Announcement • May 09
Bayer Announces Positive Topline Results from the Phase III REVEAL Study Bayer announced positive topline results from the Phase III REVEAL study, an investigator-initiated study by Brigham and Women’s Hospital that evaluated the investigational PET/CT radiotracer I 124 evuzamitide. The study met the primary endpoints of sensitivity (the ability of a test to identify individuals who have the condition) and specificity (the ability of a test to identify individuals who do not have the condition) for the diagnosis of cardiac amyloidosis based on visual scan interpretation. I 124 evuzamitide is an investigational PET radiotracer–a radioactive diagnostic imaging agent injected into the body before a PET scan to assist with visualization–being studied in patients with suspected cardiac amyloidosis. I 124 evuzamitide is an investigational compound and has not been approved by any health authority for use in any country for any indication. The compound was previously granted Breakthrough Therapy Designation for PET imaging in patients with suspected or known cardiac amyloidosis as well as Orphan Drug status for both light-chain amyloidosis (AL) and transthyretin amyloidosis (ATTR) in the U.S. and the EU. Bayer plans to discuss the data and submission for regulatory approval with the FDA and other health authorities. Cardiac amyloidosis typically takes between 2-4 years from symptom onset to diagnosis, yet there is no single, non-invasive test for the reliable detection and diagnosis of the disease. I 124 evuzamitide is one of two investigational amyloid radiotracers that Bayer acquired from Attralus Inc. The compound is also known as AT-01. The acquisition, announced in early 2026, expanded Bayer’s radiology pipeline with complementary tracers targeting systemic amyloid disease and reinforced the company’s strategy to build a leading position in imaging for cardiovascular and other serious conditions. Cardiac amyloidosis is a severe, progressive disease caused by the accumulation of misfolded proteins (amyloid) in heart tissue, making it stiff and thick which can impair its ability to pump blood effectively. As the disease is underdiagnosed, current estimates state the condition impacts approximately 400,000 patients worldwide, though the number is likely greater. Without appropriate diagnosis and treatment, cardiac amyloidosis can lead to heart failure, frequent hospitalizations and early mortality. Currently, there is no single, non-invasive test that can reliably detect and diagnose cardiac amyloidosis or quantify and monitor myocardial amyloid burden. Despite increasing disease awareness by health care providers, a prolonged diagnostic journey is common, with patients often consulting several specialists and receiving multiple imaging procedures before an accurate diagnosis. The REVEAL (“Research with EVuzamitide I 124 to Elucidate Cardiac AmyLoidosis”) study is an investigator-initiated Phase III clinical trial of the investigational diagnostic imaging agent I 124 evuzamitide in patients with suspected cardiac amyloidosis with Brigham and Women’s Hospital in Boston, MA, as the study sponsor. The main purpose of the study was to evaluate the efficacy and safety of the investigational radiotracer I 124 evuzamitide for diagnosing cardiac amyloidosis in participants with suspected cardiac amyloidosis compared to clinical standard of care (SoC) diagnosis. Secondary analyses assessed diagnostic performance in ATTR and AL subtypes. The imaging test used in this study was a positron emission tomography computed tomography (PET/CT) scan. REVEAL is a multicenter, open-label, single-arm Phase III study conducted at 19 centers in the United States, evaluating 170 adults with suspected cardiac amyloidosis. Participants received a single intravenous dose of I 124 evuzamitide, followed by cardiac and partial-body PET/CT imaging, 3-5 hours post-injection. All PET/CT images were independently read by experienced cardiac PET physicians, assessing visual presence or absence of cardiac tracer uptake, blinded to clinical data. SoC diagnosis was independently adjudicated by clinical amyloidosis experts, blinded to PET results, using routine diagnostic data collected up to 60 days after imaging. Diagnostic sensitivity and specificity of I 124 evuzamitide were determined using SoC diagnosis as the reference standard. Announcement • May 06
Bayer Aktiengesellschaft (XTRA:BAYN) entered into an agreement to acquire Perfuse Therapeutics, Inc. for $2.5 billion. Bayer Aktiengesellschaft (XTRA:BAYN) entered into an agreement to acquire Perfuse Therapeutics, Inc. for $2.5 billion on May 6, 2026. Under the terms of the agreement, the transaction carries a total potential value of up to $2.45 billion, comprising a $300 million upfront payment and additional development, regulatory, and commercial milestone payments based on success criteria.
The acquisition is subject to and will become effective after receiving the necessary antitrust clearances and Perfuse stockholder approvals.
BofA Securities, Inc. acted as financial advisor and Baker & McKenzie LLP acted as legal advisor for Bayer Aktiengesellschaft. Centerview Partners LLC acted as financial advisor and Goodwin Procter LLP acted as legal advisor for Perfuse Therapeutics, Inc. Announcement • Apr 01
Bayer AG Announces Appointment of Nelson Ambrogio as President of U.S. Pharmaceuticals, Effective May 1, 2026 Bayer announced a leadership change within its Pharmaceuticals’ Worldwide Markets organization to accelerate the strong performance and growth of its key pharmaceutical products in the U.S. Effective May 1, 2026, Nelson Ambrogio, currently President of Bayer’s global Radiology business, will be appointed President of Bayer U.S. Pharmaceuticals. Nelson Ambrogio will guide the U.S. Pharmaceuticals organization into its next chapter of growth and build on the strong momentum and performance of the company’s pharmaceutical business in its largest and fastest-growing market. Nelson Ambrogio will be responsible for commercial pharmaceutical operations in the U.S. during a pivotal time of growth for the business, ensuring the continued strong performance of Bayer’s key growth brands in prostate cancer, cardiovascular care, women’s healthcare and as the company prepares its future portfolio in secondary stroke prevention. Nelson Ambrogio will join the company’s Worldwide Markets Leadership Team, reporting directly to Sebastian Guth, Chief Operating Officer of Bayer’s Pharmaceuticals Division. Sebastian Guth will continue to oversee the growth of all global markets in his role as Chief Operating Officer of Bayer Pharmaceuticals as the company accelerates its momentum. He will retain his role as the President of the Bayer Group in the U.S. and remain based in New Jersey. Announcement • Mar 16
Bayer Announces Kerendia Meets Primary Endpoint In Investigational Phase III Find-Ckd Study In Patients With Non-Diabetic Chronic Kidney Disease Bayer announced that the Phase III study FIND-CKD (NCT05047263) — investigating the efficacy and safety of KERENDIA (finerenone) versus placebo when added to standard of care in adult patients with non-diabetic chronic kidney disease (CKD) — has met its primary endpoint. The results demonstrated a statistically significant improvement versus placebo in the primary efficacy outcome of estimated glomerular filtration rate (eGFR) slope, defined as the mean annual rate of change from baseline to Month 32, a validated surrogate endpoint for kidney disease progression. The safety profile of KERENDIA in the FIND-CKD study was consistent with its established safety profile. The FIND-CKD clinical trial data will be presented at an upcoming scientific conference. Bayer anticipates submitting the data to the U.S. Food and Drug Administration (FDA) to extend the indication of KERENDIA to non-diabetic CKD patients. Since 2021, KERENDIA has been approved to reduce the risk of cardiovascular death, hospitalization for heart failure (HF), non-fatal myocardial infarction, sustained eGFR decline, and end-stage kidney disease in adult patients with CKD associated with type 2 diabetes (T2D). In July 2025, KERENDIA also received FDA approval for the treatment of heart failure with left ventricular ejection fraction (HF LVEF) =40%. FIND-CKD is the fifth consecutive Phase III clinical trial where KERENDIA met its primary endpoint, adding to a clinical trial program of more than 20,000 patients across multiple patient populations with heart and kidney diseases. FIND-CKD is the largest Phase III study to date focused on non-diabetic chronic kidney disease (CKD) and now expands KERENDIA’s clinical data in CKD to both diabetic and non-diabetic patients. KERENDIA is currently approved by the FDA for use in adults with CKD associated with type 2 diabetes (T2D) and heart failure with left ventricular ejection fraction (HF LVEF) =40%. The Phase III FIND-CKD study investigated finerenone compared to placebo in addition to standard of care in more than 1,500 patients with non-diabetic CKD etiologies, of which etiologies included hypertension and chronic glomerulonephritis (inflammation of the kidneys’ blood filters). Patients were randomized to receive either