On January 13, 2026 Bayer AG reported the strategic focus for its Pharmaceuticals Division in 2026 on the occasion of the 44th J.P. Morgan Healthcare Conference in San Francisco.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Capitalizing on new launch momentum, the company will drive significant global regulatory expansions and market penetration across its pharmaceutical portfolio. High-value commercial products and an accelerating modality-rich pipeline across oncology, cardiology, neurology, and immunology have firmly cemented the Pharmaceuticals Division’s growth for the coming years. Five pivotal worldwide approvals in 2025 underscore a landmark year of strategic execution, validating the successful advancement of Bayer’s ambitious pharmaceutical growth strategy.

"We are now clearly seeing the success of our strategy. We have fundamentally accelerated Bayer Pharmaceutical’s growth runway with multiple high-impact launches across oncology, cardiology, and women’s health," said Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of Bayer’s Pharmaceuticals Division. "Our strategic focus remains on delivering transformative medicines to patients faster, powered by our cutting-edge R&D expertise, dynamic operating model, partnership-driven innovation, AI-enabled development, and commitment to commercial excellence. Our Pharmaceuticals Division is poised for sustainable growth over the coming years."

Innovating to capture additional market opportunity in cardiovascular and cerebrovascular medicine

Bayer is advancing its global leadership in cardiovascular disease management through world-class science, strategic partnerships, and a high-value pipeline designed to deliver both patient and shareholder impact.

Asundexian, an investigational, once daily, oral Factor XIa inhibitor, has been investigated as a potential treatment for secondary stroke prevention. Each year, approximately 12 million people worldwide will experience a stroke. Of these, 20-30% will be a recurrent stroke.1,2 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.3 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.2,4,5 Topline data from the Phase III OCEANIC-STROKE study showed it met its primary safety and efficacy endpoints. OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor and these results underscore the blockbuster potential of asundexian in secondary stroke prevention. 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.

Additionally, Bayer is driving forward its global leadership in cardiovascular and renal disease, leveraging integrated capabilities and robust partnerships to unlock new value streams. The FDA and Japan’s Ministry of Health, Labour and Welfare (MHLW), among other regulatory authorities, have approved finerenone (marketed as Kerendia) for patients with heart failure with left ventricular ejection fraction (LVEF) of ≥40%, based on the positive results from the pivotal Phase III study FINEARTS-HF, further building on its established efficacy in chronic kidney disease (CKD) associated with type 2 diabetes. Applications in HF with LVEF ≥40% are under review in additional markets, including the EU and China. Ongoing, dedicated Phase III heart failure and chronic kidney disease programs (MOONRAKER and THUNDERBALL) continue to evaluate Kerendia’s potential across a broad spectrum of patients and clinical settings of Cardiovascular-Kidney-Metabolic (CKM) conditions. In November 2025, late-breaking, topline data from the Phase III study FINE-ONE presented at the American Society of Nephrology’s Kidney Week showed it met its primary safety and efficacy endpoints. For important risk and use information about KERENDIA, please see the full Prescribing Information.

The European Commission granted marketing authorization for Beyonttra (acoramidis), marketed by Bridge Bio in the U.S., to treat wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Beyonttra slows the amyloidogenic process that results in ATTR-CM.

Beyond current successes, Bayer is actively shaping the future of cardiology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. This includes AB-1002, an investigational single-dose gene therapy in development for congestive heart failure (CHF) developed together with AskBio Inc., a wholly owned subsidiary of Bayer. AB-1002 is progressing well in Phase II. Its Phase I results were published in Nature Medicine and it has been granted Pioneering Regenerative Medical Product designation (SAKIGAKE) by Japan’s MHLW.

Additionally, Bayer has initiated the Phase II SIRIUS study of BAY-3018250, a first-in-class anti–alpha-2 antiplasmin (α2AP) antibody designed to enable targeted thrombolysis in deep vein thrombosis (DVT), and a Phase I clinical study of BAY-3670549, an investigational, highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor, with the potential to help control the electrical activity of heart cells in patients with atrial fibrillation. Bayer’s commitment to cutting-edge science is further underscored by the company’s licensed dilated cardiomyopathy program with Dewpoint Therapeutics, which leverages condensate biology to develop genotype-guided therapies for dilated cardiomyopathy patients with specific genetic mutations. Concurrently, securing exclusive rights in Japan to aficamten from Cytokinetics—a cardiac myosin inhibitor in development for hypertrophic cardiomyopathy—strengthens Bayer’s precision cardiology footprint and expands its strategic market access.

