Press Release FeedGet the RSS feed
Menu

Business Wire

Ionis partner Roche announces new Phase 3 data showing sefaxersen significantly reduced proteinuria in people with IgA nephropathy (IgAN)

Roche Holding

– Sefaxersen achieved a statistically significant 43.1% reduction in proteinuria, a key indicator of kidney damage, relative to placebo at 37 weeks with consistent treatment effects across all prespecified patient subgroups –

– Sefaxersen inhibits complement factor B production and has the potential to reduce kidney inflammation and slow IgAN disease progression –

– Investigational sefaxersen is intended to be a once-monthly subcutaneous injection and designed to enable convenient self-administration at home –

– Despite recent advances, many people with IgAN remain at risk of disease progression and kidney failure, highlighting the need for additional targeted treatment options for those who do not respond to initial therapy –

CARLSBAD, Calif., October 23, 2026--Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) partner Roche announced today late-breaking oral presentation data from the ongoing Phase 3 IMAgINATION study in adults with primary IgA nephropathy (IgAN) receiving optimized standard of care, demonstrating that investigational sefaxersen achieved a statistically significant and clinically meaningful 43.1% reduction in proteinuria (95% confidence interval [CI]: 32.5 - 52.0, P<0.0001), relative to placebo at 37 weeks, as measured by 24-hour urine protein-to-creatinine ratio (UPCR). Proteinuria is a key indicator of kidney damage and a reduction in UPCR is strongly associated with the preservation of long-term kidney function. Results presented at the American Society of Nephrology (ASN) Kidney Week 2026 also showed that, among patients with baseline hematuria (blood in urine), a greater proportion of patients achieved hematuria resolution at Week 37 with sefaxersen versus placebo.

"These data support our belief that sefaxersen is uniquely positioned to treat IgA nephropathy, demonstrating significant and clinically meaningful reduction in proteinuria and offering the potential to help reduce the need for long-term dialysis or kidney transplantation," said Brett P. Monia, Ph.D., chief executive officer, Ionis. "Sefaxersen is a powerful example of the broad impact of Ionis' innovative science, and based on these results, we believe it has the potential to be an important new treatment option for people living with IgA nephropathy."

The treatment effect in all prespecified subgroups was consistent with the clinically meaningful reductions in proteinuria shown in the primary endpoint results. Sefaxersen was well tolerated with a safety profile consistent with the previously reported Phase 2 study, exhibiting no new safety signals.

  1. HealthcareRocheRoche’s divarasib demonstrated best-in-class efficacy, advancing the standard of care in previously treated KRAS G12C-mutated lung cancerCompanies: Roche HoldingDivarasib monotherapy demonstrated superior efficacy over first-generation KRAS G12C inhibitors, lowering the risk of disease progression or death by 42% and the overall risk of death by 44%, in the phase III Krascendo 1 study1,2 At the time of primary analysis, divarasib achieved a median overall survival of approximately 18 months, compared to 12 months for sotorasib or adagrasib1,2 No new safety signals were observed with divarasib; the most common treatment-related adverse events were mainly low grade and manageable1,2 Data presented as a late-breaking abstract during a Presidential Symposium at the 2026 ESMO Congress and simultaneously published in The New England Journal of Medicine1,2 Basel, 25 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today pivotal results from the phase III Krascendo 1 study, which demonstrated the superior efficacy of investigational divarasib, a next-generation KRAS G12C inhibitor, compared with current standard of care KRAS G12C inhibitors in people with previously treated KRAS G12C-mutated non-small cell lung cancer (NSCLC).1,2 Participants treated with divarasib monotherapy lived significantly longer, lowering the risk of death by 44% compared with sotorasib or adagrasib (overall survival, OS, HR 0.56, [95% CI: 0.41-0.78], p=0.0005).1,2 Median OS for divarasib is currently approximately 18 months, compared to 12 months for the control arm (see table below).1,2 No