Bayer's Asundexian and Kerendia Deliver Clinical Wins, but Roundup Clouds Persist Ahead of Supreme Court Ruling
13.06.2026 - 19:04:57 | boerse-global.de
Bayer is juggling two high-stakes timelines. While its pipeline picks up speed with regulatory reviews for Asundexian and a landmark kidney-drug study hitting its mark, the legal fallout from the Monsanto acquisition shows no sign of retreating. Investors are left to weigh clinical promise against courtroom exposure as the U.S. Supreme Court prepares to rule on the Durnell glyphosate case.
The European Medicines Agency has formally validated Bayer’s marketing application for Asundexian, kicking off the review process for the Factor XIa inhibitor. The drug is designed to prevent strokes without the elevated bleeding risks associated with older anticoagulants. The pivotal OCEANIC-STROKE trial showed a 26% risk reduction for recurrent stroke versus placebo, with no significant increase in major bleeding. Bayer has also filed for approval in the U.S. and China, where regulators have granted priority review — an indication they see a clear medical need.
The timing is strategic. Xarelto, Bayer’s blockbuster anticoagulant, lost patent protection and saw revenue plunge by a third to $2.6 billion in 2025. Asundexian is meant to fill that gap, and the company is ahead of Bristol Myers Squibb and Johnson & Johnson, whose competing drug Milvexian remains in clinical development.
On a parallel track, Bayer’s kidney drug Kerendia notched a major milestone. The Phase III FIND-CKD study met its primary endpoint, showing that the drug significantly slows kidney function decline in non-diabetic patients. Cardiovascular risks such as heart failure also dropped versus placebo. The data were presented at the European Renal Association congress and published simultaneously in the New England Journal of Medicine — a combination the industry views as a strong validation signal. Kerendia is currently approved only for diabetic patients, but the new indication targets a much larger pool: roughly 850 million people worldwide suffer from chronic kidney disease, and more than half are non-diabetic.
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Behind the scenes, Bayer is reshuffling management to accelerate growth. The consumer health division is getting new leadership as part of the "Road to Billions" strategy. Samantha Avivi, previously head of North America, becomes global marketing chief for over-the-counter drugs. The company also created a standalone U.S. president role. In pharma, Dr. Jost Reinhard will take over radiology operations in August.
Yet the legal overhang from Roundup remains impossible to ignore. In early June, the opt-out deadline passed for Bayer’s latest settlement deal aimed at future glyphosate claims. The agreement could cost up to $7.25 billion. CEO Bill Anderson has not disclosed how many plaintiffs chose to opt out; the tally is still being assessed. A court hearing for final approval is scheduled for July.
The bigger event is the U.S. Supreme Court, which is expected to rule on the Durnell case by the end of June. That decision could directly affect roughly 80% of the outstanding glyphosate lawsuits against Bayer. For the stock, next month’s judicial calendar matters at least as much as the FDA’s decision on Asundexian.
Shares closed at €36.06 on Friday, marking a minimal 0.36% gain. The stock has slipped about 5% year to date and remains nearly 28% below its 52-week high of €49.93. Still, it has clawed back roughly 44% from the August 2025 trough of €25.09. The long-term moving average sits at €35.99 — a level the stock is barely holding.
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On the balance sheet, free cash flow improved to €2.1 billion in 2025, while net debt shrank from €32.6 billion to €29.8 billion. Nubeqa and Kerendia are already contributing to revenue growth, and two other products received market approvals last year.
For now, Bayer waits on twin verdicts: one from the EMA on Asundexian, and another from the Supreme Court on glyphosate. Both will determine whether the company can finally turn the page on its long-running legal saga and focus on a pipeline that is beginning to show real momentum.
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