This Immunology video highlights major regulatory approvals, late-stage clinical progress, and delivery innovations. Developments span autoimmune and inflammatory diseases, with implications for treatment access, patient convenience, and regulatory pathways.
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Top Stories Covered In This Video
Chapters
0:00 Introduction
0:08 Sanofi: EU approved Wayrilz (rilzabrutinib) for ITP, first BTK inhibitor in the setting, based on LUNA 3
0:47 J&J / Tremfya: EC okayed guselkumab for paediatric plaque psoriasis from age 6, first IL-23 inhibitor with a paediatric indication
1:19 AstraZeneca / Saphnelo: EU approved subcutaneous pre-filled pen for SLE, matching IV benefits per TULIP-SC 1:45 InnoCare: China NMPA cleared Phase 2 trial of oral TYK2 inhibitor ICP-488 in cutaneous lupus
2:13 Takeda–Halozyme: Global deal to apply ENHANZE to vedolizumab (Entyvio) for SC delivery options
2:31 J&J / OTTAVA: De Novo submission to FDA for soft-tissue robotic system, backed by IDE data; second IDE for hernia trials
2:57 MoonLake / sonelokimab: FDA feedback supports BLA pathway in HS using existing trials
3:26 Royalty Pharma–Teva: Up to $500M funding framework to advance anti-IL-15 TEV-‘408 in vitiligo
3:58 How to reach us
Transcript
Welcome to the latest edition of Immunology Updates, covering recent breakthroughs in the field. Brought to you by LucidQuest.
First, Wayrilz received EU approval for immune thrombocytopenia. The decision is based on LUNA 3, a Phase 3 trial in adult ITP with n=202 and a 12–24 week double-blind period. Common adverse events included diarrhea, nausea, headache, abdominal pain, and COVID-19. Rilzabrutinib is now the first BTK inhibitor for adult ITP refractory to other treatments, with durable platelet responses and quality-of-life gains that may guide prescribers and payers as full data emerge.
Next, the European Commission approved guselkumab, Tremfya, for moderate to severe paediatric plaque psoriasis from age 6. In PROTOSTAR, a Phase 3 study in patients aged 6–17 with n=120, Week 16 endpoints met PASI 75 and IGA 0 or 1, with safety consistent with adults. This is the first paediatric indication for an IL-23 inhibitor.
The Commission also approved Saphnelo, anifrolumab, as a subcutaneous pre-filled pen for adult systemic lupus erythematosus self-administration. TULIP-SC showed significant disease-activity reduction versus placebo on top of standard therapy, with interim safety aligned with intravenous dosing. This adds a convenient SC option that can scale access.
In China, InnoCare received NMPA clearance for a Phase 2 trial of ICP-488 in cutaneous lupus. ICP-488 is an oral allosteric TYK2 inhibitor that modulates IL-23, IL-12, and type 1 interferon signaling. The program advances to Phase 2 in CLE as the second indication after psoriasis.
Takeda entered a global collaboration with Halozyme to apply ENHANZE to vedolizumab, Entyvio, aiming to enhance subcutaneous delivery flexibility in ulcerative colitis and Crohn’s disease, with upfront, milestones, and royalties to Halozyme.
Johnson & Johnson submitted a De Novo request to the FDA for the OTTAVA soft-tissue robotic surgical system. The filing is supported by IDE data in upper-abdominal general surgery, and a second IDE was approved for inguinal hernia. The platform seeks marketing authorization as a multi-procedure system that leverages Ethicon tools and the Polyphonic ecosystem.
FDA feedback indicated that existing clinical data may support a BLA for sonelokimab in hidradenitis suppurativa without new HS trials. The package includes MIRA Phase 2 and VELA-1 and VELA-2 Phase 3 studies that used the stringent HiSCR75 endpoint, with mixed efficacy and a higher placebo response in VELA-2, and safety that was generally consistent.
Finally, Royalty Pharma and Teva announced up to 500 million dollars in funding to accelerate TEV-‘408, an anti-IL-15 antibody, for vitiligo. The structure includes 75 million for Phase 2b and an option for 425 million for Phase 3. TEV-‘408 is in Phase 1b for vitiligo and Phase 2a for celiac disease, with results expected to be shared in 2026.
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Why it matters
- BTK inhibition in ITP offers a novel, oral mechanism and could shift treatment lines in refractory disease.
- First paediatric IL-23 option broadens biologic access for children with plaque psoriasis.
- SC self-admin biologics in SLE align with patient preference and system-capacity goals.
- TYK2 expansion into CLE underscores small-molecule competition with injectables.
- Capital and device moves signal continued convergence of bio-pharma, delivery tech, and surgical robotics.
🗓️ Explore details and sources
- Weeks 18 December 2025–7 January 2026
- Week 7-14 January 2026
📚 Find your one-stop page for the full Immunology archive.
FAQ
What is special about Sanofi’s Wayrilz approval?
Wayrilz (rilzabrutinib) is the first BTK inhibitor approved in the EU for adult ITP refractory to other treatments, supported by LUNA 3 showing durable platelet responses and QoL improvement [1].
How does Tremfya’s new label change paediatric psoriasis care?
The EC approved guselkumab for ages 6 and up with moderate to severe plaque psoriasis, the first paediatric indication for an IL-23 inhibitor, based on PROTOSTAR efficacy and safety consistent with adults [2].
What does Saphnelo’s SC pen add for SLE patients?
The EU approval enables at-home self-administration with efficacy aligned to IV in TULIP-SC, potentially improving access and convenience for suitable patients on standard therapy [3].
What stage is InnoCare’s ICP-488 in CLE?
China’s NMPA approved a Phase 2 clinical trial for ICP-488, an oral, selective TYK2 allosteric inhibitor targeting key cytokine pathways relevant to CLE [4].
What is the goal of Takeda’s ENHANZE deal for vedolizumab?
To integrate ENHANZE for subcutaneous delivery options, aiming for greater flexibility and patient experience with Entyvio in UC and Crohn’s disease [5].
Will MoonLake need more HS trials for sonelokimab?
Per FDA feedback summarized by Dermatology Times, existing MIRA and VELA data may support a BLA without additional HS trials, with VELA-2 still important for safety context [7].
Entities / Keywords
Wayrilz; rilzabrutinib; Bruton’s tyrosine kinase; immune thrombocytopenia; Sanofi | Tremfya; guselkumab; IL-23 inhibitor; paediatric plaque psoriasis; Johnson & Johnson | Saphnelo; anifrolumab; interferon pathway; systemic lupus erythematosus; AstraZeneca | ICP-488; TYK2 allosteric inhibitor; cutaneous lupus erythematosus; InnoCare | Vedolizumab; Entyvio; ENHANZE; subcutaneous delivery; Takeda; Halozyme | OTTAVA robotic surgical system; Ethicon; De Novo; Johnson & Johnson | Sonelokimab; SLK; HiSCR75; hidradenitis suppurativa; MoonLake | TEV-‘408; anti-IL-15; vitiligo; Royalty Pharma; Teva.
References
https://www.sanofi.com/en/media-room/press-releases/2025/2025-12-23-14-06-58-3209943
https://www.takeda.com/newsroom/newsreleases/2026/collaboration-and-license/
https://www.dermatologytimes.com/view/fda-feedback-supports-bla-pathway-for-sonelokimab-in-hs