Bayer AG NA

Bayer announced that the FDA has approved a label expansion for its kidney disease drug Kerendia, also known as finerenone, to treat adults with chronic kidney disease associated with type one diabetes. The drug, a selective non-steroidal mineralocorticoid receptor antagonist, was initially approved in the United States in 2021 for chronic kidney disease associated with type two diabetes, and its label was expanded in 2025 to include adults with symptomatic chronic heart failure with a left ventricular ejection fraction of at least 40 percent. This latest approval, the drug's third in the United States, follows a Priority Review designation and is supported by positive results from the pivotal phase three FINE-ONE study, in which Kerendia added to standard of care produced a statistically significant 25 percent reduction from baseline in the urine albumin-to-creatinine ratio over six months compared with placebo. The company said the expanded indication addresses an important unmet need, as approximately 30 percent of people with type one diabetes in the United States develop chronic kidney disease. Kerendia, marketed as Firialta in some countries, is approved for chronic kidney disease associated with type two diabetes in China, Europe and Japan, and finerenone is also approved for heart failure with a left ventricular ejection fraction of at least 40 percent in Europe, Japan, China and several other markets. Year to date, Bayer's shares have risen 29.8 percent compared with the industry's 10.9 percent growth, and sales of Kerendia skyrocketed 82.9 percent in the second quarter.

Apollo-managed funds and affiliates have closed a €3 billion capital solution for Bayer, first announced on July 10, with KKR joining as a significant minority participant. Under the transaction, Apollo and KKR invested equity capital into a newly established entity holding Bayer's long-acting reversible contraceptives business, while Bayer retains a majority stake and continues to exercise full operational control, with no changes to the LARC strategy. Apollo Partner Jamshid Ehsani said the firm originated and led the multi-billion-euro capital solution, adding that Apollo has committed to deploying more than $100 billion in Germany over the coming decade. Centerview Partners served as financial advisor to the Apollo Funds, with Latham & Watkins LLP, Paul, Weiss, Rifkind, Wharton & Garrison LLP, and NautaDutilh N.V. acting as legal counsel.

Bayer announced that the FDA has granted accelerated approval to sevabertinib for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer whose tumors have HER2 tyrosine kinase domain-activating mutations. The approval was based on data from the ongoing phase I/II SOHO-01 study, which showed a 75% objective response rate, including complete responses in 6% of patients and partial responses in 70%, with 73% of responders maintaining their response for at least six months. Bayer is running the phase III SOHO-02 confirmatory study of sevabertinib versus standard treatment in previously untreated patients with advanced HER2-mutant NSCLC, and positive data could support converting the accelerated approval into traditional approval in the United States. Sevabertinib, which originated from Bayer's research collaboration with the Broad Institute of MIT and Harvard, received FDA accelerated approval in November 2025 under the brand name Hyrnuo for previously treated patients, and is also approved in China as a monotherapy for adults with unresectable, locally advanced or metastatic HER2-mutant NSCLC after at least one prior systemic therapy and in Japan for HER2-mutant NSCLC regardless of treatment line, including first-line use. In a separate press release, Bayer said it has initiated a global phase II study of BAY 3670549, an investigational highly selective GIRK4 inhibitor, in patients with atrial fibrillation who require electrical cardioversion, following a favorable safety and tolerability profile in the completed phase I first-in-human study.

Bayer and Neste, the world's leading producer of renewable diesel and sustainable aviation fuel, have finalized a commercial agreement to jointly scale Bayer's newgold® winter canola, aiming to expand acres in the Southern Great Plains of the U.S. as a feedstock for renewable diesel and sustainable aviation fuel. The collaboration will enable Bayer to significantly increase winter canola acreage, strengthening the supply of lower-carbon-intensity feedstocks to meet growing global demand for biofuels, which is estimated to rise almost threefold to approximately 40 billion gallons by 2040. The high-protein meal from the winter canola will be sold into the feed market for dairy, beef cattle, poultry, and swine. Bayer aims to launch newgold® winter canola hybrids in the fall of 2027, featuring winter-hardiness, TruFlex® technology, and pod shatter resistance. The companies are also establishing a newgold® network with additional value chain partners to support expansion and ensure a market for farmers.

