Daiichi Sankyo Co 株価情報 (OTC: DSKYF)

最新ニュース Daiichi Sankyo Co (OTC:DSKYF) 株価情報

Daiichi Sankyo was established by the merger of Daiichi Pharmaceuticals and Sankyo in 2005. As of 2023, approximately one third of revenue comes from its Japan businesses, which will shrink in the future as the company expands its global footprint. Its primary growth driver is its leading platform of antibody drug conjugates, or ADCs. Its three lead ADCs are Enhertu (HER2), Dato-DXd (TROP2), I-DXd (B7-H3), HER3-DXd (HER3), and R-DXd (CDH6). Enhertu entered the clinic in 2015 and received its first US approval in December 2019 for third-line late-stage HER2-positive breast cancer. It is also approved for HER2-positive stomach cancers and HER2 mutant non-small cell lung cancer.

DAIICHI SANKYO CO LTD ORD by Daiichi Sankyo Co., Ltd.

Daiichi Sankyo Co Ltd

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

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.

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

On Friday, the FDA accepted and granted Priority Review AstraZeneca Plc's (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) supplemental Biologics License Application (sBLA) for&nbsp;Imfinzi&nbsp;(durvalumab) for patients with muscle-invasive bladder cancer (MIBC).
The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the second quarter of 2025.
The supplement application is <a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/imfinzi-granted-priority-review-in-the-us-for-patients-with-muscle-invasive-bladder-cancer.html" rel="noreferrer noopener">based</a> on data from the NIAGARA Phase 3 trial.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/12/42341810/fda-approves-astrazenecas-blockbuster-cancer-drug-imfinzi-for-aggressive-form-of-lung-cancer" rel="noreferrer noopener">FDA Approves AstraZeneca's Blockbuster Cancer Drug Imfinzi For Aggressive Form Of Lung Cancer</a>
In the trial, patients were treated with&nbsp;Imfinzi&nbsp;in combination with neoadjuvant chemotherapy before radical cystectomy, followed by&nbsp;Imfinzi&nbsp;as adjuvant monotherapy or neoadjuvant chemotherapy before radical cystectomy.
In a planned interim analysis, perioperative&nbsp;Imfinzi&nbsp;demonstrated a 32% reduction in the risk of disease progression, recurrence, not undergoing surgery, or death versus neoadjuvant chemotherapy with radical cystectomy alone.
The estimated median event-free survival (EFS) for the&nbsp;Imfinzi&nbsp;arm has not yet been reached, versus 46.1 months for the comparator arm. An estimated 67.8% of patients treated with the&nbsp;Imfinzi&nbsp;regimen were event-free at two years, compared to 59.8% in the comparator arm.
Results from the key secondary endpoint of overall survival (OS) showed that the&nbsp;Imfinzi&nbsp;perioperative regimen reduced the risk of death by 25% versus neoadjuvant chemotherapy with radical cystectomy.
Median survival was not yet reached for either arm. An estimated 82.2% of patients treated with the&nbsp;Imfinzi&nbsp;regimen were alive at two years, compared to 75.2% in the comparator arm.
On Thursday, a&nbsp;pooled analysis of the&nbsp;TROPION-Lung05 phase 2 and the&nbsp;TROPION-Lung01 phase 3 trials <a target="_blank" href="https://www.businesswire.com/news/home/20241205215995/en/Datopotamab-Deruxtecan-Demonstrated-Meaningful-Clinical-Activity-in-Patients-with-Previously-Treated-Advanced-EGFR-Mutated-Non-Small-Cell-Lung-Cancer-in-TROPION-Lung05-and-TROPION-Lung01-Pooled-Analysis" rel="noreferrer noopener">showed</a> datopotamab deruxtecan (Dato-DXd) demonstrated clinically meaningful tumor response in patients with previously treated advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC).
These data and progression-free and overall survival results from the analysis&nbsp;were presented at the 2024 ESMO Asia Congress.
Daiichi Sankyo (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSKYF#OTC">DSKYF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>) and AstraZeneca's datopotamab deruxtecan showed a 42.7% objective response rate in previously treated patients.
Five (4.3%) complete responses, 45 (38.5%) partial responses, and 48 (41.0%) cases of stable disease were observed.
The median duration of response was 7.0 months, and the disease control rate was 86.3%. Median progression-free survival was 5.8 months, and median overall survival was 15.6 months.
Price Action: At last check on Friday, AZN stock was up 1.45% to $68.51 during the premarket session.
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After Lung Cancer Approval, AstraZeneca's Imfinzi Goes Under FDA Priority Review For Bladder Cancer

AstraZeneca And Daiichi Sankyo's Enhertu (Trastuzumab Deruxtecan) Has Received Conditional Approval In China As Monotherapy For Adult Patients With Unresectable, Locally Advanced Or Metastatic Non-Small Cell Lung Cancer Whose Tumors Have Activating HER2 Mutations And Who Have Received A Prior Systemic Therapy

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.
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Image by Robert Way via Shutterstock

