a>).
What&#8217;s Next: Kennedy seeks to be Secretary of Health and Human Services — a position that would put him in charge of the health of the American people.
The title also puts him in charge of the Food and Drug Administration, the National Institutes of Health and the Centers for Disease Control and Prevention.
He will appear before the Senate Committee on Health, Education Labor and Pensions on Thursday.
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<a href="https://www.bloomberg.com/news/articles/2025-01-28/rfk-jr-says-he-s-not-anti-vaccine-sees-critical-role-for-shots?srnd=homepage-asia" title="https://www.bloomberg.com/news/articles/2025-01-28/rfk-jr-says-he-s-not-anti-vaccine-sees-critical-role-for-shots?srnd=homepage-asia">https://www.bloomberg.com/news/articles/2025-01-28/rfk-jr-says-he-s-not-anti-vaccine-sees-critical-role-for-shots?srnd=homepage-asia</a>

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"RFK Jr. Says He's Not Anti-Vaccine, Sees Critical Role for Shots" - Bloomberg News

On Monday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca plc and Daiichi Sankyo&#8217;s (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSKYF#OTC">DSKYF</a>) Enhertu (trastuzumab deruxtecan) for adult patients with breast cancer that has progressed on one or more endocrine therapies <a href="https://www.benzinga.com/quote/AZN" target="_blank" rel="noreferrer noopener">in the metastatic setting</a>.
The FDA <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2025/enhertu-approved-in-us-for-breast-cancer-post-et.html#!" rel="noreferrer noopener">granted</a> the approval after securing Priority Review and Breakthrough Therapy Designation. It was based on results from the DESTINY-Breast06 Phase 3 trial.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/25/01/43190131/astrazeneca-to-pump-570-million-into-canada-driving-expansion-job-growth" rel="noreferrer noopener">AstraZeneca To Pump $570 Million Into Canada, Driving Expansion, Job Growth</a>
In the trial,&nbsp;Enhertu&nbsp;showed a 36% reduction in the risk of disease progression or death versus chemotherapy in the overall trial population of patients with chemotherapy-naïve HER2-low or HER2-ultralow metastatic breast cancer.
A median progression-free survival (PFS) of 13.2 months was seen in patients randomized to&nbsp;Enhertu&nbsp;compared to 8.1 months in those randomized to chemotherapy.
The confirmed objective response rate (ORR) in the overall trial population was 62.6% for&nbsp;Enhertu&nbsp;versus 34.4% for chemotherapy.
In an exploratory analysis of patients with HER2-ultralow expression,&nbsp;results were seen to be consistent between patients with HER2-low expression and HER2-ultralow expression.&nbsp;&nbsp;
Following this approval for&nbsp;Enhertu&nbsp;in the U.S., AstraZeneca is due $175 million as a milestone payment to Daiichi Sankyo.
Daiichi Sankyo recognizes Enhertu sales in the U.S. AstraZeneca reports its share of gross profit margin from&nbsp;Enhertu sales in the U.S. as Alliance Revenue in the company&#8217;s financial statements.
Recently, the FDA approved&nbsp;AstraZeneca&#8217;s Datroway&nbsp;(datopotamab deruxtecan or Dato-DXd) for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy&nbsp;for unresectable <a target="_blank" href="https://www.benzinga.com/25/01/43107651/fda-approves-astrazenecas-datroway-for-pretreated-breast-cancer-patients" rel="noreferrer noopener">or metastatic disease</a>.
Price Action: AstraZeneca stock is up 0.09% at $70.14 during the premarket session at last check Tuesday.
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FDA Approves AstraZeneca, Daiichi Sankyo's Enhertu For Certain Type Of Breast Cancer Patients

AstraZeneca And Daiichi Sankyo's ENHERTU Approved In US As First HER2-directed Therapy For Patients With HER2-low Or HER2-ultralow Metastatic Breast Cancer Following Disease Progression After One Or More Endocrine Therapies

