Immunology Today—July 8, 2026

LucidQuest

8 hours ago

This week’s Immunology update highlights regulatory progress, late-stage clinical advances, care access initiatives, partnership activity, and ongoing development across immune-mediated diseases.

In Today’s Newsletter

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💊 VOYXACT Phase 3 IgAN eGFR topline [1] [US • 02 Jul 2026]

https://www.otsuka.co.jp/en/company/newsreleases/2026/20260702_1.html
Context: Otsuka reported two-year Phase 3 VISIONARY results for VOYXACT (sibeprenlimab-szsi), a selective APRIL inhibitor in IgA nephropathy.
Key point: VOYXACT showed statistically significant eGFR stabilization with evidence of improvement versus placebo over two years.
Implication: May influence prescriber choice and payer reviews pending full data.

🧪 ZYMFENTRA testing access collaboration [2] [US • 06 Jul 2026]

https://www.accessnewswire.com/newsroom/en/business-and-professional-services/celltrion-usa-and-prometheus-laboratories-inc.-announce-sponsore-1184346
Context: Celltrion USA and Prometheus Laboratories announced sponsored access to Anser IFX therapeutic drug monitoring for eligible ZYMFENTRA patients.
Key point: The program supports clinicians evaluating transition from IV infliximab to subcutaneous infliximab maintenance therapy.
Implication: May expand screening, initiation, and follow-up at scale.

🌍 EULAR RheumaFacts care disparities [3] [Europe • 01 Jul 2026]

https://www.news-medical.net/news/20260701/EULAR-project-reveals-large-disparities-in-European-rheumatology-care.aspx
Context: EULAR’s RheumaFacts project gathered data across 36 countries to benchmark rheumatology workforce, health resources, and care access.
Key point: The analysis found disparities in rheumatologist density, non-pharmacological care, and access to biologic and targeted synthetic DMARDs.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.

🧬 Aurinia PRESERVE lupus nephritis study [4] [US • 06 Jul 2026]

https://www.businesswire.com/news/home/20260706998880/en/Aurinia-Announces-Initiation-of-PRESERVE-a-Study-Investigating-the-Combination-of-LUPKYNIS-and-Belimumab-Obinutuzumab-or-Anifrolumab-in-Patients-with-Lupus-Nephritis
Context: Aurinia initiated PRESERVE, a Phase 4 multicenter study of LUPKYNIS combinations in lupus nephritis.
Key point: The study will investigate LUPKYNIS with belimumab, obinutuzumab, or anifrolumab, with CRR at 6 months as the primary endpoint.
Implication: May influence prescriber choice and payer reviews pending full data.

💉 Galderma RelabotulinumtoxinA FDA CRL [5] [US • 01 Jul 2026]

https://www.galderma.com/news/galderma-relabotulinumtoxina-regulatory-submission-US
Context: Galderma received an FDA Complete Response Letter for the US BLA for RelabotulinumtoxinA.
Key point: The CRL cited manufacturing site inspection observations and analytical method optimization, with no safety or efficacy deficiencies noted.
Implication: Introduces a regulatory delay that may affect US launch timing and market access planning.

🌿 Piclidenoson Phase 3 psoriasis milestone [6] [US–EU • 06 Jul 2026]

https://www.dermatologytimes.com/view/first-in-class-oral-piclidenoson-reaches-pivotal-phase-3-enrollment-milestone-in-plaque-psoriasis
Context: Can-Fite BioPharma enrolled the first 247 patients for interim analysis in a pivotal Phase 3 trial of oral piclidenoson in moderate-to-severe plaque psoriasis.
Key point: The trial evaluates PASI 75 and sPGA 0/1 at week 16, with continued enrollment toward approximately 705 participants.
Implication: May influence prescriber choice and payer reviews pending full data.

🤝 UAE chronic hand eczema awareness MoU [7] [UAE • 06 Jul 2026]

https://www.zawya.com/en/press-release/companies-news/emirates-dermatology-society-and-leo-pharma-sign-mou-to-advance-chronic-hand-eczema-awareness-in-uae-xrelk49v
Context: Emirates Dermatology Society and LEO Pharma signed an MoU alongside the opening of LEO Pharma’s Expo City Dubai office.
Key point: The MoU aims to improve chronic hand eczema awareness, earlier diagnosis, patient education, and healthcare professional engagement in the UAE.
Implication: May expand screening, initiation, and follow-up at scale.

Why it matters

VOYXACT and PRESERVE both focus on renal outcomes in immune-mediated diseases, with IgAN and lupus nephritis remaining high-need areas. [1], [4]
Celltrion and Prometheus are pairing therapy access with therapeutic drug monitoring support for subcutaneous infliximab transitions. [2]
EULAR’s RheumaFacts provides a cross-country evidence base for workforce and access advocacy in European rheumatology. [3]
Galderma’s CRL and Can-Fite’s Phase 3 milestone show divergent regulatory and development paths in dermatology and aesthetics. [5], [6]
LEO Pharma’s UAE activity combines awareness, medical education, and regional infrastructure expansion. [7]

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FAQ

What did Otsuka report for VOYXACT in IgA nephropathy?

Otsuka reported positive two-year Phase 3 VISIONARY eGFR results for VOYXACT (sibeprenlimab-szsi), with statistically significant kidney function stabilization and evidence of improvement versus placebo. [1]

What is the Celltrion and Prometheus collaboration designed to do?

The collaboration provides sponsored access to Anser IFX testing for eligible ZYMFENTRA patients, supporting therapeutic drug monitoring during transition from IV to subcutaneous infliximab. [2]

What did EULAR’s RheumaFacts project find?

RheumaFacts identified disparities across Europe in rheumatologist density, multidisciplinary care access, and availability of biologic and targeted synthetic DMARDs. [3]

What is Aurinia testing in PRESERVE?

PRESERVE is a Phase 4 study of LUPKYNIS with belimumab, obinutuzumab, or anifrolumab in lupus nephritis, using complete renal response at 6 months as the primary endpoint. [4]

Why did FDA issue Galderma a CRL for RelabotulinumtoxinA?

The FDA CRL cited manufacturing site inspection observations and analytical method optimization. Galderma said safety and efficacy sections did not generate deficiencies. [5]

What is notable about Can-Fite’s piclidenoson program?

Piclidenoson is an oral A3 adenosine receptor agonist in pivotal Phase 3 testing for moderate-to-severe plaque psoriasis, with interim enrollment completed. [6]

Entities / Keywords

Otsuka Pharmaceutical, OPDC, VOYXACT, sibeprenlimab-szsi, APRIL inhibitor, IgA nephropathy, IgAN, VISIONARY, eGFR, sBLA
Celltrion USA, Prometheus Laboratories, ZYMFENTRA, infliximab-dyyb, Anser IFX, therapeutic drug monitoring, TDM, ulcerative colitis, Crohn’s disease
EULAR, RheumaFacts, rheumatic and musculoskeletal diseases, RMD, biologic DMARDs, targeted synthetic DMARDs, b/tsDMARDs
Aurinia Pharmaceuticals, LUPKYNIS, voclosporin, belimumab, obinutuzumab, anifrolumab, lupus nephritis, PRESERVE, complete renal response, CRR
Galderma, RelabotulinumtoxinA, Relfydess, FDA, BLA, Complete Response Letter, CRL, injectable aesthetics
Can-Fite BioPharma, piclidenoson, A3 adenosine receptor, A3AR, plaque psoriasis, PASI 75, sPGA
Emirates Dermatology Society, LEO Pharma, chronic hand eczema, CHE, UAE, Expo City Dubai, GCC