Enicepatide

Roche may have scrapped work on a T-cell engager (TCE) for lupus, but the company’s head of pharma told Fierce that the drugmaker still has a strategy for developing cell therapies for autoimmune diseases. As part of a wider pipeline clearout disclosed during Roche’s second-quarter earnings results released July 23, the Swiss pharma revealed that it had stopped work on RG6382, a T-cell-engaging bispecific antibody targeting CD19 and CD3. The company had been evaluating the therapy in an ongoing phase 1 open-label study of patients with systemic lupus erythematosus (SLE). But a Roche spokesperson explained to Fierce this morning that after reviewing the data to date, “it has become clear that this molecule does not have the requisite characteristics to move forward in this indication.” “Since SLE was the lead indication for this asset, this discontinuation marks the termination of its development,” the spokesperson added. Autoimmune diseases have become a popular target for cell therapies in recent years —most notably CAR-T therapies, where Kyverna Therapeutics may potentially be first to market with mivocabtagene autoleucel for stiff person syndrome. When Roche struck a $1.5 billion deal to buy Poseida Therapeutics in 2024, the pharma referenced the potential of using the biotech’s cell therapy pipeline, including a BCMAxCD19 CAR-T, to treat autoimmune disease. On a call with journalists this morning, Roche Pharmaceuticals CEO Teresa Graham acknowledged to Fierce that autoimmune disease “was indeed one of the aspects of the Poseida deal.” When asked by Fierce whether Roche is still exploring the potential of cell therapies to treat these diseases, Graham said: “Yes, we do intend to continue development, and we hope to be able to provide some more updates soon.” Today’s pipeline clearout included two drugs in phase 2 development. One of these was CT-868, a once-daily, dual GLP-1/GIP receptor agonist for Type 1 diabetes that Roche had acquired as part of its buyout of Carmot Therapeutics. Despite seeing positive phase 2 data for CT-868, Roche has decided to prioritize another Carmot asset—a once-weekly GLP-1/GIP agonist called enicepatide—for T1D instead. As enicepatide is also being evaluated for obesity, it “makes more sense” for Roche to focus on this program, executives explained on the earnings call. “We believe enicepatide has best-in-disease potential for glycemic control and can deliver maximum therapeutic differentiation for patients living with diabetes,” a spokesperson told Fierce. “Further details regarding our plans for enicepatide in T1D will be shared at a later stage.” The other mid-stage asset thrown on the scrap heap was an anti-Tie2 agonist dubbed RG6351. Roche had been assessing the therapy in the eye disease diabetic macular edema (DME) as both a monotherapy and in combination with Eylea or Vabysmo. However, a look at the data showed a “low probability” of beating Vabysmo, a spokesperson told Fierce. The study “reinforce[d] that dual inhibition of VEGF/Ang-2 with [Vabysmo] is thought to provide robust activation of the Tie2 pathway for patients with DME,” they added. Further back in Roche’s pipeline, the company discontinued a clutch of phase 1-stage drugs. Aside from the TCE, these included mosperafenib, a BRAF inhibitor that was being evaluated for solid tumors. That trial closed in April, a spokesperson told Fierce. “While data from the phase 1a/b trial has shown to be positive, we believe that licensing out this asset to a suitable partner would be the best path forward for this asset and for the wider community,” they added. Mosperafenib was joined on the discard pile by another solid tumor candidate in the form of RG6468, which was being assessed in combination with Tecentriq. Roche didn’t confirm RG6468’s mode of action, but did tell Fierce that the company had decided to halt the program after reviewing the phase 1 data. The company’s second-quarter earnings also reaffirmed Roche’s decision earlier this month to scrap two of its Huntington’s disease prospects , including the phase 2-stage tominersen, which was partnered with Ionis Pharmaceuticals.

