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  1. SaaSEvaluating China Leading Fused Silica Rod Processor Contributions to Optical InnovationLIANYUNGANG, JIANGSU, CHINA, October 22, 2026 / EINPresswire.com / -- How do modern high-precision optical systems maintain consistent light transmission and mechanical stability across extreme thermal and chemical environments? While optical designers often focus on advanced lens coatings and specialized sensor architectures, the underlying physical platform that routes light, supports delicate electrodes, and inter
  2. Chemicals & materialsAnaerobic Adhesives Market Forecast: Global Sizing, CAGR, and Regional Analysis 2026–2034The global Anaerobic Adhesives market was valued at US$ 620.25 million in 2025 and is expected to reach US$ 849.8 million by 2034; it is estimated to record a CAGR of 3.56% during 2026–2034. Anaerobic adhesives—specialized single-component engineering resins that ... Read more
  3. TravelAsphalt Additives Market Size, Demand & Growth Analysis by 2034Asphalt additives are specialized chemical and polymer-based materials used in asphalt mixtures to improve performance, durability, flexibility, and resistance to environmental conditions. These additives play a vital role in road construction, highways, airports, and roofing applications by enhancing pavement life ... Read more
  4. Chemicals & materialsAquatic Herbicides Market News and Recent Developments in Bio-Herbicide Innovations by 2034Aquatic herbicides are chemical solutions designed to manage and control invasive aquatic plants, algae, and weeds in freshwater and marine ecosystems. These products are widely applied in lakes, rivers, reservoirs, ponds, and irrigation channels to maintain water quality, support irrigation, ... Read more
  5. AutomotiveAntifreeze Market Technology Advancements and Innovation Trends 2028Antifreeze is a vital automotive and industrial fluid designed to regulate engine temperatures, prevent freezing in cold conditions, and avoid overheating in hot environments. Typically composed of glycol-based chemicals such as ethylene glycol, propylene glycol, or glycerin, antifreeze also provides ... Read more
  6. Food & drinkWhy Alcohols Still Anchor the Fermentation Chemicals Market and Who Is Challenging ThemFermentation was once mostly associated with food and beverages. Today it is a core manufacturing route for fuels, enzymes, organic acids, and specialty ingredients. As [read full press release...]
  7. Chemicals & materialsPackaging Film Market Forecast: Global Sizing, CAGR, and Regional Analysis 2026–2034The global Packaging Film market was valued at US$ 153.1 billion in 2025 and is expected to reach US$ 196.5 billion by 2034; it is estimated to record a CAGR of 2.81% during 2026–2034. Packaging films—encompassing flexible, multi-layer extruded polymer ... Read more
  8. IndustrialVulcan Plastics Highlights VULCAN® Prisma Roma Polycarbonate Roofing Sheets for Patios and PergolasVULCAN Prisma Roma clear polycarbonate pergola roof diffusing daylight over a backyard patio VULCAN Prisma Roma blue corrugated polycarbonate sheet with prismatic texture VULCAN Prisma Roma polycarbonate skylights and canopy on an industrial warehouse roof VULCAN Prisma Roma combines diffused daylight, glare reduction, impact resistance, and a lightweight design for outdoor roofing applications. TAIPEI, TAIWAN, Octob
  9. HealthcareRocheRoche presents new pivotal trial data across broad neuroimmunology portfolio at MSToronto2026Companies: Roche HoldingFenebrutinib FENtrepid and FENhance 1 & 2 late-breaking data demonstrate a therapeutic effect on chronic active lesions, addressing a primary driver of long-term disability progression in multiple sclerosis (MS) Fenebrutinib FENhance 1 & 2 Phase III pooled data show a 55% reduction in annualised relapse rate (ARR) vs active comparator Following European Commission paediatric approval on 15 October, new Ocrevus OPERETTA 2 Phase III data show 90% of children aged 10–17 remained relapse-free over two years Featured in "Best of MSToronto2026", Enspryng METEOROID Phase III data highlight significant attack reduction and improved functional recovery in MOGAD, an underserved autoimmune disease Basel, 21 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today new Phase III data for investigational fenebrutinib in multiple sclerosis (MS), demonstrating reduced markers of chronic brain inflammation as well as more comprehensive disease control versus active comparators.1-3 These findings, alongside new Ocrevus® (ocrelizumab) and Enspryng® (satralizumab) data, will be featured across more than 40 abstracts at MSToronto2026 (10th ACTRIMS- ECTRIMS Meeting), held 21 to 23 October in Toronto. Highlights include