Immunology Video Recap—January 28, 2026

This biweekly Immunology video recap highlights key regulatory actions, clinical trial progress, and important approvals in immune-mediated conditions. Notable developments include breakthroughs in treatments for autoimmune diseases and rare kidney conditions.

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Transcript

Welcome to the latest edition of Immunology Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.

Novartis has received FDA Breakthrough Therapy designation for ianalumab in the treatment of Sjögren’s disease. Ianalumab is a monoclonal antibody designed to target the underlying causes of this serious autoimmune condition. The FDA’s Breakthrough Therapy designation is aimed at expediting the regulatory review process, and the Phase 3 trials provide promising evidence of its potential as a first targeted therapy for Sjögren’s disease. This is significant, as there are currently no targeted therapies available for this condition, which affects the moisture-producing glands.

Sobi has also made strides in the immunology space. The European Commission has approved Aspaveli® (pegcetacoplan) for the treatment of C3 glomerulopathy (C3G) and primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) in patients aged 12 and older. Aspaveli® is the first approved therapy for these rare kidney diseases, providing a much-needed treatment option for both adult and adolescent patients. This approval offers hope for those suffering from progressive kidney damage, conditions that often lead to end-stage renal disease.

In the United States, argenx has received FDA acceptance of its supplemental Biologics License Application (sBLA) for VYVGART® (efgartigimod) in the treatment of adults with AChR-Ab seronegative generalized myasthenia gravis (gMG). This application has been granted priority review, with results from the Phase 3 ADAPT SERON study supporting its potential as a new treatment option. A decision on this sBLA is expected by May 10, 2026. If approved, VYVGART® could significantly expand the treatment options available for patients with limited alternatives for this rare autoimmune disease.

Sanofi has reported promising results for amlitelimab, an OX40L inhibitor, in its Phase 3 trials for moderate-to-severe atopic dermatitis (AD). In the SHORE trial, amlitelimab met all primary and secondary endpoints, showing strong efficacy in treating AD. The COAST 2 trial also demonstrated significant improvements in the US, though it missed the endpoints in Europe. These results suggest that amlitelimab may offer a new mechanism of action for AD, potentially allowing for dosing every 12 weeks.

Athos Therapeutics has received FDA clearance for its Phase 2 trial of ATH-063 in biologic-refractory ulcerative colitis. ATH-063 is an oral small molecule targeting inflammation and mucosal healing in patients with ulcerative colitis. This international Phase 2 trial will incorporate multi-omic data to provide deeper insights into the disease and could mark a step forward in precision medicine for inflammatory bowel disease (IBD).

Lastly, long-term real-world data has shown the cutaneous benefits of belimumab in the treatment of systemic lupus erythematosus (SLE) and cutaneous lupus erythematosus (CLE). A retrospective study in Germany involving 29 adults with active skin disease demonstrated that belimumab resulted in significant improvement in CLE symptoms, with sustained skin improvements lasting up to five years. These findings support the use of belimumab for the treatment of cutaneous manifestations of lupus and could influence clinical practice and future trials.

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Why it matters

Amlitelimab’s success in AD Phase 3 could pave the way for a new treatment regimen, potentially offering Q12W dosing in a market with few alternatives. [4]
Sobi’s Aspaveli approval highlights a critical new option for treating rare kidney diseases, improving patient outcomes for conditions with limited treatments. [2]
Boehringer’s deal with Simcere expands their IBD pipeline and underscores the growing interest in bispecific therapies. [7]
LEO’s Phase 3 trial in lichen sclerosus (LS) is a potential milestone, as it could address a significant unmet need in dermatology. [6]
Belimumab’s long-term data supports its use in treating cutaneous lupus, potentially influencing future treatment strategies for SLE and CLE. [8]

🗓️ Explore details and sources

Week 14-20 January 2026
Week 21-27 January 2026

📚 Find your one-stop page for the full Immunology archive.

FAQ

What is the significance of Novartis receiving FDA Breakthrough Therapy designation for ianalumab?

This designation could fast-track ianalumab’s approval for Sjögren’s disease, offering the first targeted treatment for a disease with no current options. [1]

What’s the deal with Boehringer’s partnership with Simcere?

Boehringer licensed SIM0709, a bispecific antibody targeting TL1A and IL-23p19, with promising preclinical data. The deal is worth up to €1.05B and could bolster Boehringer’s IBD portfolio. [7]

How could delgocitinib impact the treatment landscape for lichen sclerosus (LS)?

Delgocitinib could become the first approved therapy for LS, which currently has no approved treatments in the US or EU. [6]

How do the long-term real-world data on belimumab support its use in treating cutaneous lupus?

The data show sustained improvement in skin symptoms over several years, highlighting belimumab’s potential for long-term management of cutaneous lupus erythematosus (CLE) and SLE. [8]

Entities / Keywords

Ianalumab (Novartis) • Sjögren’s disease • Aspaveli (Sobi) • C3G • IC-MPGN • VYVGART (argenx) • AChR-Ab seronegative generalized myasthenia gravis (gMG) • Amlitelimab (Sanofi) • OX40L • Atopic dermatitis • DELTA CARE 1 (LEO Pharma) • Delgocitinib • Lichen sclerosus • SIM0709 (Simcere) • TL1A • IL-23p19 • Boehringer Ingelheim • Belimumab (BLyS/BAFF) • Cutaneous lupus erythematosus (CLE) • Systemic lupus erythematosus (SLE).

References

[1] https://www.novartis.com/news/media-releases/novartis-ianalumab-receives-fda-breakthrough-therapy-designation-sjogrens-disease
[2] https://www.sobi.com/en/press-releases/sobi-receives-european-commission-approval-aspavelir-pegcetacoplan-treatment-c3g-and-primary-ic-mpgn-2418695
[3] https://www.pharmiweb.com/press-release/2026-01-14/argenx-announces-fda-acceptance-of-supplemental-biologics-license-application-with-priority-review-for-vyvgart-in-achr-ab-seronegative-gmg
[4] https://www.sanofi.com/en/media-room/press-releases/2026/2026-01-23-06-00-00-3224400
[5] https://www.biospace.com/press-releases/athos-therapeutics-receives-us-fda-authorization-to-begin-multi-center-phase-2-clinical-trial-of-ath-063-in-patients-with-ulcerative-colitis
[6] https://www.leo-pharma.com/media-center/news/2026-delgocitinib-ls-trial-initiation
[7] https://www.fiercebiotech.com/biotech/boehringer-pens-eu105b-deal-simceres-preclinical-ibd-bispecific
[8] https://www.dermatologytimes.com/view/long-term-real-world-data-show-cutaneous-benefits-of-belimumab