Oncology growth engine: Leveraging blockbuster assets and precision pipeline for future leading position

Bayer’s oncology portfolio is delivering significant patient benefit and commercial success, with blockbuster Nubeqa (darolutamide) continuing its exceptional global uptake, progressing towards a market-leading position. With over 200,000 patients treated worldwide and a third approval in prostate cancer in both the U.S. and Europe, Nubeqa continues its strong growth trajectory. Total global sales are on the rise in all markets. Third approval in China is anticipated in 2026. Its comprehensive clinical development program is exploring Nubeqa’s potential in earlier prostate cancer settings, with two additional Phase III readouts expected in 2027 and 2028. Darolutamide, under the brand name Nubeqa is approved for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with ADT, with or without chemotherapy, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease. For important risk and use information about Nubeqa, please see the full Prescribing Information.

Adding to this momentum in oncology, the FDA granted accelerated approval for Bayer’s Hyrnuo (sevabertinib) for adult patients with locally advanced or metastatic non-squamous HER2-mutant non-small cell lung cancer (NSCLC), who have received prior systemic therapy. Approval followed Breakthrough Therapy Designations from both the FDA and China’s CDE and was based on results from the SOHO-01 study. Bayer received Breakthrough Therapy Designation in the US and China for sevabertinib as a first-line treatment for patients with HER2-mutant non-small cell lung cancer. The Breakthrough Therapy Designations are supported by preliminary clinical evidence from cohort F (patients who had not previously received treatment) of the ongoing Phase I/II SOHO-01 study. Sevabertinib addresses unmet needs for a patient population with limited treatment options. In addition to SOHO-01 the clinical program for sevabertinib includes ongoing trials evaluating its effectiveness as a first-line treatment for HER2-mutant NSCLC and in patients with metastatic solid tumors harboring HER2 activating mutations, excluding advanced NSCLC. For important risk and use information about Hyrnuo, please see the full Prescribing Information.

As pioneers in Targeted Radionuclide Therapy (TRT), Bayer was instrumental in helping establish Targeted Alpha Therapies (TATs) as a standard of care for patients with metastatic castration resistant prostate cancer (mCRPC) with bone metastases. The EORTC PEACE III study evaluating radium-223 dichloride (marketed as Xofigo) in combination with enzalutamide met its primary endpoint. An additional Phase III clinical study with radium-223 dichloride will be completed in 2026 and will guide decisions regarding future regulatory steps. Radium-223 dichloride is approved under the brand name Xofigo in over 50 countries for mCRPC patients with symptomatic bone metastases and no known visceral metastatic disease. For important risk and use information about Xofigo, please see the full Prescribing Information.

Bayer’s oncology pipeline is advancing precision-driven therapies, making pivotal progress by targeting challenging tumor types and previously undruggable mechanisms, proteins or pathways resistant to current therapies. This includes multiple investigational agents for KRAS-mutant cancers (an internal SOS1 inhibitor, and a partnership with Kumquat for a KRAS G12D inhibitor), next-generation TATs (225Ac-GPC3 for advanced hepatocellular carcinoma), and a PRMT5 inhibitor (from Suzhou Puhe BioPharma) for MTAP-deleted tumors, all of which have entered Phase I. Further strengthening its discovery engine, Bayer secured worldwide rights to the clinical-stage Werner helicase inhibitor (VVD 214) via Vividion, whose R&D capabilities were expanded through new facilities and the acquisition of Tavros Therapeutics. These strategic investments underscore Bayer’s commitment to driving groundbreaking innovation and securing long-term growth in oncology.

Menopause management: advancing care for women with diverse needs

Bayer achieved a big step forward in women’s health with the recent regulatory approvals of Lynkuet (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the only hormone-free therapy approved in the EU for both moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer. These milestones follow consistent positive results across all four Phase III clinical studies (OASIS 1- 4). For important risk and use information about Lynkuet, please see the full Prescribing Information.

Developing a comprehensive cell and gene therapy (CGT) portfolio

Multiple regulatory priority designations granted by authorities in the U.S., Europe and Japan and across Bayer’s CGT portfolio reflect the potential of these programs to deliver transformative patient impact. Bemdaneprocel, an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease, developed with Bayer’s wholly owned subsidiary BlueRock Therapeutics, entered pivotal evaluation in a Phase III study. AskBio’s ametefgene parvec (AB-1005), an investigational gene therapy, is being assessed in a Phase II study in moderate stage Parkinson’s disease. The first participant has been randomized in Germany while recruitments in the U.S., UK and Poland are ongoing. In ophthalmology, BlueRock’s OpCT-001, an iPSC-derived photoreceptor cell therapy for primary photoreceptor diseases, received FDA Fast Track designation and is progressing in its Phase I/IIa study.

