{"success":true,"data":{"pressRelease":{"id":"145898","rtpr_id":"nBw4FMkZSa-20260917","ticker":"BAYGN","exchange":"XETRA","all_tickers":["BAYGN"],"title":"Bayer’s KERENDIA® (finerenone) Receives FDA Approval as the First New Treatment in 30 Years for Adults with Chronic Kidney Disease (CKD) and Type 1 Diabetes","author":"Business Wire","published_at":"2026-09-17T06:30:00.105Z","article_body":"Bayer’s KERENDIA(®) (finerenone) Receives FDA Approval as the First New\nTreatment in 30 Years for Adults with Chronic Kidney Disease (CKD) and Type 1\nDiabetes\n\nKERENDIA(®) (finerenone), a non-steroidal mineralocorticoid receptor\nantagonist (MRA), is the first new treatment in more than 30 years approved by\nthe FDA for adult patients with chronic kidney disease (CKD) associated with\ntype 1 diabetes (T1D).(1,2)\n\nBayer\n\nSummary \n\nBayer today announced that the U.S. Food and Drug Administration (FDA)\napproved KERENDIA(®) (finerenone) to reduce urinary albumin-to-creatinine\nratio (UACR), which is expected to reduce the risk of sustained estimated\nglomerular filtration rate (eGFR) decline and end-stage kidney disease in\nadults with chronic kidney disease (CKD) associated with type 1 diabetes\n(T1D), following the agency’s Priority Review of the supplemental New Drug\nApplication (sNDA).(1)\n\nKey Facts\n\n\n * The FDA approved KERENDIA to reduce UACR, which is expected to slow chronic\nkidney disease progression in adults with CKD associated with T1D.(1) This\napproval is important for patients, as it is the first proven therapeutic\nadvance in CKD associated with T1D in more than 30 years.(1,2)\n\n * Approval was supported by data from the Phase III FINE-ONE clinical trial in\nadult patients with CKD associated with T1D.(1,2 )It was also supported by\nPhase III data from the FIDELIO-DKD and FIGARO-DKD trials in adults with CKD\nassociated with type 2 diabetes (T2D).(1)\n\n * Approximately 20-30% of people in the U.S. with T1D also have CKD,(3,4) which\nputs them at risk of kidney disease progression and kidney failure.(5)\n\n * KERENDIA is also approved to reduce the risk of sustained eGFR decline,\nend-stage kidney disease, cardiovascular death, non-fatal myocardial\ninfarction, and hospitalization for heart failure in adult patients with CKD\nassociated with T2D.(1)\n\n * In addition, KERENDIA is approved to reduce the risk of cardiovascular death,\nhospitalization for heart failure, and urgent heart failure visits in adult\npatients with heart failure with left ventricular ejection fraction (HF LVEF)\n≥40%.(1)\n\nWhy This FDA Approval Matters for Patients and Physicians \n\n“For more than three decades, people with chronic kidney disease and type 1\ndiabetes have had limited options to address the risk of kidney disease\nprogression,\"(2) said Dr. Janet McGill, Professor of Medicine in the Division\nof Endocrinology, Metabolism, and Lipid Research at Washington University\nSchool of Medicine in St. Louis, and Co-Chair of the study’s Executive\nCommittee. \"The approval of KERENDIA to reduce UACR, which is expected to slow\nchronic kidney disease progression in adults with type 1 diabetes, provides an\nimportant new treatment option for a population that has continued to face\nsubstantial unmet need.”(1,2)\n\nKERENDIA, a once-daily, oral treatment option, is the only MRA indicated for\nadults with CKD associated with either T2D or T1D.(1)\n\n“This approval builds on evidence linking reductions in UACR with improved\nkidney outcomes in KERENDIA’s clinical trial program in chronic kidney\ndisease associated with type 2 diabetes,”(1) said Carolina Aldworth, M.D.,\nMSc, Executive Medical Director at Bayer. “KERENDIA’s third indication\nvalidates the breadth of its clinical trial program across cardiovascular and\nkidney diseases, helping a patient population that has historically been\nclinically underserved.”(1,2)\n\nFINE-ONE Clinical Trial Results \n\nFINE-ONE (NCT05901831) was a pivotal, global, randomized, prospective,\ndouble-blind, placebo-controlled, multicenter, Phase III study in adult\npatients with CKD associated with T1D. FINE-ONE enrolled 242 adult\nparticipants with the primary objective to demonstrate whether the addition of\nKERENDIA, 10 mg or 20 mg once daily, to standard of care was superior to\nplacebo in reducing UACR over six months (averaged over months 3 and 6).(1)\nUACR is an important marker of CKD progression.(2)\n\nThe results showed:\n\n\n * KERENDIA significantly reduced UACR vs. placebo over 6 months (p=0.0001).\nReductions in UACR were observed as early as Month 3 and were sustained\nthrough Month 6.(1)\n\n\n* At Month 3, KERENDIA reduced UACR compared to placebo by 22% (ratio of Least\nSquare Geometric Mean Ratio [LSGMR] of 0.78; 95% CI: 0.68, 0.90).\n\n * At Month 6, KERENDIA reduced UACR compared to placebo by 28% (ratio of LSGMR\nof 0.72; 95% CI: 0.60, 0.86).\n\n\n\n\n * Safety and tolerability were consistent with the existing evidence for\nKERENDIA in adults with CKD associated with T2D.(1)\n\n\n* The rate of treatment-emergent adverse events was 47.1% for those treated\nwith\nKERENDIA and 49.2% for placebo.(2)\n\n * The rate of treatment-emergent serious adverse events was 11.8% for KERENDIA\nand 11.5% for placebo.(2)\n\n * Hyperkalemia, an adverse event of special interest, was observed more\nfrequently with KERENDIA (10.1%) compared to placebo (3.3%). The rate of\ntreatment discontinuation due to hyperkalemia was 1.7% and 0%,\nrespectively.(2)\n\n\n\n\nDetailed FINE-ONE trial results were presented at the American Society of\nNephrology (ASN) Kidney Week 2025 and published in the New England Journal of\nMedicine\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.nejm.org%2Fdoi%2Ffull%2F10.1056%2FNEJMoa2512854&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=New+England+Journal+of+Medicine&index=1&md5=8adeb1553d23b321d75961c38e82ad63)\n.\n\nWhy Managing UACR Matters \n\nUACR is a modifiable risk factor associated with chronic kidney disease\nprogression.(2) In the FIDELIO-DKD and FIGARO-DKD trials, reductions in UACR\nwith KERENDIA were shown to be associated with improved kidney outcomes in\nadults with CKD and T2D.(1) Together with the FINE-ONE results, this evidence\nsupported the use of UACR to bridge KERENDIA’s established kidney outcomes\nevidence from CKD associated with T2D to patients with CKD associated with\nT1D.(1)\n\nKERENDIA’s Approved Indications(1 \n)\nSince 2021, KERENDIA has been approved by the FDA to reduce the risk of\ncardiovascular death, hospitalization for HF, non-fatal myocardial infarction,\nsustained eGFR decline and end-stage kidney disease in adult patients with CKD\nassociated with T2D.\n\nIn July 2025, KERENDIA received FDA approval to reduce the risk of\ncardiovascular death, hospitalization for heart failure and urgent heart\nfailure visits in adults with HF LVEF ≥40%.\n\nNow, KERENDIA is also approved by the FDA to reduce UACR, which is expected to\nreduce the risk of sustained eGFR decline and end-stage kidney disease in\nadults with CKD associated with T1D.\n\nAbout KERENDIA \n\nKERENDIA is a non-steroidal mineralocorticoid receptor antagonist (MRA) that\nselectively and potently blocks mineralocorticoid receptor overactivation in\nthe heart and kidneys.(1)\n\nAbout KERENDIA’s Clinical Trial Program \n\nKERENDIA’s clinical trial program—called FINEOVATE—currently comprises\n12 Phase III studies with dedicated programs in HF (MOONRAKER) and CKD\n(THUNDERBALL).