Press Release: Novartis announces both ianalumab -2-

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References

1. Novartis data on files

2. Bowman S et al, Safety and efficacy of subcutaneous ianalumab (VAY736) in

patients with primary Sjogren's syndrome: a randomized, double-blind,

placebo-controlled, phase 2b dose-finding trial, Lancet 2022; 399:161-71

3. Dorner T et al, Safety and Efficacy of ianalumab in patients with

Sjogren's disease:52-week results from a randomized, placebo-controlled,

phase 2b dose-ranging study, Arhtritis and Rheumatology 2025,

77(5):560-570

4. Negrini S et al, Sjogren's syndrome: a systemic autoimmune disease, Clin

Exp Med. 2022; 22(1): 9--25

5. Mariette, Primary Sjogren's symptoms, New England Journal of Medecine,

2018, 378;10

6. VAY736, Department of health and human Services, Fast Track Designation,

US Food and Drug Administration, 2025

7. ClinicalTrials.gov NCT05350072

https://clinicaltrials.gov/study/NCT05350072 [Last accessed: August

2025]

8. ClinicalTrials.gov NCT0539214

https://clinicaltrials.gov/study/NCT05349214 [Last accessed: August 2025]

9. ClinicalTrials.gov NCT05653219

https://clinicaltrials.gov/study/NCT05653219?intr=ianalumab&aggFilters=phase:3&rank=9

[Last accessed: August 2025]

10. ClinicalTrials.gov NCT05639114

https://www.clinicaltrials.gov/study/NCT05639114 [Last accessed: August

2025]

11. ClinicalTrials.gov NCT05126277

https://clinicaltrials.gov/study/NCT05126277 [Last accessed: August

2025]

12. ClinicalTrials.gov NCT05648968

https://clinicaltrials.gov/study/NCT05648968 [Last accessed: August

2025]

13. ClinialTrials.gov NTC06470048

https://clinicaltrials.gov/study/NCT06470048 [Last accessed: August

2025]

14. Phase 2 safety and efficacy of subcutaneous (s.c.) dose ianalumab

(VAY736; Anti-BAFFR mAB) administered monthly over 28 weeks in patients

with Systemic Lupus Erythematosus (SLE) of moderate-to-severe activity,

ACR congress, available at : Phase 2 Safety and Efficacy of Subcutaneous

(s.c.) Dose Ianalumab (VAY736; Anti-BAFFR mAb) Administered Monthly over

28 Weeks in Patients with Systemic Lupus Erythematosus (SLE) of

Moderate-to-Severe Activity - ACR Meeting Abstracts

https://acrabstracts.org/abstract/phase-2-safety-and-efficacy-of-subcutaneous-s-c-dose-ianalumab-vay736-anti-baffr-mab-administered-monthly-over-28-weeks-in-patients-with-systemic-lupus-erythematosus-sle-of-moderate-to-severe/

[Last accessed: August 2025]

15. A Phase 2 Study of ianalumab in patients with primary immune

thrombocytopenia previously treater with at least two lines of therapy,

EHA congress, available at: EHA Library - The official digital education

library of European Hematology Association (EHA)

https://library.ehaweb.org/eha/2025/eha2025-congress/4159389/charlotte.bradbury.a.phase.2.study.of.ianalumab.in.patients.with.primary.html?f=

[Last accessed: August 2025]

16. Novartis to strengthen oncology pipeline with agreement to acquire

Morphosys [AG Press release]. [Press release]. Available at: Novartis to

strengthen oncology pipeline with agreement to acquire MorphoSys AG for

EUR 68 per share or an aggregate of EUR 2.7bn in cash | Novartis

https://www.novartis.com/news/media-releases/novartis-strengthen-oncology-pipeline-agreement-acquire-morphosys-ag-eur-68-share-or-aggregate-eur-27bn-cash

[Last accessed: August 2025]

17. ClinicalTrials.gov NCT05985915

https://clinicaltrials.gov/study/NCT05985915 [Last accessed: August

2025]

18. Maleki Fischbach- M, et al, Manifestations and management of Sjogren's

disease, Arthritis Res Ther. 2024;26(1):43

19. Kerry Gairy et al, Burden of illness among subgroups of px with primary

SjD and systemic involvement, Rheumatology 2021, Volume 60, Issue 4,

April 2021, Pages 1871--1881

20. Conrad N, et al, Incidence, prevalence, and co-occurrence of autoimmune

disorders over time and by age, sex, and socioeconomic status: a

population-based cohort study of 22 millions individuals in the UK,

Lancet. 2023;401(10391):1878-1890;

21. Narváez J et al, Prevalence of Sjogren's syndrome in the general

adult population in Spain: estimating the proportion of undiagnosed cases,

Sci Rep. 2020;10(1):10627

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(END) Dow Jones Newswires

August 11, 2025 01:15 ET (05:15 GMT)