Immunology Today—June 17, 2026

This week’s Immunology update highlights regulatory progress, late-stage clinical data, pediatric filing activity, emerging immune-targeted therapies, and expanded treatment access across inflammatory and dermatologic diseases.

In Today’s Newsletter

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💊 Ultomiris Priority Review in IgA nephropathy [1] [US • 15 Jun 2026]

https://www.astrazeneca.com/media-centre/press-releases/2026/ultomiris-granted-priority-review-in-the-us-as-treatment-for-adults-with-immunoglobulin-a-nephropathy.html
Context: AstraZeneca’s Alexion filed an sBLA for Ultomiris (ravulizumab), a C5 complement inhibitor, in adult IgA nephropathy.
Key point: FDA granted Priority Review based on I CAN Phase 3 interim data showing reduced proteinuria versus placebo at week 34.
Implication: May influence prescriber choice and payer reviews pending full data.

🧬 Tecentriq Priority Review in stage III dMMR/MSI-H colon cancer [2] [US • 11 Jun 2026]

https://www.roche.com/media/releases/med-cor-2026-06-11
Context: Roche submitted Tecentriq (atezolizumab) plus chemotherapy for adjuvant stage III dMMR/MSI-H colon cancer after surgery.
Key point: FDA granted Priority Review, with a decision expected by 09 Oct 2026, based on the Alliance ATOMIC Phase 3 study.
Implication: May influence prescriber choice and payer reviews pending full data.

🧒 Entyvio IV pediatric IBD filing accepted [3] [US • 09 Jun 2026]

https://www.takeda.com/newsroom/newsreleases/2026/application-intravenous-entyvio-pediatric/
Context: Takeda filed Entyvio IV (vedolizumab) for moderately to severely active ulcerative colitis and Crohn’s disease in patients aged 2 years and older.
Key point: FDA accepted the sBLA, with a PDUFA goal date in Q1 2027.
Implication: May expand screening, initiation, and follow-up at scale.

🧴 Zasocitinib beats deucravacitinib in plaque psoriasis [4] [11 Jun 2026]

https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-outperforms-deucravacitinib-study/
Context: Takeda compared zasocitinib (TAK-279), an oral TYK2 inhibitor, with deucravacitinib in the Phase 3 LATITUDE Atlas study.
Key point: Zasocitinib showed statistical superiority on PASI 100 at week 16 and all key secondary endpoints.
Implication: May influence prescriber choice and payer reviews pending full data.

🧫 Celldex CDX-622 Phase 1 mast cell data [5] [Türkiye • 14 Jun 2026]

https://ir.celldex.com/news-releases/news-release-details/celldex-presents-positive-first-human-results-phase-1-study
Context: Celldex presented first-in-human Phase 1 data for CDX-622, a bispecific antibody targeting soluble SCF and TSLP, at EAACI in Istanbul.
Key point: CDX-622 showed rapid, dose-dependent, durable serum tryptase reductions and was well tolerated at all dose levels.
Implication: Signals pipeline investment and modality expansion.

🌿 Novartis Rhapsido Phase 3 CIndU data [6] [12 Jun 2026]

https://www.globenewswire.com/news-release/2026/06/12/3310932/0/en/novartis-remind-data-at-eaaci-show-rhapsido-potential-as-first-targeted-therapy-for-chronic-inducible-urticaria-cindu.html
Context: Novartis presented RemIND Phase 3 data for Rhapsido (remibrutinib) in chronic inducible urticaria subtypes.
Key point: Rhapsido met primary endpoints across symptomatic dermographism, cold urticaria, and cholinergic urticaria.
Implication: May influence prescriber choice and payer reviews pending full data.

💉 Lilly EBGLYSS every-8-week dosing approved [7] [US • 09 Jun 2026]

https://www.prnewswire.com/news-releases/fda-approves-lillys-ebglyss-lebrikizumab-lbkz-for-one-maintenance-dose-every-eight-weeks-in-patients-with-moderate-to-severe-atopic-dermatitis-302795876.html
Context: Eli Lilly’s EBGLYSS (lebrikizumab-lbkz) is used in adults and children aged 12 years and older with moderate-to-severe atopic dermatitis.
Key point: FDA approved a maintenance regimen of one 250 mg injection every eight weeks, supported by modeling and ADjoin extension data.
Implication: Could streamline initiation and adherence via remote prescribing and logistics.

