EDG6 modulators(Sphingosine 1-phosphate receptor Edg-6 modulators), S1PR1 modulators(Sphingosine 1-phosphate receptor Edg-1 modulators), S1PR3 modulators(Sphingosine 1-phosphate receptor Edg-3 modulators)

Therapeutic Areas

Immune System DiseasesNervous System DiseasesOther Diseases+ [2]

Active Indication

Multiple Sclerosis, Relapsing-RemittingMultiple SclerosisMultiple sclerosis relapse+ [1]

Inactive Indication

AsthmaHepatitis C, ChronicInfluenza, Human+ [7]

Originator Organization

Novartis Pharma AG

Active Organization

Mylan Pharmaceuticals Ltd.

Novartis Pharmaceuticals Corp.Novartis Europharm Ltd.

+ [6]

Inactive Organization

Novartis Pharma Services AGNovartis Farmacéutica SA

Novartis Pharmaceuticals Canada, Inc.

License Organization

Novartis AG

Tanabe Pharma Corp.

Drug Highest PhaseApproved

First Approval Date

United States (21 Sep 2010),

Multiple sclerosis relapse

RegulationBreakthrough Therapy (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (China), Orphan Drug (Japan), Orphan Drug (South Korea), Overseas New Drugs Urgently Needed in Clinical Settings (China)

Structure/Sequence

Molecular FormulaC19H34ClNO2

InChIKeySWZTYAVBMYWFGS-UHFFFAOYSA-N

CAS Registry162359-56-0

135

Clinical Trials associated with Fingolimod Hydrochloride

NCT07483632

/ Not yet recruitingPhase 3

A Phase 3 Study With an Open-Label Extension in Pediatric Participants to Evaluate the Safety, Efficacy, and Pharmacokinetics of Diroximel Fumarate and Dimethyl Fumarate for the Treatment of Relapsing Forms of Multiple Sclerosis

In this study, researchers will learn more about the study drugs diroximel fumarate (DRF) and dimethyl fumarate (DMF) in children with MS who may be experiencing relapses.
Participants will be divided into 2 groups based on their weight:
* Group A will include children who weigh 40 kilograms (kg) or less. They will receive DRF in both Part 1 and Part 2 of the study.
* Group B will include children who weigh more than 40 kg. They will be randomly assigned to receive DRF, DMF, or fingolimod. Fingolimod is a drug already used to treat MS in adults. In Part 2, they will receive DRF.
This is a 2-part study. Part 1 treatment will last 96 weeks. Participants who complete Part 1 may move to Part 2. Part 2 is an extension period. Treatment will last another 96 weeks and will help researchers learn about the long-term safety and effects of treatment.
The main goal of the study is to learn about the safety of DRF and DMF and compare their effect on relapses and brain lesions with fingolimod.
The main questions researchers want to answer are:
* How many participants have adverse events and serious adverse events?
* How often do participants relapse after treatment with DRF and DMF compared to fingolimod?
Researchers will take brain imaging scans to check for any new areas of brain inflammation and compare the brain lesions before and after treatment.
Researchers will also measure the amount of drug in the blood to understand how the body processes it. To check safety, they will monitor participants' growth and development, and compare changes in heart tests, vital signs, and lab tests. They will also use rating scales to monitor depression symptoms.
The study will be done as follows:
Part 1 (Treatment Period)
* After screening, participants will join Part 1 and be divided into 2 groups based on their weight.
* Participants in Group A will receive DRF.
* Participants in Group B will be randomly assigned to receive either DRF, DMF, or fingolimod.
* Neither the researchers nor the participants will know which drug or dose the participants will receive in Group B. Participants in Group B will also receive a placebo so they do not know which drug is being given. A placebo looks like a study drug but contains no real medicine.
* All study drugs will be taken by mouth, once or twice a day. Participants who take DRF or DMF will start with a lower dose during the 1st week, then move to a standard dose.
* Treatment in Part 1 will last for 96 weeks. Participants will have up to 11 study visits and 7 phone calls.
* Participants who do not move onto Part 2 will also have a safety follow-up period of 4 to 8 weeks. This will include 1 study visit and 1 phone call.
* The total length of Part 1, including the screening, treatment, and follow-up, will be up to 108 weeks.
Part 2 (Extension Period)
* Participants who complete Part 1 can move on to Part 2 of the study.
* All participants in Part 2 will receive DRF by mouth for 96 weeks.
* Participants will have up to 10 more study visits and 1 telephone call during treatment.
* They will also have a 4-week safety follow-up, including 1 study visit and 1 phone call.
* The total length of Part 2 will be up to 100 weeks.

