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Bayer

Bayer is a German healthcare and agriculture conglomerate. Healthcare provides close to half of the company's sales and includes pharmaceutical drugs as well as vitamins and other consumer healthcare products. The firm also has a crop science business that includes seeds, pesticides, herbicides, and fungicides, which was expanded through its 2018 acquisition of Monsanto.

Bayer AG

On Friday, the FDA approved BridgeBio Pharma, Inc.&#8217;s (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BBIO#NASDAQ">BBIO</a>) Attruby (acoramidis), an orally-administered near-complete (≥90%) stabilizer of Transthyretin (TTR) for adults with ATTR-CM to reduce cardiovascular death and <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/g42150289/attruby-acoramidis-a-near-complete-ttr-stabilizer-90-approved-by-fda-to-reduce-cardiovascular-deat" rel="noreferrer noopener">cardiovascular-related hospitalization</a>.
The FDA approval is based on ATTRibute-CM Phase 3 study results, which showed that Attruby significantly reduced death and cardiovascular-related hospitalization and improved quality of life.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/11/42072773/bridgebio-pharmas-acoramidis-shows-competitive-edge-against-pfizers-tafamidisa-in-lucrative-but-competitive-attr-cm-market" rel="noreferrer noopener">BridgeBio Pharma&#8217;s Acoramidis Shows Competitive Edge Against Pfizer&#8217;s Tafamidisa In Lucrative But Competitive ATTR-CM Market</a>
Attruby is the first and only approved product with a label specifying near-complete stabilization of TTR.
Attruby was designed to mimic a naturally occurring &#8220;rescue mutation&#8221; of the TTR gene (T119M) that targets the root cause of ATTR-CM, the destabilization of the native TTR tetramer.
Through near-complete TTR stabilization, Attruby has been shown to preserve the native function of TTR as a transport protein of thyroxine and vitamin A and to demonstrate benefit on cardiovascular outcomes.
The ATTRibute-CM Phase 3 study enrolled 632 participants with symptomatic ATTR-CM associated with either wild-type or variant TTR.
BridgeBio submitted a Marketing Authorization Application to the European Medicines Agency, with a decision expected in 2025.
BridgeBio has granted&nbsp;Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>)&nbsp;exclusive rights to commercialize acoramidis for ATTR-CM in Europe.
The company said it will provide Attruby for free to patients who participated in the trial.
William Blair writes, &#8220;We continue to view a reduction in all-cause mortality on label as a necessary distinction to gain major market share in ATTR-CM alongside Pfizer Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) tafamidis.&#8221;
Since the Attruby label doesn&#8217;t include data on overall mortality, the William Blair analyst notes Pfizer might shift its marketing focus to emphasize claims about mortality benefits.
Price Action: BBIO stock is up 24.3% at $29.10 during the premarket session at last check Monday.
Image via Shutterstock
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BAYRY

BBIO

FDA Approves BridgeBio Pharma's Drug For Rare Heart Disease, Poised To Challenge Pfizer In Lucrative Yet Competitive Market

On Monday, BridgeBio Pharma, Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BBIO#NASDAQ">BBIO</a>) presented initial outcomes from the ATTRibute-CM open-label extension (OLE) study of acoramidis in ATTR-CM at the American Heart <a target="_blank" href="https://www.benzinga.com/pressreleases/24/11/g42041623/open-label-extension-data-confirms-sustained-benefit-of-acoramidis-on-cardiovascular-outcomes-incl" rel="noreferrer noopener">Association Scientific Sessions</a>.
ATTRibute-CM was designed to evaluate the efficacy and safety of acoramidis, an investigational small-molecule stabilizer of transthyretin (TTR) gene.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/41100250/bridgebio-pharmas-lead-candidate-cuts-mortality-related-hospitalizations-in-patients-with-certain" rel="noreferrer noopener">BridgeBio Pharma&#8217;s Lead Candidate Cuts Mortality, Related Hospitalizations In Patients With Certain Type Of Heart Disease</a>
The OLE study involves 330 participants who completed the 30-month ATTRibute-CM Phase 3 study.
Key initial results from the OLE study show that continuous treatment with acoramidis led to:
<ul>
<li>A confirmed sustained improvement relative to placebo in time to the first event ( cardiovascular-related hospitalizations (CVH) or All-Cause Mortality (ACM)) starting at Month 3 in ATTRibute-CM</li>
<li>A statistically significant reduction in ACM alone of 36% by Month 36 (p=0.009) and 34% by Month 42 (p=0.006).</li>
<li>A significant reduction of composite ACM and CVH by 46% at Month 36 and 48% at Month 42, building upon the previously presented 42% reduction at Month 30 in ATTRibute-CM.</li>
<li>Acoramidis continues to be well tolerated, with no new clinically significant safety signals identified in this long-term evaluation.</li>
</ul>
The OLE data build on previously reported results from ATTRibute-CM in which acoramidis demonstrated clinically important treatment effects on mortality, CVH, and quality of life, further supporting that greater transthyretin (TTR) stabilization can improve clinical outcomes for patients.
This included a 50% reduction in the cumulative frequency of CVH relative to placebo at Month 30.
BridgeBio&#8217;s marketing application is under FDA review, with a PDUFA action date of November 29, 2024. It also has a marketing application to the European Medicines Agency, with a decision expected in 2025.
BridgeBio has granted Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) exclusive rights to commercialize ceramides for ATTR-CM in Europe.
William Blair writes that reducing overall mortality is crucial for competing in the ATTR-CM market against Pfizer Inc&#8217;s (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) tafamidis, which already includes proven mortality benefits on its label from the ATTR-ACT trial.
The analyst writes, &#8220;While Bridge Bio continues to publish analyses of acoramidis demonstrating the TTR stabilizer is safe and efficacious, we deem an on-label claim to all-cause mortality benefit as an important factor for market share in the lucrative, but competitive, ATTR-CM space.&#8221;
Price Action: BBIO stock is up 0.85% at $22.54 at the last check on Tuesday.
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BridgeBio Pharma's Acoramidis Shows Competitive Edge Against Pfizer's Tafamidisa In Lucrative But Competitive ATTR-CM Market

<ul>
<li>Approximately €70 Million in Upfront and Near-term Payments to Cytokinetics</li>
<li>Up to €490 Million in Commercial Milestone Payments, with</li>
<li>Tiered Royalties on Future Sales</li>
</ul>

CYTK

Cytokinetics And Bayer Partner For Exclusive Development And Commercialization Of Aficamten In Japan

Corporate Outlook We confirm our 2024 Group guidance for currency- and portfolio-adjusted sales growth, currencyadjusted core earnings per share, and free cash flow as published in the 2023 Annual Report. However, in view of the weaker-than-anticipated development of the agricultural market, we are revising some parts of our Group forecast. We are also making adjustments to our guidance at divisional level: While business performance is below our initial expectations at Crop Science and Consumer Health, we now see Pharmaceuticals coming in at the upper end of our revised guidance. A 13 Forecast for 2024 Initial currency-adjusted forecast for 2024 Revised currencyadjusted forecast for 2024 Initial forecast for 2024 at closing rates on Dec. 31, 2023 Revised forecast for 2024 at closing rates on Sept. 30, 2024 € billion Fx &amp; p adj. change (%) € billion Fx &amp; p adj. change (%) € billion Fx &amp; p adj. change (%) € billion Fx &amp; p adj. change (%) Sales 47 to 49 – 1 to + 3 47 to 49 – 1 to + 3 46 to 48 – 1 to + 3 45.5 to 47.5 – 1 to + 3 Crop Science – 1 to + 3 – 3 to – 1 – 1 to + 3 – 3 to – 1 Pharmaceuticals – 4 to 0 0 to + 3 – 4 to 0 0 to + 3 Consumer Health + 3 to + 6 + 1 to + 3 + 3 to + 6 + 1 to + 3 Margin (%) Margin (%) Margin (%) Margin (%) EBITDA before special items1 10.7 to 11.3 10.4 to 10.7 10.4 to 11.0 10.0 to 10.3 Crop Science 20 to 22 18 to 20 20 to 22 18 to 20 Pharmaceuticals 26 to 29 26 to 29 24 to 27 24 to 27 Consumer Health 23 to 24 23 to 24 23 to 24 23 to 24 Financial result (core)2 ~ – 2.3 ~ – 2.0 ~ – 2.2 ~ – 2.0 Tax rate (core)3 ~ 23% 24 to 25% ~ 23% 24 to 25% Free cash flow1 2 to 3 2 to 3 2 to 3 2 to 3 Net financial debt1 32.5 to 33.5 32.5 to 33.5 32.5 to 33.5 32.5 to 33.5 Special items in EBITDA1 – 2 to – 1 – 2 to – 1 – 2 to – 1 – 2 to – 1 € € € € Core earnings per share1 5.10 to 5.50 5.10 to 5.50 4.95 to 5.35 4.80 to 5

Earnings

Guidance

BAYZF

Bayer Confirms Its 2024 Guidance, Sales Of €47B-€49B And Core Earnings Per Share Of €5.10-€5.50

Bayer (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) reported quarterly earnings of $0.07 per share which missed the analyst consensus estimate of $0.17 by 61.24 percent. The company reported quarterly sales of $10.956 billion which missed the analyst consensus estimate of $11.533 billion by 5.00 percent. This is a 2.67 percent decrease over sales of $11.257 billion the same period last year.

