Bayer's Regulatory Clock Just Got Longer — and the Market Barely Blinked

US glyphosate risk assessment slips to early 2027 as Bayer advances two FDA approvals, plans euro bonds and awaits a Missouri ruling.

Bayer investors have grown accustomed to waiting. Now they will have to wait a little longer on one of the company's most closely watched fronts: the US health risk assessment of glyphosate, the active ingredient behind Roundup, has slipped from late 2026 to early 2027.

The delay, confirmed by the Department of Health and Human Services and the Environmental Protection Agency, stems from a decision by the two agencies to tighten coordination on the scientific review. A technical working group is steering the effort, drawing in the EPA's pesticide office alongside the National Cancer Institute, the FDA and the CDC. HHS Secretary Robert F. Kennedy Jr. and EPA Administrator Lee Zeldin framed the process as one grounded in the best available science, while final decision-making authority stays with the EPA under the normal review cycle mandated by US pesticide law. The public comment window on the literature screening closes on 24 September.

For the Leverkusen-based group, the revised timeline stretches out a period of regulatory uncertainty that has hung over the stock for years.

Pipeline Momentum on Two Fronts

While Washington moves at its own pace, Bayer has been pressing ahead in the lab and at the FDA. The company's stated ambition is to bring ten potential blockbuster medicines to market within a decade, and two of those high-revenue candidates are already being sold, with further launches in preparation.

September delivered tangible evidence of that push. On 17 September, the FDA approved finerenone — marketed as Kerendia — for adults with chronic kidney disease linked to type 1 diabetes. Bayer describes it as the first FDA-approved therapy for this specific condition in more than three decades. Eight days earlier, on 9 September, the agency granted accelerated approval to sevabertinib, a cancer 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 tumours and broadens the company's oncology footprint.

The agricultural side is being reshaped in parallel. More than 15 new modes of action are sitting in early-stage research within Crop Science, an effort driven largely by CropKey, Bayer's in-house digital discovery platform for identifying new crop-protection molecules.

Financing, Divestments and the Missouri Wildcard

Bayer is also tending to its balance sheet. The group is preparing to issue new long-dated euro bonds, with Deutsche Bank and BNP Paribas among the institutions leading the placement. On the portfolio side, it has agreed to sell the cancer drug Stivarga to Aachen-based Grünenthal for up to EUR 375 million.

Legal legacy risks remain the dominant swing factor in how the market values the company. Monsanto, Bayer's subsidiary, has filed for court approval of a settlement in the US Roundup litigation, according to Reuters. A final, binding resolution of those settlements is widely seen on the capital markets as the key precondition for a sustained re-rating of the shares. A ruling in one remaining class action in Missouri is expected in the coming weeks or months.

Quarterly results are scheduled for 3 November 2026.

Where the Stock Stands

The shares changed hands at EUR 49.57 on the day of the glyphosate announcement, up 34% since the start of the year. That leaves the DAX member about 8.1% below its 52-week high of EUR 53.86. Whether Bayer can close that gap will depend heavily on how quickly the new active ingredients from pharma and agriculture convert into the revenue contributions the market is expecting — and on how the Missouri courtroom and the glyphosate review ultimately resolve.