Bayer : FDA grants sevabertinib Priority Review as a first-line treatment for patients with HER2-mutant non-small cell lung cancer

About this update from Bayer Ag

Back to Newsroom Important notice This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, any securities. There will be no public offer of the securities in any jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. An investment decision regarding the securities referred to herein should only be made on the basis of the securities prospectus. This announcement is an advertisement and does not, under any circumstances, constitute a public offering or an invitation to the public in connection with any offer within the meaning of Regulation (EU) 2017/1129. The final prospectus, when published, will be available on the website of the Luxembourg Stock Exchange ( https://www.luxse.com ). The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. State security laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act or to, or for the benefit of, U.S. persons. The tender offer referenced herein is not being made, directly or indirectly, in or into the United States by use of the mails or by any means or instrumentality (including, without limitation, e-mail, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or of any facility of a national securities exchange of the United States and the tender offer cannot be accepted by any such use, means, instrumentality or facility or from within the United States. Viewing the materials you seek to access may not be lawful in certain jurisdictions. In other jurisdictions, only certain categories of person may be allowed to view such materials. Any person who wishes to view these materials must first satisfy themselves that they are not subject to any local requirements that prohibit or restrict them from doing so. If you are not permitted to view materials on this webpage or are in any doubt as to whether you are permitted to view these materials, please exit this webpage. Basis of access Access to electronic versions of these materials is being made available on this webpage by Bayer in good faith and for information purposes only. Making press announcements and other documents available in electronic format on this webpage does not constitute an offer to sell or the solicitation of an offer to buy securities issued by Bayer. Further, it does not constitute a recommendation by Bayer, or any other party to buy or sell securities issued by Bayer. Confirmation of understanding and acceptance of disclaimer By clicking on the "I AGREE" button, I certify that I am not located in the United States, Australia, Canada, South Africa or Japan or any other jurisdiction, where access to the materials is prohibited or restricted. I have read and understood the disclaimer set out above. I understand that it may affect my rights. I agree to be bound by its terms. By clicking on the "I AGREE" button, I confirm that I am permitted to proceed to electronic versions of these materials. Agree Disagree Back to Newsroom Please confirm your location here: Choose country Australia Japan Canada South Africa USA Other Go Disclaimer - Important The following materials are not directed at or to be accessed by persons located in the United States, Australia, Canada or Japan. These materials do not constitute or form a part of any offer or solicitation to purchase or subscribe for securities in the United States, Australia, Canada or Japan or in any other jurisdiction in which such offer or solicitation is not authorized or to any person to whom it is unlawful to make such offer or solicitation. The securities mentioned herein have not been, and will not be, registered under the Securities Act and may not be offered or sold in the United States, except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. There will be no public offer of the securities in the United States. In the United Kingdom the following materials are only directed at (i) investment professionals falling within Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005 (the "Order") or (ii) high net worth companies, and other persons to whom it may lawfully be communicated, falling within Article 49(2)(a) to (d) of the Order (all such persons together being referred to as "relevant persons"). The securities are only available to, and any invitation, offer or agreement to subscribe, purchase or otherwise acquire such securities will be engaged in only with, relevant persons. Any person who is not a relevant person should not act or rely on the materials or any of their contents. In relation to each member state of the European Economic Area which has implemented the Directive 2003/71/EC, and any amendments thereto (the "Prospectus Directive")(each a "Relevant Member State"), an offer to the public of the securities has not been made and will not be made in such Relevant Member State, except that an offer to the public in such Relevant Member State of any securities may be made at any time under the following exemptions from the Prospectus Directive, if they have been implemented in the Relevant Member State: to any legal entity which is a qualified investor as defined in the Prospectus Directive, to fewer than 150 natural or legal persons (other than qualified investors as defined in the Prospectus Directive), as permitted under the Prospectus Directive, or in any other circumstances falling within Article 3(2) of the Prospectus Directive; provided that no such offer shall result in a