Roche - LSW - Life Sciences & Pharmaceutical News

Filing acceptance 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 everolimus¹
Strength of evERA data demonstrate potential for giredestrant combination to help address resistance to standard-of-care therapies, and could be the first and only oral SERD combination approved in the post-CDK4/6 inhibitor setting¹
The FDA has set a Prescription Drug User Fee Act date of 18 December

Basel, 20 February 2026 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the United States (U.S.) Food and Drug Administration (FDA) has accepted the company’s New Drug Application for giredestrant, an investigational oral therapy, in combination with everolimus for the treatment of adult patients with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative, ESR1-mutated locally advanced or metastatic breast cancer following recurrence or progression on a prior endocrine-based regimen. The FDA is expected to make a decision on the approval by 18 December 2026. Giredestrant plus everolimus could be the first and only oral selective oestrogen receptor degrader (SERD) combination approved in the post-cyclin-dependent kinase (CDK)4/6 inhibitor setting.

“The clinically meaningful benefit seen with giredestrant could enable an important new treatment option to help delay disease progression or death in people with advanced, ER-positive breast cancer,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “This acceptance marks a first step towards establishing the giredestrant combination as a new standard of care in this population.”

The filing acceptance is based on the phase III evERA Breast Cancer study results, which showed that giredestrant plus everolimus reduced the risk of disease progression or death by 44% and 62% in the intention-to-treat (ITT) and ESR1-mutated populations, respectively, compared with standard-of-care endocrine therapy plus everolimus.¹ In the ESR1-mutated population, the median progression-free survival (PFS) was 9.99 months compared with 5.45 months in the giredestrant and comparator arm, respectively (stratified hazard ratio [HR]=0.38, 95% CI: 0.27-0.54, p-value=<0.0001).¹ In the ITT population, the median PFS was 8.77 months compared with 5.49 months in the giredestrant and comparator arms, respectively (HR=0.56, 95% CI: 0.44-0.71, p-value=<0.0001).¹

Overall survival (OS) data were immature at the time of analysis, but a clear positive trend has been observed in the ITT (HR=0.69, 95% CI: 0.47-1.00, p-value=0.0473) and ESR1-mutated populations (HR=0.62, 95% CI: 0.38-1.02, p-value=0.0566).¹ Follow-up for OS will continue to the next analysis. Adverse events for the giredestrant combination were manageable and consistent with the known safety profiles of the individual medicines.¹ No unexpected safety findings were observed, including no photopsia.¹

Data from evERA are being used to support filing submissions to other global health authorities.

ER-positive breast cancer accounts for approximately 70% of breast cancer cases.² Resistance to endocrine therapies, particularly in the post-CDK inhibitor setting, increases the risk of disease progression and is associated with poor outcomes.^2,3 Oral combination therapies, such as giredestrant plus everolimus, could address this by targeting two different signalling pathways while helping to minimise the impact of treatment on people’s lives without the need for injections.^4,5

evERA was the first positive phase III readout for giredestrant, followed by lidERA Breast Cancer in the early-stage setting.^1,6 The scientific rationale for lidERA was supported by prior results in the neoadjuvant setting, including the coopERA trial showing that giredestrant was superior to an aromatase inhibitor in reducing malignant cell division (Ki67 levels).⁷ This growing body of evidence underscores the potential of giredestrant to become a new standard-of-care endocrine therapy across ER-positive early-stage and advanced breast cancer.^1,6,7 In the coming weeks, Roche will submit the giredestrant phase III lidERA data in early-stage breast cancer to health authorities worldwide, including the FDA. The persevERA readout in first-line ER-positive breast cancer is expected in the first half of this year, which will provide further evidence for giredestrant in the ER-positive breast cancer treatment paradigm.

Our extensive giredestrant clinical development programme spans multiple treatment settings and lines of therapy, reflecting our commitment to deliver innovative medicines to as many people with ER-positive breast cancer as possible.

About the evERA Breast Cancer study
evERA Breast Cancer [NCT05306340] is a phase III, randomised, open-label, multicentre study evaluating the efficacy and safety of giredestrant in combination with everolimus versus standard-of-care endocrine therapy in combination with everolimus in people with oestrogen receptor (ER)-positive, human epidermal growth factor receptor 2-negative locally advanced or metastatic breast cancer who have had previous treatment with cyclin-dependent kinase (CDK)4/6 inhibitor and endocrine therapy, either in the adjuvant or locally advanced/metastatic setting.⁸

The co-primary endpoints are investigator-assessed progression-free survival in the intention-to-treat and ESR1-mutated populations, defined as the time from randomisation to the time when the disease progresses or a patient dies from any cause.⁸ The trial has been enriched for ESR1-mutated patients above the natural prevalence to assess the efficacy in this population. In the post-CDK inhibitor setting, up to 40% of people with ER-positive disease have ESR1 mutations.^9,10 Key secondary endpoints include overall survival, objective response rate, duration of response, clinical benefit rate and safety.⁸

About giredestrant
Giredestrant is an investigational, oral, potent next-generation selective oestrogen receptor degrader and full antagonist.¹¹

Giredestrant is designed to block oestrogen from binding to the oestrogen receptor (ER), triggering its breakdown (known as degradation) and stopping or slowing down the growth of cancer cells.¹²

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 ER-positive, human epidermal growth factor receptor 2 (HER2)-negative early-stage breast cancer (lidERA Breast Cancer; NCT04961996)¹³
Giredestrant plus everolimus versus SoC ET plus everolimus in ER-positive, HER2-negative, locally advanced or metastatic breast cancer (evERA Breast Cancer; NCT05306340)⁷
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)¹⁴

Giredestrant plus investigator’s choice of a cyclin-dependent kinase (CDK)4/6 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)¹⁵
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)¹⁶

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.¹⁷ Breast cancer remains the number one cause of cancer-related deaths amongst women, and the second most common cancer type.¹⁸

ER-positive breast cancer accounts for approximately 70% of breast cancer cases.² 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.¹⁹

Despite treatment advances, ER-positive breast cancer remains particularly challenging to treat due to its biological complexity.⁴ Patients often face the risk of disease progression, treatment side effects and resistance to endocrine therapy.^4,20 There is an urgent need for more effective treatments that can delay clinical progression and reduce the burden of treatment on people’s lives.^4,20

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.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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

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

References
[1] Mayer E, et al. Giredestrant (GIRE), an oral selective oestrogen receptor (ER) antagonist and degrader, + everolimus (E) in patients (pts) with ER-positive, HER2-negative advanced breast cancer (ER+, HER2– aBC) previously treated with a CDK4/6 inhibitor (i): Primary results of the Phase III evERA BC trial. Presented at: European Society for Medical Oncology (ESMO) Annual Meeting; 2025 October 17-21; Berlin, Germany. LBA #16.

[2] Kinslow C, et al. Prevalence of Estrogen Receptor Alpha (ESR1) Somatic Mutations in Breast Cancer. JNCI Cancer Spectrum; 2022 Oct;6(5):pkac060.

[3] Sahin T, et al. Post-progression treatment options after CDK4/6 inhibitors in hormone receptor-positive, HER2-negative metastatic breast cancer. Cancer Treatment Reviews. 2025 April;135:102924.

[4] Hanker A, et al. Overcoming Endocrine Resistance in Breast Cancer. Canc Cell. 2020 Apr 13;37(4):496–513.

[5] Wood L. A review on adherence management in patients on oral cancer therapies. Eur J Oncol Nurs. 2012 Sept; 16(4):432-38.

[6] 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.

[7] Hurvitz SA, et al. Neoadjuvant palbociclib plus either giredestrant or anastrozole in oestrogen receptor-positive, HER2-negative, early breast cancer (coopERA Breast Cancer): an open-label, randomised, controlled, phase 2 study. Lancet Oncol. 2023;24:1029–1041.

[8] 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 February]. Available from: https://clinicaltrials.gov/study/NCT05306340.

[9] Meisel J L, et al. Real-world estrogen receptor 1 (ESR1) testing patterns and results in U.S. patients with metastatic breast cancer, 2018-2024. JCO Oncol Pract. 2025;21:579.

[10] Chaudhary N, et al. CDK4/6i-treated HR+/HER2- breast cancer tumors show higher ESR1 mutation prevalence and more altered genomic landscape. npj Breast Cancer. 2024;10,15.

[11] 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: The ESMO Annual Meeting; 2022 September 9-13; Paris, France. Abstract #211MO.

[12] 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, USA. Abstract #P5-04-07.

[13] 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 February]. Available from: https://clinicaltrials.gov/study/NCT04961996.

[14] 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 February]. Available from: https://clinicaltrials.gov/study/NCT04546009.

[15] 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 February]. Available from: https://clinicaltrials.gov/study/NCT06065748.

[16] 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 February]. Available from: https://clinicaltrials.gov/study/NCT05296798.

[17] World Health Organization. Breast Cancer [Internet; cited 2026 February]. Available from: https://www.who.int/news-room/fact-sheets/detail/breast-cancer.

[18] World Health Organization. Cancer Today [Internet; cited 2026 February]. Available from: https://gco.iarc.fr/today/en/dataviz/bars?mode=cancer&types=1&group_populations=1&sexes=2&key=asr&age_end=14.

[19] National Cancer Institute. Hormone Therapy for Breast Cancer [Internet; cited 2026 February]. Available from: https://www.cancer.gov/types/breast/breast-hormone-therapy-fact-sheet.

[20] Başaran G, et al. Ongoing unmet needs in treating estrogen receptor-positive/HER2-negative metastatic breast cancer. Cancer Treat Rev. 2018 Feb;63:144-55.

