最新ニュース AstraZeneca (NASDAQ:AZN) 株価情報

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.

AstraZeneca PLC - American Depositary Shares

AstraZeneca PLC

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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.
Read Next: <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">AstraZeneca Aims to Restore Trust With New Leadership in China Amid Scandal and Sales Decline</a>
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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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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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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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

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

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

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

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

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

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

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

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

AstraZeneca-Merck Partnered Lynparza Shows Long-Term Survival With Reduced Death Risk Of 28% In Breast Cancer Patients

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Goldman Sachs analyst Rajan Sharma maintained a Buy rating on AstraZeneca (AZN – Research Report) today and set a price target of £155.58. The comp...

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Press Releases

AstraZeneca (AZN) Reels from China Investigation and Investor Suit – Hagens Berman

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

AZN INVESTOR NOTICE: Robbins Geller Rudman & Dowd LLP Announces that AstraZeneca PLC Investors with Substantial Losses Have Opportunity to Lead Investor Class Action Lawsuit

AstraZeneca PLC (AZN) Investors Who Lost Money Have Opportunity to Lead Securities Fraud Lawsuit

The Gross Law Firm Notifies Shareholders of AstraZeneca PLC (AZN) of a Class Action Lawsuit and an Upcoming Deadline

SHAREHOLDER ALERT: Pomerantz Law Firm Reminds Shareholders with Losses on their Investment in AstraZeneca PLC. of Class Action Lawsuit and Upcoming Deadlines - AZN

ASTRAZENECA ALERT: Bragar Eagel & Squire, P.C. Announces that a Class Action Lawsuit Has Been Filed Against AstraZeneca PLC and Encourages Investors to Contact the Firm

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

AZN Investors Have Opportunity to Lead AstraZeneca PLC Securities Fraud Lawsuit Filed by The Rosen Law Firm

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