Merck (OTC:MKGAF) Stock, Quote.Headers.trade-ideas

Merck KGaA operates in three main segments: life sciences, performance materials, and healthcare. The life sciences segment (44% of 2023 sales) primarily provides laboratory consumables and services to researchers in academia and applied fields, including the biopharmaceutical industry. In the healthcare segment (38%), Merck develops, manufactures, and sells branded pharmaceuticals with significant therapeutic concentrations in oncology, multiple sclerosis, and fertility. In its electronics segment (17%), the company offers specialty materials to manufacture a variety of products, such as semiconductors, flat-screen televisions, automobiles, and cosmetics. In 1995, the E. Merck KG family publicly sold part of the company, resulting in the current 30% public ownership of the firm.

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Merck Germany&#39;s Two Pivotal Trials Flunk In Multiple Sclerosis

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Repligen Corporation (NASDAQ: RGEN) agreed to acquire Sweden-based privately-held Metenova. 

Life Sciences Player Repligen&#39;s Strategic European Acquisition - What It Means for Investors

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Merck KGa Germany (OTC: MKGAF) (OTC: MKKGY) reported 

Merck Germany Reports 5% Decline In Q2 Sales, Expects More Decline In 2023

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CORRECTION: Merck KGaA Ticker Is "MKGAF"

<a href="https://www.eqs-news.com/news/adhoc/merck-kgaa-phase-iii-trials-of-xevinapant-in-locally-advanced-head-neck-cancer-discontinued/2079685">https://www.eqs-news.com/news/adhoc/merck-kgaa-phase-iii-trials-of-xevinapant-in-locally-advanced-head-neck-cancer-discontinued/2079685</a>
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<td>Merck KGaA / Key word(s): Study results 
			Merck KGaA: Phase III trials of xevinapant in locally advanced head &amp; neck cancer discontinued
			24-Jun-2024 / 19:00 CET/CEST 
			Disclosure of an inside information acc. to Article 17 MAR of the Regulation (EU) No 596/2014, transmitted by EQS News &ndash; a service of EQS Group AG. 
			The issuer is solely responsible for the content of this announcement.</td>
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&nbsp;
Disclosure of inside information pursuant to Article 17 of Regulation (EU) No 596/2014
Merck KGaA: Phase III trials of xevinapant in locally advanced head &amp; neck cancer discontinued
Darmstadt, June 24, 2024: Merck KGaA is investigating a treatment of xevinapant plus platinum-based chemotherapy (CRT), compared to placebo plus CRT, in patients with unresected locally advanced head and neck cancer in a phase III clinical trial (TrilynX). The company decided to discontinue this study. The decision follows a pre-planned interim analysis performed by the study&#39;s Independent Data Monitoring Committee, which found that the trial would be unlikely to meet its primary objective of prolonging event-free survival. Given the totality of the data, the company decided to also stop the phase III clinical trial X-Ray Vision (xevinapant plus radiotherapy, compared to placebo plus radiotherapy in patients who underwent resection of locally advanced head and neck cancer).
&nbsp;
Xevinapant is currently under clinical investigation and not approved for any indication anywhere in the world.
Esther D&ouml;ringer 
Merck KGaA 
Frankfurter Stra&szlig;e 250 
64293 Darmstadt 
Germany 
Phone: +49 151 1454 7809 
Email: <a href="mailto:esther.doeringer@merckgroup.com">esther.doeringer@merckgroup.com</a> 
Internet: <a href="https://www.merckgroup.com/en" title="https://www.merckgroup.com/en">https://www.merckgroup.com/en</a> 
ISIN: DE0006599905 
WKN: 659990 
Indices: DAX

Global

'Merck KGaA: Phase III trials of xevinapant in locally advanced head & neck cancer discontinued'

Merck KGaA&nbsp;(OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/mkgaf#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">MKGAF</a>) (OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/mkkgy#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">MKKGY</a>)&nbsp;<a class="editor-rtfLink" href="https://www.merckgroup.com/en/news/evobrutinib-phase-lll.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">says</a>&nbsp;its two Phase 3 EVOLUTION trials (evolutionRMS 1 and evolutionRMS 2) of evobrutinib did not meet their primary endpoints of reducing annualized relapse rates (ARR) in people with relapsing multiple sclerosis (RMS) compared to&nbsp;Sanofi SA&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>) Aubagio (teriflunomide).
The data showed the rates of 0.11 vs. 0.11 in evolutionRMS 1 and 0.15 for evobrutinib vs. 0.14 for teriflunomide in evolutionRMS 2, p=NS in both trials.&nbsp;
Teriflunomide ARR values were lower than reported in other recent Phase 3 studies.&nbsp;
The overall safety and tolerability profile was consistent with the previously reported Phase 2 trial results.&nbsp;
Investors have been unsettled regarding revenue projections due to potential liver damage associated with a specific drug category aimed at selectively targeting cells driving the adverse autoimmune response in multiple sclerosis (MS).
Despite this concern, citing some analysts, Reuters notes that Merck&#39;s drug can achieve annual peak sales well surpassing $2 billion on average.
﻿JP Morgan&nbsp;analysts expressed surprise, citing the unexpected disappointment stemming from concerns about side effects rather than the drug&#39;s effectiveness.
In a note, the analysts mentioned, &quot;We had anticipated successful trials and the product&#39;s market launch outside of the United States.&quot;