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

Hans Trees, PhDPhone: +41 79 407 72 58	Nathalie AltermattPhone: +41 79 771 05 25
Lorena CorfasPhone: +41 79 568 24 95	Simon GoldsboroughPhone: +44 797 32 72 915
Karsten KleinePhone: +41 79 461 86 83	Kirti PandeyPhone: +49 172 6367262
Yvette PetillonPhone: +41 79 961 92 50	Dr Rebekka SchnellPhone: +41 79 205 27 03

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

A once-weekly subcutaneous injection of CT-388 achieved a statistically significant placebo-adjusted weight loss of 22.5% (p < 0.001) at 48 weeks at the highest dose tested (24 mg), without reaching a weight loss plateau
54% of participants on the 24 mg dose achieved resolution of obesity (BMI <30 kg/m2) vs. 13% in the placebo group
CT-388 demonstrated a safety and tolerability profile generally consistent with its drug class with no new or unexpected safety signals

Basel, 27 January 2026 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive topline results from CT388-103, a Phase II clinical trial of CT-388, an investigational dual GLP-1/GIP receptor agonist being developed for the treatment of obesity. The study found that once-weekly subcutaneous injections of CT-388 (titrated up to 24 mg) resulted in significant and clinically meaningful placebo-adjusted weight loss of 22.5% (efficacy estimand) without reaching a weight loss plateau at 48 weeks. A clear dose-response relationship on the weight loss was observed. For the treatment-regimen estimand, the placebo-adjusted weight loss achieved with CT-388 was 18.3% (p-value < 0.001). At week 48 for the 24 mg dose, 95.7% of CT-388 treated participants achieved a weight loss of ≥5%, 87% achieved ≥10%, 47.8% achieved ≥20%, and 26.1% achieved ≥30%. 73% of participants who were pre-diabetic at baseline and treated with CT-388 at 24 mg achieved normal blood glucose levels at week 48 compared to 7.5% in the placebo group.

The treatment was well-tolerated, with the majority of gastrointestinal-related adverse events being mild-to-moderate, generally consistent with the incretin class of medicines. In addition, the treatment discontinuation rate due to adverse events was low (5.9% in CT-388 arms; 1.3% in placebo arm). The full results of the study will be presented at an upcoming medical congress.

“We are pleased to see such meaningful weight loss in people treated with CT-388,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “The robust weight loss combined with a well-tolerated safety profile reinforces our confidence in the clinical development programme as we advance to Phase III trials.”

With its growing cardiometabolic portfolio and strong diagnostic expertise, Roche is advancing transformative standards of care to improve the lives of people living with cardiometabolic diseases as well as reducing the significant burden on healthcare systems and society.

Obesity is recognised as the greatest single risk factor for chronic disease globally. 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.

Since integrating CT-388 into the Roche pipeline, we have designated it as a fast-track asset and significantly accelerated its clinical development to bring this potential therapy to patients. CT-388 is currently being investigated in an additional Phase II study (CT388-104) to evaluate the efficacy, safety and tolerability of CT-388 in participants who are living with obesity or are overweight and have T2D. The phase III clinical trial programme of CT-388 in obesity (Enith1 and Enith2) is expected to start this quarter. In addition to offering robust efficacy as a standalone therapy, CT-388 also plays a key role in unlocking the promise of our obesity pipeline and is considered as a combination asset for petrelintide.

About the CT-388 (103) Phase II study [NCT06525935]
The multi-center, randomized, double-blind, placebo-controlled, parallel group dose-finding Phase II trial was designed to evaluate the efficacy and safety of CT-388 at low, middle, and high doses in 469 people with obesity. It includes adults with obesity (BMI≥30.0 kg/m²) or overweight (BMI ≥27.0 and <30.0 kg/m²) with at least one weight-related comorbidity without type 2 diabetes and evaluated five dosing cohorts with different up-titration schemes with 24mg being the highest dose tested. The primary endpoint was percent change in body weight from baseline to week 48.

About CT-388
CT-388 is an investigational once-weekly subcutaneous injectable, dual GLP-1/GIP receptor agonist being developed for the treatment of obesity, type 2 diabetes, and other obesity-related comorbidities. It aims to reduce appetite and regulate blood sugar by selectively targeting and activating both receptors which integrate nutrient-derived signals to control energy homeostasis. CT-388 was designed to have potent activation of both GLP-1 and GIP receptors, but with minimal to no ß-arrestin recruitment on either receptor. This biased signalling significantly minimises receptor internalisation and consequent desensitisation, which is expected to lead to prolonged pharmacological activity.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	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: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr. Rebekka Schnell Phone: +41 79 205 27 03

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

Overall survival was twice as long for people treated with Columvi in combination with GemOx versus MabThera/Rituxan plus GemOx¹
This Columvi combination is available off-the-shelf and could offer a potentially curative treatment option for people with R/R DLBCL who are not candidates for transplant
Columvi in combination with GemOx has now been approved in more than 50 countries worldwide and recommended in international treatment guidelines^2-4

Basel, 8 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today three-year follow-up data from the pivotal phase III STARGLO study in people with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) who have received at least one prior line of therapy and are not candidates for autologous stem cell transplant (ASCT). After a median follow-up of 35.1 months, overall survival (OS) remained twice as long for people treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) plus GemOx (R-GemOx) (25.5 months versus 12.5 months, respectively [hazard ratio (HR)=0.60, 95% confidence interval (CI): 0.43-0.8]).¹Results were presented at the 67^th American Society of Hematology Annual Meeting and Exposition, 6-9 December 2025 in Orlando, Florida, US.

Subgroup analyses showed consistent results across clinically relevant subgroups of prior line of therapy and age.¹ The greatest efficacy benefit was seen in people who had received one prior line of therapy (second line, 2L), with 54.6% still alive at 36 months follow-up.¹ For these patients, median OS was not reached with Columvi in combination with GemOx versus 14.4 months (HR=0.58; 95% CI: 0.38-0.89) in the R-GemOx arm.¹ Median progression-free survival (PFS) was 20.4 versus 5.5 months (HR=0.41; 95% CI: 0.25-0.65).¹ In patients with 2L DLBCL with early relapse (within 12 months), who are typically harder to treat, the complete response rate was 56.0% and the 36 month OS rate was 46.1%.⁵

“At three years, we see flattening of the overall survival curve, suggesting the possibility of cure for relapsed/refractory DLBCL patients treated with glofitamab-GemOx,” said Jeremy Abramson, MD, Director, Jon and Jo Ann Hagler Center for Lymphoma at the Mass General Brigham Cancer Institute, US, and principal investigator of the STARGLO study. “These data continue to underscore the meaningful benefit of Glofitamab plus GemOx for patients after initial relapse, when fast and effective treatment is critical given the aggressive nature of this disease.”

“By prolonging survival, this Columvi combination could offer people with relapsed or refractory DLBCL long-term remission, and potential additional time to spend with their loved ones without signs of disease or the need for continuous therapy,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The potential of Columvi in combination with GemOx continues to be recognised globally, with approvals in more than 50 countries around the world and inclusion in multiple international treatment guidelines.”

Data add to the growing body of evidence supporting the value that this Columvi-based combination can bring to people with 2L+ DLBCL who are not candidates for ASCT or who face barriers accessing other treatment options. As an off-the-shelf and fixed-duration therapy, Columvi plus GemOx can be readily available for infusion in any setting, meaning patients could avoid crucial delays in starting treatment and allowing the possibility of a treatment-free period.

The safety profile was unchanged with extended follow up; no new signals were identified, and safety of the combination was consistent with the known safety profiles of the individual medicines. Cytokine release syndrome (CRS) remained the most common adverse event in people treated with Columvi plus GemOx (44.8%; Grade 1: 32.0%, Grade 2: 10.5%, Grade 3: 2.3%).¹ Immune recovery in the form of median B-cell and immunoglobulin M count was observed 18-24 months after end-of-treatment.¹

Based on the STARGLO data, this Columvi combination is approved in more than 50 countries worldwide, including countries in the EU, the UK, Canada, Australia, China and Mexico, with additional submissions to health authorities ongoing*. Columvi in combination with GemOx is recommended in clinical practice guidelines including the European Society For Medical Oncology, European Hematology Association and the US National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines®) with category 1 evidence for people with 2L+ DLBCL.†^2-4 The US Food and Drug Administration issued a Complete Response Letter for the supplemental Biologics License Application for Columvi in combination with GemOx for this indication.

Roche is continuing to explore the potential of Columvi across other settings including first-line (1L) DLBCL and mantle cell lymphoma (MCL) to elevate treatment standards even further. This includes the phase III SKYGLO study investigating Columvi in combination with Polivy® (polatuzumab vedotin), MabThera/Rituxan, cyclophosphamide, doxorubicin and prednisone, in 1L DLBCL, which has recently completed enrolment. In R/R MCL, the phase III GLOBRYTE study evaluating Columvi as a single agent versus investigator’s choice of therapy is currently recruiting.

About the STARGLO study
The STARGLO study [GO41944; NCT04408638] is a phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Columvi® (glofitamab) in combination with gemcitabine plus oxaliplatin (GemOx) versus MabThera®/Rituxan® (rituximab) in combination with GemOx in patients with relapsed or refractory diffuse large B-cell lymphoma who have received at least one prior line of therapy and who are not candidates for autologous stem cell transplant, or who have received two or more prior lines of therapy. Preclinical research indicated an increased antitumour effect when combining Columvi with GemOx over GemOx alone, so the STARGLO study was initiated to further explore the potential complementary effects of the treatment combination. Outcome measures include overall survival (primary endpoint), progression-free survival, complete response rate, objective response rate, duration of objective response (secondary endpoints), and safety and tolerability.

About Columvi® (glofitamab)
Columvi is a CD20xCD3 T-cell-engaging bispecific antibody designed to target CD3 on the surface of T cells and CD20 on the surface of B cells. Columvi was designed with a novel 2:1 structural format. This T-cell-engaging bispecific antibody is engineered to have one region that binds to CD3, a protein on T cells, a type of immune cell, and two regions that bind to CD20, a protein on B cells, which can be healthy or malignant. This dual-targeting brings the T cell in close proximity to the B cell, activating the release of cancer cell-killing proteins from the T cell. Columvi is part of Roche’s broad and industry-leading CD20xCD3 T-cell-engaging bispecific antibody clinical development programme that also includes Lunsumio® (mosunetuzumab), which aims to provide tailored treatment options that suit the diverse needs, preferences, and experiences of people with blood cancers and healthcare systems. Roche is investigating Columvi as a monotherapy and in combination with other medicines for the treatment of diffuse large B-cell lymphoma and mantle cell lymphoma.