On Thursday, European pharma giant AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) announced a plan to invest CA$820 million ($570 million) <a href="https://www.benzinga.com/topic/canada">in Canada, creating</a> more than 700 jobs across all business areas.
The <a href="https://www.astrazeneca.com/media-centre/press-releases/2025/astrazeneca-plans-c820-million-us570m-investment-in-canada-to-advance-growing-global-hub-and-clinical-delivery.html" target="_blank" rel="noreferrer noopener">investment</a> will support the move to a larger, state-of-the-art office facility in the greater Toronto area.
New investment in Canada will contribute to AstraZeneca&#8217;s global ambition to <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38936595/astrazeneca-targets-ambitious-80b-in-total-revenue-by-2030-through-pipeline-expansion" rel="noreferrer noopener">achieve $80 billion</a> in total revenue and bring 20 new medicines by 2030, of which eight have been delivered to date.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/01/43107651/fda-approves-astrazenecas-datroway-for-pretreated-breast-cancer-patients" rel="noreferrer noopener">FDA Approves AstraZeneca&#8217;s Datroway For Pretreated Breast Cancer Patients</a>
The company expects seven first Phase 3 clinical trial data readouts in 2025.
In 2023, AstraZeneca contributed more than CA$230 million in research and development in Candana, much of which was focused on delivering over 210 AstraZeneca global clinical studies of new medicines and indications.
Since 2023, the company&#8217;s investments in Canada have exceeded CA$1.3 billion, creating a combined 1,200 new high-skilled jobs.
In 2024, AstraZeneca completed a CA$3 billion&nbsp;agreement to acquire Ontario-based Fusion Pharmaceuticals, which is developing next-generation radioconjugates for cancer treatment.
The Fusion announcement represents one of the largest research investments made in a Canadian biotechnology company.
AstraZeneca employs more than 2,100 people across Canada.
Last week, AstraZeneca announced to restructure its leadership in China following a high-profile scandal involving its former country president, Leon Wang, <a target="_blank" href="https://www.benzinga.com/general/biotech/25/01/43065029/astrazeneca-aims-to-restore-trust-with-new-leadership-in-china-amid-scandal-and-sales-decline" rel="noreferrer noopener">and other employees</a>.
AZN Price Action: AZN stock is up 0.77% at $69.13 during the premarket session at last check Friday.
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Astrazeneca Announces A $570M Investment In Canada, Creating More Than 700 High-Skilled Jobs

Stifel initiated coverage on Cytokinetics Incorporated (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/CYTK#NASDAQ">CYTK</a>), noting the company&#8217;s catalyst rich one to two years.
The M&amp;A speculation ramped up in early 2024 after the company released SEQUOIA-HCM Phase 3 <a href="https://www.benzinga.com/analyst-ratings/analyst-color/23/12/36413624/cytokinetics-drug-potential-analyst-suggests-key-role-of-established-pharma-for-pot" target="_blank" rel="noreferrer noopener">trial data of&nbsp;aficamten</a> in December 2023. However, last year,&nbsp;Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>) decided to step back from pursuing <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/01/36616494/cytokinetics-heart-drug-is-a-multi-billion-dollar-opportunity-by-2032-despite-novar" target="_blank" rel="noreferrer noopener">the&nbsp;Cytokinetics deal</a>.
Amgen Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>), AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>), and Johnson &amp; Johnson (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/JNJ#NYSE">JNJ</a>) also all popped up as potential suitors, though the stock faded from there as a deal never materialized.
Also Read: <a href="https://www.benzinga.com/general/biotech/24/09/40778617/cytokinetics-sets-stage-for-mid-stage-study-for-heart-failure-drug-after-encouraging-data-from-ph" target="_blank" rel="noreferrer noopener">Cytokinetics Sets Stage For Mid-Stage Study For Heart Failure Drug After Encouraging Data From Phase 1 Study</a>
Cytokinetics has fallen out of favor with investors after a turbulent start to 2024, marked by a controversial Royalty Pharma Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/RPRX#NASDAQ">RPRX</a>) deal and no <a href="https://www.benzinga.com/analyst-ratings/analyst-color/24/05/38992589/heart-disease-focused-cytokinetics-operations-are-on-track-despite-acquisition-unce" target="_blank" rel="noreferrer noopener">mergers or acquisitions</a>.
Investors poorly received the structure of the Royalty Pharma deal at the time, and it continues to be a concern for many even today.
Stifel has initiated coverage with a Buy rating and a <a href="https://www.benzinga.com/quote/CYTK/analyst-ratings" target="_blank" rel="noreferrer noopener">price forecast of $80</a>. However, the outlook appears promising, with its valuation adjusted and several catalysts expected over the next 12+ months.
Stifel analyst James Condulis writes Cytokinetics&#8217; aficamten is an exceptional drug as it sets a strong competitive standard for a multi-billion-dollar obstructive hypertrophic cardiomyopathy (oHCM) market.
As the rollout of Bristol Myers Squibb Co&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Camzyos mavacamten continues, some concerns remain about its potential in treating obstructive hypertrophic cardiomyopathy (oHCM).
While the initial launch is not seen as a negative sign for mavacamten&#8217;s potential, its Risk Evaluation and Mitigation Strategy (REMS) is a barrier to fully unlocking the market.
Cytokinetics appears well-positioned to capitalize on Bristol Myers&#8217; groundwork with its second-to-market drug, aficamten, which is expected to have a best-in-class profile. There is a strong case for aficamten to secure a differentiated REMS, potentially including six-month echocardiograms (Q6M echos) as a standard.
Under conservative assumptions, aficamten could drive the U.S. oHCM market to approximately $3 billion.
Looking ahead to 2025 and 2026, Phase 3 nHCM data and early findings for HFpEF could present new opportunities. Although mergers and acquisitions are not a key focus, potential strategic interest could bring unexpected benefits.
Price Action: CYTK stock is up 3.45% at $47.40 at last check Wednesday.
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Cytokinetics Heart Drug's Future Sparks Optimism Despite M&A Hurdles and Royalty Deal Concerns: Analyst