Start Date16 Nov 2026

Sponsor / Collaborator

Biogen, Inc.

NCT07220252

/ RecruitingPhase 2/3

Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (RMS)

The primary purpose of this study is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of ublituximab in participants ages 10 to less than (<)18 years and body weight greater than or equal to (≥)25 kilograms (kg) to less than or equal to (≤)40 kg with RMS (Part A) and to evaluate the non-inferiority of ublituximab compared with fingolimod in pediatric RMS participants with body weight ≥ 25 kg (Part B). The study will further evaluate long-term safety and efficacy of ublituximab in RMS in pediatric participants during its extension period (Part C).

Start Date01 Jul 2026

Sponsor / Collaborator

TG Therapeutics, Inc.

ChiCTR2600129021

/ SuspendedPhase 4IIT

Efficacy and Safety of Fingolimod Adjunctive to Endovascular Treatment for Large Vessel Occlusion Stroke (FATE-ET Study)

Start Date16 May 2026

Sponsor / Collaborator

Xinqiao Hospital

[+1]

100 Clinical Results associated with Fingolimod Hydrochloride

100 Translational Medicine associated with Fingolimod Hydrochloride

100 Patents (Medical) associated with Fingolimod Hydrochloride

3,942

Literatures (Medical) associated with Fingolimod Hydrochloride

31 Dec 2026·Gut Microbes

A commensal protozoan exacerbates acetaminophen-induced liver injury by producing free sphingosine

Article

Author: Yan, Xiaoqing ; Cheng, Wanpeng ; Sun, Qian ; Wei, Yanxia ; Shen, Yusi ; Kou, Yanbo ; Chen, Qiuchong ; Liu, Xiangye ; Shi, Zhen ; Wang, Yugang ; Zhu, Xiuwen ; Liao, Longxiang ; Zhou, Yuan ; Liu, Zhuanzhuan

The mechanisms by which the gut microbiota influence host disease outcomes remain poorly understood. As an integral yet overlooked component of this microbial community, the role of gut commensal protists in host physiology and pathology is even more ambiguous. Here, we show that the protozoan Tritrichomonas musculis (T. mu) remotely increases host sensitivity to drug-induced liver injury via the production of free sphingosine. Inhibiting sphingosine kinases (SPHKs) with PF543 or K145, or antagonizing sphingosine 1-phosphate receptor (S1PR) with FTY720, abolished the effect of T. mu-mediated exacerbation of acetaminophen (APAP)-induced liver injury (AILI), pointing to a sphingosine-SPHK1/2-S1P-S1PR axis underlying T. mu's remote modulation of hepatic drug sensitivity. Moreover, using U-¹³C‑palmitic acid and U-¹³C‑glucose metabolic flux tracing, we propose a novel model for sphingosine synthesis in T. mu. In this model, T. mu synthesizes sphingosine by using oxaloacetate, likely generated via the glyoxylate cycle, as a two‑carbon unit donor, rather than directly employing intact palmitic acid to supply the long‑chain carbon skeleton. Collectively, these findings not only deepen our understanding of how the gut microbiota, particularly the underappreciated gut protists, influence extra-intestinal disease outcomes via the gut-distal organ axis, but also reveal the tip of the iceberg regarding the unique metabolic pathways of gut commensal protists.