Radiology: Advancing innovation and expanding into Molecular Imaging

Bayer continues to advance innovation in medical imaging with gadoquatrane, its investigational low-dose magnetic resonance imagining (MRI) contrast designed to reduce the gadolinium dose by up to 60% compared to other macrocyclic MRI contrast agents. Building on positive Phase III results, Bayer has submitted marketing authorization applications in key markets worldwide, including the U.S., EU, Japan, and China. Complementing progress in its existing portfolio, Bayer announced the strategic acquisition of two investigational radiotracers – AT-01 (a Positron Emission Tomography or PET tracer in Phase III of clinical development) and AT-05 (a tracer for Single Photon Emission Computed Tomography, or SPECT, currently in Phase I) – for the diagnosis of cardiac amyloidosis. This step marks Bayer’s entry into diagnostic tracers and underscores its ambition to expand in molecular imaging, aiming to broaden diagnostic options and enhance patient outcomes.

(Press release, Bayer, JAN 13, 2026, View Source [SID1234662029])

On January 13, 2026 Ipsen (Euronext: IPN; ADR: IPSEY) reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for IPN60340 in combination with venetoclax and azacitidine (Ven-Aza) in first line unfit acute myeloid leukemia, an aggressive blood cancer affecting older adults. IPN60340 is an investigational first-in-class monoclonal antibody targeting BTN3A, a key immune-regulatory molecule broadly expressed across cancer. Breakthrough Therapy Designation is intended to expedite the development and review of medicines for serious or life-threatening conditions with evidence of a substantial clinical improvement. IPN60340 previously received Orphan Drug Designations from the U.S. Food and Drug Administration and European Medicines Agency in July 2025.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"This Breakthrough Therapy Designation recognizes both the urgent need for new treatment options for people living with acute myeloid leukemia and the promising data seen so far in the development program for IPN60340," said Christelle Huguet, PhD, EVP and Head of R&D, Ipsen. "We look forward to working closely with the FDA as we advance to the next stage of clinical development and continue to deliver medicines with the potential to be transformative to people living with cancer."

This Breakthrough Therapy Designation is based on data from the Phase I/II EVICTION trial. Updated clinical data orally presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) (n=57)1 from the EVICTION trial showed treatment with IPN60340 in combination with Ven-Aza achieved very encouraging high responses. In this single-arm trial, treatment with IPN60340 and Ven-Aza (n=38), resulted in a near doubling of the complete response relative to those seen in historical standard of care data across all molecular subtypes in newly diagnosed patients including sub-types typically less responsive to standard of care (Ven-Aza).1,2 IPN60340 in combination with Ven-Aza was also shown to be well tolerated, underscoring IPN60340’s potential as a novel immunotherapy to improve outcomes for patients with AML. Based on these preliminary data, we look forward to discussing the design of the Phase II/III development plans with the FDA for IPN60340 in H1 2026.

About the EVICTION trial

EVICTION is a first-in-human, dose-escalation (Part 1) and cohort-expansion (Part 2) clinical trial of IPN60340 (ICT01) in patients with various advanced relapsed or refractory solid or hematologic cancers that have exhausted standard-of-care treatment options, as well as newly-diagnosed AML. More information on the EVICTION trial can be found at clinicaltrials.gov (NCT04243499).

About IPN60340 (ICT01)

IPN60340 is a humanized, anti-BTN3A (also known as CD277) monoclonal antibody that promotes the recognition and elimination of tumor cells by γ9δ2 T cells, which are responsible for immunosurveillance of malignancy and infections. The three isoforms of BTN3A targeted by IPN60340 are overexpressed on many solid tumors (e.g., melanoma, urothelial cell, colorectal, ovarian, pancreatic, and lung cancer) and hematologic malignancies (e.g., leukemia and lymphomas) and are also expressed on the surface of innate (e.g., γδ T cells and NK cells) and adaptive immune cells (T cells and B cells). Binding to BTN3A is essential for the activation of the anti-tumor immune response of γ9δ2 T cells. By altering the conformation of BTN3A, IPN60340 promotes this binding, thereby selectively activating circulating γ9δ2 T cells. This leads to migration of γ9δ2 T cells out of the circulation and into the tumor tissue, and triggers a downstream immunological cascade through secretion of pro-inflammatory cytokines, including but not limited to IFNγ and TNFα, further augmenting the anti-tumor immune response. Anti-tumor activity and efficacy of IPN60340 have been shown in patients across several cancer indications. IPN60340 is an investigational therapy under evaluation for people 75 years or older living with acute myeloid leukemia who due to comorbidities are prevented from receiving treatment with intensive chemotherapy.