Needham analyst has initiated coverage on Absci Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ABSI#NASDAQ">ABSI</a>), a drug and target discovery company that harnesses deep learning AI and synthetic biology to expand proteins&#8217; therapeutic potential.
The rapid growth of artificial intelligence/machine learning (AI/ML) has led to the emergence of numerous companies that are difficult to tell apart. This challenge is worsened by the fact that clinical proof of concept (POC) in this area is still years away.
Recently, Absci entered into a strategic collaboration with&nbsp;Advanced Micro Devices Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMD#NASDAQ">AMD</a>) to enhance its&nbsp;<a target="_blank" href="https://www.benzinga.com/25/01/42874399/amd-invests-20m-in-absci-to-boost-ai-drug-discovery" rel="noreferrer noopener">AI drug discovery capabilities</a>.
Needham analyst Gil Blum writes that Absci sets itself apart with its practical focus on drug development.
Absci leverages its proprietary synthetic biology technology (SoluPro) to internally generate large experimental datasets that can be further refined using AI/ML.
The company has demonstrated an ability to rapidly develop indication-agnostic leads while focusing on highly optimized agents to reduce downstream clinical failure.
Needham writes that Absci&#8217;s core technologies, SoluPro and ACE, are essential for a successful tech-bio company. These high-throughput platforms generate large-scale, well-documented binding affinity data for biologics.
By combining this robust data with AI/ML, Absci can quickly identify and improve lead candidates through an iterative process. This capability was showcased by the rapid development of the company&#8217;s TL1A candidate, ABS-101.
Needham has initiated with a Buy rating and a <a target="_blank" href="https://www.benzinga.com/quote/ABSI/analyst-ratings" rel="noreferrer noopener">price forecast of $9</a>. Blum writes that Absci builds its value through proprietary assets it develops in-house, such as ABS-101, 201, 301, and 501.
The company focuses on creating first-in-class or best-in-class therapies, progressing them from discovery to early clinical trials. Instead of handling commercialization, Absci plans to partner with other companies after proving the concept in clinical trials.
Additionally, Absci works with pharmaceutical partners like Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>), Almirall SA, and AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) on early-stage projects. These collaborations provide milestone payments and royalties, offering steady income with less financial risk.
This approach allows Absci to quickly advance and monetize clinical-stage assets, aligning well with its AI/ML-driven platform.
Price Action: ABSI stock is up 23% at $3.96 at the last check on Wednesday.
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Analyst Praises AMD-Partner Absci's Practical Approach, Sees 118% Stock Upside

