Bayer's Dual Track: FDA Green Light for Kerendia, Agrar Pipeline Takes Shape

FDA clears Bayer's Kerendia for chronic kidney disease in type-1 diabetes adults, the first new option in over 30 years, as Bayer awaits a Roundup ruling.

Bayer secured a long-awaited regulatory win on Tuesday when the US Food and Drug Administration cleared Kerendia (finerenone) for chronic kidney disease in adults with type-1 diabetes — the first new treatment option for this patient population in more than three decades.

FINE-ONE Data Underpin Approval

The decision rests on the Phase III FINE-ONE trial, which enrolled 242 adults. At the six-month mark, the study demonstrated a highly statistically significant reduction in the urine albumin-to-creatinine ratio, a key indicator of kidney function. The ratio fell 22 percent by month three and 28 percent by month six. Hyperkalemia emerged as a side effect in 10.1 percent of treated patients versus 3.3 percent on placebo — a figure physicians will likely monitor closely when prescribing.

Kerendia now stands as the only approved therapy specifically tailored to this patient group. For Bayer's pharmaceutical division, the expanded label opens an additional growth avenue in a market that has seen precious few new treatments arrive.

Fresh Capital for LARC Unit

The approval lands as Bayer also recalibrates its financing strategy. Proceeds are flowing into a new entity housing the company's long-acting contraceptive franchise, with the group retaining both majority ownership and operational control. For a company that posted group revenue of EUR 45.6 billion in its most recent fiscal year, the transaction creates extra financial headroom without surrendering strategic command of the business line.

Agrar Division Delivers First Products

On the agricultural side, Bayer has brought the first two of ten planned products to market, each targeting peak annual sales of at least EUR 500 million. The company reaffirmed its goal of generating more than EUR 1 billion in Clean EBITDA improvements in the division by 2029. These launches form part of a broader effort to reposition the crop science business and give investors something concrete to weigh against the legal overhang.

Deepening its sustainability push, Bayer also struck a commercial agreement with Finland's Neste to jointly scale the cultivation of "newgold" winter rapeseed for biofuel production. The partnership signals that Bayer is looking beyond classic crop protection chemicals toward feedstocks tied to the energy transition — a move that could help diversify the division's earnings profile over the medium term.

Roundup Settlement Awaits Missouri Judge

Still looming large is the glyphosate litigation. Bayer's Monsanto unit is seeking approval in a Missouri federal court for a USD 7.25 billion settlement covering tens of thousands of claims alleging cancer risks from the herbicide. A hearing took place last Monday, and the stock has slipped 1.3 percent since.

Share Price Holds Above Key Moving Averages

The equity has been treading water of late. Bayer closed Wednesday at EUR 48.72, just above its 50-day moving average of EUR 48.47. That leaves the shares roughly 9.5 percent below their 52-week high of EUR 53.86, reached in July, though they remain up 32 percent year-to-date. More recently, the stock changed hands at EUR 49.10, adding 0.5 percent on the day and staying well clear of its 200-day average of EUR 42.39 — a signal that the medium-term uptrend remains intact. The gap to that July peak now stands at about 8.8 percent.

Over the past 30 days the price has barely budged, reflecting the wait-and-see stance of many investors. Until the Roundup ruling lands, the chart is likely to stay rangebound, even if operational milestones such as the new crop products and the Neste tie-up are being received favorably. That tension — legal uncertainty on one side, strategic progress on the other — continues to define the Bayer story.