requirement to publish a prospectus pursuant to Article 3 of the Prospectus Directive or supplement a prospectus pursuant to Article 16 of the Prospectus Directive. For the purposes of this provision, the expression an "offer to the public" in relation to any securities in any Relevant Member State means the communication in any form and by any means of sufficient information on the terms of the offer and any securities to be offered so as to enable an investor to decide to purchase any securities, as the same may be varied in that Relevant Member State by any measure implementing the Prospectus Directive in that Relevant Member State, and the expression "Prospectus Directive" includes any relevant implementing measure in each Relevant Member State. Viewing the materials you seek to access may not be lawful in certain jurisdictions. In other jurisdictions, only certain categories of person may be allowed to view such materials. Any person who wishes to view these materials must first satisfy themselves that they are not subject to any local requirements that prohibit or restrict them from doing so. If you are not permitted to view materials on this webpage or are in any doubt as to whether you are permitted to view these materials, please exit this webpage. Basis of access Access to electronic versions of these materials is being made available on this webpage by Bayer in good faith and for information purposes only. Making press announcements and other documents available in electronic format on this webpage does not constitute an offer to sell or the solicitation of an offer to buy securities issued by Bayer. Further, it does not constitute a recommendation by Bayer, or any other party to buy or sell securities issued by Bayer. Confirmation of understanding and acceptance of disclaimer By clicking on the "I AGREE" button, I certify that I am not located in the United States, Australia, Canada or Japan or any other jurisdiction, where access to the materials is prohibited or restricted. I have read and understood the disclaimer set out above. I understand that it may affect my rights. I agree to be bound by its terms. By clicking on the "I AGREE" button, I confirm that I am permitted to proceed to electronic versions of these materials. I Agree I Do Not Agree Back to Newsroom Please confirm your location here: Choose country Australia Japan Canada South Africa USA Other Go Important Notice This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, any securities. There will be no public offer of the securities in any jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. An investment decision regarding the securities referred to herein should only be made on the basis of the securities prospectus. This announcement is an advertisement and does not, under any circumstances, constitute a public offering or an invitation to the public in connection with any offer within the meaning of Regulation (EU) 2017/1129. The final prospectus, when published, will be available on the website of the Luxembourg Stock Exchange ( https://www.luxse.com ). The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act" ), or any U.S. State security laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act or to, or for the benefit of, U.S. persons. The tender offer referenced herein is not being made, directly or indirectly, in or into the United States by use of the mails or by any means or instrumentality (including, without limitation, e-mail, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or of any facility of a national securities exchange of the United States and the tender offer cannot be accepted by any such use, means, instrumentality or facility or from within the United States. Viewing the materials you seek to access may not be lawful in certain jurisdictions. In other jurisdictions, only certain categories of person may be allowed to view such materials. Any person who wishes to view these materials must first satisfy themselves that they are not subject to any local requirements that prohibit or restrict them from doing so. If you are not permitted to view materials on this webpage or are in any doubt as to whether you are permitted to view these materials, please exit this webpage. Basis of access Access to electronic versions of these materials is being made available on this webpage by Bayer in good faith and for information purposes only. Making press announcements and other documents available in electronic format on this webpage does not constitute an offer to sell or the solicitation of an offer to buy securities issued by Bayer. Further, it does not constitute a recommendation by Bayer, or any other party to buy or sell securities issued by Bayer. Confirmation of understanding and acceptance of disclaimer By clicking on the "I AGREE" button, I certify that I am not located in the United States, Australia, Canada, South Africa or Japan or any other jurisdiction, where access to the materials is prohibited or restricted. I have read and understood the disclaimer set out above. I understand that it may affect my rights. I agree to be bound by its terms. By clicking on the "I AGREE" button, I confirm that I am permitted to proceed to electronic versions of these materials. I Agree I Do Not Agree Back to Newsroom Important notice This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, any securities. There will be no public offer of the securities in any jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. An investment