Merck Germany's Two Pivotal Trials Flunk In Multiple Sclerosis

Germany's Merck KGaA Says Results From EVOLUTION Clinical Trials Showed Evobrutinib Did Not Meet Its Primary Endpoint In People With Relapsing Multiple Sclerosis

Repligen Corporation&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/rgen#NASDAQ">RGEN</a>) agreed to acquire Sweden-based privately-held&nbsp;Metenova.&nbsp;
Metenova is projected to generate revenues of $24 million to $25&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/09/g34900749/repligen-announces-agreement-to-acquire-fluid-management-innovator-metenova" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">million for fiscal year 2023</a>.&nbsp;
The company recently entered the single-use mixing market with the launch of its MixOne platform, leveraging the success of its existing stainless steel (repeat-use) product line.
Metenova is expected to contribute approximately $5 million in revenue to Repligen in Q4 of 2023 and $25 million-$27 million in 2024, with 20%-25% revenue growth in 2025 forward.&nbsp;
The acquisition is anticipated to be accretive to Repligen&#39;s adjusted gross and operating margins in 2024 and to be accretive to adjusted EPS in 2025.
The transaction is expected to be completed in the coming weeks.
According to&nbsp;William Blair, this agreement significantly expands Repligen&#39;s market reach by granting the company access to the lucrative $1 billion mixing&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/money/best-sectors-to-invest-in-right-now/" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">sector</a>&nbsp;and enhancing its capabilities in fluid management.
Repligen has consistently demonstrated a strong history of strategic acquisitions to bolster its product portfolio, and Metenova&#39;s addition follows recent fluid management deals like FlexBiosys, ARTeSYN, Bioflex, EMT, and NMS.&nbsp;
These additions complement an existing $50 million fluid management division.
This move aligns with the company&#39;s strategic focus on vertical integration and enhanced supply chain control, as highlighted during last year&#39;s investor day.
While Metenova does have some shared end-user customers, its primary sales channel involves collaborating with engineering firms overseeing new construction projects.&nbsp;
Repligen aims to capitalize on its existing end-user relationships to gain a competitive edge, particularly against rivals like&nbsp;Merck KGaA&nbsp;(OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/mkgaf#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">MKGAF</a>) (OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/mkkgy#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">MKKGY</a>), especially in the stainless steel segment.
William Blair&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/quote/RGEN/analyst-ratings" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">reaffirms the Outperform rating</a>&nbsp;by highlighting Repligen&#39;s long-term positioning and opportunity in the bioprocessing capacity.
Price Action:&nbsp;RGEN shares are down 0.34% at $158.45 on the last check Tuesday.

Life Sciences Player Repligen's Strategic European Acquisition - What It Means for Investors

Merck KGa Germany&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkgaf#OTC">MKGAF</a>) (OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/mkkgy#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">MKKGY</a>) reported&nbsp;<a class="editor-rtfLink" href="https://www.merckgroup.com/investors/reports-and-financials/earnings-materials/2023-q2/en/2023-Q2-Press-Release-EN.pdf" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Q2</a>&nbsp;sales of &euro;5.3 billion, down 4.8% Y/Y.
The company said that while net Life Science and Electronics sales declined in softer markets, Healthcare delivered an organic sales growth of 11.9%.
The strong growth of the Healthcare business&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/money/best-sectors-to-invest-in-right-now/" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">sector</a>&nbsp;largely offset the decline in Life Science and Electronics, resulting in the organic development of Group sales of &minus;1.1%.&nbsp;
Despite the strong earnings growth of Healthcare, Group EBITDA pre declined by &minus;12.8% (organically &minus;7.0%) to &euro; 1.55 billion, primarily due to decreased sales volumes and the proportionately lower share of higher-margin products.&nbsp;
Profit fell 19% to &euro;706 million. Operating profit fell 18% to &euro;969 million, with margin compressing from 21.1% to 18.3%.
In a statement, the company cited &quot;persistently high inventory levels of our Life Science customers, the further delayed recovery of the market for semiconductor materials, an increased cost level due to inflation, and an even stronger negative foreign exchange impact.&quot;
Merck Germany has updated its 2023 forecast, and it now expects an organic sales growth of &minus;2% to +2% (previously +1% to +4%) along with an organic decline in EBITDA pre by &minus;9% to &minus;3% (previously: &minus;5% to 0%).&nbsp;
Excluding the Covid-19 business, Group sales are expected to grow organically by +1% to +5% (previously: +4% to +7%).&nbsp;
Both net sales and EBITDA pre will likely be impacted by negative foreign exchange effects of &minus;6% to &minus;3% (previously: &minus;5% to &minus;2%).&nbsp;
&quot;For us, 2023 remains a transition year,&quot; said Bel&eacute;n Garijo, Chair of the Executive Board and CEO of Merck. &quot;In the second quarter, our Healthcare business once again proved to be a growth driver... We remain confident of our mid-term growth ambition and in delivering &euro; 25 billion in sales by 2025.&quot;