About diffuse large B-cell lymphoma (DLBCL)
DLBCL is an aggressive (fast-growing) type of non-Hodgkin lymphoma (NHL) and the most common form, accounting for about one in three cases of NHL.⁶ Approximately 160,000 people worldwide are diagnosed with DLBCL each year, with comparable incidence rates across regions.^7,8 Medical practices, including pathological classification, diagnosis, staging, initial treatment and relapse management, are similarly approached worldwide.^8-11 While it is generally responsive to treatment in the frontline, as many as 40% of people will relapse or have refractory disease, at which time salvage therapy options are limited and survival is short.^12,13 Improving treatments earlier in the course of the disease and providing much needed alternative options could help to improve long-term outcomes.

About Roche in haematology
Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and Tecentriq® (atezolizumab). Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from clinical practice.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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

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

*Countries that have approved Columvi in combination with GemOx in R/R DLBCL include: Argentina, Australia, Bahrain, Bosnia and Herzegovina, Canada, China, the European Union, Iceland, Lebanon, Liechtenstein, Macedonia, Malaysia, Mexico, New Zealand, Norway, Oman, Paraguay, Peru, Qatar, South Korea, Taiwan, Thailand, United Arab Emirates, United Kingdom, Uruguay.

†NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.

References
[1] Abramson JS, et al. Sustained clinical benefit of glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab plus GemOx (R-GemOx) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 3-year follow-up of STARGLO. Presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #5519.

[2] Eyre TA, at al. Lymphomas: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Ann Oncol. 2025;36(11):1263-1284.

[3] Thieblemont C, et al. Large B-cell lymphoma (LBCL): EHA Clinical Practice Guidelines for diagnosis, treatment, and follow-up. HemaSphere. 2025;9:e70207.

[4] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.1.2025.

[5] Abdulhaq H, et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) vs rituximab (R)-GemOx in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Efficacy and safety in patient subgroups. Presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #3743.

[6] UpToDate. Patient education: Diffuse large B cell lymphoma in adults (Beyond the Basics). [Internet; cited December 2025]. Available from: https://www.uptodate.com/contents/diffuse-large-b-cell-lymphoma-in-adults-beyond-the-basics.

[7] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited December 2025]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.

[8] Budde LE, et al. Characterizing the US Patient Population Receiving Rituximab with Gemcitabine and Oxaliplatin (R-GemOx) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma Using Real-World Data. Blood. 2024;144(1):2373.

[9] Yamshon, et al. Outcomes of Relapsed or Refractory Diffuse Large B-Cell Lymphoma Treated With R-GemOx: A Multicenter Cohort Study. Hematol. 2025;100(4):606-615.
[10] Sineshaw HM, Zettler CM, Prescott J, et al. Real-world patient characteristics, treatment patterns, and treatment outcomes of patients with diffuse large B-cell lymphoma by line of therapy. Cancer Med. 2024 Apr;13(7):e7173.
[11] Koff JL, Larson MC, Martin P et al. LEO Consortium for Real World Evidence (CReWE): Outcomes after Second-Line Therapy in Large B-Cell Lymphoma by Treatment Era. Blood (2023) 142 (Supplement 1): 307.

[12] Fabbri N, et al. Second-line treatment of diffuse large B-cell lymphoma: Evolution of options. Semin Hematol 2023; 60(5): 305–312.
[13] Sehn LH, et al. Diffuse Large B-Cell Lymphoma. N Engl J Med. 2021;384(9):842-858.

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

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	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: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

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 Columvi STARGLO ASH English

The point-of-care test delivers PCR-accurate results in just 15 minutes, enabling healthcare providers to act quickly and prevent severe complications and onward transmission.
Detects and differentiates between three types of Bordetella infection that can cause similar cough symptoms, ensuring patients receive the right diagnosis at the earliest opportunity.
Early diagnosis can reduce the risk of complications and severe disease in vulnerable groups such as infants and the elderly, by enabling faster, more precise care decisions.

Basel, 2 December 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that its first point-of-care test for the diagnosis of whooping cough (pertussis) and other Bordetella infections, has been granted U.S. Food and Drug Administration (FDA) 510(k) clearance and Clinical Laboratory Improvement Amendments of 1988 (CLIA) waiver, in addition to CE IVDR certification. The groundbreaking PCR test uses the cobas® liat system to deliver results in just 15 minutes in GP practices and Emergency Rooms. This speed enables physicians to diagnose patients during their consultation and take immediate action to provide appropriate antibiotics that can prevent severe complications and onward transmission.

Pertussis affects people of all ages but can be more severe in children, causing an estimated 24.1 million cases and 170,000 deaths annually.¹ A major diagnostic challenge is that early symptoms are often indistinguishable from other respiratory illnesses. This lack of rapid, accessible diagnostics causes clinicians to treat based on symptoms, a delay that allows the disease to progress and leads to severe outcomes, especially for vulnerable groups.

"Faster and more accurate clinical decisions are critical for reducing the risk of severe complications and ultimately stopping the transmission of Bordetella infections.” said Matt Sause, CEO of Roche Diagnostics. “This new test allows clinicians to quickly make a definitive and precise diagnosis to ensure patients get the right treatment earlier."

The test not only detects Bordetella infections but also differentiates between three key species: B. pertussis, the cause of classic whooping cough; B. parapertussis, which causes a milder pertussis-like illness that may not respond to standard treatments; and B. holmesii, an emerging pathogen increasingly associated with pertussis-like symptoms and potential diagnostic challenges.

Whooping cough is a cyclical disease that typically peaks in severity every three to five years.² With a surge underway³, the increase in cases has been further amplified by interruptions in routine vaccinations during the pandemic, along with waning immunity and vaccine hesitancy. These factors have driven infections across all age groups, including older children and adults, where symptoms can be less typical and harder to recognise.

Bordetella infections, including whooping cough, are a significant challenge for clinicians due to the similarity of early symptoms to other respiratory infections. Accurately identifying Bordetella among these conditions is essential to delivering the right treatment and ensuring timely intervention.

About the cobas® liat system
The test is delivered using the cobas® liat system, already used by healthcare professionals worldwide for point-of-care diagnostics. The compact system delivers PCR-accurate definitive results in 20 minutes or less to aid in patient care decisions. This new assay expands the cobas® liat system’s capabilities, complementing existing respiratory assays for the detection of SARS-CoV-2, Influenza A, Influenza B, Respiratory Syncytial Virus (RSV), and Group A Streptococcus (Strep A). By enabling clinicians to test for a range of conditions during the patient consultation, the system empowers faster, more decisive care decisions and reduces reliance on central laboratory facilities.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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

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

References
[1] Yeung KHT, Duclos P, Nelson EAS, Hutubessy RCW. An update of the global burden of pertussis in children younger than 5 years: a modelling study. Lancet Infect Dis. 2017;17(9):974-980. doi:10.1016/S1473-3099(17)30390-0.

[2] CDC. https://www.cdc.gov/pertussis/outbreaks/index.html

[3] PAHO.https://www.paho.org/en/news/26-8-2025-paho-calls-strengthened-vaccination-and-surveillance-amid-spread-antibiotic

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

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	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: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

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

Lunsumio provides high rates of deep and long-lasting responses in third-line and later follicular lymphoma, a disease that typically becomes harder to treat each time a patient relapses^1,2
Lunsumio subcutaneous offers a new treatment option that can significantly reduce administration time to approximately one minute
Availability of Lunsumio SC allows patients to receive treatment aligned to clinical requirements and lifestyle preferences

Basel, 19 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission has granted conditional marketing authorisation of Lunsumio® (mosunetuzumab) subcutaneous (SC) for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. Approval is based on results from the phase I/II GO29781 study, which showed that Lunsumio SC had pharmacokinetic non-inferiority compared with intravenous (IV) administration, with no unexpected safety signals.³

“Building on the benefits of its fixed-duration dosing schedule, Lunsumio can now be administered with a one-minute subcutaneous injection, providing people with relapsed or refractory follicular lymphoma an additional treatment option to help meet their individual clinical requirements and lifestyle preferences,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Developing new formulations of our medicines is part of our commitment to offering greater flexibility and a better treatment experience for patients.”

Lunsumio SC is a fixed-duration treatment that can be initiated in the outpatient setting and has the potential to substantially reduce treatment administration time with an approximately one-minute injection, compared with a 2-4 hour IV infusion.

Lunsumio has shown a favourable benefit-risk profile and high rates of deep and durable remissions with both IV and SC administration routes in third-line or later (3L+) FL.^1,4 Lunsumio IV was the first bispecific antibody approved for 3L+ FL and has shown sustained responses, with 57% of patients who achieved a CR still in remission at five years.¹ Long-term data from the SC and IV arms of the GO29781 study will be presented at the 67th American Society of Hematology (ASH) Annual Meeting and Exposition.

These data have been submitted to other healthcare authorities around the world, including the US Food and Drug Administration.

Phase III studies involving Lunsumio SC are ongoing, including the MorningLyte trial investigating Lunsumio SC in combination with lenalidomide in previously untreated FL. Lunsumio, along with Columvi® (glofitamab), is part of Roche’s industry-leading CD20xCD3 bispecific antibody portfolio. Continuing to explore new formulations and combinations of these medicines across different disease areas and lines of treatment is part of Roche’s commitment to improve the patient experience and provide more choice to suit diverse patient and healthcare system needs.

About the GO29781 study
The GO29781 study is a phase II, multicentre, open-label, dose-escalation and expansion study evaluating the safety, efficacy and pharmacokinetics of Lunsumio® (mosunetuzumab), administered both as an intravenous (IV) and subcutaneous (SC) treatment, in people with relapsed or refractory B-cell non-Hodgkin lymphoma. The primary objective for the SC cohort was to show pharmacokinetic (PK) non-inferiority of the SC formulation of Lunsumio compared with the IV formulation, based on the study’s co-primary endpoints. Key secondary endpoints include complete response (CR) rate, objective response rate (ORR), duration of response, progression-free survival, safety and tolerability.

