Bayer's Two-Front FDA Streak Lifts Pharma Story as Glyphosate Cloud Lingers
Published on 09/18/2026 at 02:40 | Editorial boerse-global.de
Two regulatory green lights landed at Bayer's doorstep within the space of a week, handing the German life-sciences group a fresh pair of arguments for its pharmaceutical turnaround — even as the market's reaction stayed notably restrained.
The more consequential of the two came on Thursday, when the US Food and Drug Administration cleared Kerendia (finerenone) for a new use: chronic kidney disease in adults with type 1 diabetes. It marks the first new treatment option for that patient population in the United States in roughly three decades. According to company figures, between 20 and 30 percent of American type 1 diabetics develop the kidney condition.
Just a day earlier, the agency had granted accelerated approval to sevabertinib as a first-line therapy for adults with HER2-mutated non-small cell lung cancer, widening Bayer's oncology footprint into a patient group that until now had few options. The accelerated pathway itself signals that regulators see an urgent unmet medical need.
The evidence behind Kerendia's third indication
The kidney decision rests on the Phase III FINE-ONE trial, which enrolled 242 participants and was published in the New England Journal of Medicine in March. Treatment cut the urine albumin-to-creatinine ratio (UACR) by 22 percent at three months and 28 percent at six months versus placebo, with a highly significant p-value of 0.0001. Hyperkalemia appeared in 10.1 percent of treated patients against 3.3 percent on placebo. The FDA reviewed the application under its priority-review track, a nod to the high medical need involved.
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Kerendia was already approved for chronic kidney disease linked to type 2 diabetes and for heart failure. The new label represents the drug's third application and the first worldwide approval for this specific group — the US is now the first country to clear Kerendia for type 1 diabetics with kidney disease.
A pipeline firing on more than one cylinder
Bayer expects peak annual sales of more than EUR 3 billion for Kerendia across all indications. The drug's revenue had already climbed 75 percent to over EUR 600 million in the first half of the year, well before this latest expansion. That trajectory suggests Kerendia is maturing into a load-bearing pillar of the pharma business rather than a single-product story.
The agricultural unit is contributing its own momentum. Crop Science has brought two of ten planned new products to market, each carrying an expected peak annual revenue of at least EUR 500 million, with the remaining launches confirmed. Beyond the core crop-protection and seed operations, Bayer has struck a commercial agreement with Finnish energy company Neste to jointly scale winter rapeseed newgold for biofuel production — an effort to draw extra revenue from its agricultural technology.
What the tape is saying
Investors took the news in stride. The stock closed Thursday at EUR 49.17, up 0.7 percent on the day, and was trading at EUR 49.15 by mid-morning as the Kerendia headline circulated, a gain of 0.6 percent intraday. Over the past week the shares have added 1.4 percent, framing the move as a continuation of a recent upward drift rather than an isolated spike. Year to date, the equity is up 33 percent, reflecting growing confidence in the group's pharma and agricultural strategy. Bayer's market capitalization currently stands at EUR 48.46 billion.
The new approval is unlikely to trigger a sudden revaluation on its own, but it reinforces the narrative of a pharmaceutical division expanding beyond individual blockbusters. Attention now turns to whether Kerendia's momentum shows up as concrete revenue jumps in coming quarterly reports.
The unresolved variable
Weighing against the operational wins is the multibillion-dollar glyphosate litigation. A US court is still reviewing the proposed USD 7.25 billion settlement, in which Bayer is the defendant. Until a final ruling arrives, that uncertainty remains a factor investors are likely to keep alongside the pipeline progress — the piece of the story that will help determine how much of the recent optimism the shares can hold onto.
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