Bayer's Pharma Pipeline Delivers Twin FDA Wins as Roundup Settlement Awaits Missouri Ruling
Published on 09/18/2026 at 13:31 | Editorial boerse-global.de
Bayer's pharmaceutical division has notched two separate regulatory victories in quick succession, securing expanded US approvals for both its kidney drug Kerendia and its oncology candidate Sevabertinib — a pair of wins that underscore the company's push to build out its high-margin medicines business while it continues wrestling with legal and financial baggage elsewhere.
The more recent of the two came Thursday, when the FDA broadened Kerendia's label to cover adults with chronic kidney disease stemming from Type 1 diabetes. It marks the first new treatment option for that patient population in roughly three decades. The decision rests on the Phase 3 FINE-ONE trial, which enrolled 242 patients. After six months, finerenone — the active ingredient — cut the urine albumin-to-creatinine ratio (UACR), a key marker of kidney damage, by 25% versus placebo. The effect measured 22% at three months and 28% at six months, with 68.1% of treated patients achieving at least a 30% UACR reduction compared with 46.6% in the placebo arm.
For the German conglomerate, it is the third US green light for the molecule. Kerendia first won approval in 2021 for chronic kidney disease linked to Type 2 diabetes, followed in 2025 by a nod for heart failure with mildly reduced ejection fraction (HFmrEF). With the Type 1 diabetes expansion, the drug now addresses a third, historically underserved segment — one that had gone without a novel therapy for decades.
Oncology Approval Adds a Second Growth Lever
Separately, Bayer obtained accelerated FDA clearance for Sevabertinib, marketed as Hyrnuo, as a first-line option for adults with locally advanced or metastatic non-squamous non-small cell lung cancer. The approval is contingent on an activating HER2/ERBB2-TKD mutation. The accelerated pathway allows Bayer to bring the product to the US market ahead of completing full confirmatory studies — a signal to investors that the pharma unit keeps delivering even as the company's agrochemical litigation drags on.
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HER2-mutant non-small cell lung cancer is considered a hard-to-treat subgroup with limited therapeutic choices, making the clearance a meaningful addition to Bayer's oncology pipeline as it works to lessen its reliance on legacy crop-science operations.
Roundup Settlement Still Hangs on a Judge
The legal front remains unsettled. Bayer subsidiary Monsanto last Monday asked a Missouri court to approve a $7.25 billion settlement aimed at resolving a portion of the cancer claims tied to its Roundup weedkiller. According to Reuters, Bayer faces roughly 65,000 lawsuits across US state and federal courts. A judge's sign-off would make the legal exposure at least partly more predictable, but no ruling has been issued yet.
Analysts Bullish, but the Stock Stays Subdued
Wall Street sentiment has been constructive. Barclays raised its price target on Bayer from EUR 60 to EUR 70 on September 8 while reaffirming an "Overweight" rating. A day later, Deutsche Bank Research reiterated its buy recommendation with a EUR 60 target. Both houses see considerable upside from current levels.
The market's reaction to the Kerendia news, however, was muted. Bayer shares were trading at EUR 48.56 on Friday, down 1.1% intraday, and remain 9.8% below their 52-week high of EUR 53.86 reached in early July. The tepid response suggests investors are weighing the pharma headlines against the company's ongoing legal and financial challenges. On Thursday, the stock had closed at EUR 49.17, up 0.7% from the prior session, with a 12-month gain of 78% and a year-to-date advance of 33%. The gap to that July peak stood at 8.7% as of Thursday's close.
Institutional interest is ticking up as well. French asset manager Amundi disclosed that it raised its voting stake in Bayer from 2.96% to 3.04% in mid-September, with the regulatory filing published Thursday. Holding roughly 29.9 million shares indirectly, Amundi remains a relatively small but expanding shareholder within Bayer's total of just over 982 million voting rights.
Bayer thus finds itself advancing on two fronts at once: broadening an established medicine into a third indication and adding a fresh oncology asset, while a large European asset manager nudges its stake higher. How the company's well-known pressure points evolve in the coming weeks will likely matter more for the share price than either approval on its own.
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