fingolimod / Generic mfg. - LARVOL DELTA

No evidence of disease activity after fingolimod treatment: A three-year real-world comparison of pre- and post-treatment outcomes in multiple sclerosis. (PubMed, Mult Scler Relat Disord) - "In this real-world switch cohort, fingolimod was associated with a marked reduction in relapse activity in RRMS, while disability worsening persisted in SPMS. NEDA-3 rates differed substantially by phenotype, supporting phenotype-specific expectations and the value of real-world risk stratification."

Journal • Real-world evidence • CNS Disorders • Multiple Sclerosis

MMR SEROLOGIC STATUS IN MULTIPLE SCLEROSIS AFTER AUTOLOGOUS STEM CELL TRANSPLANTATION (EBMT 2026) - "Background: Multiple sclerosis (MS) patients undergoing autologous stem cell transplantation (ASCT) after carmustine, cytarabine, etoposide, melphalan (BEAM) or cyclophosphamide (Cy) chemotherapy plus rabbit anti-thymocyte globulin (rATG) are considered as naïve to vaccines and offered revaccination; live vaccines as measles/mumps/rubella (MMR) are not recommended before 24 months from ASCT with concern about vaccine-induced infectious disease...The two patients who lost either MMR (ID23) or rubella immunity (ID35) had both low titles at baseline; prior to ASCT, they had received interferon and 3 lines of therapy (interferon, fingolimod, ocrelizumab), respectively... In our real-life population of ASCT-treated MS, the vast majority of patients retained MMR immunity with a slight decline of vaccine titres over time confirming that MMR revaccination could be safely postponed after 24 months from ASCT and probably offered only in selected patients at high risk (i.e...."

CNS Disorders • Infectious Disease • Measles • Multiple Sclerosis • Mumps • Rubella • Transplantation

Effects of disease-modifying drugs on serum neurofilament light chain, chitinase-3-like-1 protein levels, and selected plasmacytoid dendritic cell biomarkers in relapsing-remitting multiple sclerosis. (PubMed, Afr J Lab Med) - "B-cell therapy (rituximab) depletes circulating CD20+ B cells in cerebrospinal fluid, but their specific effects in RRMS remain limited. Disease-modifying drug type (IFN-b-1A, fingolimod, and B-cell therapy) impacts NFL and CHI3L1 serum levels as drug response biomarkers and relates to clinical data of MS patients, but has no diverse impact on the migratory and tolerogenic function of pDCs. The serum NFL and CHI3L1 need to be validated as drug response biomarkers in RRMS patients, evaluating the DMDs' effect on immunocellular level by studying migratory and tolerogenic functions of pDCs."

Biomarker • Journal • CNS Disorders • Inflammation • Multiple Sclerosis • CD20 • CHI3L1 • NEFL

B-cell-driven relapse and anti-CD20 rescue therapy after Alemtuzumab in RRMS: case report and literature review. (PubMed, Front Immunol) - "Early ocrelizumab switch resulted in rapid clinical and radiological recovery and sustained stability...Prior exposure to fingolimod has been observed in several cases, but does not uniformly account for the observed phenotype...Lymphocyte subtyping should be performed, and a predominance of CD19+ B cells can guide a timely therapeutic switch to anti-CD20 therapy. Further studies are needed to define whether this represents a distinct post-IRT immunopathological entity."

Journal • Review • CNS Disorders • Inflammation • Multiple Sclerosis

Evaluation of Clinical and Radiologic Relapses around Pregnancy Loss in Women with Multiple Sclerosis (ACTRIMS Forum 2026) - "Overall clinical relapse rates following pregnancy loss (11%) were lower than pre-conception rates (28%) and this holds true across all types of pregnancy loss in our cohort. Among the 37 pregnancy losses with complete MRI data, the majority (78%) of MRI scans were stable before pregnancy and after pregnancy loss (compared to 22% of MRIs with new T2 lesions and 5% with Gd+ lesions after pregnancy loss). All wwMS with new T2/Gd+ lesions on post-pregnancy loss MRIs were treated with either natalizumab, glatiramer acetate, fingolimod or dimethyl fumarate prior to conception."

Clinical • CNS Disorders • Multiple Sclerosis

Post-Marketing Skin Cancer Safety Concerns with Fingolimod in MS (ACTRIMS Forum 2026) - "For each skin cancer-related adverse event (all skin cancer as well as by subtype for cutaneous melanoma, cutaneous basal cell carcinoma, and cutaneous squamous cell carcinoma), the proportional reporting ratio (PRR), information component (IC), reporting odds ratio (ROR), and adjusted ROR (aROR) were computed using natalizumab and alemtuzumab as the active comparator reference group. Fingolimod was associated with disproportionate reporting of skin cancer, with the strongest association observed for cutaneous basal cell carcinoma. These findings support the need for dermatologic monitoring and warrant evaluation in future prospective cohort studies. The application of active-comparator restricted disproportionality analysis may help improve signal detection study design in future pharmacovigilance studies."

