MEDIA

FDA grants Priority Review for Roche’s Tecentriq for a certain type of stage III colon cancer

Thu, 11 Jun 2026 05:00:00 GMT

Filing acceptance is based on the phase III Alliance ATOMIC study showing Tecentriq plus chemotherapy reduced recurrence or death risk by 50% versus chemotherapy alone¹
Nearly one in three patients with stage III colon cancer relapse within five years, highlighting a critical need for new adjuvant treatment options^2,3
If approved, Tecentriq plus chemotherapy could provide a new standard of care for the treatment of stage III dMMR/MSI-H* colon cancer after surgery

Basel, 11 June 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) filing for adjuvant Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with chemotherapy in stage III deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colon cancer, a type of tumour characterised by high mutation rates. The FDA has granted Priority Review and is expected to make a decision on the approval by 9 October 2026.

“This filing acceptance brings us closer to establishing adjuvant Tecentriq plus chemotherapy as a new standard of care for certain types of early colon cancer," said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The ATOMIC results demonstrate that Tecentriq plus chemotherapy can substantially reduce the risk of disease recurrence or death, helping more patients remain cancer-free following surgery.”

"One in three patients with stage III colon cancer will relapse within five years, underscoring the need for new adjuvant treatment options,” said Michael Sapienza, CEO, Colorectal Cancer Alliance. “This milestone represents a critical step toward a reality where treatment is tailored to a patient’s specific tumor biology from the very beginning, giving them a better chance of preventing a recurrence."

The application is based on the landmark ATOMIC study, recently published in The New England Journal of Medicine. ATOMIC demonstrated that adding Tecentriq to standard FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%, compared to chemotherapy alone for people with stage III dMMR colon cancer, determined by an immunohistochemistry test, such as the VENTANA® MMR RxDx Panel. The 36-month disease-free survival was 86% for Tecentriq combined with FOLFOX6 compared with 76% in the FOLFOX6 alone group. The safety profile was consistent with previous studies of Tecentriq and FOLFOX6.¹

Colon cancer remains one of the world's most common and deadliest tumours.⁴ Over one million people are diagnosed globally each year, and despite surgery and chemotherapy, approximately 30% of stage III patients relapse within five years.^2-4 Approximately 15% of colon cancer patients present with dMMR/MSI-H tumours, which indicate a higher mutation rate and thus have the potential to respond to immunotherapy.⁵

Roche is pursuing further regulatory filings for Tecentriq, including with the European Medicines Agency, to bring this first immunotherapy-based adjuvant option to patients with dMMR/MSI-H colon cancer worldwide.

The ATOMIC study was sponsored by the National Cancer Institute (NCI) and conducted by the Alliance for Clinical Trials in Oncology in partnership with Roche and the Arbeitsgemeinschaft Internistische Onkologie (AIO) group in Germany. It highlights Roche’s commitment to working alongside leading academic groups to tackle some of the most challenging cancers.

About the ATOMIC study
ATOMIC (A021502, NCT02912559) is a phase III, randomised, open-label, multicentre study investigating the addition of Tecentriq® (atezolizumab) to FOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil, and oxaliplatin) in patients with stage III colon cancer who have a deficiency in DNA mismatch repair (dMMR). The trial enrolled 712 patients. Participants were randomised 1:1 to receive either FOLFOX6 plus Tecentriq for 12 cycles (six months) followed by Tecentriq monotherapy for 13 cycles (an additional six months), or FOLFOX6 alone for 12 cycles. The primary endpoint is disease-free survival (DFS).

About Tecentriq® (atezolizumab)
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer, and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations.

About Roche in cancer immunotherapy
To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.roche.com/solutions/focus-areas/oncology/cancer-immunotherapy

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.

All trademarks used or mentioned in this release are protected by law.

[*] Deficient DNA mismatch repair (dMMR) and microsatellite instability-high (MSI-H)

References
[1] Sinicrope F, et al. Atezolizumab plus FOLFOX for Stage III Mismatch Repair–Deficient Colon Cancer. N Engl J Med. 2026;394:1155-1166.
[2] Gonzalez B, et al. Analyzing recurrence in colorectal cancer: Is a five years follow-up enough? Annals of Oncology. 2024;35(1);11.
[3] Nors J et al. Incidence of Recurrence and Time to Recurrence in Stage I to III Colorectal Cancer: A Nationwide Danish Cohort Study. JAMA Oncology. 2024;10(1):54–62.
[4] World Health Organization. Cancer [Internet; cited 2026 June]. Available from: https://www.who.int/news-room/fact-sheets/detail/cancer.
[5] Boland CR, et al. Microsatellite Instability in Colorectal Cancer. Gastroenterology. 2010;138:2073–2087.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
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Roche Investor Relations

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Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

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Media&Investor Release FDA grants Priority Review for Tecentriq English

Roche announces global collaboration with Nurix Therapeutics to co-develop and co-commercialise potential best-in-class BTK degrader bexobrutideg across malignant haematology, immunology and neurology

Mon, 08 Jun 2026 05:00:00 GMT

Agreement offers potential best-in-class targeted protein degrader therapy option for people living with B-cell malignancies
Collaboration adds to Roche’s oncology pipeline and offers potential indications in immunology (chronic spontaneous urticaria) and neurology (multiple sclerosis)
Bexobrutideg utilises a novel approach to eliminate the Bruton’s Tyrosine Kinase (BTK) protein, potentially overcoming existing resistance mechanisms found with current standard-of-care BTK inhibitors

Basel, 08 June 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it has entered into an exclusive licensing and collaboration agreement with Nurix Therapeutics, Inc. (Nasdaq: NRIX). Under the terms of this agreement, the two companies will collaborate to co-develop and co-commercialise bexobrutideg (NX-5948), Nurix’s investigational Bruton’s Tyrosine Kinase (BTK) degrader. The collaboration encompasses a clinical development plan spanning B-cell malignancies, immunology and neurology. The addition of bexobrutideg complements Roche’s existing strengths in haematology and provides a cross-therapeutic opportunity to extend the pipeline's reach in immunology and neurology.

Patients with B-cell–driven malignancies continue to face significant unmet need despite advances with BTK inhibitors and other therapies. In haematology, many patients with CLL ultimately experience disease progression due to acquired resistance mutations, incomplete pathway suppression, or intolerance that limits long-term use, and treatment options remain limited once patients relapse.

BTK-targeting assets represent a leading class within the expanding non-Hodgkin lymphoma (NHL) and CLL markets. The combined market is projected to reach $41 billion by 2031, with BTK inhibitors (BTKi) expected to remain the sales-leading class at approximately $19 billion.¹ This growth is particularly evident in the CLL sector, which is forecast to increase from $12 billion in 2024 to $16 billion by 2035.²

Bexobrutideg, an oral targeted BTK degrader, is planned for Phase 3 clinical trial initiation in summer 2026 for the second-line treatment of CLL. Available clinical data suggests it has the potential to become a best-in-class treatment option with higher efficacy and more favorable tolerability than established therapies. In addition, it offers the potential to overcome resistance mechanisms found in current standard-of-care BTK inhibitors. This collaboration creates a unique opportunity to leverage Roche’s industry-leading malignant haematology portfolio.

Levi Garraway, Roche Chief Medical Officer and Head of Global Product Development: “At Roche, our goal is to create new possibilities for patients with challenging diseases. We believe bexobrutideg could represent a major leap forward in the fight against complex blood cancers and other diseases. We are proud to join forces with Nurix to accelerate these potential breakthroughs.”

Arthur T. Sands, M.D., Ph.D., president and chief executive officer of Nurix Therapeutics: “We believe Roche is the ideal partner to help translate the promise of targeted protein degradation into meaningful impact for patients worldwide. As a single agent, bexobrutideg has shown highly promising results in B cell malignancy clinical trials to date and we can now rapidly expand our Phase 3 program enhanced by Roche’s global reach. We are also excited to explore combination regimens utilising selected agents from Roche’s portfolio of successful B-cell malignancy drugs. In addition, collaborating with Roche uniquely enables our ability to extend the cross-therapeutic opportunity of bexobrutideg in immunology and neurology.”

While BTK is a proven target in B-cell malignancies, it is also a critical signaling node driving various conditions in immunology and neurology. Because of bexobrutideg's ability to eliminate both the kinase and scaffolding functions of BTK across immune cell types it has the potential for improved efficacy and durability in these diseases.

Terms of the agreement
Under the terms of the agreement, Nurix will receive an upfront cash payment of USD 700 million and is eligible to receive development, regulatory and sales milestones for a potential total deal value of up to USD 2.3 billion. Development costs will be shared 40% by Nurix and 60% by Roche. The parties will equally split the profits and losses from U.S. commercialisation. Nurix and Roche will co-commercialise bexobrutideg in the United States across all indications. Outside of the United States, Roche will be responsible for commercialisation, with Nurix receiving royalties ranging from the low- to high-teens.

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

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.

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

All trademarks used or mentioned in this release are protected by law.

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

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +41 79 398 38 53	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03	Irène Stephan Phone: +41 79 377 83 75

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

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Media&Investor Release Collaboration with Nurix Therapeutics English

FDA accepts New Drug Application for Roche’s giredestrant in ER-positive early-stage breast cancer, the first and only oral SERD with positive phase III results in the curative setting

Tue, 02 Jun 2026 05:00:00 GMT

Filing acceptance, under priority review, based on phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy¹
Giredestrant represents the first significant advance in adjuvant endocrine therapy in over 20 years^1-3
Giredestrant has the potential to become a new standard-of-care in the adjuvant setting; more than 90% of ER-positive breast cancer cases are diagnosed at an early-stage (I-III)^4-7
The FDA has set a Prescription Drug User Fee Act date of 30 November 2026

Basel, 02 June 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the United States (US) Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under Priority Review for giredestrant, an investigational oral selective oestrogen receptor degrader (SERD), as an adjuvant treatment for adults with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative, stage I, II, and III breast cancer. The FDA is expected to make a decision on the approval by 30 November 2026.

“Giredestrant represents the first major endocrine therapy advance in early-stage ER-positive breast cancer in decades, where the chance for cure is highest,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The FDA’s filing acceptance brings us closer to delivering a new standard-of-care with the potential to fundamentally change the treatment paradigm for people with early-stage disease.”

The filing acceptance is based on the phase III lidERA Breast Cancer study results, which showed adjuvant giredestrant significantly reduced the risk of invasive disease recurrence or death (iDFS) by 30% compared with standard-of-care endocrine therapy (SoC ET) (hazard ratio [HR]=0.70, 95% confidence interval [CI] 0.57-0.87, p=0.0014).¹ At three years, 92.4% of patients in the giredestrant arm were alive and free of invasive disease versus 89.6% in the SoC ET arm.¹ The iDFS benefit was consistent across all clinically relevant subgroups.¹ Overall survival (OS) data were immature at the time of this analysis, but a clear positive trend was observed.¹ Follow-up for OS will continue to the next analysis. Giredestrant was well tolerated; adverse events were manageable and consistent with its known safety profile.¹ The treatment discontinuation rate for giredestrant was 5.3% versus 8.2% with SoC ET.¹

Additional analyses from the giredestrant programme were presented at the 2026 American Society of Clinical Oncology Congress. This growing body of evidence continues to reinforce the clinical benefit profile of giredestrant and its potential to meaningfully improve outcomes across ER-positive early-stage and advanced breast cancer.