a fenebrutinib late-breaking presentation and an Enspryng presentation in the “Best of MSToronto2026.4 “Addressing long-term disability progression to preserve people’s independence remains a critical challenge in neuroinflammatory diseases, and particularly in multiple sclerosis,” said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. “Our recent data indicate that fenebrutinib can inhibit disease activity inside and outside the central nervous system, underscoring its potential to transform care for people living with relapsing and primary progressive forms of multiple sclerosis.” Fenebrutinib targets progressive biology inside the brain New data from the pivotal trials in RMS (FENhance 1 and 2) and PPMS (FENtrepid) support the potential of fenebrutinib as the first and only high-efficacy oral medicine for both forms of MS. Reduction of chronic active lesions (Late-breaking oral #O137): In the first prospective demonstration of a therapeutic effect on chronic active lesions in MS Phase III clinical trials, data show fenebrutinib reduced the volume of slowly expanding lesions (SELs) by up to 30% (p<0.001) in RMS (over 96 weeks) and PPMS (over 120 weeks), along with a 62% (p=0.001) reduction in accumulation of paramagnetic rim lesions (PRLs) in RMS, versus active comparators. These findings demonstrate that fenebrutinib directly targets chronic neuroinflammation in the brain, a primary driver of disability progression in MS.1 Comprehensive disease control (Poster #P1434): In the pooled RMS trials, three quarters (75%) of fenebrutinib-treated patients showed no evidence of disease activity (NEDA-3) meaning zero relapses, zero MRI activity and zero worsening disability at nearly two years, a 70% reduction (p<0.001) versus the comparator. These results show fenebrutinib’s potential to suppress disease activity and delay progression.2 Preserving brain volume and function (Oral #O089): Pooled RMS data show fenebrutinib reduced the annualised relapse rate (ARR) by 55% versus the comparator (p<0.001) over 96 weeks. In addition, fenebrutinib reduced annual total brain volume loss by 23% (p<0.001) and 12-week composite confirmed disability progression by 16% (p=0.04). These findings demonstrate fenebrutinib’s potential to control relapses, to slow brain tissue loss caused by neuronal cell death and to preserve function.3 Ocrevus provides consistent benefits across all age groups New data show that Ocrevus provides significant and consistent efficacy across a broad MS patient population, from children 10 years of age to older adults. Two-year data and immune function in paediatric MS (3 posters on the Phase III OPERETTA 2 study): 90% of children with relapsing-remitting MS (RRMS) treated with Ocrevus, who were 10-17 years old at trial entry, remained free of relapses over two years (#P1439).5 Ocrevus selectively depleted target B cells with little to no effect on other immune cells (#P1407), while preserving pre-existing immunity to common childhood vaccines in 81–100% of patients (#P1415). The European Commission approved Ocrevus in this indication on 15 October, following FDA approval in May.6,7 Two-year data in patients >55 years old (Poster #P1426 on the Phase IIIb CONSONANCE study): 53% of participants over 55 years old treated with Ocrevus showed no disability progression after two years, similarly to younger participants (55%), showing Ocrevus maintains its effect on progression as people age.8 Switching from other treatments to Ocrevus: Real-world data show progression was the leading reason for patients switching from ofatumumab to Ocrevus (ePoster #EP2733).9 A separate analysis of patients treated with Ocrevus or ofatumumab for one year show Ocrevus was associated with lower MRI lesion activity (Poster #P0305).10 Enspryng reduces risk of attack and is associated with improved recovery Exploratory analyses of the pivotal METEOROID trial suggest that in addition to significantly lowering the risk of relapse (AAN 2026), Enspryng was associated with improved recovery and reduced disability progression, which is critical to prevent permanent damage to the optic nerves, spinal cord or brain in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). These findings reinforce Enspryng’s potential to become the first FDA-approved treatment for MOGAD, with a decision in the U.S. expected in January 2027.4,11 Relapse recovery (Oral #O035): Patients treated with Enspryng achieved numerically superior recovery at 12 weeks post relapse versus placebo (median change in Expanded Disability Status Scale [EDSS] of -2 vs -0.5). Overall function was stable (median 0) with Enspryng, compared to worsening (median 0.5) with placebo, as measured with the EDSS at the end of the double-blind period or first relapse.4 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 can act throughout the body and also cross the blood-brain barrier into the CNS to target chronic inflammation. It is uniquely designed to target relapsing and progressive biology by inhibiting 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. While most current BTK inhibitors are covalent and irreversible, meaning they form a permanent chemical bond with the enzyme, fenebrutinib is non-covalent and reversible, meaning it binds and then eventually releases the enzyme. 