Clinical • P4 data • Basal Cell Carcinoma • CNS Disorders • Cutaneous Melanoma • Genetic Disorders • Melanoma • Multiple Sclerosis • Non-melanoma Skin Cancer • Oncology • Skin Cancer • Solid Tumor • Squamous Cell Carcinoma • Squamous Cell Skin Cancer

Real-World Effectiveness and Safety of Cladribine Tablets in Patients with Relapsing Multiple Sclerosis after Suboptimal Response to Prior Oral or Infusion Disease-Modifying Therapy: 24‑Month Analysis from the US-Based Phase 4 MASTER-2 Study (ACTRIMS Forum 2026) - P | "The most common prior DMTs were ocrelizumab (28.2%), dimethyl fumarate (20.7%), teriflunomide (16.0%), fingolimod (15.4%), and natalizumab (13.3%)... This 24-month real-world analysis showed sustained low relapse rates, high self-reported treatment adherence, and favorable tolerability, with no new or unexpected safety findings with CladT in patients with RMS who switched from oral or infusion DMTs."

Clinical • P4 data • Real-world • Real-world effectiveness • Real-world evidence • CNS Disorders • Infectious Disease • Multiple Sclerosis • Novel Coronavirus Disease

Results of the Gilenya Pregnancy Registry (ACTRIMS Forum 2026) - "Additionally, an indirect comparison of GPR with an external natalizumab-exposed comparator from a German MS registry (DMSKW cohort) was performed. In GPR, pregnancy outcomes were available for 188 prospectively and 98 retrospectively reported pregnancies; PRIM included 1481 prospectively reported pregnancies. Fingolimod exposure during pregnancy was associated with an increased risk of MCMs compared with EUROCAT and indirectly compared with the DMSKW cohort. These findings support current label recommendations to provide medical advice on the potential fetal risk. In addition, the possibility of severe MS exacerbation in women who discontinue fingolimod due to pregnancy, and alternative family planning therapies, should be discussed."

CNS Disorders • Multiple Sclerosis • Musculoskeletal Diseases

Real-world COVID-19 immunity in multiple sclerosis (CoVaR-MS): A longitudinal follow up study. (PubMed, Mult Scler Relat Disord) - "We conducted a real-world longitudinal study (n = 235) including PwMS (n = 205; Alemtuzumab, Dimethyl fumarate, Fingolimod, Interferon, Natalizumab, Ocrelizumab, no-DMT) and Healthy volunteers (HV) (n = 30)...Ocrelizumab lowered serological but maintained cellular immunity; whilst Fingolimod lowered both. Data support boosters in PwMS, more so on Ocrelizumab and Fingolimod."

Journal • Real-world evidence • CNS Disorders • Immunology • Infectious Disease • Multiple Sclerosis • Novel Coronavirus Disease • Respiratory Diseases

Retrospective Case Series of Pediatric-Onset Multiple Sclerosis in Central Texas (ACTRIMS Forum 2026) - "Initial DMT choices included B-cell therapies (15/24 - ocrelizumab, ublituximab, and rituximab), S1P modulators (5/24 all fingolimod), Interferon therapy (2/24), and dimethyl fumarate (2/24)...2 patients were switched off B-cell therapy due to side effects (infections and infusion reaction) to fingolimod and natalizumab...Over this time frame, there were 2 clinical relapses on DMT (1 on interferon and 1 on dimethyl fumarate); both patients were switched to a S1P modulator (1 of fingolimod and 1 on ozanimod)... In our population of patients, most of the EDA occurred prior to DMT initiation, further enforcing the ideal of early and aggressive treatment for POMS. After DMT initiation, EDA only occurred in patients on moderate-efficacy therapies (interferon therapy, fingolimod, and dimethyl fumarate). Patients on HE DMT had less EDA compared to patients on ME DMT."

Retrospective data • CNS Disorders • Infectious Disease • Multiple Sclerosis • Ocular Inflammation • Ophthalmology • Optic Neuritis • Pediatrics

A Retrospective Cohort Study to Assess the Patient Characteristics, Clinical and Economic Outcomes and Treatment Patterns in People with Primary Progressive Multiple Sclerosis in the United States (ACTRIMS Forum 2026) - "People with PPMS experience substantial clinical and economic burden characterized by high comorbidities, increased HCRU/HCCs, and low treatment rates, underscoring the unmet need in a population with only one approved DMT in the US."

