Bayer’s Chinese Stroke Bet Faces a Regulatory Headwind and a Legal Storm

Bayer faces mixed fortunes: China accepts Asundexian stroke drug filing, while FDA issues warning on Nubeqa ads. Stock down 22% from peak amid glyphosate legal woes.

The week ended on a split screen for Bayer. One hand offered a promising regulatory green light in China for its stroke candidate Asundexian, while the other drew a US Food and Drug Administration rebuke over marketing for its prostate cancer drug Nubeqa. The stock, trading at €38.05, sits roughly 22% below its February peak of €49.17, reflecting the market’s cautious stance.

A Door Opens in Beijing

On April 29, 2026, China’s National Medical Products Administration formally accepted Bayer’s marketing application for Asundexian. The filing rests on the Phase III OCEANIC-STROKE trial, which showed a 26% reduction in ischemic strokes compared to placebo, with no increase in major bleeding events. For Bayer, this is a strategic beachhead in a market where strokes are the leading cause of death and case numbers surged to 20.8 million between 2010 and 2021.

Morgan Stanley estimates Asundexian’s global peak sales potential at up to €4 billion. The company is simultaneously pursuing approvals in other regions and plans to unveil 13 abstracts from its stroke pipeline at the European Stroke Organisation Conference in Maastricht from May 6 to 8. Among them will be two late-breaking analyses from the OCEANIC-STROKE study.

FDA’s Untitled Letter and a Recall

The same week brought unwelcome news from the US regulator. The FDA issued an Untitled Letter on April 30 criticizing Bayer’s promotional materials for Nubeqa, specifically a YouTube video and a Spanish-language TV ad. The agency flagged “attention-grabbing visuals” and rapid scene changes that it said pushed risk information into the background. While Bayer did mention side effects such as cardiac events and seizures, the FDA noted that critical details were missing—including warnings that heart conditions in Nubeqa patients could be fatal and that seizure risks preclude certain activities.

Separately, Bayer recalled specific sizes of its Afrin Original nasal spray in the US due to missing child-resistant packaging and incomplete labeling. Both incidents are operationally manageable but underscore the regulatory scrutiny Bayer faces across its product lines.

The Glyphosate Shadow Grows Longer

The legal overhang around Roundup continues to darken. A US federal judge recently described Bayer’s proposed $7.25 billion class-action settlement as a “dirty deal,” casting doubt on its viability. The Supreme Court heard oral arguments in a related case on April 27, with a decision expected by the end of June. Bayer has set aside roughly €5 billion in provisions for glyphosate-related claims.

Adding to the pressure, internal emails have surfaced suggesting that Bayer promised a “small token of appreciation” to an EPA administrator in exchange for removing cancer warnings from Roundup labels. The revelation is likely to further complicate the company’s legal position.

What Lies Ahead

Nineteen analysts rate Bayer stock an average “Outperform,” with a mean price target of €46.53—about 22% above the current level. The next major test comes on May 12, 2026, when Bayer releases its first-quarter results. Management has guided for full-year adjusted EBITDA of €9.6 billion to €10.1 billion.

Investors are waiting for more concrete progress on Asundexian’s global approval path before pricing in its full potential. Meanwhile, the Supreme Court ruling on glyphosate, expected by late June, could redefine the legal landscape for thousands of pending lawsuits—and determine whether Bayer’s €5 billion provision proves sufficient.