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 Enspryng® (satralizumab) Enspryng, developed by Chugai, a member of the Roche Group, is a humanised monoclonal antibody that binds to both soluble and membrane-bound interleukin-6 receptors (IL-6R), thereby inhibiting IL-6 mediated signalling, a key pathway involved in inflammation. Enspryng incorporates Chugai’s proprietary antibody recycling technology, which enables pH-dependent binding to IL-6R and repeated engagement of the target, extending antibody circulation and supporting sustained inhibition of IL-6 mediated signalling. Enspryng is the first and only IL-6R inhibitor treatment currently approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD), including in the U.S. and E.U., with a well-established safety profile in over 16,000 patients. Enspryng was also recently approved for the treatment of thyroid eye disease (TED) in the U.S. Roche is committed to developing Enspryng in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling, including myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD) and autoimmune encephalitis (AIE). About Roche in Neurology Neurology is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new diagnostics and treatments that help improve the lives of people with chronic and potentially devastating diseases globally. Roche is investigating more than a dozen medicines for neurological conditions, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Roche Diagnostics has developed a broad range of approved and investigational tools, including digital and blood-based tests and cerebrospinal fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor neurological conditions. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today. 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] Oh J, et al. Fenebrutinib Shows a Therapeutic Effect on MS Progressive Biology: Outcomes on Paramagnetic Rim Lesions and Slowly Expanding Lesions in the Phase III FENhance I/II and FENtrepid Trials in Relapsing and Primary Progressive Multiple Sclerosis (#O137). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 23 October 2026; Toronto, Canada. [2] Cerqueira JJFCA, et al. No Evidence of Disease Activity With Fenebrutinib vs Teriflunomide in Relapsing Multiple Sclerosis: Results From the Phase III FENhance 1 and 2 Trials (#P1434). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [3] Sormani MP, et al. Efficacy of Fenebrutinib Versus Teriflunomide in Relapsing Multiple Sclerosis: Pooled Analysis Results From the FENhance 1 and 2 Studies (#O089). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 21 October 2026; Toronto, Canada. [4] Marignier R, et al. Severity and Recovery of Relapses in Patients with Relapsing MOGAD Treated with Satralizumab: Results from the Phase 3 METEOROID Study (#O035). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [5] Deiva K, et al. OPERETTA 2: Continued Follow-Up of the Efficacy and Safety Profile of Ocrelizumab in Pediatric Relapsing-Remitting MS (#P1439). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [6] Bar-Or A, et al. Impact of Ocrelizumab vs Fingolimod on Immune Function in Pediatric Patients With MS in the OPERETTA 2 Study (#P1407). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [7] Banwell B, et al. Vaccination and Disease-Modifying Therapies: Impact of Ocrelizumab vs Fingolimod on Preexisting Vaccine Seropositivity and Vaccine-Preventable Infections in Pediatric Patients With MS in OPERETTA 2 (#P1415). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [8] Butzkueven H, et al. Ocrelizumab Maintains Clinical and Safety Outcomes in Older Patients (>55 Years) with Progressive Multiple Sclerosis: 2-Year Results from the CONSONANCE Study (#P1426). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 22 October 2026; Toronto, Canada. [9] Marriott J, et al. Switching Patients with Multiple Sclerosis from Ofatumumab to Ocrelizumab: A Real-World Study of Canadian Healthcare Professionals (#EP2733). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 21-23 October 2026; Toronto, Canada. [10] Ziemssen T, et al. Brain Volume Loss and T2 Lesion Activity in RRMS: Real-World Longitudinal Comparison of Ocrelizumab vs. Ofatumumab (#P0305). Presented at: MSToronto2026 10th Joint ACTRIMS-ECTRIMS Meeting; 21 October 2026; Toronto, Canada. [11] Levy M, et al. Safety and Efficacy of Satralizumab in Patients with Relapsing Myelin Oligodendrocyte Glycoprotein Antibody-associated Disease (MOGAD): Results from the Phase 3 METEOROID Trial (PL5.006). Presented at: 78th Annual Meeting of the American Academy of Neurology (AAN) 2026; 21 April 2026; Chicago, IL, USA. 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 MSToronto2026 English