Group sales were +6% at constant exchange rates (CER) 1 , -2% when reported in CHF and +8% in USD 2 , in the first six months, driven by high demand for innovative medicines and diagnostics. Pharmaceuticals Division sales were +6% at CER, -1% when reported in CHF and +8% in USD, due to continued high growth in sales of our medicines across disease areas; Xolair (allergic asthma, chronic hives, food allergies), Hemlibra (haemophilia A), Ocrevus (multiple sclerosis), Phesgo (breast cancer) and Vabysmo (severe eye diseases) were the top growth drivers. Diagnostics Division sales were +3% at CER, -3% when reported in CHF and +6% in USD, driven by demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions. Core operating profit was +10% at CER, -1% when reported in CHF, driven by higher sales and other revenue; IFRS operating profit was -6% in CHF due to the appreciation of the Swiss franc. Core earnings per share were +9% at CER (-2% in CHF); IFRS diluted earnings per share were -8% in CHF due to the appreciation of the Swiss franc. Highlights: US Priority Reviews for giredestrant in an early-stage breast cancer, Enspryng in thyroid eye disease, Tecentriq in colon cancer as well as Gazyva/Gazyvaro in idiopathic nephrotic syndrome and primary membranous nephropathy, two autoimmune diseases affecting the kidneys US acceptance of a supplemental Biologics License Application for the Lunsumio and Polivy combination for blood cancer and Gazyva/Gazyvaro for systemic lupus erythematosus Positive phase III data on divarasib in lung cancer; presentation of promising data on fenebrutinib in multiple sclerosis (phase III), Gazyva/Gazyvaro in three autoimmune diseases (phase III) and enicepatide (CT-388) and petrelintide in obesity (phase II) Launch of Axelios 1 , a transformative next-generation sequencing platform based on the innovative SBX technology, enabling the fastest DNA sequencing at scale EU CE mark for two blood tests: Elecsys pTau217 to detect Alzheimer’s pathology and Elecsys IGRA TB to identify latent tuberculosis infection US approval for Ventana PTEN (SP218) RxDx Assay , the first companion diagnostic to assess the levels of a key protein in prostate cancer Global collaboration agreement with Nurix Therapeutics for the BTK degrader bexobrutideg across malignant haematology, immunology and neurology Agreement to acquire PathAI to transform AI-driven diagnostics Outlook for 2026 confirmed. Outlook for 2026 Roche (SIX: RO, ROP; OTCQX: RHHBY) expects an increase in Group sales in the mid single digit range (CER) for 2026. Core earnings per share are targeted to develop in the high single digit range (CER). Roche expects to further increase its dividend in Swiss francs. Key figures CHF millions % change January–June 2026 2025 At CER 1 In CHF In USD Group sales 30,364 30,944 6 -2 8 Pharmaceuticals Division 23,629 23,985 6 -1 8 Diagnostics Division 6,735 6,959 3 -3 6 Core operating profit 11,856 12,010 10 -1 Core EPS – diluted (CHF) 10.85 11.08 9 -2 IFRS operating profit 9,671 10,330 6 -6 Roche CEO Thomas Schinecker : “Our strong momentum continued in the first half of the year, driven by a 6% sales increase at constant exchange rates and significant positive pipeline development. We reported positive phase III data for divarasib , reinforcing its potential as a best-in-class therapy in advanced lung cancer. Our regulatory momentum accelerated significantly as the US FDA granted five Priority Reviews: giredestrant in early-stage breast cancer, Enspryng in thyroid eye disease, Tecentriq in colon cancer and Gazyva/Gazyvaro in two autoimmune kidney diseases. In Diagnostics, we reached major milestones with the launch of our transformative, highly cost-effective Axelios 1 sequencing solution, alongside EU CE mark for key diagnostic tests, including the Elecsys pTau217 blood test for Alzheimer’s pathology and the Elecsys IGRA TB blood test, which delivers automated, scalable latent tuberculosis screening to laboratories worldwide. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Backed by our robust pipeline, we are well-positioned for sustained future growth. We confirm our outlook.” Group results In the first six months of 2026, Roche sales were +6% at CER, -2% when reported in CHF, to CHF 30.4 billion due to strong demand for pharmaceutical products and diagnostic solutions. The appreciation of the Swiss franc against most currencies, notably the US dollar, had a significant impact on the results reported in Swiss francs compared to constant exchange rates. Core operating profit was +10% at CER (-1% in CHF) to CHF 11.9 billion, driven by higher sales and other revenue. Core earnings per share were +9% at CER (-2% in CHF). IFRS operating profit was -6% in CHF to CHF 9.7 billion. IFRS diluted earnings per share were -8% in CHF. The IFRS results were impacted by the appreciation of the Swiss franc. Sales in the Pharmaceuticals Division were +6% at CER, -1% when reported in CHF, to CHF 23.6 billion, with our medicines across disease areas continuing their strong growth. The top five growth drivers – Xolair, Hemlibra, Ocrevus, Phesgo and Vabysmo – achieved total sales of CHF 11.0 billion, an increase of 12% at CER, or 4% in CHF, compared to the first six months of 2025. Sales of products with expired patents (Avastin, Herceptin, MabThera/Rituxan, Lucentis and Actemra/RoActemra) were CHF 2.6 billion, a decrease of 8% at CER, or 15% in CHF, compared to the first six months of 2025. In the United States , sales were +6% at CER, -3% when reported in CHF, due to continued growth of Xolair, Hemlibra, Polivy (blood cancer) and Tecentriq. This growth more than compensated for the lower sales of Perjeta (breast cancer) and Kadcyla (breast cancer) as well as the impact of biosimilar erosion on Actemra/RoActemra (rheumatoid arthritis). Sales in Europe were +1% at CER, or -1% when reported in CHF, as demand for Ocrevus, Evrysdi (spinal muscular atrophy) and Phesgo more than offset the impact of lower sales of Actemra/RoActemra due to biosimilar competition and Perjeta because of the conversion of patients to Phesgo. In Japan , sales were +11% at CER, -5% when reported in CHF, mainly due to product supply to third parties, as well as the uptake of Elevidys (Duchenne muscular dystrophy) and continued growth of Lunsumio (blood cancer), Vabysmo and Hemlibra. Sales in the International region were +10% at CER, or +4% when reported in CHF, led by Phesgo, Vabysmo, Hemlibra, Ocrevus and Polivy. In China, sales were -9% at CER, or -12% when reported in CHF, due to the base effect of a severe flu season in 2025 on Xofluza sales. The Diagnostics Division’s sales were +3% at CER, -3% when reported in CHF, to CHF 6.7 billion, driven by growth in demand for immunodiagnostic and clinical chemistry products as well as pathology and molecular solutions. This growth more than offset the impact of healthcare pricing reforms in China. Sales in the Europe, Middle East and Africa (EMEA) region were +3% at CER, -1% when reported in CHF, driven by higher sales of immunodiagnostic products, the clinical chemistry portfolio and molecular solutions. In North America , sales were +8% at CER, -1% when reported in CHF, due to growth across the Core Lab and Pathology Lab customer areas. Sales in Asia-Pacific were -5% at CER, or -12% when reported in CHF, mainly due to the healthcare pricing reforms in China, partially offset by growth in demand for clinical chemistry and immunodiagnostic products across the rest of the region. In Latin America , sales were +10% at CER, or +5% when reported in CHF. Pharmaceuticals: key developments Compound Milestone Regulatory Gazyva/Gazyvaro Several autoimmune diseases FDA grants Priority Review for Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy (pMN) The Priority Review decision is based on results from the phase III MAJESTY study, where Gazyva/Gazyvaro achieved significantly higher complete remission rates at two years compared to tacrolimus. If approved, Gazyva/Gazyvaro will be the first FDA-approved therapy for pMN, following global approvals in lupus nephritis and ongoing regulatory filings in systemic lupus erythematosus and idiopathic nephrotic syndrome. pMN is a chronic autoimmune disease with no FDA- or EMA-approved therapies to date; when left untreated, up to 30% of patients progress to kidney failure over a period of 10 years. More information: Media Release , 15 July 2026 Enspryng Thyroid eye disease FDA grants Priority Review for Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED) The filing application is based on improvements seen across key efficacy endpoints from the global phase III SatraGO-1 and SatraGO-2 studies, including proptosis (bulging eyes) and diplopia (double vision) in active TED. Enspryng has the potential to become the first at-home subcutaneous disease-modifying standard of care for TED. TED is an autoimmune disease affecting approximately 155 out of every 100,000 people that can lead to facial disfigurement and vision-threatening complications if left untreated. More information: Media Release , 30 June 2026 Lunsumio and Polivy Blood cancer FDA accepts supplemental Biologics License Application for Lunsumio and Polivy combination for relapsed or refractory large B-cell lymphoma (LBCL) Filing acceptance is based on data from the phase III SUNMO study, where subcutaneous Lunsumio VELO plus Polivy demonstrated a 59% reduction in risk of disease progression or death. People with relapsed or refractory LBCL represent a population with one of the highest unmet needs in lymphoma and require timely access to effective therapies. If approved, this outpatient-ready regimen could enable access to care in the community setting, where most US patients receive treatment. More information: Media release , 18 June 2026 Tecentriq Colon cancer FDA grants Priority Review for Tecentriq for a certain type of stage III colon cancer Filing acceptance is based on data from the phase III Alliance ATOMIC study showing Tecentriq plus chemotherapy reduced recurrence or death risk by 50% versus chemotherapy alone. Nearly one in three patients with stage III colon cancer relapses within five years, highlighting a critical need for new adjuvant treatment options. If approved, Tecentriq plus chemotherapy could provide a new standard of care for the treatment of stage III dMMR/MSI-H colon cancer after surgery. More information: Media Release , 11 June 2026 Giredestrant Breast cancer FDA accepts New Drug Application for giredestrant in ER-positive early-stage breast cancer, the first and only oral selective oestrogen receptor degrader with positive phase III results in the curative setting Filing acceptance, under Priority Review, is based on phase III data showing giredestrant reduced the risk of invasive disease recurrence or death by 30% compared with standard-of-care endocrine therapy. Giredestrant represents the first significant advance in adjuvant endocrine therapy in over 20 years. Giredestrant has the potential to become a new standard-of-care in the adjuvant setting; more than 90% of ER-positive breast cancer cases are diagnosed at an early stage (I‒III). The FDA has set a Prescription Drug User Fee Act date of 30 November 2026. More information: Media Release , 2 June 2026 Phase III, pivotal and other key read-outs Divarasib Lung cancer Divarasib shows superiority in head-to-head phase III trial against approved KRAS G12C inhibitors in non-small cell lung cancer Phase III (Krascendo 1) demonstrates best-in-class potential for patients with previously treated advanced KRAS G12C non-small cell lung cancer. Divarasib showed clinically meaningful improvements in progression-free survival compared to approved KRAS G12C inhibitors; no new safety signals were observed. Statistical significance for overall survival was achieved at the interim analysis in this poor-prognosis patient population. More information: Media Release , 2 July 2026 Fenebrutinib Multiple sclerosis Fenebrutinib significantly reduces relapses versus standard of care to approximately one every 17 years in relapsing multiple sclerosis (RMS) Late-breaking phase III FENhance 1 and 2 study results showed superiority of investigational fenebrutinib compared to teriflunomide in reducing relapses and brain lesions in RMS. Both studies showed positive trends in reducing disability progression with fenebrutinib compared to teriflunomide. Fenebrutinib could become a first-in-class BTK inhibitor and the first and only high-efficacy oral medication for both RMS and primary progressive multiple sclerosis (PPMS). More information: Media Release , 22 April 2026 Other Alzheimer’s integrated portfolio presentation Roche presents new data on Alzheimer’s disease from across its integrated pharmaceuticals and diagnostics portfolio at AAIC Five oral presentations in a featured research session highlighted trontinemab, including new long-term data from the phase Ib/IIa Brainshuttle AD study and the design of phase III PrevenTRON study in preclinical Alzheimer’s disease. New data on Roche’s CE-marked Elecsys pTau217 blood test were presented on its use for the diagnosis of Alzheimer’s disease in both primary and secondary care. More information: Media Release , 7 July 2026 Nurix Therapeutics collaboration Roche announces global collaboration with Nurix Therapeutics to co-develop and co-commercialise potential best-in-class BTK degrader bexobrutideg across malignant haematology, immunology and neurology Agreement offers potential best-in-class targeted protein degrader therapy option for people living with B-cell malignancies. Collaboration adds to Roche’s oncology pipeline and offers potential indications in immunology (chronic spontaneous urticaria) and