Bayer has announced the initiation of a global Phase II clinical trial evaluating BAY 3670549, an investigational highly selective GIRK4 inhibitor, as a potential new treatment for atrial fibrillation, the most common sustained cardiac arrhythmia affecting over 60 million people worldwide. The randomized, double-blind, placebo-controlled study will assess the drug's efficacy, safety, and pharmacokinetics in adult patients with AFib who require electrical cardioversion. Positive data from the Phase I first-in-human study supported advancing the compound, which emerged from Bayer's strategic research alliance with the Broad Institute of MIT and Harvard. If successful, BAY 3670549 could offer an alternative to electrical cardioversion, the current gold standard for restoring normal heart rhythm.

The diabetic nephropathy and diabetes kidney disease market across the seven major markets is valued at approximately USD 8.80 billion in 2025 and is projected to grow at a compound annual growth rate of about 5% from 2026 to 2036, according to a new report from ResearchAndMarkets.com. The total prevalent DKD population in the 7MM is estimated at nearly 34 million cases in 2025, with the United States accounting for nearly 15 million cases and representing the largest regional market. Approximately 70% of US DKD cases occur among individuals aged 60 years and older. Antidiabetic therapies generate the highest DKD-related revenue across the 7MM. Key marketed therapies include JARDIANCE from Boehringer Ingelheim and Eli Lilly, KERENDIA from Bayer, and FARXIGA/FORXIGA from AstraZeneca. In March 2026, a Phase III study of KERENDIA met its primary endpoint in chronic kidney disease patients, showing a statistically significant improvement in estimated glomerular filtration rate slope versus placebo. Emerging pipeline candidates include esaxerenone from Daiichi Sankyo, SER150 from Serodus, bremelanotide from Palatin Technologies, and INV-202 from Novo Nordisk and Inversago Pharma. The report highlights persistent unmet needs such as limited disease-modifying therapies, cardiovascular risk, and delayed diagnosis, creating opportunities for differentiated treatments.

MustGrow Biologics Corp achieved a net profit of about $300,000 in Q2 2026, a sharp turnaround from a loss of $1.1 million in the same quarter last year, driven by licensing revenue of approximately $1.4 million from its Bayer partnership. TerraSante sales revenue was only $75,000 with a negative gross margin of about $17,000 due to costly air freight from Asia, but year-to-date sales as of August 15 reached roughly $900,000, up 46% compared to all of 2025. Operating expenses normalized at about $900,000 per quarter, and the company ended the quarter with $4.4 million in cash and $5.2 million in working capital. Management expects gross margins to improve to 25-40% as it shifts to ocean freight, and production capacity is projected at CAD15-25 million at nameplate, though the company still faces manufacturing hiccups and periods of being sold out. The next Bayer milestone is not expected until 2027 at the earliest, and regulatory progress for TerraMG in the US and Canada remains slow.

Bayer announced that the Phase III REVEAL study, evaluating the investigational PET radiotracer iodine 124 evuzamitide for diagnosing cardiac amyloidosis, met its primary endpoints in sensitivity and specificity, with results presented as a late-breaker at ESC 2026 and published in JAMA. The study, conducted at 18 U.S. centers with 170 adults, showed a majority-read sensitivity of 94% and specificity of 86% for cardiac amyloidosis, with subtype analyses for ATTR and AL also meeting secondary endpoints. Safety data indicated that 32.4% of patients experienced at least one treatment-emergent adverse event, with only one related to the radiotracer, and no deaths or related discontinuations. I 124 evuzamitide, previously granted Breakthrough Therapy Designation and Orphan Drug status, is not yet approved, and Bayer plans to discuss regulatory submission with the FDA and other authorities.