This approval is based on a primary analysis that explored Lunsumio administered subcutaneously in patients with 3L+ follicular lymphoma. Results from the primary analysis showed PK non-inferiority compared with IV administration, and the ORR and CR rates in patients treated with the fixed-duration, subcutaneous formulation of Lunsumio were 74.5% (95% confidence interval [CI]: 64.4-82.9%) and 58.5% (95% CI: 46.9-68.6%), respectively, as evaluated by the independent review faculty. The median duration of CR was 20.8 months (95% CI: 18.8-not evaluable [NE]) for patients receiving Lunsumio SC. The most common all-grade adverse events were injection-site reactions (60.6%; all Grade 1-2), fatigue (35.1%), and cytokine release syndrome (CRS; 29.8%). Overall, the rate and severity of CRS were low; events were low grade (Grade 1-2, 27.7%; Grade 3, 2.1%), occurred during cycle 1 and all fully resolved in a median of two days (range 1-15 days).³

About follicular lymphoma
Follicular lymphoma (FL) is the most common slow-growing (indolent) form of non-Hodgkin lymphoma, accounting for about one in five cases.^2,5 It typically responds well to treatment but is often characterised by periods of remission and relapse.² The disease typically becomes harder to treat each time a patient relapses, and early progression can be associated with poor long-term prognosis.⁵ It is estimated that more than 110,000 people are diagnosed with FL each year worldwide.^5,6

About Lunsumio® (mosunetuzumab)
Lunsumio is a first-in-class CD20xCD3 T-cell engaging bispecific antibody designed to target CD20 on the surface of B cells and CD3 on the surface of T cells. This dual targeting activates and redirects a patient’s existing T cells to engage and eliminate target B cells by releasing cytotoxic proteins into the B cells. A robust clinical development programme for Lunsumio is ongoing, investigating the molecule as a monotherapy and in combination with other medicines, for the treatment of people with B-cell non-Hodgkin lymphomas, including follicular lymphoma and diffuse large B-cell lymphoma, other blood cancers and autoimmune disorders.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person, we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from clinical practice.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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

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

References
[1] Budde E, et al. Fixed treatment duration mosunetuzumab continues to demonstrate clinically meaningful outcomes in patients with relapsed/refractory (R/R) follicular lymphoma (FL) after ≥2 prior therapies: 5-year follow-up of a pivotal Phase II study. Presented at: ASH Annual Meeting and Exposition; 2025 Dec 6-9; San Diego, CA, USA. Abstract #5352.
[2] Adult Non-Hodgkin Lymphoma Treatment-Health Professional Version (PDQ®) National Cancer Institute [Internet; cited November 2025]. Available from: https://www.cancer.gov/types/lymphoma/hp/adult-nhl-treatment-pdq#link/_552_toc.
[3] Roche data on file.
[4] Assouline S, et al. Fixed-duration subcutaneous mosunetuzumab continues to demonstrate high rates of durable responses in patients with relapsed/refractory follicular lymphoma after ≥2 prior therapies: 3-year follow-up from a pivotal Phase II study. Presented at: ASH Annual Meeting and Exposition; 2025 Dec 6-9; San Diego, CA, USA. Abstract #5353.
[5] Cancer.Net. Lymphoma - Non-Hodgkin: Subtypes. [Internet; cited November 2025]. Available from: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/subtypes.
[6] World Health Organization. Numbers derived from GLOBOCAN 2022. Non-Hodgkin Lymphoma Factsheet [Internet; cited November2025]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/34-non-hodgkin-lymphoma-fact-sheet.pdf.

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

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	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: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

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

The first (FENhance 2) of two pivotal RMS studies met its primary endpoint, showing investigational fenebrutinib significantly reduced relapses compared to teriflunomide
In a pivotal PPMS study (FENtrepid), fenebrutinib slowed disability progression at least as effectively as OCREVUS, the only approved therapy in PPMS
Full data from both studies will be shared at upcoming medical meetings; once the second RMS study (FENhance 1) has read out, which is expected in the first half of 2026, all data together will be considered for submission to regulatory authorities

Basel, 10 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the first Phase III (FENhance 2) of two pivotal, similarly-designed Phase III studies (FENhance 1 and 2) in patients with relapsing multiple sclerosis (RMS) met its primary endpoint. Fenebrutinib, an investigational Bruton’s tyrosine kinase (BTK) inhibitor, significantly reduced the annualised relapse rate (ARR) compared to teriflunomide over a period of at least 96 weeks of treatment.

Additionally, the Phase III FENtrepid pivotal study evaluating fenebrutinib, compared with OCREVUS® (ocrelizumab) in patients with primary progressive multiple sclerosis (PPMS), met its primary endpoint. The results showed that fenebrutinib was non-inferior compared to ocrelizumab, the only approved therapy in PPMS, as measured by a delay in the onset of composite confirmed disability progression over a period of at least 120 weeks of treatment. A numerical benefit for fenebrutinib compared to ocrelizumab was seen as early as week 24, and lasted throughout the observation period.

“Fenebrutinib substantially reduced the number of relapses in RMS and slowed disability progression in PPMS. These unprecedented results suggest that fenebrutinib could potentially become a best-in-disease medicine as the first high-efficacy, oral treatment for people with RMS or PPMS,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Therefore, these pivotal results for fenebrutinib may offer new hope for people living with MS, and they reaffirm our enduring commitment to the MS community.”

Liver safety was consistent with previous fenebrutinib studies. Additional safety data is being further evaluated. The results of the second RMS Phase III trial (FENhance 1) are expected by the first half of 2026.

Fenebrutinib targets cells in the immune system known as B cells and microglia. Targeting B cells helps control the acute inflammation that causes relapses, while targeting microglia inside the brain addresses the chronic damage that is thought to drive long-term disability progression. Fenebrutinib, a non-covalent BTKi, is designed to have high potency, selectivity and reversibility. This design allows it to act throughout the body, and also to cross the blood-brain barrier into the central nervous system (CNS) targeting chronic inflammation.

About the FENhance 1 and 2 studies
FENhance 1 and 2 are similarly designed Phase III multicentre, randomised, double-blind, double-dummy, parallel-group studies to evaluate the efficacy and safety of investigational fenebrutinib compared with teriflunomide in a total of 1,497 adult patients with RMS. Eligible participants were randomised 1:1 to receive treatment with either oral fenebrutinib twice a day (and placebo matched to oral teriflunomide once a day) or oral teriflunomide once a day (and placebo matched to oral fenebrutinib twice a day) for at least 96 weeks.

The primary endpoint is annualised relapse rate (ARR). Key secondary endpoints include the time to onset of composite 24-week confirmed disability progression (cCDP24), 12-week confirmed disability progression (CDP12) and 24-week confirmed disability progression (CDP24).

Following the double-blind treatment period, patients have the option to enter an open-label extension (OLE) phase, in which all patients receive treatment with fenebrutinib.

About the FENtrepid study
FENtrepid is a Phase III multicentre, randomised, double-blind, double-dummy, parallel-group study to evaluate the efficacy and safety of fenebrutinib compared with OCREVUS in 985 adult patients with PPMS. Eligible participants were randomised 1:1 to receive treatment with either daily oral fenebrutinib (and placebo matched to intravenous [IV] OCREVUS) or IV OCREVUS (and placebo matched to oral fenebrutinib) for at least 120 weeks.

The primary endpoint is the time to onset of 12-week composite confirmed disability progression (cCDP12). The cCDP incorporates three measures of disability – total functional disability measured by the Expanded Disability Status Scale (EDSS), walking speed measured by the timed 25-foot walk (T25FW), and upper limb function measured by the nine-hole peg test (9HPT). This comprehensive composite endpoint offers greater sensitivity than the EDSS alone, capturing additional aspects of disability and often earlier. Key secondary endpoints include the time to onset of 24-week composite confirmed disability progression (cCDP24), 12-week confirmed disability progression (CDP12) and 24-week confirmed disability progression (CDP24).

Following the double-blind treatment period, patients have the option to enter an open-label extension (OLE) phase, in which all patients receive treatment with fenebrutinib.

About fenebrutinib
Fenebrutinib is an investigational oral, central nervous system (CNS)-penetrant, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor with an optimised pharmacokinetics (PK) profile. Fenebrutinib has been shown to be 130 times more selective for BTK vs. other kinases. Fenebrutinib is an inhibitor of both B-cell and microglia activation. This dual inhibition may be able to reduce both multiple sclerosis disease activity and disability progression, thereby potentially addressing the key unmet medical need of disability progression in people living with multiple sclerosis and providing comprehensive multiple sclerosis care. The fenebrutinib Phase III programme includes two similarly-designed trials in relapsing multiple sclerosis (RMS) (FENhance 1 and 2) with active comparator teriflunomide and the only trial in primary progressive multiple sclerosis (PPMS) (FENtrepid) in which a BTK inhibitor is being evaluated against OCREVUS.

About OCREVUS® (ocrelizumab)
OCREVUS is a humanised monoclonal antibody designed to target CD20-positive B cells, a specific type of immune cell thought to be a key contributor to myelin (nerve cell insulation and support) and axonal (nerve cell) damage. OCREVUS IV and OCREVUS subcutaneous (SC; marketed as OCREVUS ZUNOVO® [ocrelizumab hyaluronidase-ocsq] in the U.S.) are the only therapies approved for both RMS (including relapsing-remitting multiple sclerosis [RRMS] and active, secondary progressive multiple sclerosis [SPMS], as well as clinically isolated syndrome [CIS] in the U.S.) and primary progressive multiple sclerosis (PPMS). Both OCREVUS IV and SC are administered every six months. The initial IV dose is given as two 300 mg infusions two weeks apart with subsequent doses given as single 600 mg infusions. OCREVUS SC is given as a single 920 mg subcutaneous injection every six months.

About multiple sclerosis
Multiple sclerosis is a chronic disease that affects more than 2.9 million people worldwide. People with all forms of multiple sclerosis experience disease progression from the beginning of their disease. Therefore, an important goal of treating multiple sclerosis is to slow, stop and ideally prevent progression as early as possible.

Approximately 85% of people with multiple sclerosis have a relapsing form of the disease (RMS) characterised by relapses and also worsening disability over time. Primary progressive multiple sclerosis (PPMS) is a debilitating form of the disease marked by steadily worsening symptoms but typically without distinct relapses or periods of remission. Approximately 15% of people with multiple sclerosis are diagnosed with the primary progressive form of the disease. Until the FDA approval of OCREVUS®, there had been no FDA-approved treatments for PPMS and OCREVUS is still the only approved treatment for PPMS.