Earnings Misses

Bayer Q3 2024 Adj. EPADS $0.07 Misses $0.17 Estimate, Sales $10.956B Miss $11.533B Estimate

On Tuesday, Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for elinzanetant for moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause or caused by <a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38896489/bayer-highlights-detailed-data-from-twin-late-stage-trials-on-experimental-menopause-candidate-se" rel="noreferrer noopener">adjuvant endocrine therapy</a>.
The EMA <a target="_blank" href="https://www.bayer.com/media/en-us/bayer-submits-eu-marketing-authorization-application-for-elinzanetant-to-treat-moderate-to-severe-vasomotor-symptoms/" rel="noreferrer noopener">submission</a> is based on Phase 3 development program OASIS results.
OASIS 1 and 2 data were published in the Journal of the American Medical Association (<a href="https://doi.org/10.1001/jama.2024.14618" target="_blank" rel="noreferrer noopener">JAMA</a>) in August.
Detailed results of the Phase 3 study OASIS 3, which provided additional efficacy and safety data over 52 weeks, were presented at the Menopause Society annual meeting in September.
The data showed that elinzanetant <a target="_blank" href="https://www.bayer.com/media/en-us/data-from-phase-iii-study-oasis-3-support-efficacy-and-long-term-safety-of-investigational-compound-elinzanetant-in-the-treatment-of-moderate-to-severe-vasomotor-symptoms-associated-with-menopause/" rel="noreferrer noopener">met</a> the primary endpoint, demonstrating a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms from baseline to week 12 compared to placebo.
There was no minimum threshold of moderate to severe VMS for inclusion in the study, and at baseline, women had a mean of 6.7 VMS (standard deviation, SD 7.2) in the elinzanetant group and 6.8 in the placebo group (SD 6.2).
After 12 weeks of treatment, VMS was reduced to 1.6 (SD 2.5) in the elinzanetant group and 3.4 (SD 4.2) in the placebo group.
The VMS reductions were maintained throughout the study. In addition, improvements were seen in sleep disturbances and menopause-related quality of life measures with <a target="_blank" href="https://www.benzinga.com/24/03/37822314/bayers-third-menopausal-relief-drug-trial-meets-primary-goal-german-conglomerate-seeks-fda-approval" rel="noreferrer noopener">elinzanetant use over 52 weeks</a>.
Last week, the FDA <a target="_blank" href="https://www.bayer.com/media/en-us/us-food-and-drug-administration-fda-accepts-new-drug-application-for-elinzanetant/" rel="noreferrer noopener">accepted</a> Bayer&#8217;s marketing application for elinzanetant seeking approval for moderate-to-severe vasomotor symptoms.
On Monday, Bayer submitted an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide, seeking&nbsp;approval&nbsp;for the use of darolutamide in combination with androgen deprivation therapy in patients with metastatic hormone-<a target="_blank" href="https://www.benzinga.com/general/biotech/24/10/41315864/bayer-seeks-european-approval-for-third-indication-for-cancer-drug-darolutamide" rel="noreferrer noopener">sensitive prostate cancer</a>.
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Photo: Taljat David/Shutterstock.com

Large Cap

Eurozone

Bayer Seeks European Approval For Its Menopause Drug

On Monday, Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) submitted an application to the European Medicines Agency (EMA) for the oral androgen receptor inhibitor (ARi) darolutamide.
Bayer is seeking <a target="_blank" href="https://www.bayer.com/media/en-us/bayer-submits-application-for-third-indication-of-darolutamide-in-the-eu/" rel="noreferrer noopener">approval</a> for the use of darolutamide in combination with androgen deprivation therapy (ADT) in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The compound is already approved in mHSPC, under the brand name Nubeqa, in combination with ADT and docetaxel in over 80 markets.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40801594/roivant-sciences-unveils-new-vant-subsidiary-for-in-licensed-pulmonary-hypertension-drug-from-bay" rel="noreferrer noopener">Roivant Sciences Unveils New &#8216;Vant&#8217; Subsidiary For In-Licensed Pulmonary Hypertension Drug From Bayer</a>.
The compound is also approved in combination with ADT for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease in more than 85 countries.
Results from the Phase III ARANOTE trial, on which this new submission is based, showed that darolutamide plus&nbsp;ADT&nbsp;significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54), in <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40881070/bayer-targets-expanded-use-approval-for-prostate-cancer-drug-reveals-encouraging-data-from-pivota" rel="noreferrer noopener">patients with mHSPC</a>.
Consistent benefits in radiological progression-free survival (rPFS) were observed across prespecified subgroups, including patients with high- and low-volume mHSPC.
Treatment-emergent adverse events (TEAEs) were low and similar between treatment groups and the safety analysis reconfirmed the established tolerability profile of darolutamide as observed in the ARAMIS and ARASENS trials.
The ARANOTE results were simultaneously presented at the 2024 ESMO Congress and published in&nbsp;The Journal of Clinical Oncology.
Darolutamide is developed jointly by Bayer and a Finnish pharmaceutical company, Orion Corporation.
In June, a Pennsylvania judge drastically reduced a $2.25 billion verdict against Bayer, cutting it down to $400 million in a case involving a man who claimed he developed cancer from using the <a href="https://www.benzinga.com/news/24/06/39185732/judge-slashes-bayers-massive-2b-roundup-verdict-to-400m" target="_blank" rel="noreferrer noopener">company&#8217;s Roundup weedkiller</a>.
Image by PDPics from Pixabay
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</ul>