  10. AIRocheFDA approves Roche’s Enspryng, a first-in-class IL-6R inhibitor, as the first and only at-home subcutaneous treatment option for thyroid eye disease (TED)Companies: Roche HoldingFDA approval based on Phase III SatraGO-1 and -2 studies, with SatraGO-2 demonstrating a significant reduction in eye bulging (proptosis) and improvement in diplopia (double vision), with a favourable safety profile, regardless of TED activity or duration1,2 Enspryng (satralizumab) represents an important advance for people with TED, offering the first at-home SC treatment option every four weeks during maintenance phase, allowing for greater flexibility in how treatment is administered1 Enspryng is an anti-IL-6R mAb using novel recycling antibody technology designed to inhibit IL-6 signalling upstream of autoantibody-driven pathology2,3 TED is a rare autoimmune disease affecting approximately 155 out of every 100,000 people in the US that can lead to facial disfigurement and vision-threatening complications if left untreated3-7 Basel, 16 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved Enspryng® (satralizumab) for the treatment of adults with thyroid eye disease (TED), providing patients with the first and only at-home subcutaneous treatment option. Enspryng can be administered by a person living with TED or a caregiver following training from a healthcare provider.1 “Today’s FDA approval of Enspryng provides an important new option for people with thyroid eye disease, who have long faced limited treatment choices,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “As the first subcutaneous treatment for this condition, Enspryng offers a positive safety and efficacy profile and the potential for at-home administration.” "Treating thyroid eye disease requires balancing efficacy, safety, and the practical realities of long-term treatment,” said César A. Briceño, MD, Clinical Trial Investigator and Associate Professor of Ophthalmology at the Scheie Eye Institute, University of Pennsylvania. “As a clinical trial investigator, I have seen firsthand the potential of targeted therapies such as Enspryng. The availability of an effective subcutaneous treatment option could provide greater flexibility for both patients and physicians while reducing the logistical burden associated with infusion-based therapies. Enspryng has the potential to meaningfully expand our therapeutic options for patients with thyroid eye disease." The totality of data from the pivotal Phase III SatraGO programme (SatraGO-1 and SatraGO-2) provided clinically meaningful improvements in patients with TED.1,2 While SatraGO-1 did not meet its pre-specified primary efficacy endpoint at Week 24, SatraGO-2 achieved significant and clinically meaningful difference in proptosis response (52.9% in the Enspryng group compared to 23.4% in the placebo group) and in diplopia reduction (60.7% in the Enspryng group compared to 25.8% in the placebo group) in the active TED population.1,2 Consistent results were achieved in the overall population (including both active and chronic patients) in SatraGO-2.1,2 No new safety signals were identified in the SatraGO trials, with Enspryng’s safety profile consistent with its known profile in neuromyelitis optica spectrum disorder (NMOSD).1,2 Full results were shared at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Fall Scientific Symposium in October 2025.2 “Thyroid eye disease not only affects a person’s eyes through bulging and vision problems, but it also takes a profound emotional toll on confidence, identity, relationships and daily life,” said Christine Gustafson, Chief Executive Officer of the TED Community Organization. “Until now, our community has had very limited choices. The approval of Enspryng represents a critical turning point through a convenient, targeted option.” The approval in TED, following a priority review designation, marks the second indication for Enspryng, following an approval in neuromyelitis optica spectrum disorder (NMOSD) in 2020.1,8,9 This follows a recent acceptance by the FDA for priority review in myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD).10 Enspryng is also being studied in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling. About