About Roche in Neuroscience
Neuroscience is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Roche is investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	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: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr. Rebekka Schnell Phone: +41 79 205 27 03

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

All rights reserved ©2025 F. Hoffmann-La Roche Ltd.
Group Communications, Grenzacherstrasse 124, CH-4070 Basel, Switzerland

Unsubscribe | Privacy Policy

Phase III ALLEGORY study met primary and all key secondary endpoints with Gazyva/Gazyvaro, an anti-CD20 monoclonal antibody designed for enhanced B cell depletion
Gazyva/Gazyvaro has the potential to be a transformative new standard of care for up to 3.4 million people affected by systemic lupus erythematosus (SLE) worldwide
If approved, Gazyva/Gazyvaro would be the first anti-CD20 therapy for SLE to directly target B cells, a key driver of inflammation and disease activity¹
These positive results follow the recent US FDA approval and positive EU CHMP opinion for Gazyva/Gazyvaro in lupus nephritis, alongside positive phase III data from the INShore study in idiopathic nephrotic syndrome

Basel, 3 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today statistically significant and clinically meaningful results from the phase III ALLEGORY study of Gazyva®/Gazyvaro® (obinutuzumab) in adults with systemic lupus erythematosus (SLE) on standard therapy. The study met its primary endpoint showing a higher percentage of people achieved a minimum four-point improvement in SLE Responder Index 4 (SRI-4) at one year (52 weeks) with Gazyva/Gazyvaro versus standard therapy.² SRI is a tool that assesses changes in disease severity, symptoms and physical condition to indicate whether treatment is effective at controlling disease activity. All key secondary endpoints were also met. No new safety signals were identified, and safety was in line with the well-characterised profile of Gazyva/Gazyvaro.

“Systemic lupus erythematosus is a lifelong condition that can cause irreversible damage to the major organs in the body, leading to life-threatening complications. These pivotal results are unprecedented in demonstrating that by effectively controlling disease activity, Gazyva/Gazyvaro may delay or prevent further organ damage in people with SLE,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “We look forward to sharing the data with global health authorities, with the goal of making this potentially transformative new standard of care available as quickly as possible.”

All key secondary endpoints were met, with results showing statistically significant and clinically meaningful benefits with Gazyva/Gazyvaro versus standard therapy including British Isles Lupus Assessment Group based Composite Lupus Assessment (BICLA) response at week 52, sustained corticosteroid control from week 40 to 52, sustained SRI-4 from week 40 to 52, a six-point improvement in SLE disease activity score (SRI-6) at 52 weeks, and time to first flare over 52 weeks as defined by the British Isles Lupus Assessment Group (BILAG) index.¹

SLE affects over three million people worldwide, mostly women diagnosed between the ages of 15 and 45, with women of colour disproportionately impacted.^3-5 Frequent flares of disease activity inflame and damage multiple organs. Around half of the patients will progress to lupus nephritis, a potentially life-threatening kidney complication, within five years of diagnosis.^6-8 Achieving better disease control can reduce flares, limit further damage to the organs and lower the risk of developing lupus nephritis.^9,10

Data will be presented at an upcoming medical meeting and shared with health authorities as soon as possible, including the US Food and Drug Administration and the European Medicines Agency. If approved, Gazyva/Gazyvaro would be the first anti-CD20 therapy for SLE to directly target B cells, an underlying cause of disease.²

ALLEGORY is the third positive phase III study for Gazyva/Gazyvaro in immune-mediated diseases, in addition to REGENCY in lupus nephritis and INShore in idiopathic nephrotic syndrome. This growing evidence suggests that Gazyva/Gazyvaro, designed to attack and destroy targeted B cells, both directly and together with the body's immune system, may help address disease activity across a spectrum of autoimmune or immune-related diseases.

In addition to SLE, Gazyva/Gazyvaro is being investigated in children and adolescents with lupus nephritis, as well as adults with membranous nephropathy, as part of our ambition to be leaders in immune-mediated rheumatology and nephrology diseases.

About Gazyva/Gazyvaro
Gazyva®/Gazyvaro® (obinutuzumab) is a humanised monoclonal antibody designed with a Type II anti-CD20 region, for direct B cell death and a glycoengineered Fc region, for higher binding affinity and increased antibody-dependent cellular cytotoxicity (ADCC).¹¹CD20 is a protein found on certain types of B cells. Gazyva/Gazyvaro is approved for adults with lupus nephritis in the US who are receiving standard therapy. In October 2025, the European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approval in the European Union, with a final decision expected from the European Commission in the near future. Gazyva/Gazyvaro is also approved in 100 countries for various types of haematological cancers.

About the ALLEGORY study
ALLEGORY [NCT04963296] is a phase III, randomised, double-blind, placebo-controlled, multicentre study, investigating the efficacy and safety of Gazyva®/Gazyvaro® (obinutuzumab) compared with standard therapy in adults with systemic lupus erythematosus (SLE) on standard therapy. The study enrolled approximately 300 people, who were randomised 1:1 to receive Gazyva/Gazyvaro or placebo for up to one year (52 weeks), followed by an open-label period with Gazyva/Gazyvaro for up to 104 weeks. The primary endpoint is the percentage of people who achieve SLE Responder Index four at week 52.

About systemic lupus erythematosus
Systemic lupus erythematosus (SLE) is a potentially life-threatening autoimmune disease that affects more than three million people worldwide, and rising.^3,12 Due to the non-specific symptoms, it can take two to six years for an accurate diagnosis. During this time, disease severity and organ damage, due to repeated flares of disease activity, typically worsens and quality of life declines.^9,13,14

Around half of people with SLE will develop lupus nephritis within five years of a lupus diagnosis.^7,8 In lupus nephritis, the disease activity primarily affects the kidneys and there is a risk of end-stage kidney disease, where dialysis and transplant are the only treatment options.

There is a need for additional targeted therapies that can effectively control disease activity and potentially delay or prevent the onset of lupus nephritis.^15,16

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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

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

References
[1] Yap DYH, Chan TM. B Cell Abnormalities in Systemic Lupus Erythematosus and Lupus Nephritis-Role in Pathogenesis and Effect of Immunosuppressive Treatments. Int J Mol Sci. 2019 Dec 10;20(24):6231.
[2] Clinicaltrials.gov. A study to evaluate the efficacy and safety of obinutuzumab in participants with systemic lupus erythematosus (ALLEGORY). [Internet; cited 2025 October 30]. Available from: https://clinicaltrials.gov/study/NCT04963296.
[3] Tian J, et al. Global epidemiology of systemic lupus erythematosus: a comprehensive systematic analysis and modelling study. Ann Rheum Dis. 2023 Mar;82(3):351-56.
[4] Bindroo MA, et al. Late Onset Systemic Lupus Erythematosus - Clinical and Autoantibody Profile and its Comparison with Young Onset Systemic Lupus Erythematosus. Mediterr J Rheumatol. 2023 Jul 29;34(4):454–59
[5] Barber MRW, et al. The global epidemiology of SLE: narrowing the knowledge gaps. Rheumatology (Oxford). 2023 Mar 29;62(Suppl 1):i4-9
[6] Mahajan A, et al. Systemic lupus erythematosus, lupus nephritis and end-stage renal disease: a pragmatic review mapping disease severity and progression. Lupus. 2020 Sep;29(9):1011-20.
[7] Bechler KK, et al. Predicting patients who are likely to develop Lupus Nephritis of those newly diagnosed with Systemic Lupus Erythematosus. AMIA Annu Symp Proc. 2023 Apr 29:2022:221-30.
[8] Anders HJ et al. Lupus nephritis. Nat Rev Dis Primers. 2020 Jan 23;6(1):7.
[9] Kandane-Rathnayake R, et al. Association of Lupus Low Disease Activity State And Remission With Reduced Organ Damage And Flare in Systemic lupus erythematosus Patients With High Disease Activity. Rheumatology (Oxford). 2025 May 1;64(5):2741-48.
[10] Adamichou C, et al. Flares in systemic lupus erythematosus: diagnosis, risk factors and preventive strategies. Mediterr J Rheumatol. 2017 Mar 28;28(1):4-12.
[11] Herter S, et al. Preclinical activity of the type II CD20 antibody GA101 (obinutuzumab) compared with rituximab and ofatumumab in vitro and in xenograft models. Mol Cancer Ther. 2013 Oct;12(10):2031-42.
[12] Rees F, et al. The worldwide incidence and prevalence of systemic lupus erythematosus: a systematic review of epidemiological studies. Rheumatology (Oxford). 2017 Nov 1;56(11):1945-61.
[13] Nightingale AL, et al. Presentation of SLE in UK primary care using the Clinical Practice Research Datalink. Lupus Sci Med. 2017 Feb 10;4(1):e000172.
[14] Murimi-Worstell IB, et al. Association between organ damage and mortality in systemic lupus erythematosus: a systematic review and meta-analysis. BMJ Open. 2020 May 21;10(5):e031850.
[15] Hocaoglu M et al. Incidence, prevalence, and mortality of lupus nephritis: a population-based study over four decades using the Lupus Midwest Network. Arthritis & Rheumatol 2023 Apr;75(4):567-73.
[16] Mok C, et al. Treatment of lupus nephritis: consensus evidence and perspectives. Nat Rev Rheumatol. 2023 Apr;19(4):227-38.

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

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	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: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

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

Findings further demonstrate the effectiveness of Roche’s approved medicines in advancing treatment standards for people with blood disorders
Data from innovative pipeline signals progress toward improved outcomes in haemophilia A, lymphoma, and multiple myeloma

Basel, 3 November 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it will showcase 46 abstracts, including 12 oral presentations, from its industry-leading haematology portfolio at the 67^th American Society of Hematology (ASH) Annual Meeting and Exposition, held 6-9 December 2025 in Orlando, Florida, US.

“The data we will present at this year’s ASH meeting underscore our commitment to driving innovation across haematology and reflect meaningful progress towards improved treatment of multiple blood disorders,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development.

