Immunology Today—July 1, 2026

This week’s Immunology update highlights regulatory decisions, clinical trial progress, expanded treatment access, pediatric label expansions, and advances across immune-mediated diseases.

In Today’s Newsletter

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💊 Wayrilz approved in Japan for immune thrombocytopenia [1] [Japan • 23 Jun 2026]

https://www.sanofi.com/en/media-room/press-releases/2026/2026-06-23-05-15-00-3315701
Context: Wayrilz (Sanofi; rilzabrutinib) is an oral reversible BTK inhibitor for persistent or chronic immune thrombocytopenia.
Key point: Japan’s MHLW granted marketing and manufacturing authorization based on LUNA 3 Phase 3 data.
Implication: May influence prescriber choice and payer reviews pending full data.

⚠️ Sobi receives FDA CRL for NASP in uncontrolled gout [2] [US • 26 Jun 2026]

https://www.sobi.com/en/press-releases/sobi-receives-complete-response-letter-fda-nasp-nanoencapsulated-sirolimus-plus-pegadricase-2465072
Context: NASP (Sobi; nanoencapsulated sirolimus plus pegadricase) is under FDA review for adult uncontrolled gout.
Key point: FDA requested mainly CMC and contract manufacturing facility data, with no clinical safety or efficacy concerns affecting approvability.
Implication: Introduces competition that may affect pricing and formulary access.

🧬 Agomab outlines NOV-ERA Phase 2b design for ontunisertib [3] [Global • 23 Jun 2026]

https://agomab.com/wp-content/uploads/2026/06/20260623-Ontunisertib-Ph2b-study-design_FINAL.pdf
Context: Ontunisertib (Agomab; oral GI-restricted ALK5/TGF-β RI inhibitor) is being developed for fibrostenosing Crohn’s disease.
Key point: Agomab aligned with FDA on key NOV-ERA Phase 2b elements, including endoscopic passability at Week 24 as the primary endpoint.
Implication: May influence prescriber choice and payer reviews pending full data.

🇰🇷 Tremfya gains reimbursed IBD use in Korea [4] [Korea • 30 Jun 2026]

https://www.koreabiomed.com/news/articleView.html?idxno=32248
Context: Tremfya (Johnson & Johnson; guselkumab) is an IL-23 p19 inhibitor approved in Korea for Crohn’s disease and ulcerative colitis.
Key point: Korea reimbursement took effect on 01 Jun 2026 for eligible moderate-to-severe active Crohn’s disease or ulcerative colitis patients.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧫 Palisade Bio clears FDA IND for PALI-2108 Phase 2 UC study [5] [US • 29 Jun 2026]

https://www.globenewswire.com/news-release/2026/06/29/3318948/0/en/palisade-bio-receives-fda-clearance-of-ind-for-pali-2108-and-plans-to-initiate-global-phase-2-ascentra-uc-study-in-ulcerative-colitis.html
Context: PALI-2108 (Palisade Bio; oral PDE4 inhibitor prodrug) is planned for moderately to severely active ulcerative colitis.
Key point: FDA cleared the IND for ASCENTRA-UC, a Phase 2 trial expected to enroll about 204 patients in North America and Europe.
Implication: May influence prescriber choice and payer reviews pending full data.

🔌 SetPoint System treats first North Carolina RA patient [6] [US • 29 Jun 2026]

https://www.biospace.com/press-releases/arthritis-osteoporosis-consultants-of-the-carolinas-treats-first-patient-in-north-carolina-with-the-setpoint-system-a-device-based-treatment-for-rheumatoid-arthritis
Context: SetPoint System (SetPoint Medical) is an FDA-approved vagus nerve-mediated neuroimmune modulation therapy for rheumatoid arthritis.
Key point: Arthritis & Osteoporosis Consultants of the Carolinas completed the first SetPoint System procedure in North Carolina.
Implication: May expand screening, initiation, and follow-up at scale.

🧪 Biohaven starts pivotal Phase 3 BHV-1300 trial in Graves’ disease [7] [29 Jun 2026]

https://www.prnewswire.com/news-releases/biohaven-advances-a-new-class-of-precision-immunology-therapies-first-mode-extracellular-protein-degrader-bhv-1300-begins-phase-3-pivotal-trial-in-graves-disease-302812720.html
Context: BHV-1300 (Biohaven; MoDE extracellular protein degrader) targets the TSHR-IgG1 autoantibody in Graves’ disease.
Key point: Biohaven enrolled the first patient in a pivotal Phase 3 trial evaluating restoration of normal thyroid function at 26 weeks without antithyroid drug use.
Implication: May influence prescriber choice and payer reviews pending full data.

👧 AbbVie’s SKYRIZI gains US pediatric psoriatic disease approval [8] [US • 26 Jun 2026]

https://news.abbvie.com/2026-06-26-SKYRIZI-R-risankizumab-rzaa-Now-FDA-Approved-for-Pediatric-Use-in-Psoriatic-Disease
Context: SKYRIZI (AbbVie; risankizumab-rzaa) is an IL-23 inhibitor used in immune-mediated disease.
Key point: FDA approved SKYRIZI for patients aged 6 years and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis.
Implication: May influence prescriber choice and payer reviews pending full data.

