Bayer Aktien Stock Price, News & Analysis

Bayer (OTC:BAYRY) announced initiation of the ASSESS Phase IIa randomized, double-blind, placebo-controlled study (NCT07211685) of BAY 3401016, an investigational monoclonal antibody that may block Semaphorin 3A (Sema3A) to address kidney damage in Alport Syndrome (AS).

The first-in-patient adult trial includes an extension phase and follows Bayer’s research collaboration with Evotec. The program has received Fast Track and Orphan Drug designations from the U.S. FDA. The study aims to evaluate the efficacy and safety of BAY 3401016 in slowing loss of kidney function in adults with rapidly progressing AS.

Bayer (OTC:BAYRY) announced that the QUANTI Pediatric study of investigational MRI contrast agent gadoquatrane met primary and secondary endpoints when used at 0.04 mmol Gd/kg—a 60% dose reduction versus macrocyclic GBCAs dosed at 0.1 mmol Gd/kg. The study showed similar pharmacokinetic behavior in children (birth to <18) as in adults. Results were presented at RSNA (Nov 30–Dec 4, 2025).

Based on positive QUANTI data, Bayer has submitted marketing authorization applications for gadoquatrane in multiple markets, including Japan, the U.S., the EU, and China. If approved, gadoquatrane would be the lowest-dose macrocyclic GBCA in those markets.

Bayer (OTC:BAYRY) announced the start of SUNFLOWER, a Phase III investigational study testing the 52 mg levonorgestrel-releasing intrauterine system Mirena for treatment of nonatypical endometrial hyperplasia (NAEH).

The randomized study will compare Mirena versus an oral progestin, plans to enroll 207 patients across about 90 centers in three countries, and is expected to complete after roughly 18 months. Mirena is globally available in more than 120 countries and is approved in the U.S. for contraception (up to 8 years) and for heavy menstrual bleeding (up to 5 years) but is not FDA approved for NAEH. The company cites a high unmet need, noting approximately 121 per 100,000 women develop NAEH each year and current absence of approved U.S. medical therapies.

Bayer Crop Science (OTC:BAYRY) launched EverGol Rise in Canada, a single‑formulation pulse seed treatment combining four active ingredients to expand control to seed‑ and soil‑borne pathogens including ascochyta.

The product is premeasured at 100 ml/100 kg, requires no mixing, offers deeper pigment for visual coverage, and will be sold in 9 L jugs and 27 L drums. Bayer completed over 90 pre‑commercial trials across Western Canada and plans commercial availability for the 2026 growing season.

Bayer (BAYRY) announced on December 1, 2025 that its MEDRAD® Centargo multi-patient CT injection system received FDA 510(k) clearance to expand compatible contrast agent presentations to include single-dose vials in addition to Imaging Bulk Package (IBP) presentations.

The company also added Visipaque (iodixanol) single-dose vials as Centargo’s fifth compatible contrast agent, joining Ultravist (iopromide), Isovue (iopamidol), Optiray (ioversol) and Omnipaque (iohexol). Bayer says the update targets high-throughput imaging suites by enabling greater flexibility, reduced contrast waste, and integration with Bayer’s Cortenic™ Connectivity workflow solutions for scanner and radiology system connectivity.

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.