Key presentations include:

Haemophilia A

Hemlibra® (emicizumab): New post-marketing data from the Beyond ABR study show that, in the first year after switching to Hemlibra prophylaxis from factor VIII prophylaxis, people with various levels of baseline joint impairment had low bleeding rates, associated with overall improvements in joint health, and a shift towards higher activity levels.¹ These findings add to the wealth of clinical and real-world evidence in support of Hemlibra as it continues to redefine standards of care for people living with haemophilia A.^2-11
NXT007: Positive phase I/II results, including new data from a global study in people with haemophilia A with and without factor VIII inhibitors, suggest the potential of Roche’s next-generation investigational bispecific antibody to normalise haemostasis.^12-14 These data support the progression of NXT007 into phase III clinical development planned for 2026, including a head-to-head study against Hemlibra.
SPK-8011QQ: Pre-clinical data on Roche’s next-generation investigational AAV gene therapy, show significantly enhanced haemostatic potency compared with SPK-8011 (dirloctocogene samoparvovec) in ex vivo and in vivo mouse models.¹⁵ Findings support the ongoing evaluation of SPK-8011QQ, furthering previous learnings on the safety and durability of SPK-8011, with phase IIb study initiation planned for 2026.

Lymphoma

Lunsumio® (mosunetuzumab): Preliminary data from the US extension arm of the phase III CELESTIMO study investigating Lunsumio plus lenalidomide, in people with second-line or later (2L+) relapsed or refractory (R/R) follicular lymphoma (FL), support its potential as an effective and well-tolerated outpatient treatment option.¹⁶
Lunsumio plus Polivy® (polatuzumab vedotin): Long-term follow-up data from the phase Ib/II GO40516 study demonstrate sustained improvements in objective response rate (ORR) and progression-free survival with this combination in people with 2L+ large B-cell lymphoma (LBCL).¹⁷ Additionally, patient-reported outcomes from the phase III SUNMO study show treatment with Lunsumio plus Polivy was associated with delayed deterioration in physical function and improvements in fatigue, pain, and emotional function, in people with transplant-ineligible R/R LBCL.¹⁸
Columvi® (glofitamab): Three-year follow-up and subgroup analyses from the phase III STARGLO study show continued superior survival outcomes with Columvi in combination with gemcitabine and oxaliplatin (GemOx) for people with R/R diffuse large B-cell lymphoma (DLBCL) compared with MabThera®/Rituxan® (rituximab) and GemOx, including people with second-line DLBCL and primary refractory disease or early relapse.*^19-20

Multiple myeloma

Cevostamab: Clinical and exploratory biomarker analysis from the phase Ib CAMMA-1 study shows investigational cevostamab in combination with pomalidomide and dexamethasone induces high ORR, very good partial response (VGPR) or better rates, and durable remissions, in R/R multiple myeloma.²¹
First data from the phase Ib CAMMA-3 study highlight that subcutaneous cevostamab monotherapy delivers deep and durable responses in people with late-line R/R multiple myeloma.²²
These data support the progression of cevostamab in combination with pomalidomide and dexamethasone into phase III clinical development for people with 2L+ R/R multiple myeloma, with study initiation planned for 2026.

Overview of key presentations featuring Roche medicines

Medicine	Abstract title	Abstract number/presentation details
cevostamab	Tumor clearance, T-cell fitness and minimal residual disease (MRD) outcomes in patients with relapsed/refractory multiple myeloma (RRMM) treated with cevostamab plus pomalidomide and dexamethasone: Biomarker analyses from CAMMA 1 arm b	#252 oral presentation Session: 654. Multiple Myeloma: Pharmacologic Therapies: Advances in Treatment Strategies for Relapsed/Refractory Multiple Myeloma Saturday 6 December 2025 3:15pm EST
cevostamab	Subcutaneous cevostamab demonstrates manageable safety and clinically meaningful activity in relapsed/refractory multiple myeloma (RRMM): First results from the phase Ib CAMMA 3 study	#700 oral presentation Session: 654. Multiple Myeloma: Pharmacologic Therapies: Bi, Tri and Beyond: Innovations in Bispecific and Trispecific Antibodies for Multiple Myeloma Sunday 7 December 2025 5:15pm EST
Columvi® (glofitamab)	CRS-RS.5p predictive model informs risk stratification and cytokine release syndrome management following glofitamab treatment in patients with relapsed or refractory diffuse large B-cell lymphoma	#2559 poster presentation Session: 803. Emerging Tools, Techniques, and Artificial Intelligence in Hematology: Poster I Saturday 6 December 2025 5:30pm-7:30pm EST
	Glofitamab plus gemcitabine and oxaliplatin (GemOx) vs rituximab (R)-GemOx in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): efficacy and safety in patient subgroups	#3743 poster presentation Session: 629. Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies: Poster II Sunday 7 December 2025 6pm-8pm EST
	Glofitamab in combination with polatuzumab vedotin demonstrates high and durable efficacy in patients with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) in the second-line (2L) and third-line and later (3L+) setting: A subgroup analysis	#5510 poster presentation Session: 629. Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies: Poster III Monday 8 December 2025 6pm-8pm EST
	Sustained clinical benefit of glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab plus GemOx (R-GemOx) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 3-year follow-up of STARGLO	#5519 poster presentation Session: 629. Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies: Poster III Monday 8 December 2025 6pm-8pm EST
Hemlibra® (emicizumab)	Evolution of joint health and physical activity in people with hemophilia A without factor VIII inhibitors switching to emicizumab prophylaxis: A second interim analysis of the BEYOND ABR study	#1285 poster presentation Session: 322. Hemophilia A and B: Clinical and Epidemiological: Poster III Saturday 6 December 2025 5:30pm-7:30pm EST
Lunsumio® (mosunetuzumab)	Fixed treatment duration subcutaneous mosunetuzumab monotherapy in elderly/unfit patients with previously untreated diffuse large B-cell lymphoma: Interim results from the Phase II MorningSun study	#62 oral presentation Session: 629. Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies: Overcoming Barriers in Frontline Therapy: Bispecific Antibodies for Older Adults with DLBCL Saturday 6 December 2025 9:45am EST
	Fixed-duration subcutaneous (SC) mosunetuzumab, with maintenance therapy, in patients (pts) with previously untreated high-tumor burden follicular lymphoma (HTB FL): Longer follow-up and exploratory circulating tumor (ct)DNA analysis of the Phase II MorningSun study	#228 oral presentation Session: 623. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: FL and WM Saturday 6 December 2025 3:15pm EST
	Long-term follow-up with sustained progression-free survival (PFS) benefit after subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin compared with rituximab plus polatuzumab vedotin in patients with relapsed or refractory (R/R) B-cell non-Hodgkin Lymphoma	#1020 oral presentation Session: 629. Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies: Improving Outcomes in Rare Large Cell Lymphomas Monday 8 December 2025 5:45pm EST
	Promising response rates and manageable safety with mosunetuzumab plus lenalidomide (Mosun-Len) in patients with relapsed/refractory (R/R) follicular lymphoma (FL): US extension cohort from the Phase III CELESTIMO study	#1800 poster presentation Session: 623. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster I Saturday 6 December 2025 5:30pm-7:30pm EST
	Improvements in health-related quality of life (HRQoL) in the SUNMO study: subcutaneous (SC) mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) versus rituximab, gemcitabine and oxaliplatin (R-GemOx) in patients (pts) with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) after at least one prior therapy	#5509 poster presentation Session: 629. Aggressive Lymphomas, Immunotherapy including Bispecific Antibodies: Poster III Monday 8 December 2025 6pm-8pm EST
	Fixed treatment duration mosunetuzumab continues to demonstrate clinically meaningful outcomes in patients with relapsed/refractory (R/R) follicular lymphoma (FL) after ≥2 prior therapies: 5-year follow-up of a pivotal Phase II study	#5352 poster presentation Session: 623. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III Monday 8 December 2025 6pm-8pm EST
	Fixed-duration subcutaneous mosunetuzumab continues to demonstrate high rates of durable responses in patients with relapsed/refractory follicular lymphoma after ≥2 prior therapies: 3-year follow-up from a pivotal Phase II study	#5353 poster presentation Session: 623. Mantle Cell, Follicular, Waldenstrom's, and Other Indolent B Cell Lymphomas: Clinical and Epidemiological: Poster III Monday 8 December 2025 6pm-8pm EST
Lunsumio / Columvi	Patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) preferred fixed-duration treatments with less frequent administrations in the era of novel bispecific antibodies (BsAbs)	#6179 poster presentation Session: 902. Health Services and Quality Improvement: Lymphoid Malignancies: Poster III Monday 8 December 2025 6pm-8pm EST
	Diverse preferences for treatment options in relapsed/refractory (R/R) follicular lymphoma (FL): Survey results from patients in the United States (US)	#6180 poster presentation Session: 902. Health Services and Quality Improvement: Lymphoid Malignancies: Poster III Monday 8 December 2025 6pm-8pm EST
	Differences in patient-reported time toxicity between bispecific antibody (BsAb) options: Impact of treatment duration and dosing frequency on patient-reported time burden in relapsed/refractory (R/R) follicular lymphoma (FL) and diffuse large B-cell lymphoma (DLBCL)	#6181 poster presentation Session: 902. Health Services and Quality Improvement: Lymphoid Malignancies: Poster III Monday 8 December 2025 6pm-8pm EST
NXT007	NXT007 prophylaxis in people with hemophilia A with or without FVIII inhibitors: a global phase I/II multiple-ascending-dose study	#302 oral presentation Session: 322. Hemophilia A and B: Clinical and Epidemiological: Prophylaxis Across the Age Spectrum Saturday 6 December 2025 4:15pm EST
	Ex Vivo Evaluation of the Procoagulant Effect of NXT007 Prophylaxis in People with Hemophilia A without Factor VIII Inhibitors: Phase I/II Study (NXTAGE)	#3061 poster presentation Session: 322. Hemophilia A and B: Clinical and Epidemiological: Poster II Sunday 7 December 2025 6pm-8pm EST
	Pharmacodynamic biomarkers in people with hemophilia A receiving multiple ascending doses of NXT007	#4841 poster presentation Session: 322. Hemophilia A and B: Clinical and Epidemiological: Poster III Monday 8 December 2025 6pm-8pm EST
Polivy® (polatuzumab vedotin)	Transcriptional profiling refines DLBCL classification and identifies subtypes with distinct therapeutic vulnerabilities	#49 oral presentation Session: 621. Lymphomas: Translational – Molecular and Genetic - Subtyping strategies to unlock new therapeutic vulnerabilities Saturday 6 December 2025 9:30am EST
Polivy® (polatuzumab vedotin)	Assessment of the prognostic value of FDG PET-derived markers and responses in POLARIX	#5329 poster presentation Session: 622. Lymphomas: Translational – Non-Genetic: Poster III Monday 8 December 2025 6pm-8pm EST
SPK-8011QQ	Preclinical evaluation of SPK-8011QQ, an adeno-associated virus gene therapy for people with hemophilia A leveraging the dirloctocogene samoparvovec platform encoding an activated protein C-resistant B-domain deleted factor VIII	#1068 oral presentation Session: 801. Gene Therapies: Technological Developments in Gene Therapy Monday 8 December 2025 5:45pm EST
Venclexta®/ Venclyxto® (venetoclax)**	Long-term immune reconstitution and final 1-year follow-up after fixed-duration venetoclax-obinutuzumab (VenO) in first-line (1L) chronic lymphocytic leukemia (CLL): results from the Phase III CRISTALLO trial	#682 oral presentation Session: 642. Chronic Lymphocytic Leukemia: Clinical and Epidemiological: Frontline Treatment Strategies for CLL Sunday 7 December 2025 5:15pm EST
	Results from PARADIGM - a phase 2 randomized study comparing venetoclax and azacitidine to conventional induction chemotherapy for newly diagnosed fit adults with acute myeloid leukemia	Plenary session Sunday 7 December 2025 2pm-4pm EST
	Fixed-duration versus continuous targeted treatment for previously untreated chronic lymphocytic leukemia: Results from the randomized CLL17 trial	Plenary session Sunday 7 December 2025 2pm-4pm EST