neurology (multiple sclerosis). Bexobrutideg utilises a novel approach to eliminate the Bruton’s tyrosine kinase (BTK) protein, potentially overcoming existing resistance mechanisms found with current standard-of-care BTK inhibitors. More information: Media Release , 8 June 2026 Obesity portfolio data presentation Roche presents new data advancing its obesity portfolio at the American Diabetes Association’s 2026 scientific sessions Late-breaking phase II data highlight enicepatide’s (CT-388) efficacy and safety, reinforcing its potential to deliver best-in-class weight loss across a broad population of people living with overweight or obesity. Late-breaking data from the phase II ZUPREME-1 trial showcase petrelintide’s efficacy, safety and compelling tolerability profile, which has the potential to redefine the weight management experience for people living with overweight or obesity. A phase II multi-arm trial evaluating enicepatide and petrelintide fixed-dose combinations will be initiated in the coming months to develop a differentiated treatment option. More information: Media Release , 1 June 2026 Oncology portfolio data presentation Roche presents new data at ASCO 2026, reinforcing giredestrant’s potential to transform the treatment paradigm in early breast cancer New data were presented from the lidERA study on giredestrant’s potential as a new standard of care for adjuvant ER-positive breast cancer across all menopausal stages. Primary results were presented from the persevERA study on the numerical improvement in progression-free survival observed with first-line giredestrant plus palbociclib in advanced, endocrine-sensitive disease. Overall, Roche highlighted data on nine approved and investigational medicines – including bispecific antibodies, antibody-drug conjugates and brain-permeable molecules – that target urgent needs in breast, blood, lung and other cancers. More information: Media Release , 19 May 2026 Ophthalmology portfolio data presentation Roche presents extensive data showcasing its industry-leading ophthalmology portfolio at ARVO 2026 New real-world data confirm the potent retinal drying of Vabysmo in neovascular or ‘wet’ age-related macular degeneration (nAMD) and diabetic macular edema (DME). Key data for Susvimo demonstrate its potential to provide lasting disease control through continuous delivery, while reducing treatment burden. Roche presented more than 45 abstracts at ARVO 2026, including 20 oral presentations across five retinal conditions. More information: Media Release , 30 April 2026 Pharmaceuticals sales Sales CHF millions As % of sales % change January–June 2026 2025 2026 2025 At CER In CHF Pharmaceuticals Division 23,629 23,985 100.0 100.0 6 -1 United States 12,229 12,670 51.8 52.8 6 -3 Europe 4,520 4,566 19.1 19.0 1 -1 Japan 1,360 1,425 5.8 5.9 11 -5 International 5,520 5,324 23.3 22.3 10 4 International: Asia-Pacific, CEETRIS (Central Eastern Europe, Türkiye, Russia and Indian subcontinent), Latin America, Middle East, Africa, Canada, others Top 20 best-selling pharmaceuticals Total United States Europe Japan International CHF m % CHF m % CHF m % CHF m % CHF m % Ocrevus Multiple sclerosis 3,470 7 2,300 2 758 10 - - 412 30 Hemlibra Haemophilia A 2,492 11 1,313 9 502 4 171 9 506 26 Vabysmo Eye diseases (nAMD, DME, RVO) 2,059 8 1,333 1 386 5 75 26 265 65 Tecentriq Cancer immunotherapy 1,704 6 815 9 410 -3 146 -2 333 17 Xolair 3 Chronic hives, food allergies 1,673 27 1,673 27 - - - - - - Perjeta 3 Breast cancer 1,389 -7 551 -11 238 -14 24 -23 576 0 Phesgo Breast cancer 1,318 18 318 0 425 9 88 15 487 47 Actemra/RoActemra 3 RA, COVID-19 1,074 -9 515 -9 238 -21 140 8 181 -3 Evrysdi Spinal muscular atrophy 968 17 323 15 335 17 39 -1 271 25 Kadcyla 3 Breast cancer 916 -6 310 -14 248 -4 39 2 319 3 Polivy Blood cancer 808 20 381 28 128 -18 98 16 201 47 Alecensa Lung cancer 795 6 261 4 126 -4 93 8 315 13 MabThera/Rituxan 3 Blood cancer, RA 609 5 402 14 62 -9 6 -11 139 -10 Activase/TNKase 3 Cardiac diseases 555 11 531 11 - - - - 24 12 Gazyva/Gazyvaro 3 Blood cancer, lupus nephritis 489 7 240 4 117 -1 17 14 115 21 Herceptin 3 Breast and gastric cancer 462 -12 94 -14 136 -7 2 -36 230 -14 Avastin 3 Various cancer types 414 -15 125 -12 35 37 36 -44 218 -13 Pulmozyme 3 Cystic fibrosis 204 -8 145 -5 29 -11 - 26 30 -18 Columvi Blood cancer 196 70 91 28 53 116 - - 52 173 Enspryng Acute inflammation of brain, spinal cord and optic nerves 195 22 50 20 23 20 79 18 43 37 DME: diabetic