Bayer Seeks European Approval For Third Indication For Cancer Drug Darolutamide

Johnson &amp; Johnson&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/jnj#NYSE">JNJ</a>), via its subsidiary called Red River Talc, for the third time, filed for voluntary bankruptcy to resolve thousands of lawsuits related to its talc products. Red River Talc has filed for Chapter 11 bankruptcy to equitably resolve all of JNJ&#39;s present and future talc-related claims in a bankruptcy court in the Southern District of Texas.
JNJ faces more than 62,000 lawsuits for its talc-based products, primarily its baby powders. The lawsuits allege that its talc products contain asbestos, which caused many women to develop ovarian cancer. JNJ insists that talc-based products are safe and do not cause cancer. JNJ has permanently discontinued the sale of its talc-based Johnson&#39;s Baby Powder.
So far this year, JNJ&#39;s shares have risen 4.7% compared with the&nbsp;industry&#39;s 23.5% increase.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/52/78741.jpg?v=633076405" />
Image Source: Zacks Investment Research
<h2>JNJ&#39;s Two Failed Bankruptcy Attempts</h2>
Johnson &amp; Johnson&#39;s subsidiary, LTL Management, which was established to manage claims in the cosmetic talc litigation, filed for voluntary bankruptcy twice in New Jersey. However, both the bankruptcy filings were rejected by courts stating that J&amp;J was not in enough financial stress to qualify for bankruptcy.
<h2>JNJ&#39;s New Plan and 3rd Bankruptcy Filing</h2>
In May 2024, LTL Management proposed a new plan committing to pay claimants a present value of approximately $6.5 billion to be paid over 25 years, which could resolve 99.75% of all pending talc lawsuits against the company.
J&amp;J said that Red River filed the bankruptcy case after it received support from around 83% of current claimants for the proposed bankruptcy plan. This&nbsp;exceeds the 75% approval threshold required by the U.S. Bankruptcy Code to secure confirmation of the proposed plan. Red River also increased its settlement commitment by $1.75 billion to approximately $8 billion.
<h2>Several Rulings Against JNJ in Talc Lawsuits</h2>
Several juries have ruled against Johnson &amp; Johnson in talc lawsuits over the years. In one such ruling, in 2018, JNJ was ordered by a Missouri court to pay $4.7 billion in damages to 22 women who made such allegations, affirming a St. Louis court jury&#39;s verdict given earlier. Though the verdict was reduced to $2.1 billion by an appeals court in June 2020, it still rejected J&amp;J&#39;s appeal to overturn the 2018 jury verdict. JJohnson &amp; Johnson paid the award, which, including interest, totaled approximately $2.5 billion. In April 2023, J&amp;J offered to pay $8.9 billion over a period of 25 years to completely resolve its cosmetic talc litigation.
JNJ believes that resolving the claims via the civil law system would take years and incur significant costs for the company. The talc lawsuits have also hurt the company&#39;s goodwill and reputation. It believes that resolving the litigation through this proposed reorganization plan would be more efficient and would compensate claimants on time. &nbsp;However, some attorneys of the claimants feel Johnson &amp; Johnson is manipulating the bankruptcy process so that it can delay jury trials and also underpay the claimants. However, the higher settlement offer and a high percentage of claimant support may improve JNJ&#39;s chances of success after the previous two failures.
<h2>JNJ&#39;s Zacks Rank and Stocks to Consider</h2>
J&amp;J currently has a Zacks Rank #3 (Hold).
<div class="chart_embed">
<h3>Johnson &amp; Johnson Stock Price and Consensus</h3>
<img alt="Johnson &amp; Johnson Price and Consensus" src="https://staticx-tuner.zacks.com/images/charts/93/1727080281.png" style="height:265px; width:591px" title="" />
Johnson &amp; Johnson price-consensus-chart | Johnson &amp; Johnson Quote
Some better-ranked drug/biotech companies are Eli Lilly (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/lly#NYSE">LLY</a>), Pfizer&nbsp;and Bayer (OTC: <a class="ticker" href="https://www.benzinga.com/stock/bayry#OTC">BAYRY</a>). While Lilly sports a Zacks Rank #1 (Strong Buy), Pfizer and Bayer have a Zacks Rank #2 (Buy) each.
The Zacks Consensus Estimate for Lilly&#39;s 2024 earnings has risen from $13.78 to $16.49 per share over the past 60 days. For 2025, earnings estimates have risen from $19.44 to $23.97 per share over the same timeframe. Year to date, Lilly&#39;s stock has risen 58.1%.
</div>
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.
The Zacks Consensus Estimate for Pfizer&#39;s 2024 earnings has risen from $2.38 to $2.62 per share in the past 60 days, while that for 2025 has risen from $2.74 per share to $2.85 per share. Pfizer&#39;s shares have risen 2.2% year to date.
Pfizer beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.82%.
Estimates for Bayer&#39;s 2024 earnings have risen from $1.35 to $1.38 per share over the past 60 days. For 2025, earnings estimates have risen from $1.42 to $1.44 per share over the same timeframe. Year to date, Bayer&#39;s stock has declined 13.4%.
<a href="https://www.zacks.com/stock/news/2340100/johnson-johnson-files-for-bankruptcy-over-talc-lawsuits-for-the-third-time?cid=CS-BENZ-FT-analyst_blog|company_news_medical_sector-2340100">To read this article on Zacks.com click here.</a>

Earnings Beats

Management

Markets

Johnson & Johnson Files for Bankruptcy Over Talc Lawsuits for the Third Time

On Monday, Bayer&nbsp;AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) said results from the Phase 3 ARANOTE trial have shown that darolutamide plus androgen deprivation therapy (ADT) significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54), in patients with metastatic hormone-sensitive prostate cancer (mHSPC).
The company adds that darolutamide plus ADT now has &#8216;positive data&#8217; both with and without docetaxel.
The <a target="_blank" href="https://www.bayer.com/media/en-us/darolutamide-plus-adt-significantly-reduced-the-risk-of-radiological-progression-or-death-compared-to-placebo-plus-adt-in-patients-with-mhspc/" rel="noreferrer noopener">results</a> were presented at the 2024 ESMO Congress and simultaneously published in&nbsp;The Journal of Clinical Oncology.
Bayer plans to submit the data from the ARANOTE trial to health authorities globally to support the expanded use of darolutamide in patients with mHSPC.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40801594/roivant-sciences-unveils-new-vant-subsidiary-for-in-licensed-pulmonary-hypertension-drug-from-bay" rel="noreferrer noopener">Roivant Sciences Unveils New &#8216;Vant&#8217; Subsidiary For In-Licensed Pulmonary Hypertension Drug From Bayer</a>.
Darolutamide is already approved for mHSPC under the brand name Nubeqa in combination with ADT and docetaxel and for non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.
The product was developed jointly by Bayer and a Finnish pharmaceutical company, Orion Corporation.
Consistent benefits in radiological progression-free survival (rPFS) were observed across patient subgroups, including high- and low-volume mHSPC, with a risk reduction by 40% and 70%, respectively.
An analysis of immature data of overall survival (OS), which measures the time from treatment until death from any cause, suggested a potential benefit with darolutamide plus ADT vs. placebo plus ADT.
The ARANOTE data also suggested numerical clinical benefits across all other secondary endpoints, including delaying the time to CRPC, PSA progression, pain progression, and initiation of subsequent systemic therapy compared to placebo plus ADT.
Incidences of treatment-emergent adverse events (TEAEs) were low (most were grade 1 or 2) and similar between treatment arms, and treatment discontinuations due to TEAEs were lower in patients receiving darolutamide compared to placebo plus ADT (6.1% vs 9.0%).
In the second quarter of 2024, Nubeqa <a target="_blank" href="https://www.bayer.com/en/investors/quarterly-reports" rel="noreferrer noopener">generated</a> sales of 380 million euros, up 89% year over year.
Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide. Prostate cancer diagnoses are projected to increase from 1.4 million annually in 2020 to 2.9 million by 2040.
Image by PDPics from Pixabay
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Bayer Targets Expanded Use Approval For Prostate Cancer Drug, Reveals Encouraging Data From Pivotal Study

Tuesday,&nbsp;Roivant Sciences Ltd.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ROIV#NASDAQ">ROIV</a>) created Pulmovant to in-license from Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) exclusive worldwide rights to develop and <a target="_blank" href="https://www.benzinga.com/pressreleases/24/09/g40788639/roivant-unveils-new-pipeline-program-mosliciguat-a-potential-first-in-class-and-best-in-category-i" rel="noreferrer noopener">commercialize mosliciguat</a>.
Bayer received an upfront cash payment of ~$14 million, with up to an additional $280 million agreed upon for future development, regulatory, commercial milestone payments, and tiered high-single-digit sales-based royalties.
Mosliciguat is an inhaled, once-daily sGC activator with targeted delivery to the lungs via a dry powder inhaler.
Pulmovant presented data from the proof-of-concept Phase 1b ATMOS study during the European Respiratory Society Congress.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/09/40778228/whats-going-in-with-vivek-ramaswamy-founded-roivant-sciences-stock-on-monday" rel="noreferrer noopener">What&#8217;s Going In With Vivek Ramaswamy-Founded Roivant Sciences Stock On Monday</a>?
The ATMOS Phase 1b trial assessed the efficacy, safety, tolerability, and pharmacokinetics of mosliciguat in participants with pulmonary hypertension aged between 18 and 80. Overall, 38 patients received mosliciguat in this study.
In the per-protocol set of patients (N=20), mosliciguat 1.0, 2.0, and 4.0 mg doses led to mean-max peak reductions in pulmonary vascular resistance&nbsp;(PVR) from baseline of -25.9%, -38.1%, and -36.3%, respectively. The company adds the &#8220;clinically meaningful&#8221; data is &#8220;one of the highest reductions seen in PH trials to date.&#8221;
The company highlights that mosliciguat is unlike other inhaled PH therapies. It requires one inhalation a day, whereas other PH therapies require multiple inhalations at various points during the day.
&#8220;We are impressed with the data generated so far, particularly the PVR results, and we believe its differentiated mechanism as an sGC activator can have maximal impact on PH-ILD patients, a large population with severe disease, high morbidity and mortality, and few treatment options,&#8221; said Matt Gline, Roivant&#8217;s CEO.
Notably, a similar effect on PVR was observed in the pharmacodynamic analysis set (N=37), which included both responsive and non-responsive participants to inhaled nitric oxide (NO).
Pulmovant will advance the clinical program to assess mosliciguat in its global Phase 2 PHocus study in patients with PH-ILD, a subgroup of Group 3 PH.
Approximately 120 patients will be enrolled in the study, starting imminently.
Price Action: ROIV stock is down 1.88% at $12.27 at the last check on Tuesday.
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</ul>