SatraGO-1 and -2 SatraGO-1 (NCT05987423) and -2 (NCT06106828) are identically designed, Phase III, randomised, placebo-controlled, multicentre studies to determine the efficacy, durability and tolerability of Enspryng for the treatment of adults with active, moderate‑to‑severe TED and chronic TED. The studies enrolled a total of 258 patients from 19 countries. Participants were randomised 1:1 to receive Enspryng or placebo. The primary endpoints were the proportion of participants with active, moderate-to-severe TED who achieved an at least 2 mm reduction in proptosis in the study eye from baseline at week 24.2,3 About thyroid eye disease (TED) TED, also known as Graves’ ophthalmopathy, is a complex inflammatory autoimmune disease, affecting the area around the eyes and the eyes themselves, that can be sight-threatening, debilitating and disfiguring.4,5 The most common symptoms are redness, swelling of the eyes, eyelid retraction, appearance of a stare, bulging of one or both eyes (proptosis), double vision (diplopia) and pain.4,6 TED is a progressive rare disease that affects approximately 155 people out of every 100,000.3-5,7 It most commonly occurs in people with hyperthyroidism, approximately 50% of whom experience at least mild TED, but it can also affect people with hypothyroidism or normal thyroid function.4,11 Despite existing approved treatments for TED, a medical need remains for therapies that are effective, well-tolerated, and have a convenient route of administration.3 About Enspryng® (satralizumab) Enspryng, developed by Chugai, a member of the Roche Group, is a humanised monoclonal antibody that is designed to bind to both soluble and membrane-bound interleukin-6 receptors (IL-6R), thereby inhibiting IL-6 mediated signalling, a known key pathway involved in inflammation. Enspryng incorporates Chugai’s proprietary antibody recycling technology, which enables pH-dependent binding to IL-6R and repeated engagement of the target, extending antibody circulation and supporting sustained inhibition of IL-6 mediated signalling.1-3,12 Enspryng is the first and only IL-6R inhibitor treatment currently approved in approximately 90 countries for neuromyelitis optica spectrum disorder (NMOSD), including in the European Union and United States, with a well established safety profile in over 16,000 patients.1,13 Roche is committed to developing Enspryng in additional neurological autoimmune and inflammatory diseases that may benefit from inhibition of IL-6 mediated signalling, including autoimmune encephalitis (AIE) and myelin oligodendrocyte glycoprotein antibody-associated disease (MOGAD). The FDA granted priority review of the Enspryng supplemental Biologics License Application (sBLA) for MOGAD in September 2026 with an approval decision expected in January 2027.10 Enspryng has orphan drug designation in the United States and European Union for NMOSD and MOGAD and in the United States for anti-NMDA receptor autoimmune encephalitis (anti-NMDAR AIE) and leucine-rich glioma-inactivated 1 autoimmune encephalitis (LGI1 AIE). About Roche in Ophthalmology At Roche, we are on a mission to save and restore eyesight. Over 330 million people around the world are blind, or living with vision loss, creating a profound personal and socioeconomic burden. With the broadest pipeline in Ophthalmology, we continue to invest at scale to redefine what is medically possible in eye care. Our comprehensive ophthalmology pipeline integrates diverse targets, advanced delivery systems, cell and gene therapies, and AI-augmented imaging capabilities, targeting multiple vision-threatening conditions, including retinal vascular and diabetic eye diseases, geographic atrophy, and autoimmune conditions, such as thyroid eye disease and uveitic macular edema. 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] Enspryng (satralizumab) Prescribing Information. [2] Briceño C, et al. Primary Results of the Phase 3 SatraGO-1 and SatraGO-2 Trials: Efficacy and Safety of Satralizumab in Thyroid Eye Disease. Presented at the American Society of Ophthalmic Plastic and Reconstructive Surgery (ASOPRS) Fall Scientific Symposium, October 16–17, 2025. [3] Ezra D, Collins A, Haskova Z, et al. Targeting IL-6 Receptor Signaling with Satralizumab in Thyroid Eye Disease: Design of the Phase 3 SatraGO-1 and SatraGO-2 Trials. Ophthalmol Ther. 2025;14(12):3119-3132. doi:10.1007/s40123-025-01255-3 [4] McAlinden C. An overview of thyroid eye disease. Eye Vis (Lond). 2014;1:9. doi:10.1186/s40662-014-0009-8 [5] Bartalena L, Piantanida E, Gallo D, Lai A, Tanda ML. Epidemiology, Natural History, Risk Factors, and Prevention of Graves' Orbitopathy. Front Endocrinol (Lausanne). 