decision regarding the securities referred to herein should only be made on the basis of the securities prospectus. This announcement is an advertisement and does not, under any circumstances, constitute a public offering or an invitation to the public in connection with any offer within the meaning of Regulation (EU) 2017/1129. The final prospectus, when published, will be available on the website of the Luxembourg Stock Exchange ( https://www.luxse.com ). The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. State security laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act or to, or for the benefit of, U.S. persons. The tender offer referenced herein is not being made, directly or indirectly, in or into the United States by use of the mails or by any means or instrumentality (including, without limitation, e-mail, facsimile transmission, telephone and the internet) of interstate or foreign commerce, or of any facility of a national securities exchange of the United States and the tender offer cannot be accepted by any such use, means, instrumentality or facility or from within the United States. Viewing the materials you seek to access may not be lawful in certain jurisdictions. In other jurisdictions, only certain categories of person may be allowed to view such materials. Any person who wishes to view these materials must first satisfy themselves that they are not subject to any local requirements that prohibit or restrict them from doing so. If you are not permitted to view materials on this webpage or are in any doubt as to whether you are permitted to view these materials, please exit this webpage. Basis of access Access to electronic versions of these materials is being made available on this webpage by Bayer in good faith and for information purposes only. Making press announcements and other documents available in electronic format on this webpage does not constitute an offer to sell or the solicitation of an offer to buy securities issued by Bayer. Further, it does not constitute a recommendation by Bayer, or any other party to buy or sell securities issued by Bayer. Confirmation of understanding and acceptance of disclaimer By clicking on the "I AGREE" button, I certify that I am not located in the United States, Australia, Canada, South Africa or Japan or any other jurisdiction, where access to the materials is prohibited or restricted. I have read and understood the disclaimer set out above. I understand that it may affect my rights. I agree to be bound by its terms. By clicking on the "I AGREE" button, I confirm that I am permitted to proceed to electronic versions of these materials. Agree Disagree Back to Newsroom Please confirm your location here: Choose country Australia Japan Canada South Africa USA Other Go Important Notice This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, any securities. There will be no public offer of the securities in any jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act"), or any U.S. State security laws and may not be offered or sold in the United States or to, or for the benefit of, U.S. persons absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act. Viewing the materials you seek to access may not be lawful in certain jurisdictions. In other jurisdictions, only certain categories of person may be allowed to view such materials. Any person who wishes to view these materials must first satisfy themselves that they are not subject to any local requirements that prohibit or restrict them from doing so. If you are not permitted to view materials on this webpage or are in any doubt as to whether you are permitted to view these materials, please exit this webpage. Basis of access Access to electronic versions of these materials is being made available on this webpage by Bayer in good faith and for information purposes only. Making press announcements and other documents available in electronic format on this webpage does not constitute an offer to sell or the solicitation of an offer to buy securities issued by Bayer. Further, it does not constitute a recommendation by Bayer, or any other party to buy or sell securities issued by Bayer. Confirmation of understanding and acceptance of disclaimer By clicking on the "I AGREE" button, I certify that I am not located in the United States, Australia, Canada, South Africa or Japan or any other jurisdiction, where access to the materials is prohibited or restricted. I have read and understood the disclaimer set out above. I understand that it may affect my rights. I agree to be bound by its terms. By clicking on the "I AGREE" button, I confirm that I am permitted to proceed to electronic versions of these materials. I Agree I Do Not Agree Back to Newsroom Please confirm your location here: Choose country Australia Japan Canada South Africa USA Other Go Important Notice This announcement does not contain or constitute an offer of, or the solicitation of an offer to buy or subscribe for, any securities. There will be no public offer of the securities in any jurisdiction. Neither this announcement nor anything contained herein shall form the basis of, or be relied upon in connection with, any offer or commitment whatsoever in any jurisdiction. An investment decision regarding the securities referred to herein should only be made on the basis of the securities prospectus. This announcement is an advertisement and does not, under any circumstances, constitute a public offering or an invitation to the public in connection