The World Health Organization (WHO) published the&nbsp;<a class="editor-rtfLink" href="https://www.who.int/news/item/26-07-2023-who-endorses-landmark-public-health-decisions-on-essential-medicines-for-multiple-sclerosis" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">new</a>&nbsp;editions of the Model Lists of Essential Medicines (EML) and Essential Medicines for Children (EMLc), which include important new medicines for multiple sclerosis, cancer, infectious diseases, and cardiovascular conditions, among others.
For the first time World Health Organization is reportedly considering adding obesity drugs to its &quot;essential medicines list,&quot; used to guide government purchasing decisions in low- and middle-income countries, the U.N. agency.
A group of three doctors and a researcher in the U.S. proposed including obesity drugs on the list for the first time earlier this year, focusing mainly on the active ingredient liraglutide in&nbsp;Novo Nordisk A/S&#39;s&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/nvo#NYSE">NVO</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/03/31554694/novo-nordisks-obesity-drug-may-find-place-on-world-health-organizations-essential-medicines-list" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">obesity drug Saxenda</a>.
A WHO expert panel recommended&nbsp;<a class="editor-rtfLink" href="https://apps.who.int/iris/bitstream/handle/10665/371291/WHO-MHP-HPS-EML-2023.01-eng.pdf" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">against</a>&nbsp;adding the drugs for weight loss, citing the &quot;uncertain long-term clinical benefit and safety in this patient population.&quot;
The Expert Committee recommended the inclusion of cladribine branded Mavenclad by&nbsp;EMD Serono&nbsp;and&nbsp;Merck KGaA&nbsp;(OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/mkgaf#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">MKGAF</a>), (OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/mkkgy#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">MKKGY</a>),&nbsp;Teva Pharmaceuticals Inc&#39;s&nbsp;(NYSE:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/teva#NYSE" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">TEVA</a>) Copaxone (glatiramer acetate), and rituximab branded as Rituxan/MabThera and usually sold by&nbsp;Roche Holdings AG&nbsp;(OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/rhhby#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">RHHBY</a>), as individual medicines on the EML&#39;s complementary list for treating multiple sclerosis.
The panel said their inclusion would &quot;address an important public health need and support global advocacy efforts to reduce the global burden of multiple sclerosis.&quot;
Two monoclonal antibody treatments for Ebola Zaire were also added to the list: Ebanga (ansuvimab), made by&nbsp;Ridgeback Biotherapeutics, and&nbsp;Regeneron Pharmaceuticals Inc&#39;s&nbsp;(NASDAQ:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/regn#NASDAQ" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">REGN</a>) Inmazeb (atoltivimab, maftivimab and odesivimab combined).
Naltrexone and acamprosate, both available as generics and designed to treat alcohol-use disorder, were also added and ready-to-use therapeutic food (RUTF) to treat severe malnutrition in children under five.
Photo via Wikimedia Commons

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Novo Nordisk's Obesity Drug Saxenda Not Included In WHO's Essential Drug List

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ABCM

Watching Abcam; Co Seeing Takeover Interest From Danaher, Agilent Technologies, Germany's Merck KGaA

RBC Capital Markets&nbsp;has downgraded&nbsp;Abcam PLC&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/abcm#NASDAQ">ABCM</a>) from Outperform to Sector Perform with a price target of $22,&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/quote/ABCM/analyst-ratings" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">down from $23</a>.
The analyst writes that it has always liked Abcam&#39;s fundamentals but sees activist investor engagement and anticipation of a potential bid as likely to drive material share volatility.
Earlier today, Abcam filed an investor presentation, urging shareholders to vote against all resolutions at the company&#39;s July 12&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/06/b32919000/abcam-highlights-successful-execution-of-strategic-priorities-to-drive-shareholder-value" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Extraordinary General Meeting</a>.
The company points out that under CEO Alan Hirzel&#39;s leadership, Abcam has transformed as a business, created significant value for all stakeholders, and outperformed the market.
The company is on track to deliver its 2024 revenue and profit margin goals.
The analyst says any major players in the life science tools space could be interested in Abcam, with its leading position in high-margin research antibodies, strong growth and margin trajectory, and brand and distribution reach.&nbsp;
Thermo Fisher Scientific Inc&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/tmo#NYSE">TMO</a>),&nbsp;Danaher Corporation&nbsp;(NYSE:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/dhr#NYSE" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">DHR</a>),&nbsp;Merck KGaA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkgaf#OTC">MKGAF</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkkgy#OTC">MKKGY</a>),&nbsp;Agilent Technologies Inc&nbsp;(NYSE:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/a#NYSE" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">A</a>),&nbsp;Bio-Techne Corp&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/tech#NASDAQ">TECH</a>) and&nbsp;Revvity Inc&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/rvty#NYSE">RVTY</a>) could be interested, based on their EBITDA, current leverage and an assumption of max 3x leverage.
Private equity would potentially be interested.
Price Action:&nbsp;ABCM shares are down 6.95% at $20.76 on the last check Tuesday.