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

Monday, AstraZeneca&nbsp;Plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) 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 <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/b40779283/datopotamab-deruxtecan-showed-median-overall-survival-of-14-6-months-in-patients-with-advanced-non" rel="noreferrer noopener">one prior line of therapy</a>.
Detailed results showed a clinically meaningful trend toward improving overall survival (OS) with datopotamab deruxtecan (Dato-DXd) compared to docetaxel.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40737381/astrazeneca-in-trouble-for-employee-detentions-in-china-over-illegal-activities" rel="noreferrer noopener">AstraZeneca In Trouble For Employee Detentions in China Over Illegal Activities</a>.
Dato-DXd is an engineered TROP2-directed DXd antibody-drug conjugate discovered by Daiichi Sankyo Ltd (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.
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 (hazard ratio [HR] 0.94; p=0.530).
In the prespecified subgroup of patients with nonsquamous NSCLC, datopotamab deruxtecan showed a 2.3-month improvement in OS compared to docetaxel (14.6 vs. 12.3 months).
The safety profile of datopotamab deruxtecan in TROPION-Lung01 was consistent with the previous analysis, including lower rates of dose reduction (20%, 30%) and discontinuation (8%, 12%) due to adverse events compared to docetaxel.
At the World Conference on Lung Cancer (WCLC), the British pharma giant shared results from the NeoCOAST-2 Phase 2 platform trial of Imfinzi&nbsp;(durvalumab) in multiple combinations, before and after surgery, in patients with early-stage (Stage IIA–IIIB) resectable NSCLC.
Preliminary results from the trial arm testing neoadjuvant Imfinzi plus datopotamab deruxtecan and carboplatin demonstrated a pathological complete response rate of 34.1% and a major pathological response rate of 65.9%.
Recently, the FDA approved&nbsp;AstraZeneca&#8217;s Imfinzi&nbsp;(durvalumab) in combination with chemotherapy for adult patients with resectable early-stage NSCLC and no known epidermal growth factor receptor mutations or anaplastic&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40416174/fda-approves-astrazenecas-blockbuster-cancer-drug-imfinzi-in-combination-with-chemo-for-non-small" rel="noreferrer noopener">lymphoma kinase rearrangements</a>.
Price Action: AZN stock is down 1.16% at $79.95 during the premarket session at last check Tuesday.
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Image by Robert Way via Shutterstock

AstraZeneca's Investigational Cancer Drug Disappoints In Late-Stage Lung Cancer Trial

In a market landscape clouded by <a href="https://www.benzinga.com/markets/cryptocurrency/24/08/40199294/wall-street-rebounds-after-selloff-vix-falls-dollar-surges-against-yen-whats-driving-marke">recession fears, sell-offs and rebounds</a>, Macquarie has identified 10 Asian stocks it believes are primed for a comeback. 
Amidst the turmoil of declining global markets, these stocks have weathered the impact of the recent drawdown and are now positioned as <a href="https://www.benzinga.com/markets/asia">top buying opportunities</a>.
Macquarie&#8217;s list of &#8220;highest conviction&#8221; stocks includes semiconductor giants:
<ul>
<li>Taiwan Semiconductor Manufacturing Co Ltd (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/TSM#NYSE">TSM</a>)</li>
<li>SK Hynix Inc (OTCPK: HXSCF) (OTCPK: HXSCL) and </li>
<li>Alchip Technologies Ltd (OTCPK: ALCPF).</li>
</ul>
These companies reflect a bullish stance on the technology sector despite current concerns surrounding Nvidia Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVDA#NASDAQ">NVDA</a>), <a href="https://www.cnbc.com/2024/08/07/macquarie-names-10-asia-stocks-that-have-borne-the-brunt-of-sell-off.html">reported</a> CNBC.
Other notable names include: 
<ul>
<li>Hitachi Ltd (OTCPK: HTHIF) (OTCPK: HTHIY)</li>
<li>NEC Corp (OTC:<a class="ticker" href="https://www.benzinga.com/stock/NIPNF#OTC">NIPNF</a>)</li>
<li>Wiwynn Corp. </li>
<li>Sugi Holdings Co Ltd </li>
<li>Daiichi</li>
<li>Sankyo Co Ltd (OTCPK:DSKYF) (OTCPK:DSNKY), and </li>
<li>HD Hyundai Electric. </li>
</ul>
These selections underscore Macquarie&#8217;s confidence in Asia&#8217;s ability to weather global market challenges.
According to Macquarie equity strategists led by Peter Williamson, &#8220;As stock pickers, we focus on a basket of stocks that we believe will emerge from the current drawdown, and which will present a buying opportunity for investors as this bout of volatility subsides.&#8221;
Read Also: <a href="https://www.benzinga.com/news/24/08/40169330/nvidia-microsoft-apple-amazon-erase-1-1-trillion-in-monday-sell-off-bubble-burst-or-market-correctio">Nvidia, Microsoft, Apple, Amazon Erase $1.1 Trillion In Monday Sell-Off: Bubble Burst Or Market Correction?</a>
Why These Stocks? They maintain robust fundamental growth drivers, making them compelling choices for long-term investors, the strategists say.
These companies can withstand emerging macro uncertainties, such as a recession or the unwinding of the Japanese yen carry trade. 
The week opened with Japan&#8217;s stock market <a href="https://www.benzinga.com/markets/equities/24/08/40152271/mohamed-el-erian-grant-cardone-and-matt-weller-warn-of-deepening-global-market-selloff-as-yen-ri">taking a nosedive of over 12%</a> on Monday before rebounding slightly. The S&amp;P 500 too, experienced its worst single-day performance in nearly two years, plummeting 3% in one day.
The technology and banking sectors saw significant declines as investors scrambled.
Macquarie&#8217;s strategy reflects a calculated gamble on the resilience and potential growth of Asian markets. 
While market volatility persists, Macquarie&#8217;s conviction in these stocks provides a potential pathway to profits for savvy investors.
Read Next: 
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</ul>

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Recession-Resilient Asian Stock Picks: TSMC, SK Hynix Among This Analyst's Top 10