Contracts

ROIV

Roivant Sciences Unveils New 'Vant' Subsidiary For In-Licensed Pulmonary Hypertension Drug From Bayer

Friday, BridgeBio Pharma Inc.&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/BBIO#NASDAQ">BBIO</a>) presented additional data from an analysis of its Phase 3 ATTRibute-CM and open-label extension study of acoramidis in ATTR-CM at the European <a target="_blank" href="https://www.benzinga.com/pressreleases/24/08/g40654449/bridgebio-shares-data-on-serum-ttr-increase-when-switching-participants-from-placebo-and-tafamidis" rel="noreferrer noopener">Society of Cardiology (ESC) 2024</a>.
The data included change from baseline in serum TTR levels in participants receiving acoramidis versus those receiving tafamidis in the placebo group in ATTRibute-CM at Month 30, as well as serum TTR levels in patients who transitioned from placebo and tafamidis to acoramidis.
Also Read: <a target="_blank" href="https://www.benzinga.com/general/biotech/24/08/40652720/alnylam-pharmaceuticals-stock-falls-after-detailed-vutrisiran-data-for-a-condition-with-stiff-hea" rel="noreferrer noopener">Alnylam Pharmaceuticals Stock Falls After Detailed Vutrisiran Data For A Condition With Stiff Heart Muscles</a>.
Transthyretin amyloidosis (ATTR-CM) occurs when the liver produces faulty transthyretin (TTR) proteins. Clumps of these abnormal proteins (called fibrils) build up in the heart's main pumping chamber.
In participants who switched from Pfizer Inc's (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/PFE#NYSE">PFE</a>) Vyndaqel&nbsp;(tafamidis) and placebo in the ATTRibute-CM study to acoramidis in its open-label extension (OLE), there was a mean of 3.0mg/dL increase in serum TTR at Month 1 of the OLE (n=21, p=0.01) and mean of 3.4mg/dL increase in serum TTR at Month 6 of the OLE (n=18, p=0.01).
BridgeBio submitted a marketing application to the FDA, which has been accepted with a PDUFA action date of November 29, and a marketing application to the European Medicines Agency, with a decision expected in 2025.
BridgeBio has granted Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) exclusive rights to commercialize acoramidis for ATTR-CM in Europe.
Price Action: BBIO stock is up 12.50% at $27.69 at the last check on Friday.
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</ul>

Why Is BridgeBio Pharma Stock Trading Higher On Friday?

Regeneron Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/regn#NASDAQ">REGN</a>) announced that the European Commission&nbsp;approved odronextamab for treating adult patients with relapsed or refractory (R/R) follicular lymphoma&nbsp;or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.
The drug has been approved under the brand name Ordspono.
The approval is based on results from the phase I ELM-1 and pivotal phase II ELM-2 trials, which demonstrated robust, durable response rates in adults with R/R FL or R/R DLBCL.
Regeneron&#39;s shares have rallied 37.3% year to date against the industry&#39;s decline of 0.2%.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/f5/75596.jpg?v=1262470421" />
Image Source: Zacks Investment Research
<h3>Positive Study Results Help REGN</h3>
Results from ELM-2 (n=128), as assessed by an independent review committee, showed an objective response rate (ORR) of 80%, with 73% achieving a complete response&nbsp;in R/R FL.
Results from ELM-2 (n=127) in patients who were CAR-T therapy naive, as assessed by an IRC showed 52% ORR, with 31% achieving a CR in R/R DLBLCL.
Results from ELM-1 (n=60) in patients who had progressed after CAR-T therapy, as assessed by an IRC, showed 48% ORR, with 32% achieving a CR.
The approval in the EU is the first regulatory approval of Ordspono in the world for these patients. Ordspono is a bispecific antibody that acts by linking the lymphoma cell to a killer T cell.
Approval in the EU was mostly expected as the European Medicines Agency&#39;s Committee for Medicinal Products for Human Use recommended approval of odronextamab.
The EMA previously granted odronextamab Orphan Designation for FL and DLBCL.
<h3>REGN Suffers Setback With Odronextamab</h3>
Earlier, the company&#39;s efforts to get odronextamab approved in the United States suffered a setback. The regulatory body issued complete response letters (CRLs) for its BLA for odronextamab in March 2024. The BLA is seeking the approval of the candidate R/R FL and R/R DLBCL.
The sole issue with the approval is related to the enrollment status of the confirmatory trials.
The CRLs (one for R/R FL and one for R/R DLBCL) did not identify any issue with the clinical efficacy or safety, trial design, labeling or manufacturing.
<h3>How Will the Approval Help Regeneron?</h3>
The successful development of these oncology drugs should be a great boost for REGN. It will also reduce its dependence on sales of lead ophthalmology drug Eylea and profits from asthma drug Dupixent for growth.
The firm is looking to strengthen its oncology franchise, which currently comprises Libtayo (cemiplimab-rwlc), indicated in certain patients with advanced basal cell carcinoma, advanced cutaneous squamous cell carcinoma and advanced non-small cell lung cancer.
The company is investigating the use of odronextamab as a monotherapy and in combination across earlier lines of therapy in challenging-to-treat lymphomas. This includes the registrational ELM-1 and ELM-2 studies, the phase III OLYMPIA development program, which is one of the largest clinical programs in lymphoma evaluating odronextamab in earlier lines of therapy and additional B-NHLs and early-stage trials with chemotherapy-free combinations.
A phase II study for fianlimab, an antibody to LAG-3, in combination with Libtayo for perioperative non-small cell lung cancer, was also initiated. A phase II/III study for fianlimab, in combination with Libtayo for perioperative melanoma, was also initiated.
<h3>Regulatory Setbacks Derail REGN</h3>
Last week, REGN received a CRL from the FDA for its BLA for pipeline candidate linvoseltamab.
The BLA is seeking FDA approval for linvoseltamab to treat R/R multiple myeloma that has progressed after at least three prior therapies.
Regeneron stated that the sole issue identified in the CRL is related to findings from a pre-approval inspection at a third-party fill/finish manufacturer for another company&#39;s product candidate.&nbsp;The CRL delays the potential approval of the candidate.
REGN has a collaboration agreement with Bayer (OTC: <a class="ticker" href="https://www.benzinga.com/stock/bayry#OTC">BAYRY</a>) for Eylea. The company records net product sales of Eylea and Eylea HD in the United States and Bayer records its net product sales outside the country. Regeneron records its share of profits in connection with sales of Eylea outside the United States.
Regeneron has a collaboration agreement with Sanofi (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>) for Dupixent. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits/losses in connection with the global sales of both drugs.
<h3>Zacks Rank</h3>
Regeneron currently carries a Zacks Rank #3 (Hold).
<a href="https://www.zacks.com/stock/news/2327848/regeneron-s-bispecific-antibody-obtains-ec-nod-for-lymphoma?cid=CS-BENZ-FT-analyst_blog|company_news_medical_sector-2327848">To read this article on Zacks.com click here.</a>