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Abcam Downgrade: Analyst Trims Expectations Amid Activist Investor Engagement and Potential Bid Anticipation

Roche Holdings AG&#39;s&nbsp;&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/rhhby#OTC">RHHBY</a>) Phase 2 FENopta study of oral fenebrutinib for relapsing forms of multiple sclerosis (RMS)&nbsp;<a class="editor-rtfLink" href="https://www.roche.com/media/releases/med-cor-2023-05-17" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">met</a>&nbsp;its primary and secondary endpoints.
The data showed oral fenebrutinib significantly reduced magnetic resonance imaging (MRI) markers of MS disease activity in the brain compared to placebo.&nbsp;
Additionally, pre-clinical data have shown fenebrutinib to be potent and highly selective, and it is the only reversible inhibitor currently in Phase 3 trials for MS.
Fenebrutinib significantly reduced the total number of new gadolinium-enhancing T1 brain lesions compared to the placebo, the trial&#39;s primary endpoint (p=0.0022).&nbsp;
Additionally, fenebrutinib significantly reduced the number of new or enlarging T2 brain lesions compared to placebo, a secondary endpoint.&nbsp;
Furthermore, more patients treated with fenebrutinib were free from new gadolinium-enhancing T1 brain lesions and new or enlarging T2-weighted brain lesions compared to placebo.&nbsp;
T1 lesions are a marker of active inflammation, and T2 lesions represent the disease burden or lesion load.
The Phase 3 fenebrutinib clinical trial program in RMS and primary progressive MS (PPMS) is ongoing.
Competitor&nbsp;Merck KGaA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkgaf#OTC">MKGAF</a>) said in April that FDA placed a partial clinical hold on initiating new patients on evobrutinib in the&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/04/b31762160/initiation-of-new-patients-on-evobrutinib-paused-in-the-u-s-fully-enrolled-phase-iii-evobrutinib-s" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Phase 3 EVOLUTION trial for RMS</a>.
Reuters&nbsp;<a class="editor-rtfLink" href="https://www.reuters.com/business/healthcare-pharmaceuticals/roche-says-new-ms-drug-shown-reduce-brain-lesions-2023-05-17/" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">noted</a>&nbsp;that Merck was previously seen to lead the race to win approval in the MS segment.
Sanofi SA&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sny#NASDAQ">SNY</a>) encountered similar problems with its drug candidate.

Roche's Investigational Drug For Relapsing Multiple Sclerosis Reduces Brain Lesions, Data Shows

<ul>
<li>Nektar Therapeutics&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nktr#NASDAQ">NKTR</a>) announced a strategic plan to reprioritize assets and&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/04/n31842677/nektar-therapeutics-announces-strategic-reprioritization-and-cost-restructuring-plan" 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">restructure costs</a>.&nbsp;</li>
<li>Regarding clinical programs, Nektar will prioritize the development of rezpegaldesleukin (Rezpeg), either in collaboration with current partner&nbsp;Eli Lilly And Co&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/lly#NYSE">LLY</a>) or potentially on its own in the future.&nbsp;</li>
<li>Phase 1b results of Rezpeg in atopic dermatitis were cited as support for the continued development of the asset.&nbsp;</li>
<li>In February, the company reported topline data from the Phase 2 study of Rezpeg in systemic lupus erythematosus patients, demonstrating that the&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/02/31045182/why-nektar-therapeutics-stock-is-plunging-today" 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">trial missed the primary endpoint</a>.</li>
<li>Also Read:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/04/26815587/after-bristol-myers-cuts-ties-nektar-implements-cost-restructuring" 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">After Bristol Myers Cuts Ties, Nektar Implements Cost Restructuring</a>.</li>
<li>In addition, the company will continue to evaluate NKTR-255, a PEGylated IL-15, in two Phase 2 trials, one in diffuse large B-cell lymphoma and one in bladder cancer (the JAVELIN Bladder Medley study, in collaboration with partner&nbsp;Merck KGaA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkgaf#OTC">MKGAF</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkkgy#OTC">MKKGY</a>).</li>
<li>Nektar also plans to file an IND for one or both of two preclinical candidates in autoimmune diseases in 2024.</li>
<li>The company&rsquo;s workforce in San Francisco will be decreased by roughly 60% to a total headcount of 55.&nbsp;</li>
<li>The cost restructuring efforts are expected to extend the cash runway into the middle of 2026.&nbsp;</li>
<li>Brian Kotzin, Chief Medical Officer, will be stepping down but will continue to serve as a strategic advisor. Mary Tagliaferri, the current Chief Development Officer, will assume the role of Chief Medical Officer.</li>
<li>Jillian Thomsen will resign from her CFO role and depart the company in June. The company has appointed Sandra Gardiner as the new acting CFO.</li>
<li>William Blair&nbsp;writes that based on rezpeg&rsquo;s clinical profile presented to date (especially with two setbacks) and the highly competitive autoimmune field, questions from investors could arise regarding the asset&rsquo;s potential roles in various treatment paradigms.</li>
<li>The analyst notes that to alter investor perception, management will likely require meaningful business development opportunities to replenish the pipeline.</li>
<li>Price Action:&nbsp;NKTR shares closed 6.26% higher at $0.9831 on Monday.</li>
</ul>