finerenone 10mg or 20mg, based on serum potassium levels and eGFR, or placebo on top of individually tolerated maximum labeled doses of a renin-angiotensin system (RAS)-blocking therapy such as an angiotensin-converting enzyme (ACE) inhibitor or an angiotensin II receptor blocker (ARB). The primary endpoint was the mean annual rate of change in eGFR from baseline to 32 months. The safety endpoints were the occurrence of treatment-emergent adverse events (AEs), treatment-emergent serious AEs, and hyperkalemia AEs. KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) that selectively and potently blocks mineralocorticoid receptor overactivation in the heart and kidneys. FIND-CKD is the largest Phase III study to date focused on non-diabetic CKD and investigated KERENDIA in a population spanning different etiologies of non-diabetic CKD. KERENDIA (finerenone) is indicated to reduce the risk of: sustained estimated glomerular filtration rate (eGFR) decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D) (10mg, 20mg tablets); cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adult patients with heart failure with left ventricular ejection fraction (HF LVEF) =40% (10mg, 20mg, 40mg tablets). KERENDIA can cause hyperkalemia. The risk for developing hyperkalemia increases with decreasing kidney function and is greater in patients with higher baseline potassium levels or other risk factors for hyperkalemia. Measure serum potassium and eGFR in all patients before initiation of treatment with KERENDIA and dose accordingly. Do not initiate KERENDIA if serum potassium is >5 mEq/L. Measure serum potassium periodically during treatment with KERENDIA and adjust dose accordingly. More frequent monitoring may be necessary for patients at risk for hyperkalemia, including those on concomitant medications that impair potassium excretion or increase serum potassium. KERENDIA can cause worsening of renal function in patients with heart failure. Rarely, severe events associated with worsening renal function, including events requiring hospitalization, have been observed. Measure eGFR in all patients before initiation of treatment or with dose titration of KERENDIA and dose accordingly. Announcement • Mar 12
Bayer Aktiengesellschaft to Report Q4, 2026 Results on Feb 24, 2027 Bayer Aktiengesellschaft announced that they will report Q4, 2026 results on Feb 24, 2027 Announcement • Mar 09
Bayer Aktiengesellschaft to Report Q3, 2026 Results on Nov 03, 2026 Bayer Aktiengesellschaft announced that they will report Q3, 2026 results on Nov 03, 2026 Announcement • Mar 06
Missouri Court Grants Preliminary Approval of Roundup Class Settlement to Resolve Current and Future Claims A judge in the Circuit Court of the City of St. Louis, Missouri granted preliminary approval of a class action settlement to resolve current and potential future Roundup claims alleging non-Hodgkin lymphoma (NHL) injuries. The motion was filed by leading plaintiff law firms representing the class. Following preliminary approval, the next step in the legal process involves notice to potential class members and a 90-day period, ending on June 4, during which members of the class can opt out or file objections. Once this next phase is complete, the court will hold a fairness hearing on July 9 and decide whether to grant final approval of the settlement, which will be subject to potential appeals. All lawsuits in Missouri brought by class settlement members are stayed, except for opt outs, until the Court reaches a final judgement on the class settlement. The class settlement follows a decision by the U.S. Supreme Court to grant review of the Durnell case. The expectation of Supreme Court review of the cross-cutting question in this litigation – whether state claims based on failure-to-warn theories are preempted by federal law – helped make this settlement possible. The Supreme Court case is unaffected by the settlement and is critical to resolving substantial outstanding damage awards subject to pending appeals, which are not covered by the settlement. The Supreme Court case is also critical to resolving the regulatory uncertainty which jeopardizes the availability of current and future agricultural innovations, with potentially severe consequences for farmers and the American food system. Announcement • Feb 28
Bayer Reports Results for the Investigational Targeted Radionuclide Therapy 225Ac-PSMA-Trillium in Advanced Metastatic Prostate Cancer Bayer announced results from the ongoing global Phase I first-in-human, dose-escalation PAnTHa study (NCT06217822) evaluating the safety, tolerability and preliminary efficacy of 225Ac-PSMA-Trillium (BAY 3563254), a next-generation targeted alpha therapy (TAT) in patients with advanced metastatic castration-resistant prostate cancer (mCRPC). The dose for expansion was successfully identified, with 80% of patients achieving a PSA50 response at the expansion dose. New data were presented during the 2026 American Society of Clinical Oncology Genitourinary Cancers Symposium, taking place in San Francisco, CA, United States, from February 26-28, 2026. These clinical data represent the first disclosure for 225Ac-PSMA-trillium and were selected as part of the rapid oral session focused on advanced prostate cancer research. They support advancing 225Ac-PSMA- Trillium to the next phase of clinical development. TAT is a strategic pillar of precision oncology at Bayer, with the potential to accelerate novel treatment options for patients with mCRPC. 225Ac-PSMA- trillium (BAY 35 63254) is a next-generation investigational TAT labeled with actinium-225 and comprising a novel PSMA (prostate-specific membrane antigen)-targeting small molecule with a customized albumin-binding moiety. The compound is designed specifically to increase uptake within the tumor, with the goal to provide a differentiated safety and efficacy profile. Prostate cancer is the second most commonly diagnosed cancer in men with less than three years median survival among metastatic patients, who have developed castration-resistance. There is an increasing unmet need to improve the outcomes of men with mCRPC. Announcement • Feb 26
Bayer Announces XOFIGO (Radium-223 Dichloride) Plus Enzalutamide Demonstrates Significant Overall Survival Benefit In PEACE-3 Trial In Patients With Metastatic Castration-Resistant Prostate Cancer With Bone Metastases Bayer announced that final results from the pivotal investigational Phase III PEACE-3 trial demonstrate that first-line treatment with XOFIGO® (radium-223 dichloride) in combination with enzalutamide, an androgen receptor pathway inhibitor (ARPI), resulted in a significant overall survival (OS) benefit, reducing the risk of death by 24% versus enzalutamide alone (hazard ratio [HR] 0.76; 95% confidence interval [CI] 0.60-0.96; p=0.0096) in men with metastatic castration-resistant prostate cancer (mCRPC) and bone metastases. These data will be presented by the European Organization for Research and Treatment of Cancer (EORTC) coalition in an oral session at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) 2026 (Oral abstract #15; February 26, 2026. 8:15 – 8:25 AM PST) and published simultaneously in Annals of Oncology. Updated results for radiological progression-free survival (rPFS), the primary endpoint of the trial, will also be shared. XOFIGO is indicated for the treatment of patients with castration-resistant prostate cancer, symptomatic bone metastases and no known visceral metastatic disease. XOFIGO is not approved in this investigational indication in combination with enzalutamide. The PEACE-3 trial is an international, randomized, open-label, Phase III trial designed to investigate the efficacy and safety of XOFIGO in combination with enzalutamide in patients with mCRPC and bone metastases. The primary endpoint was rPFS by investigator assessment, with key secondary endpoints including OS, time to subsequent systemic treatment, pain progression, and symptomatic skeletal events. At the time of the final OS analysis, men receiving XOFIGO plus enzalutamide demonstrated a statistically significant improvement in the key secondary endpoint of OS compared to those receiving enzalutamide alone, with a 24% reduction in risk of death (HR 0.76; 95% CI 0.60-0.96; p=0.0096). Median OS was 38.2 months with XOFIGO plus enzalutamide versus 32.6 months with enzalutamide alone. The final OS results build on the primary analysis, published in Annals of Oncology, which showed a significant improvement in the primary endpoint of radiological progression-free survival (rPFS) with the combination versus enzalutamide alone (19.4 vs. 16.4 months respectively; HR 0.69; 95% CI 0.54–0.87; p=0.0009). Grade 3 or higher treatment emergent adverse events (TEAE) were recorded in 69% of patients in the combination arm versus 58% of patients treated with enzalutamide alone. No individual TEAE Grade 3 or higher has increased by more than 5% in the combination arm compared to the enzalutamide arm alone. Announcement • Feb 18