On Tuesday, Merck &amp; Co Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>) reported second-quarter sales of $16.1 billion, up 7% year-over-year, beating the <a href="https://www.benzinga.com/calendars/earnings" target="_blank" rel="noreferrer noopener">consensus estimate of $15.84 billion</a>. Excluding the impact of foreign exchange, sales increased 11%.
Merck reported adjusted EPS of $2.28, a shift from an EPS loss of $(2.06), beating the&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/24/07/b40032257/merck-announces-second-quarter-2024-financial-results" rel="noreferrer noopener">consensus of $2.15</a>.
The pharmaceutical unit booked&nbsp;$14.41 billion&nbsp;in revenue, up 7% year over year. Growth in oncology, cardiovascular, and vaccines, partially offset by declines in diabetes and virology, drove the growth.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/07/39846796/merck-gets-legal-victory-as-appeals-court-dismisses-shingles-vaccine-some-1-200-lawsuits" rel="noreferrer noopener">Merck Gets Legal Victory As Appeals Court Dismisses Shingles Vaccine Some 1,200 Lawsuits</a>.
Merck&#8217;s blockbuster cancer immunotherapy Keytruda generated&nbsp;$7.27 billion&nbsp;in revenue during the quarter, up 16% from the year-earlier period.&nbsp;
Merck also reported a marginal increase of 1% in sales of Gardasil to $2.48 billion, a vaccine that prevents cancer from HPV, the most common sexually transmitted infection in the U.S. Growth was largely offset by lower sales in China.
The newly approved Winrevair (sotatercept) for adults with pulmonary arterial hypertension generated <a target="_blank" href="https://www.benzinga.com/general/biotech/24/03/37958211/mercks-11b-bet-pays-as-fda-approves-sotatercept-for-rare-lung-disease" rel="noreferrer noopener">sales of $70 million</a>.
During the quarter, the FDA approved&nbsp;Merck&#8217;s Capvaxive (Pneumococcal 21-valent Conjugate Vaccine) to&nbsp;protect against 21 strains of bacteria to prevent a severe form of&nbsp;pneumococcal disease, as the first pneumococcal conjugate vaccine specifically <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39376762/fda-approves-mercks-pneumococcal-vaccine-as-first-shot-designed-for-adults" rel="noreferrer noopener">designed to protect adults</a>.
Also, the company, with its partner Daiichi Sankyo (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSKYF#OTC">DSKYF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>) received an FDA Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of patritumab deruxtecan (HER3-DXd) for a <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39526817/fda-declines-to-approve-merck-daiichi-sankyo-partnered-lung-cancer-drug" rel="noreferrer noopener">certain type lung cancer</a>.
Guidance:&nbsp;Merck revised and narrowed its full-year 2024 forecasts.&nbsp;
The company expects 2024 sales of $63.4 billion—$64.4 billion, compared to previous guidance of $63.1 billion—$64.3 billion and the consensus of&nbsp;$64.34 billion.
The U.S. pharma giant expects 2024 adjusted EPS of&nbsp;$7.94 to $8.04, compared to prior guidance of $8.53-$8.65 and consensus of&nbsp;$8.16.
The outlook includes one-time charges of $0.77 per share For <a target="_blank" href="https://www.benzinga.com/general/biotech/24/01/36535176/today-is-cancer-focused-deals-day-johnson-johnson-scoops-up-ambrx-biopharma-as-merck-boosts-cance" rel="noreferrer noopener">Harpoon</a> and <a target="_blank" href="https://www.benzinga.com/news/24/07/39754237/mercks-acquisition-of-eyebio-finalized" rel="noreferrer noopener">Eyebio</a> acquisitions.&nbsp;
Price Action: MRK stock is down 3.19% at $123.70 during the premarket session at last check Tuesday.
Read Next:
<ul>
<li><a 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-" target="_blank" rel="noreferrer noopener">Merck Competes With Sanofi/AstraZeneca As Its RSV Treatment Drug Meets Primary Goal In Late-Stage Study In Infants</a>.</li>
</ul>
Photo Courtesy of Merck

Earnings

Guidance

Merck's Q2 Earnings: Revenue And EPS Beat Helped By Strong Keytruda Sales, But Acquisition Costs Bites Into Annual Profit Forecast

On Wednesday, the FDA issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) seeking accelerated approval of Daiichi Sankyo (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSKYF#OTC">DSKYF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSNKY#OTC">DSNKY</a>) and Merck &amp; Co Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>)&nbsp;patritumab deruxtecan (HER3-DXd) for adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or <a target="_blank" href="https://www.benzinga.com/pressreleases/24/06/b39515260/patritumab-deruxtecan-bla-submission-receives-complete-response-letter-from-fda-due-to-inspection-" rel="noreferrer noopener">more systemic therapies</a>.
The CRL results from findings about an inspection of a third-party manufacturing facility.
The CRL did not identify any issues with the efficacy or safety data submitted.
Patritumab deruxtecan is a specifically engineered potential first-in-class HER3-directed DXd antibody-drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed by Daiichi Sankyo and Merck.
In December, the FDA accepted and granted Priority Review to the Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd).
If approved, patritumab deruxtecan would be a first-in-class HER3-directed DXd antibody-drug conjugate <a target="_blank" href="https://www.benzinga.com/pressreleases/23/12/b36360381/patritumab-deruxtecan-granted-priority-review-in-the-u-s-for-certain-patients-with-previously-trea" rel="noreferrer noopener">for these patients</a>.
&#8220;We will work closely with the FDA and the third-party manufacturer to address the feedback as quickly as possible in order to bring the first HER3-directed medicine to patients with previously-treated EGFR-mutated non-small cell lung cancer,&#8221; said Ken Takeshita, MD, Global Head, R&amp;D, Daiichi Sankyo. &#8220;We remain confident in the ability to develop this medicine to its full potential.&#8221;
The BLA is based on the primary results from the&nbsp;HERTHENA-Lung01&nbsp;pivotal phase 2 trial.
In HERTHENA-Lung01, patritumab deruxtecan was studied in 225 patients, which demonstrated an objective response rate (ORR) of 29.8%, including one complete response and 66 partial responses.
The median duration of response (DoR) was 6.4 months.
Read Next: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/06/39362935/why-is-pfizer-partner-biontech-stock-trading-lower-on-monday" rel="noreferrer noopener">Why Is Pfizer Partner BioNTech Stock Trading Lower On Monday</a>?
Price Action: At the last check on Thursday, MRK shares were down 1.04% at $130.14.
Photo via Company

