On January 13, 2026 Tahoe Therapeutics and Alloy Therapeutics reported that they are forming a jointly seeded new company focused on developing first-in-class antibody-drug conjugates (ADCs) for patients with hard-to-treat cancers.

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The joint venture will advance two ADC programs directed at novel tumor targets discovered by Tahoe using its proprietary Mosaic platform and large-scale, perturbative single-cell datasets. The collaboration reflects a strong strategic fit between Tahoe’s ability to identify high-confidence, tumor-selective targets using its AI-powered virtual cell models and Alloy’s end-to-end capabilities in biologic drug engineering, ADC design, and company creation through its venture studio 82VS.

Over the past year, Tahoe analyzed a subset of its proprietary multi-million-cell datasets and identified tens of tumor-specific surface antigens, many of which had taken decades to discover previously, and most of which are novel. Tahoe subsequently validated the most promising targets across multiple independent assays and clinical samples. After rigorous evaluation, Alloy recognized the exceptional therapeutic potential of these targets, catalyzing the decision to jointly spin out a dedicated ADC development company around two of them.

"We are excited to partner with Tahoe and were immediately impressed by the depth and quality of biological insight generated by the Mosaic platform," said Errik Anderson, Founder and CEO of Alloy Therapeutics. "With our track record of 20 clinical programs discovered with Alloy platforms and services, including multiple drugs in Phase III, we are well positioned to translate the cutting-edge biology from world-class target rich companies like Tahoe into optimized therapeutics."

Under the structure of the joint venture, Tahoe and Alloy will co-invest, co-build, and co-lead the new company. Tahoe will contribute its novel targets and biomarker insights, while Alloy will provide its ADC engineering platforms, translational development expertise, and 82VS company creation infrastructure. Together, the team aims to efficiently advance both ADC programs to key value-inflection points suitable for independent financing or pharma partnerships.

"Our datasets and AI models are enabling the discovery of novel targets," said Nima Alidoust, co-founder and CEO of Tahoe Therapeutics. "Alloy, which has had a strong track record in developing first-in-class biologics, shares this excitement with us, and that is a strong validation of the biology discovered by our platform. This joint venture is also a preview of the business model our platform enables: building new companies alongside partners with complementary capabilities."

Combining Tahoe’s AI-powered approach to understanding novel tumor biology with Alloy’s fully integrated drug discovery, development, and company creation capabilities creates a highly efficient path to translate novel biologic insights into first-in-class drugs for patients in need.

(Press release, Tahoe Therapeutics, JAN 13, 2026, View Source [SID1234662031])

On January 13, 2026 Modella AI, a leader in artificial intelligence for life sciences, reported that it has been acquired by AstraZeneca, expanding the companies’ existing collaboration to advance the application of multi-modal AI foundation models and AI agents across AstraZeneca’s global oncology portfolio.

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The acquisition follows a multi-year agreement with AstraZeneca announced in July 2025 and will integrate Modella AI’s generative and agentic AI platform into AstraZeneca’s oncology research and development organization, supporting efforts to accelerate clinical development, enhance biomarker discovery, and enable the next wave of data-driven decision-making across the pipeline.

"Oncology drug development is becoming more complex, more data-rich, and more time-sensitive, and our companies expect AI solutions that are not only powerful but truly deployable in global trials and clinical settings," said Gabi Raia, Chief Commercial Officer of Modella AI. "By joining AstraZeneca, we can apply our multimodal foundation models and agentic AI platform across a world-class oncology pipeline to accelerate development and help improve outcomes for patients with cancer," added Jill Stefanelli, PhD, co-founder and Chief Executive Officer of Modella AI.

"Modella AI was built at the intersection of pathology, clinical data, and advanced generative AI to tackle some of the hardest problems in oncology," said Faisal Mahmood, PhD, co-founder of Modella AI and Professor at Mass General Brigham. "Integrating our foundation models directly into AstraZeneca’s research ecosystem will help translate methodological advances into real-world impact faster."

"AstraZeneca is transforming its drug discovery and clinical development through the deployment of innovative and impactful AI solutions. The acquisition of Modella AI provides state-of-the-art frontier pathology foundation models and AI agents that will continue to enable the development of targeted therapeutics along with diagnostics in our oncology portfolio," said Jorge Reis-Filho, Chief of AI for Science Innovation at AstraZeneca.

The acquisition will embed Modella AI’s multi-modal foundation models and AI agents into AstraZeneca’s oncology R&D environment, enabling the generation of new biological and clinical insights, as well as greater automation, scalability, and consistency across data-intensive workflows. The financial details of the transaction were not disclosed.

(Press release, AstraZeneca, JAN 13, 2026, View Source [SID1234662030])

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.

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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 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 Zonsen PepLib Biotech Inc. ("PepLib") reported that it has entered into a worldwide license agreement with Novartis for an undisclosed peptide-based asset in the field of radioligand therapies (RLTs). Under the agreement, Novartis has obtained an exclusive worldwide license and will be responsible for the development and commercialization activities for the asset.

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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

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The asset has been developed internally by PepLib to date. Through this transaction, Novartis, an experienced global leader in RLTs, will advance the program to its next stage of development. The asset is expected to complement Novartis’ existing RLT portfolio and to leverage the company’s strong capabilities in the field to potentially bring a new targeted treatment option to patients worldwide.

"We are pleased to announce this new agreement with Novartis, a global leader in radioligand therapies," said Lei Chen, Chairman and Co-founder of PepLib. "We have advanced this peptide asset internally and believe that Novartis, with its deep expertise and proven track record in RLTs, is well-positioned to take the program forward and help translate our early work into a potential medicine for patients."

"Novartis is committed to expanding and strengthening our radioligand therapy portfolio to transform care for patients," said Shiva Malek, Global Head of Oncology, Biomedical Research, Novartis. "This asset complements our industry-leading efforts to advance promising next-generation RLTs and builds on our pipeline of innovative therapies for people living with cancer."

Under the terms of the agreement, PepLib will receive an upfront payment of USD 50 million, with the potential to receive additional development, regulatory, and sales milestone payments, and is also eligible for tiered royalties on future global net sales.

(Press release, Novartis, JAN 13, 2026, View Source [SID1234662028])