Monsanto Announces Roundup™ Class Settlement Agreement to Resolve Current and Future Claims Monsanto announced a proposed U.S. nationwide class settlement designed to resolve current and future Roundup™ claims alleging Non-Hodgkin lymphoma (NHL) injuries through a long-term claims program. Leading plaintiff law firms representing the class filed a motion seeking preliminary approval of the settlement in the Circuit Court of the City of St. Louis, Missouri. The proposed class combined with Supreme Court review in the Durnell case are independently necessary and mutually reinforcing steps in the company's multipronged strategy designed to significantly contain the Roundup™ litigation. To fund the class, Bayer will make declining capped annual payments for up to 21 years totaling up to 7.25 billion U.S. dollars, following court approval. The long-term payment stream will provide the company with both greater certainty and control regarding its litigation costs for current claims and potential future claims. Separately, Bayer also has reached agreements to settle certain other Roundup™ (glyph GMOs) cases on confidential terms. Additionally, earlier this year Monsanto settled eight remaining PCB verdicts related to the Sky Valley Education Center (SVEC) in the state of Washington on confidential terms. Bayer also previously resolved PCB environmental cases with the U.S. states of Illinois and West Virginia. In total, and subject to a final audit, these resolutions including litigation costs will lead to an increase of the provision and liabilities for litigation from 7.8 billion euros (including 6.5 billion euros for glyphosate) as of September 30, 2025, to 11.8 billion euros (including 9.6 billion euros for glyphosate). Based on a first estimate of all litigation related payouts of approximately 5 billion euros in 2026, Bayer expects a negative free cash flow for this year. To reflect the settlement agreements in the financial statements, Bayer is shifting its announcement of 2025 year-end financial results and 2026 guidance to March 4. The immediate financing of these resolutions, as well as certain bond maturities, are secured by a bank loan facility of 8 billion U.S. dollars. Ultimate financing is planned to utilize senior bonds and instruments receiving equity-credit by rating agencies and not an authorized capital increase. Bayer is taking the Roundup™-related actions solely to contain the litigation, and the settlement agreements do not contain any admission of liability or wrongdoing. Indeed, leading regulators worldwide, including the U.S. EPA and EU regulatory bodies, continue to conclude based on an extensive body of science, that glyphosate-based herbicides - critical tools that farmers rely on to produce affordable food and feed the world - can be used safely and are not carcinogenic. In addition to these settlements, the company will continue to pursue other elements of its multi-pronged strategy including supporting legislation at the state and federal level, regulatory actions and other measures that are intended to help achieve regulatory clarity and contain litigation risk. Regulatory uncertainty jeopardizes the availability of current and future agricultural innovations, with potentially severe consequences for farmers and the American food system. Supreme Court case and settlements are independently necessary and mutually reinforcing strategies The Roundup™ settlements follow a decision by the U.S. Supreme Court to grant review of the Durnell case. The expects to expect to increase the next year. Announcement • Feb 06
Bayer's Asundexian Demonstrated A Substantial 26% Reduction in Stroke After a Non-Cardioembolic Ischemic Stroke or High-Risk Transient Ischemic Attack, With No Increase in ISTH Major Bleeding Versus Placebo Bayer presented the results from the global, pivotal Phase III OCEANIC-STROKE study evaluating the use of its investigational, once-daily, oral, Factor XIa inhibitor asundexian (50mg) compared to placebo, both in combination with antiplatelet therapy. Asundexian significantly reduced ischemic stroke by 26% (csHR 0.74; 95% CI 0.65–0.84; pOCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor which demonstrated superiority in reducing recurrent ischemic stroke compared to placebo. Alongside the primary findings, secondary endpoints showed asundexian reduced the risk of a stroke of any kind (ischemic and hemorrhagic) by 26% (6.6% vs. 8.8%; csHR 0.74; 95% CI, 0.65 to 0.84; pFor the safety analyses, there was no increase in the rate of ISTH major bleeding between asundexian compared to placebo (1.9% vs. 1.7%; HR 1.10; 95% CI, 0.85–1.44). For the pre-specified secondary safety endpoints, the risk of bleeding was similar compared to the rates seen in the placebo arm. OCEANIC-STROKE enrolled all common stroke subtypes in its design, classified by the TOAST (Trial of Org 10172 in Acute Stroke Treatment) criteria. Among patients with an index ischemic stroke, the study enrolled patients with large-artery atherosclerosis (43%), small-vessel occlusion (lacune) (23%), stroke of undetermined etiology (30%), other determined etiology (3%), and cardioembolic stroke (2%). Across all TOAST subtypes evaluated, rates of recurrent ischemic stroke were lower with asundexian compared with placebo. Asundexian has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for stroke prevention in patients after a non-cardioembolic ischemic stroke. Asundexian is an investigational compound and has not been approved by any health authority for use in any country for any indication. The OCEANIC-STROKE study investigated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once-daily compared to placebo, for prevention of ischemic stroke in patients after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA) in combination with antiplatelet therapy. It is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that randomized 12,327 participants worldwide. The primary endpoint was time to ischemic stroke; the primary safety endpoint was major bleeding. Announcement • Jan 27
Bayer to Present Results from Phase III Oceanic-Stroke Study of Asundexian in Secondary Stroke Prevention Bayer announced that the main results from its global, landmark Phase III study OCEANIC-STROKE of asundexian in secondary stroke prevention, will be presented during two late-breaking sessions at the upcoming American Stroke Association's International Stroke Conference (ISC) 2026. The conference will be held February 4-6 in New Orleans, Louisiana, USA. The research to be presented demonstrates the longstanding commitment of Bayer as a leader in cardiovascular and cerebrovascular medicine, advancing innovation in thrombosis prevention. In November 2025, Bayer announced the OCEANic-STROKE study met its primary efficacy and safety endpoints. OCEANIC-ST ROKE is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that enrolled over 12,300 patients. Bayer late-breaking presentations on the Phase III study OCEAN IC-STROKE at ISC 2026 include: Late Breaker:Factor XIa Inhibition with Asundexian in Acute Non-Cardioembolic Stroke or High-Risk Transient Ischemic Attack: Primary Results of the OCEANIC-STroKE Trial; Presenter: Mike Sharma, MD, McMaster University, Population Health Research Institute (PHRI). ISC invited symposium; Thursday, February 5, 2026; 11:15 a.m. - 11:27 a.m. CST; Main Event Late Breaking Science Trials, Hall D. Asundexian is an investigational agent and has not been approved by any health authority for use in any country for any indication. Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. FXIa has a minor role in the formation of a hemostatic plug that seals the leak at the site of vessel injury. However, FXIa is thought to contribute to the formation of pathological thrombus growth and vessel blockage. About Bayer's Commitment in Cardiovascular and Cerebrovascular Medicines: Bayer is a leader in cardiology and is dedicated to further developing treatment options in cardiovascular (CV) diseases. We have set a clear focus on developing therapies to treat cardiovascular and cerebrovascular diseases (e.g., stroke, heart failure, cardiomyopathies, and chronic kidney disease) and it is ambition to take a leading role in the care of patients with these diseases. Our strategy is to unlock the strong potential of the future CV market by transforming Bayer's portfolio into precision cardiology, addressing the high CV disease burden, and driving the long-term growth. Bayer's portfolio already includes several products and compounds in various stages of preclinical and clinical development. Announcement • Jan 08
Askbio Inc. Announces Fda Acceptance of Investigational New Drug (Ind) Application for Ab-1009 Gene Therapy for Treatment of Late-Onset Pompe Disease AskBio Inc. announced that the United States Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application for AB-1009, an adeno-associated virus (AAV) gene therapy being developed for the treatment of late-onset Pompe disease (LOPD). With this announcement, the AB-1009 program advances to Phase 1/Phase 2, and AskBio has initiated a clinical trial in the United States to explore the safety of AB-1009. The company anticipates recruiting its first patient in early 2026. In addition to the initiation of the AB-1009 PROGRESS-GT LOPD (NCT07282847) clinical trial program, the therapy was recently granted FDA Fast Track and Orphan Drug designations. The FDA Fast Track process is designed to facilitate the development and expedite the review of new therapeutics that are intended to treat serious conditions and fill unmet medical needs. The purpose of the process is to get important new therapeutics to patients earlier. Therapeutics that receive this designation benefit from eligibility for more frequent meetings with the FDA to discuss the clinical development plan and, if relevant criteria are met, eligibility for Accelerated Approval and Priority Review. AskBio's clinical trial of ACTUS-101 (NCT03533673) in participants with LOPD will remain active but no longer recruit. Announcement • Nov 24