01 Dec 2026·CLINICAL IMMUNOLOGY

Comparative multi-analyte serum protein differences between generic and brand-name dimethyl fumarate, fingolimod, and teriflunomide in multiple sclerosis

Article

Author: Moog, Tatum M ; Stüve, Olaf ; Anderson, Benjamin J ; Taylor, Sophia M ; Sguigna, Peter V ; Burgess, Katy W ; Light, David Y ; Santoyo, Jose R ; Tran, Diem H ; Punnen, Tom G ; Okuda, Darin T ; Jones-McCreary, Morgan C ; Wright, Crystal M

Multiple sclerosis (MS) is treated with branded or generic disease-modifying therapies (DMTs), with increasing concern for the composition and quality of off-patent products. Our objective was to evaluate differences in disease-specific biomarkers, a potential indicator of suboptimal therapeutic exposure, between individuals treated with branded and generic DMTs. We compared biomarker variability in MS individuals (n=1,124) treated with generic or brand-name fumarates (diroximel fumarate, dimethyl fumarate (DMF)), fingolimod, and teriflunomide. In the generic DMF group, higher coefficients of variation (COV) for CXCL9, CCL20, and TNFSF13B were observed, with a paradoxically lower variability for CXCL13. Higher COVs for CXCL9 were observed with generic fingolimod and for CXCL9 and CXCL13 with generic teriflunomide when compared to brand. Additionally, all generic DMTs demonstrated higher multi-variable variability index values across 18 proteins associated with MS disease activity. Greater biomarker variability with generic formulations may reflect differences in therapeutic exposure and less consistent disease control.

01 Dec 2026·JOURNAL OF THEORETICAL BIOLOGY

A stochastic agent-based model for naive CD8+ T cell recirculation dynamics in mice

Article

Author: Elrefaei, Nagat ; Christian, David A ; Adams, Thomas A

Understanding the dynamics of T cell recirculation is vital for predicting immune responses and providing mechanistic insights into T cell migration. In this work we present a stochastic agent-based mathematical model for naive CD8⁺ T cell dynamics and recirculation patterns in mice. This work includes the ability to interrogate the earliest stages of T cell trafficking using a dataset with uniquely dense temporal sampling. Measurements beginning at 10 min post-transfer enabled characterization of the rapid redistribution phase that is often missed in studies with coarser sampling intervals. The model structure includes the bloodstream, lymph nodes, spleen, and other parts of the body where naive T cells recirculate. The model is governed by migration parameters designed according to the physiological nature of the system components. A parameter estimation technique was used to fit the model to experimental data while maintaining a reasonable level of stochasticity. The results show that the simulated naive CD8⁺ T cell counts in the different tissues matched the experimental data up to 47 h post T cell transfer. The model incorporates lymph node size heterogeneity and distinct splenic red and white pulp compartments to better capture naive CD8⁺ T cell recirculation dynamics. The robustness of the model was demonstrated by simulating the effect of FTY720 drug on T cell counts in the bloodstream at two different drug doses and over the span of one week, which is much longer than the original training period. This work offers a novel tool for quantifying T cell recirculation parameters and enables predictive capabilities for T cell dynamics.

110

News (Medical) associated with Fingolimod Hydrochloride

21 Oct 2026

·www.biospace.com

Roche presents new pivotal trial data across broad neuroimmunology portfolio at MSToronto2026

Fenebrutinib 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% (p55 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 pro 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 . 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 Pro 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: media.relations@roche.com Tristan Schmitz Phone: +41 79 529 70 35 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 Irène 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: bruno.eschli@roche.com Dr Sabine Borngräber Phone: +41 61 68-88027 e-mail: sabine.borngraeber@roche.com Dr Birgit Masjost Phone: +41 61 68-84814 e-mail: birgit.masjost@roche.com Investor Relations North America Loren Kalm Phone: +1 650 225 3217 e-mail: kalm.loren@gene.com Attachment Media&Investor Release MSToronto2026 English

Clinical ResultPhase 3Drug Approval

07 Oct 2026

·www.biospace.com

Novartis advances multiple sclerosis innovation with late-breaking remibrutinib and broad portfolio data at MSToronto2026