Bayer's $7.25 billion Roundup settlement survived another legal hurdle as the Eighth Circuit rejected an objectors' challenge, keeping the case in Missouri state court where a review is scheduled for September 14. The settlement covers roughly 65,000 current US claims, though the per-claim figure of about $111,500 is not a projected payout, as the structure also includes future cases and individual allocations. Shares traded at $14.10, about 84.8% above the $7.63 GF Value estimate, indicating investors expect a stronger outcome. The ruling advances the process but does not finalize it, as Bayer still needs final approval and a framework that withstands further objections.

Bayer announced it will present 11 oral presentations across its cardiovascular, kidney, and secondary stroke prevention programs at the European Society of Cardiology Congress 2026 in Munich, Germany, from August 28-31. The presentations include late-breaking data from the Phase III FIND-CKD trial evaluating KERENDIA (finerenone) in patients with chronic kidney disease without diabetes and hypertensive nephropathy, and the INFINITY pooled analysis of KERENDIA in CKD patients with and without atherosclerotic cardiovascular disease. Full results from the Phase III REVEAL study of the investigational PET radiotracer iodine 124 evuzamitide for cardiac amyloidosis will be shared for the first time, along with a new analysis from the Phase III OCEANIC-STROKE trial of asundexian in secondary stroke prevention.

Bayer Inc. announced that Health Canada has expanded the market authorization of LYNKUET (elinzanetant) to treat moderate to severe vasomotor symptoms caused by adjuvant endocrine therapy related to breast cancer. The approval makes LYNKUET the first treatment option in Canada for this patient population, building on its July 2025 authorization for menopausal vasomotor symptoms. The expanded indication is supported by the Phase III OASIS-4 study, which evaluated elinzanetant in women receiving adjuvant endocrine therapy who experienced moderate to severe vasomotor symptoms. LYNKUET is a once-daily oral dual neurokinin-1 and neurokinin-3 receptor antagonist, and Bayer notes that hormone therapy is not recommended for women with a history of hormone receptor-positive breast cancer, making non-hormonal options an important clinical need.

Bayer AG reported a 3% increase in group sales to EUR24 billion for the first half of 2026, with core earnings per share up 3% to EUR3.66. The CropScience division delivered 5.5% sales growth and expanded its EBITDA margin to 31%, while Pharma's new products Nubeqa and Karendia combined for 66% growth, offsetting declines in Xarelto and Eylea. Free cash flow was negative EUR2.7 billion, driven by EUR2.5 billion in litigation-related payouts, and net financial debt stood at EUR33.6 billion, expected to fall to EUR29-30 billion following a EUR3 billion equity investment from Apollo. CEO Bill Anderson highlighted a landmark U.S. Supreme Court ruling in Monsanto v. Durnell as a victory providing regulatory clarity and strengthening the company's litigation containment strategy.

The congestive heart failure market across the seven major markets was valued at USD 9 billion in 2025 and is projected to grow at a compound annual growth rate of 8% during the 2026 to 2036 forecast period, according to a new report from DelveInsight. The United States accounted for the largest share of the 7MM market in 2025, with nearly 7.4 million diagnosed prevalent cases out of approximately 21.1 million total diagnosed prevalent cases across the seven major markets. Growth is expected to be driven by the rising prevalence of cardiovascular diseases, an aging population, and the anticipated launch of emerging therapies such as Omecamtiv Mecarbil from Cytokinetics, Ziltivekimab from Novo Nordisk, CardiALLO Cell Therapy from BioCardia, and Umiposgene Parvec from Bayer. The report also highlights a robust clinical pipeline that includes candidates from AstraZeneca, Boehringer Ingelheim, Mesoblast, and AskBio, among others.