The US FDA recently accepted the NDA for giredestrant in combination with everolimus for those with ESR1-mutated, ER-positive advanced breast cancer based on the evERA results, with a decision expected in December 2026.

Roche’s expanding giredestrant clinical development programme spans distinct treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

Globally, 2.3 million people are diagnosed with breast cancer each year.⁸ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and the majority are diagnosed in the early-stage.^9,10 Currently, up to a third of people eventually experience recurrence on or after adjuvant endocrine therapy treatment for early-stage breast cancer.^10-12 Additionally, many have to interrupt or stop treatment early due to safety or tolerability issues, thereby increasing the risk of death.^13,14 These limitations underscore the need for more effective and better-tolerated options that can enhance adherence and prevent or delay disease recurrence.

About the lidERA Breast Cancer study
lidERA Breast Cancer [NCT04961996] is a phase III, randomised, open-label, multicentre study evaluating the efficacy and safety of adjuvant giredestrant versus standard-of-care endocrine therapy in people with medium- or high-risk stage I-III oestrogen receptor-positive, human epidermal growth factor receptor 2-negative breast cancer.¹⁵ Over 4,100 patients were enrolled in the study.¹⁵

The primary endpoint is invasive disease-free survival (iDFS) excluding unrelated cancers in other organs (second primary non-breast cancers).¹⁵ Key secondary endpoints include overall survival, iDFS including second primary non-breast cancers, disease-free survival and safety.¹⁵

About giredestrant
Giredestrant is an investigational, oral, potent next-generation selective oestrogen receptor degrader and full antagonist.¹⁶

Giredestrant is designed to block oestrogen from binding to the oestrogen receptor, triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.¹⁷

Giredestrant has an extensive clinical development programme and is being investigated in five company-sponsored phase III clinical trials that span multiple treatment settings and lines of therapy to benefit as many people as possible:

Giredestrant versus standard-of-care endocrine therapy (SoC ET) as adjuvant treatment in oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)¹⁵
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)¹⁸
Giredestrant plus palbociclib versus letrozole plus palbociclib in ER-positive, HER2-negative, endocrine-sensitive, recurrent locally advanced or metastatic breast cancer (persevERA Breast Cancer; NCT04546009)¹⁹
Giredestrant plus investigator’s choice of a cyclin-dependent kinase 4/6 (CDK4/6) inhibitor versus fulvestrant plus a CDK4/6 inhibitor in ER-positive, HER2-negative advanced breast cancer resistant to adjuvant endocrine therapy (pionERA Breast Cancer; NCT06065748)²⁰
Giredestrant plus Phesgo® (pertuzumab, trastuzumab, and hyaluronidase subcutaneous) versus Phesgo in ER-positive, HER2-positive locally advanced or metastatic breast cancer (heredERA Breast Cancer; NCT05296798)²¹

About oestrogen receptor (ER)-positive breast cancer
Globally, the burden of breast cancer continues to grow, with 2.3 million women diagnosed and 670,000 dying from the disease every year.8 Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.²²

ER-positive breast cancer accounts for approximately 70% of breast cancer cases, and the majority are diagnosed in the early-stage.9 A defining feature of ER-positive breast cancer is that its tumour cells have receptors that attach to oestrogen, which can contribute to tumour growth.²³

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity.²⁴ Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy.^{24, 25}There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.^{24, 25}

About Roche in breast cancer
Roche has been advancing breast cancer research for more than 30 years, and it continues to be a major focus of research and development. Our legacy began with the development of the first targeted therapy for human epidermal growth factor receptor 2-positive breast cancer, and we continue to push the boundaries of science to address the complexities of all breast cancer subtypes.

By leveraging our dual expertise in pharmaceuticals and diagnostics, we are dedicated to providing tailored treatment approaches and improving outcomes for every patient, from early to advanced stages of the disease. Together with our partners, we are relentlessly pursuing a cure, as we strive for a future where no one dies from breast cancer.

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

All trademarks used or mentioned in this release are protected by law.

References
[1] Bardia A, et al. Giredestrant vs standard-of-care endocrine therapy as adjuvant treatment for patients with estrogen receptor-positive, HER2-negative early breast cancer: Results from the global Phase III lidERA Breast Cancer trial. Presented at: San Antonio Breast Cancer Symposium (SABCS); 2025 December 9-12; San Antonio, Texas, United States. #GS1-10.
[2] Baum M, et al. Anastrozole alone or in combination with tamoxifen versus tamoxifen alone for adjuvant treatment of postmenopausal women with early breast cancer: first results of the ATAC randomised trial. Lancet. 2002;359(9324):2131-9.
[3] Thürlimann B, et al. A Comparison of Letrozole and Tamoxifen in Postmenopausal Women with Early Breast Cancer. N Engl J Med; 2005;353:2747-57.
[4] F. Hoffmann‑La Roche Ltd. (2026) SEER Explorer All BCa by Stage. Data on file.
[5] F. Hoffmann‑La Roche Ltd. (2026) Stage Distribution. Data on file.
[6] F. Hoffmann‑La Roche Ltd. (2026) KREBS and TRM. Data on file.
[7] F. Hoffmann‑La Roche Ltd. (2026). UK_CRUK_EDHub_IncidenceByStageRCRD_DataTable2026-01-08. Data on file.
[8] World Health Organization. Breast Cancer [Internet; cited 2026 June]. Available from: https://www.who.int/news-room/fact-sheets/detail/breast-cancer
[9] Kinslow C, et al. Prevalence of Estrogen Receptor Alpha (ESR1) Somatic Mutations in Breast Cancer. JNCI Cancer Spectrum; 2022;6(5):pkac060.
[10] Shaughnessy J, et al. Real-world risk of recurrence and treatment outcomes with adjuvant endocrine therapy in patients with stage II-III HR+/HER2- early breast cancer. Breast. 2025;81:104437.
[11] Pan H, et al. 20-Year Risks of Breast-Cancer Recurrence after Stopping Endocrine Therapy at 5 Years. NEJM. 2017;377:1836–46.
[12] Khatpe AS, et al. Nexus between PI3K/AKT and Estrogen Receptor Signaling in Breast Cancer. Cancers (Basel). 2021;13(3):369.
[13] Hershman DL, et al. Early discontinuation and non-adherence to adjuvant hormonal therapy are associated with increased mortality in women with breast cancer. Breast Cancer Res Treat. 2011;126:529–37.
[14] Rosso R, et al. Adherence to Adjuvant Endocrine Therapy in Breast Cancer Patients. Curr Oncol. 2023;30(2):1461-72.
[15] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2- Negative Early Breast Cancer (lidERA Breast Cancer) [Internet; cited 2026 June]. Available from: https://clinicaltrials.gov/study/NCT04961996
[16] Martin M, et al. Giredestrant (GDC-9545) vs physician choice of endocrine monotherapy (PCET) in patients (pts) with ER+, HER2– locally advanced/metastatic breast cancer (LA/mBC): Primary analysis of the phase 2, randomised, open-label acelERA BC study. Presented at: ESMO Annual Meeting; 2022 September 9-13; Paris, France. Abstract #211MO.
[17] Metcalfe C, et al. GDC-9545: A novel ER antagonist and clinical candidate that combines desirable mechanistic and pre-clinical DMPK attributes. Presented at: SABCS; 2018 December 4-8; San Antonio, Texas, United States. Abstract #P5-04-07.
[18] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) [Internet; cited 2026 June]. Available from: https://clinicaltrials.gov/study/NCT05306340
[19] ClinicalTrials.gov. A Study Evaluating the Efficacy and Safety of Giredestrant Combined With Palbociclib Compared With Letrozole Combined With Palbociclib in Participants With Estrogen Receptor-Positive, HER2- Negative Locally Advanced or Metastatic Breast Cancer (persevERA Breast Cancer) [Internet; cited 2026 June]. Available from: https://clinicaltrials.gov/study/NCT04546009
[20] ClinicalTrials.gov. A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/ 6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) [Internet; cited 2026 June]. Available from: https://clinicaltrials.gov/study/NCT06065748
[21] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer) [Internet; cited 2026 June]. Available from: https://clinicaltrials.gov/study/NCT05296798.
[22] World Health Organization. Cancer Today [Internet; cited 2026 June]. Available from: https://gco.iarc.fr/today/en/dataviz/bars?mode=cancer&types=1&group_populations=1&sexes=2&key=asr&age_end=14.
[23] National Cancer Institute. Hormone Therapy for Breast Cancer [Internet; cited 2026 June]. Available from: https://www.cancer.gov/types/breast/breast-hormone-therapy-fact-sheet
[24] Hanker A, et al. Overcoming Endocrine Resistance in Breast Cancer. Canc Cell. 2020;37(4):496–513.
[25] Başaran G, et al. Ongoing unmet needs in treating estrogen receptor-positive/HER2-negative metastatic breast cancer. Cancer Treat Rev. 2018;63:144-55.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +41 79 398 38 53	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03	Irène Stephan Phone: +41 79 377 83 75

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

Media&Investor Release lidERA FDA Filing Acceptance English

Roche to present new data advancing its obesity portfolio at the American Diabetes Association’s 2026 Scientific Sessions

Mon, 01 Jun 2026 05:00:00 GMT

Late-breaking Phase II data highlight enicepatide’s (CT-388) efficacy and safety, reinforcing its potential to deliver best-in-class weight loss across a broad population of people living with overweight or obesity
Late-breaking data from the Phase II ZUPREME-1 trial showcase petrelintide’s efficacy, safety, and compelling tolerability profile, which has the potential to redefine the weight management experience for people living with overweight or obesity
A Phase II multi-arm trial evaluating enicepatide and petrelintide fixed-dose combinations will be initiated towards mid-2026 to develop a differentiated treatment option

Basel, 1 June 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that new data from its obesity portfolio will be presented at the 2026 Scientific Sessions of the American Diabetes Association® (ADA). The insights demonstrate significant progress in addressing a range of unmet needs for people living with obesity or overweight such as long-term treatment adherence, which could be supported by a favorable safety and tolerability profile.

“The data we will present at ADA highlight the growing strength of our obesity portfolio, exemplified by the robust efficacy and distinct tolerability profiles of enicepatide and petrelintide,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The clinical insights from these studies demonstrate how our portfolio may offer more tailored, individualised treatment options for people living with obesity.”

The data presented on Roche’s obesity assets include:

Enicepatide (CT-388): Late-breaking data from the Phase II (CT388-103) study will highlight clinical weight loss outcomes from investigational enicepatide in people living with overweight/obesity. The dual GLP-1/GIP receptor agonist is also being investigated in an additional Phase II study (CT388-104) to evaluate its efficacy, safety and tolerability in participants who are living with obesity or are overweight and have type 2 diabetes (T2D). These data suggest that enicepatide could emerge as an important medicine in its own right and also a key backbone for potential combination therapies from Roche’s cardiometabolic pipeline.
Petrelintide: Late-breaking data from the Phase II ZUPREME-1 trial highlight the efficacy and safety of petrelintide, an investigational human amylin analog being evaluated for weight management in people living with overweight and obesity. The ongoing Phase II petrelintide monotherapy trial, ZUPREME-2 is evaluating petrelintide versus placebo in people living with obesity or overweight and T2D. As monotherapy and in combination with enicepatide, petrelintide can become an important component of Roche's portfolio.