Late-breaking data from positive Phase III REMODEL-1/-2 trials will show efficacy and safety pro remibrutinib in RMS Novartis to hold virtual investor event highlighting REMODEL data and remibrutinib in MS Phase III NEOS late-breaker will expand evidence for Kesimpta ® (ofatumumab) in pediatric MS, where current approved treatment options remain limited New Kesimpta data from STHENOS study in treatment-naive relapsing MS and from KATHAROS breastfeeding study will be presented Basel, October 07 , 2026 – Novartis will present new data from its multiple sclerosis (MS) portfolio with 46 abstracts at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting. Among these is a late-breaking abstract featuring the Phase III REMODEL-1/-2 results, underscoring the potential of remibrutinib and reinforcing the company’s long-standing commitment to advancing care for people living with MS. A second late-breaking abstract will present new Kesimpta ® (ofatumumab) data in pediatric MS, where significant treatment needs remain. Additional presentations will further expand the Kesimpta evidence base, including research on pregnancy outcomes and breastfeeding that aims to inform family planning decisions, as well as the use of Kesimpta versus disease-modifying therapies commonly used as first-line treatments in treatment-naïve patients. “For decades, Novartis has helped shape the treatment landscape for people living with multiple sclerosis through scientific innovation,” said Nazem Atassi, Global Head, Neuroscience and Gene Therapy Development, Novartis. “At MSToronto2026, we are sharing Phase III results from REMODEL-1 and REMODEL-2 evaluating remibrutinib, an oral BTK inhibitor, alongside new evidence across our MS portfolio. Together, these data reflect our continued commitment to addressing unmet needs across different stages of life and disease.” Investor call on remibrutinib in MS Following the presentation of the REMODEL data at MSToronto2026, Novartis will host a conference call for investors to provide updates on the data and the potential for remibrutinib in MS. Key abstracts include: Abstract Title Presentation Details Remibrutinib Efficacy and Safety of Remibrutinib vs Teriflunomide in Relapsing Multiple Sclerosis: Results of the Phase 3 REMODEL-1/-2 Trials Presentation ID O139 Oral Presentation October 23, 11:25 – 11:35 a.m. ET Kesimpta (ofatumumab) Efficacy and Safety of Ofatumumab and Siponimod Versus Fingolimod in Pediatric Multiple Sclerosis: The Innovative Phase 3 NEOS Study Presentation ID O138 Oral Presentation October 23, 11:15 – 11:25 a.m. ET Ofatumumab Versus Physicians’ Choice of Disease Modifying Therapy in Treatment-Naive People Living With Relapsing Multiple Sclerosis: Final Efficacy Results of The Phase 3b STHENOS Study Presentation ID P0390 Poster Session 1 October 21, 4:30 – 6:30 p.m. ET Ofatumumab Versus Physicians’ Choice of Disease-Modifying Therapy in Treatment-Naive People Living With Relapsing Multiple Sclerosis: Final Safety and Tolerability Results of The Phase 3b STHENOS Study Presentation ID EP2632 ePoster Ofatumumab Versus Physicians’ Choice of Disease Modifying Therapy in Treatment-Naive People Living With Relapsing Multiple Sclerosis: Final Healthcare Resource Utilization Results of the Phase 3b STHENOS Study Presentation ID EP2625 ePoster Evaluating Ofatumumab Excretion in Breastmilk of Women Living With Relapsing Multiple Sclerosis: Interim Results of the Phase 4 KATHAROS Study Presentation ID EP2565 ePoster Pregnancy and Infant Outcomes in Women With Relapsing Multiple Sclerosis Following Exposure to Ofatumumab: Latest Evidence From the PRIM Study Presentation ID P1139 Poster Session 2 October 22, 4:30 – 6:30 p.m. ET About Novartis Neuroscience Neurological diseases are deeply personal, affecting people of any age, from newborns to seniors, often striking in the prime of life. In multiple sclerosis (MS), Novartis has helped shape the treatment landscape for decades through scientific innovation and leadership in advancing care for people living with MS. We remain focused on addressing unmet needs and pursuing new approaches that may improve outcomes for people across the MS journey. Building on this foundation, we're doubling down on our commitment to neurology, expanding our legacy of innovation in MS and spinal muscular atrophy (SMA) to work in neuroimmunology, neurodegeneration, and neuromuscular diseases. Our goal is to protect people’s health across their lifespan, developing more treatment options that lead to better outcomes. Disclaimer This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “look forward,” or similar expressions, or by express or implied discussions regarding: potential new products; potential new indications for existing products; potential product launches or potential future revenues from any such products; results of ongoing clinical trials; or potential future, pending or announced transactions; potential future sales or earnings; strategy, plans, expectations or intentions, including discussions regarding our continued investment into new R&D capabilities and manufacturing; or our capital structure. You should not place undue reliance on these statements. Such forward-looking statements are based on the current beliefs and expectations of management regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations could be affected by, among other things, uncertainties concerning: global healthcare cost containment, including ongoing government, payer and general public pricing and reimbursement pressures and requirements for increased pricing transparency; the success of our key products, commercial priorities and strategy; research and development of new products, including clinical trial results and additional analysis of existing clinical data; our ability to obtain or maintain proprietary intellectual property protection, including the ultimate extent of the impact on Novartis of the loss of patent protection and exclusivity on key products; our ability to realize the strategic benefits, operational efficiencies or opportunities expected from our external business opportunities; the development or adoption of new technologies, including artificial intelligence, and new business models; potential significant breaches of information security or disruptions of our information technology systems; actual or potential legal proceedings, including regulatory actions or delays or government regulation related to the products and pipeline products described in this press release; safety, quality, data integrity, or manufacturing issues; major macroeconomic and geo- and socio-political developments, including the impact of any potential tariffs on our products or the impact of war in certain parts of the world; future global exchange rates; future demand for our products; and other risks and factors referred to in Novartis AG’s most recently filed Form 20-F and in subsequent reports filed with, or furnished to, the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 300 million people worldwide. Reimagine medicine with us: Visit us at and connect with us on LinkedIn , Facebook , X/Twitter and Instagram . # # # Novartis Media Relations E-mail: media.relations@novartis.com Novartis Investor Relations Central investor relations line: +41 61 324 7944 E-mail: investor.relations@novartis.com