FDA Declines To Approve Merck-Daiichi Sankyo Partnered Lung Cancer Drug

Biotech stocks are high-risk, high-return opportunities that are under the mercy of several <a href="https://www.benzinga.com/trading-ideas/short-ideas/14/03/4375961/binary-events-and-volatility">make-or-break catalysts, most of which are binary events.</a> It pays to remain cognizant of the timing of these catalysts and which way they will likely pan out. 
Benzinga brings to investors a weekly feature focusing on five key catalysts that could impact the stock prices of the respective companies in an appreciable manner.
1. Arrowhead Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ARWR#NASDAQ">ARWR</a>)
<ul>
<li>Date: Tuesday, June 25</li>
<li>Catalyst: Discussion of Phase 3 PALISADE study of investigational plozasiran in patients with genetically confirmed or clinically diagnosed familial chylomicronemia syndrome </li>
</ul>
On June 3, the company released Phase 3 topline results, which showed the study met the primary endpoint, and key secondary endpoints and demonstrated statistical significance versus placebo. The stock rose over 7% on the day. The company is scheduled to discuss the data at the Cardiometabolic event on Tuesday as part of its 2024 Summer Series of R&amp;D Webinars.
The company expects to file an NDA for plozasiran in FCS around year-end, with a potential launch in 2025.
Arrowhead ended Friday&#8217;s session up 7.19% at $25.50, according to Benzinga Pro data. Chardan has a Buy rating on Arrowhead and a $60 price target: &#8220;We expect 2024 to be a data rich year for Arrowhead,&#8221; said Chardan analyst Keay Nakae in a June 3 note.
&#8220;We believe that at the current price, the balance of risk/reward is highly favorable for the stock going forward,&#8221; he said.
2. Intellia Therapeutics, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NTLA#NASDAQ">NTLA</a>)
<ul>
<li>Date: Tuesday, June 25</li>
<li>Catalyst: redosing data from the Phase 1 study of NTLA-2001, which is based on CRISPR/Cas9 gene-editing technology, </li>
</ul>
The data, which is to be presented at the &nbsp;Peripheral Nerve Society&nbsp;Annual Meeting being held in Montreal, Canada, will offer insight into the safety and pharmacodynamics of redosing patients. NTLA-2001 is being evaluated for Transthyretin amyloidosis, or ATTR amyloidosis, a rare, progressive and fatal disease.&nbsp;Interim Phase 1 clinical data showed the administration of NTLA-2001 led to consistent, deep and long-lasting TTR reduction. The gene-editing candidate is being jointly developed with Regeneron Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>).
The stock added 0.74% on Friday before closing at $24.22.
See Also: <a href="https://www.benzinga.com/money/best-biotech-stocks">Best Biotech Stocks</a>
3. Merck &amp; Co., Inc. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MRK#NYSE">MRK</a>)
<ul>
<li>Date: Wednesday, June 26</li>
<li>Catalyst: PDUFA date for antibody-drug conjugate patritumab deruxtecan as a treatment option for a certain type of non-small cell lung cancer.</li>
</ul>
The ADC candidate is being tested in patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies.
Lung cancer is the second most common cancer and the leading cause of cancer-related deaths worldwide, with non-small cell lung cancers accounting for approximately 85% of all lung cancers. EGFR mutations occur in 14%-38% of all NSCLC tumors worldwide.
<a href="https://www.benzinga.com/general/biotech/23/10/35349800/merck-signs-multi-billion-deal-with-japans-daiichi-sankyo-for-cancer-therapy-drug-development">Patritumab deruxtecan is one of the three drugs Merck acquired</a> from Japan&#8217;s Daiichi Sankyo Company, Limited (OTC:<a class="ticker" href="https://www.benzinga.com/stock/DSKYF#OTC">DSKYF</a>) last year.
Merck settled Friday&#8217;s session 0.81% higher at $130.72.
4. Verona Pharma plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/VRNA#NASDAQ">VRNA</a>)
<ul>
<li>Date: Wednesday, June 26</li>
<li>Catalyst: PDUFA date for ensifentrine that is being evaluated as maintenance treatment of patients with Chronic obstructive pulmonary disease&nbsp;</li>
</ul>
Raleigh, North Carolina-based Verona Pharma is a clinical-stage biopharma working on therapies for respiratory diseases. If ensifentrine gets the nod, it has the potential to become the first inhaled non-steroidal therapy for the treatment of respiratory diseases that combines bronchodilator and anti-inflammatory activities in one molecule, the company said. It is prepping for the commercial launch of ensifentrine in the third quarter.
Verona added 2.11% on Friday and ended at $15.
5. X4 Pharmaceuticals, Inc. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/XFOR#NASDAQ">XFOR</a>)
<ul>
<li>Date: Thursday, June 27 (8 a.m. EDT)</li>
<li>Catalyst: new interim Phase 2 data for mavorixafor in severe congenital neutropenia, which results from very low levels of neutrophils &#8211; a type of white blood cells that are used to treat several infections, especially bacterial.</li>
</ul>
The data will be presented at a virtual investor event hosted by the company. X4 Pharma rallied over 5% to $1.01.
The SPDR&nbsp;S&amp;P&nbsp;Biotech ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/XBI#NYSE">XBI</a>), an exchange-traded fund that tracks the S&amp;P Biotechnology Select Industry Index, ended Friday at $92.38, up 2.77%. For the year, the EFF has gained 3.46%, underperforming the broader S&amp;P 500 Index.
Read Next: <a href="https://www.benzinga.com/general/biotech/24/06/39430498/fda-approves-expanded-use-for-sareptas-rare-muscular-dystrophy-gene-therapy">FDA Approves Expanded Use For Sarepta&#8217;s Rare Muscular Dystrophy Gene Therapy</a>
Image Via Shutterstock

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5 Biotech Stocks With Key Catalysts This Week: Merck, Intellia, Verona, And More

<ul>
<li>DESTINY-Breast06 results show Daiichi Sankyo and AstraZeneca&#39;s ENHERTU is the first HER2 directed medicine and antibody drug conjugate to demonstrate clinically meaningful benefit for patients in this setting</li>
<li>Additionally, data from DESTINY-Breast03 and DESTINY-Breast07 trials in HER2 positive metastatic breast cancer reinforce ENHERTU as standard of care in second-line setting and highlight potential in first-line setting</li>
</ul>

