Bayers, Busy

Bayer's Busy September: Three FDA Green Lights, a €375 Million Exit, and a $7.25 Billion Waiting Game

Published on 09/23/2026 at 07:11 | Editorial boerse-global.de

Bayer launched a GIRK4 trial, won FDA approval for sevabertinib and a third Kerendia indication, and seeks approval of a $7.25 billion Roundup settlement.

Forscherin im weiĂźen Kittel pipettiert an einem beleuchteten Laborarbeitsplatz vor einem Bildschirm mit 3D-MolekĂĽlstruktur
Pharmazeutisches Forschungslabor – Wissenschaftlerin mit Pipette, Molekülstruktur-Monitor, blaue LED-Beleuchtung Illustration mit AI erstellt.

Bayer packed an unusual amount of news into the first half of September. Within a single day — September 9 — the Leverkusen-based group launched a Phase II trial of an investigational GIRK4 inhibitor for patients with atrial fibrillation, secured accelerated FDA approval for its cancer drug sevabertinib, and struck a commercial agreement with Neste to scale up cultivation of newgold® winter rapeseed. The common thread: a company trying to prove its pipeline can carry the story while its legal past keeps tugging at the other sleeve.

A Cardiology Bet and an Oncology Win, Same Day

The GIRK4 program targets one of the most common heart rhythm disorders worldwide, extending Bayer's cardiovascular development footprint into new therapeutic territory. The sevabertinib clearance, meanwhile, gives the company a first-line option for adults with HER2-mutated non-small cell lung cancer — a closely watched corner of targeted oncology and a meaningful commercial foothold.

The Neste partnership points in a different direction entirely. The two companies aim to broaden the raw-material base for more sustainable biofuels while establishing the seed offering in the renewable-energy space.

Crop Science Trims Costs as New Products Roll Out

On the agricultural side, Bayer reported on September 1 that two of ten planned new crop science products have already reached the market. Cost reductions in the division have climbed to nearly €400 million, according to Reuters — a figure that underscores how much of the segment's improvement is coming from the expense line rather than the top line.

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GrĂĽnenthal Takes Stivarga Off Bayer's Hands

Portfolio pruning continued with the divestment of the cancer drug Stivarga to Grünenthal. The transaction could bring Bayer total proceeds of up to €375 million, structured as upfront and milestone-linked payments. Handing older medicines to specialized partners is a well-worn route to freeing up administrative and marketing capacity, letting the group concentrate on higher-margin products and newer active ingredients. Bayer also retains a slice of Stivarga's upside through the agreed milestones.

Kerendia Notches a Third Indication

Regulatory momentum extends beyond sevabertinib. The FDA granted marketing authorization for Kerendia, whose active ingredient is finerenone, in chronic kidney disease associated with type 1 diabetes — the third approved indication for the therapy. Together with the pipeline news, the approval reinforces the case that Bayer's pharma rebuild is producing tangible results.

Missouri Hears the $7.25 Billion Settlement Case

Overshadowing all of it: the long-running Roundup litigation, inherited with the 2018 Monsanto acquisition. Monsanto filed on September 14 with a court in Missouri seeking approval of a comprehensive $7.25 billion settlement aimed at resolving roughly 65,000 pending U.S. claims and cutting a major chunk of litigation risk. A hearing on final approval took place the same day before the Missouri Circuit Court. No formal ruling has been issued; the judge's decision is expected at a later date. For investors, the deal represents a significant step toward containing years of uncertainty — but it is not yet signed, sealed, and delivered.

Where the Stock Stands

The equity has been steady through the noise. Bayer shares closed yesterday at €49.49, up 0.7%, putting the stock 16% above its 200-day moving average of €42.58. Today the price sits at €49.54, a gain of 0.8% on the day, and the shares are up 34% since the start of the year.

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