BAYER AG S/ADR (BAYRY) news covers developments at Bayer AG, a global life science enterprise active in health care and nutrition. Company communications highlight updates across its Pharmaceuticals Division, radiology business and crop science activities, giving investors and observers insight into how Bayer advances its pipeline and product portfolio.
Recent pharmaceutical news emphasizes growth in oncology, cardiology, neurology, immunology and women’s health. Examples include updates on asundexian for secondary stroke prevention, finerenone (Kerendia) in cardiovascular-kidney-metabolic conditions, and oncology assets such as Nubeqa for prostate cancer, Hyrnuo for HER2-mutant non-small cell lung cancer, and Xofigo for metastatic castration-resistant prostate cancer with bone metastases. Bayer also reports on Lynkuet, a hormone-free treatment for moderate to severe hot flashes due to menopause, and a Phase III SUNFLOWER study evaluating Mirena for nonatypical endometrial hyperplasia.
News items also describe Bayer’s work in radiology and molecular imaging, including the low-dose MRI contrast agent gadoquatrane and the acquisition of investigational tracers AT-01 and AT-05 for diagnosing cardiac amyloidosis. Additional coverage highlights cell and gene therapy programs for Parkinson’s disease and ophthalmic conditions, as well as collaborations such as the agreement with Soufflé Therapeutics to develop a heart-targeted siRNA therapy for a form of dilated cardiomyopathy.
On the agriculture side, Bayer Crop Science Canada announcements feature launches like Sivanto Energy for flea beetle control in canola and EverGol Rise for pulse disease control. Together, these updates illustrate how Bayer seeks to execute its mission “Health for all, Hunger for none” through pharmaceutical innovation, diagnostic imaging advances and crop protection solutions.
Bayer (BAYRY) reported interim Phase III results showing NUBEQA reduced the risk of metastasis or death by 58% in DASL-HiCaP.
The trial enrolled 1,106 prostate cancer patients at high risk of recurrence, comparing NUBEQA with placebo alongside androgen deprivation therapy and radiation. At median follow-up of 3.8 years, the primary endpoint, metastasis-free survival measured by conventional imaging, favored NUBEQA (hazard ratio 0.42; 95% confidence interval 0.27–0.66; p=0.0001). Four-year metastasis-free survival was 95% versus 88%. Risk of prostate-specific antigen progression or death fell 53%, with four-year rates of 91% versus 83%. Four-year overall survival was 97% versus 95%; follow-up continues to evaluate long-term survival. Grade ≥3 adverse events occurred in 43% versus 36%. The results are scheduled for presentation at ESMO 2026.
Bayer (BAYRY, BAYZF) will present cardiovascular research at the HFSA Annual Scientific Meeting on October 9–12, 2026, in Phoenix, Arizona.
The program includes one late-breaking presentation and five posters. A post-hoc analysis, conducted after the Phase III REVEAL study, will address investigational iodine 124 evuzamitide imaging in patients with suspected cardiac amyloidosis. Bayer will also present designs for three ongoing finerenone heart failure trials—CONFIRMATION-HF, FINALITY-HF and REDEFINE-HF—and results from two retrospective studies examining initiation and persistence of steroidal mineralocorticoid receptor antagonist treatment in heart failure.
Bayer (BAYRY, BAYZF) has partnered with actress and menopause advocate Melissa Joan Hart to raise awareness about its prescription treatment Lynkuet.
Lynkuet (elinzanetant) 60mg capsules is an FDA-approved, hormone-free treatment to reduce moderate to severe hot flashes due to menopause. Hart will share her personal experience with hot flashes and encourage women to discuss treatment options with healthcare providers. She joins Bayer’s “Life Doesn’t Stop for a Hot Flash” campaign as the first anniversary of Lynkuet’s October 2025 FDA approval approaches.
Hart is a paid Bayer spokesperson and is not taking Lynkuet. Her participation includes a Reddit Ask Me Anything campaign. A discussion guide for conversations with healthcare providers is available at lynkuet.com.
Bayer (BAYRY) received FDA acceptance of its supplemental application for KERENDIA to treat adults with chronic kidney disease without diabetes.