Roche continues to advance its weight management pipeline rapidly, moving both enicepatide and petrelintide into Phase III development while initiating a Phase II multi-arm combination trial in mid-2026.

Roche is pleased to invite investors and analysts to participate in its virtual event on Monday, 8 June 2026, that will highlight the new data from the Phase II CT388-103 study of enicepatide, as well as from the Phase II ZUPREME-1 study of petrelintide.

Additional details on presentations at the ADA’s Scientific Sessions are included below and the full abstracts will be available in Diabetes.

Asset	Title / Lead author	Abstract / presentation details
Enicepatide (CT-388)	CT-388, a cAMP Signal-Biased GLP-1/GIP Receptor Agonist, Achieves Clinically Meaningful Weight Loss in People With Overweight/Obesity: A 48-Week Phase 2 Study. Lingvay I, et al.	Late Breaking Poster Session (2813-LB) Sunday, 07 June 12:30 pm - 1:30 pm CT
Enicepatide (CT-388)	As above	E-Theater presentation Monday, 08 June 12:30pm CT
Petrelintide	Amylin as a Novel Diabetes and Obesity Therapy. Garvey T, et al.	Scientific Symposium Friday, 05 June 3:45pm - 5:15pm CT
	Petrelintide, a human amylin analog for weight management: efficacy and safety from the Phase 2 trial, ZUPREME-1. Garvey T, et al.	Late Breaking Poster Session (3083-LB) Sunday, 07 June 12:30 pm - 1:30 pm CT (ePoster: Saturday, June 06 1:30pm - 1:40pm CT)
	Petrelintide elicits distinct effects on eating pattern and maintains locomotor activity compared to semaglutide in rats with diet-induced obesity Gradel A, et al.	Poster Presentation Monday, 08 June 12:30 pm - 1:30 pm CT
	Long-acting amylin analog petrelintide does not delay gastric emptying Griffin J, et al.	Poster Presentation Monday, 08 June 12:30 pm - 1:30 pm CT

About Enicepatide (CT-388)
Enicepatide is an investigational once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist being developed for the treatment of people living with obesity and associated comorbidities including type 2 diabetes (T2D). Enicepatide was designed to have potent activity on both the GLP-1 and GIP receptors but with minimal to no beta-arrestin recruitment on either receptor. This biased signalling significantly minimises receptor internalisation and consequent desensitisation, which is expected to lead to prolonged pharmacological activity.

About Petrelintide
Petrelintide is an investigational long-acting amylin analog suitable for once-weekly subcutaneous administration that has been designed with chemical and physical stability with no fibrillation around neutral pH, allowing for co-formulation and co-administration with other peptides.¹ Amylin is produced in the pancreatic beta cells and co-secreted with insulin in response to ingested nutrients. Amylin receptor activation has been shown to reduce body weight by restoring sensitivity to the satiety hormone leptin^2,3inducing a sense of feeling full faster.

About Obesity
Obesity is recognised as the greatest single risk factor for chronic disease globally. The condition is associated with many health challenges and more than 200 comorbidities, including type 2 diabetes, cardiovascular diseases, fatty liver, and chronic kidney disease. By 2035, over four billion people (more than half of the global population) are projected to be living with excess weight or obesity, a trend affecting nearly every country. This rise is driven by a complex mix of genetics and biology as well as behavioural, environmental and socioeconomic factors, placing an increased strain on healthcare systems due to the associated burden of comorbidities and reduced quality of life.

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

All trademarks used or mentioned in this release are protected by law.

References
[1] Eriksson et al. Presentation at ObesityWeek, November 1–4, 2022, San Diego, CA. Link: https://www.zealandpharma.com/media/0gnfxg4b/zp8396-sema-coformulation-obesityweek-2022.pdf.
[2] Mathiesen et al. Eur J Endocrinol 2022;186(6):R93–R111
[3] Roth et al. Proc Natl Acad Sci U S A 2008;105(20):7257–7262

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
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Dr Rebekka Schnell Phone: +41 79 205 27 03	Irène Stephan Phone: +41 79 377 83 75

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

Media&Investor Release ADA 2026 curtain raiser English

Roche launches the Liver Disease Panel, the first suite of certified algorithms to support Chronic Liver Disease management

Wed, 27 May 2026 05:00:00 GMT

Roche introduces the first comprehensive library of certified healthcare algorithms to support chronic liver disease (CLD) management
The Liver Disease Panel includes LiverPRO—a certified algorithm developed by the health tech company Evido—requiring only age and routine blood markers for the timely detection of liver fibrosis
With CLD affecting 1.5 billion people worldwide, the non-invasive panel solution covers care along the patient pathway from fibrosis risk identification to the surveillance of liver cancer

Basel, 27 May 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today the launch of its comprehensive Liver Disease Panel, a suite of certified algorithms designed to help clinicians better identify and manage chronic liver disease (CLD). By bringing together biomarker-based diagnostics and advanced digital algorithms, including the CE-marked algorithm LiverPRO, the Liver Disease Panel supports better-informed clinical decisions, from timely fibrosis risk identification, to the surveillance of liver cancer.

Chronic liver disease represents a growing global health challenge, with 1.5 billion people affected worldwide.¹ CLD remains widely undiagnosed, as early stages may often present without symptoms, leading to missed opportunities for early intervention and avoidable progression to advanced disease, which can include cirrhosis and liver cancer. The drivers behind CLD are wide-ranging. In addition, the increasing prevalence of metabolic conditions like MASLD (Metabolic dysfunction-Associated Steatotic Liver Disease) now affects 38% of the global population and is becoming the fastest-growing cause of liver cancer worldwide.²

“Chronic liver disease impacts millions of lives around the world, and patients need effective care at every stage of their journey,” said Matt Sause, CEO Roche Diagnostics. “With the Liver Disease Panel, we are enabling clinicians to identify risk earlier, intervene sooner, and manage this disease more effectively, helping to improve liver care and support better patient health.”

From Detection to Care: Optimising the Liver Care Pathway
The Liver Disease Panel is designed to support clinical decision-making across key stages of the chronic liver disease pathway, from timely risk identification and disease assessment to treatment guidance in future versions of the panel. By combining complementary biomarkers within advanced digital algorithms, the panel helps clinicians make more confident, evidence-based decisions using routinely available clinical data.

In leveraging advanced biomarkers, like Elecsys® PRO-C3 within powerful digital tools like ADAPT³ and now LiverPRO, the Liver Disease Panel transforms the patient journey by enabling broader reach and timely patient detection through a scalable approach to assessing fibrosis severity. Through the integration of biomarker innovation with algorithm analysis, the Liver Disease Panel reduces reliance on invasive tests and provides a proactive, preventive model of care.

Investing in digital diagnostics to advance the standard of care
Roche is investing in digital innovation to advance the standard of care in liver disease. Through a collaboration with the health tech company Evido, the Liver Disease Panel includes LiverPRO, an innovative algorithm that adapts to existing patient data—requiring only age and and a minimum of three out of nine common blood-based biomarkers to assess the risk of liver fibrosis. By leveraging accessible routine lab results, LiverPRO supports timely intervention, helping clinicians act sooner and improving disease management before patients reach advanced stages of the disease. LiverPRO has been endorsed in the EASL Patient Trajectory Guidance as an alternative and scalable first-line test for liver fibrosis, confirming that the tool standardizes patient referrals and speeds up the identification of high-risk cases using a non-invasive technology.⁴

About the Liver Disease Panel
The Liver Disease Panel represents Roche’s first comprehensive digital portfolio of biomarker and digital algorithm solutions designed to support care across key stages of the chronic liver disease pathway. This includes conditions along the liver disease spectrum, including metabolic dysfunction-associated steatotic liver disease (MASLD) to metabolic dysfunction-associated steatohepatitis (MASH) and hepatocellular carcinoma (HCC).

This library brings together clinically validated algorithms into a single, secure platform. It combines tools like LiverPRO for likelihood of having liver fibrosis, ADAPT with Roche's Elecsys® PRO-C3 for assessing severity of liver fibrosis, and GAAD with Roche's Elecsys® AFP and Elecsys® PIVKA II for aid in diagnosis of hepatocellular carcinoma (HCC)—with trusted clinical tools such as the FIB-4 Index³, MELD Scores³, ALBI Score³, Child-Pugh Score³, and the Lille Model³. Each solution is certified and automated within clinical workflows, ensuring patient data is handled with the highest standards required for a medical device.

The Liver Disease Panel, available on the navify® Algorithm Suite, marks a significant step in Roche’s strategy to provide digital health solutions for the growing global burden of chronic liver disease. It seamlessly integrates with existing hospital systems, giving clinicians a single point of access to order and view algorithm results. The Liver Disease Panel will be available in markets across Europe.

About navify
The navify portfolio from Roche includes more than 130 digital solutions for labs, hospitals and patients worldwide in commercial or research phases. navify solutions connect the healthcare community with a robust digital infrastructure to integrate data efficiently and to accelerate clinician access to innovations as well as operational and medical insights. This work includes collaborating with other innovative companies such as Fortinet in cybersecurity services. The navify platform is designed to deliver security at every step of the data analytical process with ISO/IEC 27001 certification for the Information Security Management System. All data is encrypted at rest and in transit. The solution is operated in compliance with applicable laws and regulations in the USA with HIPAA (Health Insurance Portability and Accountability) as well as with GDPR (General Data Protection Regulation) regulations in Europe.

Healthcare professionals can visit navify to browse and request a growing number of next generation digital solutions from Roche and other companies — all designed to drive operational and clinical excellence, built on the foundational pillars of digital trust. More information is also available at navify.com.

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

ELECSYS and NAVIFY are trademarks of Roche. All other product names and trademarks are the property of their respective owners.

References
[1] Vento, S., & Cainelli, F. (2022). Chronic liver diseases must be reduced worldwide: it is time to act. The Lancet Global Health, 10(4), e471–e472. https://doi.org/10.1016/s2214-109x(22)00047-x
[2] Younossi, Z. M., Kalligeros, M., & Henry, L. (2025). Epidemiology of metabolic dysfunction-associated steatotic liver disease. Clinical and Molecular Hepatology, 31(Suppl), S32–S50. https://doi.org/10.3350/cmh.2024.0431
[3] Legal manufacturer: Evidencio B.V.
[4] Brouwer, W. P., Ginès, P., Tsochatzis, E. A., et al. (2026). Steatotic liver disease trajectory: A holistic EASL guidance on the multidisciplinary approach to screening and patient management. JHEP Reports, 8(3), 101798. https://doi.org/10.1016/j.jhepr.2026.101798

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +41 79 398 38 53	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03	Irène Stephan Phone: +41 79 377 83 75

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Media Release Liver Disease Panel English

Roche to present new data at ASCO 2026, reinforcing giredestrant's potential to transform the treatment paradigm in early breast cancer

Tue, 19 May 2026 05:00:00 GMT

New giredestrant data from the lidERA study on its potential as a new standard of care for adjuvant ER-positive breast cancer across all menopausal stages
Primary results from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease
Overall, nine approved and investigational medicines, including bispecific antibodies, antibody-drug conjugates and brain-permeable molecules, with ASCO data targeting urgent needs in breast, blood, lung and other cancers

Basel, 19 May 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) will present new data from nine approved and investigational medicines across more than 15 indications at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, held 29 May to 2 June in Chicago.