Bayer Announces Positive Topline Results from the Global Phase III Study Oceanic-Stroke, with Its Investigational, Once Daily, Oral FXIa Inhibitor asundexian Bayer announced positive topline results from the global Phase III study OCEANIC-STROKE, with its investigational, once daily, oral FXIa inhibitor asundexian. The study met its primary efficacy and safety endpoints. Asundexian 50 mg once daily significantly reduced the risk of ischemic stroke compared to placebo, both in combination with antiplatelet therapy, in patients after a non-cardioembolic ishemic stroke or high-risk ischemic attack. There was no increase in the risk of ISTH major bleeding in patients treated with asundexian compared to placebo, both in collaboration with antiplatelet therapy. Detailed results of OCEANIC-ST ROKE will be presented at an upcoming scientific congress. Each year, approximately 12 million people worldwide will experience a stroke. Of these, 20-30% will be a recurrent stroke. Despite available secondary stroke prevention options, the risk of secondary stroke remains high. One in five stroke survivors will have another stroke within five years. Stroke is the second leading cause of death globally, and recurrent ischemic strokes tend to be more disabling and carry a higher mortality risk than the first stroke. Asundexian has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) as a potential treatment for stroke prevention in patients after a non- cardioembolic ischemic stroke. Asundexian is an investigational compound and has not been approved by any health authority for use in any country for any indication. The OCEANIC-STroKE study investigated the efficacy and safety of the oral Factor XIa inhibitor asundexian 50 mg once day compared to placebo, for prevention of ischemic stroke in patients after a non- Cardioembolic ischemic attack (TIA) in combination with antiplatelet Therapy. It is a multicenter, international, randomized, placebo-controlled, double-blind, parallel group and event-driven study, that has enrolled over 12,300 patients. The main study results will be presented at an upcoming Scientific congress. Factor XIa (FXIa) is a protein in the blood coagulation pathway with different roles in hemostasis and thrombosis. FXIa has a minor role in the formation of a hemostatic plug that seals the leak of a hemostatic plug. Announcement • Nov 21
U.S. FDA Approves HYRNUO®? (sevabertinib) for Previously Treated Patients with HER2-Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer Bayer announced that the U.S. Food and Drug Administration (FDA) has approved HYRNUO (sevabertinib), an oral, reversible, tyrosine kinase inhibitor (TKI), for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Regulatory approval for HYRNUO is based on results from the ongoing Phase I/II SOHO-01 trial. In 2024, the U.S. FDA granted HYRNUO Breakthrough Therapy designation for the treatment of adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 (ERBB2) mutations, and who have received a prior systemic therapy. HYRNUO is derived from Bayer’s strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA. HYRNUO is indicated for the treatment of adult patients with locally advanced or metastatic non-squamous non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations, as detected by an FDA-approved test, and who have received a prior systemic therapy. This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Announcement • Nov 14
Bayer Aktiengesellschaft to Report Q2, 2026 Results on Aug 04, 2026 Bayer Aktiengesellschaft announced that they will report Q2, 2026 results on Aug 04, 2026 Announcement • Nov 06
Bayer Announces New Phase III Investigational Data from the Pivotal Fine-One Trial Bayer announced new Phase III investigational data from the pivotal FINE-ONE trial showing that KERENDIA®? (finerenone) significantly reduced urine albumin-to-creatinine ratio (UACR) from baseline over six months by 25% compared to placebo in patients with type 1 diabetes (T1D) and chronic kidney disease (CKD) who were receiving standard of care (95% CI=0.75 [0.65; 0.87; p=0.0001). These late-breaking data were presented at the opening plenary session of the American Society of Nephrology (ASN) Kidney Week 2025 in Houston by Dr. Hiddo Lambers Heerspink, Professor of Clinical Trials and Personalized Medicine at the University Medical Center Groningen, Netherlands, and Chair of the study's Steering Committee. In July 2025, KERENDIA also received U.S. Food and Drug Administration (FDA) approval for the treatment of heart failure with left ventricular ejection fraction (HF LVEF) of 40%. FINE-ONE (FINErenone efficacy and safety in chronic kidney disease and type ONE diabetes; NCT05901831) is a pivotal, global, randomized, prospective, double-blind, multicenter, Phase III study in people with T1D and CKD. Bayer plans to submit a supplemental New Drug Application (sNDA) to the U.S. FDA based on the results of FInerenone anD EmpaglifloziN in participants with chronic kidney disease and type 2 diabetes using a UACR Endpoint; NCT05254004002) trial in patients with T2D and CKD, which investigated simultaneous administration of finerenone and a sodium-glucose transport protein 2 inhibitor (SGLT2i),2 will be presented as two late-breaking analyses. KERENDIA's clinical trial program--called FINEOVATE--currently comprises 10 Phase III studies with dedicated programs in HF (MOONRAker) and CKD (THUNDERBALL). The MOONRAker program includes FINEARTS-HF as well as the ongoing, collaborative, investigator-sponsored studies REDEFINE-HF,CONFIRMATION-HF and finalITY-HF. The THUNDERBALL CKD program consists of the completed studies FIDELIO-DKD, FIGARO-DKD, and FINE-ONE as well as the ongoing investigational studies FIND-CKD, and FIONA-OLE. Announcement • Oct 25
Bayer Announces U.S. Food and Drug Administration Approval for Moderate to Severe Hot Flashes Due to Menopause Bayer announced the U.S. Food and Drug Administration (FDA) has approved Lynkuet®? (elinzanetant) 60mg capsules, the first and only dual neurokinin (NK) targeted therapy, neurokinin 1 (NK1) and neurokinin 3 (NK3) receptor antagonist, for the treatment of moderate to severe hot flashes due to menopause. Inhibition of Substance P and Neurokinin B through antagonism of NK1 and NK3 receptor signaling on kisspeptin/neurokinin B/dynorphin (KNDy) neurons can modulate neuronal activity in the therapy associated with hot flashes. Lynkuet soft gel capsules are taken once daily at bedtime, with or without food. The FDA approval is supported by data from three Phase III clinical trials (OASIS 1, OASIS 2 and OASIS 3) that evaluated the safety and efficacy of Lynkuet for the treatment of moderate tosevere hot flashes due to menopase. The efficacy of Lynkuet for The treatment of moderate to severe hot flash due to menopause was demonstrated in the first 12 weeks of two randomized, double-blind, placebo-controlled, multicenter clinical trials, OASIS 1 and OASIS 2, in 796 menopausal women. The co-primary efficacy endpoints in both trials were the mean change in frequency and severity of moderate to severe hot flashes from baseline to weeks 4 and 12, including day and night hot flashes. The safety of Lynkuet was evaluated in three randomized, double- blind, placebo-controlled, multic enter clinical trials (OASIS 2 andOASIS 3) in 1,420 women. In OASIS 3, 627 women received Lynkuet or placebo for up to 52 weeks to evaluate long-term safety. It's important to know that women who are pregnant should not take Lynkuet. Lynkuet can cause serious side effects, including central nervous system effects and daytime impairment, increased liver blood test values, risk of pregnancy loss, and risk of seizures in people with a history of seizures. The common side effects of LYNKUET include headache, fatigue, dizziness, feeling drowsy or sleepy, stomach (abdominal) pain, rash, diarrhea, and muscle spasms. Announcement • Oct 10
