Immunology Today—November 26, 2025

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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🧴 Dupixent EU approval for chronic spontaneous urticaria [1] [EU • 25 Nov 2025]

https://www.sanofi.com/en/media-room/press-releases/2025/2025-11-25-06-00-00-3194015

Context: LIBERTY-CUPID Phase 3 program assessed add-on dupilumab vs antihistamines alone at 24 weeks in patients 12+ naïve to anti-IgE.

Key point: European Commission approved Dupixent for moderate-to-severe CSU with inadequate H1-antihistamine response and anti-IgE-naïve status, first targeted EU option in over a decade.

Implication: Introduces competition that may affect pricing and formulary access.

🤖 Parakeet Health adds Aegis Medical Group and Schweiger Dermatology [2] [US • 19 Nov 2025]

https://www.prnewswire.com/news-releases/schweiger-dermatology-and-aegis-medical-group-transform-patient-engagement-with-generative-ai-platform-from-parakeet-health-302619406.html

Context: Generative AI voice agents for scheduling, referrals, billing, outreach, multilingual, across 7,900+ providers.

Key point: Partnerships reported increased bookings at Schweiger vs prior system, with higher conversion per outreach.

Implication: Could streamline initiation and adherence via remote prescribing and logistics.

🫀 Endoscopic gallbladder stone removal post EUS-GBD in high-risk elderly (Korea) [3] [20 Nov 2025]

https://www.koreabiomed.com/news/articleViewAmp.html?idxno=29688

Context: Single-center study, 43 high-risk acute calculous cholecystitis patients, Dec 2024–Jul 2025; stones cleared via endoscope through metal stents 4–6 weeks after EUS-GBD.

Key point: Reported complete removal in most patients and low recurrence, suggesting a surgery alternative in high-risk elderly.

Implication: Could inform practice and payer discussions, interpretation depends on study design and confounding control.

🧬 AGA: start advanced drugs early in Crohn’s disease [4] [US • 20 Nov 2025]

https://www.upi.com/Health_News/2025/11/20/Crohns-disease-guidelines-advanced-drugs/6871763649786/

Context: Updated AGA guidelines published in Gastroenterology recommend against step-up for moderate-to-severe disease.

Key point: Recommends first-line use of biologics and targeted agents, with thiopurines not favored for induction.

Implication: May influence prescriber choice and payer reviews pending full data.

🧪 EULAR debuts EAPSDAS disease activity score for APS [5] [EU • 19 Nov 2025]

https://www.news-medical.net/news/20251119/EULAR-develops-new-disease-activity-score-for-antiphospholipid-syndrome.aspx

Context: Task force defined TMN and obstetric scales from consensus items; initial validation completed, prospective studies pending.

Key point: New scale aims to quantify APS disease activity, distinct from severity, for trials and routine monitoring.

Implication: Could inform practice and payer discussions, interpretation depends on study design and confounding control.

💊 Biogen–Dayra macrocyclic peptide collaboration [6] [US • 24 Nov 2025]

https://investors.biogen.com/news-releases/news-release-details/biogen-and-dayra-therapeutics-announce-research-collaboration

Context: Research deal to discover oral macrocyclic peptides for immunology targets; Dayra receives $50M upfront, option and milestones per program.

Key point: Modality seeks biologic-like efficacy and safety in oral format, broadening Biogen’s early immunology pipeline.

Implication: Signals pipeline investment and modality expansion.

🧠 KIIT-DU and Sun Pharma Science Foundation symposium on autoimmunity [7] [19 Nov 2025]

https://news.kiit.ac.in/kiitnews/kiit-du-sun-pharma-science-foundation-organize-national-symposium-on-autoimmunity-and-autoimmune-diseases/

Context: One-day India event gathered 250+ experts, with sessions on IBD metabolism, SLE heterogeneity, vasculitis targeting, NF-κB, CAR-T for autoimmunity, gut–brain axis.

Key point: Academic–industry forum highlighted emerging mechanisms and targeted therapies across autoimmune conditions.

Implication: May expand screening, initiation, and follow-up at scale.

Why it matters

EU CSU approval adds a new targeted option where antihistamines fall short, potentially shifting EU care pathways.
Early-use biologics guidance in Crohn’s may pressure US payers to align coverage with evidence-based starts.
Minimally invasive gallbladder strategies could reduce surgical burden in aging, high-risk populations.
Oral macrocycles, if successful, could blur lines between small molecules and biologics in immunology.
Standardized APS activity scoring can improve trial comparability and real-world monitoring.

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FAQ

What makes Dupixent’s CSU approval notable in the EU?

It is the first targeted CSU medicine approved in the EU in over a decade, for patients 12+ uncontrolled on H1-antihistamines and naïve to anti-IgE, backed by Phase 3 data at 24 weeks [1].

Which agents does the AGA now favor first-line in moderate-to-severe Crohn’s?

The guideline recommends starting with advanced agents including multiple monoclonal antibodies and upadacitinib, moving away from step-up; thiopurines are not favored for induction [4].

How strong is the evidence for endoscopic gallbladder stone removal after EUS-GBD?

It is a single-center study with high clearance and low recurrence in 43 high-risk patients, suggesting feasibility but requiring broader validation [3].

What is EAPSDAS and how is it used in APS?

EAPSDAS is a disease activity score with separate TMN and obstetric scales to track APS activity over time; it has initial validation and awaits prospective studies [5].

What is the strategic aim of Biogen’s deal with Dayra?

To add oral macrocyclic peptides as a modality that could deliver biologic-like effects orally, expanding Biogen’s early immunology pipeline, with $50M upfront to Dayra [6].

How did Parakeet Health demonstrate impact with new partners?

Schweiger Dermatology reported more than double bookings and higher conversion vs its prior system after deploying Parakeet’s AI engagement platform [2].

Entities / Keywords

Dupixent, dupilumab; Sanofi, Regeneron; chronic spontaneous urticaria, CSU; Aegis Medical Group; Schweiger Dermatology; Parakeet Health; EUS-GBD; endoscopic gallbladder stone removal; AGA guidelines; Crohn’s disease; biologics; upadacitinib; EULAR; EAPSDAS; antiphospholipid syndrome, APS; Biogen; Dayra Therapeutics; macrocyclic peptides; KIIT-DU; Sun Pharma Science Foundation.