Immunology Today—February 18, 2026

LucidQuest

14 hours ago

This week’s Immunology update summarizes key developments in clinical trials, regulatory actions, approvals, and new product launches within the field. Notable progress and milestones are highlighted, with a focus on advancements that may significantly impact patient care and treatment options.

In Today’s Newsletter

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✅ Gazyva/Gazyvaro meets Phase III endpoint in primary membranous nephropathy [1] [EU/US • 16 Feb 2026]

https://www.roche.com/media/releases/med-cor-2026-02-16
Context: The MAJESTY study showed significant improvement in remission rates with Gazyva/Gazyvaro (obinutuzumab) compared to tacrolimus, targeting kidney function preservation.
Key point: Potential first approved treatment for primary membranous nephropathy, a disease affecting over 90,000 people in the US and EU.
Implication: May shift treatment paradigms in autoimmune kidney diseases.

🧬 Galderma launches Restylane Defyne and Refyne in Japan [2] [JP • 11 Feb 2026]

https://www.galderma.com/news/galderma-expands-restylane-portfolio-japan
Context: These are the first hyaluronic acid injectables using OBT™ (Optimal Balance Technology) in Japan, expanding treatment options for facial wrinkles.
Key point: Restylane Defyne and Refyne offer flexibility and natural movement, enhancing aesthetic outcomes.
Implication: May increase market competition and patient access to injectable treatments in Japan.

🧪 Barzolvolimab shows long-term improvements in CSU [3] [US • 11 Feb 2026]

https://www.prnewswire.com/news-releases/barzolvolimab-provides-long-term-improvements-for-spontaneous-urticaria-302685484.html
Context: After 52 weeks of treatment, barzolvolimab demonstrated durable effects in patients with chronic spontaneous urticaria.
Key point: 71% of patients achieved a complete response, with effects lasting up to 28 weeks after treatment.
Implication: Barzolvolimab could become a transformative option for CSU, offering prolonged efficacy post-treatment.

🔬 InnoCare initiates Phase II/III trial of soficitinib in CSU [4] [CN • 12 Feb 2026]

https://www.prnewswire.com/news-releases/innocare-announces-first-patient-dosed-in-the-phase-ii-iii-clinical-trial-of-novel-tyk2-inhibitor-soficitinib-for-chronic-spontaneous-urticaria-in-china
Context: Soficitinib, a novel TYK2 inhibitor, is progressing through trials for CSU, aiming to provide a new treatment avenue for patients.
Key point: Soficitinib targets key inflammatory pathways, with clinical trials also underway for other autoimmune diseases.
Implication: Could offer new treatment options for CSU in China, with potential global expansion.

💊 STADA and Bio-Thera’s Gotenfia receives EU approval [5] [EU • 13 Feb 2026]

https://www.prnewswire.com/news-releases/stada-and-bio-thera-receive-european-marketing-authorization-for-gotenfia-a-biosimilar-to-simponi-302687571.html
Context: Gotenfia (golimumab biosimilar) receives European Commission approval for several autoimmune diseases, offering an alternative to Simponi.
Key point: The biosimilar could reduce costs and expand patient access to biologic treatments.
Implication: Increased competition in the autoimmune treatment space could lead to lower prices and improved patient access.

🧴 Neutrogena launches Evenly Clear for adult acne [6] [US • 11 Feb 2026]

https://www.prnewswire.com/news-releases/neutrogena-unveils-a-new-acne-solution-for-adults-codesigned-with-leading-dermatologists-302684415.html
Context: Neutrogena’s new acne line targets adult acne, addressing both breakouts and post-acne marks with a dermatologist-designed approach.
Key point: The line features six products aimed at tackling common adult skin concerns like stress and hormonal acne.
Implication: Offers a clinically backed solution for adult acne, tapping into an underserved market segment.

🌏 Eli Lilly’s Mirikizumab approved for bowel diseases in China [7] [CN • 12 Feb 2026]

https://vohnetwork.com/news/global/eli-lilly-gets-china-approval-for-bowel-disease-drug-mirikizumab
Context: Mirikizumab receives regulatory approval for moderately-to-severely active Crohn’s disease and ulcerative colitis in China.
Key point: The approval expands treatment access to millions of patients in the world’s second-largest pharmaceutical market.
Implication: Enhances China’s options for advanced therapies in inflammatory bowel diseases.

Why it matters

Immunology treatments continue to show promising advances, especially in autoimmune kidney diseases and dermatology.
Biosimilars like Gotenfia are making biological treatments more accessible and cost-effective.
Chronic spontaneous urticaria is seeing breakthroughs, with drugs like barzolvolimab and soficitinib showing promise for long-term efficacy.
Global access is expanding, with approval of treatments like Mirikizumab in China, a key move in the growing pharmaceutical market.

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FAQ

What new treatments were approved for primary membranous nephropathy?

Roche’s Gazyva/Gazyvaro showed positive Phase III results, potentially becoming the first treatment approved for this autoimmune kidney disease [1].

What new options are available for adult acne?

Neutrogena launched Evenly Clear™, a clinically designed acne solution tailored for adults, targeting both breakouts and post-acne marks [6].

Where has Gotenfia been approved and for what conditions?

Gotenfia (golimumab biosimilar) has been approved in the EU for multiple autoimmune diseases, providing a more affordable option for patients [5].

What does the approval of Mirikizumab in China mean?

Mirikizumab’s approval expands treatment options for moderate-to-severe Crohn’s disease and ulcerative colitis in China, a major milestone for the drug in a key market [7].

Entities / Keywords

Roche; Gazyva/Gazyvaro; primary membranous nephropathy; Phase III; MAJESTY
Galderma; Restylane Defyne; Restylane Refyne; hyaluronic acid; OBT™
Barzolvolimab; CSU; spontaneous urticaria; Phase 2
InnoCare; Soficitinib; TYK2 inhibitor; chronic spontaneous urticaria; Phase II/III
STADA; Bio-Thera; Gotenfia; golimumab biosimilar; EU approval
Neutrogena; Evenly Clear™; acne treatment; adult acne
Eli Lilly; Mirikizumab; Crohn’s disease; ulcerative colitis; China approval