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Merck & Company Inc

Merck & Co., Inc. is a global healthcare company that provides human health pharmaceuticals across various therapeutic areas under brands such as Keytruda, Gardasil, ProQuad, Vaxneuvance, Bridion, Prevymis, Winrevair, Januvia, and Janumet. It also offers veterinary pharmaceuticals, vaccines, and health management solutions, including livestock products under brands like Nuflor, Bovilis, Banamine, and Safe-Guard, as well as companion animal products under Bravecto, Sentinel, Nobivac, and Panacur. The company has development and commercialization agreements for three of Daiichi Sankyo's deruxtecan ADC candidates, co-development and co-commercialization of AstraZeneca's Lynparza products, a license for LM-299 from LaNova, and collaborations with Eisai, Bayer, Ridgeback Biotherapeutics, Moderna, and Infinimmune. Founded in 1891, Merck & Co., Inc. is headquartered in Rahway, New Jersey.

Price · split & dividend adjusted

Why is Merck & Company Inc (MRK) moving?

Q2 2026
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Merck's Pipeline and Label Wins Offset Medicare Pricing Threat

  • Tulisokibart Phase 3 Win Boosts Immunology Pipeline Merck's anti-TL1A antibody tulisokibart met the main goal in a Phase 3 ulcerative colitis trial, a first for this type of drug. This strengthens Merck's pipeline beyond cancer and helps offset future Keytruda competition, supporting the stock.

    This is a new positive pipeline event that directly addresses Merck's post-Keytruda growth story.

  • FDA and EU Approvals Expand Keytruda, Welireg, and Capvaxive Labels Merck won new approvals for Keytruda+Welireg in kidney cancer, Capvaxive in children, and Keytruda+Padcev in bladder cancer in the EU. These expand patient populations and should lift sales of these drugs.

    These are new regulatory wins that broaden Merck's marketed products and drive revenue growth.

  • Proposed CMS Rule to Make Medicare Drug Price Negotiations Permanent A proposed CMS rule would make Medicare drug price negotiations permanent, directly pressuring Merck's pricing. This regulatory overhang could cap future revenue growth and weighs on the stock.

    This is a new regulatory threat that could negatively impact Merck's pricing and profits.

  • Abu Dhabi Logistics Hub to Expand Regional Distribution Merck (MSD) is partnering with Abu Dhabi to explore a regional logistics hub, which could improve supply chain resilience and access to its therapies in the Middle East. This supports long-term demand.

    This new partnership could enhance Merck's distribution and market access in a growing region.

Latest
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Merck's pipeline wins and deals offset Keytruda competition

  • Tulisokibart hits Phase 2b goal in skin disease Merck's anti-TL1A drug tulisokibart met its main goal in a mid-stage hidradenitis suppurativa trial, with 72% of high-dose patients responding versus 35% on placebo. This is the first positive Phase 2 result for this drug class in dermatology, opening a new growth area beyond cancer and supporting the stock.

    New clinical win shows pipeline diversification beyond Keytruda, a key positive for future revenue.

  • Merck licenses KRAS cancer drug for up to $2.13B Merck paid $400 million upfront for global rights to SciBrunch's SPR2015, a preclinical KRAS G12D inhibitor for pancreatic, colorectal and lung cancers, with total deal value up to $2.13 billion. This adds a promising early cancer asset, though it will cause a $0.13 per share charge in Q3 results.

    New licensing deal expands oncology pipeline, a strategic positive despite a small near-term earnings hit.

  • Oral drug delivery tech enters human testing MSD began a Phase 1 trial of a proprietary drug using Cyprumed's oral delivery technology, triggering a milestone payment. If successful, this could let Merck turn injectable peptides into pills, a big manufacturing and patient convenience advantage that supports the pipeline.

    New technology milestone that could improve drug delivery and extend product lifecycles.

  • AstraZeneca's $2B bet on Keytruda rival Summit AstraZeneca will invest $2 billion in Summit Therapeutics and lead trials combining Summit's ivonescimab with AstraZeneca's cancer drugs. Ivonescimab has already beaten Keytruda in lung cancer survival, so this deepens the competitive threat to Merck's biggest franchise ahead of its 2028 patent expiry.

    New competitive escalation directly pressures Keytruda, Merck's largest revenue source.

Q3 2026
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Merck's Q3: Pipeline Wins and Guidance Raise Offset Keytruda Threats

  • Keytruda Label Expansions and Phase 3 Wins Merck expanded Keytruda's labels in breast and bladder cancer and reported a Phase 3 win in endometrial cancer. These broaden use and support sales growth, helping offset looming competition.

    Shows continued growth for Merck's top drug, a key positive for the quarter.

  • FDA Approves LIPFENDRA, First Oral PCSK9 Inhibitor Merck won FDA approval for LIPFENDRA, the first oral PCSK9 inhibitor for high cholesterol. This opens a new market and diversifies revenue beyond oncology.

    A major new product approval that adds a new growth driver.

  • Q2 Beat and Raised Full-Year Guidance Merck beat Q2 estimates with $16.61 billion revenue and raised full-year guidance to $66.3–67.3 billion. The strong results and outlook boosted investor confidence.

    Directly reflects financial performance and management confidence.

  • Keytruda Competitive Threats and Other Headwinds Keytruda faces threats from ivonescimab, AstraZeneca's $2 billion Summit investment, and a pre-2028 biosimilar. Also, a congressional probe, generic Janumet XR, lost COVID revenue, and acquisition charges weighed.

    Highlights the main risks that could pressure Merck's stock despite positives.

News & notes moving MRK
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CanSino issues urgent announcement after hitting daily limit up: mRNA cancer vaccine development still in early stage

CanSino surged to the daily limit up on the last trading day before the National Day holiday, with its share price breaking through the previous consolidation range and reaching a new stage high since April 2023, while its H shares also moved higher in tandem. On October 1, CanSino issued a stock movement announcement stating that the company had noted recent market developments regarding mRNA technology, as well as the release or planned disclosure of overseas clinical stage data for mRNA cancer vaccines. CanSino made clear that the mRNA platform is one of the technology platforms in its portfolio, and that the company is developing preventive mRNA vaccines and therapeutic biologics, as well as related delivery systems. In the therapeutic area, it is advancing research and development of mRNA vaccines for indications including glioblastoma, rhabdomyosarcoma, and cervical cancer, as well as the development of In Vivo CAR-related therapies, all of which are currently in early stages. In August this year, Merck and Moderna jointly announced that their personalized messenger RNA cancer vaccine met its primary endpoint in a Phase III trial, making it the first therapeutic vaccine proven effective in a large-scale Phase III clinical trial globally. On August 25, CanSino's official WeChat account announced that its subsidiary CanSino Shanghai Biologics had formally signed a strategic cooperation framework agreement with Depush Hangzhou Biotechnology for the joint development of personalized therapeutic mRNA cancer vaccines. The two parties will jointly advance the research, development, and commercialization of personalized therapeutic mRNA cancer vaccines, with a global focus on gastrointestinal solid tumors and rare tumor treatment areas. It should be noted that CanSino's entire mRNA product line has not yet moved beyond the early research and development stage, and innovative drug development carries multiple uncertainties including technical failure, clinical results falling short of expectations, and approval delays, while competition in the domestic mRNA vaccine sector is also becoming increasingly intense.
688185.CG · Technology · Neutral CanSino clarified its mRNA cancer vaccine programs (glioblastoma, rhabdomyosarcoma, cervical cancer, In Vivo CAR) remain in early stages despite the stock's limit-up.
德普世(杭州)生物科技有限责任公司 · Demand · Positive Depush Hangzhou signed a strategic cooperation framework agreement with CanSino Shanghai Biologics to jointly develop personalized therapeutic mRNA cancer vaccines.
MRK · Technology · Positive Merck's partnered personalized mRNA cancer vaccine met its primary endpoint in a Phase III trial, the first such therapeutic vaccine success.
MRNA · Technology · Positive Moderna's jointly announced personalized mRNA cancer vaccine met its primary endpoint in a Phase III trial.
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Trump Administration Picks 10 Drugmakers for New 340B Rebate Pilot

The Trump administration has selected 10 companies, including AbbVie, Amgen, Pfizer, and GSK, for a new pilot program that tests a rebate model for drugs purchased under a federal program benefiting uninsured and low-income patients. The 340B Rebate Model Pilot takes effect on January 1 and allows the selected manufacturers to verify and pay rebates for 21 discounted drugs purchased under the government's 340B drug pricing program, rather than offering savings upfront as under the current discount model. The participating drugmakers are AbbVie, Amgen, Astellas, AstraZeneca, Bristol Myers, GSK, Merck, Pfizer, and Teva. The Health Resources and Services Administration, the HHS unit overseeing the program, said the approach helps address compliance concerns proactively rather than relying primarily on retrospective reviews, audits, and dispute resolution processes. The pilot marks the Trump administration's second attempt to overhaul the decades-old drug discount program, after a federal judge blocked HRSA's first 340B rebate pilot following a case brought by hospital groups last year.
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Aging Population › Chronic-Disease Pharma Franchises Regulation
4503.JP · Regulation · Positive Astellas is one of the selected manufacturers participating in the 340B rebate pilot program.
ABBV · Regulation · Positive AbbVie is one of 10 selected manufacturers in the new 340B rebate pilot, allowing it to pay rebates after purchase rather than upfront discounts.
AMGN · Regulation · Positive Amgen is selected for the 340B Rebate Model Pilot, shifting it to a post-purchase rebate model for discounted drugs.
AZN.LSE · Regulation · Positive AstraZeneca is selected for the 340B rebate pilot, letting it verify and pay rebates rather than give upfront discounts.
BMY · Regulation · Positive Bristol Myers is among the 10 drugmakers chosen for the administration's 340B rebate pilot taking effect January 1.
GSK.LSE · Regulation · Positive GSK is named among the 10 drugmakers in the new 340B rebate model pilot taking effect January 1.
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Biotech & Genomic Medicine▲4impact 4