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Analyst Says Nektar Therapeutics' Rezpeg Prioritization Likely to Spark Investor Questions

<ul>
<li>The FDA has&nbsp;<a class="editor-rtfLink" href="https://www.merckgroup.com/en/news/evobrutinib-12-04-2023.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">placed</a>&nbsp;a partial clinical hold on initiating new patients on Germany&#39;s&nbsp;Merck KGaA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkgaf#OTC">MKGAF</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkkgy#OTC">MKKGY</a>) evobrutinib and patients with less than 70 days of exposure to study medication in the U.S.&nbsp;</li>
<li>The ongoing Phase 3 EVOLUTION trial program of evobrutinib in relapsing multiple sclerosis (RMS) will continue as planned, with all participants remaining on treatment as all are beyond 70 days of exposure to study medication.</li>
<li>The decision was in response to laboratory values suggestive of drug-induced liver injury during phase 3 studies, stressing that the two cases identified had been asymptomatic and the patient&#39;s liver enzymes had fully normalized after discontinuing the study medication.</li>
<li>&quot;Merck is working closely with the FDA to establish the best path forward for the benefit of patients in current and future trials with evobrutinib,&quot; the company said in a statement.</li>
<li>The FDA&#39;s decision impacts just two patients. Reuters&nbsp;<a class="editor-rtfLink" href="https://www.reuters.com/business/healthcare-pharmaceuticals/merck-shares-dive-after-us-pauses-new-patients-evobrutinib-2023-04-12/" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">reported</a>&nbsp;that recruitment for a phase 3 drug trial was already complete with 2,000 participants, and an ongoing study will continue as planned.</li>
<li>The Phase 3 trial program of evobrutinib is on track to read out in Q4 of 2023.</li>
<li>Price Action:&nbsp;On the European stock exchange, shares plunged 6.3% to &euro;162.45.</li>
</ul>

FDA Issues Partial Clinical Hold On Merck Germany's Multiple Sclerosis Study

<ul>
<li>Germany&rsquo;s&nbsp;Merck KGaA&nbsp;(OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/mkgaf#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">MKGAF</a>) (OTC:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/mkkgy#OTC" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">MKKGY</a>) has&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/03/b31508805/merck-kgaa-darmstadt-germany-strengthens-oncology-franchise-by-securing-exclusive-worldwide-rights" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">regained exclusive</a>&nbsp;worldwide rights to develop, manufacture, and commercialize its checkpoint blocker Bavencio (avelumab) from&nbsp;Pfizer Inc&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/pfe#NYSE">PFE</a>).</li>
<li>The news comes just a few weeks after Pfizer announced plans to buy antibody-drug conjugate (ADC) company&nbsp;Seagen Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/sgen#NASDAQ">SGEN</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/23/03/31319372/seagens-43b-deal-to-double-pfizers-early-stage-oncology-pipeline-seagen-says-is-right-step" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">at $43 billion</a>.</li>
<li>Pfizer will exit its global partnership with Merck KGaA over the PD-L1 MAb on 30 June, handing over all future clinical work and commercialization and swapping a 50% profit share for a 15% royalty.&nbsp;</li>
<li>Merck KGaA and Pfizer will continue operationalizing their respective ongoing clinical trials for Bavencio, and Merck KGaA will control all future research and development activities.&nbsp;</li>
<li>Product manufacturing and supply chain will remain solely with Merck KGaA ensuring continuous and reliable access to Bavencio for patients.</li>
<li>Bavencio was discovered in-house at Merck KGaA, and the alliance with Pfizer was executed in 2014 to co-develop and co-commercialize Bavencio.&nbsp;</li>
<li>Price Action:&nbsp;PFE shares are down 0.24% at $40.30 on the last check Monday.</li>
</ul>