REGN

Regeneron's Bispecific Antibody Obtains EC Nod for Lymphoma

Regeneron Pharmaceuticals, Inc. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/regn#NASDAQ">REGN</a>) reported earnings per share of $11.56, which beat the Zacks Consensus Estimate of $10.57. The company recorded an EPS of $10.24 in the year-ago period.
The upside in the bottom line can be attributed to higher revenues.
Total revenues increased 12% year over year to $3.54 billion, fueled by higher Dupixent, Eylea HD and Libtayo sales. Revenues also beat the Zacks Consensus Estimate of $3.38 billion.&nbsp;
Shares are trading up in response to the better-than-expected results.
Regeneron&#39;s shares have risen 22.8% year to date against the industry&#39;s decline of 0.6%.
<img alt="Zacks Investment Research" src="https://staticx-tuner.zacks.com/images/articles/charts/8d/73084.jpg?v=2091733934" /> 
Image Source: Zacks Investment Research
<h3>Quarterly Highlights</h3>
Eylea&#39;s sales in the United States declined 18% year over year to $1.2 billion, primarily due to increased competition resulting in lower volumes and a reduced net selling price.
Please note that Regeneron co-developed Eylea with the HealthCare unit of Bayer AG (OTC: <a class="ticker" href="https://www.benzinga.com/stock/bayry#OTC">BAYRY</a>). Regeneron records net product sales of Eylea in the United States and Bayer does the same outside the country. Regeneron records its share of profits/losses in connection with the sales of Eylea outside the United States.
In August 2023, the FDA approved Eylea HD (higher dose of Eylea) for the treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.
Eylea HD generated revenues of $304 million in the United States, driven by the addition of new patients and the transition of patients from other anti-VEGF products, including Eylea.
Total Eylea and Eylea HD sales in the United States were $1.53 billion, up 2% year over year. The figure also beat the Zacks Consensus Estimate of $1.52 billion.
Total revenues include collaboration revenues of $1.52 billion from Sanofi (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>) and Bayer. The figure increased 15.7% from that recorded in the year-ago quarter. Total collaboration revenues beat the Zacks Consensus Estimate of $1.43 billion.
Sanofi&#39;s collaboration revenues increased 21% to $1.1 billion, driven by profits associated with higher Dupixent sales. We note that Sanofi records global net product sales of Dupixent and Kevzara, while Regeneron records its share of profits/losses in connection with the global sales of both drugs. Dupixent&#39;s sales increased 27% year over year to $3.5 billion.
Bayer&#39;s collaboration revenues totaled $375 million, down 1% year over year.
Regeneron records net product sales of Praluent in the United States and Sanofi does the same outside the country. SNY pays REGN a royalty on such sales. Regeneron records global net product sales of Libtayo and pays Sanofi a royalty on such sales.
Total Libtayo sales came in at $297.4 million, up 42% year over year. The figure beat the Zacks Consensus Estimate of $285 million.
Praluent&#39;s net sales in the United States were $56.1 million. Kevzara recorded global sales of $109.7 million, up 10% from the year-ago quarter&#39;s level.
Adjusted R&amp;D expenses jumped 10% year over year to $1.1 billion due to the advancement of the company&#39;s late-stage oncology programs, and higher headcount and headcount-related costs. Adjusted SG&amp;A expenses increased 19% to $667 million due to higher commercialization-related expenses to support the launch of Eylea HD and higher headcount and headcount-related costs.
<h3>Pipeline and Regulatory Update</h3>
In June 2024, the European Commission approved Dupixent as an add-on maintenance treatment for adults with uncontrolled chronic obstructive pulmonary disease (COPD) characterized by raised blood eosinophils.
However, in May 2024, the FDA extended the target action date of its priority review of the supplemental biologics license application (sBLA) for Dupixent as an add-on maintenance treatment in certain adult patients with uncontrolled COPD by three months. The revised target action date is Sep 27, 2024.
The FDA accepted (for priority review) the sBLA for Dupixent as an add-on maintenance treatment for adolescents aged 12 to 17 years with inadequately controlled chronic rhinosinusitis with nasal polyposis (CRSwNP), with a target action date of Sep 15, 2024.
The European Medicines Agency&#39;s, Committee for Medicinal Products for Human Use adopted a positive opinion recommending conditional marketing authorization of odronextamab to treat adults with relapsed/refractory (R/R) follicular lymphoma or R/R diffuse large B-cell lymphoma (DLBCL), after two or more lines of systemic therapy.
Regeneron initiated a phase II study on fianlimab, an antibody to LAG-3, in combination with Libtayo, for the treatment of perioperative non-small cell lung cancer. A phase II/III study evaluating fianlimab, in combination with Libtayo, for treating perioperative melanoma was also initiated.
A phase II study was initiated for trevogrumab, an antibody to myostatin (GDF8), in combination with semaglutide with and without garetosmab, for the treatment of obesity.
<h3>Our Take</h3>
Regeneron&#39;s performance in the second quarter was impressive with both the top and bottom lines surpassing their respective estimates.
<div class="chart_embed">
Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise
<img alt="Regeneron Pharmaceuticals, Inc. Price, Consensus and EPS Surprise" src="https://staticx-tuner.zacks.com/images/charts/df/1722516299.png" style="height:265px; width:596px" title="" />
Regeneron Pharmaceuticals, Inc. price-consensus-eps-surprise-chart | Regeneron Pharmaceuticals, Inc. Quote
</div>
While Eylea sales have been under pressure due to competition from Roche&#39;s (OTC: <a class="ticker" href="https://www.benzinga.com/stock/rhhby#OTC">RHHBY</a>) Vabysmo, the uptake of the higher dose of the drug is encouraging as Eylea patients transition to the higher dose.
Regeneron&#39;s efforts to broaden its oncology portfolio and foray into the lucrative obesity space are also encouraging.
The uptake of Vabysmo has been outstanding. Roche has designed Vabysmo to block pathways involving Ang-2 and VEGF-A. Roche recorded CHF 1.8 billion of Vabysmo sales in the first half of 2024 on strong demand in all regions.
<h3>Zacks Rank</h3>
Regeneron currently carries a Zacks Rank #3 (Hold).
<a href="https://www.zacks.com/stock/news/2314372/regeneron-regn-tops-on-q2-earnings-eylea-hd-dupixent-fuel-sales?cid=CS-BENZ-FT-analyst_blog|earnings_article-2314372">To read this article on Zacks.com click here.</a>

RHHBY

Regeneron Tops on Q2 Earnings, Eylea HD, Dupixent Fuel Sales

An Australian judge has dismissed a <a href="https://www.benzinga.com/news/large-cap/24/01/36842117/weedkiller-woes-australian-court-nears-decision-in-bayers-roundup-trial">class action lawsuit</a> alleging that Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYZF#OTC">BAYZF</a>) Roundup weedkiller causes a type of blood cancer. This ruling is a significant victory for Bayer, facing numerous similar lawsuits in the United States.
Justice Michael Lee of Australia&#8217;s Federal Court ruled that the evidence was insufficient to link Roundup to non-Hodgkin&#8217;s lymphoma (NHL), a type of cancer that begins in the lymphatic system, part of the body&#8217;s germ-fighting immune system.
Related: <a target="_blank" href="https://www.benzinga.com/news/24/06/39185732/judge-slashes-bayers-massive-2b-roundup-verdict-to-400m" rel="noreferrer noopener">Judge Slashes Bayer&#8217;s Massive $2B Roundup Verdict To $400M</a>.
The decision supports Bayer&#8217;s stance that Roundup, a glyphosate-based herbicide, is safe.
Reuters highlights the company asserts it &#8220;fully stands behind its glyphosate-based products, which have been used around the world for almost 50 years.&#8221;
The Australian class action suit united more than 1,000 claimants, marking one of approximately 40 cases outside the United States, primarily in Canada and Australia.
The lead claimant, Kelvin McNickle, 41, allegedly used Roundup for over two decades before developing NHL at 35.
Bayer has won 14 of the last 20 Roundup trials in the United States. However, a series of losses in late 2023 and early 2024 resulted in over $4 billion in damages awarded to plaintiffs, significantly impacting investor confidence.
Despite this recent win, Bayer still faces over 50,000 outstanding claims in the United States. A U.S. court recently denied Bayer&#8217;s request for an agreement to prevent future cases.
To mitigate litigation risks, Bayer has replaced glyphosate with new active ingredients in its household products in the U.S. while continuing to sell glyphosate-based weedkillers to farmers, who heavily rely on it.
In May, Bayer&#8217;s Monsanto unit secured a significant victory. A Washington state appeals court overturned a $185 million verdict against the company over chemical contamination at a <a target="_blank" href="https://www.benzinga.com/news/large-cap/24/05/38593423/bayers-monsanto-scores-legal-victory-as-185m-verdict-overturned" rel="noreferrer noopener">Seattle-area school</a>.&nbsp;
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</ul>
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo: Shutterstock