The proposed use is alongside background standard of care. In the Phase III FIND-CKD trial, KERENDIA met the primary endpoint measuring kidney function decline. Mean annual decline through month 32 was −3.3 versus −4.0 mL/min/1.73 m²/year with placebo, a statistically significant difference of 0.7. A secondary combined outcome of kidney failure, sustained kidney function decrease ≥57%, heart failure hospitalization or cardiovascular death also improved: hazard ratio 0.77, p=0.04.
Serious treatment-emergent adverse events occurred in 20.9% versus 21.2% with placebo; hyperkalemia, or elevated blood potassium, occurred in 17% versus 13.3%. The application acceptance is not approval of this proposed indication.
Bayer (BAYRY) plans to invest 2.2 billion U.S. dollars in a new pharmaceutical manufacturing site in New Albany, Ohio. Bayer expects around 600 new jobs and roughly 1,500 construction jobs. The first module, for drug substance manufacturing, is expected to become operational in 2031; a second, for drug product manufacturing, is planned to follow in 2034. The site will initially support oncology, cardiovascular and renal care.
Bayer (BAYRY, BAYZF) plans to relaunch Alka-Seltzer Plus as Alka-Seltzer Cold in 2026 across U.S. mass, drug and food retailers. Planned changes include simplified packaging, value-focused price points and entry pack sizes, plus a money-back guarantee. Bayer intends the new name and packaging to help shoppers identify cough/cold options more easily.
Bayer (BAYRY) launched MiraSOFT, a stool softener in its Mira portfolio, at CVS Pharmacy and on cvs.com. The product contains docusate sodium and is available in more than 7,000 CVS Pharmacy stores, where shoppers can find it in the digestive health aisle. It is intended for occasional constipation when used as directed.
Bayer (BAYRY) received FDA acceptance and Priority Review for Lynkuet’s proposed treatment of hot flashes linked to breast cancer endocrine therapy.
The supplemental application is based on the 52-week Phase III OASIS-4 trial in 474 women receiving endocrine therapy for treatment or prevention of hormone receptor-positive breast cancer. Elinzanetant met both primary endpoints: reducing the mean daily frequency of moderate to severe hot flashes from baseline at weeks 4 and 12 compared with placebo. The trial was conducted at 90 sites outside the U.S.
Somnolence, fatigue and diarrhea were reported more often with elinzanetant during the first 12 weeks, when it was compared with placebo. Lynkuet was approved in October 2025 for moderate to severe hot flashes due to menopause; the proposed endocrine-therapy use remains under FDA review.
Robigo announced a Series A financing led by Leaps by Bayer (BAYRY), with participation from Illumina Ventures, SVG Thrive, Congruent Ventures and Endeavor8, to advance engineered microbial biopesticides.
The funding will accelerate planned U.S. launches of a soybean Sudden Death Syndrome product in 2028 and a lettuce and berry fungal disease product in 2029. Robigo reports its SDS microbe matches current chemistries at half the cost, while its second product tripled yields versus untreated controls. The company plans to expand its pipeline to additional soil‑borne pathogens in broadacre crops, targeting a $10 billion addressable market. Its ARGO™ platform is said to cut development time from three to five years to under 20 months.
Bayer (BAYRY) received U.S. FDA approval for KERENDIA (finerenone) on September 17, 2026 as the first new treatment in over 30 years for adults with chronic kidney disease (CKD) associated with type 1 diabetes (T1D), to reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce the risk of sustained eGFR decline and end-stage kidney disease.
Approval followed Priority Review of a supplemental NDA and is primarily supported by the Phase III FINE-ONE trial in CKD with T1D, plus prior FIDELIO-DKD and FIGARO-DKD data in CKD with type 2 diabetes. In FINE-ONE, once-daily KERENDIA 10 mg or 20 mg reduced UACR versus placebo at Month 3 by 22% (LSGMR 0.78; 95% CI: 0.68–0.90) and at Month 6 by 28% (LSGMR 0.72; 95% CI: 0.60–0.86), with safety and tolerability consistent with earlier CKD/T2D data. Hyperkalemia occurred in 10.1% of KERENDIA patients vs 3.3% on placebo, with 1.7% discontinuing due to hyperkalemia.
KERENDIA is now FDA‑approved for three indications spanning CKD with T2D, CKD with T1D, and heart failure with LVEF ≥40%.