Merck's Tulisokibart Hits Primary Endpoint in Hidradenitis Suppurativa Phase IIb Study

Merck announced that its phase IIb MK-7240-012 study of tulisokibart in patients with moderate to severe hidradenitis suppurativa met its primary endpoint. In the trial, 72% of patients on the high dose of tulisokibart, 480 mg every two weeks, and 64% on the medium dose, 480 mg every four weeks, achieved Hidradenitis Suppurativa Clinical Response 50 at week 16, compared with 35% on placebo. In an exploratory analysis, 52% of patients on the low dose, 240 mg every four weeks, achieved HiSCR50, a 17% improvement over placebo. Tulisokibart also showed numerical improvements on the non-ranked key secondary endpoint of HiSCR75 at week 16, with response rates of 41% for the high-dose group, 40% for the medium-dose group and 29% for the low-dose group, versus 15% for placebo. Merck said the results represent the first positive phase II data for an anti-TL1A monoclonal antibody in dermatology and that it plans to advance tulisokibart into phase III development for hidradenitis suppurativa; the candidate, added through the 2023 acquisition of Prometheus Biosciences, is also being studied across six indications, including phase III trials in ulcerative colitis and Crohn's disease.
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Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics ▲Technology
MRK · Technology · Positive Merck's tulisokibart met the primary endpoint in the Phase IIb hidradenitis suppurativa study and will advance to Phase III.
Prometheus Biosciences · Capital · Positive Tulisokibart, added via Merck's 2023 acquisition of Prometheus Biosciences, showed positive Phase IIb data.
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Aging Population▲

Merck Q2 Revenue Rises 5.1% to $16.61 Billion, Beats Estimates

Merck reported second-quarter revenues of $16.61 billion, up 5.1% year on year and 2.1% above analysts' expectations, as the nine branded pharmaceuticals stocks tracked by the report collectively beat consensus revenue estimates by 6.6%. The company beat analysts' EPS estimates but missed analysts' full-year EPS guidance estimates, and its stock is up 16.2% since reporting, trading at $148.50. Among peers, Corcept Therapeutics posted the group's best quarter with revenues of $256.1 million, up 31.7% year on year and 21.6% above expectations, while Zoetis delivered the weakest performance with revenues of $2.47 billion, flat year on year and 1.5% below expectations. Collegium Pharmaceutical reported revenues of $199.9 million, up 6.3% year on year but 0.7% below expectations, and Pfizer reported revenues of $15.03 billion, up 2.6% year on year and 4.4% above expectations. As a group, share prices of the tracked companies have held steady, up 2.1% on average since the latest earnings results.
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Aging Population › Chronic-Disease Pharma Franchises ▲Demand
MRK · Capital · Positive Merck's Q2 revenue rose 5.1% to $16.61B, beating estimates, though full-year EPS guidance was missed.
COLL · Capital · Neutral Collegium reported revenue up 6.3% YoY but 0.7% below expectations, a mixed earnings result.
CORT · Capital · Positive Corcept posted the group's best quarter with revenue up 31.7% YoY and 21.6% above expectations.
PFE · Capital · Positive Pfizer reported revenue of $15.03B, up 2.6% YoY and 4.4% above expectations.
ZTS · Capital · Negative Zoetis delivered the group's weakest performance with revenue flat YoY and 1.5% below expectations.
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Biotech & Genomic Medicine▲

MSD Starts Phase I Trial Using Cyprumed Oral Delivery Tech

MSD has initiated a Phase I clinical trial of one of its proprietary drug candidates formulated using Cyprumed GmbH's licensed oral drug delivery technology, marking the first Cyprumed technology program to enter human clinical development and triggering a milestone payment from MSD. The study follows the two companies' Non-Exclusive License and Option Agreement announced in April 2025 to develop oral formulations of MSD's peptides using Cyprumed's technology. Under that agreement, Cyprumed is eligible to receive up to $493 million in upfront, development, regulatory and net sales milestones associated with products developed under the collaboration. Cyprumed CEO Florian Föger called the trial start an important milestone and a strong validation of the company's technology, noting its goal of overcoming challenges such as the impact of food on drug absorption. Cyprumed is a drug delivery technology company based in Innsbruck, Austria, focused on oral administration of therapeutic peptides including GLP-1 analogues, macrocycles and mini-proteins.
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Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity ▲Technology
Cyprumed GmbH · Technology · Positive First Cyprumed oral delivery technology program entered human clinical development, validating its platform and triggering a milestone payment from MSD.
MRK · Technology · Positive MSD initiated a Phase I trial of a proprietary drug candidate using Cyprumed's licensed oral delivery tech, advancing its pipeline.
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Biotech & Genomic Medicine▼5

Merck and Daiichi Sankyo Withdraw US Filing for Ifinatamab Deruxtecan in Small-Cell Lung Cancer

Merck & Co., Inc. and Daiichi Sankyo announced on September 25 that they voluntarily withdrew the U.S. application for ifinatamab deruxtecan in adults whose extensive-stage small-cell lung cancer progressed during or after platinum-based chemotherapy, after FDA discussions concluded the submitted evidence, including Phase 2 results, did not satisfy accelerated-approval requirements. The withdrawal removes a previously announced October 10, 2026 FDA target decision date, and no replacement filing timetable was announced. The partners pointed to tumor activity data reported in September 2025 showing a confirmed objective response rate of 48.2% among 137 patients receiving 12 mg/kg in IDeate-Lung01, with a median response duration of 5.3 months, though the trial did not compare the drug against standard chemotherapy. Merck continues development through the randomized Phase 3 IDeate-Lung02 trial, which compares ifinatamab deruxtecan with physician-selected chemotherapy after one prior platinum-based regimen and where Daiichi Sankyo said enrollment was nearly complete, alongside continuing Phase 3 studies in prostate and esophageal cancers. Safety remains central: in the Phase 2 dataset, Grade 3 or higher treatment-related adverse events occurred in 36.5% of patients, and independently adjudicated treatment-related interstitial lung disease or pneumonitis occurred in 12.4%, including two fatal cases, while the FDA placed IDeate-Lung02 on partial clinical hold in December 2025 after more fatal interstitial lung disease events than expected, a hold lifted in January 2026 following added safeguards.
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Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) ▼Regulation
Biotech & Genomic Medicine › Oncology Therapeutics ▼Regulation
4568.JP · Regulation · Negative Daiichi Sankyo's partnered US filing for ifinatamab deruxtecan was withdrawn after FDA concluded the Phase 2 evidence did not meet accelerated-approval requirements.
MRK · Regulation · Negative Merck and Daiichi Sankyo voluntarily withdrew the US accelerated-approval filing for ifinatamab deruxtecan in small-cell lung cancer after FDA discussions found the evidence insufficient.
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Shanghai Sprout and Merck Reach $2.13 Billion KRAS Inhibitor Licensing Deal

China's innovative drug industry has welcomed another major licensing deal. Shanghai Sprout and Merck jointly announced a global exclusive licensing agreement for SPR2015, a preclinical oral KRAS G12D (ON) inhibitor, with a potential total value of $2.13 billion, including an upfront payment of $400 million, with the remainder tied to development and commercialization milestones. Meanwhile, Summit Therapeutics, the overseas partner of Akeso, announced that AstraZeneca will make a $2 billion strategic equity investment in Summit and intends to lead clinical exploration of Akeso's first-in-class tumor immunotherapy 2.0 cornerstone drug ivonescimab in combination with AstraZeneca's Sonesitatug Vedotin for treating multiple gastrointestinal tumors. The two parties also signed a memorandum of understanding to further advance clinical exploration of ivonescimab combined with a range of AstraZeneca antibody-drug conjugates and other anti-tumor drugs. Boosted by the news, as of 10:01 a.m. on September 29, 2026, the STAR Market Biotech ETF managed by Penghua Fund, with ticker 588250, saw its underlying index, the SSE STAR Market Biomedical Index with code 000683, rise 1.10%. Among constituents, InventisBio rose 5.16%, Micro-Tech Nanjing rose 3.84%, Hotgen Biotech rose 3.13%, and Huiyu Pharmaceutical and Yound Biotechnology followed the gains. China Securities pointed out that the medical device sector has reached an inflection point in 2026, and stocks with improving performance are expected to see dual recovery in valuation and earnings. High-value consumables and in-vitro diagnostics segments are expected to gradually clear the impact of centralized procurement price cuts in the second half of the year, and leaders in niche tracks will accelerate growth.
About megatrends
Biotech & Genomic Medicine › Oncology Therapeutics ▲Capital
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Capital
Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) ▲Capital
上海思璞锐 · Capital · Positive Shanghai Sprout is the licensor of SPR2015, receiving $400M upfront and up to $2.13B in a global exclusive deal with Merck.
MRK · Capital · Positive Merck signs a global exclusive licensing deal for SPR2015 KRAS G12D inhibitor worth up to $2.13B, expanding its oncology pipeline.
9926.HK · Capital · Positive Akeso's partner Summit gets a $2B AstraZeneca equity investment and AZ will lead clinical exploration of Akeso's ivonescimab in combination therapies.
AZN.LSE · Capital · Positive AstraZeneca makes a $2B strategic equity investment in Summit and signs an MOU to advance ivonescimab combinations with its ADCs.
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Biotech & Genomic Medicine▲