with any offer within the meaning of Regulation (EU) 2017/1129. The final prospectus, when published, will be available on the website of the Luxembourg Stock Exchange ( https://www.luxse.com ). The securities referred to herein will not be registered under the U.S. Securities Act of 1933, as amended (the "U.S. Securities Act" ), or any U.S. State security laws and may not be offered or sold in the United States absent registration or an applicable exemption from the registration requirements under the U.S. Securities Act or to, or for the benefit of, U.S. persons. Viewing the materials you seek to access may not be lawful in certain jurisdictions. In other jurisdictions, only certain categories of person may be allowed to view such materials. Any person who wishes to view these materials must first satisfy themselves that they are not subject to any local requirements that prohibit or restrict them from doing so. If you are not permitted to view materials on this webpage or are in any doubt as to whether you are permitted to view these materials, please exit this webpage. Basis of access Access to electronic versions of these materials is being made available on this webpage by Bayer in good faith and for information purposes only. Making press announcements and other documents available in electronic format on this webpage does not constitute an offer to sell or the solicitation of an offer to buy securities issued by Bayer. Further, it does not constitute a recommendation by Bayer, or any other party to buy or sell securities issued by Bayer. Confirmation of understanding and acceptance of disclaimer By clicking on the "I AGREE" button, I certify that I am not located in the United States, Australia, Canada, South Africa or Japan or any other jurisdiction, where access to the materials is prohibited or restricted. I have read and understood the disclaimer set out above. I understand that it may affect my rights. I agree to be bound by its terms. By clicking on the "I AGREE" button, I confirm that I am permitted to proceed to electronic versions of these materials. I Agree I Do Not Agree Back to Newsroom Disclaimer This website is intended to provide information to an international audience outside the USA and UK. Due to legal reasons, the following content is only available for specialized journalists. To access these pages, please confirm that you are a medical journalist and that you would like to accredit to the Bayer press portal. I hereby confirm that I am a medical journalist outside the UK and the US. Continue Back to Newsroom Disclaimer This website is intended to provide information to an international audience outside the UK. Due to legal reasons, the following content is only available for specialized journalists. To access these pages, please confirm that you are a medical journalist and that you would like to accredit to the Bayer press portal. I hereby confirm that I am a medical journalist outside the UK. Continue DocCheck-EN SPECIALIZED PRESS Export-LatestNews Export-PH Pharmaceuticals Research & Innovation Cancer Bayer May 18 , 2026 | 14:29 PM Europe/Amsterdam Not intended for U.S. and UK Media FDA grants sevabertinib Priority Review as a first-line treatment for patients with HER2-mutant non-small cell lung cancer Summary The U.S. Food and Drug Administration (FDA) has granted sevabertinib Priority Review designation, recognizing its potential to address a critical unmet need. Priority Review specifically applies to the evaluation of medicines that, if approved, would provide significant improvement in the safety or effectiveness of the treatment, diagnosis or prevention of a serious condition. 1 / Regulatory submission for first-line use of sevabertinib is based on results from the ongoing Phase I/II SOHO-01 trial evaluating the efficacy and safety of sevabertinib in patients with advanced HER2-mutant non-small cell lung cancer (NSCLC) / In December 2025, the U.S. FDA and the Center for Drug Evaluation (CDE) in China both granted sevabertinib Breakthrough Therapy to expedite the development of sevabertinib for first-line use in patients with HER2-mutant NSCLC given its potential to provide substantial benefit over available therapies in an area of high unmet need / In November 2025, sevabertinib, under the brand name Hyrnuo™, received FDA accelerated approval for patients with previously treated advanced HER2-mutant NSCLC Berlin, May 18, 2026 - Bayer today announced that sevabertinib has been granted Priority Review status by the US Food and Drug Administration (FDA) for the first-line treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have HER2 (ERBB2) tyrosine kinase domain (TKD) activating mutations. "The FDA's Priority Review decision for sevabertinib is an important milestone that underscores Bayer's commitment to precision oncology, addressing critical unmet needs in patients with HER2 -mutant NSCLC," said Christian Rommel, Ph.D., Head of Research and Development at Bayer's Pharmaceuticals Division. "Patients with HER2 -mutant NSCLC currently have limited treatment options, and there is an urgent need for more effective and better tolerated therapies that can be used early in the disease course to help improve survival outcomes." The regulatory application for first-line use of sevabertinib is based on preliminary clinical evidence from cohort F (patients who had not previously received treatment) of the ongoing Phase I/II SOHO-01 Study (NCT05099172) 2 evaluating the efficacy and safety of