FDA accepts Bayer filing and Bayer stock loses 1.32 percent

Published on 10/08/2026 at 12:30 | Editorial responsibility: Rafael Müller, Editor-in-Chief AD HOC NEWS

FIND-CKD enrolled 1,584 adults with non-diabetic kidney disease. Bayer stock costs EUR 43.33 on October 8, 2026 versus EUR 43.91.

Flatlay-Anordnung mit Aktienzertifikat, ISIN-Karte, Tabletten und unbeschrifteter Blisterpackung — Bayer AG (DE000BAY0017): Flatlay mit Aktienzertifikat, ISIN-Karte, weißen Tabletten und unbeschrifteter Blisterverpackung auf weißem Untergrund, Illustration mit AI erstellt.

Bayer (ISIN DE000BAY0017) was trading at EUR 43.33 at Lang & Schwarz on October 8, 2026 at 12:22 p.m. CEST, down 1.32 percent versus the prior close of EUR 43.91. The U.S. Food and Drug Administration accepted Bayer's supplemental application for Kerendia in non-diabetic chronic kidney disease on October 8, 2026, according to Business Wire.

Kerendia targets wider kidney care

The filing seeks approval for adults with chronic kidney disease who do not have diabetes and receive standard care. The application is based on the Phase III FIND-CKD trial, which enrolled 1,584 adults, according to Business Wire.

The trial reported a mean annual estimated glomerular filtration rate decline of 3.30 milliliters per minute per 1.73 square meters with Kerendia, versus 4.00 with placebo. That 0.70 difference gives the regulatory filing a measurable clinical anchor, while the application still requires FDA review before any new approval.

Safety data add a counterweight

Serious adverse events occurred in 20.90 percent of patients receiving Kerendia and 21.20 percent of those receiving placebo, a 0.30 percentage-point gap, according to Business Wire. Hyperkalemia occurred in 17.00 percent of Kerendia patients versus 13.30 percent with placebo, making safety monitoring an important part of the commercial assessment.

For the broader Bayer group, second-quarter 2026 revenue was EUR 10.872 billion and EBITDA before special items was EUR 2.144 billion, according to Bayer's investor materials. The company has scheduled its third-quarter 2026 results for November 3, 2026, according to Bayer.

Stock stays below its yearly high

Bayer's Lang & Schwarz price of EUR 43.33 stood 19.64 percent below the 52-week high of EUR 53.92 and within the EUR 25.78 to EUR 53.92 range on October 8, 2026. Market capitalization was EUR 42.5 billion at the same market-data snapshot.

JPMorgan had kept its Overweight rating and EUR 61.00 target on October 1, 2026, according to FinanzNachrichten. The bank warned that early third-quarter expectations could be too high because of timing effects in agriculture, while its full-year estimates were broadly unchanged.

The prior close at Lang & Schwarz was EUR 43.91 on October 7, 2026, leaving the October 8 price down 1.32 percent at the 12:22 p.m. CEST snapshot. The further course of trading is shown by the continuously updated real-time quote of Bayer stock.