2020;11:615993. doi:10.3389/fendo.2020.615993 [6] Thyroid eye disease. British Thyroid Foundation. Accessed October 12, 2026. https://www.btf-thyroid.org/thyroid-eye-disease-leaflet [7] Moledina M, Damato EM, Lee V. The changing landscape of thyroid eye disease: current clinical advances and future outlook. Eye (Lond). 2024;38(8):1425-1437. doi:10.1038/s41433-024-02967-9 [8] FDA grants Priority Review to Roche’s Enspryng, the first and only at-home subcutaneous treatment option for thyroid eye disease (TED). Accessed October 12, 2026. https://www.roche.com/media/releases/med-cor-2026-06-30 [9] FDA Approves Roche’s ENSPRYNG for Neuromyelitis Optica Spectrum Disorder (NMOSD). Accessed October 12, 2026. https://www.roche.com/media/releases/med-cor-2020-08-17 [10] U.S. FDA grants Priority Review for Roche’s Enspryng for MOGAD, an autoimmune disease with no approved treatments. Accessed October 12, 2026. https://www.roche.com/media/releases/med-cor-2026-09-10 [11] Bahn RS. Emerging pharmacotherapy for treatment of Graves' disease. Expert Rev Clin Pharmacol. 2012;5(6):605-607. doi:10.1586/ecp.12.54 [12] Heo YA. Satralizumab: First Approval. Drugs. 2020;80(14):1477-1482. doi:10.1007/s40265-020-01380-2 [13] Enspryng (satralizumab) Summary of Product Characteristics. Accessed October 12, 2026. https://www.ema.europa.eu/en/documents/product-information/enspryng-epar-product-information_en.pdf 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 Enspryng TED FDA English
  11. HealthcareRocheRoche’s fenebrutinib is the first BTK inhibitor to receive U.S. FDA filing acceptance in both relapsing and primary progressive multiple sclerosisCompanies: Roche HoldingFenebrutinib cut relapses by 51% and 58% vs teriflunomide in Phase III RMS trials (FENhance 1 & 2) while showing a consistent, positive trend in delaying disability1 Fenebrutinib became the first investigational medicine in more than a decade to slow disability progression in a Phase III PPMS trial (FENtrepid), with numerical benefit vs Ocrevus2 Fenebrutinib is designed to address two drivers of MS – acute inflammation causing relapses and chronic brain inflammation driving disability progression1,2 If approved, fenebrutinib would become the first BTK inhibitor and first high-efficacy oral treatment for both RMS and PPMS, offering a new option for the nearly 1 million Americans living with MS3 Basel, 30 September 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the United States Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) under priority review for fenebrutinib, an investigational non-covalent Bruton’s tyrosine kinase (BTK) inhibitor for the treatment of relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The filing acceptance is based on data from the comprehensive clinical programme, including the Phase III FENhance 1 and 2 RMS studies and the Phase III FENtrepid PPMS study.1,2 "People living with multiple sclerosis need treatments that go beyond controlling relapses to help preserve function and independence as the disease progresses," said Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development. "Three Phase III studies have demonstrated the potential for fenebrutinib to address both relapsing and progressive disease, thereby bringing us closer to an oral treatment that could make a meaningful difference across the MS spectrum." “Ocrevus transformed how we treat MS, helping more than 525,000 people live a life less defined by their disease. Yet, over a third of all people with MS still receive lower-efficacy treatment,” said Teresa Graham, Roche’s Chief Executive Officer, Pharma. “If approved, fenebrutinib could open a new chapter as the first high-efficacy oral therapy for both relapsing and primary progressive MS, helping to control disease activity while giving people more flexibility and choice.” Concurrently addressing the life-disrupting relapses and long-term disease progression – the slow, steady loss of physical and mental abilities over time – remains one of the greatest challenges in MS.4 Fenebrutinib is designed to act throughout the body and to cross the blood-brain barrier into the central nervous system to target both the acute inflammation that causes relapses and the chronic inflammation that is thought to drive disability progression.1,2 The NDA for fenebrutinib is supported by three positive Phase III studies: The FENhance 1 and 2 RMS studies showed that fenebrutinib significantly reduced relapses and both active and chronic brain lesions compared with standard of care, teriflunomide. Fenebrutinib reduced the annualised relapse rate (ARR) by 51.1% (p<0.001) in FENhance 1 and 58.5% (p<0.00001) in FENhance 2 compared with teriflunomide over 96 weeks. This equates to patients having approximately one relapse every 17 