Legal

Bayer Weedkiller Lawsuit Dismissed By Australian Judge: Insufficient Evidence Linking Roundup To Blood Cancer

A Pennsylvania judge on Tuesday drastically reduced a $2.25 billion verdict against Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>), cutting it down to $400 million in a case involving a man who claimed he developed cancer from using the company&#8217;s Roundup weedkiller.
The jury in the Philadelphia Court of Common Pleas had initially awarded John McKivison $250 million in compensatory damages and $2 billion in punitive damages, finding that his non-Hodgkin&#8217;s lymphoma was caused by long-term use of Roundup at his home.
However, Judge Susan Schulman later adjusted the damages to $50 million in compensatory and $350 million in punitive, citing Bayer&#8217;s challenges.
Bayer intends to appeal to the Superior Court of Pennsylvania, arguing that the trial included misleading and &#8220;inflammatory&#8221; testimony. Reuters noted that the company also called for legislative reform to shield companies that comply with federal labeling standards.
McKivison&#8217;s legal team expressed satisfaction that the jury&#8217;s decision to link Roundup to cancer was upheld.
However, they plan to appeal for the reinstatement of the original $2.25 billion verdict, stating that the reduction deviates from established Pennsylvania law.
Despite numerous studies indicating that glyphosate, the active ingredient in Roundup, is safe for human use, the product has faced extensive legal challenges.
Roundup, once widely used in U.S. households, saw its home-use sales phased out by Bayer last year.
Bayer has faced over 165,000 claims in the U.S. alleging that Roundup causes non-Hodgkin&#8217;s lymphoma. Although Bayer has won 14 of the last 20 trials, recent losses have led to over $4 billion in verdicts, shaking investor confidence and company hopes for an end to the litigation.
In 2020, Bayer settled many pending cases for up to $9.6 billion, but future claims remain unresolved, with more than 50,000 still pending.
Price Action: BAYRY shares closed at $7.79 on Tuesday.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo via Wikimedia Commons

Media

Judge Slashes Bayer's Massive $2B Roundup Verdict To $400M

European equities ended Monday broadly positive, while the U.S. market was closed for <a href="https://www.benzinga.com/24/05/39027079/is-the-us-stock-market-open-on-memorial-day-why-the-s-p-500-could-end-the-year-on-a-high-note">the Memorial Day holiday. </a>
Traders maintained an overall positive risk sentiment on European assets, driven by near-total certainty that the European Central Bank (ECB) will deliver a rate cut at its June meeting.
Three key ECB members — chief economist Philip Lane, Finland Central Bank governor Olli Rehn and France Central Bank governor François Villeroy de Galhau — made reassuring statements indicating a rate cut is imminent.
<ul>
<li>&#8220;A June rate cut is appropriate if the inflation outlook holds,&#8221; Lane said. </li>
<li>&#8220;Inflation is converging to our 2% target in a sustained way, making it the right time in June to ease the monetary policy stance and start cutting rates,&#8221; Rehn said. </li>
<li>&#8220;Barring a surprise, a June rate cut is a done deal,&#8221; Villeroy said. </li>
</ul>
Traders now almost fully price in a June rate cut and expect a total of 65 basis points in cuts (more than two cuts but less than three) by the end of the year.
The euro, as tracked by the Invesco CurrencyShares Euro Currency Trust (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/FXE#NYSE">FXE</a>), inched 0.1% higher to 1.0840. 
<h3 class="wp-block-heading">Monday&#8217;s Performance In Major European Indices</h3>
<figure class="wp-block-table is-style-stripes"> 
<table>
<thead>
<tr>
<th class="has-text-align-center" data-align="center">Country</th>
<th>US-Based ETF</th>
<th>Price</th>
<th>1-day %chg</th>
</tr>
</thead>
<tbody>
<tr>
<td class="has-text-align-center" data-align="center">Spain – IBEX 35</td>
<td>iShares MSCI Spain ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EWP#NYSE">EWP</a>)</td>
<td>11,335</td>
<td>0.79%</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Italy – FTSE MIB </td>
<td>iShares MSCI Italy ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EWI#NYSE">EWI</a>)</td>
<td>34,751</td>
<td>0.75%</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">France – CAC 40</td>
<td>iShares MSCI France Index Fund (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/EWQ#NYSE">EWQ</a>)</td>
<td>8,142</td>
<td>0.62%</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">EU – Euro Stoxx 50</td>
<td>iShares Europe ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IEV#NYSE">IEV</a>)</td>
<td>5,065</td>
<td>0.58%</td>
</tr>
<tr>
<td class="has-text-align-center" data-align="center">Germany – DAX </td>
<td>Global X Dax Germany ETF (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/DAX#NYSE">DAX</a>)</td>
<td>18,793</td>
<td>0.53%</td>
</tr>
</tbody>
</table>
</figure>
<h3 class="wp-block-heading">Monday&#8217;s Stock Movers In Europe</h3>
Monday&#8217;s top performers on the Euro Stoxx 50 index included:
<ul>
<li>RWE AG (OTCPK: RWEOY) +2.55%</li>
<li>Bayer AG (OTCPK: BAYRY) +2.32%</li>
<li>Volkswagen AG (OTCPK: VWAGY) +1.65%</li>
<li>Enel Società per Azioni (OTCPK: ENLAY) +1.6%</li>
<li>Iberdrola S.A. (OTCPK: IBRDY) +1.5%</li>
<li>Eni S.p.A. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/E#NYSE">E</a>) +1.38%</li>
</ul>
European pharma giant Novo Nordisk A/S (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVO#NYSE">NVO</a>) and France luxury powerhouse LVMH-Moet Hennessy Louis Vuitton (OTCPK: LVMUY) closed 0.9% lower and 0.8% higher, respectively. 
Dutch chipmaker firm ASML Holding N.V. (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ASML#NASDAQ">ASML</a>) closed 0.2% higher, notching the third straight session of gains. 
Among carmakers, Stellantis N.V. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/STLA#NYSE">STLA</a>) rose 1.5%. Ferrari N.V. (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/RACE#NYSE">RACE</a>) closed up 0.7%, positively reacting to its victory in Sunday's Formula 1 Grand Prix in Monte Carlo.
Among major banks, UBS Group AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UBS#NYSE">UBS</a>) outperformed, up 1%. 
Read now: <a href="https://www.benzinga.com/news/24/05/39028061/alibaba-signs-david-beckham-as-global-brand-ambassador-for-e-commerce-platform">Alibaba Signs David Beckham As Global Brand Ambassador For E-Commerce Platform</a>
Photo via Shutterstock.

Macro Notification

Market Summary

Mid Cap

Currency ETFs

Global

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European Equities Close Higher As Traders Bank On Imminent ECB Rate Cut: What's Driving Markets Monday?