New research by Economist Enterprise, supported by Bayer, finds that integrating self-care into formal health systems can improve health outcomes, expand access, and reduce pressure on overstretched health systems, potentially delivering approximately US$ 179 billion in annual economic benefits. The report, titled "Making self-care work: integrating self-care into health systems," underscores that self-care works best when it is part of a supported path through health systems, with reliable information, affordable access, and clear referral pathways. It identifies three priorities for making self-care a more effective part of mainstream healthcare: turning policy commitments into action, expanding access through trusted and equitable support, and strengthening evidence, measurement, and accountability. The research highlights examples such as Germany's "green prescriptions" and Indonesia's GERMAS movement as demonstrations of how self-care can be embedded within broader healthcare delivery systems.

Kairos Pharma announced a strategic collaboration with Bayer to evaluate its lead antibody ENV-105 in combination with Bayer's XOFIGO for metastatic castration-resistant prostate cancer involving bone. ENV-105 is a first-in-class CD105/BMP signaling inhibitor, and XOFIGO is the only FDA-approved alpha-emitting radiopharmaceutical for this indication. The combination targets a global addressable market estimated at $570 million to $1.3 billion. Kairos Pharma's Phase 2 data for ENV-105 showed an 86% clinical benefit rate in resistant mCRPC, with median progression-free survival exceeding 13 months. The collaboration aims to address drug resistance by re-sensitizing tumors to XOFIGO's targeted alpha therapy.

Investment in AI-driven drug discovery has surged past $2 billion as the technology cuts development timelines by 70% and doubles clinical success rates, according to a new BCC Research report. The report finds that AI reduces the traditional 4-to-5-year discovery phase to 12-to-18 months while lowering R&D costs by 30% to 40%. AI-validated targets show a 2.5 times greater probability of progressing through clinical development, with regulatory approval rates rising from 10-to-15% to 20%. The United States accounts for 60% of global investment, with major funding rounds including Generate: Biomedicines at over $500 million, Exscientia at over $500 million, and Kailera Therapeutics with a $600 million Series B. Key players include Atomwise, Exscientia, Generate: Biomedicines, Iambic Therapeutics, Recursion, Schrödinger, Insilico Medicine, and Benevolent AI, alongside pharmaceutical giants Pfizer and Bayer.

Bayer has sold a minority, non-controlling stake in its newly established long-acting reversible contraceptives business to Apollo for €3 billion. The deal, expected to close in the third quarter of 2026, gives Apollo a stake in products including Mirena, Jaydess, Kyleena, and Jadelle while Bayer retains full operational control. CFO Dr Judith Hartmann said the transaction strengthens Bayer's capital structure and enhances financial flexibility amid bond maturities and litigation costs, including those related to the Roundup weed killer. The move comes as Bayer pursues a broader pharma dealmaking strategy, recently announcing a $2.45 billion acquisition of Perfuse Therapeutics to build on its Eylea franchise.

Most European stock markets closed on a strong note Thursday, led by gains in pharmaceuticals and defensive sectors. The pan-European Stoxx 600 gained 1.41%, while Germany's DAX jumped 2.16% to a new record high and the UK's FTSE 100 rose 1.67%. Easing inflation and interest rate concerns, a new German government reform package, and encouraging corporate news fueled the positive mood. In Germany, Bayer soared nearly 9% after consolidating its U.S. Roundup business into a new unit, and France's Sodexo surged 7.5% on stronger-than-expected quarterly performance and an upgraded full-year revenue forecast.

European stocks moved higher on Thursday as gains in defensive stocks offset a loss of momentum in the AI-driven tech rally. The pan-European Stoxx 600 rose half a percent to 642.57, while Germany's DAX gained 0.4 percent, France's CAC 40 surged 0.6 percent, and the UK's FTSE 100 was up half a percent. Roche Holdings rose about 2 percent after its experimental drug divarasib showed better potential than existing therapies in a late-stage lung cancer study. Bayer climbed 5.2 percent on plans to consolidate its US Roundup business into a new unit, and Sodexo soared 9 percent after raising its full-year organic revenue growth forecast.