new safety findings were observed with divarasib and the most common treatment-related adverse events (TRAEs) were mainly low grade and manageable.1,2 These data were presented as a late-breaking abstract during a Presidential Symposium at the 2026 European Society for Medical Oncology (ESMO) Congress and simultaneously published in The New England Journal of Medicine.1,2 “The phase III Krascendo 1 results demonstrate the potential for divarasib to become a new standard of care for people with previously treated KRAS G12C-mutated lung cancer,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. "The superior efficacy against the current standard of care demonstrated in this head-to-head trial reinforces divarasib's best-in-class profile. We are working closely with health authorities to bring this new treatment option to the people who need it.” The G12C mutation is one of the most common KRAS mutations, found in approximately one in eight people with NSCLC.3,4 Accumulating evidence suggests that people with NSCLC who have the KRAS G12C mutation may have poorer outcomes than those who have the unmutated KRAS gene (wild-type disease).5,6 Despite the approval of current, first-generation KRAS G12C-targeted treatments, there remains a significant unmet need for more effective therapy options. “New life-extending treatments are greatly needed, as most patients with this type of cancer will eventually relapse after initial therapy, and there are limited effective treatments for recurrent disease,” said study lead author Ferdinandos Skoulidis, MD, PhD, Professor of Thoracic/Head and Neck Medical Oncology at The University of Texas MD Anderson Cancer Center. “The Krascendo 1 results highlight divarasib’s practice-changing potential, as the first KRAS inhibitor to meaningfully improve overall survival for people with previously treated KRAS G12C-mutated lung cancer, compared with current treatment options.” The Krascendo 1 study is the only global head-to-head study to evaluate a next-generation KRAS G12C inhibitor versus approved first-generation KRAS G12C inhibitors.1,2 The study met primary and key secondary endpoints, and divarasib demonstrated statistically significant and clinically meaningful improvements in OS and progression-free survival (PFS) over sotorasib or adagrasib.1,2 In addition to the OS benefit, divarasib reduced the risk of disease progression or death by 42% (PFS HR 0.58, [95% CI: 0.44-0.76], p<0.0001).1,2 The OS and PFS benefit was consistent across clinically relevant subgroups, and was observed regardless of PD-L1 expression or KEAP1 mutation status.1,2 The objective response rate (ORR) with divarasib was nearly double that of sotorasib or adagrasib.1,2 Key efficacy results from the phase III Krascendo 1 study:1,2 Primary and key secondary endpointsDivarasib arm (n=167)*Control arm (adagrasib, sotorasib) (n=171)*Hazard Ratio / (95% CI)p-value Median OS (months) 17.712.0HR 0.56 (0.41-0.78)p=0.0005 Median PFS (months) 9.8 5.7 HR 0.58 (0.44-0.76)p<0.0001 12-month PFS rate (%)44% 24%-- Confirmed ORR (%)*58%32%-- Median DOR (months)* 11.96.9-- *Assessed in response-evaluable population (n=328; ten patients [divarasib arm, n=6; control arm, n=4] did not have measurable disease at baseline and were excluded from the response-evaluable set). Duration of Response (DOR) evaluated in those who responded to treatment (divarasib arm, n=94; control arm, n=54). The safety profile of divarasib monotherapy was consistent with the known class effects of KRAS G12C inhibitors.1,2 The most common TRAEs comprised GI toxicity (most commonly, diarrhoea, nausea, and vomiting) and hepatotoxicity.1,2 Fewer participants discontinued treatment due to TRAEs with divarasib (4.8% versus 11.7%) and the rate of serious TRAEs was approximately half that of sotorasib or adagrasib (7.8% versus 15.2% respectively), despite patients remaining on treatment for more than twice as long (11.3 months compared with 5.0 months).1,2 Roche is advancing a comprehensive phase III clinical development programme in NSCLC, investigating divarasib as both a monotherapy and as a chemotherapy-free combination, across different disease settings and lines of therapy. The US Food and Drug Administration granted Breakthrough Therapy Designation to divarasib in 2022, and in 2026, Orphan Drug Designation for KRAS G12C-mutated NSCLC. About Krascendo 11,2 The Krascendo 1 study [NCT06497556] is the only global head-to-head study evaluating a Kirsten rat sarcoma virus (KRAS) G12C inhibitor in direct comparison with first-generation approved KRAS G12C inhibitors. This phase III, randomised, open-label, multicentre study evaluates the efficacy and safety of divarasib monotherapy versus sotorasib or adagrasib in people with previously treated KRAS G12C-mutated advanced or metastatic non-small cell lung cancer. The study includes 338 adults, randomised to receive either divarasib once daily (n=167) or, either sotorasib once daily or adagrasib twice daily (n=171). The primary endpoint is blinded independent central review (BICR)-assessed progression-free survival. Secondary endpoint measures include overall survival, confirmed objective response, duration of response, as well as other efficacy and safety measures. About divarasib Divarasib is an investigational, best-in-class, next-generation, oral, KRAS G12C inhibitor, discovered and developed by researchers within Roche and Genentech. It has shown greater potency and selectivity in preclinical studies compared with first-generation KRAS G12C-targeting treatments, sotorasib or adagrasib, with superior efficacy demonstrated in people with previously treated KRAS G12C-mutated NSCLC.1,2,7 Divarasib is designed to selectively bind to the KRAS G12C protein, locking the protein in an inactive (off) state, thereby turning off its tumour-driving signalling.7,8,9 Divarasib’s comprehensive clinical development programme is anchored by three phase III studies: StudyInterventionPatient population Krascendo 1 [NCT06497556]Divarasib monotherapy vs sotorasib or adagrasib Previously treated KRAS G12C-mutated advanced or metastatic NSCLC (second-line) Krascendo 2 [NCT06793215]Divarasib plus pembrolizumab (chemotherapy-free combination) vs chemotherapy plus pembrolizumabPreviously untreated KRAS G12C-mutated advanced NSCLC (first-line) Krascendo 3 [NCT07541170]Adjuvant divarasib monotherapy vs immunotherapy or observationResected stage II–IIIB KRAS G12C-mutated NSCLC after standard of care chemoimmunotherapy (early-stage) Divarasib underpins Roche’s diversified pipeline targeting the RAS signalling pathway, including other mutant-selective inhibitors and a pan-RAS inhibitor, designed to extend the benefits of RAS inhibition strategies to more patients. About KRAS G12C-mutated non-small cell lung cancer Despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths worldwide, surpassing the combined mortality rates of breast, prostate, and stomach cancers.10,11 Each year, it claims the lives of 1.8 million people, with non-small cell lung cancer (NSCLC) accounting for approximately 85% of cases.10,12 KRAS is one of the most frequently mutated genes in lung cancer, occurring in approximately 25% of newly diagnosed lung cancers, and is associated with poor prognosis for patients.9 The G12C mutation is one of the most common KRAS mutations, found in approximately 12-14% of NSCLC cases.3,4 The KRAS gene produces the KRAS protein, which acts as a cellular control switch, cycling between an active (on) and inactive (off) state to regulate cell growth and proliferation, making it a critical target for new therapeutic strategies.9 G12C mutation locks the KRAS protein in its active (on) state, leading to continuous, unregulated signalling for cell growth, driving tumour proliferation.8,9 About Roche in lung cancer Roche is committed to advancing the field of lung cancer treatments, leveraging more than 20 years of deep scientific expertise to improve patient outcomes and their overall experience. Roche’s strong commitment to investment in research and development has built a robust portfolio of approved medicines and companion diagnostics, which empowers physicians to better understand a patient's disease and optimise care. Roche’s broad portfolio includes approved medicines such as Alecensa® (alectinib), Tecentriq® (atezolizumab), and Rozlytrek® (entrectinib). Its extensive pipeline includes investigational treatments across three key focus areas: small cell lung cancer, non-small cell lung cancer (NSCLC) with actionable genomic alterations (AGA), and NSCLC without AGA. Utilising diverse approaches, ranging from cancer-cell-killing ‘cytotoxics’ and immunotherapies to treatments targeting specific characteristics of cancer cells, we aim to translate scientific discoveries into meaningful progress in patient care. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. References [1] Skoulidis F, et al. Krascendo 1: efficacy and safety of divarasib vs sotorasib or adagrasib in previously treated locally advanced or metastatic KRAS G12C-mutated NSCLC. Presented at: ESMO Congress; 2026 October 23-27; Madrid, Spain. #LBA5. [2] Skoulidis F, et al. Divarasib as compared with sotorasib or adagrasib in KRAS G12C–mutated NSCLC. N Engl J Med 2026; DOI: 10.1056/NEJMoa2605703 [3] Nassar AH, et al. Distribution of KRAS (G12C) Somatic Mutations across Race, Sex, and Cancer Type. N Engl J Med. 2021; 384 (2): 185-187. [4] Lee JK, et al. Comprehensive pan-cancer genomic landscape of KRAS altered cancers and real-world outcomes in solid tumors. NPJ Precis Oncol. 2022;9;6(1):91. [5] Wankhede D, et al. Prognostic role of KRAS G12C mutation in non-small cell lung cancer: a systematic review and meta-analysis. Diagnostics. 2023: 25;13(19): 3043. [6] Isaksson J, et al. KRAS G12C Mutant Non-Small Cell Lung Cancer Linked to Female Sex and High Risk of CNS Metastasis: Population-based Demographics and Survival Data From the National Swedish Lung Cancer Registry. Clin Lung Cancer. 2023: 24(6):507-518. [7] Endres NF, et al. Discovery and Characterization of Divarasib (GDC-6036), a Potent Covalent Inhibitor of KRAS G12C. J Med Chem. 2026; 69 (5): 5147-5165. [8] Friedlaender A, et al. KRAS as a druggable target in NSCLC: rising like a phoenix after decades of development failures. Cancer Treat Rev. 2020;85:101978. [9] Pakkala S, et al. Personalized therapy for lung cancer: striking a moving target. JCI Insight. 2018; 3 (15). [10] World Health Organization. Global cancer burden growing, amidst mounting need for services [Internet; cited 2026 September]. Available from: https://www.who.int/news/item/01-02-2024-global-cancer-burden-growing--amidst-mounting-need-for-services. [11] American Lung Association. Lung Cancer Statistics [Internet; cited 2026 September]. Available from: https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/resource-library/lung-cancer-fact-sheet. [12] World Health Organization. Lung cancer [Internet; cited 2026 September]. Available from: https://www.who.int/news-room/fact-sheets/detail/lung-cancer. Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: [email protected] Tristan Schmitz Phone: +41 79 529 70 35Nathalie Altermatt Phone: +41 79 771 05 25 Lorena Corfas Phone: +41 79 568 24 95Simon Goldsborough Phone: +44 797 32 72 915 Karsten Kleine Phone: +41 79 461 86 83Kirti Pandey Phone: +41 79 398 38 53 Yvette Petillon Phone: +41 79 961 92 50Irène Stephan Phone: +41 79 377 83 75 Albert Thottiyil Phone: +41 79 775 66 12 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: [email protected] Sabine Borngräber Phone: +41 61 68-88027 e-mail: [email protected] Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: [email protected] Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: [email protected] Attachment Media&Investor Release divarasib in KRAS G12C lung cancer English
  2. HealthcareRoche’s divarasib demonstrated best-in-class efficacy, advancing the standard of care in previously treated KRAS G12C-mutated lung cancerCompanies: Roche HoldingBasel, 25 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today pivotal results from the phase III Krascendo 1 study, which demonstrated the superior efficacy of investigational divarasib, a next-generation KRAS G12C inhibitor, compared with current standard of care KRAS G12C inhibitors in people with previously treated KRAS G12C-mutated non-small cell lung cancer (NSCLC).1,2 Participants treated with divarasib monotherapy lived significantly longer, lowering the risk of death by 44% compared with sotorasib or adagrasib (overall survival, OS, HR 0.56, [95% CI: 0.41-0.78], p=0.0005).1,2 Median OS for divarasib is currently approximately 18 months, compared to 12 months for the control arm (see table below).1,2 No new safety findings were observed with divarasib and the most common treatment-related adverse events (TRAEs) were mainly low grade and manageable.1,2 These data were presented as a late-breaking abstract during a Presidential Symposium at the 2026 European Society for Medical Oncology (ESMO) Congress and simultaneously published in The New England Journal of Medicine.1,2