Reported Earlier, Daiichi Sankyo And AstraZeneca's ENHERTU Shows Progression-Free Survival To 13.2 Months In HR Positive, HER2 Low Metastatic Breast Cancer

On Tuesday,&nbsp;AstraZeneca Plc&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) said the survival results did not reach statistical significance in the overall trial population in the TROPION-Lung01&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/24/05/b39026556/datopotamab-deruxtecan-showed-clinically-meaningful-overall-survival-improvement-vs-chemotherapy-i" rel="noreferrer noopener">phase 3 trial</a>.
Topline overall survival (OS) results from the&nbsp;<a target="_blank" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04656652%3Fterm%3DTROPION-Lung01%26rank%3D1&amp;esheet=54016616&amp;newsitemid=20240526450256&amp;lan=en-US&amp;anchor=TROPION-Lung01&amp;index=1&amp;md5=d468d3a7d1287a60345db17296bbbddb" rel="noreferrer noopener">TROPION-Lung01</a>&nbsp;phase 3 trial, which previously met the dual primary endpoint of progression-free survival (PFS), numerically favored&nbsp;datopotamab&nbsp;deruxtecan (Dato-DXd) compared to docetaxel for locally advanced or metastatic non-small cell lung cancer (NSCLC) patients treated with at least&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/09/34818340/better-than-chemotherapy-astrazenecadaiichi-sankyo-partnered-cancer-drug-meets-primary-goal-in-br" rel="noreferrer noopener">one prior line of therapy</a>.&nbsp;
Also Read:&nbsp;<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">AstraZeneca Targets Ambitious $80B In Total Revenue By 2030 Through Pipeline Expansion</a>.
In the pre-specified subgroup of patients with nonsquamous NSCLC,&nbsp;datopotamab&nbsp;deruxtecan showed a clinically meaningful improvement in OS compared to docetaxel, the current standard of care chemotherapy.
Datopotamab deruxtecan is a&nbsp;specifically&nbsp;engineered TROP2-directed DXd antibody drug conjugate discovered by&nbsp;Daiichi Sankyo&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 Daiichi Sankyo and AstraZeneca.
The final&nbsp;analysis of OS&nbsp;builds on the PFS results&nbsp;<a target="_blank" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.daiichisankyo.com%2Ffiles%2Fnews%2Fpressrelease%2Fpdf%2F202310%2F20231023_E3.pdf&amp;esheet=54016616&amp;newsitemid=20240526450256&amp;lan=en-US&amp;anchor=presented&amp;index=2&amp;md5=a59038286fa0325179251a2c5faae080" rel="noreferrer noopener">presented</a>&nbsp;at the European Society for Medical Oncology 2023 Congress, which&nbsp;showed&nbsp;that datopotamab&nbsp;deruxtecan demonstrated a statistically significant improvement in PFS in the overall trial population and a clinically meaningful PFS benefit in patients with nonsquamous NSCLC.&nbsp;
The safety profile of&nbsp;datopotamab&nbsp;deruxtecan in TROPION-Lung01 was consistent with the previous analysis, including fewer dose reductions or discontinuations due to adverse events compared to docetaxel and with no new safety concerns identified. No new interstitial lung disease events of any grade were adjudicated as drug-related.
&#8220;Datopotamab deruxtecan is the only investigational therapy to show a clinically meaningful survival improvement in patients with previously treated nonsquamous non-small cell lung cancer versus docetaxel, which has long been unsurpassed in this post-targeted treatment and post-immunotherapy setting,&#8221; said Susan Galbraith, Executive Vice President, Oncology R&amp;D, AstraZeneca.
TROPION-Lung01 enrolled approximately 600 patients.
Price Action: AZN shares were down 2.40% at $76.66 at the last check on Tuesday.
Image by Robert Way via Shutterstock

Why Is AstraZeneca Stock Trading Lower On Tuesday?

AstraZeneca plc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) <a href="https://www.astrazeneca.com/media-centre/press-releases/2024/enhertu-improved-pfs-in-her2-low-and-ultralow.html" target="_blank" rel="noreferrer noopener">reported</a> topline data from a metastatic breast cancer treatment study.
The results showed that&nbsp;Enhertu&nbsp;(trastuzumab deruxtecan) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared to standard-of-care chemotherapy in the primary trial population of patients with HR-positive, HER2-low (IHC 1+ or 2+/ISH-) metastatic breast cancer following one or more lines of endocrine therapy.
A statistically significant and clinically meaningful improvement in PFS was also observed in the overall trial population (patients with HER2-low and HER2-ultralow [defined as IHC 0 with membrane staining; IHC &gt;0&lt;1+] metastatic breast cancer).&nbsp;
Related: <a href="https://www.benzinga.com/general/biotech/24/04/38430571/astrazeneca-posts-bumper-earnings-on-strong-sales-from-cancer-drugs-sticks-to-annual-guidance" target="_blank" rel="noreferrer noopener">AstraZeneca Posts Bumper Earnings On Strong Sales From Cancer Drugs, Sticks To Annual Guidance</a>.
A prespecified subgroup analysis showed that clinically meaningful improvement was consistent between patients with HER2-low and HER2-ultralow&nbsp;expression.
Overall survival (OS) data were not mature at the time of the analysis. However, Enhertu showed an early trend towards an OS improvement. It was compared to standard-of-care chemotherapy in patients with HER2-low metastatic breast cancer and the overall trial population. 
The trial will continue to assess OS and other secondary endpoints further.
Enhertu&nbsp;is a HER2-directed DXd antibody-drug conjugate discovered by&nbsp;Daiichi Sankyo&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 is being jointly developed and commercialized by AstraZeneca and Daiichi Sankyo.
Concurrently, AstraZeneca's&nbsp;Truqap&nbsp;(capivasertib) in combination with&nbsp;Faslodex&nbsp;(fulvestrant) has been&nbsp;<a target="_blank" href="https://www.astrazeneca.com/media-centre/press-releases/2024/truqap-recommended-for-eu-breast-cancer-approval.html" rel="noreferrer noopener">recommended</a>&nbsp;for approval in the European Union for adult patients with estrogen receptor (ER)-positive, HER2‑negative locally advanced or metastatic breast cancer with one or more PIK3CA, AKT1, or PTEN-alterations following recurrence or progression on or after an endocrine-based regimen.
The Committee for Medicinal Products for Human Use of the European Medicines Agency based its opinion on the CAPItello-291&nbsp;Phase 3 trial results.
Truqap in combination with Faslodex reduced the risk of disease progression or death by 50%. Compare that to Faslodex alone in patients with tumors harboring PI3K, AKT, or PTEN alterations (based on a hazard ratio of 0.50, p=&lt;0.001; median PFS 7.3 versus 3.1 months).
Price Action:&nbsp;AZN shares are up 1.65% at $76.41&nbsp;during the premarket session at the last check Monday.