🧴 Glenmark launches Winlevi in European acne markets [8] [Europe • 11 Jun 2026]

https://glenmark.b-cdn.net/gpl_pdfs
Context: Glenmark launched Winlevi (clascoterone 10 mg/g cream) across key European markets for acne vulgaris.
Key point: The launch follows European Commission authorization to Cassiopea and includes direct and partner-led market entries.
Implication: Introduces competition that may affect pricing and formulary access.

Why it matters

Regulatory momentum is concentrated in immunology, oncology, nephrology, and dermatology, with multiple FDA Priority Review or filing milestones. [1,2,3]
Head-to-head evidence is becoming more prominent in crowded inflammatory disease markets. [4]
Mast cell, TSLP, BTK, TYK2, IL-13, and complement pathways remain central to next-wave immune-mediated disease development. [1,4,5,6,7]
Dermatology launches are shifting toward lower treatment burden, differentiated mechanisms, and regional access expansion. [7,8]

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FAQ

What is the FDA reviewing for Ultomiris in IgA nephropathy?

FDA accepted and granted Priority Review to AstraZeneca’s Alexion sBLA for Ultomiris in adults with IgA nephropathy. The review is based on I CAN Phase 3 interim proteinuria data, with eGFR follow-up continuing. [1]

What did Roche report for Tecentriq in stage III dMMR/MSI-H colon cancer?

Roche said FDA granted Priority Review to Tecentriq plus chemotherapy after surgery. The filing is based on the ATOMIC Phase 3 study in stage III dMMR colon cancer. [2]

Which pediatric IBD indication did Takeda file for Entyvio IV?

Takeda filed Entyvio IV for moderately to severely active ulcerative colitis and Crohn’s disease in pediatric patients aged 2 years and older. FDA set a Q1 2027 PDUFA goal date. [3]

How did zasocitinib compare with deucravacitinib?

Takeda reported that zasocitinib was statistically superior to deucravacitinib in the Phase 3 LATITUDE Atlas plaque psoriasis study. The primary endpoint was PASI 100 at week 16. [4]

What is CDX-622 designed to do?

Celldex’s CDX-622 is a bispecific antibody targeting soluble SCF and TSLP. Phase 1 data showed serum tryptase reductions, a marker consistent with mast cell depletion. [5]

What changed for Lilly’s EBGLYSS dosing?

FDA approved EBGLYSS maintenance dosing every eight weeks for eligible patients with moderate-to-severe atopic dermatitis. Lilly said this allows as few as six maintenance injections per year. [7]

Entities / Keywords

Ultomiris, ravulizumab, AstraZeneca, Alexion, IgA nephropathy, IgAN, C5 complement inhibitor, I CAN Phase 3
Tecentriq, atezolizumab, Tecentriq Hybreza, Roche, stage III colon cancer, dMMR, MSI-H, ATOMIC, FOLFOX6
Entyvio, vedolizumab, Takeda, pediatric ulcerative colitis, pediatric Crohn’s disease, IBD, KEPLER, WEBB
Zasocitinib, TAK-279, Takeda, TYK2 inhibitor, deucravacitinib, plaque psoriasis, LATITUDE Atlas, PASI 100
CDX-622, Celldex, soluble SCF, TSLP, mast cells, serum tryptase, EAACI
Rhapsido, remibrutinib, Novartis, chronic inducible urticaria, CIndU, symptomatic dermographism, cold urticaria, cholinergic urticaria, RemIND
EBGLYSS, lebrikizumab-lbkz, Eli Lilly, atopic dermatitis, IL-13, ADjoin, every-8-week maintenance dosing
Winlevi, clascoterone, Glenmark, Cassiopea, Cosmo, acne vulgaris, topical androgen-receptor inhibitor, Europe