Immunology Today—November 5, 2025

Catch the latest immunology news, featuring industry updates, clinical progress, and biopharma innovations.

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🧠 Johnson & Johnson submits sBLA for STELARA® in pediatric ulcerative colitis [1] [US • 31 Oct 2025]

https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-application-to-u-s-fda-for-stelara-ustekinumab-in-the-treatment-of-pediatric-ulcerative-colitis
Context: STELARA® is being submitted for expanded approval in children aged 2+ with moderately to severely active ulcerative colitis, based on Phase 3 UNIFI Jr results.
Key point: The submission reflects the need for more treatment options in pediatric UC.
Implication: Potentially broadens STELARA®’s indication, addressing a significant unmet need in pediatric inflammatory bowel disease.

💊 AbbVie announces positive Phase 3 results for upadacitinib (RINVOQ®) in vitiligo [2] [US • 29 Oct 2025]

https://news.abbvie.com/2025-10-29-AbbVie-Announces-Positive-Topline-Results-from-Phase-3-Pivotal-Studies-Evaluating-Upadacitinib-RINVOQ-R-in-Adults-and-Adolescents-with-Vitiligo
Context: Upadacitinib achieved significant improvements in vitiligo patients, with positive results in both co-primary endpoints of T-VASI 50 and F-VASI 75.
Key point: This represents a milestone as no systemic therapies have been approved for vitiligo re-pigmentation.
Implication: Could change treatment paradigms in vitiligo, offering a first systemic therapy for this autoimmune skin disorder.

🤝 Novartis reports Phase III ianalumab results in Sjögren’s disease [3] [EU • 29 Oct 2025]

https://www.novartis.com/news/media-releases/novartis-ianalumab-first-drug-reduce-disease-activity-and-patient-burden-sjogrens-disease-phase-iii-trials
Context: Ianalumab showed consistent improvements in disease activity and patient-reported outcomes in Sjögren’s disease.
Key point: The drug met the primary endpoint, offering a potentially first targeted treatment for this complex autoimmune disease.
Implication: Could become the first approved treatment for Sjögren’s disease, a condition with significant unmet medical needs.

🧬 Boehringer Ingelheim licenses Kyowa Kirin’s autoimmune small molecule program [4] [EU • 30 Oct 2025]

https://www.boehringer-ingelheim.com/science-innovation/human-health-innovation/boehringer-licenses-autoimmune-disease-small-molecule-program
Context: Boehringer Ingelheim secures exclusive rights to develop a small molecule for autoimmune diseases.
Key point: This new program adds to Boehringer’s autoimmune pipeline and aims to address critical gaps in autoimmune disease treatments.
Implication: Expansion into small molecule treatments may diversify Boehringer’s autoimmune portfolio.

🔬 Roche’s Gazyva/Gazyvaro shows positive Phase III results in SLE [5] [EU • 3 Nov 2025]

https://www.roche.com/media/releases/med-cor-2025-11-03
Context: Gazyva/Gazyvaro demonstrated a significant reduction in disease activity in SLE patients, including a favorable impact on multiple key secondary endpoints.
Key point: It may become the first anti-CD20 therapy for SLE, targeting B cells involved in disease inflammation.
Implication: If approved, Gazyva/Gazyvaro could become a new standard of care for SLE, a chronic and debilitating autoimmune disease.

🧪 Neutrolis presents proof-of-concept data for DNASE1L3 in autoimmune diseases [6] [US • 29 Oct 2025]

https://www.globenewswire.com/news-release/2025/10/29/3176704/0/en/Neutrolis-Presented-First-in-Human-Proof-of-Concept-Data-Validating-DNASE1L3-Mediated-Neutrophil-Extracellular-Trap-NET-Clearance-as-a-Therapeutic-Approach-in-Autoimmunity-at-Ameri.html
Context: Neutrolis demonstrated that its DNASE1L3 analogue significantly improves multi-organ function by clearing NETs in systemic lupus erythematosus (SLE).
Key point: This new therapeutic approach could be a non-immunosuppressive option for autoimmune diseases.
Implication: The technology offers an innovative pathway for treating autoimmune disorders with fewer side effects than traditional therapies.

🧬 Sonoma Biotherapeutics shows promising Phase 1 data for SBT-77-7101 in RA [7] [US • 29 Oct 2025]

https://www.businesswire.com/news/home/20251029046316/en/Sonoma-Biotherapeutics-Announces-Positive-Interim-Safety-and-Efficacy-Data-from-Phase-1-REGULATE-RA-Study-of-SBT-77-7101-in-Refractory-Rheumatoid-Arthritis
Context: SBT-77-7101, an engineered Treg therapy, showed promising safety and efficacy in refractory rheumatoid arthritis (RA) patients, including significant reductions in joint counts.
Key point: No dose-limiting toxicities observed, and significant clinical improvement was noted in many patients.
Implication: Could provide a new, durable, targeted therapy for patients with treatment-resistant RA.