Mission Bio Tapestri Data From Merck and Incyte Headed to World CDx Summit

Mission Bio announced that Merck & Co. and Incyte will each present new data generated using its Assay Services and Tapestri Platform at the 16th World Clinical Biomarkers & Companion Diagnostics Summit, alongside a third presentation from Mission Bio itself featuring new clinical data in acute myeloid leukemia. Merck scientist Sydney Hart will present functional genomics findings from a targeted DNA and RNA single-cell assay built with Mission Bio's Assay Services team to study how CRISPR-edited genetic variants affect immune cell function in autoimmune and inflammatory disease, work that links target validation to drug development decision-making. Incyte's Erin Crowgey will present new single-cell clinical data on INCA033989, a monoclonal antibody targeting mutant calreticulin-positive cells in essential thrombocythemia and myelofibrosis, generated with a custom Tapestri assay measuring 46 proteins and 37 genes in the same cell, showing depletion of mutant CALR-positive cells and repopulation by wild-type cells with relevant clinical improvements. Mission Bio Chief Medical Officer Zivjena Vucetic will present clinical study data showing single-cell multiomics achieved 93% sensitivity for measurable residual disease in AML compared to 43% for flow cytometry and 71% for other molecular methods, with additional evidence supporting more accurate stratification of relapse-free survival. The three presentations illustrate how single-cell multiomics connects genetic variation to cellular function, characterizes treatment response in individual cell populations, and identifies residual disease with greater resolution across drug development pipelines.
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Biotech & Genomic Medicine › Life-Science Tools & Sequencing ▲Technology
Biotech & Genomic Medicine › Diagnostics & Precision Testing ▲Technology
Mission Bio · Demand · Positive Merck and Incyte will present data generated using Mission Bio's Assay Services and Tapestri Platform, demonstrating adoption of its products by pharma customers.
INCY · Technology · Positive Incyte presents new single-cell clinical data on INCA033989 generated with Mission Bio's custom Tapestri assay, showing mutant CALR-positive cell depletion and clinical improvements.
MRK · Technology · Positive Merck scientist presents functional genomics findings from a targeted DNA/RNA single-cell assay built with Mission Bio's Assay Services to study CRISPR-edited variants in immune cells.
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Merck's CAPVAXIVE Added to Ontario Publicly Funded Adult Pneumococcal Immunization Program

Merck's CAPVAXIVE has been included in Ontario's publicly funded adult pneumococcal immunization program, the company announced. The vaccine, approved by Health Canada for adults 18 and older, helps prevent invasive pneumococcal disease caused by 21 Streptococcus pneumoniae serotypes, including serious infections such as sepsis, meningitis, and bacteremic pneumonia. Canadian surveillance data from 2019 to 2023 showed that the serotypes included in CAPVAXIVE accounted for approximately 65% of IPD cases in adults aged 18 to 49, approximately 74% of cases in adults aged 50 to 64, and approximately 80% of cases in adults aged 65 and older, based on data from the Public Health Agency of Canada. Matthew Thornhill, Executive Director of the Vaccines and HIV Business Unit at Merck Canada, said Ontario's decision reflects the importance of ensuring immunization programs continue to respond to changing public health needs and disease trends. In Canada, approximately 3,000 cases of invasive pneumococcal disease are reported each year.
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Biotech & Genomic Medicine › Vaccines (Recombinant & Traditional) ▲Demand
MRK · Regulation · Positive CAPVAXIVE added to Ontario's publicly funded adult pneumococcal immunization program, expanding access for Merck's vaccine.
Merck Canada Inc. · Regulation · Positive Merck Canada announced CAPVAXIVE's inclusion in Ontario's publicly funded adult pneumococcal immunization program.
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Biotech & Genomic Medicine▲5impact 4

Merck Licenses SciBrunch's SPR2015 KRAS Inhibitor in $2.13 Billion Deal

Merck has entered into an exclusive global license agreement with SciBrunch Therapeutics for SPR2015, an investigational preclinical oral KRAS G12D (ON) inhibitor. Under the deal, SciBrunch grants Merck exclusive rights to develop, manufacture and commercialize SPR2015 worldwide, receiving a $400 million upfront payment plus milestone payments tied to development, commercialization and other activities across multiple indications, for a total potential aggregate value of $2.13 billion. The transaction has closed, and Merck will record a pre-tax charge of $400 million, or approximately $0.13 per share, in its GAAP and non-GAAP third-quarter 2026 results. SciBrunch founder, chairman and chief executive Tao Hu said the agreement validates the company's R&D platform and the potential of SPR2015 against unmet needs in pancreatic, colorectal, lung and other major malignant tumors. BofA Securities acted as exclusive financial advisor to SciBrunch.
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Biotech & Genomic Medicine › Oncology Therapeutics ▲Competition
Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity Capital
MRK · Capital · Positive Merck licenses SPR2015 KRAS G12D inhibitor for $400M upfront and up to $2.13B total, adding a preclinical oncology asset to its pipeline.
SciBrunch Therapeutics Co., Ltd. · Capital · Positive SciBrunch grants Merck exclusive global rights to SPR2015, receiving $400M upfront plus milestones worth up to $2.13B total.
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Biotech & Genomic Medicine▲impact 4

Moderna and Merck's Melanoma Vaccine Meets Phase 3 Endpoint

Moderna and Merck reported that their Phase 3 INTerpath-001 trial of personalized cancer vaccine intismeran autogene plus Keytruda met its primary endpoint in melanoma, with full data presented earlier this month at the European Society for Medical Oncology Congress 2026. Moderna is also in talks with Middle East partners about potential investment and manufacturing cooperation, pairing its mRNA oncology push with efforts to extend its geographic footprint and industrial capabilities beyond its original COVID-19 franchise. The company recently won FDA approval of mFlusiva, its mRNA flu vaccine for adults 50 and older, underscoring its push to build a non-seasonal respiratory portfolio. Moderna's narrative projects $4.5 billion revenue and $782.2 million earnings by 2029, yielding a $119.56 fair value, a 40% downside to its current price, while some of the most optimistic analysts assume revenue could reach about US$8.5 billion and earnings turn positive by 2029.
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Biotech & Genomic Medicine › mRNA Platforms ▲Technology
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Demand
Biotech & Genomic Medicine › Oncology Therapeutics ▲Technology
Biotech & Genomic Medicine › Vaccines (Recombinant & Traditional) ▲Regulation
MRNA · Technology · Positive Moderna's personalized cancer vaccine intismeran autogene met the Phase 3 primary endpoint in melanoma, validating its mRNA oncology platform.
MRNA · Regulation · Positive Moderna recently won FDA approval of mFlusiva, its mRNA flu vaccine for adults 50 and older, expanding its non-seasonal respiratory portfolio.
MRNA · Capital · Neutral Moderna is in talks with Middle East partners about potential investment and manufacturing cooperation.
MRK · Technology · Positive Merck's Keytruda combined with Moderna's intismeran autogene met the Phase 3 primary endpoint in melanoma, a positive clinical readout for its oncology franchise.
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Biotech & Genomic Medicine▲3impact 4

Merck's Remigromig Meets Primary Goal in Phase IIb/III DME Study

Merck announced positive top-line data from the phase IIb/III BRUNELLO study of its investigational candidate remigromig, also known as MK-3000 and formerly EYE103, in adults with diabetic macular edema. The study met its primary endpoint, with both the 0.5-mg and 0.8-mg doses of remigromig demonstrating non-inferiority to ranibizumab 0.5-mg for mean change from baseline in best-corrected visual acuity at week 52, and both doses were generally well tolerated. Higher rates of proliferative diabetic retinopathy, vitreous hemorrhage and treatment discontinuations due to adverse effects were seen in the remigromig groups compared with ranibizumab, and Merck said further analyses are underway to characterize these findings. Remigromig is a first-in-class tetravalent, tri-specific antibody designed to activate the Wnt pathway, and Merck noted it is the first new mechanism of action in 20 years to achieve phase III results non-inferior to anti-VEGF therapy. BRUNELLO is the first of two phase IIb/III studies of remigromig in DME, alongside the ongoing pivotal BAROLO study in DME and the phase II SUPER TUSCAN study in neovascular age-related macular degeneration and retinal vein occlusion, with year-one results planned for the American Academy of Ophthalmology Annual Meeting in October 2026.
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Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity Competition
MRK · Technology · Positive Remigromig met the primary endpoint in the phase IIb/III BRUNELLO DME study, a first-in-class tri-specific antibody with a novel mechanism.
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Biotech & Genomic Medicine▲2impact 4