Bayer on Tuesday asked Washington to impose duties on glyphosate imported from China, saying it was being sold at artificially low prices. The move angered U.S. farmers, who say duties would increase herbicide costs and add to their financial woes. Bayer filed the petition through its subsidiary Monsanto to the U.S. Department of Commerce and the U.S. International Trade Commission, seeking antidumping and countervailing duties. The company is the only U.S. maker of glyphosate and said the domestic business is not sustainable. Farm groups including the National Corn Growers Association and the American Soybean Association criticized the petition, saying it would limit competition and hurt farmers already struggling with high input costs.

The S&P 500 Health Care Index Sector jumped 7.48% during the week, driven by major dealmaking and legal victories. Merck KGaA agreed to acquire Bio-Techne for $73 per share in cash, valuing the deal at an enterprise value of approximately $11.3 billion, a 36% premium that sent Bio-Techne shares up more than 20%. AbbVie announced an all-cash acquisition of Apogee Therapeutics at $135.11 per share, a total equity value of about $10.9 billion, causing Apogee shares to rally 52%. The U.S. Supreme Court handed Bayer a sweeping 7-2 victory, ruling that federal pesticide regulations shield the company from state-law claims alleging Roundup should have carried a cancer warning, a decision expected to sharply reduce litigation that has cost Bayer more than $10 billion. Eli Lilly entered an R&D and licensing collaboration with China's Abbisko Therapeutics worth up to $1.9 billion, while Novartis and privately held Antares Therapeutics announced a cancer drug development deal also worth up to $1.9 billion.

The U.S. Supreme Court ruled 7-2 that Bayer cannot be held liable under state laws for failing to warn about cancer risks on its Roundup weedkiller, because federal regulations do not require such a label. The decision reverses a Missouri court ruling that had awarded $1.25 million to John Durnell, who claimed Roundup caused his non-Hodgkin's lymphoma. The ruling is expected to effectively end roughly 65,000 unresolved lawsuits against Bayer, which has already paid about $11 billion in settlements and plans a $7.25 billion deal to settle remaining claims. Bayer's stock surged as much as 24% on the news, its biggest jump in over two decades. Opponents warn the decision could shield manufacturers of pesticides and other products from accountability under state tort law.

Bayer shares rallied 17% to close at $13.16 after the U.S. Supreme Court issued a 7-2 ruling that federal pesticide law preempts state-law failure-to-warn claims when the EPA has made a definitive safety determination. The decision is expected to significantly curb Roundup-related litigation costs by reinforcing that companies complying with federally approved labeling cannot be held liable under varying state tort laws. The stock's surge came on notably high trading volume and compares to a 2.2% gain over the prior four weeks. Bayer is expected to report quarterly earnings of $0.23 per share on revenues of $12.32 billion, and the stock currently carries a Zacks Rank #2, or Buy.

The global nematicides market is projected to grow from USD 2.07 billion in 2025 to USD 3.14 billion by 2035, at a compound annual growth rate of 4.27%, according to a report by SNS Insider. Chemical nematicides dominated with a 72.5% share in 2025, while biological nematicides are the fastest-growing segment at a 16.1% CAGR, driven by regulatory restrictions and organic farming expansion. North America held the largest regional share at 38.5% in 2025, with the U.S. market alone valued at USD 0.69 billion and expected to reach USD 1.04 billion by 2035. The Asia-Pacific region is the fastest-growing market, fueled by horticultural export growth in China, India, Vietnam, and Thailand. Key players include BASF SE, Bayer AG, Syngenta AG, Corteva Agriscience, and FMC Corporation.