\n\n\n * The MOONRAKER program includes \nFINEARTS-HF\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04435626&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FINEARTS-HF&index=2&md5=78241192b1a21e9f16632cbdd73cc17e)\n\n,(6) the ongoing, collaborative, investigator-sponsored studies \nREDEFINE-HF\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06008197&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=REDEFINE-HF&index=3&md5=f52c3c92e0a36afc80781a2a3295f6cc)\n\n,(7) \nCONFIRMATION-HF\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06024746&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=CONFIRMATION-HF&index=4&md5=376e06f38482d1b70708478f530f33de)\n\n(8) and \nFINALITY-HF\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06033950&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FINALITY-HF&index=5&md5=f920e55cf270e92a746e6969bed773ae)\n\n,(9) as well as the ongoing studies \nFIORE\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07188805&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FIORE&index=6&md5=b7df6b298b2536ff75d70fd99393a8a2)\n\n(10) and \nFIORELLO\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07192952&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FIORELLO&index=7&md5=3bedede4f52fd1f54c7f0470b8a2a709)\n\n.(11)\n\n * The THUNDERBALL CKD program consists of the completed studies \nFIDELIO-DKD\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT02540993&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FIDELIO-DKD&index=8&md5=3f0e306655e57f06afd53fc4fec9fd9e)\n\n,(12) \nFIGARO-DKD\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT02545049&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FIGARO-DKD&index=9&md5=5bb4610e3746169a4e175d5b1e64096e)\n\n,(13) \nFINE-ONE\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05901831&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FINE-ONE&index=10&md5=6f371c3e11ac67cc13d669a622cf953c)\n\n(14) and \nFIND-CKD\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05047263&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FIND-CKD&index=11&md5=79665e7ff5bf62ed414289638ec5a45a)\n\n(15) as well as the ongoing investigational pediatric studies, \nFIONA\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05196035&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FIONA&index=12&md5=f1eedbf218bfccb10c3dcf488fe928a8)\n\n(16) and \nFIONA-OLE\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05457283&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FIONA-OLE&index=13&md5=c400a6788abc2084d37a1ec69faef62e)\n\n.(17)\n\nIMPORTANT SAFETY INFORMATION\n\nCONTRAINDICATIONS:\n\n\n * Hypersensitivity to any component of this product\n\n * Concomitant use with strong CYP3A4 inhibitors\n\n * Patients with adrenal insufficiency\n\nWARNINGS AND PRECAUTIONS:\n\n\n * Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing\nhyperkalemia increases with decreasing kidney function and is greater in\npatients with higher baseline potassium levels or other risk factors for\nhyperkalemia.\n\n\n\nMeasure serum potassium and eGFR in all patients before initiation of\ntreatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if\nserum potassium is >5 mEq/L. Measure serum potassium periodically during\ntreatment with KERENDIA and adjust dose accordingly. More frequent monitoring\nmay be necessary for patients at risk for hyperkalemia, including those on\nconcomitant medications that impair potassium excretion or increase serum\npotassium.\n\n * Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause\nworsening of renal function in patients with heart failure. Rarely, severe\nevents associated with worsening renal function, including events requiring\nhospitalization, have been observed.\n\n\n\nMeasure eGFR in all patients before initiation of treatment or with dose\ntitration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients\nwith heart failure and an eGFR <25 mL/min/1.73 m(2 )is not recommended.\nMeasure eGFR periodically during maintenance treatment with KERENDIA in\npatients with heart failure. Consider delaying up-titration or interrupting\ntreatment with KERENDIA in patients who develop clinically significant\nworsening of renal function.\n\nMOST COMMON ADVERSE REACTIONS:\n\n\n * The adverse reactions reported in ≥1% of patients on KERENDIA and more\nfrequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs\n3%), and hyponatremia (1.3% vs 0.7%). Events related to worsening renal\nfunction were reported more frequently in the KERENDIA group (18%) compared\nwith placebo (12%) in patients with HF LVEF ≥40%.\n\nDRUG INTERACTIONS:\n\n\n * Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4\ninhibitors is contraindicated. Avoid concomitant intake of grapefruit or\ngrapefruit juice.\n\n * Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug\ninitiation or dosage adjustment of either KERENDIA or the moderate or weak\nCYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate.\n\n * Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with\nstrong or moderate CYP3A4 inducers.\n\n * Sensitive CYP2C8 Substrates at KERENDIA 40 mg: Monitor patients more\nfrequently for adverse reactions caused by sensitive CYP2C8 substrates if\nKERENDIA 40 mg is coadministered with such substrates, since minimal\nconcentration changes may lead to serious adverse reactions.\n\nUSE IN SPECIFIC POPULATIONS:\n\n\n * Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day\nafter treatment.\n\n * Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic\nimpairment (Child Pugh C) and consider additional serum potassium monitoring\nwith moderate hepatic impairment (Child Pugh B).\n\nINDICATIONS: \n\nKERENDIA (finerenone) is indicated to:\n\n\n * reduce the risk of sustained estimated glomerular filtration rate (eGFR)\ndecline, end-stage kidney disease, cardiovascular death, non-fatal myocardial\ninfarction, and hospitalization for heart failure in adult patients with\nchronic kidney disease (CKD) associated with Type 2 diabetes (T2D) (10 mg, 20\nmg tablets)\n\n * reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce\nthe risk of sustained estimated glomerular filtration rate (eGFR) decline and\nend-stage kidney disease in adults with CKD associated with Type 1 diabetes\n(T1D) (10 mg, 20 mg tablets)\n\n * reduce the risk of cardiovascular death, hospitalization for heart failure,\nand urgent heart failure visits in adult patients with heart failure with left\nventricular ejection fraction (HF LVEF) ≥40% (10 mg, 20 mg, 40 mg tablets)\n\nPlease see the full Prescribing Information for KERENDIA.\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Flabeling.bayerhealthcare.com%2Fhtml%2Fproducts%2Fpi%2FKerendia_PI.pdf&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=Please+see+the+full+Prescribing+Information+for+KERENDIA.&index=14&md5=77a69052b389f2ff7e83b9d185494a1e)\n\nAbout Bayer’s Commitment in Cardiovascular and Kidney Diseases \n\nBayer’s legacy in cardiovascular care spans decades of scientific innovation\nand patient-focused research. As a long-standing leader in cardiology, Bayer\nhas consistently advanced therapies that address the complex interplay between\nthe heart and kidneys—two organs deeply connected in both health and\ndisease. Today, that heritage continues to guide our commitment to developing\ninnovative treatments for patients facing high unmet medical needs. With a\ngrowing portfolio of approved therapies and promising compounds in\ndevelopment, Bayer is shaping the future of cardiovascular care through\nprecision medicine, scientific rigor, and a deep sense of purpose.