On Friday, the U.S. Food and Drug Administration (FDA) approved AstraZeneca Plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Datroway&nbsp;(datopotamab deruxtecan or Dato-DXd) for adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior endocrine-based therapy and chemotherapy <a target="_blank" href="https://www.benzinga.com//node/43069016" rel="noreferrer noopener">for unresectable or metastatic disease.</a>
The approval was based on results from the&nbsp;TROPION-Breast01&nbsp;Phase 3 trial.
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In TROPION-Breast01,&nbsp;Datroway&nbsp;significantly reduced the risk of disease progression or death by 37% compared to the investigator&#8217;s choice of chemotherapy as assessed by blinded independent central review (BICR). Median progression-free survival (PFS) was 6.9 months in patients treated with&nbsp;Datroway&nbsp;versus 4.9 months with chemotherapy.
The safety profile of&nbsp;Datroway&nbsp;was consistent with the known profile of this medicine, with no new safety concerns identified.
In the&nbsp;Datroway&nbsp;arm, the interstitial lung disease (ILD) rate was 4.2% and the majority of events were low grade.
Datroway&nbsp;is a specifically engineered TROP2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSKYF#OTC">DSKYF</a>), and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
Recently, the FDA approved&nbsp;AstraZeneca&#8217;s Calquence in combination with bendamustine and rituximab for adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/25/01/43062308/fda-approves-astrazenecas-calquence-combo-therapy-for-untreated-mantle-cell-lymphoma" rel="noreferrer noopener">stem cell transplantation.</a>
Price Action: AZN stock is up 2.43% at $68.22 at last check Tuesday.
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FDA Approves AstraZeneca's Datroway For Pretreated Breast Cancer Patients

<ul>
<li>First approval in the U.S. for Daiichi Sankyo and AstraZeneca's DATROWAY based on TROPION-Breast01 results showing 37% reduction in the risk of disease progression or death versus chemotherapy</li>
<li>Second DXd antibody drug conjugate approved in U.S. based on Daiichi Sankyo's DXd technology</li>
</ul>

Reported Friday, FDA Approves Daiichi Sankyo And AstraZeneca's DATROWAY AS A New Treatment Option For HR Positive, HER2 Negative Breast Cancer In The U.S.

AstraZeneca Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) has restructured its leadership in China following a high-profile scandal involving its former country president, Leon Wang, and other employees.
In September, Chinese authorities detained five current and former employees of&nbsp;AstraZeneca as part of a broader investigation into alleged illegal activities&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/41754167/why-is-astrazeneca-stock-sinking-on-tuesday" rel="noreferrer noopener">in the pharmaceutical sector</a>.
The investigation focused on potential breaches of data privacy laws and the importation of unlicensed cancer medications.
Also Read: <a target="_blank" href="https://www.benzinga.com/25/01/43062779/popular-ozempic-wegovy-selected-for-next-round-of-medicare-drug-price-negotiations" rel="noreferrer noopener">Popular Ozempic, Wegovy Selected For Next Round Of Medicare Drug Price Negotiations</a>
A report said that senior executives at&nbsp;AstraZeneca China&nbsp;are embroiled in an insurance fraud case, marking one of the most extensive scandals in China's pharmaceutical industry in recent years.
The pharmaceutical giant aims to restore its reputation and revitalize sales in its critical Chinese market, which has faced challenges from investigations into alleged illegal sales practices.
The overhaul includes new appointments in the oncology division, a key area under scrutiny.
The company has replaced Michael Lai with Alex Lin as country general manager, the Financial Times <a target="_blank" href="https://www.ft.com/content/7cb45fcd-5a6f-4e2b-9a67-c5a164132883" rel="noreferrer noopener">noted</a> citing sources familiar with the matter.
Lai, a senior manager under Wang, has transitioned to the U.S., where he now oversees a major cancer drug and reports directly to the head of oncology.
Meanwhile, AstraZeneca has promoted Mary Guan, previously from its general medicines unit, to head the oncology division in China. These changes are part of a broader effort to signal a departure from the past leadership.
AstraZeneca has acknowledged cooperating fully with Chinese authorities but has not received formal explanations for the investigation. Reports suggest the probe centers on the alleged illegal importation of the cancer drug Imjudo from Hong Kong to China, where the drug remains unapproved.
The company's former oncology head, Yin Min, who led the department during the alleged infractions, was also detained.
The Financial Times writes that the company has faced reduced engagement from Chinese hospitals and a dip in sales, which are attributed partly to concerns about regulatory scrutiny.
AstraZeneca is banking on new leadership and innovative drugs like the breast cancer treatment Enhertu to regain trust and momentum. Recently added to the Chinese state health insurance scheme, Enhertu is seen as a crucial component of the company's strategy to stabilize its position in the market.
Observers suggest further changes in the leadership team may be forthcoming as the company works to demonstrate a clean break from its troubled past.
Price Action: AZN stock is down 0.15% at $66.81 at the last check on Friday.
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Image by Robert Way via Shutterstock