  3. HealthcareRocheRoche presents interim phase III data showing sefaxersen significantly reduced proteinuria in people with IgA nephropathy (IgAN)Companies: Roche HoldingSefaxersen achieved a statistically significant 43.1% reduction in proteinuria, a key indicator of kidney damage, relative to placebo at 37 weeks with consistent treatment effects across all prespecified patient subgroups1 As the first antisense oligonucleotide (ASO) evaluated in IgAN, sefaxersen inhibits complement factor B production and has the potential to slow IgAN disease progression by reducing kidney inflammation2 Investigational sefaxersen is intended to be a once-monthly subcutaneous injection and designed to enable convenient self-administration at home3 Despite recent advances, many people with IgAN remain at risk of disease progression and kidney failure, highlighting the need for additional targeted treatment options for those who do not respond to initial therapy4,5 Basel, 23 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today late-breaking oral presentation data from the ongoing phase III IMAgINATION study in adults with primary IgA nephropathy (IgAN) receiving optimised standard of care, demonstrating that investigational sefaxersen achieved a statistically significant and clinically meaningful 43.1% reduction in proteinuria (95% confidence interval [CI]: 32.5 - 52.0, P<0.0001), relative to placebo at 37 weeks, as measured by 24-hour urine protein-to-creatinine ratio (UPCR).1 Proteinuria is a key indicator of kidney damage and a reduction in UPCR is strongly associated with the preservation of long-term kidney function.6,7 Results presented at the American Society of Nephrology (ASN) Kidney Week 2026 also showed that, among patients with baseline haematuria (blood in urine), a greater proportion of patients achieved haematuria resolution at Week 37 with sefaxersen versus placebo.1 “These phase III results demonstrate the potential for sefaxersen to meaningfully reduce protein in the urine, a key indicator of kidney damage, in people with IgA nephropathy,” said Levi Garraway, MD, PhD, Roche's Chief Medical Officer and Head of Global Product Development. “By inhibiting complement factor B in the liver, sefaxersen may offer a novel approach to slow disease progression in IgAN, potentially helping patients delay or avoid long-term dialysis or kidney transplantation.” The treatment effect in all prespecified subgroups was consistent with the clinically meaningful reductions in proteinuria shown in the primary endpoint results.1 Sefaxersen was well tolerated with a safety profile consistent with the previously reported phase II study, exhibiting no new safety signals.1,2 Sefaxersen is an investigational once-monthly subcutaneous injection designed to enable convenient self-administration for people with IgAN.3 The IMAgINATION study will continue as a blinded study to evaluate the change in kidney function over two years, as measured by estimated glomerular filtration rate (eGFR) at week 105. Data will be shared with health authorities, with the goal of bringing this treatment to patients as soon as possible. Typically diagnosed before the age of 40, IgAN affects at least 25 adults per million worldwide each year.8,9 IgAN, also known as Berger’s disease, is a chronic and progressive autoimmune disease that leads to end-stage kidney disease in up to 50% of patients within 20 years of diagnosis.5,10 It is the most common form of primary glomerulonephritis (inflammation of the tiny filters, glomeruli, in the kidneys) and is a major cause of chronic kidney disease as well as kidney failure.8 About sefaxersen Investigational sefaxersen is the first highly specific liver-directed antisense oligonucleotide (ASO) inhibitor of factor B production being evaluated in IgA nephropathy (IgAN).2 Serum complement factor B levels are elevated in people with IgAN. When we reduce these levels, it in turn reduces the level of protein in urine, which is a key indicator of improved kidney function.11,12 Sefaxersen is designed to provide sustained control of the alternative complement pathway, an important pathway in IgAN, enabling once-monthly subcutaneous dosing and is intended for self-administration in people with IgAN.3 In phase I and II trials, sefaxersen was shown to be generally well tolerated in healthy volunteers and people with IgAN who were at high risk of progression, and reduced proteinuria and plasma complement factor B.2,13 Roche licensed sefaxersen