This biweekly Immunology video recap highlights key developments across autoimmune and inflammatory diseases. It covers late-stage clinical progress, long-term data readouts, regulatory decisions, and biosimilar access updates.
🎯 Watch Our Video Summary Capturing Immunology News from the Last Two Weeks
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🗓️ Explore details and sources
- Week 11-17 February 2026
- Week 18-24 February 2026
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Top Stories Covered In This Video
Chapters
0:00 Introduction
0:09 Roche: Gazyva/Gazyvaro Phase 3 win in primary membranous nephropathy
0:45 InnoCare: First patient dosed for TYK2 inhibitor soficitinib in CSU (China)
1:19 STADA, Bio-Thera: EU marketing authorization for golimumab biosimilar Gotenfia
1:53 Eli Lilly: China approval for mirikizumab in IBD (Crohn’s, UC)
2:21 Novartis: Remibrutinib hits Phase 3 endpoint in chronic inducible urticaria
2:57 Takeda: Pediatric UC Phase 3 KEPLER remission data for ENTYVIO (vedolizumab)
3:41 Johnson & Johnson: TREMFYA durable UC outcomes through Week 140 (QUASAR LTE)
4:25 Savara: FDA files MOLBREEVI BLA in autoimmune PAP (PDUFA 22 Aug 2026)
4:58 How to reach us
Transcript
Welcome to the latest edition of Immunology Updates, covering breakthroughs in the past two weeks. Brought to you by LucidQuest.
First, Roche reported Phase 3 MAJESTY success for Gazyva, also marketed as Gazyvaro, in primary membranous nephropathy. In this global study in adults, obinutuzumab, an anti-CD20 antibody, was compared with tacrolimus, with a two-year readout. Roche said the trial met its primary endpoint, complete remission at two years, and safety was consistent with the known profile, with no new safety signals. Next steps will depend on full data disclosure, and could shape prescriber and payer decisions.
Next, InnoCare announced that the first patient has been dosed in China in a Phase II/III trial of soficitinib, also called ICP-332, for chronic spontaneous urticaria. The company describes soficitinib as a selective TYK2 inhibitor. While the release focused on the dosing milestone rather than detailed trial design, it signals ongoing investment in autoimmune dermatology programs and an expanding modality mix.
Third, STADA and Bio-Thera said the European Commission granted EU marketing authorization for Gotenfia, BAT2506, a biosimilar to golimumab, marketed as Simponi. Bio-Thera leads development and supply, while STADA will commercialize across the EU, the UK, Switzerland, and selected countries. With launch preparations underway and timing not specified, this approval adds new competition that could affect pricing and formulary access.
Fourth, Eli Lilly received regulatory approval in China for mirikizumab to treat moderately-to-severely active Crohn’s disease and ulcerative colitis. The source described this as Lilly China’s first clearance for an innovative medicine in digestive immunity, with launch timing and pricing not disclosed. The approval may influence prescribing patterns and payer reviews as access decisions evolve.
Fifth, Novartis said remibrutinib met the Phase 3 primary endpoint in the RemIND program for chronic inducible urticaria, including symptomatic dermographism, cold urticaria, and cholinergic urticaria. Novartis reported significantly higher complete response rates versus placebo at Week 12, and said it submitted a supplemental new drug application to the FDA for symptomatic dermographism. If confirmed by full data, this could broaden options in a high-burden urticaria subset.
Sixth, Takeda reported Phase 3 KEPLER pediatric ulcerative colitis data for ENTYVIO, vedolizumab administered intravenously. KEPLER enrolled patients ages 2 to 17. After open-label induction in 120 patients, 93 responders were randomized to maintenance dosing every eight weeks. Takeda said the primary endpoint was met, with 47.3 percent clinical remission at Week 54 among randomized patients, and safety generally consistent with adult experience. This readout supports the case for expanding evidence in pediatric inflammatory bowel disease.
Seventh, Johnson and Johnson highlighted long-term ulcerative colitis outcomes for TREMFYA, guselkumab, through Week 140 in the QUASAR long-term extension, which the company said was presented at ECCO 2026. In adults with moderately-to-severely active ulcerative colitis, J&J reported 80.8 percent clinical remission, 53.6 percent endoscopic remission, and 78.6 percent histo-endoscopic mucosal improvement at Week 140, as defined in the release. These durability signals may factor into future positioning and reimbursement discussions.