Hesperos and Bayer Consumer Health Develop First Human-On-A-Chip Model of Stress-Induced Cognitive Dysfunction Hesperos, Inc. announced the publication of a new peer-reviewed study, developed in collaboration with Bayer Consumer Health. The study introduces the first human-relevant microphysiological system (MPS) capable of modeling central nervous system (CNS) stress responses and evaluating potential therapeutic compounds. Stress has been implicated in a wide range of neurological conditions, including memory loss, impaired learning, and increased risk for neurodegenerative disorders such as Alzheimer's disease and other forms of dementia. cortisol, the body's primary stress hormone, has long been linked to cognitive decline in both a time- and concentration-dependent manner, but until now researchers have lacked functional in vitro models to study its effects on neural networks and identify potential therapeutic strategies. The research team developed a functional non-animal model of stress-induced synaptic dysfunction using human induced pluripotent stem cell (iPSC)-derived cortical neurons cultured on microelectrode arrays. By measuring long-term potentiation (LTP), a key correlate of learning and memory, the model successfully reproduced the concentration- and time-dependent effects of cortisol on neural networks. Key findings from the study include: Recapitulation of stress effects: Chronic exposure to cortisol disrupted neuronal network activity and impaired LTP, mimicking stress-related cognitive decline observed in humans. Therapeutic rescue: Echinacea extract and its active ingredient, dodeca-2E,4E,8Z,10Z-tetraenoic acid N-isobutyl amide, were shown to significantly alleviate stress-induced deficits in LTP. Alternative to animal testing: The system highlights the potential of microphysiological platforms to replace traditional animal models in preclinical stress and neurodegenerative disease research. The study adds to a growing body of evidence supporting organ-on-a-Chip systems as a powerful, biologically relevant platform for evaluating CNS disorders and therapeutic interventions. In addition to modeling stress, the technology has been applied to Alzheimer's, Parkinson's, and other neurological conditions. Announcement • Sep 22
Bayer First Company to Advance Cell Therapy as Well as Gene Therapy Against Parkinson's Disease Bayer announced progress for two potential therapies against Parkinson's disease (PD). A first participant received randomized treatment in the pivotal Phase III clinical trial, exPDite-2, of Bemdaneprocel, an investigational cell therapy for PD. At the same time, first European participants have been randomized in REGENERATE-PD, a Phase II clinical trial of AB-1005, an investigational gene therapy. Both therapies are focused on treating moderate-stage PD and are being developed in collaboration with Bayer's wholly owned, independently operated subsidiary companies, BlueRock Therapeutics LP (bemdaneprocel) and AskBio Inc. (AB-1005) respectively. Bemdaneprocel and AB-1005 are investigational therapies which have not been approved by any regulatory authority, and their efficacy and safety have not been established or fully evaluated. When transplanted, they have the potential to re-form neural networks that have been severely affected by Parkinson's disease and to potentially restore motor and non-motor function to patients. In 2021 bemdaneprocel received Fast Track Designation and in 2024 a Regenerative Medicine Advanced Therapy (RMAT) designation from the FDA. Data from the Phase I trial's 12 participants presented at the 2024 International Congress of Parkinson's Disease and Movement Disorders (MDS) demonstrated good tolerability, with no serious adverse events related to drug product at 24 months post-surgery. Bemdaneprocell has not been approved for treatment of any disease or medical condition by any health authority.exPDite-2 is the first Phase III pivotal clinical trial for an investigational allogeneic pluripotent stem cell derived therapy to treat Parkinson's disease. In a Phase I study with 12 participants, bemdaneprocel was well tolerated, with no serious adverse eventsrelated to drug product at 24 months pre-surgery. Bem Daneprocel has not been approved for treatment the disease or medical condition by anyhealth authority.exPDite- 2 is the first Phase III pivotal trial for an investigational allogenic pluripotent stem cellderived therapy to treat Parkinson's disease; In a Phase I study with12 participants, bemdanepROcel was well tolerated, with No serious adverse events related to drug products at 24 months post-sur surgery. Bemdanepropar has not been approved for treatment to treat Parkinson's disease. Announcement • Aug 16
Bayer®? Aspirin Introduces Aspirina to the U.S. Pain Market Bayer's Aspirina, the #1 pain relief option in Mexico, is now available for purchase in the United States, bringing a well-known brand to the Hispanic community. With a deep commitment to Hispanic consumers, Aspirina is poised to provide an accessible and effective solution for pain relief. As the Hispanic population in the U.S. continues to grow, currently representing 19% of the population and projected to reach 28% by 2060, Bayer Aspirin recognizes the importance of connecting with this vibrant community. The Aspirina pain relief option resonates deeply with cultural values and family traditions of those from Mexican and Latin American descent who have been using it as a long-standing pain relief option. Many U.S. consumers of Hispanic origin grew up with Bayer's Aspirina-- their parents and grandparents relied on it, instilling trust and nostalgia for the brand. Due to those deep connections, Aspirina has a 99% awareness rate in Mexico, with 67% of consumers using it regularly. With this inclusion in the U.S. market, the company invite consumers to reconnect with a product that represents reliability, familiarity and their heritage. Bayer invented modern aspirin 125 years ago, and it's the most trusted aspirin brand for pain relief in the U.S. Many pain relie brands have come and gone over the last century, but Bayer®? Aspirin continues to be one of the most trusted pain brands on the market. Aspirina is available at select Walmart and Walgreens, making it easy for families to find the pain relief they know. join the launch of Aspirina in the U.S. and rediscover a brand that feels like home -- a trusted companion in the journey of life. For over 125 years, Bayer®? Aspirina has been a leading aspirin brand in proven pain relief. Aspirina is a powerful pain relie and fever reducer that contains 500 mg of the active ingredient aspirin (NSAID). It provides fast and effective multi-symptom relief of headaches, muscle pain, toothaches, menstrual pain and minor arthritis pain for adults and children over 12, when used as directed. Aspirina is coated to make it easy to shallow and is free of caffeine. nonsteroidal anti-inflammatory drug. Announcement • Jul 29
Bayer Aktiengesellschaft to Report Q3, 2025 Results on Nov 12, 2025 Bayer Aktiengesellschaft announced that they will report Q3, 2025 results on Nov 12, 2025 Announcement • Jul 08
Bayer Ag and BlueRock Therapeutics LP Announces First Patient Receives Investigational Therapy in Phase 1/2a Clinical Trial of OpCT-001 for the Treatment of Primary Photoreceptor Diseases Bayer AG and BlueRock Therapeutics LP announced that the first patient received the investigational therapy in CLARICO, a Phase 1/2a clinical trial of OpCT-001, an investigational induced pluripotent stem cell (iPSC)-derived cell therapy for the treatment of primary photoreceptor diseases. OpCT-001 is the first iPSC-derived investigational cell therapy to be clinically tested for treating primary photoreceptor (PR) diseases, which are a subgroup of inherited retinal disorders that includes retinitis pigmentosa and cone-rod dystrophy. Primary photoreceptor diseases affect the structure and function of the photoreceptor cells in the retina, leading to irreversible vision loss in both children and adults. OpCT-001 aims to restore vision in patients with primary photoreceptor diseases by replacing degenerated cells in the retina with functional cells. Phase 1 will focus on safety and features a dose-escalation design. Phase 2 is designed to gather additional safety data and assess the effect of OpCT-001 on measures of visual function, functional vision, and anatomic measures of engraftment in different clinical subgroups. Phase 1 will include 4 planned dose levels to be administered across 4 cohorts (Cohorts 1 through 4). Dose escalation in Phase 1 will be conducted using a standard 3+3 scheme in which a total of 12 to 24 legally blind participants (~3 to 6 per cohort) will receive OpCT-001. Two of novel investigational cell therapies,emdaneprocel (BRT-DA01) for the treatment of Parkinson's disease and OpCT-001 for the treatment of primary photorceptor diseases are clinical stage programs. Bemdaneprocel has RMAT (Regenerative Medicine Advanced Therapy) and Fast Track designation from the US FDA (Food and Drug Administration) and is being tested in a Phase 3 clinical trial, exPDite-2. OpCT-001 has Fast Track designation from the FDA and is being tested in a phase 1 clinical trial, Clarico. BlueRock was founded in 2016 as a joint venture of Versant Ventures and Leaps by Bayer, the impact investing arm of Bayer AG that invests in paradigm-shifting breakthrough innovation. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the initiation, timing, progress, activities, goals and reporting of results of any preclinical programs and clinical trials and research and development programs, the potential benefits, timing and future operation of the agreements with FUJIFILM Cellular Dynamics and Opsis Therapeutics, the ability to advance therapies into, and successfully initiate, enroll and complete clinical trials, the potential clinical utility of product candidates, the regulatory pathway of, and the timing or likelihood of any regulatory filings and approvals for, any product candidates, and the ability to, and the ability to, and the ability to, to, and extent of, potentially commercial development programs. Announcement • Jul 02
