Roche Expands Haematology Pipeline Through Strategic Collaboration with Nurix Therapeutics on Investigational BTK Degrader

Roche Expands Haematology Pipeline Through Strategic Collaboration with Nurix Therapeutics on Investigational BTK Degrader

(IN BRIEF) Roche and Nurix Therapeutics have entered into an exclusive global licensing and collaboration agreement to co-develop and co-commercialise bexobrutideg, also known as NX-5948, an investigational oral BTK degrader with potential applications across malignant haematology, immunology and neurology. The collaboration is designed to advance bexobrutideg as a potential best-in-class targeted protein degrader therapy for B-cell malignancies, including chronic lymphocytic leukaemia, while also exploring its use in chronic spontaneous urticaria and multiple sclerosis. Unlike conventional BTK inhibitors, bexobrutideg is designed to eliminate the BTK protein, removing both kinase activity and scaffolding function, which may help overcome resistance mechanisms seen with current treatments. Roche and Nurix plan to initiate a Phase 3 trial in summer 2026 for second-line CLL. Under the agreement, Nurix will receive USD 700 million upfront and may receive milestone payments bringing the potential total deal value to USD 2.3 billion. The companies will share development costs, co-commercialise the therapy in the United States and split U.S. profits and losses equally, while Roche will commercialise outside the U.S. with Nurix receiving royalties. The transaction is expected to close in the third quarter of 2026, subject to customary conditions.

(PRESS RELEASE) BASEL, 8-Jun-2026 — /EuropaWire/ — Roche has entered into an exclusive licensing and collaboration agreement with Nurix Therapeutics, Inc. to co-develop and co-commercialise bexobrutideg, also known as NX-5948, an investigational oral Bruton’s Tyrosine Kinase degrader with potential use across B-cell malignancies, immunology and neurology.

The collaboration will focus on advancing bexobrutideg as a potential best-in-class targeted protein degrader therapy for people living with B-cell malignancies, while also exploring opportunities in chronic spontaneous urticaria and multiple sclerosis. The agreement strengthens Roche’s oncology pipeline, particularly in malignant haematology, and creates a broader cross-therapeutic opportunity in immune-mediated and neurological diseases.

Bexobrutideg is designed to take a different approach from conventional BTK inhibitors. Rather than only blocking BTK kinase activity, the investigational therapy uses targeted protein degradation to eliminate the BTK protein from cells. This mechanism may remove both the kinase activity and scaffolding function of BTK, potentially helping to overcome resistance mechanisms that can emerge with current standard-of-care BTK inhibitors.

Despite progress in BTK inhibitors and other treatment options, patients with B-cell-driven malignancies continue to face substantial unmet medical needs. In chronic lymphocytic leukaemia, many patients eventually experience disease progression due to acquired resistance mutations, incomplete pathway suppression or intolerance that limits long-term therapy. Once relapse occurs, treatment choices can remain limited.

BTK-targeting therapies are among the leading classes in the growing non-Hodgkin lymphoma and chronic lymphocytic leukaemia markets. Roche highlighted market projections indicating that the combined NHL and CLL market could reach USD 41 billion by 2031, with BTK inhibitors expected to remain the leading class by sales at approximately USD 19 billion. The CLL segment alone is forecast to grow from USD 12 billion in 2024 to USD 16 billion by 2035.

Bexobrutideg is planned to enter Phase 3 clinical testing in summer 2026 for second-line treatment of chronic lymphocytic leukaemia. Available clinical data suggest that the therapy may have the potential to offer strong efficacy and favourable tolerability compared with established treatment approaches. Its ability to degrade BTK may also help address treatment-emergent resistance seen with existing BTK inhibitors.

Levi Garraway, Roche Chief Medical Officer and Head of Global Product Development, said Roche’s aim is to create new possibilities for patients with challenging diseases. He noted that bexobrutideg could represent an important advance in complex blood cancers and other conditions, and said Roche is pleased to work with Nurix to accelerate the potential of the therapy.