U.S.&nbsp;drug wholesaler&nbsp;Cencora Inc&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/COR#NYSE">COR</a>), formerly&nbsp;AmerisourceBergen, is notifying affected individuals about their personal and&nbsp;highly sensitive&nbsp;medical information stolen during a cyberattack earlier this year.&nbsp;
The healthcare giant revealed that the breached data includes patient names, postal addresses, dates of birth, health diagnoses, and medication details.
In letters this week, TechCrunch&nbsp;<a target="_blank" href="https://techcrunch.com/2024/05/24/cencora-americans-health-data-stolen-breach-cyberattack/?guccounter=1" rel="noreferrer noopener">reported</a>&nbsp;that Cencora had obtained patients&#8217; data through partnerships with other drug makers as part of its patient support programs.&nbsp;
These partnerships include pharmaceutical companies such as AbbVie Inc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/ABBV#NYSE">ABBV</a>), Acadia Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/ACAD#NASDAQ">ACAD</a>), Bayer AG (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYZF#OTC">BAYZF</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>), Novartis AG (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/NVS#NYSE">NVS</a>), and Regeneron Pharmaceuticals Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/REGN#NASDAQ">REGN</a>), among others.
The nature of the cyberattack, which began on February 21, has not been disclosed.&nbsp;
After filing a notice with government regulators, Cencora publicly acknowledged the breach on February 27.&nbsp;
Despite the disclosure, the company has not revealed how many individuals were affected or how many have been notified&nbsp;to date.&nbsp;
Mike Iorfino, a spokesperson for Cencora, confirmed these details in an email to TechCrunch.
This incident is the latest in a series of cyberattacks targeting the&nbsp;U.S.&nbsp;healthcare sector. Recently,&nbsp;UnitedHealth Group Inc&nbsp;(NYSE:<a class="ticker" href="https://www.benzinga.com/stock/UNH#NYSE">UNH</a>)-owned Change Healthcare and Ascension&#8217;s hospital network experienced significant breaches and&nbsp;<a target="_blank" href="https://www.benzinga.com/news/large-cap/24/04/38388554/patient-data-compromised-unitedhealth-group-admits-ransom-payment-in-cyberattack" rel="noreferrer noopener">operational disruptions</a>.&nbsp;
Related: <a href="https://www.benzinga.com/government/24/05/38563578/us-senate-grills-unitedhealth-ceo-over-cyberattack-fallout-ransom-payment" target="_blank" rel="noreferrer noopener">US Senate Grills United Health&#8217;s Cyberattack Fallout, Ransom Payment</a>.
However, Cencora maintains &#8220;no connection&#8221; between its incident and those affecting Change Healthcare and Ascension.
As a major distributor, Cencora&nbsp;handles around 20% of&nbsp;pharmaceuticals sold and distributed in the United States.
Read Next:&nbsp;<a target="_blank" href="https://www.benzinga.com/news/large-cap/24/02/37134638/us-federal-trade-commission-investigates-drug-shortages-amid-allegations-of-market-manipulation" rel="noreferrer noopener">US&nbsp;Federal Trade Commission Investigates Drug Shortages Amid Allegations Of Market Manipulation</a>.
Price Action:&nbsp;COR shares are down 0.41% at $217.70&nbsp;at the last check&nbsp;on Friday.
Disclaimer: This content was partially produced with the help of AI tools and was reviewed and published by Benzinga editors.
Photo by Bits And Splits on Shutterstock

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After UnitedHealth Cyberattack, Drug Distributor Cencora Notifies Americans' Health Information Stolen In Data Breach In February

Bayer AG&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>) (OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYZF#OTC">BAYZF</a>)&nbsp;<a target="_blank" href="https://www.bayer.com/media/en-us/elinzanetant-significantly-reduces-frequency-and-severity-of-moderate-to-severe-hot-flashes-associated-with-menopause/" rel="noreferrer noopener">will</a>&nbsp;present detailed results from the Phase 3 studies OASIS 1 and 2, showing&nbsp;that the investigational compound elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms (hot flashes) associated with menopause compared to placebo.&nbsp;
The company released the topline data showing&nbsp;elinzanetant&nbsp;met all four primary&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/01/36538587/menopause-management-bayers-non-hormonal-treatment-option-shows-efficacy-in-trial" rel="noreferrer noopener">endpoints in both studies</a>.
These data will be presented at the 2024 American College of Obstetricians and Gynecologists (ACOG) Annual Clinical &amp; Scientific Meeting.
Related:&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/03/37716027/german-conglomerate-bayer-goes-johnson-johnson-way-to-tackle-its-cancer-related-lawsuits" rel="noreferrer noopener">German Conglomerate Bayer Goes Johnson &amp; Johnson Way To Tackle Its&nbsp;Cancer Related&nbsp;Lawsuits</a>.
Elinzanetant met all four primary endpoints in both studies, demonstrating statistically significant reductions in the frequency and severity of moderate to severe VMS from baseline to&nbsp;week&nbsp;4 and 12 compared to placebo.&nbsp;
Elinzanetant showed in OASIS 1&nbsp;significant mean reductions&nbsp;versus placebo for&nbsp;frequency&nbsp;at week 4 with -3.29 and week 12 with -3.22 and&nbsp;for&nbsp;severity&nbsp;at week 4 with -0.33 and week 12 with -0.40.&nbsp;
In OASIS 2,&nbsp;elinzanetant&nbsp;demonstrated significant mean reductions versus placebo for&nbsp;frequency&nbsp;at week 4 with -3.04 and at week 12 with -3.24 and for&nbsp;severity&nbsp;at week 4 with -0.22 and at week 12 with -0.29.&nbsp;
The safety profile of elinzanetant was favorable in both studies with headache and fatigue being the most frequent&nbsp;treatment emergent&nbsp;adverse events (TEAEs) within the elinzanetant groups.
In addition,&nbsp;elinzanetant&nbsp;met its key secondary endpoints&nbsp;showing&nbsp;a statistically significant reduction in the frequency of VMS from baseline to week&nbsp;1&nbsp;and improved sleep disturbances and&nbsp;menopause-related&nbsp;quality of life compared to placebo.&nbsp;
In March, Bayer announced&nbsp;the topline results of the OASIS 3&nbsp;Phase 3 study evaluating the efficacy and long-term safety of the investigational compound&nbsp;elinzanetant&nbsp;versus placebo.&nbsp;
OASIS 3 is the third Phase 3 study in the OASIS&nbsp;<a target="_blank" href="https://www.benzinga.com/24/03/37822314/bayers-third-menopausal-relief-drug-trial-meets-primary-goal-german-conglomerate-seeks-fda-approval" rel="noreferrer noopener">clinical development program</a>.&nbsp;
Bayer will submit the data from the OASIS 1, 2&nbsp;and&nbsp;3 studies to health authorities for approval of marketing authorizations of&nbsp;elinzanetant&nbsp;for moderate to severe VMS associated with menopause.
Read Next: <a href="https://www.benzinga.com/news/24/03/37492549/bayer-holds-splitting-into-separate-units-for-three-years-focus-shifts-on-tackling-challenges" target="_blank" rel="noreferrer noopener">Bayer Holds Splitting Into Separate Units For Three Years, Focus Shifts On Tackling Challenges</a>
Photo by ClareM via Shutterstock

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DARE

Bayer Highlights Detailed Data From Twin Late-Stage Trials On Experimental Menopause Candidate, Seeks Regulatory Approval