Emerging Markets

Management

AstraZeneca Aims to Restore Trust With New Leadership in China Amid Scandal and Sales Decline

On Friday, the U.S. Department of Health and Human Services (HHS) unveiled the selection of 15 additional drugs covered under Medicare Part D for price negotiations, building on efforts to reduce <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">prescription drug costs</a>.
These negotiations, mandated by the Inflation Reduction Act, will take place in 2025, with the new prices slated to take effect in 2027.
The selected drugs, used to treat conditions like cancer, diabetes, and asthma, represented approximately $41 billion in Medicare Part D costs between November 2023 and October 2024, accounting for 14% of the program's total expenses.
Under the finalized <a target="_blank" href="https://www.cms.gov/newsroom/press-releases/hhs-announces-15-additional-drugs-selected-medicare-drug-price-negotiations-continued-effort-lower" rel="noreferrer noopener">guidance</a> for the second negotiation cycle, drug manufacturers have until February 28, 2025, to decide on their participation.
The selected drug list for the second cycle of negotiations is:&nbsp;
<ul>
<li>Novo Nordisk's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) diabetes and weight loss drugs, Ozempic, Rybelsus, and Wegovy.</li>
<li>Pfizer Inc.'s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) Ibrance for breast cancer and Xtandi for prostate cancer.</li>
<li>GSK Plc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GSK#NYSE">GSK</a>) Asthma and Chronic obstructive pulmonary disease treatment Trelegy Ellipta and Breo Ellipta.</li>
<li>Teva Pharmaceutical Industries Ltd.'s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TEVA#NYSE">TEVA</a>) Huntington's disease and Tardive dyskinesia drug Austedo, Austedo XR.</li>
<li>Abbvie Inc.'s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>) irritable bowel syndrome treatment Linzess and depression drug Vraylar.</li>
<li>Bristol-Myers Squibb Co's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/BMY#NYSE">BMY</a>) Pomalyst for a type of blood cancer.</li>
<li>Boehringer Ingelheim's lung disease drug Ofev and diabetes med Tradjenta.</li>
<li>AstraZeneca Plc&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) cancer drug Calquence</li>
<li>Salix Pharmaceuticals' irritable bowel syndrome drug Xifaxan</li>
<li>Merck &amp; Co Inc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) diabetes drug Janumet; Janumet XR.</li>
<li>Amgen Inc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AMGN#NASDAQ">AMGN</a>) psoriasis drug Otezla</li>
</ul>
CMS will evaluate factors such as the drug's clinical benefit, its role in addressing unmet medical needs, and its impact on specific populations, alongside considerations for research, production, and distribution costs.
The first negotiation cycle in 2023 resulted in agreements for price reductions on 10 drugs, with discounts ranging from 38% to 79% off list prices.
The new prices, effective January 2026, are expected to save $6 billion in prescription drug costs annually and reduce out-of-pocket expenses for Medicare beneficiaries by an <a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41166018/medicare-drug-price-negotiation-program-gets-final-guidance-for-second-cycle-1-5b-savings-expecte" rel="noreferrer noopener">estimated $1.5 billion</a>.
Looking ahead, CMS plans to expand the program, selecting up to 15 additional drugs for the third cycle and 20 more in subsequent cycles. The Inflation Reduction Act also introduces an out-of-pocket cap of $2,000 for Medicare Part D enrollees starting in 2025. Approximately 11 million beneficiaries are expected to benefit from the cap, saving a projected $7.2 billion annually.
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Government

Regulations

TEVA

Popular Ozempic, Wegovy Selected For Next Round Of Medicare Drug Price Negotiations