\n\nAbout Bayer \n\nBayer is a global enterprise with core competencies in the life science fields\nof health care and nutrition. In line with its mission, “Health for all,\nHunger for none,” the company’s products and services are designed to help\npeople and the planet thrive by supporting efforts to master the major\nchallenges presented by a growing and aging global population. Bayer is\ncommitted to driving sustainable development and generating a positive impact\nwith its businesses. At the same time, the Group aims to increase its earning\npower and create value through innovation and growth. The Bayer brand stands\nfor trust, reliability and quality throughout the world. In fiscal 2025, the\nGroup employed around 88,000 people and had sales of 45.6 billion euros.\nR&D expenses amounted to 5.8 billion euros. For more information, go to\nwww.bayer.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.bayer.com&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=www.bayer.com&index=15&md5=1feb9d12344f4ca041e81b75219217bf)\n.\n\nFind more information at https://pharma.bayer.com/ \n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fpharma.bayer.com%2F&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fpharma.bayer.com%2F&index=16&md5=4887f9e6dd1ff01b3e760e7d39a2b01c)\n\nFollow us on LinkedIn: Bayer | Pharmaceuticals: Overview | LinkedIn \n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fshowcase%2Fbayer-pharmaceuticals%2F&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=Bayer+%7C+Pharmaceuticals%3A+Overview+%7C+LinkedIn&index=17&md5=51829a4555f691fea900ace4dff41a3f)\n\nFollow us on Facebook: http://www.facebook.com/bayer \n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.facebook.com%2Fbayer&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=http%3A%2F%2Fwww.facebook.com%2Fbayer&index=18&md5=447cc8bb29b143c8963c7ac32c5b2ddc)\n\nFollow us on X: @BayerUS\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fx.com%2FBayerUS%3Flang%3Den&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=%40BayerUS&index=19&md5=7a1d7ad008db890244ea0dcbc0c45f32)\n\nForward-Looking Statements \n\nThis release may contain forward-looking statements based on current\nassumptions and forecasts made by Bayer management. Various known and unknown\nrisks, uncertainties and other factors could lead to material differences\nbetween the actual future results, financial situation, development or\nperformance of the company and the estimates given here. These factors include\nthose discussed in Bayer’s public reports, which are available on the Bayer\nwebsite at www.bayer.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.bayer.com%2F&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=www.bayer.com&index=20&md5=6f4e6f29c25f5dba1df8f6cc8549a0ab)\n. The company assumes no liability whatsoever to update these forward-looking\nstatements or to conform them to future events or developments.\n       \n (1) KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer \n HealthCare Pharmaceuticals, Inc: September 2026 \n (2) Heerspink HJL, Birkenfeld AL, Cherney DZI, et al; FINE-ONE Investigators. \n Finerenone in type 1 diabetes and chronic kidney disease. N Engl J Med. \n 2026;394(10):947-957. doi:10.1056/NEJMoa2512854. \n (3) Rossing P, Per-Henrik Groop, Singh R, Lawatscheck R, Tuttle KR. Prevalence \n of Chronic Kidney Disease in Type 1 Diabetes Among Adults in the U.S. Diabetes \n Care. Published online June 10, 2024. doi:https://doi.org/10.2337/dc24-0335 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdoi.org%2F10.2337%2Fdc24-0335&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fdoi.org%2F10.2337%2Fdc24-0335&index=21&md5=51508414d1b72478c1dba8499afbf231)                             \n (4) Tuttle KR, Reynolds CL, Kornowske LM, et al. Prevalence and severity of \n chronic kidney disease in a population with type 1 diabetes from a United \n States health system: a real-world cohort study. The Lancet Regional Health - \n Americas. 2025;47:101130. doi:https://doi.org/10.1016/j.lana.2025.101130 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdoi.org%2F10.1016%2Fj.lana.2025.101130&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fdoi.org%2F10.1016%2Fj.lana.2025.101130&index=22&md5=2f6642fec0d9ca87dafe27179f1c3fba)                             \n (5) Heerspink H, et al. Rationale and design of a randomised phase III \n registration trial investigating finerenone in participants with type 1 \n diabetes and chronic kidney disease: The FINE-ONE trial Diabetes Research and \n Clinical Practice, 2023; 204 \n (6) Study to Evaluate the Efficacy (Effect on Disease) and Safety of \n Finerenone in Participants With Heart Failure and Left Ventricular Ejection \n Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to \n 40% (FINEARTS-HF) Clinical trial registration No. NCT04435626. \n https://clinicaltrials.gov/study/NCT04435626 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04435626&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04435626&index=23&md5=dcc35610feb3608386e8cff176b963ff)                             \n (7) A Study to Determine the Efficacy and Safety of Finerenone on Morbidity \n and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF). \n Clinical trial registration No. NCT 06008197. \n https://www.clinicaltrials.gov/study/NCT06008197 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06008197&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06008197&index=24&md5=d1cf7362cfa80ed5977d90e9c70f8886)                             \n .     \n (8) A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in \n Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF) \n (CONFIRMATION). Clinical trial registration No. NCT06024746. \n https://www.clinicaltrials.gov/study/NCT06024746 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06024746&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06024746&index=25&md5=219406a15c570709d3a99e57090dfb7b)                             \n .     \n (9) A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients \n with Heart Failure Who are Intolerant or Not Eligible for Treatment with \n Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF). Clinical trial \n registration No. NCT06033950. https://www.clinicaltrials.gov/study/NCT06033950 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06033950&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06033950&index=26&md5=d35f22a495dcc7317a436bffec19f81a)                             \n .     \n (10) A Study to Learn More About How Well Finerenone Works, How Safe it is, \n and How it Moves Into, Through, and Out of the Body Compared to Placebo When \n Taken With Standard Treatment in Children With Heart Failure and Left \n Ventricular Systolic Dysfunction (FIORE). Clinical trial registration No. \n NCT07188805. https://clinicaltrials.gov/study/NCT07188805 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07188805&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07188805&index=27&md5=0d5cc48ff32cd5dd81e2fe6f0e385868)                             \n .     \n (11) A Study to Learn More About How Safe Finerenone is, When it is Taken for \n a Longer Time With Standard Treatment, in Children and Young Adults With Heart \n Failure and Left Ventricular Systolic Dysfunction (FIORELLO). Clinical trial \n registration No. NCT07192952. https://clinicaltrials.gov/study/NCT07192952 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07192952&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07192952&index=28&md5=c440794e9df75a1ccadd3929f312e5e6)                             \n .     \n (12) Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes \n Mellitus and Diabetic Kidney Disease (FIDELIO-DKD) Clinical trial registration \n No. NCT02540993. https://clinicaltrials.gov/study/NCT02540993 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT02540993&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT02540993&index=29&md5=0126ea434bb94a7ce8ce47bca6b32dc1)                             \n .     \n (13) Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes \n Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD) \n Clinical trial registration No. NCT02545049 \n https://clinicaltrials.gov/study/NCT02545049 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT02545049&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT02545049&index=30&md5=7ea3c2a9868a6d3c08dfb63793d89e3f)                             \n .     \n (14) A Study to Learn How Well the Study Treatment Finerenone Works and How \n Safe it is in People With Long-term Decrease in the Kidneys’ Ability to Work \n Properly (Chronic Kidney Disease) Together With Type 1 Diabetes (FINE-ONE). \n Clinical trial registration No. NCT05901831. \n https://www.clinicaltrials.gov/study/NCT05901831 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05901831&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05901831&index=31&md5=a014b60cad14c055b597337350620d09)                             \n .     \n (15) A Trial to Learn How Well Finerenone Works and How Safe it is in Adult \n Participants With Non-diabetic Chronic Kidney Disease (FIND-CKD). Clinical \n trial registration No. NCT05047263. \n https://www.clinicaltrials.gov/study/NCT05047263 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05047263&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05047263&index=32&md5=4646f0cbe1a93d6086f864758546c747)                             \n .     \n (16) A Study to Learn More About How Well the Study Treatment Finerenone \n Works, How Safe it is, How it Moves Into, Through and Out of the Body, and the \n Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin \n Receptor Blocker in Children with Chronic Kidney Disease and Proteinuria \n (FIONA). Clinical trial registration No. NCT05196035. \n https://www.clinicaltrials.gov/study/NCT05196035 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05196035&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05196035&index=33&md5=fd6363c33451101722a0ed5c80d8e314)                             \n .     \n (17) A Study to Learn More About How Safe the Study Treatment Finerenone is in \n Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker \n Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age \n With Chronic Kidney Disease and Proteinuria (FIONA OLE). Clinical trial \n registration No. NCT05457283. https://www.clinicaltrials.gov/study/NCT05457283 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05457283&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05457283&index=34&md5=dbb172092c2334455fc0de1f2ecc7678)                             \n .     \n\n\nCOR-KER-US-0224-1 9/26\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260916814212/en/\n(https://www.businesswire.com/news/home/20260916814212/en/)\n\nMedia Contact: \n\nJoshua Mansbach\n\nBayer Media Relations\n\njoshua.mansbach@bayer.com \n(mailto:joshua.mansbach@bayer.com) \n+1.201.626.8929\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw4FMkZSa-20260917","title":"Bayer’s KERENDIA® (finerenone) Receives FDA Approval as the First New Treatment in 30 Years for Adults with Chronic Kidney Disease (CKD) and Type 1 Diabetes","author":"Business Wire","ticker":"BAYGN","created":"2026-09-17T06:30:00.105Z","tickers":["BAYGN"],"exchange":"XETRA","article_body":"Bayer’s KERENDIA(®) (finerenone) Receives FDA Approval as the First New\nTreatment in 30 Years for Adults with Chronic Kidney Disease (CKD) and Type 1\nDiabetes\n\nKERENDIA(®) (finerenone), a non-steroidal mineralocorticoid receptor\nantagonist (MRA), is the first new treatment in more than 30 years approved by\nthe FDA for adult patients with chronic kidney disease (CKD) associated with\ntype 1 diabetes (T1D).(1,2)\n\nBayer\n\nSummary \n\nBayer today announced that the U.S. Food and Drug Administration (FDA)\napproved KERENDIA(®) (finerenone) to reduce urinary albumin-to-creatinine\nratio (UACR), which is expected to reduce the risk of sustained estimated\nglomerular filtration rate (eGFR) decline and end-stage kidney disease in\nadults with chronic kidney disease (CKD) associated with type 1 diabetes\n(T1D), following the agency’s Priority Review of the supplemental New Drug\nApplication (sNDA).(1)\n\nKey Facts\n\n\n * The FDA approved KERENDIA to reduce UACR, which is expected to slow chronic\nkidney disease progression in adults with CKD associated with T1D.(1) This\napproval is important for patients, as it is the first proven therapeutic\nadvance in CKD associated with T1D in more than 30 years.(1,2)\n\n * Approval was supported by data from the Phase III FINE-ONE clinical trial in\nadult patients with CKD associated with T1D.(1,2 )It was also supported by\nPhase III data from the FIDELIO-DKD and FIGARO-DKD trials in adults with CKD\nassociated with type 2 diabetes (T2D).(1)\n\n * Approximately 20-30% of people in the U.S. with T1D also have CKD,(3,4) which\nputs them at risk of kidney disease progression and kidney failure.(5)\n\n * KERENDIA is also approved to reduce the risk of sustained eGFR decline,\nend-stage kidney disease, cardiovascular death, non-fatal myocardial\ninfarction, and hospitalization for heart failure in adult patients with CKD\nassociated with T2D.(1)\n\n * In addition, KERENDIA is approved to reduce the risk of cardiovascular death,\nhospitalization for heart failure, and urgent heart failure visits in adult\npatients with heart failure with left ventricular ejection fraction (HF LVEF)\n≥40%.(1)\n\nWhy This FDA Approval Matters for Patients and Physicians \n\n“For more than three decades, people with chronic kidney disease and type 1\ndiabetes have had limited options to address the risk of kidney disease\nprogression,\"(2) said Dr. Janet McGill, Professor of Medicine in the Division\nof Endocrinology, Metabolism, and Lipid Research at Washington University\nSchool of Medicine in St. Louis, and Co-Chair of the study’s Executive\nCommittee. \"The approval of KERENDIA to reduce UACR, which is expected to slow\nchronic kidney disease progression in adults with type 1 diabetes, provides an\nimportant new treatment option for a population that has continued to face\nsubstantial unmet need.”(1,2)\n\nKERENDIA, a once-daily, oral treatment option, is the only MRA indicated for\nadults with CKD associated with either T2D or T1D.(1)\n\n“This approval builds on evidence linking reductions in UACR with improved\nkidney outcomes in KERENDIA’s clinical trial program in chronic kidney\ndisease associated with type 2 diabetes,”(1) said Carolina Aldworth, M.D.,\nMSc, Executive Medical Director at Bayer. “KERENDIA’s third indication\nvalidates the breadth of its clinical trial program across cardiovascular and\nkidney diseases, helping a patient population that has historically been\nclinically underserved.”