(Press release, Ipsen, JAN 13, 2026, View Source [SID1234662014])

On January 13, 2026 Bayer AG reported the strategic focus for its Pharmaceuticals Division in 2026 on the occasion of the 44th J.P. Morgan Healthcare Conference in San Francisco.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Capitalizing on new launch momentum, the company will drive significant global regulatory expansions and market penetration across its pharmaceutical portfolio. High-value commercial products and an accelerating modality-rich pipeline across oncology, cardiology, neurology, and immunology have firmly cemented the Pharmaceuticals Division’s growth for the coming years. Five pivotal worldwide approvals in 2025 underscore a landmark year of strategic execution, validating the successful advancement of Bayer’s ambitious pharmaceutical growth strategy.

"We are now clearly seeing the success of our strategy. We have fundamentally accelerated Bayer Pharmaceutical’s growth runway with multiple high-impact launches across oncology, cardiology, and women’s health," said Stefan Oelrich, Member of the Board of Management, Bayer AG, and President of Bayer’s Pharmaceuticals Division. "Our strategic focus remains on delivering transformative medicines to patients faster, powered by our cutting-edge R&D expertise, dynamic operating model, partnership-driven innovation, AI-enabled development, and commitment to commercial excellence. Our Pharmaceuticals Division is poised for sustainable growth over the coming years."

Innovating to capture additional market opportunity in cardiovascular and cerebrovascular medicine

Bayer is advancing its global leadership in cardiovascular disease management through world-class science, strategic partnerships, and a high-value pipeline designed to deliver both patient and shareholder impact.

Asundexian, an investigational, once daily, oral Factor XIa inhibitor, has been investigated as a potential treatment for secondary stroke prevention. Each year, approximately 12 million people worldwide will experience a stroke. Of these, 20-30% will be a recurrent stroke.1,2 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.3 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.2,4,5 Topline data from the Phase III OCEANIC-STROKE study showed it met its primary safety and efficacy endpoints. OCEANIC-STROKE is the first successfully completed Phase III study of a Factor XIa inhibitor and these results underscore the blockbuster potential of asundexian in secondary stroke prevention. 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.

Additionally, Bayer is driving forward its global leadership in cardiovascular and renal disease, leveraging integrated capabilities and robust partnerships to unlock new value streams. The FDA and Japan’s Ministry of Health, Labour and Welfare (MHLW), among other regulatory authorities, have approved finerenone (marketed as Kerendia) for patients with heart failure with left ventricular ejection fraction (LVEF) of ≥40%, based on the positive results from the pivotal Phase III study FINEARTS-HF, further building on its established efficacy in chronic kidney disease (CKD) associated with type 2 diabetes. Applications in HF with LVEF ≥40% are under review in additional markets, including the EU and China. Ongoing, dedicated Phase III heart failure and chronic kidney disease programs (MOONRAKER and THUNDERBALL) continue to evaluate Kerendia’s potential across a broad spectrum of patients and clinical settings of Cardiovascular-Kidney-Metabolic (CKM) conditions. In November 2025, late-breaking, topline data from the Phase III study FINE-ONE presented at the American Society of Nephrology’s Kidney Week showed it met its primary safety and efficacy endpoints. For important risk and use information about KERENDIA, please see the full Prescribing Information.

The European Commission granted marketing authorization for Beyonttra (acoramidis), marketed by Bridge Bio in the U.S., to treat wild-type or variant transthyretin amyloidosis in adult patients with cardiomyopathy (ATTR-CM). Beyonttra slows the amyloidogenic process that results in ATTR-CM.

Beyond current successes, Bayer is actively shaping the future of cardiology with a robust and diversified pipeline, strategically positioned to address critical unmet needs and drive significant long-term value. This includes AB-1002, an investigational single-dose gene therapy in development for congestive heart failure (CHF) developed together with AskBio Inc., a wholly owned subsidiary of Bayer. AB-1002 is progressing well in Phase II. Its Phase I results were published in Nature Medicine and it has been granted Pioneering Regenerative Medical Product designation (SAKIGAKE) by Japan’s MHLW.