💥 Neurocrine pens $880M deal with TransThera for NLRP3 inhibitors [8] [China/US • 3 Nov 2025]

https://www.fiercebiotech.com/biotech/neurocrine-pens-880m-deal-chinas-transthera-red-hot-immunology-target?itm_source=parsely-api
Context: Neurocrine Biosciences secures exclusive rights to NLRP3 inhibitors for multiple diseases, targeting an inflammation pathway linked to various chronic conditions.
Key point: NLRP3 inhibitors are seen as a promising new class of drugs to tackle inflammation-driven diseases like cardiovascular disease and neurodegenerative conditions.
Implication: This deal strengthens Neurocrine’s immunology pipeline and could lead to new treatments for a range of conditions.

💡 Arcutis launches roflumilast cream for pediatric atopic dermatitis [9] [US • 30 Oct 2025]

https://www.dermatologytimes.com/view/roflumilast-cream-0-05-now-commercially-available-for-pediatric-atopic-dermatitis
Context: Roflumilast cream 0.05% is now available in the US for pediatric patients with mild to moderate atopic dermatitis.
Key point: This steroid-free, once-daily cream shows significant efficacy and safety, with improvements in eczema severity and itch.
Implication: Provides a new, non-steroidal treatment option for young children with atopic dermatitis.

Why it Matters

STELARA®’s pediatric UC expansion [1]: The filing for pediatric ulcerative colitis could provide a much-needed treatment for younger patients with inflammatory bowel disease.
Upadacitinib in vitiligo [2]: AbbVie’s Phase 3 success marks a major milestone for vitiligo treatment, offering a systemic option for re-pigmentation.
Ianalumab for Sjögren’s [3]: Could become the first targeted therapy for Sjögren’s disease, addressing an unmet need in autoimmune heumatology.
Gazyva/Gazyvaro in SLE [5]: These positive results position Gazyva/Gazyvaro as a potentially transformative therapy for SLE, a severe and chronic autoimmune condition.
Neutrolis and DNASE1L3 in autoimmune diseases [6]: Offers a novel mechanism for treating autoimmune diseases, potentially without the drawbacks of traditional immunosuppressive drugs.
Treg therapy for RA [7]: Sonoma’s engineered Treg therapy shows promise in treating refractory RA, with a favorable safety profile and signs of durability.
NLRP3 inhibitors for inflammation [8]: Neurocrine’s deal with TransThera represents a significant investment in inflammation-related diseases, with applications across multiple therapeutic areas.
Roflumilast for pediatric AD [9]: A new steroid-free treatment offers improved control of atopic dermatitis in young children, with a favorable safety profile.

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FAQ

What did Johnson & Johnson submit to the FDA for STELARA®?

They submitted a supplemental Biologics License Application (sBLA) for STELARA® to treat pediatric ulcerative colitis, supported by Phase 3 data from the UNIFI Jr trial [1].

What results did AbbVie announce for upadacitinib in vitiligo?

Upadacitinib achieved the co-primary endpoints of significant improvements in T-VASI 50 and F-VASI 75 scores in Phase 3 studies, marking a potential breakthrough in vitiligo treatment [2].

What is ianalumab’s potential in treating Sjögren’s disease?

Ianalumab showed significant improvement in disease activity in Phase 3 trials and could become the first targeted therapy for Sjögren’s disease, a condition with no current targeted treatments [3].

How does Gazyva/Gazyvaro perform in SLE?

Gazyva/Gazyvaro showed significant improvement in disease activity and met all key secondary endpoints in Phase III trials for systemic lupus erythematosus [5].

What is the significance of Neutrolis’ DNASE1L3 therapy?

Neutrolis presented positive first-in-human data showing that DNASE1L3 clears neutrophil extracellular traps (NETs), offering a novel approach to treating autoimmune diseases like lupus and rheumatoid arthritis [6].

What early data did Sonoma Biotherapeutics report for SBT-77-7101?

Sonoma’s engineered Treg therapy showed promising safety and efficacy in refractory rheumatoid arthritis patients, with significant reductions in disease activity [7].

What is Neurocrine’s deal with TransThera about?

Neurocrine secured the rights to develop NLRP3 inhibitors from TransThera for multiple inflammation-related diseases, potentially offering new treatments for conditions like cardiovascular disease and neurodegeneration [8].

What is the new pediatric atopic dermatitis treatment from Arcutis?

Arcutis launched roflumilast cream 0.05% for children aged 2-5 with mild to moderate atopic dermatitis, offering a steroid-free treatment with significant clinical benefits [9].

Entities / Keywords

Johnson & Johnson; STELARA®; pediatric ulcerative colitis
AbbVie; upadacitinib; RINVOQ®; vitiligo
Novartis; ianalumab; Sjögren’s disease
Boehringer Ingelheim; Kyowa Kirin; autoimmune disease; small molecule
Roche; Gazyva/Gazyvaro; systemic lupus erythematosus
Neutrolis; DNASE1L3; autoimmune diseases; NETs
Sonoma Biotherapeutics; SBT-77-7101; rheumatoid arthritis
Neurocrine; NLRP3 inhibitors; inflammation
Arcutis; roflumilast cream; pediatric atopic dermatitis