Phase 3

01 Oct 2026

·www.biospace.com

Oculis Joins the National Multiple Sclerosis Society’s Campaign to End MS

Oculis and the National Multiple Sclerosis Society’s campaign share a common goal to accelerate breakthroughs in MS research and improve patients’ quality of life ZUG, Switzerland, October 1, 2026 -- Oculis Holding AG (Nasdaq: OCS / XICE: OCS) (“Oculis”), a global biopharmaceutical company focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology, is partnering with the National Multiple Sclerosis Society on its Campaign to End MS, as the industry partner focusing on Vision, officially launching today, on October 1, 2026. This 5-year campaign aims to accelerate research breakthroughs, improve access to care, and create a future where no one lives with the uncertainty of multiple sclerosis (MS). By bringing together people affected by MS, researchers, healthcare leaders, advocates, and supporters, the campaign seeks to translate scientific progress into meaningful advances in treatment and care, while strengthening the resources and support available to the MS community. Oculis’ sponsorship reflects a shared commitment to advancing innovation, addressing unmet needs, and improving the lives of people affected by MS. As part of the campaign, the National Multiple Sclerosis Society is convening respected MS thought leaders, health industry and corporate leaders, researchers, and healthcare providers across three programs: a CEO Roundtable, Big Bets for Breakthroughs: The MS Research Symposium, and the Campaign to End MS Gala. Riad Sherif, M.D., Chief Executive Officer of Oculis, said, "Our sponsorship of the National MS Society's Campaign to End MS marks the beginning of what we believe will be a long-term partnership with an organization that has spent 80 years advancing research and care for people living with MS. We share the Society's commitment to accelerating progress for people affected by MS and, through our Privosegtor development program, we are working to advance a much-needed neuroprotective treatment option for patients experiencing optic neuritis and acute MS relapses.” Oculis is currently developing Privosegtor with the aim to provide the first neuroprotective therapy for optic neuritis (ON), a common MS relapse type and often the first manifestation of MS, with broad potential applicability in other neuro-ophthalmic and neurological diseases. Following the successful Phase 2 ACUITY trial, Oculis launched the PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research) program, which includes two registrational trials in ON. In addition, following positive pre-IND FDA feedback supporting Privosegtor’s development strategy for treating acute MS relapses, Oculis is on track to submit the related IND in the fourth quarter of this year. The Company plans to host an R&D Day in Q4 to provide updates on its pipeline and development programs, including Privosegtor. - Ends - About Privosegtor Privosegtor, a novel peptoid small-molecule candidate that crosses the blood-brain and retinal barriers, has the potential to become the first neuroprotective therapy for optic neuritis (ON) and other neuro-ophthalmic and neuro-axonal diseases. Positive results from the ACUITY Phase 2 trial showed Privosegtor’s neuroprotective potential, as evidenced by improvements in visual function, corroborated by anatomical preservation of the retina, including GCIPL and RNFL layers, and reduced neurofilament levels in the blood after an acute episode of optic neuritis. Consistent results were observed in animal models of glaucoma, optic neuritis, and multiple sclerosis (MS), where Privosegtor preserved retinal ganglion cells and was associated with improvements in mobility (clinical function disability) in the MS model. Privosegtor has received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) and Priority Medicines (PRIME) designation from the European Medicines Agency (EMA) as well as Orphan Drug designation from both the FDA and the EMA for ON. Privosegtor is currently being evaluated in Oculis’ PIONEER (Privosegtor Investigation in Optic Neuropathies Efficacy Evaluation Research) program, which includes two registrational trials in ON and one registrational trial in non-arteritic anterior ischemic optic neuropathy (NAION). Building on the ACUITY Phase 2 dataset in ON and constructive FDA pre-IND feedback, Oculis is also planning an IND submission for Privosegtor for the treatment of acute MS relapses. Privosegtor is an investigational drug and has not received regulatory approval for commercial use in any country. About MS MS is a chronic immune-mediated disease affecting approximately 2.8 million people worldwide, including around 850,000 in the U.S. alone. 