Bayer Announces Executive Changes for North America Bayer announced the appointment of Priyal Patel as Cluster Chief Financial Officer (CFO) for North America, effective July 1, 2025. In her new role, Patel will oversee financial strategy and operations across Bayer’s North American businesses while continuing to serve as Head of Treasury for Bayer North America. She succeeds Guru Ramamurthy, who was recently appointed the new CFO for Bayer’s Crop Science division. With over two decades of experience, Patel brings deep financial expertise and a proven record of leadership. Since joining Bayer in 2008, Patel has held a variety of finance leadership roles, including Finance Business Partner for the Crop Science division, Director of Investor Relations, and most recently, Head of North America Treasury. In this capacity, she led a strategic reorganization of the treasury team and developed innovative strategies to navigate volatile capital markets and support investment and insurance needs across the region. Announcement • Jun 19
Bayer Files for Approval of Gadoquatrane to the US Food and Drug Administration Bayer announced the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for its investigational contrast agent gadoquatrane for contrast-enhanced magnetic resonance imaging of the CNS and other body regions in adults and pediatric patients including term neonates. The submitted dose is 0.04 mmol gadolinium per kilogram body weight. If approved, gadoquatrane would become the lowest dose macrocyclic GBCA available in the U.S., corresponding to a 60% reduction compared to macrocyclic GBCAs dosed at 0.1 mmol Gd/kg body weight. The submission of gadoquatrane to the US FDA is based on positive data from the pivotal Phase III QUANTI studies evaluating the efficacy and safety of gadoquatrane in adult and pediatric patients globally. The first results from the Phase III QUANTI CNS study were presented at the European Congress of Radiology (ECR) in February of this year and further results are planned to be presented at upcoming scientific meetings. Nearly 40 million MRI scans are performed each year in the United States. Bayer recently announced the submission of gadoquatran to the Ministry of Health, Labour, and Welfare (MHLW) in Japan, marking the first application for marketing authorization for the investigational contrast agent. Further regulatory applications to health authorities worldwide are planned for the coming months. The pivotal QUANTI clinical development program investigated gadoquatrane at a dose of 0.04 mmol Gd/kg bodyweight, which represents a 60% lower gadolinium dose compared to macrocyclic contrast agents dosed at 0.1mmol Gd/kg body weight; Submitted dose corresponds to a 60% reduction in gadolinium compared to macrocyclic contrast agent dosed at 0.1 mmol Gd/kg bodyweight. The pivotal QUANTIclinical development program investigated gadoqu at a dose of 0.4 mmol Gd/kg body body weight, which represents a 60% low gadolinium dose compared to microcyclic contrast agents dosed At 0.1 mmol GD/kg body weight. QANTI consisted of two large multinational, randomized, prospective double-blind, crossover Phase III studies - QUANTI CNS (Central Nervous System) and QUANTI OBR (Other Body Regions) - as well as the QUANTI Pediatric study. In total, 808 patients in 15 countries participated in the program. The QUANTI study results show that gadoquatrane met the primary and secondary efficacy endpoints of the studies assessing visualization parameters and lesion detection. Results of QUANTI Pediatric demonstrated that the pharmacokinetic behavior of gadoquatrane In children is similar to that in adults. The observed safety profile in adults as well as pediatric patients from birth to < 18 years of age in the QUANTI studies was generally consistent with previous data on gadoquatrane and other macrocyclic GBCAs. No new safety signals were observed. With an estimated 65 million procedures performed annually worldwide, contrast-enhanced MRI plays a key role in the healthcare continuum. MRI is a non-invasive, radiation-free imaging method that provides detailed images of the body, helping to identify and distinguish potential abnormalities in organs and tissues. This supports physicians in answering critical medical questions related to the detection and monitoring of diseases. Building on a century of expertise, Bayer is committed to innovative products and high-quality services in diagnostic imaging to enhance patient care. Its leading radiology portfolio features contrast agents and devices for precise administration across modalities including computed tomography (CT), X-ray and magnetic resonance imaging (MRI), and positron emission tomography (PET). Bayer's comprehensive offerings also include formatics solutions and a medical imaging platform with digital and artificial intelligence (PET). Bayer's comprehensive solutions and a medical imaging platform With digital and artificial intelligence (PIT). Bayer's comprehensive offerings also includes digital and artificial intelligence (P). Announcement • Jun 05
U.S. FDA Approves Third Indication of Darolutamide for Patients with Advanced Prostate Cancer Orion Corporation announced that the U.S. Food and Drug Administration (FDA) has approved the oral androgen receptor inhibitor (ARi) darolutamide in combination with androgen deprivation therapy (ADT) for use in patients with metastatic castration-sensitive prostate cancer (mHSPC), which is also known as metastatic hormone-sensitive prostate cancer (m HSPC). The approval is based on positive results from the pivotal Phase III ARANOTE trial, which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT (HR 0.54; 95% CI 0.41-0.71; P<0.0001) in patients with mHSPC. With this approval, darolutamide plusADT is indicated in the U.S. for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease. Prostate cancer is the second most common cancer in men and the fifth most common cause of cancer death in men worldwide. In 2022, an estimated 1.5 million men were diagnosed with prostate cancer, and about 397,000 died from the disease worldwide. Prostate cancer diagnoses are projected to increase to 2.9 million by 2040. Darolutamide, under the brand name Nubeqa®?, is already approved in combination with ADT and docetaxel in over 85 markets around the world. It's also approved in combination with ADT for the treatment of patients with non-metastastatic castration-resistant breast cancer (nmCRPC). An approval process in the EU for the treatment of mHSPC in combination with ADT (without docetaxel) is already underway by Bayer. Nubeqa achieved blockbuster status in September 2024, with annual sales reported by Bayer reaching EUR 1.52 billion for the full year of 2024. Darolutamide is developed jointly by Orion and Bayer. About the ARANOTE trial The ARANOTE trial is a randomized, double-blind, placebo-controlled Phase III study designed to assess the efficacy and safety of darolutamide plus adT in patients with mHSP C. 669 patients were randomized 2:1 to receive 600 mg of darolutamide twice daily or matching placebo in addition to ADT. The primary endpoint of this study is rPFS, measured as time from randomization to date of first documented radiological progressive disease or death due to any cause, whichever occurs first. Secondary endpoints include overall survival (time to death from any cause), time to first castration resistant event, time to initiation of subsequent anti-cancer therapy, time to prostate-specific antigen (PSA) progression, PSA undetectable rates, time to pain progression, and safety assessments. Announcement • Jun 03
Elinzanetant Significantly Reduces Frequency of Moderate to Severe Vasomotor Symptoms Associated with Endocrine Therapy for Breast Cancer in Phase III Oasis-4 Study as Per Bayer Elinzanetant announced that the investigational compound elinzanetant showed a statistically significant reduction in the frequency of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) from baseline to weeks 4 and 12, versus placebo, in women taking endocrine therapy for treatment or prevention of hormone receptor (HR+) breast cancer. Elinzanetant has also shown in key secondary endpoints statistically significant improvements in sleep disturbances and menopause-related quality of life from baseline to week 12 versus placebo. Further secondary endpoints showed a reduction in VMS frequency at week 1 and in VMS severity at weeks 4 and 12 versus placebo. The safety profile over 52 weeks observed in the OASIS-4 study is generally consistent with previously conducted studies and published data on elinzanetant in postmenopausal women with VMS. Elinzanetant is the first dual neurokinin targeted therapy, antagonizing NK-1 and NK-3 receptors, in late-stage clinical development globally for the treatment of moderate to severe VMS due to menopause or associated with endocrine therapy for breast cancer, administered orally once daily. This international study represents the fourth Phase III study in the clinical OASIS program and results are being presented at the American Society of Clinical Oncology (ASCO) Annual Meeting and have been simultaneously published in the New England Journal of Medicine (NEJM). Detailed results from the Phase III OASIS-4 study found that the investigational compound el In the Phase III OASIS, currently comprises four Phase III studies: OASIS-1, -2, -3 and -4. OASIS-1 and -2 investigated the efficacy and safety of elinzanetant administered orally once daily in women with moderate to severe VMS associated with menopause over 26 weeks and randomized 396 and 400 postmenopausal women between 40 and 65 years across 184 sites in 15 countries. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Announcement • Apr 30