"Roche’s ASCO data reflect our commitment to addressing those cancers that impose the highest burden on patients and society," said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development. "In particular, our ASCO data highlight significant advances in breast cancer, including the latest results for giredestrant and our evolving approach to HER2-positive metastatic disease."

Redefining the standard of care in breast cancer
Roche's ASCO 2026 focus is on giredestrant, an investigational, oral, selective oestrogen receptor degrader (SERD) being studied in early and advanced oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer.

This subtype accounts for approximately 70% of breast cancer cases, and the majority are diagnosed in the early stage.^1,2 Data from three phase III trials demonstrate giredestrant's potential as a future standard of care endocrine therapy across multiple disease stages:

lidERA Breast Cancer: Building on the transformational results shared in December 2025, which demonstrated a 30% reduction in the risk of invasive disease recurrence or death,³ new data will indicate whether the efficacy and safety of giredestrant remain consistent across pre- and post-menopausal patients with early breast cancer. The lidERA data have been submitted to the U.S. Food and Drug Administration (FDA).
persevERA Breast Cancer: Primary results investigating giredestrant in combination with palbociclib as a first-line therapy in locally advanced or metastatic cancer will be presented. These data will provide context following the announcement that while the study did not meet its primary endpoint, the giredestrant combination showed a numerical improvement in this distinct patient population, suggesting that giredestrant is active in the first-line setting.
evERA Breast Cancer: New post-progression treatment analyses will be shared exploring the sustained clinical benefit for people treated with giredestrant plus everolimus in the post-cyclin-dependent kinase 4/6 inhibitor setting. The U.S. FDA recently accepted the New Drug Application for giredestrant based on the positive evERA data.

Our ASCO data also highlight progress in HER2-positive breast cancer, an area Roche has led for over 30 years:

RG6596/ZN-A-1041 in HER2-positive breast cancer: Preliminary results from a phase Ic expansion trial will provide early information on the safety and efficacy of ZN-A-1041, a highly blood-brain barrier-permeable, HER2-selective tyrosine kinase inhibitor, in combination with other HER2-targeted therapies, for patients with pre-treated HER2-positive metastatic breast cancer. Designed for enhanced brain penetration, ZN-A-1041 may improve the ability to prevent and treat brain metastases, a major challenge in metastatic breast cancers.

Advancing precision medicine and novel combinations
Roche is also presenting data from its diverse pipeline targeting specific genetic drivers and difficult-to-treat cancers, including:

Divarasib in non-small cell lung cancer (NSCLC): Roche will present results from the Krascendo 170 phase Ib/II study evaluating the next-generation oral KRAS G12C inhibitor divarasib combined with pembrolizumab in treatment-naive patients with KRAS G12C+ advanced NSCLC. These data informed the phase III Krascendo 2 study, which investigates this combination as a first-line therapy regardless of PD-L1 status. Divarasib is currently being evaluated in three pivotal phase III studies as a monotherapy or in chemotherapy-free combinations.
Lunsumio® (mosunetuzumab) plus Polivy® (polatuzumab vedotin) in diffuse large B-cell lymphoma (DLBCL): Roche will present updated data from the phase III SUNMO trial to further establish the efficacy and safety of Lunsumio plus Polivy compared to chemotherapy (R-GemOx) particularly in second-line patients with relapsed/refractory DLBCL who are not eligible for transplant. This first combination of a bispecific antibody and antibody-drug conjugate could potentially provide patients who often face poor prognoses and significant treatment burdens with an effective, fixed-duration, chemotherapy-free regimen.

Overview of key presentations featuring Roche medicines and molecules:

Medicine or molecule	Abstract title	Abstract number/ presentation details
Breast cancer
Giredestrant	Giredestrant (GIRE) + palbociclib (PALBO) vs letrozole (LET) + PALBO as first-line (1L) therapy in patients (pts) with estrogen receptor-positive, HER2-negative locally advanced or metastatic breast cancer (ER+, HER2– LA/mBC): Primary analysis of the phase III persevERA Breast Cancer (BC) trial	#LBA1006 oral Breast Cancer — Metastatic Tuesday 02 June 2026 11:45 - 11:57 AM CDT
Giredestrant	Efficacy and safety of giredestrant (GIRE) in patients (pts) with estrogen receptor-positive, HER2-negative early breast cancer (ER+, HER2– eBC) in the phase III lidERA BC clinical trial: Results by menopausal status	#502 oral Breast Cancer —Local/Regional/Adjuvant Saturday 30 May 2026 1:39 - 1:51 PM CDT
Giredestrant	Post-progression treatment (tx) analyses of evERA Breast Cancer (BC): A phase III trial of giredestrant (GIRE) + everolimus (E) in patients (pts) with estrogen receptor-positive, HER2-negative advanced BC (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i)	#1016 rapid oral Breast Cancer — Metastatic Sunday 31 May 2026 12:00 - 12:06 PM CDT
RG6596/ ZN-A-1041	Safety and efficacy of ZN-A-1041, a highly blood–brain barrier (BBB)-permeable HER2 tyrosine kinase inhibitor (TKI), + trastuzumab deruxtecan (T-DXd) or pertuzumab-trastuzumab (PH) in HER2-positive metastatic breast cancer (HER2+ mBC): Phase Ic expansion results from the ZN-A-1041-101-US trial	#1055 poster Breast Cancer — Metastatic Monday 01 June 2026 1:30 - 4:30 PM CDT
Itovebi® (inavolisib)	Outcomes by lobular (lob) histology status at initial diagnosis in patients (pts) in the INAVO120 phase 3 trial with PIK3CA-mutated (mut), hormone receptor-positive (HR+), HER2-negative (HER2–), endocrine-resistant advanced breast cancer (aBC) treated with inavolisib (INAVO)/placebo (PBO) + palbociclib (PALBO) + fulvestrant (FULV)	#1079 poster Breast Cancer — Metastatic Monday 01 June 2026 1:30 - 4:30 PM CDT
Kadcyla® (trastuzumab emtansine)	Adjuvant antibody–drug conjugate (ADC) eligibility and corresponding prognosis in HER2+ early breast cancer (eBC): A US-based real-world comparison of KATHERINE and DESTINY-Breast05 populations	#535 poster Breast Cancer —Local/Regional/Adjuvant Monday 01 June 2026 1:30 - 4:30 PM CDT
Blood cancer
Lunsumio® (mosunetuzumab) and Polivy® (polatuzumab vedotin)	Mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) versus rituximab, gemcitabine and oxaliplatin (R-GemOx) in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL): Updated efficacy and safety from the phase 3 SUNMO study including in second-line (2L) versus third-line plus (3L+) patient subgroups	#7007 oral Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia Saturday 30 May 2026 5:12 - 5:24 PM CDT
Columvi® (glofitamab)	Fixed-duration glofitamab monotherapy in relapsed/refractory (R/R) mantle cell lymphoma (MCL) with/without prior Bruton's tyrosine kinase inhibitor (BTKi) exposure: updated data after a 3.5-year follow-up	#7006 oral Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia Saturday 30 May 2026 5:00 - 5:12 PM CDT
Polivy	Outcomes by LymphoMAP archetypes in untreated diffuse large B-cell lymphoma from the POLARIX trial	#7017 rapid oral Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia Friday 29 May 2026 2:12 - 2:18 PM CDT
Columvi, Lunsumio and Polivy	Multivariable analyses (MVAs) of overall survival (OS) in the phase 3 SUNMO, STARGLO and POLARGO trials in relapsed/refractory large B-cell lymphoma (LBCL)	#7093 poster Hematologic Malignancies —Lymphoma and Chronic Lymphocytic Leukemia Monday 01 June 2026 9:00 - 12:00 PM CDT
Lung cancer
Divarasib	First-line (1L) divarasib plus pembrolizumab (pembro) in advanced or metastatic KRAS G12C+ non-small cell lung cancer (NSCLC): results from the Krascendo-170 study	#8510 clinical science symposium Lung Cancer — Non-Small Cell Metastatic Saturday 30 May 2026 8:36 - 8:48 AM CDT
Tecentriq® (atezolizumab)	Transcriptomic analyses of molecular subsets and correlations with clinical outcomes from the phase 3 IMforte study of lurbinectedin (lurbi) + atezolizumab (atezo) maintenance treatment (Tx) in extensive-stage small-cell lung cancer (ES-SCLC)	#8014 rapid oral Lung Cancer — Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Sunday 31 May 2026 5:12 - 5:18 PM CDT
Tecentriq	IMforte: Quality-adjusted time without symptoms or toxicity (Q-TWiST) analysis of first-line maintenance (1Lm) treatment (Tx) with lurbinectedin (lurbi) + atezolizumab (atezo) vs atezo in extensive-stage small cell lung cancer (ES-SCLC)	#8086 poster Lung Cancer — Non-Small Cell Local-Regional/Small Cell/Other Thoracic Cancers Sunday 31 May 2026 9:00 - 12:00 PM CDT
Gastrointestinal cancer
Tecentriq	IMbrave251: Final analysis of atezolizumab (atezo) plus lenvatinib (lenva) or sorafenib (sora) vs lenva or sora alone in locally advanced or metastatic hepatocellular carcinoma (LA/mHCC) previously treated with atezo and bevacizumab (bev)	#4002 oral Gastrointestinal Cancer —Gastroesophageal, Pancreatic, and Hepatobiliary Monday 01 June 2026 10:09 - 10:21 AM CDT
Tecentriq	Health-related quality of life (HRQOL) in the phase 3 trial of standard chemotherapy alone or combined with atezolizumab as adjuvant therapy for patients with stage III deficient DNA mismatch repair (dMMR) colon cancer (Alliance A021502, ATOMIC)*	#3626 poster Gastrointestinal Cancer —Colorectal and Anal Saturday 30 May 2026 9:00 - 12:00 PM CDT
Bladder cancer
Tecentriq	Patient-reported outcomes from IMvigor011: A phase 3 study of circulating tumor (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer (MIBC)	#4627 poster Genitourinary Cancer — Kidney and Bladder Sunday 31 May 2026 9:00 - 12:00 PM CDT

*Study led by the Alliance for Clinical Trials in Oncology and supported by Roche

About Roche in oncology
For over 60 years, Roche has delivered transformative medicines and diagnostics, redefining the treatment of some of the most challenging cancers. Driven by a vision of a future where cancer can be cured, we focus our efforts on cancers with the highest societal impact and where we bring deep expertise, including breast, lung, and blood cancers, while pursuing breakthrough innovation in other areas of unmet need. Our pipeline features a diverse array of modalities, from small molecules and antibodies to next-generation ADCs and allogeneic CAR T-cell therapies. By advancing best-in-class precision medicine, pioneering novel combinations, and leveraging key technologies and partnerships, Roche tackles oncology's toughest challenges with the goal of delivering life-changing outcomes for people with cancer.

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

All trademarks used or mentioned in this release are protected by law.