FDA Approves Merck and Eisai's WELIREG Plus LENVIMA for Advanced Kidney Cancer

The U.S. Food and Drug Administration has approved the dual oral regimen of WELIREG (belzutifan) plus LENVIMA (lenvatinib) for the treatment of adult patients with advanced renal cell carcinoma with a clear cell component following a PD-1 or PD-L1 inhibitor, Merck and Eisai announced. The approval is based on data from the Phase 3 LITESPARK-011 trial, in which WELIREG plus LENVIMA reduced the risk of disease progression or death by 26% compared to cabozantinib, with a median progression-free survival of 14.6 months versus 10.6 months. The combination also showed an objective response rate of 53% versus 40% for cabozantinib, while overall survival did not meet statistical significance at the final analysis. WELIREG plus LENVIMA is the first approved combination of a HIF-2 alpha inhibitor and a multi-targeted VEGFR-TKI for these patients, and the companies said the LITESPARK-011 results will be presented at the upcoming European Society for Medical Oncology Congress 2026 in Madrid, Spain.
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Biotech & Genomic Medicine › Oncology Therapeutics ▲Regulation
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint Competition
4523.JP · Regulation · Positive FDA approved Eisai's LENVIMA in combination with WELIREG for advanced renal cell carcinoma, a regulatory approval for its drug.
MRK · Regulation · Positive FDA approved Merck's WELIREG plus LENVIMA combination for advanced renal cell carcinoma, a regulatory approval expanding its oncology portfolio.
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Biotech & Genomic Medicine▲2

Merck Wins FDA Label Update for Winrevair in Newly Diagnosed PAH

Merck won an FDA label update adding HYPERION trial data for adults recently diagnosed with pulmonary arterial hypertension, sending shares up about 1.0% to $149.56 at 11.19am ET on Thursday. In the 320-person trial, Winrevair plus background therapy cut the risk of clinical worsening by 76% versus placebo, with first events occurring in 10.6% of treated patients compared with 36.9% of those receiving placebo. The broader label could support earlier use of the therapy, though commercial gains still hinge on diagnosis, insurance coverage and how long patients stay on treatment. Merck shares trade at $149.56, 23.8% above GuruFocus' $120.80 GF Value estimate.
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Biotech & Genomic Medicine › Cardiovascular & Heart-Failure Therapeutics ▲Demand
MRK · Regulation · Positive FDA label update adds HYPERION trial data for Winrevair, supporting earlier use in newly diagnosed PAH patients.
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Biotech & Genomic Medicine▲

Inhibrx Cancer Drug Nearly Doubles Keytruda Response Rate, Stock Falls 8.8%

Inhibrx Biosciences said its experimental cancer drug INBRX-106 combined with Merck's Keytruda produced a confirmed objective response rate of 48.3% versus 26.5% for Keytruda alone in the Phase 2 portion of its HexAgon study in treatment-naive, PD-L1-positive metastatic or unresectable recurrent head and neck squamous cell carcinoma. The study enrolled 68 patients, with 63 evaluable for the primary endpoint, and four patients, or 13.8%, on the combination achieved a complete response versus none on Keytruda alone. Median progression-free survival was 9.6 months for the combination versus 4.9 months for Keytruda alone as of the August 19 data cutoff, and among 10 evaluable HPV-positive patients the confirmed response rate was 80% versus 33.3% among nine patients on Keytruda alone. Inhibrx plans to add approximately 50 HPV-positive oropharyngeal cancer patients to the Phase 2 study to support a potential accelerated regulatory pathway, estimating the U.S. could have approximately 30,000 HPV-positive head and neck cancer patients by 2029, including around 6,000 first-line recurrent patients, representing a $1 billion annual sales opportunity. Despite the data, Inhibrx shares fell 8.8% to $110.45, a move CEO Mark Lappe told Reuters the company could not explain, while Stifel analyst Dara Azar called the results competitive against the difficult OX40 target.
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Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Technology
Biotech & Genomic Medicine › Oncology Therapeutics ▲Technology
INBX · Technology · Positive INBRX-106 plus Keytruda nearly doubled confirmed response rate (48.3% vs 26.5%) and improved PFS in the HexAgon Phase 2 study.
MRK · Technology · Positive Keytruda was the backbone comparator and the combination showed markedly better response rates than Keytruda alone.
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Insider Monkey·10dRead more →
United States
Biotech & Genomic Medicine▲

CDC Acknowledges One Pennsylvania Measles Death After Weeks of Resistance

The CDC has acknowledged one of the four measles-related deaths reported by Pennsylvania, ending weeks of resistance by the agency. The CDC's "Measles Cases and Outbreaks" page lists 3,471 cases nationwide as of Sept. 18, compared with 2,289 in all of 2025. Of the 3,471 cases, 9 percent, or 301 individuals, have resulted in hospitalizations, and 95 percent of all cases were in people not vaccinated with the MMR shot, which Merck and GSK market in the U.S. Pennsylvania is the hardest-hit state, with 792 cases as of Sept. 21. Pennsylvania Secretary of Health Debra Bogen recently asked the CDC for rapid-response assistance known as Epi-Aid, but only if the agency recognizes the state's four measles-associated deaths.
About megatrends
Biotech & Genomic Medicine › Vaccines (Recombinant & Traditional) ▲Demand
GSK.LSE · Demand · Positive Measles outbreak with 95% of cases in unvaccinated people boosts demand for GSK's MMR vaccine.
MRK · Demand · Positive Measles outbreak with 95% of cases in unvaccinated people boosts demand for Merck's MMR vaccine.
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Seeking Alpha·11dRead more →
United StatesGermany
MRK▲3impact 4

Moderna Jumps 5% as 1,137-Patient Melanoma Data Looms on October 24

Moderna shares rose another 5% to $181.51 on Tuesday morning, extending a 516% year-to-date gain, as investors position ahead of a late-October readout for the company's personalized cancer therapy. Moderna said detailed Phase 3 results for intismeran autogene, developed with Merck, will be presented at the European Society for Medical Oncology Congress in a Presidential Symposium on October 24. The data come from the INTerpath-001 study, which enrolled 1,137 participants and tested intismeran plus Merck's Keytruda against Keytruda alone in high-risk melanoma patients whose tumors had been surgically removed; Moderna reported last month that the trial met its primary endpoint of recurrence-free survival and a key secondary endpoint of distant metastasis-free survival, with both companies calling the improvements statistically significant and clinically meaningful, but releasing no underlying numbers. BioNTech, the other large messenger RNA developer, is up just 5% year to date at $100.42, a contrast that suggests the market is pricing an intismeran-specific outcome rather than a broad re-rating of the mRNA platform. Moderna and Merck are running intismeran across nine mid-stage and late-stage studies in other tumor types, including non-small cell lung cancer, bladder cancer and renal cell carcinoma, so the October 24 hazard ratios and survival curves carry binary risk for a stock that has rallied on a top-line conclusion rather than a dataset.
MRNA · Technology · Positive Moderna's personalized cancer therapy intismeran autogene met Phase 3 endpoints and detailed melanoma data will be presented October 24.
MRK · Technology · Positive Moderna's intismeran plus Merck's Keytruda met primary and secondary endpoints in the Phase 3 melanoma trial, with detailed data due October 24.
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24/7 Wall St.·12dRead more →
JapanUnited States
Biotech & Genomic Medicine▲2

Merck Wins Japanese Approval for Subcutaneous KEYTRUDA QLEX

Merck received Japanese approval for KEYTRUDA QLEX, also known as KEYJECT, its first subcutaneous formulation of KEYTRUDA, cleared for all existing local indications in the country. The new subcutaneous version offers an alternative to intravenous dosing and is aimed at faster administration for patients and clinicians. The approval broadens Merck's oncology treatment options in Japan, a key international market for its immunotherapy portfolio, and supports the view that the company can deepen the KEYTRUDA franchise rather than rely on a single route of administration. The article notes that convenience-driven launches do not directly address questions about pricing pressure, GARDASIL softness, or eventual KEYTRUDA loss of exclusivity that analysts have already flagged as risks. The balance still appears positive for the Merck narrative, but only if subcutaneous use contributes to the company's wider plan for more than 20 pipeline growth drivers.
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Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Regulation
MRK · Regulation · Positive Japanese approval of subcutaneous KEYTRUDA QLEX broadens Merck's oncology options in a key market and deepens the KEYTRUDA franchise.
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Simply Wall St·12dRead more →
United StatesEuropean Union
Biotech & Genomic Medicine▲

FDA Approves WINREVAIR Label Update Adding Phase 3 HYPERION Data for Newly Diagnosed PAH

Merck announced that the U.S. Food and Drug Administration has approved an update to the U.S. product label for WINREVAIR, also known as sotatercept-csrk, for injection at 45mg and 60mg, based on the Phase 3 HYPERION trial. In HYPERION, which enrolled 320 adults newly diagnosed with pulmonary arterial hypertension at intermediate to high risk of disease progression, adding WINREVAIR to background therapy reduced the risk of clinical worsening events by 76% compared with placebo, with a hazard ratio of 0.24 and a 95% confidence interval of 0.14 to 0.41 and a p value below 0.0001. A first clinical worsening event occurred in 10.6% of patients who received WINREVAIR, or 17 of 160, versus 36.9%, or 59 of 160, of those on placebo, and the mean time since PAH diagnosis was 7.2 months. The label update also adds safety information, including monitoring of hemoglobin and platelets before each dose for the first 5 doses, and notes that the most common adverse reactions in HYPERION were epistaxis at 31.9% versus 6.9%, telangiectasia at 26.3% versus 11.3% and increased hemoglobin at 11.3% versus 1.3%. Separately, Merck said the European Respiratory Society this month published clinical guidelines for the treatment of PAH that are the first formal clinical guidelines to include WINREVAIR, giving it a strong recommendation and grading the certainty of evidence as high.
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Biotech & Genomic Medicine › Cardiovascular & Heart-Failure Therapeutics ▲Regulation
MRK · Regulation · Positive FDA approved a WINREVAIR label update adding Phase 3 HYPERION data showing a 76% reduction in clinical worsening risk for newly diagnosed PAH patients.
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Business Wire·12dRead more →
United States
MRK3