Contracts

SGEN

Merck Germany Regains Exclusive Global Rights To Cancer Drug From Pfizer

<ul>
<li>The FDA&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/03/b31461372/incyte-announces-fda-approval-of-zynyz-retifanlimab-dlwr-for-the-treatment-of-metastatic-or-recurr" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">granted accelerated approval</a>&nbsp;to&nbsp;Incyte Corporation&#39;s&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/incy#NASDAQ">INCY</a>) Zynyz (retifanlimab-dlwr) for adult patients with metastatic or recurrent locally advanced Merkel cell carcinoma (MCC).&nbsp;</li>
<li>Continued approval of Zynyz for this indication may be contingent on verification and description of clinical benefit in confirmatory trials.</li>
<li>Also Read:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/analyst-ratings/analyst-color/23/03/31420186/analyst-writes-incytes-opzelura-provides-deepening-relapse-prevention-povo-data-int" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Analyst Writes Incyte&#39;s Opzelura Provides Deepening, Relapse Prevention; Povo Data Intriguing In Depigmented Skin Disorder</a>.</li>
<li>MCC is a rare and aggressive type of skin cancer that frequently appears as a single, painless, reddish-purple skin nodule on the head, neck, and arms in skin exposed to sunlight.</li>
<li>The FDA approval was based on data from the POD1UM-201 trial.</li>
<li>Among chemotherapy-na&iuml;ve patients (n=65), Zynyz monotherapy resulted in an objective response rate (ORR) of 52%.&nbsp;</li>
<li>Complete response was seen in 12 patients (18%), and 22 patients (34%) showed partial response.&nbsp;</li>
<li>Among the responding patients, the duration of response (DOR) ranged from 1.1 to 24.9+ months.</li>
<li>76% (26/34) experienced a DOR of six months or longer, and 62% (21/34) experienced a DOR of 12 months or longer by landmark analysis.</li>
<li>MacroGenics Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mgnx#NASDAQ">MGNX</a>) developed the therapy and was licensed to Incyte in 2017.</li>
<li>Incyte&#39;s product competes with&nbsp;Merck &amp; Co Inc&#39;s&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mrk#NYSE">MRK</a>) Keytruda, and&nbsp;Merck KGaA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkgaf#OTC">MKGAF</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkkgy#OTC">MKKGY</a>) &amp;&nbsp;Pfizer Inc&#39;s&nbsp;(NYSE:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/stock/pfe#NYSE" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">PFE</a>) Bavencio, approved to treat MCC.</li>
<li>The list&nbsp;<a class="editor-rtfLink" href="https://www.keytruda.com/financial-support/" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">price</a>&nbsp;for each dose of Keytruda when it is given every three weeks is $10,683.52.</li>
<li>Incyte said the monthly treatment price with Zynyz will be comparable with other drugs in the same class that is currently available,&nbsp;<a class="editor-rtfLink" href="https://www.reuters.com/business/healthcare-pharmaceuticals/us-fda-approves-incytes-therapy-skin-cancer-2023-03-22/" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Reuters</a>&nbsp;reported.</li>
<li>Price Action:&nbsp;INCY shares closed at $72.26 on Wednesday.</li>
</ul>

Small Cap

INCY

MGNX

Incyte Would Now Compete With Merck, Pfizer As Its Skin Cancer Treatment Scores FDA Accelerated Approval

<ul>
<li>PDS Biotechnology Corporation&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/pdsb#NASDAQ">PDSB</a>) announced an&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/23/01/g30254159/pds-biotech-announces-exclusive-global-license-agreement-for-investigational-il-12-tumor-targeted-" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">exclusive global license agreement</a>&nbsp;with&nbsp;Merck KGaA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkgaf#OTC">MKGAF</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkkgy#OTC">MKKGY</a>) for the tumor-targeting IL-12 fusion protein M9241 (formerly known as NHS-IL12), which will join the pipeline as PDS0301.&nbsp;</li>
<li>Under the terms of the agreement, PDS Biotech will receive from Merck KGaA an exclusive license to M9241.&nbsp;</li>
<li>PDS Biotech will assume responsibility for the future development, commercialization, and manufacturing of M9241.</li>
<li>Related:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/12/30214674/pds-biotechnology-triple-combo-therapy-shows-21-months-of-overall-survival-in-hpv-positive-cancer" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">PDS Biotechnology Triple Combo Therapy Shows 21 Months Of Overall Survival In HPV-Positive Cancers</a>.</li>
<li>Under the terms of the agreement, Merck KGaA will receive an upfront cash payment of $5 million and will be entitled to up to $11 million in development and regulatory milestone payments, including first commercial sales for the first two indications, and up to $105 million in commercial milestones, and a 10% royalty on future sales of M9241 with standard step-down provisions.&nbsp;</li>
<li>Merck KGaA will receive 378,787 shares of PDS Biotech&#39;s shares valued at $5 million.</li>
<li>Price Action:&nbsp;PDSB shares are down 12.50% at $11.55 on the last check Tuesday.</li>
</ul>