*Based on the STARGLO data, Columvi in combination with GemOx is approved in 49 countries for the treatment of R/R DLBCL including the EU, UK, Australia and Canada. On 2 July 2025, the US Food and Drug Administration issued a Complete Response Letter for the supplemental Biologics License Application for Columvi in combination with GemOx for this indication.

**Venclexta/Venclyxto is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche Group, in the US, and commercialised by AbbVie outside of the US.

About Roche in haematology

Roche has been developing medicines for people with malignant and non-malignant blood diseases for more than 25 years; our experience and knowledge in this therapeutic area runs deep. Today, we are investing more than ever in our effort to bring innovative treatment options to patients across a wide range of haematologic diseases. Our approved medicines include MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro® (obinutuzumab), Polivy® (polatuzumab vedotin), Venclexta®/Venclyxto® (venetoclax) in collaboration with AbbVie, Hemlibra® (emicizumab), PiaSky® (crovalimab), Lunsumio® (mosunetuzumab) and Columvi® (glofitamab). Our pipeline of investigational haematology medicines includes T-cell-engaging bispecific antibody cevostamab, targeting both FcRH5 and CD3, and off-the-shelf allogeneic CAR-T therapies. Our scientific expertise, combined with the breadth of our portfolio and pipeline, also provides a unique opportunity to develop combination regimens that aim to improve the lives of patients even further.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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

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

References
[1] Kruse-Jarres R, et al. Evolution of joint health and physical activity in people with hemophilia A without factor VIII inhibitors switching to emicizumab prophylaxis: A second interim analysis of the BEYOND ABR study. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #1285.

[2] Callaghan MU, Negrier C, Paz-Priel I, et al. Long-term outcomes with emicizumab prophylaxis for hemophilia A with or without FVIII inhibitors from the HAVEN 1-4 studies. Blood. 2021;137(16):2231-2242.

[3] Wang S, et al. A Randomized, Multicenter, Open-label, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of Prophylactic Emicizumab Versus No Prophylaxis in Persons with Hemophilia A in the Asia-Pacific region (HAVEN 5). Research and practice in thrombosis and haemostasis, 2020, 4(SUPPL 1), 480.

[4] Négrier C, et al. Emicizumab in people with moderate or mild haemophilia A (HAVEN 6): a multicentre, open-label, single-arm, phase 3 study. Lancet Haematol. 2023 Mar;10(3):e168-e177.

[5] Pipe S.W, et al. Emicizumab Prophylaxis for the Treatment of Infants with Severe Hemophilia A without Factor VIII Inhibitors: Results from the Interim Analysis of the HAVEN 7 Study. Blood 2022; 140 (Supplement 1): 457–459.

[6] Jiménez-Yuste V, et al. Safety and efficacy of long-term emicizumab prophylaxis in hemophilia A with factor VIII inhibitors: A phase 3b, multicenter, single-arm study (STASEY). Res Pract Thromb Haemost. 2022 Nov 14;6(8):e12837.

[7] Wall C, et al. Efficacy and Safety of Emicizumab Prophylaxis in Severe Haemophilia A without Inhibitors: A Report from the UK Haemophilia Centre Doctors’ Organisation (UKHCDO). Presented at: International Society for Thrombosis and Haemostasis (ISTH) Congress; 2021 July 17 – 21. Abstract #PB0511.

[8] Khairnar R, et al. Improvement in Annualized Bleed Rate in Patients with Hemophilia A Initiating Emicizumab – Physician Reported Outcomes from the Adelphi Hemophilia A Disease Specific Programme™. Presented at: American Society of Hematology (ASH) Annual Meeting and Exposition; 2021 December 11 – 14. Abstract #P1961.

[9] Poon M-C, et al. Real-World Outcomes of Emicizumab in Hemophilia A with or without FVIII Inhibitors from the Canadian Hemophilia Bleeding Disorder Registry. 2022. Blood. 140 (1); 8465 – 8467.

[10] Callaghan MU, et al. Safety and Efficacy of Emicizumab in Persons with Hemophilia A With or Without FVIII Inhibitors: Pooled Data from Four Phase III Studies (HAVEN 1–4). Blood 2020; 136 (Supplement 1): 3–5.

[11] Makris M, et al. Emicizumab and thrombosis: The story so far. J Thromb Haemost. 2019;17:1269-72.

[12] Mancuso ME, et al. NXT007 prophylaxis in people with hemophilia A with or without FVIII inhibitors: a global phase I/II multiple-ascending-dose study. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #302.

[13] Kiialainen A, et al. Pharmacodynamic biomarkers in people with hemophilia A receiving multiple ascending doses of NXT007. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #4841.

[14] Nogami K, et al. Ex Vivo Evaluation of the Procoagulant Effect of NXT007 Prophylaxis in People with Hemophilia A without Factor VIII Inhibitors: Phase I/II Study (NXTAGE). To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #3061.

[15] Frey N, et al. Preclinical evaluation of SPK-8011QQ, an adeno-associated virus gene therapy for people with hemophilia A leveraging the dirloctocogene samoparvovec platform encoding an activated protein C-resistant B-domain deleted factor VIII. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #1068.

[16] Sano D, et al. Promising response rates and manageable safety with mosunetuzumab plus lenalidomide (Mosun-Len) in patients with relapsed/refractory (R/R) follicular lymphoma (FL): US extension cohort from the Phase III CELESTIMO study. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #1800.

[17] Ghosh N, et al. Long-term follow-up with sustained progression-free survival (PFS) benefit after subcutaneous (SC) mosunetuzumab in combination with polatuzumab vedotin compared with rituximab plus polatuzumab vedotin in patients with relapsed or refractory (R/R) B-cell non-Hodgkin Lymphoma. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #1020.

[18] Buddle LE, et al. Improvements in health-related quality of life (HRQoL) in the SUNMO study: subcutaneous (SC) mosunetuzumab plus polatuzumab vedotin (Mosun-Pola) versus rituximab, gemcitabine and oxaliplatin (R-GemOx) in patients (pts) with relapsed/refractory (R/R) large B-cell lymphoma (LBCL) after at least one prior therapy. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #5509.

[19] Abramson JS, et al. Sustained clinical benefit of glofitamab plus gemcitabine and oxaliplatin (GemOx) versus rituximab plus GemOx (R-GemOx) in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): 3-year follow-up of STARGLO. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #5519.

[20] Abdulhaq H, et al. Glofitamab plus gemcitabine and oxaliplatin (GemOx) vs rituximab (R)-GemOx in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL): Efficacy and safety in patient subgroups. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #3743.

[21] Harrison S, et al. Tumor clearance, T-cell fitness and minimal residual disease (MRD) outcomes in patients with relapsed/refractory multiple myeloma (RRMM) treated with cevostamab plus pomalidomide and dexamethasone: Biomarker analyses from CAMMA 1 arm b. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #252.

[22] Ho J, et al. Subcutaneous cevostamab demonstrates manageable safety and clinically meaningful activity in relapsed/refractory multiple myeloma (RRMM): First results from the phase Ib CAMMA 3 study. To be presented at: ASH Annual Meeting; 2025 Dec 6-9; Orlando, FL, USA. Abstract #700.

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

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	Lorena Corfas Phone: +34 620 29 25 51
Simon Goldsborough Phone: +44 797 32 72 915	Karsten Kleine Phone: +41 79 461 86 83
Kirti Pandey Phone: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

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

Basel, 30 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that Roche’s wholly owned subsidiary Bluefin Merger Subsidiary, Inc., has accepted for payment all shares validly tendered and not validly withdrawn pursuant to its tender offer for all outstanding shares of common stock of 89bio, Inc. (“89bio”, NASDAQ: ETNB) at a price of $14.50 per share in cash, plus a non-tradeable contingent value right (CVR) to receive certain milestone payments of up to an aggregate of $6.00 per share in cash. The tender offer expired at one minute following 11:59 p.m., New York City time, on October 29, 2025, and was not extended.

Citibank, N.A., the depositary for the tender offer, advised Roche that a total of approximately 94,113,710 shares of 89bio’s common stock were validly tendered and not validly withdrawn in the tender offer (excluding shares tendered by notice of guaranteed delivery for which certificates have not yet been “received”), which represent approximately 60.49% of the total number of shares of 89bio’s common stock outstanding.