Finally, Savara said the FDA filed the biologics license application for MOLBREEVI in autoimmune pulmonary alveolar proteinosis, also called autoimmune PAP, and granted Priority Review. Savara reported a PDUFA target action date of 22 Aug 2026, and referenced plans for EU and UK submissions by the end of Q1 2026. If approved, this could represent an important new option in a rare autoimmune lung disease.
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Why it matters
- Multiple late-stage wins across kidney and immunology programs may reshape standard-of-care options, pending full datasets and labels [1], [5], [6], [7].
- China continues to expand access to IBD and immunology medicines, spanning approvals (mirikizumab) and trial execution (soficitinib) [2], [4].
- EU biosimilar approvals (golimumab) can broaden access and accelerate payer-driven switching dynamics [3].
- Regulatory momentum in rare disease (autoimmune PAP) sets clear near-term milestones, with an explicit US action date [8].
🗓️ Explore details and sources
- Week 11-17 February 2026
- Week 18-24 February 2026
📚 Find your one-stop page for the full Immunology archive.
FAQ
What is Roche’s lead claim for Gazyva/Gazyvaro (obinutuzumab) in primary membranous nephropathy?
Roche said the Phase 3 MAJESTY study met its primary endpoint, complete remission at two years vs tacrolimus, with no new safety signals reported in the release [1].
What happened in InnoCare’s soficitinib (ICP-332) CSU program in China?
InnoCare announced first patient dosed in a Phase II/III trial for chronic spontaneous urticaria in China (additional trial specifics not provided in the excerpt) [2].
What does the EU marketing authorization for Gotenfia mean for golimumab access?
STADA and Bio-Thera said the European Commission granted marketing authorization for Gotenfia, a Simponi-referencing golimumab biosimilar, with launches planned in coming weeks and months (timing not specified) [3].
What is the scope of Eli Lilly’s mirikizumab approval in China, per the provided source?
The source says China approved mirikizumab for moderately-to-severely active Crohn’s disease and ulcerative colitis, with launch timing and pricing not disclosed [4].
What did Novartis report for remibrutinib in chronic inducible urticaria (CIndU)?
Novartis reported positive topline Phase 3 RemIND results with higher complete response rates vs placebo across three CIndU types, and said it filed an sNDA with FDA for symptomatic dermographism [5].
What is Savara’s key FDA milestone for MOLBREEVI in autoimmune PAP?
Savara said FDA filed the MOLBREEVI BLA and granted Priority Review, with a PDUFA target action date of 22 Aug 2026 [8].
Entities / Keywords
Gazyva, Gazyvaro (obinutuzumab), Roche, anti-CD20, MAJESTY, primary membranous nephropathy (PMN)
Soficitinib (ICP-332), InnoCare Pharma, TYK2 inhibitor, chronic spontaneous urticaria (CSU), China
Gotenfia (golimumab, BAT2506), STADA, Bio-Thera, Simponi biosimilar, European Commission, CHMP, EMA
Mirikizumab, Eli Lilly, Crohn’s disease, ulcerative colitis (UC), inflammatory bowel disease (IBD), China approval
Remibrutinib, Novartis, BTK inhibitor, RemIND, chronic inducible urticaria (CIndU), symptomatic dermographism, sNDA, FDA
ENTYVIO (vedolizumab), Takeda, KEPLER, pediatric ulcerative colitis, ECCO
TREMFYA (guselkumab), Johnson & Johnson, QUASAR LTE, histo-endoscopic mucosal improvement (HEMI), Week 140
MOLBREEVI, Savara, autoimmune pulmonary alveolar proteinosis (autoimmune PAP), BLA, Priority Review, PDUFA (22 Aug 2026)
References
https://www.roche.com/media/releases/med-cor-2026-02-16
https://vohnetwork.com/news/global/eli-lilly-gets-china-approval-for-bowel-disease-drug-mirikizumab
https://www.takeda.com/newsroom/newsreleases/2026/entyvio-phase-3-pediatric-data/