PDSB

PDS Biotech, Merck Germany Enter Licensing Pact For Investigational Cancer Treatment

<ul>
<li>Mersana Therapeutics Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/mrsn#NASDAQ">MRSN</a>)&nbsp;<a class="editor-rtfLink" href="https://www.merckgroup.com/en/news/adc-mersana-20-12-2022.html" 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">signed</a>&nbsp;a deal for developing antibody-drug conjugates (ADCs) for cancer treatment with Germany&#39;s&nbsp;Merck KGaA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkgaf#OTC">MKGAF</a>) (OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkkgy#OTC">MKKGY</a>).</li>
<li>Mersana would receive $30 million in an upfront payment and up to $800 million in development, regulatory and commercial milestones.</li>
<li>Related:&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/general/biotech/22/08/28412151/mersana-gsk-ink-1-36b-biobuck-deal-for-cancer-focused-therapy" 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">Mersana, GSK Ink $1.36B Biobuck Deal For Cancer-Focused Therapy</a>.</li>
<li>Under the agreement, Mersana would develop cancer drug candidates against up to two targets that would utilize its platform to combine Merck KGaA&#39;s proprietary antibodies.</li>
<li>Pre-clinical activities will be split between the companies. Merck Germany will be solely responsible for all clinical development and potential commercialization activities relating to any resulting product candidates.</li>
<li>Mersana said it was also eligible to receive royalties of up to low double-digit percentages on global net sales for any approved ADCs developed under the agreement.</li>
<li>Price Action:&nbsp;MRSN shares are down 2.68% at $5.82 on the last check Friday.</li>
<li>Photo Via Company</li>
</ul>

MRSN

Mersana Inks Cancer Therapy Development Deal With Merck Germany

<ul>
<li>Merck KGaA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkgaf#OTC">MKGAF</a>) and&nbsp;GlaxoSmithKline Plc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/gsk#NASDAQ">GSK</a>) have&nbsp;<a class="editor-rtfLink" href="https://www.merckgroup.com/en/news/bintrafusp-alfa-agreement-with-gsk.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">ended their $4 billion collaboration</a>&nbsp;on cancer treatment, bintrafusp alfa.</li>
<li>Merck said the move was a mutual decision, primarily due to&nbsp;<a class="editor-rtfLink" href="https://www.merckgroup.com/en/news/bintrafusp-alfa-037-update-20-01-2021.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">disappointing lung cancer trial data</a>, adding that GSK made no milestone payments and no future milestone obligations remain.</li>
<li>Merck KGaA said in January that a late-stage lung cancer study testing bintrafusp alfa against&nbsp;Merck &amp; Co Inc&#39;s&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mrk#NYSE">MRK</a>) Keytruda, in a type of lung cancer, was stopped early because the drug was unlikely to show the desired effect.</li>
<li>GSK did not pay out any milestone payments through the deal and will not do so in the future, either. Merck collected &euro;300 million upfront in 2019 through the pact, with an additional &euro;500 million in milestones and &euro;2.9 billion in sales possible down the line.</li>
<li>Bintrafusp alfa is bifunctional immunotherapy designed to combine a TGF-&beta; trap with the anti-PD-L1 mechanism in one fusion protein.&nbsp;</li>
<li>The drug was supposed to control tumor growth by enhancing or restoring anti-tumor responses in the immune system.&nbsp;</li>
<li>Price Action:&nbsp;GSK stock is up 0.03% at $38.34 during the market session on the last check Thursday.</li>
</ul>

GlaxoSmithKline, Merck KGaA End $4B Cancer Drug Pact

<ul>
<li>Nektar Therapeutics Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/nktr#NASDAQ">NKTR</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/21/09/n23030747/nektar-announces-new-clinical-collaboration-with-merck-kgaa-darmstadt-germany-and-pfizer-inc-to-co" 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">has entered into a new oncology clinical collaboration</a>&nbsp;with&nbsp;Merck KGaA&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkgaf#OTC">MKGAF</a>) and&nbsp;Pfizer Inc&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/pfe#NYSE">PFE</a>) to evaluate the maintenance regimen of NKTR-255 in combination with avelumab in bladder cancer study.</li>
<li>The Phase 2 JAVELIN Bladder Medley study will include locally advanced or metastatic urothelial carcinoma (UC) patients.</li>
<li>NKTR-255 is wholly owned by Nektar and is currently being evaluated in two separate clinical studies in both liquid and solid tumors.</li>
<li>Avelumab is marketed in the U.S. as Bavencio, is co-developed and co-commercialized by Merck KGaA and Pfizer.</li>
<li>The study will begin enrolling patients in Q1 of 2022.</li>
<li>Price Action:&nbsp;NKTR shares are up 4.53% at $17.08 during the market session on the last check Tuesday.</li>
</ul>

