Immunology Today—November 12, 2025

LucidQuest

6 days ago

This week’s immunology update spotlights key developments, regulatory milestones, and the latest progress shaping the biopharma landscape.

In Today’s Newsletter

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🧠 Sanofi & Regeneron submit Dupixent for FDA priority review in AFRS [1] [US • 7 Nov 2025]

https://www.sanofi.com/en/media-room/press-releases/2025/2025-11-07-13-00-00-3183599
Context: Sanofi & Regeneron’s Dupixent shows positive Phase 3 results in allergic fungal rhinosinusitis (AFRS), with a new submission for FDA approval.
Key point: If approved, Dupixent will be the first and only medicine specifically for AFRS.
Implication: Potential breakthrough for treating AFRS, an autoimmune disease with limited current options.

💊 Otsuka’s sibeprenlimab shows promise in IgA nephropathy [2] [US • 10 Nov 2025]

https://www.otsuka.co.jp/en/company/newsreleases/2025/20251110_1.html
Context: Sibeprenlimab shows a 54.3% placebo-adjusted reduction in proteinuria at 12 months in the Phase 3 VISIONARY trial.
Key point: FDA priority review granted for BLA submission.
Implication: A potential first-line therapy for IgA nephropathy, offering new hope for kidney disease patients.

🔬 Takeda’s mezagitamab shows sustained kidney function in IgA nephropathy [3] [Japan/US • 7 Nov 2025]

https://www.takeda.com/newsroom/newsreleases/2025/new-data-mezagitamab/

Context: Takeda’s mezagitamab maintains stable kidney function 18 months post-treatment in IgA nephropathy.
Key point: Data shows sustained proteinuria reduction and no serious adverse events.
Implication: A promising option for patients with IgA nephropathy, a disease with limited treatment options.

🌐 Pfizer showcases leading dermatology treatments at CIIE [4] [China • 10 Nov 2025]

https://global.chinadaily.com.cn/a/202511/10/WS69119d9ea310fc20369a43c3.html
Context: Pfizer highlights Cibinqo, Staquis, and Litfulo for skin diseases at the China International Import Expo.
Key point: The company focuses on JAK inhibitors for treating autoimmune skin conditions like atopic dermatitis and alopecia areata.
Implication: Pfizer is at the forefront of dermatology innovation, with new treatments for inflammatory skin diseases.

💡 Accipiter Biosciences announces $12.7M seed funding [5] [US • 6 Nov 2025]

https://www.globenewswire.com/news-release/2025/11/06/3182363/0/en/Accipiter-Biosciences-Emerges-from-Stealth-with-12-7-Million-in-Seed-Financing-to-Deliver-de-novo-Protein-Therapies-for-Complex-Diseases.html
Context: Accipiter develops de novo biologics for complex diseases and secures $12.7M to advance immunology and oncology programs.
Key point: The funding supports the development of multifunctional biologics to treat autoimmune and cancer-related diseases.
Implication: Accipter’s unique biologics technology could transform drug development by creating more effective and targeted treatments.

🔍 UK approves Delgocitinib for chronic hand eczema (CHE) [6] [UK • 5 Nov 2025]

https://www.dermatologytimes.com/view/uk-clinicians-gain-first-nice-approved-che-jak-inhibitor
Context: NICE recommends delgocitinib as the first topical pan-JAK inhibitor for moderate-to-severe chronic hand eczema (CHE).
Key point: Delgocitinib is shown to improve CHE severity and reduce symptoms, offering a steroid-free treatment option.
Implication: This approval represents a significant advancement in treating CHE, a common yet difficult-to-manage skin condition.

🩺 FDA approves linaclotide for pediatric IBS-C [7] [US • 5 Nov 2025]

https://www.medpagetoday.com/gastroenterology/irritablebowelsyndrome/118331
Context: The FDA approves linaclotide (Linzess) for treating irritable bowel syndrome with constipation (IBS-C) in children 7+.
Key point: This makes linaclotide the first approved treatment for IBS-C in pediatric patients.
Implication: A major milestone in treating pediatric IBS-C, improving outcomes for children suffering from this chronic gastrointestinal condition.

⚖️ South Korea faces rheumatologist shortage [8] [South Korea • 10 Nov 2025]

https://www.koreabiomed.com/news/articleView.html?idxno=29552
Context: South Korea experiences a growing shortage of rheumatologists, especially in regional areas, putting patient care at risk.
Key point: The imbalance in specialist distribution threatens access to care for patients with complex autoimmune diseases.
Implication: Urgent policy changes are needed to ensure adequate rheumatology care across the country.

🧪 AnaptysBio reports Phase 2 failure for rosnilimab in ulcerative colitis [9] [US • 10 Nov 2025]

https://ir.anaptysbio.com/news-releases/news-release-details/anaptys-announces-phase-2-trial-rosnilimab-did-not-meet-primary
Context: AnaptysBio announces that rosnilimab did not meet efficacy endpoints in moderate-to-severe ulcerative colitis in Phase 2 trials.
Key point: The trial will be discontinued, but development for rheumatoid arthritis continues.
Implication: Despite the setback in ulcerative colitis, rosnilimab may still have potential in other indications.

