Bayer A G Stock Price, News & Analysis

Bayer (OTC:BAYRY) reported topline Phase III OCEANIC-STROKE results for oral FXIa inhibitor asundexian 50 mg once daily. The study met its primary efficacy and safety endpoints: asundexian plus antiplatelet therapy significantly reduced ischemic stroke risk versus placebo plus antiplatelet therapy, with no increase in ISTH major bleeding. Bayer said it will engage health authorities globally to prepare marketing‑authorization submissions and will present detailed results at an upcoming scientific congress. Asundexian has U.S. FDA Fast Track designation and remains investigational, not approved for any indication.

Bayer (OTC: BAYRY) announced that on November 20, 2025 the U.S. FDA granted accelerated approval to HYRNUO (sevabertinib) for adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) harboring HER2 (ERBB2) tyrosine kinase domain activating mutations, after prior systemic therapy.

The approval follows Priority Review and is based on objective response rate (ORR) and duration of response (DoR) from the Phase I/II SOHO-01 trial; continued approval may require a confirmatory trial. HYRNUO previously received Breakthrough Therapy designation in 2024.

Bayer (OTC:BAYRY) launched the nationwide “Science Delivers” campaign on November 10, 2025, inviting Americans to share personal stories about how science improves health, food, technology and daily life.

The initiative includes a Declaration on Science published in major outlets, an interactive website (ScienceDelivers.com), national ads, a video spotlighting scientific milestones, and interactive “Science, Sealed, Delivered” mailboxes collecting digital postcards at events such as the 2025 Borlaug Dialogue.

The campaign also aims to help the public spot misinformation and promote evidence‑based thinking.

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.