Moderna Shares Jump 9.4% on Positive Phase 3 Melanoma Vaccine Data

Moderna shares climbed 9.4% in the afternoon session as positive Phase 3 INTerpath-001 trial results for its personalized cancer vaccine, intismeran autogene, given alongside Merck's Keytruda in high-risk melanoma patients continued to drive momentum. The advance extended earlier gains from the clinical study rather than reflecting new company disclosures, and the stock has also been bolstered by Wall Street upgrades from Argus and Bank of America. Regulatory sentiment improved further after the Food and Drug Administration approved Moderna's updated 2026-2027 COVID-19 vaccines. These developments follow a $2.6 billion convertible note offering completed in late August to provide dedicated funding for ongoing oncology development. Moderna is up 442% since the beginning of the year and, at $167.16 per share, is trading close to its 52-week high of $174.38 from August 2026.
MRNA · Technology · Positive Positive Phase 3 INTerpath-001 results for its personalized cancer vaccine intismeran autogene drove the 9.4% jump.
MRNA · Capital · Positive Wall Street upgrades from Argus and Bank of America, plus the $2.6B convertible note funding oncology development, are separate financial events.
MRNA · Regulation · Positive FDA approved Moderna's updated 2026-2027 COVID-19 vaccines, a distinct regulatory approval.
MRK · Technology · Neutral Keytruda is the combination partner in the positive Phase 3 melanoma trial, but the news is Moderna's vaccine data, not a Merck-specific development.
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DenmarkUnited StatesUnited Kingdom
Biotech & Genomic Medicine▼

Novo Rebrands as Novo, Lilly Wins FDA Nod, GE HealthCare Nears $1B Sofie Deal

Novo Nordisk will shorten its name to Novo and update its logo, with its trademark bull shifting to face right, as the Danish drugmaker battles Eli Lilly for dominance in the obesity-drug market. CEO Mike Doustdar is pushing to make Novo leaner and more competitive, and the company will detail its updated corporate strategy at a Capital Markets Day on September 21 in London. Separately, Eli Lilly said the U.S. FDA granted full approval for an all-oral regimen combining its estrogen receptor antagonist Inluriyo and kinase inhibitor Verzenio as a late-line option for adults with estrogen receptor-positive, HER2-negative breast cancer with an ESR1 mutation whose disease progressed after one or more prior endocrine therapies. GE HealthCare Technologies is in advanced talks to acquire Sofie Biosciences for about $1 billion, a deal that would expand its presence in radioactive diagnostic agents used with medical scans, according to the Financial Times. Summit Therapeutics said ivonescimab reduced the risk of death by 27% versus Merck's Keytruda in a late-stage lung cancer trial, with median overall survival of 30.8 months versus 22.6 months. Medtronic launched an exchange offer to split off at least 80.1% of MiniMed Group, allowing shareholders to exchange ordinary shares for MiniMed common stock at a 7% discount.
About megatrends
Biotech & Genomic Medicine › Oncology Therapeutics ▲Technology
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▼Competition
Biotech & Genomic Medicine › Diagnostics & Precision Testing ▲Capital
Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity Competition
Biotech & Genomic Medicine › Diabetes Devices (CGM & Insulin Delivery) Capital
GEHC · Capital · Positive GE HealthCare in advanced talks to acquire Sofie Biosciences for about $1 billion, expanding its radioactive diagnostic agents business.
LLY · Regulation · Positive FDA granted full approval for Lilly's all-oral Inluriyo plus Verzenio regimen for ESR1-mutant ER-positive, HER2-negative breast cancer.
MDT · Capital · Positive Medtronic launched an exchange offer to split off at least 80.1% of MiniMed Group at a 7% discount.
NVO · Capital · Neutral Novo rebrands and shortens name to Novo, with CEO pushing to make it leaner and more competitive ahead of a Sept 21 Capital Markets Day strategy update.
Sofie Biosciences · Capital · Positive GE HealthCare is in advanced talks to acquire Sofie Biosciences for about $1 billion, expanding its radioactive diagnostic agents business.
MMED · Capital · Positive MiniMed is being split off from Medtronic via an exchange offer at a 7% discount, creating its own public listing.
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Seeking Alpha·14dRead more →
United States
MRK▲

Pfizer's Dividend Streak Stalls at $0.43 as Peers Keep Raising

Pfizer's decade-long streak of annual dividend increases has stalled, with its quarterly payout holding at $0.43 through the September 1, 2026 payment after the January 2026 ex-dividend date matched the prior four quarters instead of rising. The 6.20% yield remains covered by reaffirmed 2026 adjusted diluted EPS guidance of $2.80 to $3.00 against a run-rate $1.72 annual payout, and Q1 2026 adjusted EPS of $0.75 beat consensus for a fifth consecutive quarter above estimates. Cash outflow is real, with $2.4 billion in dividends paid in Q1 alone and $9.8 billion for full-year 2025, while Pfizer completed no buybacks in 2025 and anticipates none in 2026 despite $3.3 billion of unused authorization. On the August 4, 2026 call, incoming interim CFO Cecile Guegan said Pfizer would keep maintaining and over the long term growing the dividend, and Chairman and CEO Albert Bourla said the dividend will be maintained and eventually start growing again after the loss-of-exclusivity period. Peers have not frozen their payouts: Merck raised its quarterly from $0.81 to $0.85 starting with the December 2025 ex-date, and Bristol-Myers Squibb nudged its payout from $0.62 to $0.63 with the January 2026 ex-date. The pressure behind the pause is visible in the mix, with Comirnaty down 59% and Paxlovid down 62% in Q1 2026 and roughly $1.5 billion in additional generic and biosimilar headwind guided for the year, partly offset by launched and acquired products growing 22% operationally and Vyndamax exclusivity now running to June 2031.
PFE · Capital · Negative Pfizer's decade-long streak of annual dividend increases stalled at $0.43, with no buybacks in 2025 or 2026 despite $3.3 billion unused authorization.
PFE · Demand · Negative Comirnaty fell 59% and Paxlovid 62% in Q1 2026, with roughly $1.5 billion of additional generic and biosimilar headwind guided for the year.
BMY · Capital · Positive Bristol-Myers Squibb nudged its quarterly payout from $0.62 to $0.63 with the January 2026 ex-date, continuing to raise dividends while Pfizer's stalled.
MRK · Capital · Positive Merck raised its quarterly dividend from $0.81 to $0.85 starting with the December 2025 ex-date, in contrast to Pfizer's frozen payout.
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24/7 Wall St.·16dRead more →
European UnionUnited StatesIcelandLiechtensteinNorway
Biotech & Genomic Medicine▲2impact 4

Merck Wins Positive EU CHMP Opinion for KEYTRUDA Plus Padcev in Resectable Muscle-Invasive Bladder Cancer

Merck announced that the European Medicines Agency's Committee for Medicinal Products for Human Use adopted a positive opinion recommending approval of KEYTRUDA, the company's anti-PD-1 therapy, in combination with Padcev as neoadjuvant treatment and then continued after radical cystectomy as adjuvant treatment for adults with resectable muscle-invasive bladder cancer. The recommendation, which also includes KEYTRUDA SC, known as KEYTRUDA QLEX in the U.S., will now be reviewed by the European Commission for marketing authorization in the European Union, Iceland, Liechtenstein and Norway, with a final decision expected by the fourth quarter of 2026. The opinion is based on results from the Phase 3 KEYNOTE-B15 trial, also known as EV-304, conducted in collaboration with Pfizer and Astellas, in which the perioperative regimen reduced the risk of event-free survival events by 47% (HR=0.53) and the risk of death by 35% (HR=0.65) versus neoadjuvant chemotherapy and surgery in cisplatin-eligible patients, while pathologic complete response reached 55.8% versus 32.5%. If approved, KEYTRUDA plus Padcev would become the first and only PD-1 inhibitor plus antibody-drug conjugate regimen in the European Union for patients with MIBC regardless of cisplatin eligibility. In June 2026, the European Commission approved the combination for cisplatin-ineligible adults with resectable MIBC based on the Phase 3 KEYNOTE-905 trial, and in July 2026 the U.S. Food and Drug Administration approved it for adults with MIBC regardless of cisplatin eligibility based on KEYNOTE-B15.
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Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Regulation
Biotech & Genomic Medicine › Antibody-Drug Conjugates (ADC) ▲Regulation
Biotech & Genomic Medicine › Oncology Therapeutics ▲Regulation
MRK · Regulation · Positive EU CHMP positive opinion recommends approval of KEYTRUDA plus Padcev for resectable muscle-invasive bladder cancer, advancing toward EU marketing authorization.
4503.JP · Regulation · Positive The positive CHMP opinion is based on the Phase 3 KEYNOTE-B15/EV-304 trial conducted in collaboration with Astellas, whose Padcev is part of the recommended regimen.
PFE · Regulation · Positive The positive CHMP opinion is based on the Phase 3 KEYNOTE-B15/EV-304 trial conducted in collaboration with Pfizer, whose Padcev is part of the recommended regimen.
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Business Wire·16dRead more →
United States
Biotech & Genomic Medicine▲