🧬 PDS Biotechnology presents promising data at SITC 2025 [10] [US • 10 Nov 2025]

https://www.globenewswire.com/news-release/2025/11/10/3184578/37149/en/pds-biotechnology-announces-translational-data-showing-strong-immunological-and-clinical-activity-of-pds0101-and-pds01adc-presented-at-sitc-2025.html
Context: PDS Biotechnology presents strong clinical and immunological data on its therapies PDS0101 and PDS01ADC for HPV-positive cancers.
Key point: Translational data suggest robust immune activation and clinical benefit in advanced cancers.
Implication: PDS0101 and PDS01ADC could become key immunotherapies for hard-to-treat cancers.

💥 AstraZeneca’s FASENRA shows efficacy in HES [US • 10 Nov 2025]

https://www.biospace.com/press-releases/statistically-significant-natron-phase-iii-trial-results-for-hypereosinophilic-syndrome-show-fasenra-delayed-time-to-first-flare-or-worsening-of-disease
Context: AstraZeneca’s FASENRA demonstrates significant results in a Phase III trial for hypereosinophilic syndrome (HES), delaying disease flare-ups.
Key point: FASENRA significantly reduced the risk of flare-ups and improved fatigue in HES patients.
Implication: This data supports FASENRA’s potential as a new treatment for HES, a rare eosinophilic disorder.

Why it Matters

Dupixent for AFRS: Dupixent could be the first approved treatment for AFRS, addressing a significant unmet need in chronic rhinosinusitis with fungal hypersensitivity [1].
Sibeprenlimab in IgA nephropathy: Otsuka’s sibeprenlimab shows promise for IgA nephropathy, with the potential to slow kidney disease progression [2].
Mezagitamab for IgA nephropathy: Takeda’s mezagitamab offers hope for managing kidney function and reducing proteinuria in IgA nephropathy [3].
Pfizer’s dermatology innovations: Pfizer’s JAK inhibitors could reshape the treatment landscape for inflammatory skin diseases [4].
Accipiter Biosciences’ de novo biologics: Accipiter’s unique platform could lead to breakthroughs in treating complex diseases like cancer and autoimmune disorders [5].
Delgocitinib for CHE: NICE approval for delgocitinib provides a new, non-steroidal option for patients with chronic hand eczema [6].
Linaclotide for pediatric IBS-C: Linaclotide’s approval in children offers a much-needed treatment option for pediatric IBS-C [7].
Rheumatologist shortage in Korea: The growing shortage of rheumatologists in South Korea poses a serious challenge to patient care, especially in rural areas [8].
AnaptysBio’s trial setback: While rosnilimab did not meet Phase 2 endpoints in ulcerative colitis, the company is shifting focus to rheumatoid arthritis [9].
PDS Biotechnology’s immunotherapies: PDS0101 and PDS01ADC show strong immune activation and clinical benefit in advanced cancers [10].
FASENRA for HES: AstraZeneca’s FASENRA could offer a new treatment for hypereosinophilic syndrome, improving patient quality of life [11].

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FAQ

What did Sanofi & Regeneron submit to the FDA for Dupixent?

They submitted a supplemental Biologics License Application (sBLA) for Dupixent to treat allergic fungal rhinosinusitis (AFRS) in adults and children aged 6 and older [1].

What is sibeprenlimab’s role in treating IgA nephropathy?

Sibeprenlimab showed a 54.3% placebo-adjusted reduction in proteinuria in Phase 3 trials, providing potential for the treatment of IgA nephropathy [2].

How effective is Takeda’s mezagitamab for IgA nephropathy?

Mezagitamab showed stable kidney function and significant reductions in proteinuria through 18 months in Phase 1b trials for IgA nephropathy [3].

What is Pfizer’s focus at CIIE?

Pfizer presented its JAK inhibitors, including Cibinqo, Staquis, and Litfulo, for the treatment of atopic dermatitis and alopecia areata at CIIE [4].

What is Accipiter Biosciences developing?

Accipiter is developing de novo biologics for complex diseases, including immunology and oncology, using a computational platform to design multifunctional proteins [5].

How did NICE approve delgocitinib for CHE?

NICE recommended delgocitinib cream for moderate-to-severe chronic hand eczema, marking it as the first topical pan-JAK inhibitor for this indication [6].

What did AnaptysBio report about rosnilimab in ulcerative colitis?

Rosnilimab did not meet efficacy endpoints in Phase 2 trials for ulcerative colitis and the trial will be discontinued [9].

What is PDS Biotechnology’s new data on immunotherapies?

PDS Biotechnology presented promising data for its HPV-targeted immunotherapy PDS0101 and its novel PDS01ADC, showing strong clinical activity in cancer [10].

What were AstraZeneca’s results for FASENRA in HES?

FASENRA showed significant delay in disease flare-ups and improved fatigue in a Phase III trial for hypereosinophilic syndrome [11].

Entities / Keywords

Sanofi; Regeneron; Dupixent; allergic fungal rhinosinusitis
Otsuka; sibeprenlimab; immunoglobulin A nephropathy
Takeda; mezagitamab; IgA nephropathy
Pfizer; dermatology; Cibinqo; Staquis; Litfulo
Accipiter Biosciences; de novo biologics; autoimmune diseases
AnaptysBio; rosnilimab; ulcerative colitis
PDS Biotechnology; PDS0101; PDS01ADC; cancer
AstraZeneca; FASENRA; hypereosinophilic syndrome