1-3 It is currently managed using immunomodulators or disease-modifying therapies (DMTs) that reduce the rate of relapses and therefore related relapse-associated worsening (RAW). However, relapses still persist for many patients, with an estimated 170,000 MS relapses occurring each year in the U.S. 4 During an acute relapse, neurologists commonly use a short course of high-dose corticosteroids to reduce inflammation and shorten the episode, as is also standard of care in optic neuritis. However, corticosteroids do not mitigate the long-term disability, and recovery from relapses is often incomplete, such as in optic neuritis. There are currently no neuroprotective therapies approved for MS relapses, and there remains an urgent unmet medical need for treatments that can prevent central nervous system damage. About Oculis Oculis is a global biopharmaceutical company (Nasdaq: OCS; XICE: OCS) focused on breakthrough innovations to address significant unmet medical needs in neuro-ophthalmology. Oculis’ highly differentiated late-stage clinical pipeline focuses on two core product candidates. Privosegtor is a breakthrough neuroprotective candidate in the PIONEER program, which consists of studies intended to support registration plans for treatment of optic neuropathies, including optic neuritis (ON) and non-arteritic anterior ischemic optic neuropathy (NAION). Privosegtor also has potential to be developed for additional indications in other neuro-ophthalmic and neuro-axonal diseases. Licaminlimab is a novel, topical anti-TNFα in a registrational trial, and is being developed with a genotype-based approach for treating patients with dry eye disease (DED). Headquartered in Switzerland with operations in the U.S., Iceland and Switzerland, Oculis is led by an experienced management team with a successful track record and supported by leading international healthcare investors. For more information, please visit: About the National Multiple Sclerosis Society The National MS Society, founded in 1946, is the global leader of a growing movement dedicated to creating a world free of MS. The Society funds cutting-edge research for a cure, drives change through advocacy and provides programs and services to help people affected by MS live their best lives. Oculis Contact Ms. Sylvia Cheung, CFO sylvia.cheung@oculis.com Investor Relations LifeSci Advisors Corey Davis, Ph.D. cdavis@lifesciadvisors.com Media Relations ICR Healthcare Amber Fennell oculis@icrhealthcare.com Cautionary Statement Regarding Forward Looking Statements This press release contains forward-looking statements and information. For example, statements regarding the potential benefits of the Company’s product candidates, including the potential for Privosegtor to become the first neuroprotection therapy for optic neuritis and its potential broad applicability across neurology, including in acute MS relapses, the initiation, enrollment, timing, progress and results of current and future clinical trials, Oculis’ research and development programs, regulatory and business strategy; Oculis’ future development plans; the timing or likelihood of regulatory filings and approvals; and statements about market opportunity, are forward-looking. All forward-looking statements are based on estimates and assumptions that, while considered reasonable by Oculis and its management, are inherently uncertain and are inherently subject to risks, variability, and contingencies, many of which are beyond Oculis’ control. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, assurance, prediction or definitive statement of a fact or probability. Actual events and circumstances are difficult or impossible to predict and will differ from assumptions. Results of earlier stage clinical trials may not be replicated in subsequent clinical trials. All forward-looking statements are subject to risks, uncertainties and other factors that may cause actual results to differ materially from those that we expected and/or those expressed or implied by such forward-looking statements. Forward-looking statements are subject to numerous conditions, many of which are beyond the control of Oculis, including those set forth in the Risk Factors section of Oculis’ annual report on Form 20-F and any other documents filed with the U.S. Securities and Exchange Commission (SEC). Copies of these documents are available on the SEC’s website, Oculis undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law. References: MS National Society Wallin et al., 2019, The prevalence of MS in the United States: A population-based estimate using health claims data - PubMed McGinley et al., 2021, Diagnosis and Treatment of Multiple Sclerosis: A Review - PubMed Multiple sources on relapse rate (ARR) including: Ocrelizumab versus fingolimod after natalizumab cessation in multiple sclerosis: an observational study - PubMed