Merck Rises as Keytruda Space Research Seeks New Orbital Home

Merck shares rose approximately 1.0% to $146.39 Thursday as the pharmaceutical and oncology heavyweight entered the next era of commercial space research, with its blockbuster cancer drug Keytruda already benefiting from work conducted in orbit. Research aboard the International Space Station helped scientists better understand protein crystallization, contributing to the development of a faster subcutaneous formulation of Keytruda, and NASA's research overview explains that microgravity can produce larger and more orderly protein crystals, potentially giving researchers clearer structural information. As the ISS approaches retirement, commercial stations could offer drugmakers dedicated equipment and more predictable research schedules, although regulators still lack a purpose-built approval framework for medicines manufactured in space. The commercial stakes are already enormous: Keytruda generated about $8.37 billion of Merck's latest $16.61 billion quarter, roughly half of total revenue, while the subcutaneous version contributed $463 million, or around 5.5% of Keytruda sales. At $146.39, Merck trades 21.85% above its GF Value estimate of $120.14, signaling that investors are already paying a meaningful premium to the model's estimate of fair value.
About megatrends
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Technology
Space Economy › In-Space Manufacturing & Commercial Stations ▲Demand
Biotech & Genomic Medicine › Oncology Therapeutics ▲Technology
MRK · Technology · Positive Keytruda's orbital protein-crystallization research aided development of a faster subcutaneous formulation, advancing Merck's drug technology.
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GuruFocus·17dRead more →
United StatesUnited Kingdom
Biotech & Genomic Medicine▲

Immunocore Hits 540-Patient Enrollment Target in Phase III TEBE-AM Study of Kimmtrak

Immunocore announced it has reached target enrollment of 540 patients in the phase III TEBE-AM study, which is evaluating its sole marketed drug, Kimmtrak, in patients with second-line or later advanced melanoma. The randomized, registrational trial is testing Kimmtrak as a monotherapy and in combination with Merck's PD-L1 inhibitor Keytruda versus investigator's choice in HLA-A*02:01-positive patients whose disease progressed after prior therapy, with overall survival as the primary endpoint. Immunocore expects to report top-line overall survival data from TEBE-AM as early as the end of 2026, and management says Kimmtrak could address a significant unmet need among up to 4,000 HLA-A*02:01-positive patients with previously treated advanced melanoma in the post-PD1 setting. Kimmtrak is currently approved for unresectable or metastatic uveal melanoma, and its sales rose 16% year over year to $222.6 million in the first half of 2026. Merck recorded $16.40 billion in Keytruda sales in the first half of 2026, up 4.2% year over year.
About megatrends
Biotech & Genomic Medicine › Oncology Therapeutics Demand
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint Competition
MRK · Demand · Positive Keytruda is being tested in combination with Kimmtrak in the phase III TEBE-AM melanoma study, a potential additional use for Merck's PD-L1 inhibitor.
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Zacks Investment Research·19dRead more →
United StatesChina
Biotech & Genomic Medicine▼impact 4

Eli Lilly Q2 Revenue Jumps 48% to $23 Billion as Merck Grows 5%

Eli Lilly reported second quarter revenue of $22.97 billion, up 47.7% year over year, while Merck posted $16.6 billion, up 5%, according to results from both drugmakers. Lilly's growth was driven by Mounjaro at $9.94 billion, up 91%, and Zepbound at $4.93 billion, up 46%, and the company raised its full-year guidance to $85 to $87 billion with an 85.8% gross margin. Merck's KEYTRUDA family brought in $8.4 billion, growing just 4%, and management said U.S. KEYTRUDA growth will moderate as the drug reaches peak penetration, while a $5.7 billion Terns acquisition charge pushed the company to a reported loss. Lilly's pipeline advanced with retatrutide showing weight loss approaching bariatric surgery levels in Phase 3, orforglipron, branded Foundeo, becoming the first once-daily oral GLP-1 with prescriber counts jumping from roughly 8,000 to 36,000 in one quarter, and FDA clearance of Mounjaro for cardiovascular risk reduction in type 2 diabetes on August 28. Merck is leaning on new launches including Lipvendra, the first oral PCSK9 inhibitor, and WINREVAIR, which grew 75% to $588 million, though GARDASIL China stayed weak and three Phase 3 oncology trials missed. Lilly trades at a forward P/E of 24 versus Merck at 15 with a 2.29% yield.
About megatrends
Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity ▲Demand
Biotech & Genomic Medicine › Oncology Therapeutics Competition
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▼Demand
Biotech & Genomic Medicine › Cardiovascular & Heart-Failure Therapeutics ▲Regulation
LLY · Capital · Positive Q2 revenue jumped 47.7% to $22.97B and full-year guidance was raised to $85-87B with 85.8% gross margin.
LLY · Technology · Positive Pipeline advanced: retatrutide Phase 3 weight loss near bariatric surgery levels, orforglipron became first once-daily oral GLP-1 with prescriber counts jumping to 36,000, and FDA cleared Mounjaro for cardiovascular risk reduction.
MRK · Capital · Negative Q2 revenue grew only 5% to $16.6B, KEYTRUDA growth slowed to 4%, and a $5.7B Terns acquisition charge pushed Merck to a reported loss.
MRK · Technology · Negative Three Phase 3 oncology trials missed and GARDASIL China stayed weak, though new launches Lipvendra and WINREVAIR grew.
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247wallst.com·19dRead more →
United States
Biotech & Genomic Medicine▲

Perspective Therapeutics and Merck to Test PSV359 With Keytruda in FAP-α Solid Tumors

Perspective Therapeutics has signed a clinical trial collaboration and supply agreement with Merck to evaluate its targeted alpha-particle therapy [212Pb]PSV359 in combination with Keytruda, Merck's anti-PD-1 therapy, in patients with FAP-α-positive solid tumors. The combination will be tested under an amendment to Perspective's ongoing Phase 1/2a study of [212Pb]PSV359 in certain types of non-small cell lung cancer and colorectal cancer that express fibroblast activation protein alpha, under clinicaltrials.gov identifier NCT06710756. Perspective is sponsoring the study and Merck is providing pembrolizumab at no cost, with enrollment already completed in the first three monotherapy dose cohorts. Markus Puhlmann, Perspective's Chief Medical Officer, said FAP-α is associated with the majority of solid tumors and a tumor microenvironment historically characterized by poor drug penetration and immune suppression or exclusion, and that combining targeted radiopharmaceutical treatment with a well-established immune checkpoint inhibitor may reshape the tumor environment and improve outcomes for patients with advanced FAP-α-positive solid tumors.
About megatrends
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint Competition
Biotech & Genomic Medicine › Oncology Therapeutics Technology
CATX · Technology · Positive Perspective signs clinical trial collaboration with Merck to evaluate its [212Pb]PSV359 in combination with Keytruda in FAP-α-positive solid tumors.
MRK · Technology · Positive Merck will supply Keytruda (pembrolizumab) at no cost for the combination study, expanding its immuno-oncology combination data.
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GlobeNewswire·20dRead more →
ChinaUnited StatesSouth Korea
Biotech & Genomic Medicine▼impact 4

Summit's ivonescimab cuts death risk 27% versus Keytruda in lung cancer trial

Summit Therapeutics said Sunday that its ivonescimab significantly extended survival compared with Merck's Keytruda in a late-stage lung cancer trial run by its partner Akeso in China. Ivonescimab reduced the risk of death by 27% versus Keytruda, also known as pembrolizumab, in previously untreated patients with advanced non-small cell lung cancer whose tumors expressed PD-L1, with median overall survival of 30.8 months against 22.6 months, an 8.2-month difference Summit called statistically significant. The Phase 3 HARMONi-2 trial enrolled 398 patients with a median follow-up of 36 months, and the results are being presented at the International Association for the Study of Lung Cancer's World Conference on Lung Cancer in Seoul. In the 168-patient subgroup with high PD-L1 expression, ivonescimab cut the risk of death by 42%, while the benefit was smaller and not statistically reliable in patients with lower PD-L1 expression, where the hazard ratio was 0.85 with a confidence interval crossing 1.0. Serious treatment-related adverse events occurred in 29.9% of ivonescimab patients versus 21.6% for Keytruda, though discontinuations were slightly less frequent at 4.1% versus 5%, and Summit is now recruiting for the global Phase 3 HARMONi-7 trial, expected to enroll 780 patients, while the FDA reviews a separate application in previously treated EGFR-mutated lung cancer with a Nov. 14 decision deadline.
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Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▼Competition
Biotech & Genomic Medicine › Oncology Therapeutics Competition
9926.HK · Technology · Positive Akeso's partner trial of ivonescimab showed statistically significant survival benefit versus Keytruda in advanced NSCLC.
MRK · Competition · Negative Ivonescimab beat Merck's Keytruda with a 27% reduction in death risk and 8.2-month overall survival advantage in the HARMONi-2 trial.
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Seeking Alpha·21dRead more →
United States
Biotech & Genomic Medicine▲

