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KERENDIA (finerenone) — BAYRY met the primary endpoint in the Phase III FINE-ONE trial in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD), showing a 25% reduction in urine albumin-to-creatinine ratio (UACR) vs placebo at six months (95% CI=0.75 [0.65; 0.87]; p=0.0001).
The randomized, double-blind study enrolled 242 adults; safety was consistent with prior T2D data, with similar overall TEAE and serious AE rates, while hyperkalemia was higher with finerenone (10.1% vs 3.3%). Bayer plans an sNDA submission to the FDA based on FINE-ONE results in 2026.
Bayer (OTC:BAYRY) announced FDA approval of Lynkuet (elinzanetant) 60 mg for moderate to severe hot flashes due to menopause on October 24, 2025. Lynkuet is described as the first dual NK1/NK3 receptor antagonist for this indication and is taken once daily at bedtime. Approval is supported by three Phase III trials (OASIS 1–3); OASIS 1 and 2 met co-primary endpoints at weeks 4 and 12 in 796 women, and safety was evaluated across 1,420 women with OASIS 3 including 627 participants up to 52 weeks. Lynkuet is expected to be available in the U.S. beginning November 2025.
Important safety notes include pregnancy risk, CNS daytime impairment, increased liver tests, and seizure risk.
Bayer (NASDAQ:BAYRY) announced late-breaking presentations of methods and baseline data from the global Phase III OCEANIC-STROKE study of investigational oral Factor XIa inhibitor asundexian 50 mg once daily at the 17th World Stroke Congress in Barcelona, October 22–24, 2025.
The multicenter, international, randomized, placebo-controlled, double-blind, event-driven trial enrolled >12,300 patients with non-cardioembolic ischemic stroke or high-risk TIA on standard antiplatelet therapy. Multiple sessions (plenary, free communication, and e-posters) will present study methods, baseline characteristics, sub-study participation factors, and real-world stroke burden analyses. Main study results will be presented at a future scientific congress. Asundexian remains an investigational agent and is not approved for any indication.
Bayer (NYSE:BAYRY) announced on October 7, 2025 that Cornfed Farms, a fourth-generation Mohr family operation, is the first Bayer ForwardFarm in the Midwest and the only ForwardFarm in the United States.
The designation joins Cornfed Farms with 15 other global ForwardFarms and highlights on-farm regenerative practices including no-till/minimum till, intermediate crops (CoverCress and camelina), diversified cash crops and livestock integration, and use of the Preceon Smart Corn System for data-driven insights and reduced synthetic nitrogen use.
One A Day (NASDAQ:BAYRY) announced a nationwide rebrand and new platform, “The ONE for you”, launching in fall 2025 to simplify multivitamin choice across age, gender, and life stages. The update includes a refreshed logo, brighter packaging, benefit icons (immune and bone health callouts), a new design system, and tagline lockups.
New packaging began appearing at major retailers including Walmart, Target, Walgreens, CVS, and Amazon in September 2025; a national media push and TV campaign also debuted that month, with full portfolio transition continuing into early 2026.
BlueRock Therapeutics (OTC:BAYRY) reported positive 36-month Phase I results for investigational cell therapy bemdaneprocel in Parkinson’s disease presented Oct 6, 2025. Safety at 36 months remained favorable with no adverse events related to therapy or surgery. F‑Dopa imaging suggests transplanted cells survive and engraft after stopping immunosuppression at 12 months. Motor outcomes showed clinically meaningful improvements versus baseline: MDS‑UPDRS Part III mean reductions of 17.9 points (high dose, n=7) and 13.5 points (low dose, n=4). High dose patients reported a +1 hour mean increase in “Good ON” time by PD Diary at 36 months. Participants continue in long‑term follow‑up and exPDite‑2 is planned to further evaluate benefits.
Bayer (OTC:BAYRY) has selected Interpublic Group (NYSE:IPG) as its global agency partner for creative, production, and media services for its Consumer Health division. The partnership will manage marketing activities for major brands including Aspirin, Bepanthen, Claritin, and Canesten.
The integrated agency approach aims to leverage GenAI tools and capabilities to enhance consumer engagement at the local level while maintaining global consistency. The new structure is designed to improve media buying power and deliver personalized content across markets. The partnership is set to go live on January 1, 2026, following a transition period.
Bayer (OTC:BAYRY) has announced a strategic distribution partnership with Mint Pharmaceuticals Inc. for ADALAT® XL® 30 mg tablets in Canada, effective September 3, 2025. The collaboration aims to enhance the accessibility of ADALAT® XL®, a medication indicated for chronic stable angina and mild to moderate essential hypertension management.
The partnership leverages Mint's 15-year experience in supply chain management and extensive distribution network in the Canadian market. ADALAT® XL®, which received its initial market authorization in Canada in 1995, will benefit from Mint's established infrastructure to ensure consistent availability to healthcare providers and patients across Canada.
Bayer (OTC:BAYRY) will present new data for KERENDIA® (finerenone) at the upcoming HFSA Annual Scientific Meeting in Minneapolis, September 26-29, 2025. The presentations will include two key subgroup analyses from the Phase III FINEARTS-HF trial examining treatment effects across heart failure duration and in patients with high medication burden.
The company will also present retrospective real-world data on guideline-directed medical therapy treatment patterns for newly diagnosed heart failure patients in the U.S. This follows the FDA's July 2025 approval of KERENDIA's new indication for treating adult patients with heart failure with left ventricular ejection fraction ≥40%. The drug was previously approved in July 2021 for reducing cardiovascular and kidney disease risks in adult patients with CKD associated with T2D.
Bayer (OTC:BAYRY) has announced significant progress in its dual approach to treating Parkinson's disease through both cell and gene therapies. The company has initiated two major clinical trials: the Phase III exPDite-2 trial for bemdaneprocel (cell therapy) and the Phase II REGENERATE-PD trial for AB-1005 (gene therapy).
The trials focus on treating moderate-stage Parkinson's disease, which affects over 10 million people globally. Bemdaneprocel aims to replace lost dopamine-producing cells, while AB-1005 explores gene therapy potential. The REGENERATE-PD trial is currently active in the UK, Poland, and USA, with Germany to follow.
These developments are being conducted through Bayer's subsidiaries, BlueRock Therapeutics LP and AskBio Inc., showcasing the company's comprehensive end-to-end approach in cell and gene therapy development.
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