Bayer Initiates Phase I Study Targeting GPC3 with Actinium-225 Radiopharmaceutical in Patients with Advanced Hepatocellular Carcinoma Bayer announced initiation of a Phase I clinical trial with 225Ac-GPC3 (BAY 3547926), an investigational targeted alpha radiopharmaceutical being developed to treat tumors expressing Glypican-3 (GPC3) in patients with advanced hepatocellular carcinoma (HCC). Oncofetal protein GPC3 is a membrane-associated proteoglycan which is overexpressed in 70-75% of HCC lesions making it an attractive target for targeted radionuclide therapy. The first-in-human, dose escalation study (NCT06764316) will evaluate the safety, tolerability and preliminary efficacy of BAY 3547926 alone, and as a combination therapy in patients with advanced HCC. The launch of the Phase I trial using the 225Ac-GPC3 radionuclide therapy marks an important milestone in commitment to develop new medicines targeting cancer cells with high effect size and precision to improve the lives of people living with cancer. Liver cancer, including hepatocellular carcinoma, is the third leading cause of cancer-related deaths in the world with almost 900,000 new cases annually. It is the most rapidly growing cause of cancer deaths in the US accounting for approximately 2% of new cases and 5% of cancer deaths.4 Despite recent scientific advancements, many doctors are not satisfied with the therapeutic benefits from the currently available treatments. Targeted alpha therapy (TAT) has the potential to address high unmet medical need across various cancer types. Bayer's growing TAT portfolio combines alpha particle-emitting radionuclides with different targeting moieties. 225Ac-GPC3 is the third TAT program in clinical development and the first investigational targeted radionuclide therapy for Bayer in HCC. The newly disclosed targeted alpha conjugate joins 225Ac-Pel gifatamab and 225Ac-PSMA-Trillium, which are currently in Phase I clinical trials in patients with advanced metastatic castration resistant prostate cancer. On April 28, 2025 Bayer introduced 225Ac-GPC3 in an oral presentation during the "New Drugs on the Horizon" session at the AACR (American Association of Cancer Research) Annual Meeting, showcasing preclinical characterization of the asset including the low uptake and fast clearance from normal organs as well as reduction of tumor regression in vivo models. Recognition in this special symposium highlights the company's commitment for precision oncology development portfolio. Kolluri A and Ho M (2019), The Role of Glypican-3 in Regulating Wnt, YAP, and Hedgehog in Liver Cancer. Front. Oncol. Announcement • Apr 29
Bayer Announces Changes to CFO for Crop Science Division, Effective July 1, 2025 Bayer announced that Guru Ramamurthy will become the new Chief Financial Officer (CFO) for Bayer’s Crop Science division. He will succeed Oliver Rittgen who has decided to pursue a career opportunity outside of Bayer after 25 years with the company. In his current role, Guru Ramamurthy is serving as CFO of Bayer US. The change will become effective as of July 1, 2025. With over 20 years of experience at Bayer, Ramamurthy brings extensive financial expertise and a proven track record in driving transformation and business growth. Since joining Bayer in 2001, Ramamurthy has held various finance leadership roles across multiple business segments and geographies. Prior to being appointed as the CFO of Bayer US, he served as CFO of AskBio, Bayer’s wholly owned and independently operated gene therapy company. Previously, he was the Global CFO of Bayer’s Medical Care division and has held country and regional CFO positions across diverse segments. Over the course of his career, he has held key finance roles in Germany, Italy, Japan, and the United States. Guru Ramamurthy will be based in St. Louis, MO. The successor for his current role will be announced at a later date. Oliver Rittgen joined Bayer in 2000 and served in various leadership roles across Finance. Before assuming the position as CFO for the Crop Science division in 2024, he held the CFO role for Bayer’s Consumer Health division. Prior to that, he held several regional CFO and Corporate Finance positions in Germany, Finland, and Thailand. Announcement • Apr 16
Bayer to Unveil Latest NUBEQA®? (Darolutamide) Data and Prostate Cancer Research at American Urological Association (AUA) 2025 Annual Meeting Bayer will present new data for NUBEQA®? (darolutamide) in prostate cancer at the upcoming American Urological Association (AUA) Annual Meeting taking place in Las Vegas from April 26-29, 2025. These data support the potential of NUBEQA as a treatment option across the prostate cancer disease spectrum and in diverse patient populations. NUBEQA is indicated in the U.S. for the treatment of adult patients with metastatic hormone-sensitive prostate cancer (mHSPC) in combination with docetaxel and for the treatment of adult patients With non-metastatic castration-resistant prostate cancer (nmCRPC). The company will present post-hoc analyses of ultra-low prostate-specific antigen (PSA) responses (Ischemic Heart Disease - In a study of patients with nmCRPC (ARAMIS), ischemic heart disease occurred in 3.2% of patients receiving NUBEQA versus 2.5% receiving placebo, including Grade 3-4 events in 1.7% vs. 0.4%, respectively. Ischemic events led to death in 0.3% of patients receiving NubEQA with docetaxel vs. 0.2% receiving placebo with docetaxel. Monitor for signs and symptoms of ischemic heart disease. Optimimize management of cardiovascular risk factors, such as hypertension, diabetes, or dyslipidemia. Discontinue NUBEQA for Grade 3-4 ischemic heart disease. Seizure - In ARAMIS, Grade 1-2 seizure occurred in 0.2% of patients receive NUBEQA vs. 0.2% receive placebo. Seizure occurred 261 and 456 days after initiation of NUBEQA. In ARASENS, seizure occurred in 0.6% of patients receiving NUB EQA with docetaxEL, including one Grade 3 event, vs. 0.2% received placebo with docetaxel; Seizure occurred 38 to 340 days after initiation of NUB EQA. It is unknown whether antiepileptic medications will prevent seizures with NUBEQA. Advise patients of the risk of developing a seizure while receiving NUBEQA and of engaging in any activity where sudden loss of consciousness could cause harm to themselves or others. Consider discontinuation of NUBEQA in patients who develop a seizure during treatment. Embryo-Fetal Toxicity - Safety and efficacy of NUBEQA have not been established in females. NUBEQA can cause fetal harm and loss of pregnancy. Advise males with female partners of reproductive potential to use effective contingency during treatment with NUBEQA and for 1 week after the last dose. Adverse Reactions In ARAMIS, serious adverse reactions occurred in 25% of patients of the risk of developing an seizure while receiving NUBE QA and of engaging in any activities where sudden loss of consciousness could causes harm to themselves or others. consider discontinuation of NUBE QA in patients who develop a seizures during treatment. Embryo - Safety and efficacy of NubEQA have not been establish in females. NUBE QA can cause fetal harm and Loss of pregnancy. Advise males With female partners of reproductive potential to using effective contingency during treatment with NubEQA and for 1 weeks after the last dose. Ad adverse reactions occurred in 25% to 25% of patients with the last dose. In ARAMIS, serious reactions occurred in 25% of the patients with the treatment of patients with metastatic hormone- sensitive prostate cancer. Announcement • Apr 10