Merck's Keytruda Franchise Drives $8.4 Billion as Cramer Calls It a Fantasy Defense Pick

Merck & Co. reported second-quarter worldwide sales of $16.6 billion, with its oncology franchise led by intravenous Keytruda and the subcutaneous formulation Keytruda QLEX generating $8.4 billion in quarterly revenue. The pulmonary arterial hypertension treatment Winrevair surged 75% to reach $588 million, and management raised its full-year 2026 sales guidance to a range between $66.3 billion and $67.3 billion. The company faces the loss of exclusivity for Keytruda toward the end of 2028, pushing it to fund and acquire new pipeline assets, including a personalized mRNA cancer vaccine collaboration with Moderna. According to Insider Monkey's database, 101 hedge funds held a stake in the company during the second quarter, up from 98 in the prior quarter, while short interest sits at just 0.99% of the float. Fisher Asset Management maintained the top position with 38.5 million shares, increasing its holdings by 46%.
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Biotech & Genomic Medicine › Oncology Therapeutics ▲Demand
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▲Demand
Biotech & Genomic Medicine › Cardiovascular & Heart-Failure Therapeutics ▲Demand
Biotech & Genomic Medicine › mRNA Platforms ▲Technology
MRK · Capital · Positive Q2 sales of $16.6B with Keytruda franchise at $8.4B and raised full-year 2026 guidance
MRK · Demand · Positive Winrevair revenue surged 75% to $588 million on strong product demand
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Insider Monkey·22dRead more →
United StatesUnited KingdomSwitzerland
Biotech & Genomic Medicine▲

Merck Bets on Tripled Pipeline and New Drugs to Offset 2028 Keytruda Patent Loss

Merck is relying on a growing pipeline and an expanding portfolio of newer medicines, including acquired assets, to offset the eventual loss of exclusivity for its blockbuster cancer drug Keytruda. Keytruda generated sales of $16.40 billion in the first half of 2026, up nearly 4.2% year over year, and is expected to remain strong until it loses patent exclusivity in 2028, after which biosimilars entering around 2028-2029 are likely to drive a sharp decline. Merck's phase III pipeline has almost tripled since 2021, and the company expects to launch 20 new drugs by 2030, with newer products already emerging as growth drivers: pulmonary arterial hypertension drug Winrevair and 21-valent pneumococcal conjugate vaccine Capvaxive generated $1.1 billion and $325 million, respectively, in first-half 2026 sales, while cancer drug Welireg sales surged 57% year over year to $470 million. Merck expects more than $70 billion of potential non-risk-adjusted commercial opportunity for the current pipeline by the mid-2030s, more than double the peak consensus sales estimate for Keytruda of $35 billion in 2028, and has stepped up acquisitions ahead of the patent expiry with deals for Verona Pharma, Cidara Therapeutics and Terns Pharmaceuticals. Management expects the Keytruda LOE period to look like a shallow dip with a fast return back to growth, even as Keytruda faces competition from Bristol Myers' Opdivo, Roche's Tecentriq and AstraZeneca's Imfinzi.
About megatrends
Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▼Competition
Biotech & Genomic Medicine › Biosimilars ▲Demand
Biotech & Genomic Medicine › Oncology Therapeutics Competition
Biotech & Genomic Medicine › Vaccines (Recombinant & Traditional) ▲Demand
MRK · Technology · Positive Merck's phase III pipeline nearly tripled since 2021 with 20 new drug launches expected by 2030 to offset Keytruda's 2028 patent loss.
MRK · Capital · Positive Merck stepped up acquisitions ahead of the patent expiry with deals for Verona Pharma, Cidara Therapeutics and Terns Pharmaceuticals.
Terns Pharmaceuticals, Inc. · Capital · Positive Terns Pharmaceuticals is named as one of Merck's acquisition targets ahead of the Keytruda patent expiry.
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Zacks Investment Research·23dRead more →
Thailand
MRK▲

Government in talks with 10 global drugmakers to draw research investment into Thailand, starting with a 2 billion baht MSD deal

The government is pressing ahead with negotiations with 10 global pharmaceutical companies to attract clinical research investment, manufacturing technology transfer, and workforce development into Thailand under a strategy to position the country as a Medical Investment Hub. Lalida Periswiwatana, deputy spokesperson for the Prime Minister's Office, said on September 11, 2026, that the approach falls under the Joint Public-Private Committee for Solving Economic Problems, known as the Kor Or, chaired by Prime Minister Anutin Charnvirakul, and the subcommittee on developing new national investment, chaired by Deputy Prime Minister and Finance Minister Ekniti Nitithanprapas. The government is applying an Offset Policy concept in talks with foreign companies so that government procurement extends into domestic investment. The Ministry of Public Health, under Minister Phatana Promphat, is negotiating with all 10 drugmakers, with the Board of Investment joining in considering investment promotion measures. Cooperation with MSD is the first Quick Win to show concrete results, with one new drug research program carrying an investment value of about 2 billion baht and the potential to create roughly 1,000 jobs. There are also plans to extend cooperation on technology transfer and the production of active pharmaceutical ingredients, or APIs, for a new HIV drug together with the Government Pharmaceutical Organization. Lalida said that within about two weeks the government plans to sign an additional cooperation agreement with Sandoz to draw global companies into investing and generating economic activity in Thailand, rather than having the public sector simply buy products from abroad.
MRK · Demand · Positive MSD is the first Quick Win with a ~2 billion baht new drug research program in Thailand, creating ~1,000 jobs and API/HIV drug cooperation.
SDZ.SW · Demand · Positive Thailand plans to sign an additional cooperation agreement with Sandoz within two weeks to draw its investment into the country.
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Money & Banking·23dRead more →
United States
MRK▼

Merck Shares Slip 1.91% as Analysts Eye Upcoming Earnings

Merck closed the most recent trading day at $144.71, down 1.91% from the previous session, a steeper decline than the S&P 500's 0.59% loss, while the Dow fell 0.6% and the Nasdaq dropped 0.65%. Ahead of Merck's upcoming financial release, analysts expect earnings of $2.27 per share, a year-over-year decline of 12.02%, on revenue of $17.61 billion, up 1.94% from the same quarter a year earlier. For the full year, the Zacks Consensus Estimates project earnings of $2.97 per share and revenue of $67.25 billion, changes of -66.93% and +3.45% respectively from last year. Over the past month the Zacks Consensus EPS estimate has moved 0.38% lower, and Merck currently carries a Zacks Rank #3 (Hold). The stock trades at a Forward P/E of 49.6 versus an industry average of 15.55, with a PEG ratio of 5.97 against the Large Cap Pharmaceuticals industry average of 2.01.
MRK · Capital · Negative Analysts expect Merck's upcoming earnings to fall 12.02% YoY and full-year EPS to drop 66.93%, with the consensus estimate revised lower over the past month.
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Biotech & Genomic Medicine▲impact 4

Moderna's Cancer Vaccine Trial Success Drives Stock Surge

Moderna's stock surged as much as 160% after the company announced positive Phase 3 trial results for its mRNA-based personalized cancer vaccine, which significantly reduced the risk of melanoma recurrence in over 1,100 patients when combined with Merck's Keytruda. The trial was stopped early because the efficacy was so high that standard medical ethics required allowing control-group patients access to the treatment. Despite the jump, shares remain below previous highs, and analysts caution that scaling and pricing questions remain. Meanwhile, Target reported a 5.3% sales increase and a 100% jump in earnings per share, though much of that came from a one-time $994 million tariff refund. The company's digital sales grew 8.7%, and same-day deliveries rose 25%, but analysts question whether the turnaround can sustain the stock's 60% year-to-date gain. In AI news, OpenAI's 18% quarterly growth disappointed investors, while Anthropic more than doubled revenue, and both companies are racing toward IPOs.
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Biotech & Genomic Medicine › mRNA Platforms ▲Technology
MRNA · Technology · Positive Positive Phase 3 trial results for mRNA cancer vaccine reduce melanoma recurrence risk.
TGT · Capital · Positive Target reports 5.3% sales increase and 100% EPS jump, though partly from one-time tariff refund.
Anthropic · Capital · Positive Anthropic more than doubled revenue, showing strong growth.
OpenAI · Capital · Negative OpenAI's 18% quarterly growth disappoints investors.
MRK · Demand · Positive Moderna's cancer vaccine trial success with Keytruda boosts Merck's drug sales potential.
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MRK▼

Gilead's Bixlenvo Approval Targets Niche HIV Market

Gilead Sciences has received FDA approval for Bixlenvo, a once-daily pill for adults with suppressed HIV, combining bictegravir from its blockbuster Biktarvy with lenacapavir, the foundation of its long-term HIV strategy. The drug aims to simplify treatment for patients on complex multi-pill regimens, which represent only about 5% of people living with HIV in the United States. In two late-stage studies, Bixlenvo matched the effectiveness of existing regimens at maintaining viral suppression after 48 weeks. Gilead expects the drug to be available within days, with a wholesale acquisition cost of $4,595 for a 30-day supply. However, the eligible market is narrow, and patients must complete an initial two-day dose of Sunlenca before starting Bixlenvo, while facing competition from Merck's recently approved Idvynso.
GILD · Regulation · Positive FDA approval for Bixlenvo, a new HIV drug, expands Gilead's product portfolio.
MRK · Competition · Negative Merck's recently approved Idvynso is mentioned as a competitor to Gilead's Bixlenvo.
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Biotech & Genomic Medicine▲

