Bayers, Stroke

Bayer's Stroke Drug Nears EU Clearance as Jefferies Sees More Value in Roundup Than in the Pipeline

Published on 11/15/2026 at 17:21 | Editorial boerse-global.de
Bayer expects European approval of stroke drug Asundexian next year after US clearance for Sunharbo, as it seeks to offset Xarelto generic erosion.
Bayers, Stroke, Drug, Nears, Clearance, Jefferies, Sees, More, Value, Roundup Illustration mit AI erstellt.

Bayer is steering toward a European approval of its stroke prevention drug Asundexian next year, according to a Handelsblatt report published Friday. The projection lands just days after the German group secured US clearance for the same compound, which it markets as Sunharbo.

The FDA nod, announced Tuesday, covers adults who have recently suffered a non-cardioembolic ischemic stroke or a high-risk transient ischemic attack. It is intended for use alongside antiplatelet therapy, narrowing the treated population to a precisely defined group. Bayer describes Sunharbo as the first Factor XIa inhibitor cleared anywhere in the world, and expects shipments to begin in the US between mid- and late November.

Management is counting on the drug to offset revenue lost as generics erode sales of Xarelto. Sebastian Guth, a Bayer executive, stressed the weight of the American market in the company's growth strategy in comments to Handelsblatt, which framed the approval as a significant step forward for the pharmaceutical division.

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A Second Green Light in China

Regulatory progress has not been confined to stroke care. On 4 November, Bayer announced Chinese approval for Sevabertinib as a first-line treatment for adults with unresectable, locally advanced or metastatic non-small cell lung cancer carrying activating HER2 mutations. The two clearances therefore sit in separate therapeutic areas and separate markets — one in the US for secondary stroke prevention, the other in China for a defined lung cancer population.

Quarterly Figures and a Cautious Street View

Bayer reported group revenue of EUR 10.1 billion for the third quarter of 2026, alongside EBITDA before special items of EUR 1.62 billion. Sales climbed 4.1% year on year, while the adjusted EBITDA figure advanced 6.9%. The bottom line, however, showed a group net loss of EUR 672 million.

Analysts are not yet pricing in a smooth ride. Jefferies' Michael Leuchten pointed on 6 November to a legal catalyst that media reports have flagged: the pending court approval of the broader Roundup settlement. The broker lifted its price target to EUR 48.50 from EUR 46 while keeping its "Hold" rating — a target that sits well below the stock's closing level of EUR 56.66 on Friday, when the shares ended 2.0% beneath their 52-week high.

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