Double Good News For AstraZeneca's Breast Cancer Drugs

Daiichi Sankyo and AstraZeneca&#39;s ENHERTU also demonstrated a clinically meaningful progression-free survival improvement in patients with HER2 ultralow expression 
	Plans for global regulatory submissions are
<ul>
<li>Daiichi Sankyo and AstraZeneca&#39;s ENHERTU also demonstrated a clinically meaningful progression-free survival improvement in patients with HER2 ultralow expression</li>
<li>Plans for global regulatory submissions are underway</li>
</ul>

Daiichi Sankyo And AstraZeneca's ENHERTU Shows Statistically Significant And Clinically Meaningful Improvement In HR+, HER2 Low Breast Cancer: DESTINY-Breast06 Trial Results

On Friday, the FDA approved&nbsp;Daiichi Sankyo Ltd&#8217;s&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&nbsp;AstraZeneca Plc&#8217;s&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/AZN#NASDAQ">AZN</a>) Enhertu (fam-trastuzumab deruxtecan-nxki) for unresectable or metastatic HER2 positive (immunohistochemistry [IHC] 3+) solid tumors who have received prior systemic treatment and have no&nbsp;<a target="_blank" href="https://www.benzinga.com/pressreleases/24/04/b38120526/enhertu-approved-in-the-u-s-as-first-tumor-agnostic-her2-directed-therapy-for-previously-treated-p" rel="noreferrer noopener">satisfactory alternative treatment options</a>.&nbsp;
This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
Also Read:&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/04/38110994/new-hope-for-aggressive-lung-cancer-astrazenecas-imfinzi-shows-promising-results-in-phase-3-trial" rel="noreferrer noopener">New Hope for Aggressive Lung Cancer: AstraZeneca&#8217;s Imfinzi Shows Promising Results in Phase 3 Trial</a>.
The first tumor agnostic approval of a HER2-directed therapy and ADC was based on efficacy data in 192 adult patients with previously treated unresectable or metastatic HER2 positive (IHC 3+) solid tumors who were enrolled in one of three multicenter phase 2 trials from the DESTINY clinical development program, including&nbsp;<a target="_blank" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04482309&amp;esheet=53923984&amp;newsitemid=20240405182615&amp;lan=en-US&amp;anchor=DESTINY-PanTumor02&amp;index=1&amp;md5=0f120cd67a6a0c675c64d7beecd91e82" rel="noreferrer noopener">DESTINY-PanTumor02</a>,&nbsp;<a target="_blank" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT03505710&amp;esheet=53923984&amp;newsitemid=20240405182615&amp;lan=en-US&amp;anchor=DESTINY-Lung01&amp;index=2&amp;md5=2391d02262ec6b3b4bdd206188caa4dd" rel="noreferrer noopener">DESTINY-Lung01</a>&nbsp;or&nbsp;<a target="_blank" href="https://cts.businesswire.com/ct/CT?id=smartlink&amp;url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04744831&amp;esheet=53923984&amp;newsitemid=20240405182615&amp;lan=en-US&amp;anchor=DESTINY-CRC02&amp;index=3&amp;md5=2729fa6cba32591846b74f20061341df" rel="noreferrer noopener">DESTINY-CRC02</a>.&nbsp;
In DESTINY-PanTumor02, the confirmed objective response rate (ORR) was 51.4%, and the median duration of response (DOR) range was 19.4 months.&nbsp;
In DESTINY-Lung01, a confirmed ORR of 52.9% and a median DOR range of 6.9 months were seen.&nbsp;
In DESTINY-CRC02, a confirmed ORR was 46.9%, and the median DOR range was 5.5 months.
ENHERTU is approved with Boxed WARNINGS for interstitial lung disease (ILD)/pneumonitis and Embryo-Fetal toxicity.&nbsp;
&#8220;This fifth indication in the U.S. is a significant milestone as eligible patients with previously treated metastatic HER2 positive solid tumors may now be treated with ENHERTU,&#8221; said Ken Keller, Global Head of Oncology Business and President and CEO of Daiichi Sankyo, Inc. &#8220;The accelerated approval by the FDA for this tumor agnostic indication is based on the clinically meaningful efficacy seen with ENHERTU across numerous types of metastatic cancers.&#8221;
Price Action: AZN shares are up 0.01% at $67.46 on the last check Monday.
Photo via Wikimedia Commons

AstraZeneca/Daiichi's Flagship Drug Enhertu Secures Accelerated FDA Approval For Pretreated Cancer Patients With Solid Tumor

