Bayer Faces a Pivotal Summer as Chinese Drug Hopes Collide With Supreme Court Risk

Bayer's stroke drug Asundexian advances in China as US Supreme Court weighs glyphosate liability, with a $7.25B settlement backup plan in place.

The German pharmaceutical and life sciences group is navigating a period of extraordinary complexity. On one side, a promising stroke drug has taken a crucial step forward in China. On the other, the US Supreme Court is weighing a legal challenge that could reshape the company’s multibillion-dollar glyphosate liability.

A Green Light in Beijing for Asundexian

China’s National Medical Products Administration (NMPA) accepted Bayer’s marketing application for Asundexian on 29 April 2026, a significant milestone for a drug that targets a vast patient population. Ischemic strokes affect more than 20 million people in China alone, making it the company’s most important single market for the experimental therapy.

The application is based on the Phase III OCEANIC-STROKE trial, which enrolled 12,327 participants globally. The data showed that Asundexian, a Factor XIa inhibitor, reduced the risk of ischemic stroke by 26% compared with placebo when both were combined with antiplatelet therapy. Crucially, severe bleeding events, measured by ISTH criteria, did not increase — a key safety advantage over existing anticoagulants.

Bayer is pursuing approvals with other regulators worldwide, though no health authority has yet cleared the drug. The company will present 13 abstracts at the European Stroke Organisation Congress (ESOC) in Maastricht from 6-8 May, including four sub-analyses from OCEANIC-STROKE and two late-breaking analyses with additional efficacy and safety data.

Morgan Stanley estimates peak annual sales for Asundexian could reach €4 billion, a figure that would transform Bayer’s beleaguered pharmaceuticals division.

Washington’s Divided Courtroom

While the Chinese regulatory path looks promising, the mood in Washington is far less certain. Bayer’s shares tumbled 5.5% to a new year-to-date low after oral arguments before the US Supreme Court, where justices appeared sharply divided over the company’s bid to block thousands of glyphosate lawsuits.

At the heart of the case is a Missouri plaintiff who claims Roundup, Bayer’s weedkiller, caused his cancer. The company argues that federal law preempts state-level warning requirements, pointing to the EPA’s decision not to mandate a cancer warning on product labels. Chief Justice John Roberts pushed back, emphasizing states’ rights to warn citizens about potential dangers. Justice Brett Kavanaugh, however, appeared sympathetic to Bayer’s argument for uniform national labeling standards.

A ruling is expected by the end of June. The outcome has implications for roughly 80% of the outstanding glyphosate litigation. If Bayer prevails, it would remove the plaintiffs’ strongest legal argument. If it loses, the company faces a potentially crippling wave of claims.

A Backup Plan at $7.25 Billion

Bayer is not waiting for the verdict. It has proposed a class-wide settlement of up to $7.25 billion, which a US judge has provisionally approved. Plaintiffs have until early June to join the deal.

The legal overhang is weighing heavily on the balance sheet. Bayer expects negative free cash flow of up to €2.5 billion in 2026, while net financial debt is set to climb above €32 billion. Despite these pressures, management is holding firm on its operational guidance: adjusted EBITDA of €9.6 billion to €10.1 billion for the year.

Pharma Provides a Glimmer

Away from the courtroom, Bayer’s drug pipeline is showing signs of life. The European Commission has approved Kerendia for patients with heart failure, expanding its use beyond chronic kidney disease. Bayer targets peak annual sales of €3 billion for the drug, which is expected to help fill the revenue gap as patents expire on blockbusters like Xarelto.

The company is also pushing ahead with a sweeping restructuring, cutting management positions and targeting €2 billion in annual savings by the end of 2026.

What’s Next

The immediate focus is on the first-quarter earnings report, due on 12 May. Investors will be watching for any deterioration in the underlying business, particularly given the legal distractions.

Meanwhile, the FDA issued a warning on 30 April about promotional materials for Nubeqa, Bayer’s prostate cancer drug, citing distracting visual elements and missing risk information — a reminder that regulatory scrutiny extends beyond the courtroom.

Bayer’s shares currently trade at €38.05, roughly 23% below the 52-week high of €49.17 set in February. The relative strength index of 77 suggests the stock is technically overbought in the short term, but the fundamental picture remains dominated by two binary events: the Supreme Court ruling and the Chinese drug approval. Both will define the company’s trajectory for the rest of the decade.