HEOR • Retrospective data • CNS Disorders • Depression • Infectious Disease • Multiple Sclerosis

Exit strategy patterns in second-line therapies for relapsing forms of multiple sclerosis. (PubMed, Acta Neurol Belg) - "B-cell-depleting therapies, particularly ocrelizumab, may help lower disability in active RRMS, but longer follow-up is needed to confirm sustained benefits. Personalized strategies that balance efficacy, safety, and patient-specific factors (e.g., PML risk, pregnancy) are essential. Although most patients had low baseline disability, which may limit generalizability, these findings still offer real-world insight into treatment transitions. Longer prospective studies are needed to confirm long-term outcomes."

Journal • CNS Disorders • Multiple Sclerosis

Neurofilament Light Chain Concentration in the Prediction of Treatment Response in Multiple Sclerosis. (PubMed, Eur J Neurol) - "In well-characterised MS patients treated with interferon β, fingolimod or natalizumab, clinicodemographic information provides modest prognostic value; however, NfL adds minimal incremental utility."

Biomarker • Journal • CNS Disorders • Multiple Sclerosis • IFNB1 • NEFL

Post-infectious Neuromyelitis Optica syndrome, in a MS patient under treatment with fingolimod, comorbidity of two distinct CNS autoimmunity? (ACTRIMS Forum 2026) - "Long-term therapy with rituximab was therefore initiated. This case demonstrates that viral reactivation during immunosuppressive therapy can unmask or trigger neuromyelitis optica spectrum disorder in patients previously diagnosed with multiple sclerosis. . Early differentiation between overlapping demyelinating disorders is essential for timely and appropriate management."

Clinical • CNS Disorders • Herpes Zoster • Immunology • Inflammation • Multiple Sclerosis • Neuromyelitis Optica Spectrum Disorder • Rare Diseases • Urinary Incontinence • Urology • Varicella Zoster

A radiolabeled dendrimer non-invasively identifies and tracks innate immune cell activation in a mouse model of experimental autoimmune encephalomyelitis. (PubMed, Nat Commun) - "Moreover, 18F-FMD sensitively captures therapeutic response to fingolimod (FTY720) and a CSF1R dendranib (H74DS3M8), both of which suppress immune cell activation and attenuate disease severity. These findings highlight the potential of 18F-FMD PET for specific, real-time monitoring of innate immune responses, and the applicability of the dendrimer in clinical settings for monitoring therapeutic efficacy, advancing the development of personalized, myeloid-targeted strategies for MS."

Journal • Preclinical • CNS Disorders • Immunology • Multiple Sclerosis • CSF1R

Study Design of a Phase 3, Randomized, Double-Blind Study of Ublituximab Versus Fingolimod in Children and Adolescents with Relapsing Multiple Sclerosis: ULTIMATE KIDS II (ACTRIMS Forum 2026) - "ULTIMATE KIDS II is designed to provide evidence on whether ublituximab is non-inferior to fingolimod in reducing relapses and expand understanding of the safety, efficacy, and pharmacology of B-cell depletion in POMS."

Clinical • P3 data • CNS Disorders • Multiple Sclerosis • Ophthalmology

Comparative Assessment of Switching, Healthcare Resource Utilization, and Cost Outcomes for Cladribine Tablets Versus Other Oral Disease-Modifying Therapies Among US Patients with Multiple Sclerosis Over 4 Years (ACTRIMS Forum 2026) - "This study aimed to evaluate treatment switching, HCRU, and cost outcomes among US patients with MS (PwMS) treated with CladT versus fingolimod (FTY), dimethyl fumarate (DMF), and teriflunomide (TER) over a 4-year period. This retrospective study used US claims data from the Komodo Healthcare Map Database between April 1, 2018, and March 31, 2024... PwMS treated with CladT had significantly fewer treatment switches, reduced outpatient visits, and lower medical costs than those treated with FTY, DMF, and TER."

Clinical • HEOR • CNS Disorders • Inflammation • Multiple Sclerosis

Efficacy of Ofatumumab in People With Relapsing Multiple Sclerosis and Breakthrough Disease on Oral Therapies: A Subgroup Analysis of ARTIOS in Hispanic/Latino and Not Hispanic/Latino Participants (ACTRIMS Forum 2026) - "In the ARTIOS study, OMB treatment showed similar and strong disease control in both Hispanic/Latino and Not Hispanic/Latino subpopulations of plwRMS who previously experienced suboptimal responses to fingolimod or fumarate-based therapies."