Clinical ResultPhase 2Orphan DrugBreakthrough Therapy

100 Deals associated with Fingolimod Hydrochloride

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KEGG	Wiki	ATC	Drug Bank
D04187	Fingolimod Hydrochloride	L04AE01	DB08868

R&D Status

Approved

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Indication	Country/Location	Organization	Date
Multiple Sclerosis, Relapsing-Remitting	European Union	Novartis Europharm Ltd.	17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting	Iceland	Novartis Europharm Ltd.	17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting	Liechtenstein	Novartis Europharm Ltd.	17 Mar 2011
Multiple Sclerosis, Relapsing-Remitting	Norway	Novartis Europharm Ltd.	17 Mar 2011
Multiple Sclerosis	Australia	Novartis AG	01 Feb 2011
Multiple sclerosis relapse	United States	Novartis Pharmaceuticals Corp.	21 Sep 2010

Developing

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Indication	Highest Phase	Country/Location	Organization	Date
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	United States	Tanabe Pharma Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	United States	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Japan	Tanabe Pharma Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Japan	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Australia	Tanabe Pharma Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Australia	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Belgium	Tanabe Pharma Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Belgium	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Canada	Novartis Pharmaceuticals Corp.	22 Dec 2012
Multifocal acquired demyelinating sensory and motor neuropathy	Phase 3	Canada	Tanabe Pharma Corp.	22 Dec 2012