Pfizer Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) is set to announce its fourth quarter 2023 earnings next week on 30th January. The analysts expect the US pharma giant to report an EPS loss of $(0.22) and revenues of $14.25 billion, according to data from <a href="https://www.benzinga.com/pro/feature/newsfeed" target="_blank" rel="noreferrer noopener">Benzinga Pro</a>.
Last week,&nbsp;Daiichi Sankyo Co 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>)&nbsp;<a target="_blank" href="https://www.daiichisankyo.com/files/news/pressrelease/pdf/202401/20240117_E.pdf" rel="noreferrer noopener">announced</a>&nbsp;that the U.S. Patent and Trademark Office rendered a Final Written Decision invalidating all claims of&nbsp;Seagen Inc's&nbsp;U.S. patent 10,808,039 challenged by Daiichi Sankyo in a post-grant review proceeding, related to a cancer drug.&nbsp;
In December,&nbsp;Pfizer&nbsp;agreed to donate the rights of royalties from sales of cancer drug Bavencio (avelumab) to the American Association for Cancer Research to address U.S. Federal Trade Commission concerns related to its $43-billion<a target="_blank" href="https://www.benzinga.com/general/biotech/23/12/36198526/pfizer-clears-required-regulatory-hurdles-to-complete-43b-seagen-acquisition" rel="noreferrer noopener">&nbsp;deal to buy&nbsp;Seagen</a>.
For FY24, the pharma giant expects revenue of $58.5 billion-$61.5 billion, including the expected contribution from the Seagen acquisition versus the&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/12/36213638/why-is-us-pharma-giant-pfizer-stock-trading-lower-today" rel="noreferrer noopener">consensus of $63.17 billion</a>.
The company forecasts FY24 adjusted diluted EPS guidance of $2.05-$2.25, including the expected impact of the Seagen acquisition, compared to the consensus of $3.17.
In a bid to catch up in the obesity race,&nbsp;Pfizer&nbsp;reported topline data from the Phase 2b trial of danuglipron (PF-06882961) in adults with obesity and without type 2 diabetes.&nbsp;
The study met its primary endpoint, demonstrating a statistically significant change in body weight from baseline, but danuglipron was tied to "high rates" of mild gastrointestinal side effects, leading to more than half of the patients across all dose groups&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/12/36041804/this-twice-daily-weight-loss-drug-has-adverse-side-effects-and-pfizer-wants-to-discontinue-it" rel="noreferrer noopener">dropping out from the trial</a>, sending shares lower.&nbsp;
Last week, Amit Dagar, a former senior statistical program lead at Pfizer, was found guilty of securities fraud by a&nbsp;<a href="https://www.benzinga.com/news/24/01/36693531/pfizer-insider-trading-former-employee-found-guilty-of-trading-on-successful-covid-19-paxlovid-trial" target="_blank" rel="noreferrer noopener">federal jury in Manhattan</a>.&nbsp;
Read Next:&nbsp;<a href="https://www.benzinga.com/general/biotech/24/01/36552329/pfizers-aggressive-stance-in-obesity-drugs-ceo-albert-bourla-confirms-bold-bet-despite-prior-drug" target="_blank" rel="noreferrer noopener">Pfizer&#8217;s Aggressive Stance In Obesity Drugs: CEO Albert Bourla Confirms Bold Bet Despite Prior Drug Hurdles</a>.
Price Action: PFE shares are trading 1.69% lower at $27.85 during the premarket session on the last check Thursday on a session volume of 320.951K versus the average volume (100 day) of 41.623 million.
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What's Going On With Pfizer Stock Today?

Merck &amp; Company, Inc.&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mrk#NYSE">MRK</a>) and Japan&#39;s&nbsp;Daiichi Sankyo Co.&nbsp;Ltd.&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/dskyf#OTC">DSKYF</a>)&nbsp;entered into a global development and commercialization agreement.
The companies are developing three of Daiichi Sankyo&#39;s DXd antibody-drug conjugate (ADC) candidates for patients across&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/10/b35341811/daiichi-sankyo-and-merck-announce-global-development-and-commercialization-collaboration-for-three" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">multiple types of cancer.</a>
Merck will pay Daiichi Sankyo $5.5 billion in the agreement, which has a total potential consideration of up to $22 billion.
The three drug candidates include&nbsp;patritumab deruxtecan (HER3-DXd), ifinatamab deruxtecan (I-DXd), and raludotatug deruxtecan (R-DXd).
Daiichi Sankyo aims for at least 900 billion yen ($6&nbsp;billion) of revenue from its oncology business in the fiscal year ending March 31, 2026, representing about a&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/topic/japan" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">five-fold increase over a three-year period,</a>&nbsp;according to a note by Reuters.
Daiichi Sankyo and AstraZeneca (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/azn#NASDAQ">AZN</a>) recently released topline data from the TROPION-Breast01 phase 3 trial of datopotamab deruxtecan (Dato-DXd) in previously treated patients with inoperable or metastatic hormone receptor (HR) positive,&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/09/34818340/better-than-chemotherapy-astrazenecadaiichi-sankyo-partnered-cancer-drug-meets-primary-goal-in-br" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">HER2 low or negative breast cancer.</a>
With the latest deal, the companies intend to jointly commercialize these ADC candidates worldwide, except in Japan where Daiichi Sankyo will maintain exclusive rights.&nbsp;
Daiichi Sankyo will be solely responsible for manufacturing and supply <a class="editor-rtfLink" href="https://www.benzinga.com/calendars/guidance" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">following the close of the transaction</a>. In conjunction with this transaction, Merck will record an aggregate pretax charge of&nbsp;approximately $1.70 per share, reflecting the $4 billion upfront payment and the $1.5 billion in continuation payments. This will result in a reduction of both fourth-quarter and full-year&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/calendars/earnings" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">2023 GAAP and non-GAAP results.&nbsp;</a>
Price Action:&nbsp;MRK shares are trading higher by 0.17% to $100.60 premarket on the last check Friday.&nbsp;
Now Read:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/10/35068559/drugmakers-agree-to-participate-for-medicare-drug-price-negotiation-with-biden-administration" style="background-image:initial; background-position:initial; background-size:initial; background-repeat:initial; background-attachment:initial; background-origin:initial; background-clip:initial; margin-top:0pt; margin-bottom:0pt; color:#4a6ee0" target="_blank">Drugmakers Agree To Participate For Medicare Drug Price Negotiation With Biden Administration</a>

