This week’s Immunology update highlights key advances including late-stage clinical readouts, regulatory pathway alignment, novel delivery technologies, and strategic partnerships. Developments span autoimmune and inflammatory diseases, with implications for treatment access, pipeline progression, and clinical practice.
In Today’s Newsletter
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In Today’s Newsletter
💊 Takeda taps Halozyme ENHANZE for vedolizumab [1] [08 Jan 2026]
https://www.takeda.com/newsroom/newsreleases/2026/collaboration-and-license/
Context: Vedolizumab (Entyvio) is IV and SC; ENHANZE enables rapid SC delivery.
Key point: Takeda gains exclusive ENHANZE rights for vedolizumab with upfront and milestone payments.
Implication: Signals pipeline investment and modality expansion.
🧪 Saphnelo SC meets Phase 3 efficacy in SLE (TULIP-SC) [2] [06 Jan 2026]
Context: Phase 3 SC anifrolumab vs placebo to Week 52.
Key point: Week 52 BICLA response was 56.2% vs 37.1% placebo; OCS tapering and remission signals observed.
Implication: May influence prescriber choice and payer reviews.
📊 ARN partners with Galvanic Health [3] [US • 12 Jan 2026]
Context: ARN adds analytics dashboards and KPIs.
Key point: Supports operational and financial performance.
Implication: Could streamline practice workflows and decision support.
🤖 J&J submits OTTAVA robotic system for De Novo classification [4] [US • 07 Jan 2026]
Context: Supported by IDE data in gastric-bypass surgery.
Key point: De Novo submission targeting upper-abdominal general surgery procedures.
Implication: Signals further expansion into robotic-assisted surgery.
🧬 FDA feedback supports BLA path for sonelokimab in HS [5] [08 Jan 2026]
https://www.dermatologytimes.com/view/fda-feedback-supports-bla-pathway-for-sonelokimab-in-hs
Context: Based on MIRA, VELA-1, and VELA-2 trials using HiSCR75.
Key point: FDA indicated existing data may support a BLA; VELA-2 remains informative for safety.
Implication: May influence regulatory timelines and payer expectations.
💸 Royalty Pharma funds Teva’s anti-IL-15 TEV-‘408 up to $500M [6] [11 Jan 2026]
Context: TEV-‘408 in early-stage vitiligo and celiac disease.
Key point: $75M for Phase 2b in 2026, plus $425M option for Phase 3.
Implication: Supports mid-stage development and modality expansion.
🧴 French early-access data back dupilumab in pediatric AD [7] [EU • 12 Jan 2026]
Context: Real-world early-access program for ages 6 months to 5 years.
Key point: Improvements in severity, itch, and QoL with safety consistent with trials.
Implication: Supports early-life use; observational limitations apply.
🌿 Legacy’s Cinainu cleared to Phase 3 in alopecia areata [8] [US • 07 Jan 2026]
Context: Topical botanical therapy; RAAINBOW-2 trial planned with ~500 patients.
Key point: IND clearance allows global Phase 3 across moderate–severe AA.
Implication: Adds a non-immunosuppressive option to AA pipeline.
🔬 10x + Brigham to map immune signatures in RA/SLE/GCA [9] [12 Jan 2026]
Context: Single-cell profiling in 1,000 patients.
Key point: Aims to map signatures of flare, remission, and treatment response.
Implication: Supports precision diagnostics and stratified care.
🧷 Candid plans multiple Phase 2s for TCEs in autoimmunity [10] [08 Jan 2026]
Context: BCMA and CD20 TCEs.
Key point: Early signals of deep B-cell/plasma-cell depletion with outpatient dosing.
Implication: Expands autoimmune TCE development.
Why it matters
- SC and patient-friendly delivery is expanding in I&I.
- Funding and BD deals accelerate mid-stage autoimmune assets.
- Real-world and single-cell datasets support precision care.
- Novel modalities widen options beyond JAKs and anti-TNFs.
- Robotic systems highlight adjacent tech influencing complex care pathways.
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FAQ
What did AstraZeneca report for Saphnelo SC in TULIP-SC?
A statistically significant Week 52 BICLA benefit vs placebo, with supportive steroid-sparing and remission findings, and safety consistent with IV anifrolumab [2].
How does the Takeda–Halozyme deal affect Entyvio?
Takeda obtained exclusive ENHANZE rights for vedolizumab, aiming for flexible SC delivery, with Halozyme receiving upfront, milestones, and royalties [1].
What is Johnson & Johnson seeking for OTTAVA?
A De Novo classification supported by IDE data in upper-abdominal surgery. The system is not yet marketed [4].
What is the regulatory path for sonelokimab in HS?
FDA feedback suggests existing MIRA/VELA data may support a BLA submission, with VELA-2 informing safety [5].
What are the terms of Royalty Pharma’s funding for TEV-‘408?
$75M for Phase 2b starting 2026, plus an option for $425M toward Phase 3 based on outcomes [6].
What did the French EAP show for pediatric dupilumab?
Real-world improvements in severity and QoL with safety consistent with trials; observational limits apply [7].
Entities / Keywords
Takeda; Halozyme; vedolizumab; Entyvio; ENHANZE; AstraZeneca; anifrolumab; Saphnelo; TULIP-SC; ARN; Galvanic Health; OTTAVA; MoonLake; sonelokimab; Royalty Pharma; Teva; TEV-408; Dupilumab; Legacy Healthcare; Cinainu; 10x Genomics; Brigham & Women’s; Candid Therapeutics.
References
- https://www.takeda.com/newsroom/newsreleases/2026/collaboration-and-license/
- https://www.astrazeneca.com/media-centre/press-releases/2026/saphnelo-self-administration-tulip-sc-trial-demonstrates-statistically-significant-clinically-meaningful-reduction-sle-disease-activity.html
- https://www.prnewswire.com/news-releases/american-rheumatology-and-galvanic-health-announce-strategic-partnership-to-empower-independent-rheumatology-practices-302658777.html
- https://www.jnj.com/media-center/press-releases/johnson-johnson-submits-ottava-robotic-surgical-system-to-the-u-s-food-and-drug-administration
- https://www.dermatologytimes.com/view/fda-feedback-supports-bla-pathway-for-sonelokimab-in-hs
- https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2026/Royalty-Pharma-and-Teva-Enter-Agreement-to-Accelerate-Development-of-Potential-Treatment-for-Vitiligo/default.aspx
- https://www.dermatologytimes.com/view/french-early-access-data-on-dupilumab-in-pediatric-atopic-dermatitis
- https://www.dermatologytimes.com/view/legacy-healthcare-receives-fda-clearance-to-advance-cinainu-to-phase-3-aa-clinical-trials
- https://www.prnewswire.com/news-releases/10x-genomics-launches-study-to-advance-research-in-blood-based-diagnostics-for-autoimmune-disease-302657874.html
- https://www.candidrx.com/candid-therapeutics-plans-to-initiate-multiple-phase-2-studies-following-promising-clinical-data-of-t-cell-engagers-in-autoimmune-diseases/