from Ionis Pharmaceuticals for the treatment of complement mediated diseases. About the IMAgINATION study IMAgINATION [NCT05797610] is a phase III, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of subcutaneous sefaxersen, an investigational antisense inhibitor of complement factor B, in patients with primary IgA nephropathy at high risk of progression.1,14 The study enrolled 459 people, who are randomised 1:1 to receive sefaxersen or placebo for 105 weeks.1,14 Participants may switch to open-label treatment after week 105 at the investigator's discretion or after the common-close timepoint, whichever occurs first.1,14 The primary endpoint of the study is the change from baseline in the urine protein-to-creatinine ratio at 37 weeks.1,14 About primary immunoglobulin A nephropathy (IgAN) IgAN, also known as Berger’s disease, is a serious, chronic and progressive autoimmune kidney disease affecting at least 25 adults per million worldwide each year and is typically diagnosed before the age of 40 years.8-10 In IgAN, immune complexes deposit in the kidneys, which activates the complement system’s alternative pathway, leading to inflammation and subsequent kidney damage.15 It is the most common form of primary glomerulonephritis (inflammation of kidney glomeruli) and remains a leading cause of kidney failure, with up to 50% of patients experiencing end-stage kidney disease within 20 years of diagnosis.5,8 Many current therapies aim to reduce protein levels in the urine and control blood pressure to slow progression of the disease.16 Updated KDIGO 2025 guidelines* highlight the need to address both the underlying immune-mediated causes of IgAN and the downstream consequences of kidney damage.4 While new therapies have expanded treatment options, important unmet needs remain, including improved long-term preservation of kidney function and more targeted approaches that address key drivers of disease progression.4,16 About Roche in Immunology For over two decades, Roche has advanced immune system research, creating groundbreaking targeted treatments that have transformed care for people with blood disorders, neurological conditions and autoimmune diseases. With a development pipeline exploring more than 20 medical approaches, we are targeting widespread, complex conditions like chronic lung disease (COPD) and inflammatory bowel disease (IBD), alongside lupus and autoimmune kidney diseases. Our ultimate goal is to lessen the burden of chronic immune disorders on patients, healthcare systems, and society. About Roche Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions. Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them. Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market. For more information, please visit www.roche.com. All trademarks used or mentioned in this release are protected by law. *KDIGO guidelines serve as the foundational framework for healthcare organisations, policymakers, and clinicians worldwide to standardise kidney disease diagnosis, staging, and treatment. References [1] Barratt J., et al. Sefaxersen, a Novel mRNA-Targeted Therapy for IgA Nephropathy: Interim Analysis of the Phase 3 IMAgINATION Trial. Presented at: ASN Kidney Week; 2026 Oct 20-26; Denver, CO, USA. Abstract #FR-OR104. [2] Barbour SJ, et al. A single-arm phase 2 trial of an investigational RNA therapeutic to complement factor B sefaxersen for treatment of IgA nephropathy. Kidney Int. 2026;109:592-601. [3] Barratt J, et al. IMAGINATION: a global phase 3 trial of RO7434656, an antisense oligonucleotide inhibitor of complement factor B, in IgA nephropathy. Kidney Int Rep. 2024;9 Suppl. WCN24-912. [4] Kidney Disease: Improving Global Outcomes (KDIGO) IgAN and IgAV Work Group. KDIGO 2025 Clinical Practice Guideline for the Management of Immunoglobulin A Nephropathy (IgAN) and Immunoglobulin A Vasculitis (IgAV). Kidney Int. 2025;108(4S):S1–S71. [5] Caster DJ, et al. Clinicopathological characteristics of adult IgA nephropathy in the United States. Kidney Int Rep. 2023;8:1792-1800. [6] Longhitano E, et al. Proteinuria and Progression of Renal Damage: The Main Pathogenetic Mechanisms and Pharmacological Approach. Medicina (Kaunas). 2024 Nov 6;60(11):1821. [7] Qin X, et al. Association Between Urinary Protein-to-Creatinine Ratio and Chronic Kidney Disease Progression: A Secondary Analysis of a Prospective Cohort Study. Front. Med. 2022; 9:854300. [8] Pitcher D, et al. Long-term outcomes in IgA nephropathy. Clin J Am Soc Nephrol. 