Bayer's Third FDA Nod for Kerendia Meets a Missouri Courtroom Still Holding the Wildcard
Published on 09/17/2026 at 16:10 | Editorial boerse-global.de
Bayer's pharmaceutical division notched a fresh US regulatory win on Thursday, while its crop-science arm pressed ahead with a strategic overhaul — two developments that together sketch a company trying to grow its way out from under a stubborn legal cloud.
The US Food and Drug Administration cleared Kerendia (finerenone) for a third indication, extending its use to adults with chronic kidney disease tied to type 1 diabetes. It marks the first new treatment option for that patient group in the US in more than three decades.
The approval rests on the FINE-ONE trial, which enrolled 242 participants. Over six months, finerenone cut the urine albumin-to-creatinine ratio — a key marker of kidney damage — by 28 percent versus placebo, a difference that was highly statistically significant. Roughly ten percent of treated patients developed elevated blood potassium, compared with just over three percent on placebo. Bayer estimates that about 30 percent of type 1 diabetics in the US will develop chronic kidney disease during their lifetime, a segment that has drawn scant attention from drugmakers until now.
A Third Indication, a Bigger Revenue Map
Kerendia was already approved for chronic kidney disease in type 2 diabetes and for heart failure. Adding the type 1 diabetes population widens the addressable market considerably. Bayer booked a 75 percent jump in first-half 2026 sales for the drug, topping EUR 600 million, and is now targeting peak annual revenue of more than EUR 3 billion for finerenone.
That growth matters for a conglomerate still wrestling with legal uncertainty over glyphosate and a heavy debt load. A patent-protected pharma franchise with room to scale is central to the recovery narrative, with Kerendia — alongside the company's blood-thinner successor program — counted among the main growth engines in the division.
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Agriculture: Two Products Down, Eight to Go
On the crop side, Bayer has launched the first two of ten planned products, each projected to reach peak annual sales of at least EUR 500 million. The company reaffirmed its goal of delivering more than EUR 1 billion in Clean-EBITDA improvements in the agricultural division by 2029.
The product rollout is part of a broader effort to reposition the agribusiness, and it gives investors something concrete to weigh against the legal overhang. Bayer also deepened its partnership with Finland's Neste, signing a commercial agreement to scale cultivation of "newgold" winter rapeseed for biofuel production. The tie-up signals that Bayer is looking beyond conventional crop protection toward feedstocks for the energy transition — a move that could help diversify the division's earnings profile over the medium term.
The Courtroom That Sets the Tone
For all the operational momentum, the Roundup litigation remains the single biggest swing factor for the share price. Bayer's Monsanto unit is still seeking approval from a Missouri court for a USD 7.25 billion settlement designed to resolve tens of thousands of claims alleging cancer risks from the herbicide. A hearing took place last Monday, and the stock has slipped 1.3 percent since.
Trading has been largely sideways of late. The shares closed Wednesday at EUR 48.72, just above the 50-day moving average of EUR 48.47. That leaves the stock about 9.5 percent below its 52-week high of EUR 53.86, reached in July, though it has still built a gain of around 32 percent since the start of the year.
Thursday's FDA news drew only a muted response. Bayer was quoted around EUR 49 in morning trade, edging higher on the day, and last stood at EUR 49.22 — up 0.8 percent from the previous close of EUR 48.85. That keeps the shares marginally above their 50-day average of EUR 48.44, while the gap to the EUR 53.86 peak sits at roughly 8.6 percent. Year-to-date, the advance stands at 33 percent.
The restrained reaction suggests investors view the label expansion as a positive but not a game-changing catalyst. With the stock barely moving over the past 30 days, many shareholders appear content to wait. Until the Missouri judge rules on the settlement, the chart is likely to stay range-bound — even if pipeline progress, from the Kerendia approval to the new crop products and the Neste collaboration, continues to be received as constructive. Bayer's next quarterly report in early November should show whether Kerendia's growth trajectory is feeding through to group-level numbers.
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