(1,2)\n\nFINE-ONE Clinical Trial Results \n\nFINE-ONE (NCT05901831) was a pivotal, global, randomized, prospective,\ndouble-blind, placebo-controlled, multicenter, Phase III study in adult\npatients with CKD associated with T1D. FINE-ONE enrolled 242 adult\nparticipants with the primary objective to demonstrate whether the addition of\nKERENDIA, 10 mg or 20 mg once daily, to standard of care was superior to\nplacebo in reducing UACR over six months (averaged over months 3 and 6).(1)\nUACR is an important marker of CKD progression.(2)\n\nThe results showed:\n\n\n * KERENDIA significantly reduced UACR vs. placebo over 6 months (p=0.0001).\nReductions in UACR were observed as early as Month 3 and were sustained\nthrough Month 6.(1)\n\n\n* At Month 3, KERENDIA reduced UACR compared to placebo by 22% (ratio of Least\nSquare Geometric Mean Ratio [LSGMR] of 0.78; 95% CI: 0.68, 0.90).\n\n * At Month 6, KERENDIA reduced UACR compared to placebo by 28% (ratio of LSGMR\nof 0.72; 95% CI: 0.60, 0.86).\n\n\n\n\n * Safety and tolerability were consistent with the existing evidence for\nKERENDIA in adults with CKD associated with T2D.(1)\n\n\n* The rate of treatment-emergent adverse events was 47.1% for those treated\nwith\nKERENDIA and 49.2% for placebo.(2)\n\n * The rate of treatment-emergent serious adverse events was 11.8% for KERENDIA\nand 11.5% for placebo.(2)\n\n * Hyperkalemia, an adverse event of special interest, was observed more\nfrequently with KERENDIA (10.1%) compared to placebo (3.3%). The rate of\ntreatment discontinuation due to hyperkalemia was 1.7% and 0%,\nrespectively.(2)\n\n\n\n\nDetailed FINE-ONE trial results were presented at the American Society of\nNephrology (ASN) Kidney Week 2025 and published in the New England Journal of\nMedicine\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.nejm.org%2Fdoi%2Ffull%2F10.1056%2FNEJMoa2512854&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=New+England+Journal+of+Medicine&index=1&md5=8adeb1553d23b321d75961c38e82ad63)\n.\n\nWhy Managing UACR Matters \n\nUACR is a modifiable risk factor associated with chronic kidney disease\nprogression.(2) In the FIDELIO-DKD and FIGARO-DKD trials, reductions in UACR\nwith KERENDIA were shown to be associated with improved kidney outcomes in\nadults with CKD and T2D.(1) Together with the FINE-ONE results, this evidence\nsupported the use of UACR to bridge KERENDIA’s established kidney outcomes\nevidence from CKD associated with T2D to patients with CKD associated with\nT1D.(1)\n\nKERENDIA’s Approved Indications(1 \n)\nSince 2021, KERENDIA has been approved by the FDA to reduce the risk of\ncardiovascular death, hospitalization for HF, non-fatal myocardial infarction,\nsustained eGFR decline and end-stage kidney disease in adult patients with CKD\nassociated with T2D.\n\nIn July 2025, KERENDIA received FDA approval to reduce the risk of\ncardiovascular death, hospitalization for heart failure and urgent heart\nfailure visits in adults with HF LVEF ≥40%.\n\nNow, KERENDIA is also approved by the FDA to reduce UACR, which is expected to\nreduce the risk of sustained eGFR decline and end-stage kidney disease in\nadults with CKD associated with T1D.\n\nAbout KERENDIA \n\nKERENDIA is a non-steroidal mineralocorticoid receptor antagonist (MRA) that\nselectively and potently blocks mineralocorticoid receptor overactivation in\nthe heart and kidneys.(1)\n\nAbout KERENDIA’s Clinical Trial Program \n\nKERENDIA’s clinical trial program—called FINEOVATE—currently comprises\n12 Phase III studies with dedicated programs in HF (MOONRAKER) and CKD\n(THUNDERBALL).\n\n\n * The MOONRAKER program includes \nFINEARTS-HF\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04435626&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FINEARTS-HF&index=2&md5=78241192b1a21e9f16632cbdd73cc17e)\n\n,(6) the ongoing, collaborative, investigator-sponsored studies \nREDEFINE-HF\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06008197&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=REDEFINE-HF&index=3&md5=f52c3c92e0a36afc80781a2a3295f6cc)\n\n,(7) \nCONFIRMATION-HF\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06024746&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=CONFIRMATION-HF&index=4&md5=376e06f38482d1b70708478f530f33de)\n\n(8) and \nFINALITY-HF\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06033950&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FINALITY-HF&index=5&md5=f920e55cf270e92a746e6969bed773ae)\n\n,(9) as well as the ongoing studies \nFIORE\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07188805&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FIORE&index=6&md5=b7df6b298b2536ff75d70fd99393a8a2)\n\n(10) and \nFIORELLO\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07192952&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FIORELLO&index=7&md5=3bedede4f52fd1f54c7f0470b8a2a709)\n\n.(11)\n\n * The THUNDERBALL CKD program consists of the completed studies \nFIDELIO-DKD\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT02540993&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FIDELIO-DKD&index=8&md5=3f0e306655e57f06afd53fc4fec9fd9e)\n\n,(12) \nFIGARO-DKD\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT02545049&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FIGARO-DKD&index=9&md5=5bb4610e3746169a4e175d5b1e64096e)\n\n,(13) \nFINE-ONE\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05901831&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FINE-ONE&index=10&md5=6f371c3e11ac67cc13d669a622cf953c)\n\n(14) and \nFIND-CKD\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05047263&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FIND-CKD&index=11&md5=79665e7ff5bf62ed414289638ec5a45a)\n\n(15) as well as the ongoing investigational pediatric studies, \nFIONA\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05196035&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FIONA&index=12&md5=f1eedbf218bfccb10c3dcf488fe928a8)\n\n(16) and \nFIONA-OLE\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05457283&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=FIONA-OLE&index=13&md5=c400a6788abc2084d37a1ec69faef62e)\n\n.(17)\n\nIMPORTANT SAFETY INFORMATION\n\nCONTRAINDICATIONS:\n\n\n * Hypersensitivity to any component of this product\n\n * Concomitant use with strong CYP3A4 inhibitors\n\n * Patients with adrenal insufficiency\n\nWARNINGS AND PRECAUTIONS:\n\n\n * Hyperkalemia: KERENDIA can cause hyperkalemia. The risk for developing\nhyperkalemia increases with decreasing kidney function and is greater in\npatients with higher baseline potassium levels or other risk factors for\nhyperkalemia.\n\n\n\nMeasure serum potassium and eGFR in all patients before initiation of\ntreatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if\nserum potassium is >5 mEq/L. Measure serum potassium periodically during\ntreatment with KERENDIA and adjust dose accordingly. More frequent monitoring\nmay be necessary for patients at risk for hyperkalemia, including those on\nconcomitant medications that impair potassium excretion or increase serum\npotassium.\n\n * Worsening of Renal Function in Patients with Heart Failure: KERENDIA can cause\nworsening of renal function in patients with heart failure. Rarely, severe\nevents associated with worsening renal function, including events requiring\nhospitalization, have been observed.\n\n\n\nMeasure eGFR in all patients before initiation of treatment or with dose\ntitration of KERENDIA and dose accordingly. Initiation of KERENDIA in patients\nwith heart failure and an eGFR <25 mL/min/1.73 m(2 )is not recommended.