Merck Signs Multi-Billion Deal With Japan's Daiichi Sankyo For Cancer Therapy Drug Development

AstraZeneca&nbsp;Plc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/azn#NASDAQ">AZN</a>) and&nbsp;Daiichi Sankyo&nbsp;(OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/dskyf#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">DSKYF</a>) (OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/dsnky#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">DSNKY</a>) released topline data from the TROPION-Breast01 phase 3 trial of datopotamab deruxtecan (Dato-DXd) in previously treated patients with inoperable or metastatic hormone receptor (HR) positive, HER2 low or&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/09/b34812518/datopotamab-deruxtecan-demonstrated-statistically-significant-and-clinically-meaningful-progressio" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">negative breast cancer</a>.
Dato-DXd demonstrated a statistically significant and clinically meaningful improvement for the primary endpoint of progression-free survival compared to the investigator&#39;s choice of chemotherapy.&nbsp;
Datopotamab deruxtecan&#39;s safety profile aligned with previous breast cancer clinical trials, noting no fresh safety signals. All-grade interstitial lung disease rates remained low.&nbsp;
While the overall survival (OS) data is yet to mature, the trial will persist in assessing this metric.
Breast cancer remains a global concern, with over two million diagnoses annually. Among these, HR-positive, HER2 low, or negative breast cancer is prevalent, making up more than 65% of cases.&nbsp;
Susan Galbraith, Executive Vice President, Oncology R&amp;D, at AstraZeneca, added, &quot;Today&#39;s TROPION-Breast01 news is a significant development for patients whose tumors have become insensitive to endocrine therapy.&quot;
In July,&nbsp;AstraZeneca&nbsp;reported topline data from the TROPION-Lung01 Phase 3 trial of Dato-DXd in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) treated with at&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/07/33093239/astrazeneca-shares-under-pressure-on-some-adverse-events-in-late-stage-lung-cancer-drug-trial" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">least one prior therapy</a>.
The company&#39;s shares fell after the data due to the lack of numerical detail, despite being statistically significant&mdash; a minimum 2-3 month benefit was targeted.
Price Action:&nbsp;AZN shares are up 2.66% at $68.80 during the premarket session on the last check Friday.

Better Than Chemotherapy - AstraZeneca/Daiichi Sankyo Partnered Cancer Drug Meets Primary Goal In Breast Cancer Setting

Daiichi Sankyo&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&nbsp;AstraZeneca plc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/azn#NASDAQ">AZN</a>) released initial results from the TROPION-Lung04 phase 1b trial.
The study showed that datopotamab deruxtecan (Dato-DXd) in combination with durvalumab, with or without carboplatin demonstrated encouraging responses and no new safety signals in patients with previously untreated advanced or metastatic non-small cell lung cancer (NSCLC) without&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/09/b34403897/datopotamab-deruxtecan-plus-durvalumab-showed-promising-clinical-activity-in-the-first-line-advanc" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">actionable genomic alterations</a>.&nbsp;
In previously untreated patients, datopotamab deruxtecan plus durvalumab (doublet; n=14) demonstrated an objective response rate (ORR) of 50.0%, including seven partial responses (PR) and a disease control rate (DCR) of 92.9%.&nbsp;
Response rates were higher in patients receiving datopotamab deruxtecan plus durvalumab and carboplatin (triplet; n=13), demonstrating an ORR of 76.9%, including 10 PRs and a DCR of 92.3%. Responses were observed across PD-L1 expression levels.
In both previously treated and untreated patients, the safety profiles of datopotamab deruxtecan and durvalumab with and without carboplatin were consistent with other clinical trials and with the known safety profile of each agent.&nbsp;
No grade 5 interstitial lung disease events were observed.
AstraZeneca also&nbsp;<a class="editor-rtfLink" href="https://www.astrazeneca.com/media-centre/press-releases/2023/tagrisso-plus-chemotherapy-extended-median-progression-free-survival-by-nearly-9-months-in-egfr-mutated-advanced-lung-cancer-in-flaura2-phase-iii-trial.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">released</a>&nbsp;data from the FLAURA2 Phase 3 trial showing Tagrisso (osimertinib) in combination with chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso alone in patients with locally advanced (Stage IIIB-IIIC) or metastatic (Stage IV) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).
By investigator assessment, The combination extended median progression-free survival by 8.8 months versus Tagrisso alone.&nbsp;
PFS results from blinded independent central review (BICR) were consistent, showing Tagrisso plus chemotherapy extended median PFS by 9.5 months.
The overall survival (OS) data were immature; however, a favorable trend was observed for Tagrisso plus chemotherapy.
The company additionally announced primary analysis data of the DESTINY-Lung02 Phase 2 trial of Enhertu (fam-trastuzumab deruxtecan-nxki) in previously treated patients with HER2-mutant (HER2m) unresectable and/or metastatic non-squamous&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/09/b34434175/enhertu-fam-trastuzumab-deruxtecan-nxki-demonstrated-strong-and-durable-tumor-responses-in-previou" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">non-small cell lung cancer (NSCLC)</a>.
The data showed Enhertu continued to demonstrate strong and durable tumor responses.
A confirmed objective response rate (ORR) of 49.0% and 56.0% was seen in the 5.4mg/kg arm and 6.4mg/kg arm, respectively.
Enhertu also demonstrated a median progression-free survival of 9.9 months and 15.4 months in the 5.4mg/kg and 6.4mg/kg arms, respectively.&nbsp;
A median overall survival of 19.5 months was achieved in the 5.4mg/kg arm and not reached in the 6.4mg/kg arm.
Price Action:&nbsp;AZN shares are down 3.21% at $66.03 on the last check Monday.

AstraZeneca's Reinforces Hold In Lung Cancer Settings: Touts Promising Data From Three Trials

The trial included&nbsp;patients with previously untreated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations.
The trial included&nbsp;patients with previously untreated advanced or metastatic non-small cell lung cancer (NSCLC) without actionable genomic alterations.

AZNCF

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