Ulcerative Colitis Market to Reach $9.4B by 2036, Late-Stage Drugs Advance

DelveInsight projects the ulcerative colitis market across the seven major markets—the US, EU4, UK, and Japan—will grow from approximately USD 9.4 billion in 2025 at a CAGR of 7.6% through 2036, driven by novel targeted therapies and a robust pipeline of late-stage candidates. Among these, Abivax's obefazimod, a first-in-class oral miR-124 enhancer, met its primary endpoint in Phase III ABTECT induction studies, with a pooled placebo-adjusted clinical remission rate of 16.4% at Week 8. Merck's tulisokibart, acquired via Prometheus Biosciences, achieved clinical remission in the Phase 3 ATLAS-UC study, while Roche's afimkibart, from its $7.1 billion Telavant acquisition, showed a 35% remission rate in Phase IIb TUSCANY-2. Johnson & Johnson and Protagonist Therapeutics' icotrokinra, a first-in-class oral IL-23 receptor antagonist, met its primary endpoint in the Phase 2b ANTHEM-UC trial, and Teva and Sanofi's duvakitug, backed by a $400 million Blackstone funding deal, is in Phase III. These therapies target unmet needs in moderate-to-severe disease, with the market shifting toward IL-23 inhibitors and oral advanced therapies, though biosimilars and established anti-TNFs remain widely used.
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Biotech & Genomic Medicine › Autoimmune & Immunology Therapeutics ▲Competition
ABVX.PA · Technology · Positive Abivax's obefazimod met its primary endpoint in Phase III ABTECT induction studies with a 16.4% placebo-adjusted remission rate.
JNJ · Technology · Positive J&J and Protagonist's icotrokinra met its primary endpoint in the Phase 2b ANTHEM-UC trial for ulcerative colitis.
MRK · Technology · Positive Merck's tulisokibart, acquired via Prometheus Biosciences, achieved clinical remission in the Phase 3 ATLAS-UC study.
PTGX · Technology · Positive Protagonist Therapeutics' icotrokinra, partnered with J&J, met its primary endpoint in the Phase 2b ANTHEM-UC trial.
ROP.SW · Technology · Positive Roche's afimkibart (from the $7.1B Telavant acquisition) showed a 35% remission rate in Phase IIb TUSCANY-2 for ulcerative colitis.
TEVA · Technology · Positive Teva and Sanofi's duvakitug is in Phase III for ulcerative colitis, backed by a $400 million Blackstone funding deal.
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Biotech & Genomic Medicine▼impact 4

Summit Therapeutics Soars on Positive Lung Cancer Drug Data

Summit Therapeutics shares jumped 17.3% on Thursday after its Chinese partner Akeso reported positive overall survival results for ivonescimab in a head-to-head phase III study against Merck's Keytruda in certain non-small cell lung cancer patients. The data provides fresh clinical validation for Summit's lead oncology candidate and boosts its potential in licensed markets. Akeso's HARMONi-2 study showed ivonescimab monotherapy achieved a statistically significant improvement in overall survival versus Keytruda, meeting a key secondary endpoint. This follows earlier positive progression-free survival results with a hazard ratio of 0.51. Summit is also conducting the global HARMONi-7 study in the United States to evaluate ivonescimab against Keytruda in a similar patient population. Year to date, Summit shares have lost 2%, compared with the industry's 0.9% decline.
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Biotech & Genomic Medicine › Immuno-Oncology / Checkpoint ▼Competition
Biotech & Genomic Medicine › Oncology Therapeutics ▼Competition
9926.HK · Technology · Positive positive overall survival results for ivonescimab in HARMONi-2 study
MRK · Competition · Negative ivonescimab shows superior overall survival vs Keytruda in phase III
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Merck Faces Keytruda Biosimilar Threat Ahead of 2028 Patent Expiry

Merck received a warning on Thursday as Cipla's U.S. subsidiary secured exclusive American commercialization rights to Qilu Pharmaceutical's proposed pembrolizumab biosimilar, QL2107, ahead of Keytruda's expected 2028 core patent expiration. The biosimilar is not an immediate threat, as Qilu must still complete development, win regulatory approval, and prove manufacturing capability, with Cipla taking over only if QL2107 reaches the U.S. market. Merck's Keytruda franchise, which posted $8.4 billion in quarterly sales including $463 million from the newer subcutaneous version Qlex, faces increasing competition from lower-priced alternatives. Qlex already contributes about 5.5% of franchise revenue and is a key part of Merck's patent-cliff defense. Merck's stock trades at $151.07, 25.87% above its GF Value of $120.02, raising the stakes for the company to transition patients to Qlex and build its next growth engine before biosimilars arrive.
MRK · Competition · Negative Cipla's US unit secured exclusive US commercialization rights to Qilu's proposed pembrolizumab biosimilar, threatening Merck's Keytruda franchise ahead of its 2028 patent expiry.
Cipla · Demand · Positive Cipla's US subsidiary secured exclusive American commercialization rights to Qilu's pembrolizumab biosimilar QL2107.
Qilu Pharmaceutical Co., Ltd. · Demand · Positive Qilu Pharmaceutical's proposed pembrolizumab biosimilar QL2107 gained a US commercialization partner in Cipla, advancing its path to the US market.
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Fresenius Kabi Launches Generic Sugammadex in Prefilled Syringe in U.S.

Fresenius Kabi announced the U.S. launch of its FDA-approved generic Sugammadex Injection, now available in a Simplist ready-to-administer prefilled syringe for use in operating rooms. The launch follows the expiration of exclusivity for Merck's branded Bridion in July 2026. The product is indicated to reverse neuromuscular blockade induced by rocuronium and vecuronium in adults and pediatric patients aged two years and older. Fresenius Kabi offers the 200 mg per 2 mL prefilled syringe, which requires no assembly at the point of care, aiming to streamline medication management and reduce error risk. The product is formulated, filled, and packaged in the U.S., reflecting the company's More in America commitment to domestic manufacturing and supply-chain resilience.
FRE.XETRA · Demand · Positive Fresenius Kabi launched its FDA-approved generic Sugammadex prefilled syringe in the U.S., expanding its product offering.
MRK · Competition · Negative Fresenius Kabi's generic Sugammadex launch after Bridion exclusivity expiration erodes Merck's branded Bridion franchise.
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Business Wire·31dRead more →
United States
Biotech & Genomic Medicine▲

Gilead Wins FDA Approval for Bixlenvo HIV Regimen

Gilead Sciences has received FDA approval for Bixlenvo, the smallest once-daily single-tablet regimen for HIV in virologically suppressed adults, making it the first and only option for patients unable to take existing single-tablet regimens. The drug combines bictegravir and lenacapavir, offering a high barrier to resistance and no cross-resistance to current antiretrovirals. This approval strengthens Gilead's HIV portfolio, which already includes Biktarvy, Descovy, and the rapidly growing Yeztugo, and the company has raised its 2026 HIV sales growth outlook to 9-10%, supported by a roughly $4 billion annualized PrEP business. Gilead expects Yeztugo sales to approach $1 billion in 2026, and its pipeline, including a once-weekly oral combination with Merck, offers additional upside. Shares of Gilead have gained 20.3% year to date, and the company currently holds a Zacks Rank #1 (Strong Buy).
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Biotech & Genomic Medicine › Antiviral & Infectious-Disease Therapeutics ▲Competition
GILD · Technology · Positive FDA approval of Bixlenvo, a new HIV regimen, strengthens Gilead's portfolio and raises 2026 HIV sales outlook.
MRK · Technology · Positive Mentioned as partner in Gilead's pipeline for a once-weekly oral HIV combination, indicating potential future collaboration.
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Zacks Investment Research·33dRead more →
United States
Biotech & Genomic Medicine▲

Oral PCSK9 Inhibitor Market Enters High-Growth Phase After Merck's LIPFENDRA Approval

DelveInsight reports that the PCSK9 inhibitors market is entering a high-growth phase, driven by the FDA approval of Merck's LIPFENDRA, the first oral PCSK9 inhibitor, and the emergence of next-generation oral drugs from AstraZeneca, Aqur Biosciences, and others. The market was valued at USD 3 billion in the 7MM in 2025, with the United States holding the largest share. Key pipeline candidates include Recaticimab, VERVE 102, AZD0780, AQR-008, and LIB003, with LEQVIO expected to generate the highest revenue by 2036. The report covers indications such as dyslipidemia, hypercholesterolemia, ASCVD, and others, and highlights that oral and gene therapies offer significant potential to reduce patient burden and improve adherence.
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Biotech & Genomic Medicine › Metabolic, Diabetes & Obesity ▲Competition
MRK · Regulation · Positive FDA approval of Merck's LIPFENDRA, the first oral PCSK9 inhibitor, drives the high-growth phase of the market.
AZN.LSE · Technology · Positive AstraZeneca's next-generation oral PCSK9 candidate AZD0780 is highlighted as an emerging pipeline drug.
Aqur Biosciences · Technology · Positive Aqur Biosciences' next-generation oral PCSK9 drug AQR-008 is cited as an emerging pipeline candidate.
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PR Newswire·33dRead more →