References
[1] Kinslow C, et al. Prevalence of Estrogen Receptor Alpha (ESR1) Somatic Mutations in Breast Cancer. JNCI Cancer Spectrum; 2022;6(5):pkac060.
[2] O’Shaughnessy J, et al. Real-world risk of recurrence and treatment outcomes with adjuvant endocrine therapy in patients with stage II-III HR+/HER2- early breast cancer. Breast. 2025;81:104437.
[3] Bardia A, et al. Giredestrant vs standard-of-care endocrine therapy as adjuvant treatment for patients with estrogen receptor-positive, HER2-negative early breast cancer: Results from the global Phase III lidERA Breast Cancer trial. Presented at: San Antonio Breast Cancer Symposium (SABCS); 2025 December 9-12; San Antonio, Texas, United States. #GS1-10.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +41 79 398 38 53	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03	Irène Stephan Phone: +41 79 377 83 75

Roche Investor Relations

Dr. Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr. Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr. Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

Media Investor Release ASCO curtain raiser English

Roche receives CE mark for new blood test to detect Alzheimer's pathology: Elecsys® plasma phosphorylated-tau 217 (pTau217)

Tue, 12 May 2026 05:24:41 GMT

Elecsys® pTau217 is the first blood test for Alzheimer’s disease pathology with a single‑assay design, intended to rule in and rule out amyloid pathology across primary and secondary care, offering faster diagnosis for millions of patients around the world.^1,2,5
While maintaining accuracy comparable to spinal fluid diagnostics against the gold standard PET-CT scans, the Elecsys® pTau217 test offers a more convenient, minimally invasive alternative via a routine blood draw.^1,2,4,7,8,11
Diagnosing dementia currently takes 3.5 years on average,¹¹ and an estimated 75% of people living with dementia remain undiagnosed.^6,9,11 Elecsys® pTau217 offers a simple blood test to aid in earlier, more accessible Alzheimer's disease diagnosis for millions of patients around the world.^1,2,4,5,7,8

Basel, 12 May 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it has received CE Mark for Elecsys® pTau217, a blood test developed in collaboration with Eli Lilly and Company and designed to measure the phosphorylated Tau (pTau) 217 protein, an indicator of amyloid pathology and a hallmark of Alzheimer’s disease.^1,2,4,7,8 The same cutoffs (high and low) of the blood test can be used across primary and secondary care settings, to rule in or rule out amyloid pathology in people presenting with symptoms or complaints of cognitive decline.^1,2,4,5 The early detection of the amyloid pathology is critical for Alzheimer’s diagnosis and treatment, as it enables individuals, families, and caregivers to understand the cause of symptoms, access appropriate care, and actively contribute to the planning of next steps.^3,4,5,9,10

“The launch of pTau217 marks a significant step in providing a simple, blood-based tool to diagnose Alzheimer's much earlier in the patient journey,” said Matt Sause, CEO of Roche Diagnostics. “Today, many people face a long and difficult path to a diagnosis, often relying on specialised care and costly procedures. By bringing this advanced test into routine care, we are helping physicians to support patients and families with an earlier assessment that is critical for timely intervention, while reducing pressure on healthcare systems.”

“For millions of families navigating the uncertainty of Alzheimer’s, a timely diagnosis is the first and most critical step toward meaningful care,” said Carole Ho, M.D., Executive Vice President and President, Lilly Neuroscience. “Lilly’s collaboration with Roche on the Elecsys pTau217 assay was driven by a shared commitment to bringing this innovation into routine practice, overcoming complexity in testing and enabling patients to make informed decisions about the future.”

Barriers to early and accurate diagnosis of Alzheimer’s disease exist worldwide.^9,6,11 An estimated 75% of people living with dementia remain undiagnosed,^6,9,11 and those who are diagnosed typically wait an average of around 3.5 years after cognitive decline symptoms are first noticed.^3,4,6,9 With Alzheimer’s disease representing the most common cause of dementia, improving access to tests that detect Alzheimer’s-related brain changes is critical to speeding up diagnosis.^3,4,8,9,10 Current methods to confirm amyloid pathology — such as positron emission tomography (PET) scan and cerebrospinal fluid (CSF) assessment — can be difficult to access, expensive, and can be perceived as more invasive than a simple blood test.^7,8 The pTau217 assay contributes to addressing the undiagnosed population, with reliable detection of AD pathology in individuals with early cognitive decline symptoms.^1,2,5,8

The Elecsys® pTau217 CE Mark was granted based on data from retrospective studies of a real-world population at the earliest stages of Alzheimer’s (Subjective Cognitive Decline, Mild Cognitive Impairment and Mild Dementia), a point where individuals may notice memory changes but still live independently.^1,2,5,8 This focus ensures the test performs where it is needed most: at the dawn of the disease, when timely intervention has the greatest potential to preserve independence and slow the progression of decline.^3,4,9,10

Further information will be presented at today’s Roche Diagnostics Day 2026, starting at 14:00 CET.

About Elecsys® pTau217
A positive Elecsys® pTau217 blood test result indicates a high likelihood of amyloid pathology, a hallmark of Alzheimer’s disease.^1,2,4,7,8 This can guide primary care clinicians to make timely referrals and provide specialists with the actionable data needed to advance patient evaluation and management.^2,3,4,8,9,10

A negative result indicates a low likelihood of amyloid pathology, meaning clinicians may be able to rule out Alzheimer’s disease and avoid further invasive CSF or PET investigations, helping to preserve specialist resources by shifting clinical focus to other potential causes of cognitive symptoms.^1,2,4,7,8 An indeterminate result requires additional testing to establish a diagnosis.^4,8 Elecsys® pTau217 should be used in conjunction with other clinical information.^3,4,8

The Elecsys® pTau217 assay is clinically robust, supporting flexible workflows and sample handling aligned with routine processes.^1,2,5,8 Data support its potential to refine diagnosis by providing a single, robust biomarker that is broadly available across Roche’s large installed base of instruments with a high-throughput, full-automation assay.

Following CE Mark approval, this simple and convenient blood test will leverage Roche’s broad installed base of instruments across countries accepting the CE mark, positioning Elecsys® pTau217 for rapid and wide implementation in routine practice.

This scale makes it easier for laboratories to bring accurate, minimally invasive Alzheimer’s testing closer to patients and clinicians throughout countries accepting CE mark, with the potential for expansion to the US, subject to FDA approval later this year.

About Roche in Alzheimer’s
With more than two decades of scientific research in Alzheimer’s, Roche is working towards a day when we can detect and treat the condition earlier, so we can slow, stop or even prevent its progression and preserve what makes people who they are. Today, Roche’s Alzheimer’s disease portfolio spans investigational diagnostics and medicines for different targets, types and stages of the disease.

In pharma, trontinemab is an investigational Brainshuttle bispecific 2+1 amyloid‑beta targeting monoclonal antibody specifically engineered for enhanced brain access, enabling rapid reduction of amyloid in people with Alzheimer’s disease (AD), and is currently being investigated in two Phase 3 clinical studies in early AD. Nivegacetor is a highly potent and selective oral gamma‑secretase modulator (GSM) that alters amyloid precursor protein (APP) processing to prevent amyloid accumulation and halt plaque formation, and is currently in Phase 2 clinical development for AD.

In diagnostics, Roche offers one of the broadest portfolios of biomarker assays, including the blood‑based Elecsys® pTau217, Elecsys® pTau181 and Elecsys® ApoE4 tests, in addition to CSF assays and digital solutions. These enable more effective and timely detection, diagnosis, and monitoring of the disease across the care pathway. The company also provides a wide range of research-use-only (RUO) assays that advance scientific understanding and support future innovation.

Addressing the global burden of Alzheimer’s requires more than innovative tests and treatments. This is why Roche partners with clinicians, scientists, patient advocates, policymakers and health systems to help ensure that advances in Alzheimer’s research translate into benefits for millions of people worldwide.

All trademarks used or mentioned in this release are protected by law.

References
1.Hortsch S, et al. Performance of a fully automated plasma tau phosphorylated at threonine 217 immunoassay to reflect amyloid‑beta burden in an unselected cohort representative of clinical practice. Journal of Prevention of Alzheimer’s Disease. 2026;13(5):100534. doi:10.1016/j.tjpad.2026.100534. Available at: https://www.sciencedirect.com/science/article/pii/S2274580726000580?via%3Dihub
2. Hibar DP, et al. Elecsys pTau217 plasma immunoassay detection of amyloid pathology in clinical cohorts. 2026. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC12805464/
3. Clifford Jack Jr, Dunn B, Snyder H.,et al. Revised criteria for diagnosis and staging of Alzheimer’s disease: Alzheimer’s Association workgroup. Alzheimer’s & Dementia. 2024;1–27. doi:10.1002/alz.13859. Available at: https://alz-journals.onlinelibrary.wiley.com/doi/10.1002/alz.13859
4. Schindler SE, et al. Acceptable performance of blood biomarker tests of amyloid pathology — recommendations from the Global CEO Initiative on Alzheimer’s Disease. Nature Reviews Neurology. 2024;20(7):426–439. doi:10.1038/s41582-024-00977-5. Available at: https://www.nature.com/articles/s41582-024-00977-5
5. Di Domenico A, Hortsch S, Jamal S, Caley D, Hodsdon M, Lu M, Knoll M. Evaluation of Elecsys Phospho‑Tau (217P) Plasma assay performance across care settings and cognitive statuses for Alzheimer’s disease diagnosis. Poster presented at: AD/PD 2026 – International Conference on Alzheimer’s and Parkinson’s Diseases; 17–21 March 2026; Copenhagen, Denmark (virtual/hybrid). Available at: https://medically.roche.com/global/en/neuroscience/adpd-2026/medical-material/ADPD-2026-poster-di-domenico-evaluation-of-elecsys-phospho-tau-217p-plasma-assay-performance-pdf.html
6. Orgeta V, et al. Dementia takes 3.5 years to diagnose after symptoms begin. University College London; 2025. Available at: https://www.ucl.ac.uk/news/2025/jul/dementia-takes-35-years-diagnose-after-symptoms-begin
7. Chapleau M, et al. The role of amyloid PET in imaging neurodegenerative disorders. American Journal of Neuroradiology. 2022;43(6):813–825. Available at: https://pmc.ncbi.nlm.nih.gov/articles/PMC9165727/
8. Update on Alzheimer’s diagnosis: focus on cerebrospinal fluid and blood-based biomarkers. MedizinOnline. 2024. Available at: https://medizinonline.com/en/update-on-alzheimers-diagnosis-focus-on-cerebrospinal-fluid-and-blood-based-biomarkers-2/
9. Alzheimer’s Disease International. World Alzheimer Report 2021: Journey through the diagnosis of dementia. ADI; 2021. Available at: https://www.alzint.org/resource/world-alzheimer-report-2021/
10. Roche Diagnostics. What is the value of an Alzheimer’s diagnosis? Roche Diagnostics; 2026. Available at: https://diagnostics.roche.com/global/en/healthcare-transformers/article/alzheimer-diagnosis-testing.html
11. Kusoro O, et al. Time to diagnosis in dementia: a systematic review with meta-analysis. International Journal of Geriatric Psychiatry. 2025. Summary available at: https://www.ucl.ac.uk/news/2025/jul/dementia-takes-35-years-diagnose-after-symptoms-begin

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +41 79 398 38 53	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03	Irène Stephan Phone: +41 79 377 83 75

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

Media&Investor Release pTau217 CE Mark English (2)

Roche enters into a definitive merger agreement to acquire PathAI to transform AI-driven diagnostics

Thu, 07 May 2026 05:00:00 GMT

PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities will complement Roche's digital pathology portfolio to drive laboratory efficiency
Combining Roche’s strong position in companion diagnostics and PathAI’s advanced AI platform helps accelerate clinical therapy development, foster the discovery of new biomarkers and create novel diagnostic tools
These integrated capabilities will accelerate the shift from broad intervention toward personalised healthcare for patients

Basel, 7 May 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it has entered into a definitive merger agreement to acquire PathAI, a US-based company in digital pathology and AI-powered technology for pathology laboratories and the biopharma industry. This acquisition builds on the successful partnership between Roche and PathAI, established in 2021 and scaled up in 2024 to include the development of AI-enabled companion diagnostic algorithms. Subject to the closing of the transaction, which is expected in the second half of the year, the acquired entity will become part of the Diagnostics division.

