BAYRY Reports Positive Data on Kidney Drug in Non-Diabetic CKD

Bayer BAYRY announced that finerenone achieved the primary endpoint in the late-stage FIND-CKD study, marking a key milestone in expanding its use to patients with non-diabetic chronic kidney disease (CKD).

Results from this phase III study showed that finerenone, when added to standard of care, significantly slowed kidney function decline compared to placebo, as measured by the annual change in eGFR — a validated predictor of kidney failure risk. The drug was well tolerated, consistent with its established safety profile.

Finerenone is a non-steroidal, selective mineralocorticoid receptor antagonist (nsMRA) designed to inhibit the harmful effects of mineralocorticoid receptor overactivation. This pathway plays a key role in driving CKD progression and cardiovascular damage through metabolic, hemodynamic, inflammatory and fibrotic mechanisms.

Please note that finerenone is already approved as Kerendia, or as Firialta in some countries, for the treatment of adult patients with CKD associated with type II diabetes in more than 100 countries worldwide, including China, Europe, Japan and the United States.

Bayer plans to submit data from the FIND-CKD to health authorities to extend the indication of Kerendia for non-diabetic CKD.

Shares of Bayer have surged 70.2% in the past year compared with the industry’s gain of 9.8%.

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More on Bayer’s Kerendia

FIND-CKD, the largest phase III study conducted to date in non-diabetic CKD, evaluated finerenone across a broad patient population with diverse underlying causes, including hypertension and glomerulonephritis. The results further extend the growing body of evidence supporting finerenone’s benefits beyond diabetic CKD.

Importantly, this marks the fifth successful phase III study for finerenone, which has now been evaluated in more than 20,000 patients across chronic kidney disease and heart failure populations. The consistency of outcomes reinforces its role as a foundational therapy in cardiorenal disease.

Finerenone is also approved for the treatment of heart failure with LVEF ≥ 40%. Applications in HF with LVEF ≥ 40% in additional markets, including China and Europe, are under review.

The finerenone clinical development program, FINEOVATE, comprises 10 phase III trials spanning heart failure (HF) and CKD. Within HF, the MOONRAKER program includes the completed pivotal phase III FINEARTS-HF study, along with ongoing investigator-sponsored studies, such as REDEFINE-HF, CONFIRMATION-HF and FINALITY-HF.

On the CKD side, the THUNDERBALL program comprises completed phase III studies — FIDELIO-DKD, FIGARO-DKD, FIND-CKD, and FINE-ONE — along with the phase II CONFIDENCE study and ongoing phase III pediatric studies FIONA and FIONA-OLE.

BAYRY Looks to Strengthen Portfolio

Bayer recently reported fourth-quarter results that missed sales expectations, but the company’s turnaround in 2025 was phenomenal.

Bayer Aktiengesellschaft Price, Consensus and EPS Surprise

Bayer Aktiengesellschaft price-consensus-eps-surprise-chart | Bayer Aktiengesellschaft Quote

Its new products, such as prostate cancer drug Nubeqa and kidney disease drug Kerendia (finerenone), continue to maintain their impressive momentum in the Pharmaceutical division.

The strong performance of these drugs makes up for the decline in sales of oral anticoagulant Xarelto, which is co-developed with Johnson & Johnson JNJ.

Xarelto is marketed by Johnson & Johnson in the United States. Bayer earns license revenues from JNJ for Xarelto sales in the United States.

Eylea sales continue to face pressure from generics. The introduction of Eylea 8 mg, with its extended dosing intervals, has partially offset the decline and supported overall performance.

Please note that Bayer’s HealthCare unit co-develops Eylea with Regeneron REGN, which records net product sales of Eylea in the United States. BAYRY records net product sales of Eylea outside the country. REGN records its share of profits/losses in connection with the sales of Eylea outside the United States.

Label expansion of key drugs and approval of additional drugs will further boost sales from this business. The recent FDA approval of elinzanetant for the treatment of moderate to severe menopause-related vasomotor symptoms, under the brand name Lynkuet, is a significant boost for the company.

The FDA recently granted accelerated approval to Hyrnuo (sevabertinib) for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer whose tumors have human epidermal growth factor receptor 2 tyrosine kinase domain activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy.

Encouraging developments in the Roundup litigation have lifted investor sentiment. Bayer acquired the Roundup weedkiller through its 2018 buyout of Monsanto. Since then, the company has faced numerous lawsuits alleging that Monsanto’s herbicide, whose active ingredient is glyphosate, caused cancer.

Monsanto has reached an agreement with leading plaintiffs’ law firms on a proposed class settlement related to the glyphosate litigation. This follows the decision by the U.S. Supreme Court to hear Bayer’s case, marking a positive development for the company.

BAYRY anticipated that litigation impacts would burden its cash position in 2026.

It currently carries a Zacks Rank #5 (Strong Sell).

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