\nMeasure eGFR periodically during maintenance treatment with KERENDIA in\npatients with heart failure. Consider delaying up-titration or interrupting\ntreatment with KERENDIA in patients who develop clinically significant\nworsening of renal function.\n\nMOST COMMON ADVERSE REACTIONS:\n\n\n * The adverse reactions reported in ≥1% of patients on KERENDIA and more\nfrequently than placebo were hyperkalemia (14% vs 6.9%), hypotension (4.6% vs\n3%), and hyponatremia (1.3% vs 0.7%). Events related to worsening renal\nfunction were reported more frequently in the KERENDIA group (18%) compared\nwith placebo (12%) in patients with HF LVEF ≥40%.\n\nDRUG INTERACTIONS:\n\n\n * Strong CYP3A4 Inhibitors: Concomitant use of KERENDIA with strong CYP3A4\ninhibitors is contraindicated. Avoid concomitant intake of grapefruit or\ngrapefruit juice.\n\n * Moderate and Weak CYP3A4 Inhibitors: Monitor serum potassium during drug\ninitiation or dosage adjustment of either KERENDIA or the moderate or weak\nCYP3A4 inhibitor, and adjust KERENDIA dosage as appropriate.\n\n * Strong and Moderate CYP3A4 Inducers: Avoid concomitant use of KERENDIA with\nstrong or moderate CYP3A4 inducers.\n\n * Sensitive CYP2C8 Substrates at KERENDIA 40 mg: Monitor patients more\nfrequently for adverse reactions caused by sensitive CYP2C8 substrates if\nKERENDIA 40 mg is coadministered with such substrates, since minimal\nconcentration changes may lead to serious adverse reactions.\n\nUSE IN SPECIFIC POPULATIONS:\n\n\n * Lactation: Avoid breastfeeding during treatment with KERENDIA and for 1 day\nafter treatment.\n\n * Hepatic Impairment: Avoid use of KERENDIA in patients with severe hepatic\nimpairment (Child Pugh C) and consider additional serum potassium monitoring\nwith moderate hepatic impairment (Child Pugh B).\n\nINDICATIONS: \n\nKERENDIA (finerenone) is indicated to:\n\n\n * reduce the risk of sustained estimated glomerular filtration rate (eGFR)\ndecline, end-stage kidney disease, cardiovascular death, non-fatal myocardial\ninfarction, and hospitalization for heart failure in adult patients with\nchronic kidney disease (CKD) associated with Type 2 diabetes (T2D) (10 mg, 20\nmg tablets)\n\n * reduce urinary albumin-to-creatinine ratio (UACR), which is expected to reduce\nthe risk of sustained estimated glomerular filtration rate (eGFR) decline and\nend-stage kidney disease in adults with CKD associated with Type 1 diabetes\n(T1D) (10 mg, 20 mg tablets)\n\n * reduce the risk of cardiovascular death, hospitalization for heart failure,\nand urgent heart failure visits in adult patients with heart failure with left\nventricular ejection fraction (HF LVEF) ≥40% (10 mg, 20 mg, 40 mg tablets)\n\nPlease see the full Prescribing Information for KERENDIA.\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Flabeling.bayerhealthcare.com%2Fhtml%2Fproducts%2Fpi%2FKerendia_PI.pdf&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=Please+see+the+full+Prescribing+Information+for+KERENDIA.&index=14&md5=77a69052b389f2ff7e83b9d185494a1e)\n\nAbout Bayer’s Commitment in Cardiovascular and Kidney Diseases \n\nBayer’s legacy in cardiovascular care spans decades of scientific innovation\nand patient-focused research. As a long-standing leader in cardiology, Bayer\nhas consistently advanced therapies that address the complex interplay between\nthe heart and kidneys—two organs deeply connected in both health and\ndisease. Today, that heritage continues to guide our commitment to developing\ninnovative treatments for patients facing high unmet medical needs. With a\ngrowing portfolio of approved therapies and promising compounds in\ndevelopment, Bayer is shaping the future of cardiovascular care through\nprecision medicine, scientific rigor, and a deep sense of purpose.\n\nAbout Bayer \n\nBayer is a global enterprise with core competencies in the life science fields\nof health care and nutrition. In line with its mission, “Health for all,\nHunger for none,” the company’s products and services are designed to help\npeople and the planet thrive by supporting efforts to master the major\nchallenges presented by a growing and aging global population. Bayer is\ncommitted to driving sustainable development and generating a positive impact\nwith its businesses. At the same time, the Group aims to increase its earning\npower and create value through innovation and growth. The Bayer brand stands\nfor trust, reliability and quality throughout the world. In fiscal 2025, the\nGroup employed around 88,000 people and had sales of 45.6 billion euros.\nR&D expenses amounted to 5.8 billion euros. For more information, go to\nwww.bayer.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.bayer.com&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=www.bayer.com&index=15&md5=1feb9d12344f4ca041e81b75219217bf)\n.\n\nFind more information at https://pharma.bayer.com/ \n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fpharma.bayer.com%2F&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fpharma.bayer.com%2F&index=16&md5=4887f9e6dd1ff01b3e760e7d39a2b01c)\n\nFollow us on LinkedIn: Bayer | Pharmaceuticals: Overview | LinkedIn \n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fshowcase%2Fbayer-pharmaceuticals%2F&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=Bayer+%7C+Pharmaceuticals%3A+Overview+%7C+LinkedIn&index=17&md5=51829a4555f691fea900ace4dff41a3f)\n\nFollow us on Facebook: http://www.facebook.com/bayer \n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.facebook.com%2Fbayer&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=http%3A%2F%2Fwww.facebook.com%2Fbayer&index=18&md5=447cc8bb29b143c8963c7ac32c5b2ddc)\n\nFollow us on X: @BayerUS\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fx.com%2FBayerUS%3Flang%3Den&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=%40BayerUS&index=19&md5=7a1d7ad008db890244ea0dcbc0c45f32)\n\nForward-Looking Statements \n\nThis release may contain forward-looking statements based on current\nassumptions and forecasts made by Bayer management. Various known and unknown\nrisks, uncertainties and other factors could lead to material differences\nbetween the actual future results, financial situation, development or\nperformance of the company and the estimates given here. These factors include\nthose discussed in Bayer’s public reports, which are available on the Bayer\nwebsite at www.bayer.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.bayer.com%2F&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=www.bayer.com&index=20&md5=6f4e6f29c25f5dba1df8f6cc8549a0ab)\n. The company assumes no liability whatsoever to update these forward-looking\nstatements or to conform them to future events or developments.\n       \n (1) KERENDIA (finerenone) [prescribing information]. Whippany, NJ: Bayer \n HealthCare Pharmaceuticals, Inc: September 2026 \n (2) Heerspink HJL, Birkenfeld AL, Cherney DZI, et al; FINE-ONE Investigators. \n Finerenone in type 1 diabetes and chronic kidney disease. N Engl J Med. \n 2026;394(10):947-957. doi:10.1056/NEJMoa2512854. \n (3) Rossing P, Per-Henrik Groop, Singh R, Lawatscheck R, Tuttle KR. Prevalence \n of Chronic Kidney Disease in Type 1 Diabetes Among Adults in the U.S. Diabetes \n Care. Published online June 10, 2024. doi:https://doi.org/10.2337/dc24-0335 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdoi.org%2F10.2337%2Fdc24-0335&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fdoi.org%2F10.2337%2Fdc24-0335&index=21&md5=51508414d1b72478c1dba8499afbf231)                             \n (4) Tuttle KR, Reynolds CL, Kornowske LM, et al. Prevalence and severity of \n chronic kidney disease in a population with type 1 diabetes from a United \n States health system: a real-world cohort study. The Lancet Regional Health - \n Americas. 