Clinical • CNS Disorders • Multiple Sclerosis

Study to Assess Effects of Ublituximab in Pediatric Participants With Relapsing Forms of Multiple Sclerosis (clinicaltrials.gov) - P2/3 | N=240 | Not yet recruiting | Sponsor: TG Therapeutics, Inc. | Initiation date: Dec 2025 ➔ Mar 2026

Trial initiation date • CNS Disorders • Multiple Sclerosis • Pediatrics

Pilot Study of Fingolimod Treatment in Neuronal Ceroid Lipofuscinosis Type 1. (PubMed, Neurol Genet) - "The significant reduction in NfL levels observed suggests reduced neuroaxonal damage secondary to immune modulation. This finding highlights the potential role of immune modulation in addressing underlying inflammatory processes in CLN1, even if it does not fully halt disease progression."

Journal • CNS Disorders • Epilepsy • Immune Modulation • Immunology • Inflammation • Lysosomal Storage Diseases • Metabolic Disorders • Multiple Sclerosis • Pediatrics • Rare Diseases • NEFL • PPT1

SPHK1 deficiency promotes intestinal homeostasis by ameliorating ER stress-induced gastrointestinal injury during murine graft-versus-host disease. (PubMed, Sci China Life Sci) - "FTY720, an S1P receptor antagonist, significantly inhibits ER stress-induced IEC injury. Our findings highlight the pathogenic role of host SPHK1 in gastrointestinal injury during aGVHD and suggest that targeting SPHK1 could be a therapeutic strategy for managing this condition."

Journal • Preclinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • SPHK1

In-silico characterization of deleterious non-synonymous SNPs in the human S1PR1 gene reveals structural instability and altered ligand affinity. (PubMed, PLoS One) - "Molecular docking and dynamics simulations showed that R120P and F125S weaken binding affinity for natural agonist sphingosine-1-phosphate (S1P) and FTY720P, while antagonist W146 retained strong binding...Collectively, these findings identified high-risk nsSNPs in S1PR1 gene with potential structural and functional implications, particularly in diseases involving impaired receptor signaling. These findings enhanced our understanding of how specific nsSNPs can influence disease susceptibility, drug response, and receptor function, paving the way for precision medicine approaches in treating autoimmune and inflammatory disorders."

Journal • Cardiovascular • CNS Disorders • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease • Multiple Sclerosis • Oncology • Ulcerative Colitis • S1PR1

From Neurovascular Challenge to Therapeutic Opportunity: VCAM-Targeted Nanocarriers in Acute Ischemic Stroke and Intracranial Hemorrhage (ISC 2026) - "We have developed VCAM-targeted nanocarriers (T-NCs) that leverage vascular cell adhesion molecule-1 upregulation at the inflamed BBB, achieving highly selective targeting: 20-fold higher uptake by BBB endothelial cells over untargeted controls and up to 100-fold compared to free drugs, surpassing transferrin receptor-targeted approaches by 15-fold.In AIS models, VCAM T-NCs delivered small molecules (dexamethasone and fingolimod), proteins, and mRNAs (luciferase, Cre-recombinase, IL-10, Mfsd2A, tight junction components, and thrombomodulin) directly to the BBB endothelium in affected regions. Distinct from AIS, VCAM T-NC therapy in ICH did not merely decrease macrophage counts but shifted their phenotype, promoting neuroprotective M2 polarization, as confirmed by molecular and behavioral analyses.Thus, VCAM-targeted nanocarriers represent a versatile, mechanism-tailored platform for neurovascular drug delivery. They enable precision interventions in AIS via selective BBB..."

Cardiovascular • Cerebral Hemorrhage • CNS Disorders • Hematological Disorders • Inflammation • Ischemic stroke • IL10 • MFSD2A • VCAM1

Alterations in Sphingolipid Pathway Associate with Clinical Outcomes after Intracerebral Hemorrhage (ISC 2026) - "S1P receptor modulators (fingolimod, Siponimod) reduced edema and improved recovery in preclinical and early-phase trials. These novel exploratory findings suggest that dysregulation of sphingolipid metabolism may contribute to ICH outcomes. Reduced S1P in poor-outcome lobar ICH, appearing as relatively higher levels in deep ICH, suggests a role for S1P signaling in secondary injury and recovery and highlights the need for validation in larger cohorts."

Clinical • Clinical data • Cardiovascular • Cerebral Hemorrhage • Hematological Disorders • Inflammation • Metabolic Disorders

Real-world database evaluation of drug-associated vitreous opacities and machine learning for clinical interpretability. (PubMed, Front Cell Dev Biol) - "The five highest-risk drugs were dexamethasone, brolucizumab, triamcinolone, faricimab, and fingolimod. This first systematic real-world evaluation of VO-related adverse drug reactions identifies high-risk drugs, susceptible populations, and onset patterns, thus offering guidance for preventive medication strategies. The BAG model showed higher sensitivity in real-world analysis, suggesting potential for further research in VO and floater prevention and treatment."

Journal • Real-world evidence