sevabertinib in patients with locally advanced or metastatic HER2 -mutant NSCLC. In November 2025, sevabertinib, under the brand name Hyrnuo™, received FDA accelerated approval for patients with previously treated advanced HER2 -mutant NSCLC based on objective response rate (ORR) and duration of response (DOR) data from the SOHO-01 trial (from cohort D - previously treated patients who had not received HER2- targeted therapy and cohort E - patients who had previously received HER2 -directed antibody-drug conjugates). Sevabertinib has also recently been approved by the National Medical Products Administration (NMPA) in China as monotherapy in adult patients with unresectable, locally advanced or metastatic NSCLC whose tumors have HER2 activating mutations, and who have received one prior systemic therapy. About sevabertinib Sevabertinib is a new, oral, reversible, small molecule, tyrosine kinase inhibitor (TKI) that potently inhibits mutant human HER2 , including HER2 exon 20 insertions and HER2 point mutations, as well as epidermal growth factor receptors (EGFR), with high selectivity for mutant vs wild-type EGFR. Sevabertinib works by blocking certain enzymes called tyrosine kinases, which are involved in the growth of cancer cells. Reversible TKIs can temporarily block their targets, allowing for more precise control over treatment and potentially reducing long-term side effects compared to irreversible TKIs. Sevabertinib is derived from Bayer's strategic research alliance with the Broad Institute of MIT and Harvard in Cambridge, MA, USA. As part of its clinical development program, alongside the SOHO-01 trial, sevabertinib is also being studied in patients in the Phase III SOHO-02 trial (NCT 06452277) evaluating sevabertinib in treatment naïve patients with HER2 -mutant NSCLC and in the panSOHO study (NCT06760819) in patients with metastatic or unresectable solid tumors with HER2 -activating mutations, excluding advanced NSCLC. About Non-Small Cell Lung Cancer (NSCLC) Lung cancer is the leading cause of cancer-related deaths worldwide. NSCLC is the most common type of lung cancer, accounting for more than 85% of cases. Activating HER2 mutations are found in 2% to 4% of patients with advanced NSCLC. 80% of people diagnosed with NSCLC have already progressed to advanced stages, which makes it more difficult to treat. Patients with HER2 -mutant NSCLC currently face limited treatment options, highlighting an urgent need for more effective therapies. About Oncology at Bayer Bayer is committed to delivering science for a better life by advancing a portfolio of innovative treatments. The company has the passion and determination to develop new medicines that help improve and extend the lives of people living with cancer. The oncology franchise at Bayer includes several marketed products across diverse indications and multiple compounds in different stages of clinical development. We have a wealth of expertise in areas including: Tumor Intrinsic Pathways, Targeted Radionuclide Therapies, and Next-Generation Immuno-Oncology. We are advancing prostate cancer treatment from early to metastatic stage, with the goal of extending survival while limiting side effects. Part of Bayer's focus on innovative precision oncology treatments, includes an approved TRK inhibitor exclusively designed to treat tumors that have an NTRK gene fusion, the oncogenic driver of tumor growth and spread. About Bayer Bayer is a global enterprise with core competencies in the life science fields of health care and nutrition. In line with its mission, "Health for all, Hunger for none," the company's products and services are designed to help people and the planet thrive by supporting efforts to master the major challenges presented by a growing and aging global population. Bayer is committed to driving sustainable development and generating a positive impact with its businesses. At the same time, the Group aims to increase its earning power and create value through innovation and growth. The Bayer brand stands for trust, reliability and quality throughout the world. In fiscal 2025, the Group employed around 88,000 people and had sales of 45.6 billion euros. R&D expenses amounted to 5.8 billion euros. For more information, go to www.bayer.com . Find more information at https://pharma.bayer.com Follow us on Facebook: http://www.facebook.com/bayer Forward-Looking Statements This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at www.bayer.com . The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments. Bayer AG is a holding company with operating subsidiaries worldwide. References to "Bayer" or "the company" herein may refer to one or more subsidiaries as context requires. 1 U.S. Food and Drug Administration. "Priority Review." https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/priority-review . Accessed April 2026. 2 N. Girard, H.H.F. Loong, B-C. Goh et al. 30: Phase I/II SOHO-01 study of BAY 2927088 in patients with previously treated HER2-mutant NSCLC: Safety and efficacy results from 2 expansion cohorts, Journal of Thoracic Oncology , Volume 20, Issue 3, Supplement 1,2025,Pages S5-S6,ISSN 1556-0864. Available at: https://www.sciencedirect.com/science/article/pii/S1556086425001984 . Contact for media inquiries: Silvia Grosso, phone +1 973 270 6828 Email: [email protected] Downloads 2026-0075e.pdf 2026-0075e.rtf Newsroom Sign up for our Newsletter We will keep you informed about the latest news. Sign up

View stock analysis, news, and events for Bayer Ag