2025;47:101130. doi:https://doi.org/10.1016/j.lana.2025.101130 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fdoi.org%2F10.1016%2Fj.lana.2025.101130&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fdoi.org%2F10.1016%2Fj.lana.2025.101130&index=22&md5=2f6642fec0d9ca87dafe27179f1c3fba)                             \n (5) Heerspink H, et al. Rationale and design of a randomised phase III \n registration trial investigating finerenone in participants with type 1 \n diabetes and chronic kidney disease: The FINE-ONE trial Diabetes Research and \n Clinical Practice, 2023; 204 \n (6) Study to Evaluate the Efficacy (Effect on Disease) and Safety of \n Finerenone in Participants With Heart Failure and Left Ventricular Ejection \n Fraction (Proportion of Blood Expelled Per Heart Stroke) Greater or Equal to \n 40% (FINEARTS-HF) Clinical trial registration No. NCT04435626. \n https://clinicaltrials.gov/study/NCT04435626 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04435626&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT04435626&index=23&md5=dcc35610feb3608386e8cff176b963ff)                             \n (7) A Study to Determine the Efficacy and Safety of Finerenone on Morbidity \n and Mortality Among Hospitalized Heart Failure Patients (REDEFINE-HF). \n Clinical trial registration No. NCT 06008197. \n https://www.clinicaltrials.gov/study/NCT06008197 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06008197&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06008197&index=24&md5=d1cf7362cfa80ed5977d90e9c70f8886)                             \n .     \n (8) A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in \n Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF) \n (CONFIRMATION). Clinical trial registration No. NCT06024746. \n https://www.clinicaltrials.gov/study/NCT06024746 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06024746&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06024746&index=25&md5=219406a15c570709d3a99e57090dfb7b)                             \n .     \n (9) A Study to Evaluate Finerenone on Clinical Efficacy and Safety in Patients \n with Heart Failure Who are Intolerant or Not Eligible for Treatment with \n Steroidal Mineralocorticoid Receptor Antagonists (FINALITY-HF). Clinical trial \n registration No. NCT06033950. https://www.clinicaltrials.gov/study/NCT06033950 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06033950&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT06033950&index=26&md5=d35f22a495dcc7317a436bffec19f81a)                             \n .     \n (10) A Study to Learn More About How Well Finerenone Works, How Safe it is, \n and How it Moves Into, Through, and Out of the Body Compared to Placebo When \n Taken With Standard Treatment in Children With Heart Failure and Left \n Ventricular Systolic Dysfunction (FIORE). Clinical trial registration No. \n NCT07188805. https://clinicaltrials.gov/study/NCT07188805 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07188805&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07188805&index=27&md5=0d5cc48ff32cd5dd81e2fe6f0e385868)                             \n .     \n (11) A Study to Learn More About How Safe Finerenone is, When it is Taken for \n a Longer Time With Standard Treatment, in Children and Young Adults With Heart \n Failure and Left Ventricular Systolic Dysfunction (FIORELLO). Clinical trial \n registration No. NCT07192952. https://clinicaltrials.gov/study/NCT07192952 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07192952&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07192952&index=28&md5=c440794e9df75a1ccadd3929f312e5e6)                             \n .     \n (12) Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes \n Mellitus and Diabetic Kidney Disease (FIDELIO-DKD) Clinical trial registration \n No. NCT02540993. https://clinicaltrials.gov/study/NCT02540993 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT02540993&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT02540993&index=29&md5=0126ea434bb94a7ce8ce47bca6b32dc1)                             \n .     \n (13) Efficacy and Safety of Finerenone in Subjects With Type 2 Diabetes \n Mellitus and the Clinical Diagnosis of Diabetic Kidney Disease (FIGARO-DKD) \n Clinical trial registration No. NCT02545049 \n https://clinicaltrials.gov/study/NCT02545049 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT02545049&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT02545049&index=30&md5=7ea3c2a9868a6d3c08dfb63793d89e3f)                             \n .     \n (14) A Study to Learn How Well the Study Treatment Finerenone Works and How \n Safe it is in People With Long-term Decrease in the Kidneys’ Ability to Work \n Properly (Chronic Kidney Disease) Together With Type 1 Diabetes (FINE-ONE). \n Clinical trial registration No. NCT05901831. \n https://www.clinicaltrials.gov/study/NCT05901831 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05901831&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05901831&index=31&md5=a014b60cad14c055b597337350620d09)                             \n .     \n (15) A Trial to Learn How Well Finerenone Works and How Safe it is in Adult \n Participants With Non-diabetic Chronic Kidney Disease (FIND-CKD). Clinical \n trial registration No. NCT05047263. \n https://www.clinicaltrials.gov/study/NCT05047263 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05047263&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05047263&index=32&md5=4646f0cbe1a93d6086f864758546c747)                             \n .     \n (16) A Study to Learn More About How Well the Study Treatment Finerenone \n Works, How Safe it is, How it Moves Into, Through and Out of the Body, and the \n Effects it Has on the Body When Taken With an ACE Inhibitor or Angiotensin \n Receptor Blocker in Children with Chronic Kidney Disease and Proteinuria \n (FIONA). Clinical trial registration No. NCT05196035. \n https://www.clinicaltrials.gov/study/NCT05196035 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05196035&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05196035&index=33&md5=fd6363c33451101722a0ed5c80d8e314)                             \n .     \n (17) A Study to Learn More About How Safe the Study Treatment Finerenone is in \n Long-term Use When Taken With an ACE Inhibitor or Angiotensin Receptor Blocker \n Over 18 Months of Use in Children and Young Adults From 1 to 18 Years of Age \n With Chronic Kidney Disease and Proteinuria (FIONA OLE). Clinical trial \n registration No. NCT05457283. https://www.clinicaltrials.gov/study/NCT05457283 \n (https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05457283&esheet=54605879&newsitemid=20260916814212&lan=en-US&anchor=https%3A%2F%2Fwww.clinicaltrials.gov%2Fstudy%2FNCT05457283&index=34&md5=dbb172092c2334455fc0de1f2ecc7678)                             \n .     \n\n\nCOR-KER-US-0224-1 9/26\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260916814212/en/\n(https://www.businesswire.com/news/home/20260916814212/en/)\n\nMedia Contact: \n\nJoshua Mansbach\n\nBayer Media Relations\n\njoshua.mansbach@bayer.com \n(mailto:joshua.mansbach@bayer.com) \n+1.201.626.8929\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-09-17T06:30:00.147804433Z","server_sent_at_ms":1789626600147},"received_at":"2026-09-17T06:30:00.314Z","source_url":"https://www.businesswire.com/news/home/20260916814212/en/"},"analysis":{"id":"134734","press_release_id":"145898","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":["FINE-ONE hyperkalemia rate was 10.1% with KERENDIA vs 3.3% on placebo; label requires serum potassium/eGFR monitoring and strong CYP3A4 inhibitors are contraindicated","New T1D-CKD indication is based on the UACR surrogate endpoint; reduction in sustained eGFR decline and end-stage kidney disease is described as expected, not directly demonstrated in this population"],"eventType":"fda_approval","narrative":"Bayer announced FDA approval of KERENDIA (finerenone) to reduce urinary albumin-to-creatinine ratio in adults with chronic kidney disease associated with type 1 diabetes, the first new treatment for this population in more than 30 years.\n\nThe approval followed Priority Review of the supplemental NDA and was supported by the Phase III FINE-ONE trial in 242 adults, where KERENDIA cut UACR by 22% vs placebo at Month 3 and 28% at Month 6 (p=0.0001), with safety consistent with the established type 2 diabetes data.\n\nThis is KERENDIA's third FDA indication, adding T1D-associated CKD to its 2021 CKD-T2D label and its July 2025 heart failure label, and extends the runway of one of Bayer's key growth franchises in a population where roughly 20-30% of U.S. type 1 diabetes patients also have CKD.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"First new treatment in 30 years for CKD in type 1 diabetes — KERENDIA's third label expands Bayer's cardiovascular-kidney growth franchise."},"keyFigures":{"drugName":"KERENDIA (finerenone)","phaseOfTrial":"Phase 3","customDimensions":{"uacr_lsgmr_month3":"0.78","uacr_lsgmr_month6":"0.72","bayer_fy2025_sales":"45.6 billion euros","fine_one_enrollment":242,"teae_rate_placebo_pct":49.2,"serious_ae_placebo_pct":11.5,"teae_rate_kerendia_pct":47.1,"bayer_fy2025_rd_expense":"5.8 billion euros","serious_ae_kerendia_pct":11.8,"hyperkalemia_placebo_pct":3.3,"primary_endpoint_p_value":0.0001,"us_t1d_patients_with_ckd":"20-30%","hyperkalemia_kerendia_pct":10.1,"kerendia_indication_count":3,"uacr_reduction_vs_placebo_month3":"22%","uacr_reduction_vs_placebo_month6":"28%","hyperkalemia_discontinuation_kerendia_pct":1.7}},"quotedText":"For more than three decades, people with chronic kidney disease and type 1\ndiabetes have had limited options to address the risk of kidney disease progression","namedEntities":{"people":[{"name":"Dr. Janet McGill","role":"Professor of Medicine, Washington University School of Medicine in St. Louis; Co-Chair of the FINE-ONE Executive Committee"},{"name":"Carolina Aldworth, M.D., MSc","role":"Executive Medical Director at Bayer"}],"products":["KERENDIA (finerenone)"],"companies":[{"name":"Bayer","ticker":"BAYGN","relationship":"filer / drug manufacturer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"Washington University School of Medicine in St. Louis","relationship":"academic research institution"},{"name":"New England Journal of Medicine","relationship":"publication venue for FINE-ONE results"}],"dollarAmounts":[{"amount":"45.6 billion euros","context":"Bayer fiscal 2025 group sales"},{"amount":"5.8 billion euros","context":"Bayer fiscal 2025 R&D expenses"}]},"materialImpact":{"score":4,"reasoning":"FDA approved KERENDIA's third indication under Priority Review, backed by positive Phase III FINE-ONE data, extending a key Bayer growth franchise into a population with no new treatment in 30+ years. Commercially meaningful but incremental against Bayer's ~45.6 billion euro diversified revenue base, so 4 rather than the 5 reserved for make-or-break binary FDA events."},"tickerRelevance":{"others":[],"primary":"BAYGN"},"globalImportance":52,"audienceRelevance":42,"eventTypeSecondary":["clinical_trial"],"importanceComponents":{"tickerTier":"mega-cap diversified life-sciences group (Bayer AG, OTC ADR)","eventGravity":"FDA label expansion under Priority Review; third indication for a top growth asset","usRetailAccess":"OTC ADR listing limits direct US retail float","householdBrandBoost":"moderate — Bayer is a global household brand","commercialMateriality":"meaningful for the pharmaceuticals division; incremental vs 45.6 billion euro group sales"}},"event_type":"fda_approval","event_type_secondary":["clinical_trial"],"sentiment":"bullish","material_impact_score":4,"narrative":"Bayer announced FDA approval of KERENDIA (finerenone) to reduce urinary albumin-to-creatinine ratio in adults with chronic kidney disease associated with type 1 diabetes, the first new treatment for this population in more than 30 years.\n\nThe approval followed Priority Review of the supplemental NDA and was supported by the Phase III FINE-ONE trial in 242 adults, where KERENDIA cut UACR by 22% vs placebo at Month 3 and 28% at Month 6 (p=0.0001), with safety consistent with the established type 2 diabetes data.\n\nThis is KERENDIA's third FDA indication, adding T1D-associated CKD to its 2021 CKD-T2D label and its July 2025 heart failure label, and extends the runway of one of Bayer's key growth franchises in a population where roughly 20-30% of U.S. type 1 diabetes patients also have CKD.","key_figures":{"drugName":"KERENDIA (finerenone)","phaseOfTrial":"Phase 3","customDimensions":{"uacr_lsgmr_month3":"0.78","uacr_lsgmr_month6":"0.72","bayer_fy2025_sales":"45.6 billion euros","fine_one_enrollment":242,"teae_rate_placebo_pct":49.2,"serious_ae_placebo_pct":11.5,"teae_rate_kerendia_pct":47.1,"bayer_fy2025_rd_expense":"5.8 billion euros","serious_ae_kerendia_pct":11.8,"hyperkalemia_placebo_pct":3.3,"primary_endpoint_p_value":0.0001,"us_t1d_patients_with_ckd":"20-30%","hyperkalemia_kerendia_pct":10.1,"kerendia_indication_count":3,"uacr_reduction_vs_placebo_month3":"22%","uacr_reduction_vs_placebo_month6":"28%","hyperkalemia_discontinuation_kerendia_pct":1.7}},"named_entities":{"people":[{"name":"Dr. Janet McGill","role":"Professor of Medicine, Washington University School of Medicine in St. Louis; Co-Chair of the FINE-ONE Executive Committee"},{"name":"Carolina Aldworth, M.D., MSc","role":"Executive Medical Director at Bayer"}],"products":["KERENDIA (finerenone)"],"companies":[{"name":"Bayer","ticker":"BAYGN","relationship":"filer / drug manufacturer"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"},{"name":"Washington University School of Medicine in St. Louis","relationship":"academic research institution"},{"name":"New England Journal of Medicine","relationship":"publication venue for FINE-ONE results"}],"dollarAmounts":[{"amount":"45.6 billion euros","context":"Bayer fiscal 2025 group sales"},{"amount":"5.8 billion euros","context":"Bayer fiscal 2025 R&D expenses"}]},"model_name":"glm-5.3-flash","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-09-17T06:31:05.700Z","global_importance":52,"audience_relevance":42,"importance_components":{"tickerTier":"mega-cap diversified life-sciences group (Bayer AG, OTC ADR)","eventGravity":"FDA label expansion under Priority Review; third indication for a top growth asset","usRetailAccess":"OTC ADR listing limits direct US retail float","householdBrandBoost":"moderate — Bayer is a global household brand","commercialMateriality":"meaningful for the pharmaceuticals division; incremental vs 45.6 billion euro group sales"}},"durationMs":65379,"modelName":"glm-5.3-flash"}}