This acquisition strengthens Roche’s position in Digital Pathology, which is transforming extensive manual workflows into fully automated, AI-driven processes and insights. Digital pathology enables the creation of high-resolution digital images from physical tissue on slides, allowing pathologists to use AI tools to facilitate diagnostic workflows and provide patients with faster results.

“Digital pathology has the potential to improve precision diagnosis of cancer and enable physicians to offer better tailored treatment regimens,” said Matt Sause, CEO of Roche Diagnostics. “Bringing PathAI into Roche Diagnostics will allow us to combine their best-in-class digital pathology tools with our leading oncology diagnosis platforms to deliver better insights for physicians and potentially better outcomes for patients worldwide.”

Andy Beck, CEO and Co-Founder of PathAI, adds: “Joining forces with Roche marks a new era for PathAI, enabling us to realise our mission of improving patient outcomes through AI-powered pathology at unprecedented scale and speed. Roche's global infrastructure and expertise will bring our digital diagnostics technology to patients worldwide.”

PathAI’s AISight IMS software interface is efficient and user-friendly, seamlessly integrating advanced analysis and workflow capabilities within the digital pathology laboratory. In the rapidly growing pathology market, Roche intends to scale this solution globally.

In addition, the expanded capabilities strengthen Roche’s competitiveness in precision medicine by enhancing its biopharma services. PathAI’s strength in AI-driven solutions, including clinical trial support and translational research, will complement Roche’s deep expertise in companion diagnostics. Combining these capabilities will foster the discovery of new biomarkers, potential drug targets and novel diagnostic tools, increasing the value Roche can bring to biopharma companies.

Terms of the merger agreement
The closing of the transaction is subject to customary closing conditions, including antitrust and regulatory approvals and is currently expected in the second half of the year.

Under the terms of the agreement, Roche will pay a purchase price of USD 750 million upfront and additional milestone payments of up to USD 300 million.

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

All trademarks used or mentioned in this release are protected by law.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +41 79 398 38 53	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03	Irène Stephan Phone: +41 79 377 83 75

Roche Investor Relations

Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: bruno.eschli@roche.com	Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com
Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com

Investor Relations North America

Loren Kalm
Phone: +1 650 225 3217
e-mail: kalm.loren@gene.com

Attachment

Media&Investor Roche to acquire PathAI English

Roche to present extensive data showcasing its industry-leading ophthalmology portfolio at ARVO 2026

Thu, 30 Apr 2026 05:00:00 GMT

New real-world data confirm Vabysmo’s potent retinal drying in nAMD and DME
Key data for Susvimo demonstrate its potential to provide lasting disease control through continuous delivery, while reducing treatment burden
Roche will present more than 45 abstracts at ARVO 2026, including 20 oral presentations across five retinal conditions

Basel, 30 April 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that it will showcase key real-world, product and pipeline data from its ophthalmology portfolio at the Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, held 3rd to 7th of May in Denver, Colorado, USA. The data being presented emphasise Roche’s focus on preserving vision through innovative therapies, including Vabysmo® (faricimab), Susvimo® (Port Delivery Platform with ranibizumab) and the investigational interleukin-6 (IL-6) inhibitor, vamikibart. The data cover five retinal conditions including geographic atrophy (GA), retinal vein occlusion (RVO) and uveitic macular edema (UME) as well as diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD).

“The data we will present at ARVO underscore our commitment to advances in ophthalmology in general and our retinal portfolio in particular,” said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of Global Product Development. "An important example is real-world data for nAMD and DME showing that Vabysmo dries the retina and improves retinal anatomy in both treatment-naïve and previously treated settings."

Vabysmo real-world drying data
New data from the global VOYAGER study (NCT05476926) demonstrate that six months of treatment with Vabysmo dried the retina and improved retinal anatomy in real-world clinical practice. These findings, which utilised a deep learning algorithm to analyse real-world optical coherence tomography images, showed consistent improvements across both treatment-naive patients and those previously treated with other anti-VEGF therapies.

Further highlights from Roche’s ophthalmology portfolio
Reflecting its mission to address diverse patient needs across ophthalmic conditions, Roche will present important new findings from across its ophthalmology portfolio. This includes data exploring the use of Vabysmo in RVO, reinforcing its real-world effectiveness in this patient population. Additionally, new data for Susvimo will highlight its ability to provide sustained disease control, and early data from the investigational IL-6 inhibitor, vamikibart, will offer insights for its potential role in targeting underlying retinal inflammation.

Overview of key presentations featuring Roche medicines:

Topic	Abstract Title	Presentation Details (all timings are MDT)
Vabysmo	Anatomical outcomes of faricimab in patients with diabetic macular edema: 6-month real-world imaging from the VOYAGER study	Poster #1964 - 0031 Monday 4 May 2026 3:00-4:45 PM
	Long-term effectiveness and safety of faricimab in eyes with nAMD: 2-year results from the UK FARWIDE-nAMD study	Presentation (10 mins) Tuesday 5 May 2026 1:45-2:00 PM
	Automated quantification of retinal fluid volume in patients with DME: analysis of faricimab vs aflibercept in YOSEMITE/RHINE	Presentation (10 mins) Tuesday 5 May 2026 2:00-2:15 PM
	Anatomical outcomes of faricimab in patients with neovascular age-related macular degeneration: 6-month real-world imaging from the VOYAGER study	Presentation (10 mins) Tuesday 5 May 2026 2:30-2:45 PM
	Reduction in Subretinal Hyperreflective Material Volume With Faricimab vs Aflibercept 2 mg in Treatment-Naïve nAMD: A TENAYA/LUCERNE Post Hoc Analysis	Presentation (10 mins) Tuesday 5 May 2026 2:45-3:00 PM
	One-year outcomes of faricimab patients with DME from a global, prospective observational study: the VOYAGER study	Presentation (10 mins) Tuesday 5 May 2026 5:00-5:15 PM
	One-year outcomes of faricimab treatment in eyes with nAMD from the global, prospective observational VOYAGER study	Presentation (10 mins) Thursday 7 May 2026 1:15-1:30 PM
Susvimo	Patient preference for the PDS vs intravitreal injections: year 2 results from the phase 3 Pagoda trial in patients with diabetic macular edema (DME)	Poster #1979 - 0046 Monday 4 May 2026 3:00-4:45 PM
	Retinal fluid, thickness, and leakage in PDS-treated study eyes vs intravitreal injection-treated fellow eyes in bilateral DME in the Pagoda trial	Poster #1980 - 0047 Monday 4 May 2026 3:00-4:45 PM
	Model-based pharmacokinetic simulations of the Port Delivery Platform with ranibizumab (PDS) under various real-world clinical scenarios	Poster #1981 - 0048 Monday 4 May 2026 3:00-4:45 PM
	Interim analysis of the Belvedere nAMD study: summary of PDS treatment in eyes with high injection burden	Presentation (10 mins) Thursday 7 May 2026 3:00-3:15 PM
Vamikibart	Efficacy and safety of vamikibart in patients with diabetic macular edema: first results from the phase 2 ALLUVIUM trial	Presentation (10 mins) Tuesday 5 May 2026 3:30-3:45 PM
Vamikibart	Efficacy and safety of vamikibart in combination with ranibizumab in patients with DME: first results from the phase 2 BARDENAS trial	Presentation (10 mins) Tuesday 5 May 2026 3:45-4:00 PM

About Vabysmo^® (faricimab)
Vabysmo is the first bispecific antibody approved for the eye.^1-3 It targets and inhibits two signalling pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). Ang-2 and VEGF-A contribute to vision loss by destabilising blood vessels, causing new leaky blood vessels to form and increasing inflammation. By blocking pathways involving Ang-2 and VEGF-A, Vabysmo is designed to stabilise blood vessels.^3,4 Vabysmo is approved in more than 110 countries around the world, including the United States (US), Japan, the United Kingdom and the European Union (EU) for people with nAMD and DME, and in more than 60 countries, including the US, EU and Japan, for people with macular edema following RVO.^1,2,5-8 Review by other health authorities is ongoing.

About Susvimo (Port Delivery Platform with ranibizumab)
Approved in the United States by the Food and Drug Administration (FDA) for nAMD, DME and diabetic retinopathy (DR), Susvimo is a refillable eye implant surgically inserted into the eye during a one-time, outpatient procedure.^8-10 Susvimo continuously delivers a customised formulation of ranibizumab into the eye over time.^8-10Ranibizumab is a VEGF inhibitor designed to bind to and inhibit VEGF-A, a protein that has been shown to play a critical role in the formation of new blood vessels and the leakiness of the vessels.^9-11

The customised formulation of ranibizumab delivered by Susvimo is different from the ranibizumab IVT injection, a medicine marketed as Lucentis® (ranibizumab injection)*, which is approved to treat nAMD and other retinal diseases.¹² In the EU, the devices are collectively referred to as Contivue, and have received EU certification.¹³ The drug MAA for nAMD is currently under review by the European Medicines Agency (EMA).¹³

About vamikibart
Vamikibart is an investigational monoclonal antibody that has been specifically engineered for intravitreal (IVT) administration.^14,15 It targets interleukin-6 (IL-6), a key cytokine in the inflammatory pathway in UME.^14,15 In the phase I DOVETAIL study, vamikibart provided rapid vision improvements and resolution of macular edema in people with UME.^14,15 Vamikibart was also well tolerated, with no treatment-related serious adverse events reported.¹⁵ Based on the promising phase I DOVETAIL data, Roche initiated the two identical phase III vamikibart studies MEERKAT and SANDCAT. Vamikibart is being investigated in retinal diseases with recognised inflammatory pathways, including in people with UME. Vamikibart has orphan drug designation in the USA and EU.

About Roche in Ophthalmology
Roche is focused on saving people’s eyesight from the leading causes of vision loss through pioneering therapies. Through our innovation in the scientific discovery of new potential drug targets, personalised healthcare, molecular engineering, biomarkers and continuous drug delivery, we strive to design the right therapies for the right patients.

We have the broadest retina pipeline in ophthalmology, which is led by science and informed by insights from people with eye diseases. Our pipeline includes innovative treatments across different modalities, such as antibodies, and gene and cell therapies targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and UME.

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.

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

All trademarks used or mentioned in this release are protected by law.