Nektar, Merck Germany, Pfizer Join Forces For Mid-Stage Bladder Cancer Study

<ul>
<li>Merck KGaA&#39;s&nbsp;(OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkgaf#OTC">MKGAF</a>) announced that a&nbsp;<a class="editor-rtfLink" href="https://www.emdgroup.com/en/news/bintrafusp-alfa-update-23-08-2021.html" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">Phase 2 trial of bintrafusp alfa had been discontinued</a>, as an independent data monitoring committee has determined the study is unlikely to meet its goal of improving overall survival.</li>
<li>The INTR@PID BTC 055 trial examined the drug as a first-line treatment for patients with locally advanced or metastatic biliary tract cancer combined with the chemotherapy drugs cisplatin and gemcitabine.</li>
<li>The decision to discontinue is the third strike on bintrafusp alfa, with the future of the therapy uncertain.&nbsp;</li>
<li>Merck discovered the therapy in-house but developed it with&nbsp;GlaxoSmithKline plc&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/gsk#NYSE">GSK</a>) through the $4.2 billion deal.</li>
<li>Strike two came in March when an independent review of the INTR@PID BTC 047 study determined that bintrafusp alfa caused an objective response rate of just 10.1%. This efficacy was too low to support a regulatory filing.&nbsp;</li>
<li>But Merck was not ready to abandon the asset, pointing to the BTC 055 study.</li>
<li>Two months earlier was the first strike. Bintrafusp alfa failed in a head-to-head matchup with&nbsp;Merck &amp; Co Inc&#39;s&nbsp;(NYSE: <a class="ticker" href="https://www.benzinga.com/stock/mrk#NYSE">MRK</a>) blockbuster cancer therapy Keytruda.&nbsp;</li>
<li>Price Action:&nbsp;MKGAF stock closed at $234.49 on Monday, while GSK stock is down 0.92% at $41.11 during the premarket session on the last check Tuesday.</li>
</ul>

Merck KGaA Pulls Plug On GSK-Partnered Cancer Drug Trial

<ul>
<li>Sutro Biopharma Inc&nbsp;(NASDAQ: <a class="ticker" href="https://www.benzinga.com/stock/stro#NASDAQ">STRO</a>)&nbsp;<a class="editor-rtfLink" href="https://www.benzinga.com/pressreleases/21/06/n21363711/sutro-biopharma-earns-milestone-payment-from-bispecific-antibody-drug-conjugate-collaboration-with" style="color:#4a6ee0; background:transparent; margin-top:0pt; margin-bottom:0pt" target="_blank">has received a milestone payment</a>&nbsp;under its collaboration and license agreement with the healthcare division of&nbsp;Merck KGaA&nbsp;Germany (OTC: <a class="ticker" href="https://www.benzinga.com/stock/mkgaf#OTC">MKGAF</a>).</li>
<li>The payment is related to a patient enrollment achievement in the Phase 1 dose-escalation and expansion study of M1231 in adult patients with metastatic solid tumors.</li>
<li>M1231 is an investigational bispecific antibody-drug conjugate (ADC) targeting MUC1-EGFR.</li>
<li>As part of the agreement, Sutro is manufacturing the antibody and linker-warhead for the early clinical supply and is eligible for further payments and tiered royalties.</li>
<li>Merck will be responsible for the drug product, clinical development, and commercialization of the product candidate.</li>
<li>Price Action:&nbsp;STRO shares are up 0.03% at $18.67 during the market session on the last check Tuesday.</li>
</ul>

STRO

Sutro Biopharma Receives Undisclosed Milestone Payment Under Bispecific ADC Collaboration with Merck

Merck KGaA (MKGAF) Q1 2024 Earnings Call Transcript

Emerging and Chinese pharmas playing greater role in oncology drug development

J.P. Morgan's top picks within Defensives

Merck KGaA falls after discontinuing head and neck cancer therapy

Merck KGaA: The Drop Makes The Upside All The Sweeter

Merck KGaA reports Q2 results

Merck KGaA (MKGAF) Q2 2024 Earnings Call Transcript

European exporters with stretched valuations - JPM

Japan's Eisai Pharma formed a collaboration with SEED, a Pennsylvania biotech, to develop molecular glues for targeted protein degradation of disease-causing proteins. SEED is eligible to receive up to $1.5 billion in milestones plus royalties.

Week In Review: Eisai Enters $1.5 Billion Molecular Glues Pact With SEED

Recursion: Path Forward For REC-994 Remains Despite Mixed Response

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Merck (MKGAF) Forecast

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