Clinical Result

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Phase

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


ECTRIMS2025	Not Applicable	Multiple Sclerosis	5,134	Natalizumab	kzxsniwgvy(zyufrfexmk) = mlohuhmsbt nxelowkvzo (zkvfpjhpgh )	Positive	24 Sep 2025
				Alemtuzumab	kzxsniwgvy(eodljymhfy) = mfrlhyfwam qimwkegmqd (xsprjogwby )
ECTRIMS2025	Not Applicable	Multiple Sclerosis	989	Fingolimod therapy	tiqhchgrtv(uljktltfux) = nzozcngxbg huvjkjowoo (brgxcunzgz ) View more	Positive	24 Sep 2025
ECTRIMS2025	Not Applicable	Multiple Sclerosis	1,587	Fingolimod (FTY)	lcocvvvzbl(iiaggjowyk) = zwczwxeeys apwotscscq (hzsqqvxrmn ) View more	Positive	24 Sep 2025
ECTRIMS2025	Not Applicable	Multiple Sclerosis	1,260	Interferons and glatiramer acetate	tufbxdhtsh(hzhjczaaas) = decreased from 1.2 at baseline to 0.45 after treatment initiation, representing a 62.5% reduction. drykbqqxdm (pkujnqyoac ) View more	Positive	24 Sep 2025
				Fingolimod
ACTRIMS2025	Not Applicable	Multiple Sclerosis	581	Ocrelizumab	nhvanpmypq(bxzmvyigmp) = xznhebgbnd eyormjlxhu (ukctfehiby ) View more	Negative	27 Feb 2025
				Fingolimod	nhvanpmypq(bxzmvyigmp) = ocrhgsgvke eyormjlxhu (ukctfehiby ) View more
NCT04088630 (FITCH, CTgov)	Early Phase 1	Cerebral Hemorrhage \| Brain Edema \| Hemorrhagic stroke	28	Fingolimod (Fingolimod)	kjbccpodwr = ryniplqlse hdvbrusvhf (dnhxkdvplf, zjhdzrtgqi - qqkbukivsn) View more	-	14 Jan 2025
				Fingolimod (Open-label Fingolimod)	kjbccpodwr = rvpdvkudoa hdvbrusvhf (dnhxkdvplf, kejckjszhh - gettifpchl) View more
ECTRIMS2024	Not Applicable	Multiple Sclerosis	322	Discontinuation of HET	gupxufxmwk(gcngmgqzks): HR = 4.1 (95.0% CI, 2.0 - 8.5), P-Value = <0.001 View more	Positive	18 Sep 2024
				Continuation of HET
ECTRIMS2024	Not Applicable	Multiple Sclerosis	41	Moderate-efficacy treatment	sghjewpctk(dbmhfqhvso) = gjjiubbskl dlfzhhxkds (qcbyvofvog, 2.9) View more	Positive	18 Sep 2024
ECTRIMS2024	Not Applicable	Hepatitis, Autoimmune \| Purpura, Thrombocytopenic, Idiopathic	19,343	Highly efficacious disease modifying therapy (HE-DMT), including rituximab, alemtuzumab, ocrelizumab, cladribine, mitoxantrone, fingolimod, natalizumab, ofatumumab, ponesimod, ozanimod, and siponimod	vdeigplote(ykwviroboj) = jqymduvuvt wdqtqvacjz (llvjkpkisf, 0.11 - 23.86) View more	Positive	18 Sep 2024
ECTRIMS2024	Not Applicable	Multiple Sclerosis	2,556	Glatiramer acetateNatalizumabFingolimodDimethyl fumarateCladribineTeriflunomideAlemtuzumabMitoxantrone + Glatiramer acetateNatalizumabFingolimodDimethyl fumarateCladribineTeriflunomideAlemtuzumabMitoxantronecetate + Glatiramer acetateNatalizumabFingolimodDimethyl fumarateCladribineTeriflunomideAlemtuzumabMitoxantrone + Glatiramer acetateNatalizumabFingolimodDimethyl fumarateCladribineTeriflunomideAlemtuzumabMitoxantrone + Glatiramer acetateNatalizumabFingolimodDimethyl fumarateCladribineTeriflunomideAlemtuzumabMitoxantronee + Glatiramer acetateNatalizumabFingolimodDimethyl fumarateCladribineTeriflunomideAlemtuzumabMitoxantrone + Glatiramer acetateNatalizumabFingolimodDimethyl fumarateCladribineTeriflunomideAlemtuzumabMitoxantronearate + Glatiramer acetateNatalizumabFingolimodDimethyl fumarateCladribineTeriflunomideAlemtuzumabMitoxantrone + Glatiramer acetateNatalizumabFingolimodDimethyl fumarateCladribineTeriflunomideAlemtuzumabMitoxantrone	ilrlftwfji(qqkxboycaj) = vcgycjszrv sjroxiqazd (nknzmvmbtu, 0.01 - 0.10) View more	Positive	18 Sep 2024

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