On Sunday, Pfizer (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/pfe#NYSE">PFE</a>) and AstraZeneca Plc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/azn#NASDAQ">AZN</a>) were among the pharmaceutical companies who announced they will be investing&nbsp;a total of nearly $1 billion in their operations in France, just ahead of this year&rsquo;s &ldquo;Choose France&rdquo; business summit.&nbsp;Together with the domestic Sanofi (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>), Pfizer, AstraZeneca will together invest &euro;1.87 billion which is more than&nbsp;$2 billion&nbsp;to expand their operations in the country.
AstraZeneca committed 365 million euros, which is about $394 million, to enhance its facilities at its French manufacturing facility in Dunkirk. Pfizer pledged even more, making a commitment to invest 500 million euros or $540 million over the next five years to boost its French R&amp;D capabilities. The leading investor is the Parisian drugmaker, Sanofi, who commited to invest 1 billion euros or $1.1 billion to expand its manufacturing capacity across three of its French sites. With this ambitious biomanufacturing investment, Sanofi promises&nbsp;to significantly strengthen France&rsquo;s ability to control the production of its medicines from start to finish. Moreover, Sanofi made an agreement with a&nbsp;biotech company Novavax to join forces in both expanding access to COVID-19 vaccines, as well as to explore the development of&nbsp;a next-generation flu and COVID-19 combination shot.&nbsp;The latest strategic move with which Sanofi gained access to Novavax&rsquo;s innovative vaccine technology is one of the ways the French company is trying to find new growth avenues amid a competitive landscape.
According to a document from the French government, AbbVie Inc (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/abb#NYSE">ABB</a>), GSK plc (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/gsk#NYSE">GSK</a>), Novartis AG (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/nvs#NYSE">NVS</a>) and even Johnson &amp; Johnson (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/jnj#NYSE">JNJ</a>)&rsquo;s health spinoff Kenvue&nbsp;Inc (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/kvue#NYSE">KVUE</a>) are also planning to increase their presence in France.&nbsp;
According to the French government, AbbVie commited to spend&nbsp;36 million euros or $39 million to add jobs at its aesthetic medicine facility in Annecy-Pringy while Novartis will invest 30 million euros or $32 million in the creation of a production unit for for a specific treatment of prostate cancer. Kenvue commited invest 10.7 million euros or $11.6 million in the country. By doing so, Kenvue will create 45 jobs. Also, Kenvue is to expand production of four products at its facility in Normandy.
While France is fighting for its place under the pharmaceutical sun,&nbsp;Germany is home to Bayer Aktiengesellschaft (OTC: <a class="ticker" href="https://www.benzinga.com/stock/bayry#OTC">BAYRY</a>), a global titan&nbsp;in the pharmaceutical and life sciences arena, and&nbsp;Merck &amp; Co Inc (NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mrk#NYSE">MRK</a>) that&nbsp;established itself as a leader on several fronts as it develops innovative treatments for a range of medical conditions, from chronic diseases to rare disorders.&nbsp;Together with Moderna Inc (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrna#NASDAQ">MRNA</a>), Merck developed an experimental mRNA cancer vaccine to treat melanoma. Merck and Moderna ended 2023 by reporting the benefits of the treatment that combines their vaccine with Keytruda, Merck&rsquo;s blockbuster drug, hold up after three years, more specifically,&nbsp;they lower the chance of recurrence or death from melanoma by half. Moreover, with this vaccine that trains the patient&rsquo;s immune system to recognize and attack cancer cells, Merck and Moderna announced they will expand their research to treating a non-small cell lung cancer.
But Germany is also home to smaller companies that are making a big difference in the world, like Mainz Biomed N.V. (NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mynz#NASDAQ">MYNZ</a>). Mainz Biomed is a molecular genetics diagnostics company that specializes in the early detection of cancer. It is expected to unveil breaktrhough early cancer detection results&nbsp;&nbsp;from its eAArly DETECT study at Digestive Disease Week 2024 in Washington D.C. that will kick off on May 18th. eAArly DETECT&nbsp;is a US multi-site study that enrolled 254 clinical patients across 21 specialized gastroenterology sites. Mainz Biomed will report the results of its colorectal cancer screening test&nbsp;&nbsp;that combines Fecal Immunochemical Test, DNA and mRNA biomarkers with a AI learning algorithm to differentiate between colorectal cancer, advanced adenomas, non-advanced adenomas and patient samples with no findings. Besides improving early detection rates and therefore, simultaneously lowering cancer mortality rates with its non-invasive and easy at-home test ColoAlert, Mainz Biomed is also accelerating the shift to prevention by advancing screening practices for precancerous conditions. While ColoAlert is already marketed across Europe, Mainz Biomed is also developing PancAlert, a pancreatic cancer screening test.
All in all, the above examples show that Europe is determined to fight for the pharmaceutical throne, and it is already home to life-changing breakthroughs.
DISCLAIMER: This content is for informational purposes only. It is not intended as investing advice.
This article is from an unpaid external contributor. It does not represent Benzinga&#39;s reporting and has not been edited for content or accuracy.

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Pfizer, AstraZeneca, Sanofi And Mainz Biomed To Uplevel Europe's Pharma Game

Pharmaceutical companies have been at the forefront of artificial intelligence for quite some time. Researchers have been using advanced AI models to understand disease mechanisms even before the recent surge in interest.
Wednesday, researchers at&nbsp;Alphabet Inc&#8217;s&nbsp;(NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOOG#NASDAQ">GOOG</a>) (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/GOOGL#NASDAQ">GOOGL</a>)&nbsp;Google DeepMind&nbsp;developed&nbsp;AlphaFold 3, a new&nbsp;artificial&nbsp;<a target="_blank" href="https://www.benzinga.com/topic/artificial-intelligence" rel="noreferrer noopener">intelligence (AI) model</a>.
AlphaFold&nbsp;3&nbsp;can predict the structure and interactions of biological molecules.&nbsp;This&nbsp;includes proteins, DNA, RNA, and small molecules that&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/24/05/38711266/google-deepmind-develops-latest-ai-model-to-aid-scientists-in-fighting-disease" rel="noreferrer noopener">could function as drugs</a>.&nbsp;
According to the latest McKinsey Global Institute report, AI technology could generate&nbsp;$60 billion—$110 billion annually&nbsp;in economic value for the pharmaceutical industry, as it can help speed up the process of identifying compounds, their development, and approval.
The report adds that generative&nbsp;AI&#8217;s impact on pharmaceuticals&nbsp;is expected&nbsp;to be profound as the foundational models&nbsp;are built&nbsp;on languages, images, omics, patient information, and other types of data that come together to explain and solve the disease process and effective treatment ways.
Increased drug discovery, approval, and marketing speed can help companies resolve the asset life cycle compression issue, which is the diminishing amount of time companies have to capture the value of the new drug.
McKinsey&#8217;s research shows that the time has decreased to 9.8 years from 11.7 years over the past 20 years.
Despite the speedy discovery, the average cost of discovering and developing new drugs has increased.
Generative AI using augmented foundational models can help accelerate pharma research, with drug discovery timelines cut by almost half. AI tech can have a potential economic value of $15 billion-$28 billion on research and discovery.
The report notes that, on average, ten years and around $1.4 billion are needed to bring one new drug to the market, of which 80%&nbsp;is&nbsp;<a target="_blank" href="https://www.benzinga.com/general/biotech/23/09/34818722/from-years-to-months-how-ai-is-shaping-the-landscape-of-clinical-trials" rel="noreferrer noopener">associated&nbsp;with clinical development</a>.&nbsp;
Generative AI addresses pain points by increasing efficiency across&nbsp;the clinical development process,&nbsp;unlocking the economic value of $13 billion to $25 billion.
Generative&nbsp;AI tools can deepen relationships between care providers, pharmacists, insurers, and patients&nbsp;to&nbsp;fine-tune campaign strategies in&nbsp;real time, per the report.&nbsp;
Pharma professionals and patients will have substantial data to make faster, smarter decisions, providing a potential opportunity of $18 billion to $30 billion.
In 2023, the&nbsp;World Health Organization&nbsp;unveiled a comprehensive publication highlighting critical regulatory considerations for harnessing the&nbsp;<a target="_blank" href="https://www.benzinga.com/government/23/10/35330203/world-health-organization-addresses-ai-in-healthcare-bias-outlines-guidance-for-regulatory-complianc" rel="noreferrer noopener">potential of&nbsp;AI in healthcare</a>.&nbsp;
In April,&nbsp;Bayer AG&nbsp;(OTC:<a class="ticker" href="https://www.benzinga.com/stock/BAYRY#OTC">BAYRY</a>)&nbsp;and&nbsp;Google Cloud announced a&nbsp;collaboration&nbsp;to develop AI solutions to&nbsp;<a target="_blank" href="https://www.benzinga.com/news/large-cap/24/04/38169901/google-partners-with-european-conglomerate-bayer-for-new-ai-powered-solutions-for-radiologists" rel="noreferrer noopener">support radiologists</a>.
Key players shaping the market <a href="https://www.benzinga.com/pressreleases/23/10/n35164076/artificial-intelligence-in-healthcare-market-size-worth-usd-201-3-billion-globally-by-2030-at-45-5" target="_blank" rel="noreferrer noopener">include industry giants </a>such as Nvidia Corp (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/NVDA#NASDAQ">NVDA</a>), Intel Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/INTC#NASDAQ">INTC</a>), International Business Machines Corporation (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/IBM#NYSE">IBM</a>), Google, General Electric Co (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/GE#NYSE">GE</a>), Microsoft Corporation (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MSFT#NASDAQ">MSFT</a>), Medtronic Plc (NYSE:<a class="ticker" href="https://www.benzinga.com/stock/MDT#NYSE">MDT</a>), Micron Technology Inc (NASDAQ:<a class="ticker" href="https://www.benzinga.com/stock/MU#NASDAQ">MU</a>), Amazon Web Services, and Siemens Healthineers.
Photo via Shutterstock

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From Hype To Reality, AI Reshapes Pharmaceutical Industry Across Drug Discovery To Marketing - Stocks To Watch

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DZ BANK AG Remains a Buy on Bayer (0P6S)

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Regeneron: Recent Bear Run May Be Justified -- Pharma Faces A Testing 2025

Regeneron: Recent Bear Run May Be Justified - Pharma Faces A Testing 2025

UBS analyst Geoff Haire maintained a Hold rating on Bayer (0P6S – Research Report) today and set a price target of €22.00. The company's shares clo...

Bayer (0P6S) Receives a Hold from UBS

BridgeBio Pharma (BBIO) announced that the Committee for Medicinal Products for Human Use has adopted a positive opinion recommending marketing aut...

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