Later today, Roche intends to complete the acquisition of 89bio through a merger of Bluefin Merger Subsidiary, Inc., with and into 89bio without a vote or meeting of 89bio’s stockholders. In the merger, all shares of 89bio not owned by 89bio, Roche, or their respective wholly owned subsidiaries (other than shares as to which appraisal rights have been validly exercised under Delaware law) will be converted into the right to receive the same consideration per share, including the CVR, as was received for shares validly tendered in the tender offer. Following completion of the merger, 89bio will become a wholly owned subsidiary of Roche, and 89bio’s shares will cease to be traded on the Nasdaq Global Market.

About 89bio
89bio is a clinical-stage biopharmaceutical company dedicated to the development of best-in-class therapies for patients with liver and cardiometabolic diseases who lack optimal treatment options. 89bio is in Phase 3 trials for its lead candidate, pegozafermin, for the treatment of metabolic dysfunction-associated steatohepatitis (MASH) with advanced fibrosis, including patients with compensated cirrhosis, and severe hypertriglyceridemia (SHTG). Pegozafermin is a specifically engineered, potentially best-in-class fibroblast growth factor 21 (FGF21) analog with unique glycoPEGylated technology that optimizes biological activity through an extended half-life. The company is headquartered in San Francisco. For more information, visit www.89bio.com.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	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: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

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

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This communication may include statements that are not statements of historical fact, or “forward-looking statements,” within the meaning of the federal securities laws, including with respect to Roche’s proposed acquisition of 89bio. Any express or implied statements that do not relate to historical or current facts or matters are forward-looking statements. These statements are generally identified by words or phrases such as “believe”, “anticipate”, “expect”, “intend”, “plan”, “will”, “may”, “should”, “estimate”, “predict”, “project”, “strategy”, “potential”, “continue” or the negative of such terms or other similar expressions. Such statements include, but are not limited to, the ability of Roche and 89bio to complete the transactions contemplated by the merger agreement, including each party’s ability to satisfy the conditions to the consummation of the offer contemplated thereby and the other conditions set forth in the merger agreement, statements about the expected timetable for completing the transaction, the parties’ beliefs and expectations and statements about the benefits sought to be achieved in Roche’s proposed acquisition of 89bio, the potential effects of the acquisition on both Roche and 89bio and the possibility of any termination of the merger agreement. These statements are based upon the current beliefs and expectations of Roche and 89bio’s management and are subject to significant risks and uncertainties. There can be no guarantees that the conditions to the closing of the proposed transaction will be satisfied on the expected timetable, if at all. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements, and you should not place undue reliance on these statements.

Risks and uncertainties include, but are not limited to, uncertainties as to the timing of the offer and the subsequent merger; uncertainties as to how many of 89bio’s stockholders will tender their shares in the offer; the risk that competing offers or acquisition proposals will be made; the possibility that various conditions to the consummation of the offer and the merger contemplated by the merger agreement may not be satisfied or waived, including that a governmental entity may prohibit, delay or refuse to grant approval for the consummation of the tender offer or the subsequent merger; the ability to obtain necessary regulatory approvals or to obtain them on acceptable terms or within expected timing; the effects of disruption from the transactions contemplated by the merger agreement and the impact of the announcement and pendency of the transactions on 89bio’s business; the possibility that the milestones related to the contingent value right will never be achieved and that no milestone payments may be made; and the risk of legal proceedings being brought in relation to the transactions and the outcome of such proceedings, including the risk that stockholder litigation in connection with the offer or the merger may result in significant costs of defense, indemnification and liability. The foregoing factors should be read in conjunction with the risks and cautionary statements discussed or identified in 89bio’s public filings with the SEC, including the “Risk Factors” section of 89bio’s Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent Quarterly Reports on Form 10-Q, Form 8-K and in other filings 89bio makes with the SEC from time to time as well as the tender offer materials filed by Roche and its acquisition subsidiary and the Solicitation/Recommendation Statement to be filed by 89bio, in each case as amended by any subsequent filings made with the SEC.

Neither Roche nor 89bio undertakes any obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise, except to the extent required by law.

Attachment

Media Investor Release 89bio TO Closing English

New dengue antigen test delivers high clinical sensitivity and specificity, as well as inclusivity for all four dengue virus serotypes, helps clinicians confidently distinguish dengue from other acute fever-causing illnesses.
Full automation facilitates medium to high throughput and enables improvement of lab efficiency and test traceability, while reducing the risk of human error.
Test delivers results in just 18 minutes, enabling faster laboratory workflows and patient management during outbreaks.¹

Basel, 29 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received CE mark for its Elecsys® Dengue Ag test – a high-throughput, fully automated immunoassay to be used as an aid in the diagnosis of an acute dengue virus infection. This milestone promises to set a new standard for efficiency and reliability in tackling the growing global challenge of dengue fever.

Dengue fever is the most common mosquito-borne viral illness in the world. In 2024, more cases of dengue were recorded than ever before in a 12-month period, affecting over 100 countries on all continents. During 2024, ongoing transmission, combined with an unexpected spike in dengue cases, resulted in a historic high of over 14.6 million cases and more than 12,000 dengue-related deaths. Over the past 50 years, the spread of the disease has accelerated, posing a significant global health threat as half of the world's population now lives in areas at risk of infection.²

The symptoms of dengue aren't unique, so doctors often struggle to distinguish it from other fever-causing illnesses, such as chikungunya or yellow fever. This is why early and accurate diagnosis is critical so that patients can be managed in a timely manner to prevent severe complications.

“Dengue’s rapid worldwide spread has elevated it to a serious global burden, placing a significant strain on healthcare resources,” said Matt Sause, CEO of Roche Diagnostics. “Roche is committed to supporting the global response to the rise of infectious diseases such as dengue. With our novel Elecsys Dengue antigen test, we enable healthcare systems to diagnose dengue more reliably and efficiently.”

Recognising the value of diagnostics, the World Health Organization (WHO) has developed an “Essential Diagnostics List” which includes in-vitro diagnostic solutions that should be accessible to all countries to increase timely and life-saving diagnoses. Dengue virus NS1 antigen, along with other biomarkers, is included in the WHO essential IVD list.³

About the Elecsys Dengue virus antigen immunoassay

The Elecsys Dengue Ag is an in-vitro diagnostic immunoassay for the qualitative detection of the NS1 antigen of the dengue virus in human serum and plasma, a key marker of acute infection during the first days of illness. It is intended for use on Roche’s fully automated cobas® e immunoassay analysers: cobas e 801 systems and cobas e 402 platforms – a widely used platform with an extensive installed base in laboratories worldwide.

The test has been shown to reliably detect NS1 antigen for all four dengue virus serotypes – DENV-1, DENV-2, DENV-3, and DENV-4.⁴ In clinical studies, it demonstrated 94.90% (CI: 91.44–97.26%) sensitivity in PCR-confirmed positive samples and 99.96% (CI: 99.79–100%) relative specificity in a large cohort of healthy blood donors.

Key benefits of the Elecsys Dengue Ag test include:

Reliable and Fast Results: The Elecsys Dengue Ag test has a turnaround time of 18 minutes. It is designed for use on Roche’s automated cobas e immunoassay analyzers with a throughput from 120 to up to 300 tests/hour. This ensures reliable results for effective patient management during outbreaks and supports surveillance efforts in both endemic and non-endemic settings.

Enhanced Efficiency and Traceability: The automated nature of the Elecsys and cobas instruments improves laboratory consolidation, workflow, and traceability, reducing manual activities and the potential for human error.

Comprehensive response across the entire patient journey: The Elecsys Dengue Panel, which includes the Elecsys Dengue Ag test, alongside the Elecsys Dengue IgM test and Elecsys Dengue IgG test that will be subsequently launched, is designed to cover all key serological biomarkers for dengue diagnosis. By addressing NS1 for acute infection, IgM for recent exposure, and IgG for long-term immunity, the panel equips clinicians with the tools to diagnose dengue accurately at every stage of the disease.

About Dengue

Dengue is a mosquito-borne disease transmitted to humans through the bite of infected female mosquitoes, primarily of the Aedes aegypti species. While most people have no symptoms or only mild, self-limiting ones (fever, body aches, headache), a small percentage of cases can progress to severe dengue, which is life-threatening and involves complications like bleeding and organ impairment.

The global incidence of dengue is rising sharply due to climate change expanding the mosquito's range, putting nearly half the world's population at risk.⁵ Children, the elderly, individuals with weakened immune systems, and those with underlying conditions are at higher risk of developing severe dengue. Close monitoring and fluid management are crucial to prevent severe complications.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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

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

References
[1] World Health Organization, Dengue Factsheet, August 2025, available at URL: https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue
[2] Phillips ML. Dengue reborn: widespread resurgence of a resilient vector. Environ Health Perspect. 2008 Sep;116(9):A382-8. doi: 10.1289/ehp.116-a382. PMID: 18795135; PMCID: PMC2535648. https://doi.org/10.1289%2Fehp.116-a382eClinicalMedicine. Dengue as a growing global health concern. EClinicalMedicine. 2024 Nov 25;77:102975. doi: 10.1016/j.eclinm.2024.102975. PMID: 39649133; PMCID: PMC11625016.
[3] WHO Model List of Essential In Vitro Diagnostics, September 2025, available at URL: https://edl.who-healthtechnologies.org/

[4] Elecsys® Dengue Ag method sheet, V1.0 2025-06.

[5] World Health Organization, August 2025 ,https://www.who.int/news-room/fact-sheets/detail/dengue-and-severe-dengue

https://www.who.int/news/item/03-10-2024-who-launches-global-strategic-plan-to-fight-rising-dengue-and-other-aedes-borne-arboviral-diseases

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

Hans Trees, PhD Phone: +41 79 407 72 58	Sileia Urech Phone: +41 79 935 81 48
Nathalie Altermatt Phone: +41 79 771 05 25	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: +49 172 6367262	Yvette Petillon Phone: +41 79 961 92 50
Dr Rebekka Schnell Phone: +41 79 205 27 03

Attachment

Media Release Dengue Antigen CE Mark English

Company

Resources