Bayer's Dual Regulatory Breakthroughs Cap a Week of Raised Guidance and Legal Relief
Published on 11/10/2026 at 04:01 | Editorial boerse-global.de
Bayer has secured the world's first regulatory clearance for a factor XIa inhibitor, with the US Food and Drug Administration approving Asundexian to reduce the risk of recurrent stroke. The German group described the compound as the first FXIa inhibitor ever to win marketing authorization anywhere.
The news landed a day after the stock had already advanced 3.3% to close at €56.92, a move underpinned by a cluster of catalysts spanning quarterly results, upgraded full-year targets and a courtroom victory.
Guidance Lifted on Strong Third-Quarter Showing
Roughly a week before the FDA decision, Bayer published third-quarter 2026 figures alongside an improved outlook for the year. Revenue for the period came in at €10.1 billion, a nominal increase of 4.1%. EBITDA before special items climbed 6.9% to €1.62 billion, while adjusted earnings per share reached €0.31.
For the full year, the company now expects currency-adjusted EBITDA before special items of €9.8 billion to €10.3 billion, up from its earlier range of €9.6 billion to €10.1 billion. The Pharmaceuticals division's margin guidance and the free cash flow forecast were both raised, and Bayer also projected lower net financial debt at year-end.
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Two Approvals, Two Geographies
The Asundexian green light from the FDA is the headline regulatory achievement, but it is not the only one. China's NMPA cleared Sevabertinib as a first-line therapy for adults with advanced HER2-mutated non-small cell lung cancer. The decision rested on data from the ongoing Phase I/II SOHO-01 trial.
Monsanto's Unanimous Win in Missouri
On the litigation front, Bayer subsidiary Monsanto won a unanimous jury verdict in a Roundup case in Missouri on 30 October. According to the company, it was the first such trial since the US Supreme Court ruling. The outcome provided a tangible legal catalyst behind the stock's recent upward momentum.
Reuters reported about a week ago that Bayer chief executive Bill Anderson expects court approval of the proposed glyphosate settlement — valued at $7.25 billion — before Christmas.
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Jefferies Trims Its Bearish Stance
Jefferies raised its price target on Bayer from €46 to €48.50 on Friday while keeping a neutral rating, according to media reports. The move followed the quarterly release and the upgraded annual guidance, with the broker maintaining its "Hold" recommendation.
Investors will get their next set of hard numbers on 24 February 2027, when Bayer publishes its full-year 2026 results.
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