Additionally, Bayer has initiated the Phase II SIRIUS study of BAY-3018250, a first-in-class anti–alpha-2 antiplasmin (α2AP) antibody designed to enable targeted thrombolysis in deep vein thrombosis (DVT), and a Phase I clinical study of BAY-3670549, an investigational, highly selective G-protein-coupled inwardly rectifying potassium channel 4 (GIRK4) inhibitor, with the potential to help control the electrical activity of heart cells in patients with atrial fibrillation. Bayer’s commitment to cutting-edge science is further underscored by the company’s licensed dilated cardiomyopathy program with Dewpoint Therapeutics, which leverages condensate biology to develop genotype-guided therapies for dilated cardiomyopathy patients with specific genetic mutations. Concurrently, securing exclusive rights in Japan to aficamten from Cytokinetics—a cardiac myosin inhibitor in development for hypertrophic cardiomyopathy—strengthens Bayer’s precision cardiology footprint and expands its strategic market access.

Oncology growth engine: Leveraging blockbuster assets and precision pipeline for future leading position

Bayer’s oncology portfolio is delivering significant patient benefit and commercial success, with blockbuster Nubeqa (darolutamide) continuing its exceptional global uptake, progressing towards a market-leading position. With over 200,000 patients treated worldwide and a third approval in prostate cancer in both the U.S. and Europe, Nubeqa continues its strong growth trajectory. Total global sales are on the rise in all markets. Third approval in China is anticipated in 2026. Its comprehensive clinical development program is exploring Nubeqa’s potential in earlier prostate cancer settings, with two additional Phase III readouts expected in 2027 and 2028. Darolutamide, under the brand name Nubeqa is approved for the treatment of patients with metastatic castration-sensitive prostate cancer (mCSPC) in combination with ADT, with or without chemotherapy, and with ADT alone in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients who are at high risk of developing metastatic disease. For important risk and use information about Nubeqa, please see the full Prescribing Information.

Adding to this momentum in oncology, the FDA granted accelerated approval for Bayer’s Hyrnuo (sevabertinib) for adult patients with locally advanced or metastatic non-squamous HER2-mutant non-small cell lung cancer (NSCLC), who have received prior systemic therapy. Approval followed Breakthrough Therapy Designations from both the FDA and China’s CDE and was based on results from the SOHO-01 study. Bayer received Breakthrough Therapy Designation in the US and China for sevabertinib as a first-line treatment for patients with HER2-mutant non-small cell lung cancer. The Breakthrough Therapy Designations are supported by preliminary clinical evidence from cohort F (patients who had not previously received treatment) of the ongoing Phase I/II SOHO-01 study. Sevabertinib addresses unmet needs for a patient population with limited treatment options. In addition to SOHO-01 the clinical program for sevabertinib includes ongoing trials evaluating its effectiveness as a first-line treatment for HER2-mutant NSCLC and in patients with metastatic solid tumors harboring HER2 activating mutations, excluding advanced NSCLC. For important risk and use information about Hyrnuo, please see the full Prescribing Information.

As pioneers in Targeted Radionuclide Therapy (TRT), Bayer was instrumental in helping establish Targeted Alpha Therapies (TATs) as a standard of care for patients with metastatic castration resistant prostate cancer (mCRPC) with bone metastases. The EORTC PEACE III study evaluating radium-223 dichloride (marketed as Xofigo) in combination with enzalutamide met its primary endpoint. An additional Phase III clinical study with radium-223 dichloride will be completed in 2026 and will guide decisions regarding future regulatory steps. Radium-223 dichloride is approved under the brand name Xofigo in over 50 countries for mCRPC patients with symptomatic bone metastases and no known visceral metastatic disease. For important risk and use information about Xofigo, please see the full Prescribing Information.

Bayer’s oncology pipeline is advancing precision-driven therapies, making pivotal progress by targeting challenging tumor types and previously undruggable mechanisms, proteins or pathways resistant to current therapies. This includes multiple investigational agents for KRAS-mutant cancers (an internal SOS1 inhibitor, and a partnership with Kumquat for a KRAS G12D inhibitor), next-generation TATs (225Ac-GPC3 for advanced hepatocellular carcinoma), and a PRMT5 inhibitor (from Suzhou Puhe BioPharma) for MTAP-deleted tumors, all of which have entered Phase I. Further strengthening its discovery engine, Bayer secured worldwide rights to the clinical-stage Werner helicase inhibitor (VVD 214) via Vividion, whose R&D capabilities were expanded through new facilities and the acquisition of Tavros Therapeutics. These strategic investments underscore Bayer’s commitment to driving groundbreaking innovation and securing long-term growth in oncology.