References
[1] United States (US) Food and Drug Administration (FDA). Highlights of prescribing information, Vabysmo. 2024. [Internet; cited April 2026]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761235s005lbl.pdf.
[2] Medicines and Healthcare products Regulatory Agency approves faricimab through international work-sharing initiative. [Internet; cited April 2026]. Available from: https://www.gov.uk/government/news/mhra-approves-faricimab-through-international-work-sharing-initiative.
[3] Heier JS, et al. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for nAMD (TENAYA and LUCERNE): two randomised, double-masked, phase III, non-inferiority trials. The Lancet. 2022; 399:729-40.
[4] Wykoff C, et al. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with DME (YOSEMITE and RHINE): Two randomised, double-masked, phase III trials. The Lancet. 2022; 399:741-755.
[5] European Medicines Agency. Summary of product characteristics, Vabysmo. 2026. [Internet; cited April 2026]. Available from: https://www.ema.europa.eu/en/documents/product-information/vabysmo-epar-product-information_en.pdf.
[6] Chugai obtains regulatory approval for Vabysmo, the only bispecific antibody in the ophthalmology field, for additional indication of macular edema associated with RVO. [Internet; cited April 2026]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20240326160000_1054.html.
[7] Chugai obtains regulatory approval for Vabysmo, the first bispecific antibody in ophthalmology, for nAMD and DME. [Internet; cited April 2026]. Available from: https://www.chugai-pharm.co.jp/english/news/detail/20220328160002_909.html.
[8] Roche data on file.
[9] US Food and Drug Administration (FDA). Highlights of prescribing information, Susvimo. 2025. [Internet; cited April 2026]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/761197s006lbl.pdf.
[10] Holekamp N, et al. Archway randomised phase III trial of the PDS with ranibizumab for neovascular age-related macular degeneration (nAMD). Ophthalmology. 2021.
[11] Heier JS, et al. The angiopoietin/tie pathway in retinal vascular diseases: A review. The Journal of Retinal and Vitreous Diseases. 2021;41:1-19.
[12] US FDA. Highlights of prescribing information, Lucentis. 2024. [Internet; cited April 2026]. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125156s128lbl.pdf .
[13] Roche. Roche receives CE mark for Contivue, its Port Delivery Platform containing Susvimo, for neovascular age-related macular degeneration (nAMD). 2025. [Internet; cited April 2026]. Available from: https://www.roche.com/media/releases/med-cor-2025-09-04 .
[14] Khurana RN, et al. Efficacy and Safety of Vamikibart in Patients With Uveitic Macular Edema: First Report of Phase 3 MEERKAT/SANDCAT Trials. Presented at: the American Academy of Ophthalmology annual meeting (AAO 2025); 2025 October 17; Orlando, Florida, United States.[15] Sharma S, Suhler E, Lin P, et al. A novel intravitreal anti-IL-6 monoclonal antibody for uveitic macular edema (UME): preliminary results from the phase 1 DOVETAIL study. Invest Ophthalmol Vis Sci. 2023;64(8):5100.

Roche Global Media Relations
Phone: +41 61 688 8888 / e-mail: media.relations@roche.com

Hans Trees, PhD Phone: +41 79 407 72 58	Lorena Corfas Phone: +41 79 568 24 95
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +41 79 398 38 53	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03	Irène Stephan Phone: +41 79 377 83 75

Attachment

Media Release Roche ARVO Curtain Raiser English

[Ad hoc announcement pursuant to Art. 53 LR] Roche reports strong sales growth of +6% at constant exchange rates in the first quarter of 2026; -5% in CHF due to the significant appreciation of the Swiss franc

Thu, 23 Apr 2026 05:12:42 GMT

Group sales were +6% at constant exchange rates (CER)¹, -5% when reported in CHF and +9% in USD², in the first three months, driven by high demand for our innovative medicines and diagnostics.
Pharmaceuticals Division sales were +7% at CER, -4% when reported in CHF and +10% in USD, due to continued high growth in sales of medicines for the treatment of severe diseases; Xolair (chronic hives, food allergies), Phesgo (breast cancer), Hemlibra (haemophilia A), Vabysmo (severe eye diseases) and Ocrevus (multiple sclerosis) were the top growth drivers.
Diagnostics Division sales were +3% at CER, -7% when reported in CHF and +7% in USD, as demand for core lab and pathology solutions more than offset the impact of healthcare pricing reforms in China.
Highlights:
- Positive data for: fenebrutinib for multiple sclerosis (phase III), Gazyva/Gazyvaro for an autoimmune condition affecting kidney function (phase III); and petrelintide for obesity (phase II)
- CE mark for new Elecsys NfL blood test to detect neuroinflammation in multiple sclerosis, representing a breakthrough in disease management
- Launch of the cobas MPX-E assay, a new 4-in-1 test to screen blood donors for HIV and hepatitis viruses
- Launch of the AI factory to accelerate the development of new therapeutics and diagnostics solutions
- Entry into a definitive agreement to acquire SAGA Diagnostics: SAGA’s proprietary cancer therapy response monitoring platform will strengthen Roche’s industry leading portfolio of oncology diagnostics and medicines
- Inauguration of the new research home for the Institute of Human Biology to enable scientists to pioneer human model systems for research
Outlook for 2026 confirmed

Roche CEO Thomas Schinecker: “We delivered a strong start to the year, achieving 6% Group sales growth at constant exchange rates.

Our pipeline continued to advance in areas where patients face significant unmet need, including multiple sclerosis, obesity and a severe autoimmune disease that can lead to kidney failure. We also received EU approval for a new test to detect neuroinflammation in multiple sclerosis, marking a meaningful step forward in disease management.

Our diversified portfolio across both divisions, together with continued pipeline progress, positions us well for sustained future growth in a dynamic geopolitical environment. We confirm our full-year outlook.”

Outlook for 2026
Roche (SIX: RO, ROP; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs.

Sales	CHF millions		As % of sales		% change
January–March	2026	2025	2026	2025	At CER	In CHF	In USD
Group	14,722	15,440	100.0	100.0	+6	-5	+9

Pharmaceuticals Division	11,469	11,949	77.9	77.4	+7	-4	+10
United States	5,693	6,224	38.7	40.3	+5	-9
Europe	2,234	2,320	15.2	15.0	-1	-4
Japan	649	671	4.4	4.3	+14	-3
International	2,893	2,734	19.6	17.8	+16	+6

Diagnostics Division	3,253	3,491	22.1	22.6	+3	-7	+7
International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others

Group sales
In the first three months of 2026, Roche sales were +6% at CER, -5% when reported in CHF, to CHF 14.7 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates.

Sales in the Pharmaceuticals Division were +7% at CER, -4% when reported in CHF, to CHF 11.5 billion, with medicines for severe diseases continuing their strong growth.

The top five growth drivers – Xolair, Phesgo, Hemlibra, Vabysmo and Ocrevus – achieved total sales of CHF 5.3 billion, an increase of 14% at CER, or 2% in CHF, compared to the first three months of 2025.

Sales of products with expired patents (Avastin, Herceptin, MabThera/Rituxan, Lucentis and Actemra/RoActemra) decreased by a combined CHF 0.1 billion at CER, or CHF 0.2 billion in CHF.

In the United States, sales were +5% at CER, -9% when reported in CHF, due to continued growth of Xolair and continuing uptake of Hemlibra, Polivy (blood cancer), Ocrevus and Vabysmo. This growth more than compensated for the lower sales of Perjeta (breast cancer) and Kadcyla (breast cancer).

Sales in Europe were -1% at CER, or -4% when reported in CHF, due to lower sales of Polivy, the impact of biosimilar competition on Actemra/RoActemra and Perjeta (breast cancer) due to conversion to Phesgo. This decrease was partially offset by the demand for Ocrevus and Evrysdi (spinal muscular atrophy).

In Japan, sales were +14% at CER, -3% when reported in CHF, mainly due to product supply to third parties, as well as a strong uptake of Hemlibra, Vabysmo and Polivy. Sales growth was partially offset by the decline in sales of Tamiflu and the impact of biosimilar erosion on Avastin.

Sales in the International region were +16% at CER, or +6% when reported in CHF, led by Phesgo, Vabysmo, Polivy, Alecensa (lung cancer) and Ocrevus and partially offset by lower sales of influenza medicines Xofluza and Tamiflu. In China, sales were +14% at CER, or +5% when reported in CHF, as the uptake of Phesgo, Polivy and Vabysmo gained momentum following their inclusion in the government drug reimbursement list. The continued roll-out of Alecensa was the other growth driver. The increase was partially offset by lower sales of Xofluza and Perjeta.

The Diagnostics Division’s sales were +3% at CER, -7% when reported in CHF, to CHF 3.3 billion as growth in demand for core lab and pathology solutions more than offset the impact of healthcare pricing reforms in China.

Sales in the Europe, Middle East and Africa (EMEA) region were +3% at CER, -2% when reported in CHF, driven by higher sales of clinical chemistry and immunodiagnostic products. In North America, sales were +6% at CER, -7% when reported in CHF, with growth across core, pathology and molecular lab areas. Sales in Asia-Pacific were -5% at CER, or -15% when reported in CHF, due to the healthcare pricing reforms in China. In Latin America, sales growth was +10% at CER, or 0% when reported in CHF.