Arthur T. Sands, M.D., Ph.D., President and Chief Executive Officer of Nurix Therapeutics, said Roche is an ideal partner to help bring the promise of targeted protein degradation to patients worldwide. He said bexobrutideg has shown highly promising results as a single agent in B-cell malignancy clinical trials and that Roche’s global reach will support rapid expansion of the Phase 3 programme. He also highlighted the opportunity to explore combination regimens using selected therapies from Roche’s B-cell malignancy portfolio, as well as to expand the programme into immunology and neurology.

While BTK is already a validated target in B-cell malignancies, it also plays a key role in immune and neurological disease pathways. Because bexobrutideg is designed to remove both the kinase and scaffolding functions of BTK across immune cell types, the therapy may offer improved efficacy and durability in diseases beyond oncology.

Under the terms of the agreement, Nurix will receive an upfront cash payment of USD 700 million and may receive development, regulatory and sales milestone payments, bringing the potential total deal value to up to USD 2.3 billion. Development costs will be shared, with Nurix responsible for 40% and Roche for 60%.

In the United States, Roche and Nurix will co-commercialise bexobrutideg across all indications and equally share profits and losses. Outside the United States, Roche will lead commercialisation, while Nurix will receive royalties ranging from the low-teens to high-teens.

The transaction remains subject to customary closing conditions, including expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. The companies currently expect the transaction to close in the third quarter of 2026.

Bexobrutideg is an investigational, orally bioavailable and brain-penetrant BTK degrader being developed for relapsed or refractory B-cell malignancies, with potential applications in immunology and neurology. BTK is a central signalling node involved in B-cell growth, development and immune activity. By selectively eliminating BTK protein, bexobrutideg may offer a new therapeutic path for patients whose disease is resistant to conventional BTK inhibition.

B-cell malignancies, including chronic lymphocytic leukaemia, remain a major health challenge despite recent scientific progress. CLL is a slow-growing cancer of the blood and bone marrow and is among the most common forms of leukaemia in adults. Although symptoms may subside after initial treatment, many patients require additional therapy when cancerous cells return.

Chronic spontaneous urticaria is a long-term immune-mediated skin condition marked by recurring itchy hives. Multiple sclerosis is a chronic neurological disease affecting nearly 3 million people worldwide, occurring when the immune system attacks the protective covering of nerves in the brain and spinal cord, disrupting signals throughout the body and leading to movement and neurological difficulties.

About bexobrutideg
Bexobrutideg (NX-5948) is an investigational, orally bioavailable, brain-penetrant BTK degrader for the treatment of relapsed or refractory B-cell malignancies and potentially diseases in immunology and neurology. BTK is a central signaling node controlling B cell growth, development and immunologic activity. Unlike conventional BTK inhibitors, which block BTK kinase activity, bexobrutideg harnesses the body’s natural protein disposal system. Bexobrutideg selectively eliminates BTK protein from cells, removing both its kinase activity and scaffolding function, potentially overcoming existing treatment-emergent resistance mutations and unlocking new therapeutic potential of targeting BTK.

About malignant haematology
B-cell malignancies, including chronic lymphocytic leukaemia (CLL), represent a significant health challenge where recent scientific advances can help meet high unmet medical needs. CLL is a slow-growing cancer in the blood and bone marrow and is one of the most common forms of leukemia in adults. While outcomes have improved in recent years, patients often face long treatment durations and ongoing disease management challenges. Although signs of CLL may disappear for a while after initial treatment, many people require additional treatment due to the return of cancerous cells.

About CSU and MS
CSU is a debilitating, long-term, immune mediated skin condition characterized by recurring, itchy hives. MS is a chronic disease affecting nearly 3 million people worldwide. It occurs when the immune system attacks the protective covering of nerves in the brain and spinal cord, disrupting signals throughout the body and causing movement and neurological challenges.

About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.

Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.

Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.

For more information, please visit www.roche.com.

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References
[1] Clarivate, NHL/CLL Disease Landscape and Forecast, 2024.
[2] DRG (Decision Resources Group) & Datamonitor Healthcare, CLL Market Analysis, 2025.

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SOURCE: Roche