Menopause management: advancing care for women with diverse needs

Bayer achieved a big step forward in women’s health with the recent regulatory approvals of Lynkuet (elinzanetant) for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause. It is the only hormone-free therapy approved in the EU for both moderate to severe VMS associated with menopause or caused by adjuvant endocrine therapy for breast cancer. These milestones follow consistent positive results across all four Phase III clinical studies (OASIS 1- 4). For important risk and use information about Lynkuet, please see the full Prescribing Information.

Developing a comprehensive cell and gene therapy (CGT) portfolio

Multiple regulatory priority designations granted by authorities in the U.S., Europe and Japan and across Bayer’s CGT portfolio reflect the potential of these programs to deliver transformative patient impact. Bemdaneprocel, an investigational cell therapy designed to replace the dopamine producing neurons that are lost in Parkinson’s disease, developed with Bayer’s wholly owned subsidiary BlueRock Therapeutics, entered pivotal evaluation in a Phase III study. AskBio’s ametefgene parvec (AB-1005), an investigational gene therapy, is being assessed in a Phase II study in moderate stage Parkinson’s disease. The first participant has been randomized in Germany while recruitments in the U.S., UK and Poland are ongoing. In ophthalmology, BlueRock’s OpCT-001, an iPSC-derived photoreceptor cell therapy for primary photoreceptor diseases, received FDA Fast Track designation and is progressing in its Phase I/IIa study.

Radiology: Advancing innovation and expanding into Molecular Imaging

Bayer continues to advance innovation in medical imaging with gadoquatrane, its investigational low-dose magnetic resonance imagining (MRI) contrast designed to reduce the gadolinium dose by up to 60% compared to other macrocyclic MRI contrast agents. Building on positive Phase III results, Bayer has submitted marketing authorization applications in key markets worldwide, including the U.S., EU, Japan, and China. Complementing progress in its existing portfolio, Bayer announced the strategic acquisition of two investigational radiotracers – AT-01 (a Positron Emission Tomography or PET tracer in Phase III of clinical development) and AT-05 (a tracer for Single Photon Emission Computed Tomography, or SPECT, currently in Phase I) – for the diagnosis of cardiac amyloidosis. This step marks Bayer’s entry into diagnostic tracers and underscores its ambition to expand in molecular imaging, aiming to broaden diagnostic options and enhance patient outcomes.

(Press release, Bayer, JAN 13, 2026, View Source [SID1234662029])

On January 12, 2026 Kivu Bioscience, a clinical-stage biotechnology company developing next-generation antibody-drug conjugates (ADCs) for difficult-to-treat cancers, reported that the first patient has been dosed in its Phase 1 clinical trial of KIVU-107, a next-generation PTK7-targeting ADC for patients with advanced solid tumors.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Dosing the first patient with KIVU-107 marks an important milestone for Kivu and for patients with advanced solid tumors who urgently need better treatment options," said Mohit Trikha, Ph.D., President and Chief Operating Officer, Kivu Bioscience. "Advancing KIVU-107 from preclinical development to first-in-human dosing in under 12 months underscores the efficiency of our platform and our commitment to developing a new generation of ADCs designed to expand the therapeutic window and deliver meaningful benefit to patients."

The first-in-human Phase 1 study (NCT07229313) is designed to evaluate the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of KIVU-107 in patients with advanced solid malignancies. KIVU-107 is built using GlycoConnect and HydraSpace site-specific conjugation technologies, enabling precise and stable drug-to-antibody ratios and optimized pharmacokinetics to improve the therapeutic window. KIVU-107 is designed to deliver potent, targeted cytotoxic activity in PTK7-expressing tumors while improving safety and tolerability compared to earlier-generation ADCs. The study has received regulatory approval in the United States and Australia.

(Press release, Kivu Bioscience, JAN 12, 2026, View Source [SID1234661997])

On January 12, 2026 Aim Immunotech presented its corporate presentation.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

(Presentation, AIM ImmunoTech, JAN 12, 2026, View Source [SID1234661937])