macular edema / nAMD: neovascular or ‘wet’ age-related macular degeneration / RVO: retinal vein occlusion / RA: rheumatoid arthritis Diagnostics: key developments Product Milestone cobas HDV test Roche introduces cobas hepatitis D virus (HDV) test, the first fully automated diagnostic solution to identify the most severe form of viral hepatitis The new test enables clinicians to reliably diagnose HDV and monitor patients’ treatment response. Hepatitis D affects nearly 12 million people globally and is considered the most aggressive form of viral hepatitis, often leading to liver failure and cancer faster than other types. The cobas HDV test is the first high-throughput, fully automated HDV assay on the market, addressing the urgent need for a consistent, widely accessible solution and expanding access to critical testing just as new treatments for the disease become available. More information: Media Release , 14 July 2026 Elecsys IGRA TB test Roche receives CE mark for blood test to identify tuberculosis infection The Elecsys IGRA TB test expands global access to tuberculosis infection testing, advancing progress towards the World Health Organization’s elimination targets. Performed on Roche’s industry-leading and widely available cobas immunoassay systems, the test enables laboratories to meet growing tuberculosis infection testing needs by reducing reliance on manual workflows through automation and digital solutions. The new solution provides rapid, high-throughput and cost-effective tuberculosis testing, delivers reliable results in under 24 hours and cuts standard processing times in half to just 19 minutes per patient. More information: Media Release , 9 July 2026 Axelios 1 sequencing platform Roche announces the launch of Axelios 1, a transformative next-generation sequencing platform Axelios 1 delivers a unique combination of accuracy, speed, scalability and cost efficiency, giving laboratories of all sizes the freedom to customise their workflows and explore a wider array of applications. Powered by innovative SBX technology, the platform is capable of end-to-end, same-day whole-genome sequencing in research workflows, with accurate results within hours. The Axelios 1 platform holds promise for research laboratories today, and potentially for a broad range of clinical settings in the future. More information: Media Release , 29 June 2026 Ventana PTEN (SP218) RxDx Assay Roche receives FDA approval for the first companion diagnostic to assess PTEN protein in people living with prostate cancer The new Ventana PTEN (SP218) RxDx Assay fulfills an unmet medical need by helping clinicians identify patients with PTEN protein loss who may benefit from combination treatment with Truqap. In prostate cancer, PTEN protein loss is associated with faster disease progression and reduced benefit from current standard-of-care treatments. The FDA approval reinforces Roche’s leadership in companion diagnostics and its ongoing commitment to expanding personalised healthcare to improve patient outcomes. More information: Media Release , 12 June 2026 Liver Disease Panel Roche launches the Liver Disease Panel, the first suite of certified algorithms to support chronic liver disease (CLD) management Roche introduces the first comprehensive library of certified healthcare algorithms to support CLD management. The Liver Disease Panel includes LiverPRO — a certified algorithm developed by the health tech company Evido — requiring only age and routine blood markers for the timely detection of liver fibrosis. With CLD affecting 1.5 billion people worldwide, the non-invasive panel solution covers care along the patient pathway from fibrosis risk identification to the surveillance of liver cancer. More information: Media Release , 27 May 2026 Elecsys pTau217 test Roche receives CE mark for new blood test to detect Alzheimer’s pathology: Elecsys plasma phosphorylated-tau 217 (pTau217) Elecsys pTau217 is the first blood test for Alzheimer’s disease pathology with a single‑assay design, intended to rule in and rule out amyloid pathology across primary and secondary care, offering faster diagnosis for millions of patients around the world. While maintaining accuracy comparable to spinal fluid diagnostics against the gold standard PET-CT scans, the Elecsys pTau217 test offers a more convenient, minimally invasive alternative via a routine blood draw. Diagnosing dementia currently takes 3.5 years on average, and an estimated 