Bayer's September Reckoning: Ten Blockbusters, Two FDA Wins, and a Missouri Verdict That Holds the Key

Bayer wins FDA approvals for Kerendia and sevabertinib while awaiting a Missouri court ruling on its proposed Roundup settlement.

Bayer has spent years trying to convince investors that its future lies in the laboratory rather than the courtroom. This September, both arenas are demanding attention at once.

On the pharmaceutical side, the Leverkusen-based group has set an ambitious target: ten potential blockbuster medicines brought to market within a decade. Two of those high-revenue candidates are already being commercialized, according to company statements, with further launches in preparation. The crop science division is pursuing a parallel overhaul, with more than 15 new active ingredients in early-stage research, largely driven by CropKey, the company's in-house digital discovery platform for identifying new crop protection molecules.

Fresh Approvals on Both Sides of the Portfolio

The clearest evidence of pipeline momentum arrived from the US Food and Drug Administration. On 17 September, the agency approved Finerenon under the brand name Kerendia for treating adults with chronic kidney disease associated with type-1 diabetes — a therapy Bayer describes as the first FDA-sanctioned option for this specific condition in more than three decades.

Eight days earlier, on 9 September, the FDA had already granted accelerated approval to sevabertinib, an oncology drug cleared as a first-line treatment for adults with locally advanced or metastatic non-small cell lung cancer carrying specific activating mutations. The green light covers patients with non-squamous tumors and broadens Bayer's footprint in cancer medicine.

Divestments Reshape the Portfolio

While regulators were signing off on new products, Bayer was busy shedding older assets. The company completed the sale of the Avelox brand to Ascenda Pte. Ltd. on 31 March 2026 for EUR 250 million. A second transaction — the hand-off of cancer drug Stivarga to Grünenthal for as much as EUR 375 million — is expected to close in late 2026 or early 2027.

Together, the moves point to a deliberate slimming-down, freeing resources for the core pharma and agriculture businesses.

Missouri: The Overhang That Won't Budge

Yet none of this has displaced the legal question that has shadowed Bayer since the Monsanto acquisition. On 14 September, a hearing took place before the Missouri Circuit Court on final approval of the proposed Roundup settlement, according to Reuters, which reported that Monsanto had filed for judicial sign-off on the deal. A ruling is expected at a later date and has become the single most important near-term catalyst for the stock.

The logic is straightforward. A confirmed, legally binding settlement would draw a line under future glyphosate litigation, allowing investors to value Bayer primarily on operating metrics from its pharma and crop science divisions. Without that closure, provisions and long-term financial exposure remain impossible to calculate with confidence.

The downside scenario is equally clear. Should the court reject the agreement or demand changes that blow past the financial framework, Bayer would remain exposed to case-by-case risks before US juries — a prospect that would mean prolonged legal uncertainty, fresh rounds of provisions, and unpredictable damages. The recent share-price recovery would be immediately called into question, and management's operational refocus would be slowed.

Where the Stock Stands

The market has been pricing in a gradual clean-up of legacy liabilities. Bayer shares have climbed 33% since the start of the year and currently trade at EUR 49.34, with a 52-week high of EUR 53.86 leaving the DAX member about 8.1% below its peak.

For now, the equity remains tightly tethered to news flow from the United States. A favorable ruling would likely shift attention back to pipeline milestones and portfolio streamlining — the Kerendia and sevabertinib approvals, the CropKey research engine, the completed disposals. A rejection would force a sharp reassessment.

Either way, the Missouri Circuit Court's pending decision sits at the center of the investment case. Until that verdict lands, Bayer's operational progress plays second fiddle to a single, unresolved legal question.