Pharmaceuticals: key developments

Compound	Milestone
Regulatory
Gazyva/Gazyvaro Lupus	FDA accepts application for Gazyva/Gazyvaro for the treatment of the most common form of lupus The filing was accepted based on phase III ALLEGORY data for Gazyva/Gazyvaro showing a significant reduction in disease activity compared with placebo in people with systemic lupus erythematosus (SLE). If approved, Gazyva/Gazyvaro would be the first anti-CD20 therapy to directly target B cells in SLE, potentially becoming the new standard of care for this condition. SLE is a potentially life-threatening autoimmune disease affecting more than three million people worldwide – achieving better disease control can reduce flares and may prevent irreversible organ damage. More information: Media Release, 21 April 2026
Giredestrant Breast cancer	FDA accepts New Drug Application for giredestrant in ESR1-mutated, ER-positive advanced breast cancer Filing was accepted based on phase III data showing giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in ITT and ESR1-mutated populations, respectively, versus standard-of-care endocrine therapy plus everolimus. Strength of evERA data demonstrates the potential for giredestrant combination to help address resistance to standard-of-care therapies, and that it could be the first and only oral SERD combination approved in the post-CDK4/6 inhibitor setting. The FDA has set a Prescription Drug User Fee Act date of 18 December 2026. More information: Media Release, 20 February 2026
Phase III, pivotal and other key read-outs
Enspryng MOGAD	Enspryng reduces risk of relapses by 68%, demonstrating potential to become first treatment for MOGAD The phase III METEOROID study met its primary endpoint in patients with myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). MOGAD is a rare autoimmune disease of the central nervous system characterised by unpredictable attacks of the optic nerves, spinal cord or brain that are often severe and debilitating. The data will be submitted to the regulatory authorities. More information: Media Release, 21 April 2026
Giredestrant Breast cancer	Roche provides update on phase III persevERA study in ER-positive advanced breast cancer The persevERA breast cancer study did not meet the primary objective of a statistically significant improvement in progression-free survival, but a numerical improvement was observed. Giredestrant plus palbociclib was well tolerated and adverse events were consistent with the known safety profiles of each individual treatment. The FDA recently accepted the New Drug Application based on evERA data; phase III lidERA data has been submitted to the FDA. More information: Media Release, 9 March 2026
Petrelintide Obesity	Roche announces positive phase II results for petrelintide, an amylin analogue developed for people living with overweight and obesity Petrelintide achieved up to 10.7% mean body weight reduction at week 42 versus 1.7% with placebo (p-value <0.001) while demonstrating placebo-like tolerability. At the maximally effective dose, there were no cases of vomiting and no treatment discontinuations due to gastrointestinal adverse events. The data support further development of petrelintide in chronic weight management as monotherapy and its tolerability profile also confirms its value as a combination partner. More information: Media Release, 5 March 2026
Fenebrutinib Multiple sclerosis	Fenebrutinib confirms its potential as first and only BTK inhibitor for relapsing and primary progressive multiple sclerosis (MS) in third positive phase III study (FENhance 1) FENhance 1 met its primary endpoint, showing that investigational fenebrutinib significantly reduced relapses by 51% compared to teriflunomide in relapsing multiple sclerosis (RMS), which is consistent with FENhance 2 results showing 59% reduction. FENhance 1 is the final study read-out of the fenebrutinib pivotal clinical development programme in MS, following positive results for FENhance 2 in RMS and for FENtrepid in primary progressive multiple sclerosis (PPMS). Fenebrutinib has the potential to become the first and only high-efficacy oral, brain-penetrant treatment for both RMS and PPMS, showing a profound benefit on relapsing and progressive disease biology. More information: Media Release, 2 March 2026
Gazyva/Gazyvaro Membranous nephropathy	Roche announces positive phase III results for Gazyva/Gazyvaro in primary membranous nephropathy, marking a significant milestone in treatment of this autoimmune disease MAJESTY, the first global phase III study in primary membranous nephropathy, met its primary endpoint of complete remission at two years. Up to 30% of people with membranous nephropathy progress to kidney failure over 10 years despite current treatment approaches; achieving complete remission can help delay or prevent this. Gazyva/Gazyvaro could become the first approved treatment for primary membranous nephropathy, having already achieved positive results in lupus nephritis, systemic lupus erythematosus and idiopathic nephrotic syndrome. More information: Media Release, 16 February 2026
Fenebrutinib Multiple sclerosis	Fenebrutinib is the first investigational medicine in over a decade that reduces disability progression in primary progressive multiple sclerosis (PPMS) Late-breaking phase III FENtrepid results presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026 show investigational fenebrutinib met its primary endpoint of non-inferiority compared to the current standard of care, Ocrevus, in reducing disability progression in PPMS. Fenebrutinib numerically reduced the risk of disability progression by 12% compared to Ocrevus as early as 24 weeks; additional analysis showed potential benefit in upper limb function. Fenebrutinib has the potential to become a first-in-class therapy in multiple sclerosis, as an oral, brain-penetrant BTK inhibitor for PPMS and relapsing multiple sclerosis (RMS) More information: Media Release, 7 February 2026
Other
Institute of Human Biology	Roche inaugurates new research home for the Institute of Human Biology (IHB), pioneering human model systems to accelerate drug discovery and development The new building is part of a CHF 1.4 billion site investment, reinforcing Roche’s commitment to Switzerland and the Basel life sciences cluster. The IHB enables scientists to pioneer human model systems, accelerating the development of new medicines to improve the lives of patients. Federal Councillor Elisabeth Baume-Schneider, Head of the Federal Department of Home Affairs (FDHA), attended the official opening ceremony. More information: Media Release, 23 March 2026
AI factory	Roche launches NVIDIA AI factory to accelerate the development of new therapeutics and diagnostics solutions With the addition of 2,176 NVIDIA Blackwell GPUs, Roche now operates the pharmaceutical industry’s largest announced hybrid-cloud AI factory, totalling more than 3,500 GPUs. The new computational infrastructure supports Roche’s vision of building an AI-accelerated healthcare organisation. NVIDIA AI factories help accelerate discoveries, enable more efficient clinical trials and unlock data insights at scale, ultimately advancing innovation and improved healthcare outcomes. More information: Media Release, 16 March 2026
Annual General Meeting	Roche Annual General Meeting 2026 Shareholders approved all proposals of the Board of Directors. Severin Schwan was re-elected as Chairman of the Board of Directors; all other Board members standing for election were confirmed. Shareholders approved an increase of the dividend to CHF 9.80 per share; this is the 39th consecutive dividend increase. Shareholders approved the exchange of non-voting equity securities (Genussscheine) for participation certificates. More information: Media Release, 10 March 2026
Gazyva/Gazyvaro Lupus	New England Journal of Medicine publishes phase III ALLEGORY data showing Gazyva/Gazyvaro significantly reduces disease activity in the most common form of lupus Over three quarters of people on Gazyva/Gazyvaro plus standard therapy achieved at least a four-point improvement in SRI-4, a measure that assesses disease severity and symptoms. Gazyva/Gazyvaro has the potential to become a new standard of care for people living with systemic lupus erythematosus (SLE). If approved, Gazyva/Gazyvaro would be the first type II anti-CD20 therapy for SLE to directly target B cells, a key driver of inflammation and disease activity. More information: Media Release, 6 March 2026
Change in Enlarged Corporate Executive Committee	Change to the Roche Enlarged Corporate Executive Committee Roche announced the appointment of Mark Dawson, MD, PhD, as the new Head of Roche Pharma Research and Early Development (pRED), effective 1 May 2026. Based in Basel, he will also become a member of the Enlarged Corporate Executive Committee. Mark Dawson joins Roche from the Peter MacCallum Cancer Centre, where he serves as Associate Director of Research. A leading expert in cancer biology, his work on chromatin regulation and epigenetics has been instrumental in defining the molecular mechanisms that drive cancer initiation and progression. More information: Media Release, 17 February 2026

Pharmaceuticals sales

Sales	CHF millions		As % of sales		% change
January–March	2026	2025	2026	2025	At CER	In CHF
Pharmaceuticals Division	11,469	11,949	100.0	100.0	+7	-4
United States	5,693	6,224	49.6	52.1	+5	-9
Europe	2,234	2,320	19.5	19.4	-1	-4
Japan	649	671	5.7	5.6	+14	-3
International	2,893	2,734	25.2	22.9	+16	+6

International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others

Top 20 best-selling pharmaceuticals (% change at CER¹)	Total		United States		Europe		Japan		International
Top 20 best-selling pharmaceuticals (% change at CER¹)	CHF m	%	CHF m	%	CHF m	%	CHF m	%	CHF m	%
Ocrevus Multiple sclerosis	1,692	+6	1,117	+3	363	+9	-	-	212	+24
Hemlibra Haemophilia A	1,190	+13	613	+15	252	+5	81	+18	244	+14
Vabysmo Eye diseases (nAMD, DME, RVO)	1,024	+13	652	+4	190	0	37	+39	145	+126
Tecentriq Cancer immunotherapy	811	+4	378	+6	202	-6	69	0	162	+14
Xolair³ Chronic hives, food allergies	708	+26	708	+26	-	-	-	-	-	-
Phesgo Breast cancer	686	+27	159	+2	206	+7	42	+23	279	+78
Perjeta³ Breast cancer	672	-11	263	-12	119	-15	12	-19	278	-9
Actemra/RoActemra³ RA, COVID-19	534	-4	248	-3	124	-16	66	+9	96	+5
Evrysdi Spinal muscular atrophy	464	+19	160	+15	159	+13	18	+4	127	+40
Kadcyla³ Breast cancer	439	-4	156	-11	123	-6	19	+6	141	+5
Polivy Blood cancer	407	+26	171	+26	63	-32	46	+24	127	+120
Alecensa Lung cancer	401	+12	105	-7	63	-5	43	+4	190	+39
MabThera/Rituxan³ Blood cancer, RA	292	+10	183	+16	31	-8	3	-6	75	+6
Activase/TNKase³ Cardiac diseases	255	-2	244	-2	-	-	-	-	11	-4
Gazyva/Gazyvaro³ Blood cancer, lupus nephritis	247	+10	115	+1	57	-2	9	+28	66	+45
Herceptin³ Breast and gastric cancer	234	-12	44	-16	69	-7	1	-24	120	-14
Avastin³ Various cancer types	224	-9	59	-15	14	+3	21	-29	130	-1
CellCept³ Immunosuppressant	99	+10	4	-5	28	-14	9	-16	58	+37
Enspryng Acute inflammation of brain, spinal cord and optic nerves	96	+31	22	+20	11	+20	35	+13	28	+93
Columvi Blood cancer	95	+77	43	+35	21	+84	-	-	31	+204

DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis

Diagnostics: key developments

Product	Milestone
Elecsys NfL blood test Multiple sclerosis	Roche receives CE mark for new Elecsys NfL blood test to detect neuroinflammation in multiple sclerosis (MS) The Elecsys NfL blood test detects neuroaxonal damage associated with neuroinflammation in adults diagnosed with relapsing remitting multiple sclerosis. This minimally invasive blood test enables greater patient access to monitoring of neuroinflammatory status versus current standard of care methods. By providing deeper insight into underlying neuroinflammatory activity, the Elecsys NfL blood test has the potential to enable effective MS monitoring and earlier clinical intervention. More information: Media Release, 13 April 2026
cobas MPX-E assay HIV and hepatitis viruses	Roche launches the cobas MPX-E assay, a new 4-in-1 donor screening test to further safeguard the global blood supply The cobas MPX-E test provides four critical results (for HIV, HCV, HBV and HEV) in a single test, increasing laboratory efficiency and decreasing healthcare costs. The new test delivers faster turnaround times and allows labs to implement hepatitis E (HEV) screening without requiring additional instrumentation. This assay is designed for use on the fully automated cobas x800 systems, enabling high-throughput screening with up to 8 hours of walk-away time. More information: Media Release, 30 March 2026

Diagnostics sales

Sales	CHF millions		As % of sales		% change
January–March	2026	2025	2026	2025	At CER	In CHF
Diagnostics Division	3,253	3,491	100.0	100.0	+3	-7
Customer areas
Core Lab	1,798	1,904	55.3	54.5	+4	-6
Molecular Lab	571	634	17.5	18.2	0	-10
Near Patient Care	465	536	14.3	15.4	-5	-13
Pathology Lab	419	417	12.9	11.9	+12	0
Regions
Europe, Middle East, Africa	1,206	1,236	37.1	35.4	+3	-2
North America	1,073	1,154	33.0	33.1	+6	-7
Asia-Pacific	725	853	22.3	24.4	-5	-15
Latin America	249	248	7.6	7.1	+10	0

More information on Roche’s performance in the first three months of 2026:

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

All trademarks used or mentioned in this release are protected by law.

References
[1] CER (Constant Exchange Rates). The percentage changes at constant exchange rates are calculated using simulations by reconsolidating both the 2026 and 2025 results at constant exchange rates (the average rates for the year ended 31 December 2025). For the definition of CER, see page 178 of the Roche Finance Report 2025.
[2] USD (US dollars). The percentage changes for selected sales figures at US dollars are calculated by translating both the 2026 and 2025 sales figures at the respective average US dollar exchange rate for the period in question. This supplementary information is provided to assist readers when assessing comparability with other companies.
[3] Products launched before 2015.

Cautionary statement regarding forward-looking statements
This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche.

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