75% of people living with dementia remain undiagnosed. Elecsys pTau217 offers a simple blood test to aid in earlier, more accessible Alzheimer’s disease diagnosis for millions of patients around the world. More information: Media Release , 12 May 2026 PathAI agreement Roche enters into a definitive merger agreement to acquire PathAI to transform AI-driven diagnostics PathAI’s best-in-class Image Management System (IMS) with advanced AI analysis and workflow capabilities will complement Roche’s digital pathology portfolio to drive laboratory efficiency. Combining Roche’s strong position in companion diagnostics and PathAI’s advanced AI platform helps accelerate clinical therapy development, foster the discovery of new biomarkers and create novel diagnostic tools. These integrated capabilities will accelerate the shift from broad intervention towards personalised healthcare for patients. More information: Media Release , 7 May 2026 Diagnostics sales Sales CHF millions As % of sales % change January–June 2026 2025 2026 2025 At CER In CHF Diagnostics Division 6,735 6,959 100.0 100.0 3 -3 Customer areas Core Lab 3,756 3,839 55.8 55.2 4 -2 Molecular Lab 1,196 1,250 17.7 18.0 3 -4 Near Patient Care 909 1,018 13.5 14.6 -5 -11 Pathology Lab 874 852 13.0 12.2 11 3 Regions Europe, Middle East, Africa 2,466 2,485 36.6 35.7 3 -1 North America 2,211 2,235 32.8 32.1 8 -1 Asia-Pacific 1,522 1,729 22.6 24.9 -5 -12 Latin America 536 510 8.0 7.3 10 5 More information on Roche’s performance in the first six months of 2026: Half-Year 2026 Presentation Half-Year 2026 Presentation with appendix Half-Year 2026 Finance Report Appendix with tables 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 Pharmaceuticals 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 . All trademarks used or mentioned in this release are protected by law. References [1] CER (Constant Exchange Rates). The percentage changes at constant exchange rates are calculated using simulations by reconsolidating both the 2026 and 2025 results at constant exchange rates (the average rates for the year ended 31 December 2025). For the definition of CER, see page 178 of the Roche Finance Report 2025. [2] USD (US dollars). The percentage changes for selected sales figures in US dollars are calculated by translating both the 2026 and 2025 sales figures at the respective average US dollar exchange rate for the period in question. This supplementary information is provided to assist readers when assessing comparability with other companies. [3] Products launched before 2015. Cautionary statement regarding forward-looking statements This document contains certain forward-looking statements. These forward-looking statements may be identified by words such as ‘believes’, ‘expects’, ‘anticipates’, ‘projects’, ‘intends’, ‘should’, ‘seeks’, ‘estimates’, ‘future’ or similar expressions or by discussion of, among other things, strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this document, such as: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products or new uses of existing products, including without limitation negative results of clinical trials or research projects, unexpected side effects of pipeline or marketed products; (6) increased government pricing pressures; (7) interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity and news coverage. The statement regarding earnings per share growth is not a profit forecast and should not be interpreted to mean that Roche’s earnings or earnings per share for this or any subsequent period will necessarily match or exceed the historical published earnings or earnings per share of Roche. Roche Global Media Relations Phone: +41 61 688 88 88 / e-mail: media.relations@roche.com Hans Trees, PhD Phone: +41 79 407 72 58 Lorena Corfas Phone: +41 79 568 24 95 Simon Goldsborough Phone: +44 797 32 72 915 Karsten Kleine Phone: +41 79 461 86 83 Kirti Pandey Phone: +41 79 398 38 53 Yvette Petillon Phone: +41 79 961 92 50 Dr Rebekka Schnell Phone: +41 79 205 27 03 Irène Stephan Phone: +41 79 377 83 75 Roche Investor Relations Dr Bruno Eschli Phone: +41 61 687 52 84 E-mail: bruno.eschli@roche.com Dr Sabine Borngräber Phone: +41 61 688 80 27 E-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 688 48 14 E-mail: birgit.masjost@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 32 17 E-mail: kalm.loren@gene.com Attachments Media & Investor Release Roche HY 2026 EN Communications appendix tables_HY_Results_13072026