European stocks advanced on Thursday, with the FTSE 100 closing up 0.7% at 10,529.89, as the Dow Jones Industrial Average reached a new all-time high. The FTSE 250 added 0.3% to 23,161.41, while the AIM All-Share fell 0.7% to 771.92. In New York, the Dow rose 0.9% to a record, the S&P 500 gained 0.2%, but the Nasdaq Composite slipped 0.4%. Micron Technology soared 11% after its third-quarter results and guidance beat expectations, driven by AI demand for memory bandwidth. Bayer surged 19% after the US Supreme Court overturned a lower court ruling that had exposed the company to thousands of claims over its Roundup weedkiller, a decision JPMorgan analyst Richard Vosser said covers about 80% of filed glyphosate cases. In London, 3i Group jumped 11% on strong sales figures from its key investment Action, while Barratt Redrow climbed 4.6% after major shareholder Phoenix Asset Management Partners called for increased share buybacks. EasyJet rose 6.6% as it agreed to provide limited commercial information to potential suitor Castlelake, which had made a fourth bid proposal worth 650 pence per share. Oil prices remained subdued, with Brent crude trading at 74.42 dollars a barrel, well below recent highs, easing inflation concerns.

The US Supreme Court has ruled in favor of Monsanto in the Durnell case, a decision the company says is good for science, farmers, and industries that depend on regulatory clarity for innovation. The ruling should help significantly contain the Roundup litigation after nearly a decade of legal battles, resulting in the dismissal of current warning-based claims and barring future failure-to-warn claims. Monsanto will continue to pursue final approval of the class settlement and other elements of its multi-pronged strategy to contain the litigation. The company is still reviewing the ruling and will provide a more comprehensive statement shortly.

Voyageur Pharmaceuticals has engaged Fluor Corporation to complete feasibility studies for two strategic projects advancing its vertically integrated North American supply chain for radiology contrast drugs. The first study covers a proposed iodine extraction and production facility in Oklahoma using Voyageur's patent-pending Meuller process, developed in collaboration with Bayer AG under a milestone-based funding agreement. The second study covers Voyageur's planned pharmaceutical manufacturing plant that is expected to produce finished barium and iodine-based contrast media products, integrating high-purity barite from its wholly owned Frances Creek deposit in British Columbia with domestically sourced iodine. Voyageur has budgeted US$2,350,000 for the Bayer project feasibility study and will create a final budget for the integrated drug facility study after testing its proprietary Streamline iodine drug manufacturing process. The studies are expected to be completed in early 2027, paving the way for a potential construction decision that year.

Bayer and Iambic Therapeutics have entered a drug discovery collaboration focused on small molecule discovery. Bayer will use Iambic's AI-driven platform, including its Enchant and NeuralPLexer technologies, to identify novel drug entry points and differentiated molecules for hard-to-drug targets. The partnership aims to accelerate hit identification and optimization timelines, strengthening Bayer's early portfolio. Iambic will receive an upfront payment plus milestone and royalty payments under the agreement.

The global herbicides market is projected to grow from USD 42.33 billion in 2025 to USD 75.09 billion by 2035, at a compound annual growth rate of 5.92 percent, according to a report by SNS Insider. Selective herbicides held a dominant revenue share of about 65.3 percent in 2025, while the non-selective herbicides segment is expected to grow at the fastest rate due to rising adoption in no-tillage agriculture and herbicide-tolerant crop systems. Cereals and grains accounted for approximately 41.8 percent of revenue in 2025, with fruits and vegetables forecast to be the fastest-growing crop type. North America led the global market in 2025, with the United States representing nearly 82.5 percent of regional revenues, and the U.S. market alone is expected to reach USD 19.01 billion by 2035. Europe is anticipated to reach USD 17.34 billion by 2035, with Germany making up about 28.5 percent of European revenues, while Asia Pacific is the fastest-growing region, driven by intensifying production in China and India.

Bayer has completed its acquisition of Perfuse Therapeutics, gaining full rights to the first-in-class sustained-release small molecule endothelin receptor antagonist PER-001 intravitreal implant, currently in Phase II clinical development for glaucoma and diabetic retinopathy. The deal involved an upfront payment of USD 300 million and carries a total potential value of up to USD 2.45 billion, including additional success-based milestone payments. Perfuse Therapeutics will now be fully integrated into Bayer, strengthening its pharmaceutical pipeline and ophthalmology expertise.