On Friday, the FDA approved AstraZeneca Plc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Calquence in combination with bendamustine and rituximab for adult patients with previously untreated mantle cell lymphoma who are ineligible for autologous hematopoietic <a href="https://www.benzinga.com/general/biotech">stem cell transplantation.</a>
Mantle cell lymphoma (MCL) is a rare and typically aggressive form of non-Hodgkin lymphoma (NHL), often diagnosed at an advanced stage. It is estimated that there are more than 21,000 patients diagnosed with MCL in the U.S., UK, France, Germany, Spain, Italy, Japan and China.
Also Read: <a target="_blank" href="https://www.benzinga.com/24/12/42363652/soon-after-approval-for-lung-cancer-astrazenecas-cancer-drug-imfinzi-goes-under-fda-priority-review-for-bladder-cancer" rel="noreferrer noopener">After Lung Cancer Approval, AstraZeneca&#8217;s Imfinzi Goes Under FDA Priority Review For Bladder Cancer</a>
The <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2025/calquence-combination-approved-in-us-for-1l-mcl.html" rel="noreferrer noopener">approval</a> was based on results from the ECHO Phase 3 trial presented at the European Hematology Association 2024 Congress.
Results from the ECHO trial showed Calquence  (acalabrutinib) plus bendamustine and rituximab reduced the risk of disease progression or death by 27% compared to standard-of-care chemoimmunotherapy.
Median progression-free survival was 66.4 months for patients treated with the&nbsp;Calquence&nbsp;combination versus 49.6 months with chemoimmunotherapy alone.
The approval additionally converts&nbsp;Calquence's&nbsp;accelerated approval to full approval for adult patients with MCL treated with at least one prior therapy, as granted by the FDA in October 2017.
The ECHO trial enrolled patients throughout the COVID-19 pandemic. After censoring COVID-19 deaths, progression-free survival was further improved in both arms, with the&nbsp;Calquence combination reducing the risk of disease progression or death by 36%.
Although overall survival data were not mature at the time of the analysis, when censored for COVID-19, a favorable trend was seen for overall survival despite 69% of patients in the chemoimmunotherapy arm receiving treatment with a BTK inhibitor on relapse or disease progression.
Price Action: AZN stock is up 0.06% at $66.95 at last check Friday.
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Photo: Shutterstock

FDA Approves AstraZeneca's Calquence Combo Therapy For Untreated Mantle Cell Lymphoma

<a href="https://www.cnbc.com/2025/01/17/medicare-drug-price-negotiations-list-includes-ozempic.html" title="https://www.cnbc.com/2025/01/17/medicare-drug-price-negotiations-list-includes-ozempic.html">https://www.cnbc.com/2025/01/17/medicare-drug-price-negotiations-list-includes-ozempic.html</a>

'Ozempic Is In The Next Round Of Medicare Drug Price Negotiations. See The Full List Of 15 Medications' - CNBC

AstraZeneca's CALQUENCE In Combination With Bendamustine And Rituximab Approved In US For Treatment Of Adult Patients With Previously Untreated Mantle Cell Lymphoma