years, which is the lowest relapse rate seen in Phase III MS studies. In addition, measures of disability progression, including 12-week composite confirmed disability progression (cCDP12), showed consistent positive trends favouring fenebrutinib over teriflunomide.1 The FENtrepid PPMS study showed fenebrutinib met its primary endpoint of non-inferiority compared with Ocrevus® (ocrelizumab), the current standard of care and only approved medicine for PPMS, in reducing disability progression. Fenebrutinib numerically reduced the risk of progression by 12% compared to Ocrevus, as measured by the time to onset of cCDP12 (hazard ratio [HR] 0.88; 95% confidence interval [CI]: 0.75, 1.03), with curves separating as early as 24 weeks. A consistent treatment effect on disability progression was observed across patient subgroups, including those without active inflammation, and for the entire treatment duration after 24 weeks.2 The overall rate of serious adverse events for fenebrutinib and teriflunomide, respectively, was 9% and 9% in FENhance 1 and 11% and 6% in FENhance 2. The overall rate of serious adverse events in FENtrepid was 19% for fenebrutinib and 19% for Ocrevus. Liver enzyme elevations were comparable between the fenebrutinib and teriflunomide arms in the RMS studies and observed more often with fenebrutinib compared to Ocrevus in the PPMS study. While an imbalance in reported fatalities was observed across the three pivotal studies, the deaths occurred at different timepoints and had various causes.1,2 Overall, fenebrutinib has shown a manageable safety profile across the three Phase III trials and earlier studies, with a large safety database including more than 2,700 study participants.1,2,5 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 can act throughout the body and also cross the blood-brain barrier into the CNS to target chronic inflammation. It is uniquely designed to target relapsing and progressive biology by inhibiting 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. While most current BTK inhibitors are covalent and irreversible, meaning they form a permanent chemical bond with the enzyme, fenebrutinib is non-covalent and reversible, meaning it binds and then eventually releases the enzyme. About multiple sclerosis Multiple sclerosis is a chronic disease that affects more than 3 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 are initially diagnosed with relapsing-remitting multiple sclerosis (RRMS). Relapsing forms of the disease (RMS) include RRMS and active secondary progressive MS, and people with RMS experience relapses and 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 Neurology Neurology is a major focus of research and development at Roche. Our goal is to pursue groundbreaking science to develop new diagnostics and treatments that help improve the lives of people with chronic and potentially devastating diseases globally. Roche is investigating more than a dozen medicines for neurological conditions, including multiple sclerosis, spinal muscular atrophy, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease and Duchenne muscular dystrophy. Roche Diagnostics has developed a broad range of approved and investigational tools, including digital and blood-based tests and cerebrospinal fluid (CSF) assays, aiming to more effectively detect, diagnose and monitor neurological conditions. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neurology today. 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] Oh J, et al. Efficacy and Safety of Fenebrutinib vs Teriflunomide in Relapsing Multiple Sclerosis: Results of the FENhance 1 and 2 Studies. Presented at: 2026 American Academy of Neurology (AAN) Annual Meeting; April 21, 2026; Chicago, IL, USA, and virtual. [2] Bar-Or A, et al. Efficacy and Safety of Fenebrutinib vs Ocrelizumab in Primary Progressive Multiple Sclerosis: Primary Results of the Phase III FENtrepid Study. Presented at: Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2026; February 7, 2026; San Diego, CA, USA, and virtual. [3] MS International Federation. Atlas of MS. [Internet; cited September 2026]. Available from: https://atlasofms.org/map/global/epidemiology/number-of-people-with-ms [4] Bittner S, Zipp F. Progression in multiple sclerosis - a long-term problem. Curr Opin Neurol. 2022;35(3):293-298. doi:10.1097/WCO.0000000000001044 [5] Bar-Or A, Dufek M, Budincevic H, et al. Safety and efficacy of fenebrutinib in relapsing multiple sclerosis (FENopta): a multicentre, double-blind, randomised, placebo-controlled, phase 2 trial and open-label extension study. Lancet Neurol. 2025;24(8):656-666. doi:10.1016/S1474-4422(25)00174-7 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 Fenebrutinib FDA Filing English