2023;18:727-738. [9] McGrogan A, Franssen CF and de Vries CS. The incidence of primary glomerulonephritis worldwide: a systematic review of the literature. Nephrol Dial Transplant 2011; 26: 414-430. [10] Cleveland Clinic. IgA Nephropathy [Internet; cited 2026 October 15]. Available from: https://my.clevelandclinic.org/health/diseases/5990-iga-nephropathy. [11] Chiu YL, et al. Alternative complement pathway is activated and associated with galactose-deficient IgA. Front Immunol 2021; 12: 638309. [12] Marques F, et al. Impact of early proteinuria reduction in glomerular disease and decline of kidney function: a retrospective cohort. J Clin Med. 2022;11(19):5968. [13] McCaleb ML, et al. Inhibiting the alternative pathway of complement by reducing systemic complement factor B: Randomized, double-blind, placebo-controlled phase 1 studies with Sefaxersen. Immunobiology. 2025 Mar;230(2):152876. [14] ClinicalTrials.gov. A Study to Evaluate RO7434656 in Participants With Immunoglobulin A Nephropathy (IgAN) (IMAGINATION) (NCT05797610) [Internet; cited 2026 Oct 15]. Available from: https://clinicaltrials.gov/study/NCT05797610. [15] Wu MY, et al. The emerging role of pathogenesis of IgA nephropathy. J Clin Med. 2018;7:225. [16] Floege J, et al. Current treatment of IgA nephropathy. Semin Immunopathol. 2021;43:717-728. Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: [email protected] Tristan Schmitz Phone: +41 79 529 70 35Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53Yvette Petillon Phone: +41 79 961 92 50 Irène Stephan Phone: +41 79 377 83 75Albert Thottiyil Phone: +41 79 775 66 12 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 68-75284 e-mail: [email protected] Sabine Borngräber Phone: +41 61 68-88027 e-mail: [email protected] Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: [email protected] Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: [email protected] Attachment Media Investor Release Sefaxersen IMAgINATION ASN
  4. Biotech & pharmaRoche presents interim phase III data showing sefaxersen significantly reduced proteinuria in people with IgA nephropathy (IgAN)Companies: Roche HoldingBasel, 23 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today late-breaking oral presentation data from the ongoing phase III IMAgINATION study in adults with primary IgA nephropathy (IgAN) receiving optimised standard of care, demonstrating that investigational sefaxersen achieved a statistically significant and clinically meaningful 43.1% reduction in proteinuria (95% confidence interval [CI]: 32.5 - 52.0, P<0.0001), relative to placebo at 37 weeks, as measured by 24-hour urine protein-to-creatinine ratio (UPCR).1 Proteinuria is a key indicator of kidney damage and a reduction in UPCR is strongly associated with the preservation of long-term kidney function.6,7 Results presented at the American Society of Nephrology (ASN) Kidney Week 2026 also showed that, among patients with baseline haematuria (blood in urine), a greater proportion of patients achieved haematuria resolution at Week 37 with sefaxersen versus placebo.1
  5. Biotech & pharmaZymeworks Enters into an Exclusive Global License and Collaboration Agreement with Roche for ZW209, a Trispecific T cell Engager Targeting DLL3Companies: Roche HoldingZymeworks to receive a $55 million upfront payment and a $40 million payment upon initiation of the Phase 1b trial, with potential for up to $718 million in additional development, commercial and sales-based milestones Zymeworks also eligible to receive tiered high-single-digit to mid-teen royalties on global net sales protected by patents extending into 2040’s Zymeworks … Continue reading "Zymeworks Enters into an Exclusive Global License and Collaboration Agreement with Roche for ZW209, a Trispecific T cell Engager Targeting DLL3"
  6. FinanceZymeworks Enters into an Exclusive Global License and Collaboration Agreement with Roche for ZW209, a Trispecific T cell Engager Targeting DLL3Companies: Roche HoldingZymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets while developing a diverse pipeline of novel, multifunctional biotherapeutics, today announced that it has entered into a global license and collaboration agreement with Roche for the research, development and commercialization of ZW209, a T cell engager targeting DLL3.