Daiichi Sankyo (TSE: 4568) and AstraZeneca's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted and granted Priority Review in the U.S. for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFR-mutated) non-small cell lung cancer (NSCLC) who have received prior systemic therapies, including an EGFR-directed therapy.
Datopotamab deruxtecan is a specifically engineered TROP2 directed DXd antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed 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 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 its regulatory decision, is July 12, 2025. Datopotamab deruxtecan was previously <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.daiichisankyo.com%2Ffiles%2Fnews%2Fpressrelease%2Fpdf%2F202412%2F20241209_E.pdf&amp;esheet=54176761&amp;newsitemid=20250110025651&amp;lan=en-US&amp;anchor=granted&amp;index=1&amp;md5=63ac3be3e8ea1b7016c6f1afe51b484f">granted</a> Breakthrough Therapy Designation (BTD) by the FDA for this patient population.
The BLA and BTD are based on data from the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04484142&amp;esheet=54176761&amp;newsitemid=20250110025651&amp;lan=en-US&amp;anchor=TROPION-Lung05&amp;index=2&amp;md5=d484a174b1fff7a915f6bcf0bbd4bf2f">TROPION-Lung05</a> phase 2 trial and supported by data from the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04656652&amp;esheet=54176761&amp;newsitemid=20250110025651&amp;lan=en-US&amp;anchor=TROPION-Lung01&amp;index=3&amp;md5=fcbf0320494ff306e884b868ba75286b">TROPION-Lung01</a> phase 3 trial. In addition, the BLA is supported by the <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT03401385&amp;esheet=54176761&amp;newsitemid=20250110025651&amp;lan=en-US&amp;anchor=TROPION-PanTumor01&amp;index=4&amp;md5=8acfba8e3acccde528f9021a99489936">TROPION-PanTumor01</a> phase 1 trial. In a pooled analysis of patients with previously treated advanced or metastatic EGFR-mutated NSCLC in the TROPION-Lung05 and TROPION-Lung01 trials <a href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.daiichisankyo.com%2Ffiles%2Fnews%2Fpressrelease%2Fpdf%2F202412%2F20241206_E.pdf&amp;esheet=54176761&amp;newsitemid=20250110025651&amp;lan=en-US&amp;anchor=presented&amp;index=5&amp;md5=bce953e44715738b5bcad79db8943f67">presented</a> at the European Society for Medical Oncology (ESMO) Asia 2024 Congress, datopotamab deruxtecan demonstrated clinically meaningful tumor response. The safety profile of datopotamab deruxtecan was consistent with previous reports from the TROPION-Lung05 and TROPION-Lung01 trials, with no new safety concerns identified.

FDA Grants Priority Review to Daiichi Sankyo and AstraZeneca's Datopotamab Deruxtecan for Advanced Lung Cancer Treatment

– Clinical supply agreement with AstraZeneca for global Phase 1b/2 study to evaluate the safety and early efficacy of etakafusp alfa (AB248) in combination with rilvegostomig as a first-line treatment in patients with advanced or metastatic NSCLC –
Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer and infectious diseases, today announced an agreement with AstraZeneca (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) to supply etakafusp alfa (formerly known as AB248), Asher Bio's investigational CD8+ T cell targeted interleukin-2 (IL-2) immunotherapy, to be evaluated in combination with rilvegostomig, AstraZeneca's investigational PD-1/TIGIT immuno-oncology bispecific antibody, in patients with advanced or metastatic NSCLC.

Asher Bio Announces Clinical Supply Agreement With AstraZeneca To Enable Evaluation Of Etakafusp Alfa In Combination With Rilvegostomig In A Global Phase 1b/2 Study In Non-Small Cell Lung Cancer

On Wednesday, Hutchmed (China) Limited (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/HCM#NASDAQ">HCM</a>) entered into two agreements to divest its 45% equity interest in Shanghai Hutchison Pharmaceuticals Limited (SHPL) for approximately $608 million (RMB 4.478 billion) in cash to GP Health Service Capital Co., Ltd and Shanghai Pharmaceuticals Holding Co., Ltd.
Hutchmed has been exploring opportunities to monetize the underlying value of SHPL, a non-core, non-<a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/g42754584/hutchmed-announces-us-608-million-divestment-of-non-core-joint-venture" rel="noreferrer noopener">consolidated joint venture</a>.
These transactions would allow Hutchmed to focus on its core business of discovering, developing, and commercializing novel therapies for cancers and immunological diseases, including advancing its next-generation antibody-targeted therapy conjugate programs.
SHPL primarily manufactures, sells, and distributes its own-brand prescription medicines in China, predominantly for cardiovascular diseases.
SHPL is a 50:50 joint venture established between Hutchmed and Shanghai Pharma in 2001.
In 2023, the consolidated net income attributable to Hutchmed from SHPL was $47.4 million. HUTCHMED does not consolidate revenue from SHPL.
Hutchmed plans to invest the proceeds from these transactions to further develop its internal pipeline and advance its core business strategy.
Hutchmed plans to move the first of these antibody-targeted therapy conjugates into clinical trials in the second half of 2025.
Before the transactions, Hutchmed and Shanghai Pharma each hold a 50% equity interest in SHPL. GP Health Service Capital has agreed to acquire a 35% equity interest for approximately $473 million in cash, and Shanghai Pharma will acquire a 10% equity interest for approximately $135 million in cash.
After the transactions, the investors will hold a 60% equity interest in SHPL. Out of its 35%, GP Health Service Capital retains the right to designate a third-party investment fund to acquire up to a 10% equity interest in SHPL.
Hutchmed will retain a 5% equity interest in SHPL after the transactions.
Hutchmed expects to record a gain on disposal of approximately $477 million before taxation.
On Wednesday, Hutchmed announced that the China National Medical Products Administration accepted and granted priority review of the New Drug Application for the combination of Orpathys (savolitinib) and Tagrisso (osimertinib) for locally advanced or metastatic epidermal growth factor receptor mutation-positive non-small cell lung cancer with MET amplification <a target="_blank" href="https://www.benzinga.com/pressreleases/25/01/g42757633/hutchmed-announces-nda-acceptance-in-china-with-priority-review-status-for-orpathys-and-tagrisso-c" rel="noreferrer noopener">after disease progression</a>.
The acceptance also triggers a milestone payment from AstraZeneca plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>).
Price Action: At last check on Wednesday, HCM stock was up 7.98% at $15.56 during the premarket session.
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Chinese Cancer Drug Developer Hutchmed Sharpens R&D Focus, Divests Non-Core JV For Over $600 Million