💇 AbbVie gets positive CHMP opinion for RINVOQ in severe alopecia areata [9] [EU • 29 Jun 2026]

https://news.abbvie.com/2026-06-29-AbbVie-Receives-Positive-CHMP-Opinion-for-Upadacitinib-RINVOQ-R-for-the-Treatment-of-Adults-and-Adolescents-with-Severe-Alopecia-Areata
Context: RINVOQ (AbbVie; upadacitinib) is a once-daily JAK inhibitor evaluated in the Phase 3 UP-AA program.
Key point: CHMP recommended approval for adults and adolescents with severe alopecia areata; final European Commission decision is expected in the coming months.
Implication: May influence prescriber choice and payer reviews pending full data.

🧴 Arcutis’ ZORYVE approved for plaque psoriasis down to age 2 [10] [US • 29 Jun 2026]

https://investors.arcutis.com/news-releases/news-release-details/fda-approves-arcutis-zoryver-roflumilast-cream-03-treatment-0
Context: ZORYVE cream 0.3% (Arcutis; roflumilast) is a once-daily steroid-free topical PDE4 inhibitor.
Key point: FDA approved expanded use for plaque psoriasis, including intertriginous areas, in children down to age 2.
Implication: May influence prescriber choice and payer reviews pending full data.

Why it matters

Pediatric dermatology access expanded in the US, with FDA actions for SKYRIZI in psoriatic disease and ZORYVE in plaque psoriasis [8], [10].
IBD remained active across access and pipeline news, spanning Tremfya reimbursement in Korea, PALI-2108 IND clearance, and ontunisertib Phase 2b planning [4], [5], [3].
Regulatory outcomes were mixed, with Japan approval for Wayrilz and a US FDA CRL for Sobi’s NASP that centered on manufacturing-related issues [1], [2].
Novel modalities continued moving forward, including extracellular protein degradation in Graves’ disease and neuroimmune modulation in rheumatoid arthritis [7], [6].

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FAQ

What is Wayrilz, and what did Japan approve?

Wayrilz (Sanofi; rilzabrutinib) is an oral reversible BTK inhibitor. Japan approved it for persistent or chronic immune thrombocytopenia in patients with insufficient response or tolerability issues with other treatments [1].

Did FDA reject NASP because of clinical efficacy or safety?

The source says no clinical safety or efficacy concerns were identified that impact approvability. FDA’s CRL focused mainly on CMC and contract manufacturing facility deficiencies [2].

What is notable about Tremfya reimbursement in Korea?

Tremfya (J&J; guselkumab) gained reimbursed use for eligible moderate-to-severe active Crohn’s disease or ulcerative colitis patients in Korea. Coverage took effect on 01 Jun 2026 [4].

What trials are Palisade Bio and Agomab starting in IBD?

Palisade Bio plans ASCENTRA-UC, a Phase 2 ulcerative colitis study of PALI-2108, after FDA IND clearance. Agomab outlined NOV-ERA, a Phase 2b fibrostenosing Crohn’s disease study of ontunisertib [5], [3].

What is BHV-1300 targeting in Graves’ disease?

BHV-1300 (Biohaven) is designed to degrade disease-driving TSHR-IgG1 autoantibodies. The pivotal Phase 3 trial will assess restoration of normal thyroid function at 26 weeks without antithyroid drug use [7].

Which pediatric psoriasis options changed this week?

FDA approved SKYRIZI for children 6 years and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis. FDA also approved ZORYVE cream 0.3% for plaque psoriasis in children down to age 2 [8], [10].

Entities / Keywords

Sanofi, Wayrilz, rilzabrutinib, BTK inhibitor, BTKi, immune thrombocytopenia, ITP, LUNA 3.
Sobi, NASP, nanoencapsulated sirolimus plus pegadricase, uncontrolled gout, BLA, CRL, CMC.
Agomab, ontunisertib, NOV-ERA, ALK5, TGF-β RI, fibrostenosing Crohn’s disease, FSCD.
Johnson & Johnson, J&J Innovative Medicine Korea, Tremfya, guselkumab, IL-23 p19, IBD, Crohn’s disease, ulcerative colitis.
Palisade Bio, PALI-2108, ASCENTRA-UC, oral PDE4 inhibitor prodrug, ulcerative colitis, modified Mayo Score.
SetPoint Medical, SetPoint System, neuroimmune modulation, vagus nerve stimulation, rheumatoid arthritis, RA, RESET-RA.
Biohaven, BHV-1300, MoDE, extracellular protein degrader, Graves’ disease, TSHR-IgG1, TRAb.
AbbVie, SKYRIZI, risankizumab-rzaa, pediatric plaque psoriasis, pediatric psoriatic arthritis, OptIMMize.
AbbVie, RINVOQ, upadacitinib, CHMP, severe alopecia areata, SALT, UP-AA.
Arcutis, ZORYVE, roflumilast cream 0.3%, plaque psoriasis, pediatric psoriasis, PDE4 inhibitor, MUSE.