Bayer Receives Full FDA Approval For VITRAKVI®? As First-In-Class TRK Inhibitor Bayer announced that the U.S. Food and Drug Administration (FDA) has granted full approval for VITRAKVI® (larotrectinib), a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment. VITRAKVI has demonstrated clinically meaningful and durable responses across a range of NTRK fusion-positive solid tumors. VITRAKVI was first granted accelerated approval by FDA in November 2018. This approval is based on data from three multicenter, open-label, single-arm clinical trials: LOXO-TRK-14001 (NCT02122913), SCOUT (NCT02637687), and NAVIGATE (NCT02576431). This analysis included pediatric and adult patients with unresectable or metastatic solid tumors with an NTRK gene fusion (n=339). All patients were required to have progressed following systemic therapy for their disease, if available, or would have required surgery with significant morbidity for locally advanced disease. The major efficacy outcome measures were overall response rate (ORR) and duration of response (DOR), as determined by a blinded independent review committee (BIRC) according to RECIST v1.1.1.1 Safety was assessed in 444 patients across the three trials. Pooled efficacy results showed an ORR of 60% (95% CI: 55%-65%) with a complete response (CR) rate of 24% and a partial response (PR) rate of 36%.5% of patients with complete response were pathological complete response. INDICATION: VITRAKVI is indicated for the treatment of adult and adult patients with solid tumors that: have a neurotrophic receptor tyrorosine kinase (N TRK) gene fusion without aknown acquired resistance mutation, are metast metastatic or where surgical resections is likely to result in severe mortality, and have no satisfactory alternative treatment or that have progressed following treatment; Select patients for therapy based on an FDA-approved test. Central Nervous System Effects: Central nervous system (CNS) adverse reactions occurred in patients receiving VITRAKVI, including dizziness, cognitive impairment, mood disorders, and sleep disturbances; Skeletal Fractures: Skeletal fractures can occur in patients taking VITRAKVI. Among 444 patients taking VITRAK VI is a first-in-class treatment exclusively designed to inhibit TRK. Announcement • Mar 28
Elliott Reportedly Gauge Investor Interest in Bayer's Consumer Health Business Elliott Management Corporation held talks with private equity groups in recent months to gauge interest in buying Bayer Aktiengesellschaft (XTRA:BAYN)'s consumer health business, as the US hedge fund considered reviving a pressure campaign at the German conglomerate. The activist’s discussions underscore the issues facing Bayer, with the troubled pharmaceuticals-to-agriculture group in the midst of a complicated turnaround plan under its new chief executive Bill Anderson. While the buyout groups approached expressed interest in Bayer’s consumer health business, Bayer was unlikely to carve out the unit imminently, said people familiar with the matter. Elliott did not currently own a stake in Bayer, the people added. One person familiar with Bayer’s thinking said the company was a year into a “massive restructuring”. It is introducing a new management model called “dynamic shared ownership”, which shifts decision making to lower-level employees and is expected to involve removing about half of the company’s managers. “[We] cannot afford to take our eyes off the ball now,” the person added. Markus Manns, a portfolio manager at Union Investment which owns a stake in Bayer, said a carve-out of the consumer health business would be very complex, but could be “value-generating for Bayer shareholders”. It was “incomprehensible that Bayer remains the only major pharmaceutical company still clinging to a conglomerate structure”, he added. Elliott and Bayer declined to comment. Announcement • Mar 25
Bayer Announces Management Changes, Effective April 15, 2025 Bayer announced that Dr. Mike Graham will become the new Head of Research & Development (R&D) for Bayer’s Crop Science division and serve as member of the Leadership Team. He will succeed Dr. Robert Reiter who has decided to retire after 27 years with the company and 34 years in the industry. In his current role, Mike Graham is leading the company’s Plant Breeding organization and has profound expertise in R&D and agriculture. The change will become effective as of April 15, 2025. Robert (Bob) Reiter joined the company in 1998. He helped revolutionize breeding through the use of genotypic selection and led the development of an genotyping platform. Over the years, Bob Reiter has held various senior roles in R&D helping to further shape Bayer’s seed and trait capabilities. After serving as Head of Global Supply Chain, he became Head of R&D for the Crop Science division in 2018. Under his leadership, Bayer successfully advanced upcoming blockbuster products like the new herbicide Icafolin and the Preceon Smart Corn System which has the potential to revolutionize corn production going forward. Bob Reiter will actively support his successor in taking over his new responsibilities to ensure a smooth transition. Mike Graham joined the company in 1996. From his early days as a plant breeder, he has steadily advanced his career, taking on roles with increasing responsibility. Throughout this period, he has been deeply involved in the design and development of next-generation seed, traits and customer-focused solutions. Most recently, Mike Graham has led Bayer’s global Plant Breeding organization, driving the advancement of the breeding pipeline by reimagining breeding and technical methodologies as well as spearheading the digital evolution. He will be based in St. Louis, MO. The successor to Mike Graham as Plant Breeding Lead will be announced at a later point in time. Announcement • Mar 17
Bayer Announces U.S. FDA Accepts Supplemental New Drug Application Under Priority Review for New Indication for KERENDIA®? (Finerenone) in Patients with Heart Failure with Left Ventricular Ejection Fraction of 40% Bayer announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental new drug application (sNDA) and granted Priority Review designation for KERENDIA®? (finerenone) for the treatment of adult patients with heart failure (HF) with a left ventricular ejection fraction (left ventricular ejection fraction [LVEF] of 40%) Approximately 6.7 million adults in the U.S. live with HF, of which about 55% have a LVEF 40%. Despite guideline-directed medical treatment, HF hospitalization and mortality remain high, particularly among those with comorbidities3. The FDA grants Priority Review designation for the evaluation of medicines that, if approved, would provide a significant improvement in the safety or effectiveness of the treatment, prevention, or diagnosis of a serious condition. Approximately 6.7 million adults In the U.S. live With HF, a complex clinical syndrome with symptoms and signs that result from any structural or functional impairment of ventricular filling or ejection of blood. Of these patients, about 55% have a LveF 40%. Most are balancing multiple comorbidities, such as obesity, diabetes, hypertension and chronic kidney disease (CKD). Hyperkalemia was more common with finerenone; it led to hospitalization in 0.5% [16/2,993] in the finerenone group versus 0.2% [6/2,993] in The placebo group, and no cases resulted in death. Finerenone's clinical trial program--called FINEOVATE--currently comprises 10 Phase III studies with dedicated programs in heart failure (HF) (MOONRAker) and chronic kidney disease (C KKD) respectively. The THUNDERBALL CKD program consists of the completed studies FIDELIO-DK and FIGARO-DKD, as well as the ongoing studies FIND-CKD, FIONA-OLE, FINE-ONE, and the Phase II study CONFIDENCE. KERENDIA is a non-steroidal mineralocorticoid receptor antagonist (nsMRA) and was approved by the U.S. U.S. U.C. Announcement • Mar 05
Bayer Introduces Vyconic Soybeans at Commodity Classic 2025 The Crop Science division of Bayer announced the introduction of Vyconic soybeans, a new trait technology that will be the first to feature five herbicide tolerances all in one breakthrough trait. The unveiling took place at Commodity Classic 2025 in Denver, Colorado. Vyconic soybeans will represent a leap forward in weed control, enabling farmers to manage their fields with unparalleled flexibility. Key Highlights of Vyconic Soybeans: Five Herbicide Tolerances in One Trait: Vyconic soybeans'll be the first in the industry to offer tolerance to five herbicides: dicamba, glufosinate, mesotrione, 2,4-D and glyphosate. This complex trait package will provide farmers with unparalleled flexibility to enable excellent weed control programs based on their specific needs and individual preferences. Two Additional Herbicide Tolerance Options: With mesotrione and 2,4-D, Bayer is adding two new herbicide tolerances to its previous generation of soybean traits. Both herbicides are effective against a wide range of broadleaf weeds, including Palmer amaranth and waterhemp. Excellent Yield Potential From Industry-Leading Genetics: Vyconic soy beans will feature the very latest soybean genetics along with various beneficial agronomic traits to deliver outstanding yield potential. Vyconic soybeans will offer several critical benefits for soybean farmers: Unparalleled Weed Control Flexibility: Will enable the use of five herbicides for a more robust integrated weed management program to help address specific field needs and challenges. Multiple Effective Weed Management Options: Broad-spectrum herbicide options will enable a wide range of weeds to be managed, pending EPA approval. Proactive Resistance Management: Enabling the use of multiple herbicides with different modes of action will help reduce the likelihood that weeds will develop resistance. Vyconic soybeans have an anticipated market introduction in the United States and Canada by the 2027 planting season. In the meantime, Bayer will continue to work on the development of proprietary herbicide formulations to optimize its weed management offerings. 