This acceptance also triggers a milestone payment from AstraZeneca.
The NDA is supported by data from SACHI, a multi-center, open-label, randomized, controlled, Phase III trial which evaluated the efficacy and safety of a combination of ORPATHYS&#xAE;&nbsp;and TAGRISSO&#xAE; compared to platinum-based doublet-chemotherapy (pemetrexed plus cisplatin or carboplatin), the standard-of-care treatment option in this setting. The primary endpoint of the study was progression free survival ("PFS") as assessed by investigators. Other endpoints include PFS assessed by an independent review committee, overall survival (OS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), time to response (TTR), and safety. The Independent Data Monitoring Committee ("IDMC") of SACHI has considered that the study has met the pre-defined primary endpoint of PFS in a planned interim analysis and as a result, enrollment into the study has concluded. Results from SACHI will be submitted for presentation at an upcoming scientific conference (clinicaltrials.gov identifier <a href="https://www.globenewswire.com/Tracker?data=JtDOgngiDpA1wLFpehknXaP3V6U8akglM5nGHrbKkvJx5TfrIbtNecS1603I1TBypEiMLt61pRZqRgf22dhEVrcGUJnxERlS9fcmoyfJd2zxRERBGvDZnB2av_UVGSd6">NCT05015608</a>).

Reported Wednesday, HUTCHMED And AstraZeneca's ORPATHYS-TAGRISSO Therapy Advances In China With Priority NDA Status For MET-Amplified Lung Cancer

Legal

Press Releases

Class Action Filed Against AstraZeneca PLC (AZN) - February 21, 2025 Deadline to Join – Contact The Gross Law Firm

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

AstraZeneca (AZN) Faces Securities Class Action After Reports of PRC Probe into Fraud and Corruption – Hagens Berman

Bragar Eagel & Squire, P.C. Reminds Investors That Class Action Lawsuits Have Been Filed Against AstraZeneca, IIPR, Block, and Crocs and Encourages Investors to Contact the Firm

AZN LAWSUIT ALERT: The Gross Law Firm Notifies AstraZeneca PLC Investors of a Class Action Lawsuit and Upcoming Deadline

Deadline Alert: AstraZeneca PLC (AZN) Investors Who Lost Money Urged To Contact Glancy Prongay & Murray LLP About Securities Fraud Lawsuit

Shareholders that lost money on AstraZeneca PLC(AZN) should contact Levi & Korsinsky about pending Class Action - AZN

ROSEN, THE FIRST FILING FIRM, Encourages AstraZeneca PLC Investors to Secure Counsel Before Important Deadline in Securities Class Action First Filed by the Firm – AZN

TROPION-Lung12 Phase 3 Trial Initiated Evaluating DATROWAY® as Part of Adjuvant Regimen for Patients with Early-Stage Non-Small Cell Lung Cancer at High Risk of Relapse

Contact Levi & Korsinsky by February 21, 2025 Deadline to Join Class Action Against AstraZeneca PLC(AZN)

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