This biweekly Immunology video recap highlights regulatory approvals, late-stage clinical data, filings, and emerging biologic strategies across inflammatory and autoimmune diseases.
🎯 Watch Our Video Summary Capturing Immunology News from the Last Two Weeks
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- Week 25 February – 3 March 2026
- Week 4 -10 March 2026
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Top Stories Covered In This Video
Chapters
0:00 Introduction
0:08 Dupixent approved in AFRS
0:52 NUMELVI approved for canine allergic dermatitis itch
1:23 IMAAVY filed in warm autoimmune hemolytic anemia
1:59 SKYRIZI SC induction posts positive Phase 3 Crohn’s topline
2:43 Gazyva / Gazyvaro Phase 3 lupus data land in NEJM
3:27 Tilrekimig shows Phase 2 signal in atopic dermatitis
4:11 Sotyktu wins FDA approval in psoriatic arthritis
4:47 Nipocalimab gains Fast Track in SL
5:19 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.
Dupixent, or dupilumab from Sanofi and Regeneron, received FDA approval in the United States for allergic fungal rhinosinusitis in adults and children aged six years and older who have previously undergone sino-nasal surgery. The approval is based on the Phase 3 LIBERTY-AFRS-AIMS study involving sixty-two patients. Dupilumab demonstrated reductions in sinus opacification, nasal symptoms, and the need for corticosteroids or additional surgery compared with placebo, making it the first FDA-approved therapy specifically indicated for allergic fungal rhinosinusitis.
Merck Animal Health also secured an FDA approval with NUMELVI, or atinvicitinib tablets, for the control of pruritus associated with allergic dermatitis in dogs aged six months and older. The once-daily oral therapy is a selective JAK1 inhibitor and is described as the first second-generation JAK inhibitor approved for this indication in dogs in the United States, potentially introducing new competition in veterinary dermatology treatment options.
Johnson & Johnson submitted a supplemental biologics license application to the FDA for IMAAVY, also known as nipocalimab-aahu, as a treatment for warm autoimmune hemolytic anemia. The filing is supported by results from the Phase 2/3 ENERGY study in adults with the disease. According to the company, the therapy demonstrated rapid and durable improvements in hemoglobin levels as well as reductions in fatigue, addressing a condition for which no FDA-approved therapies currently exist.
AbbVie reported positive topline results from the Phase 3 AFFIRM study evaluating subcutaneous induction with risankizumab in adults with moderately to severely active Crohn’s disease. The randomized placebo-controlled trial enrolled two hundred eighty-nine patients, many of whom had previously failed advanced therapies. At week twelve, risankizumab achieved superiority over placebo on key endpoints, including CDAI clinical remission at fifty-five percent versus thirty percent and endoscopic response at forty-four percent versus fourteen percent, with no new safety signals observed.
Roche reported Phase 3 ALLEGORY results evaluating obinutuzumab, marketed as Gazyva or Gazyvaro, in adults with systemic lupus erythematosus. The study compared obinutuzumab plus standard therapy against placebo plus standard therapy. The trial met its primary endpoint, with seventy-six point seven percent of patients achieving SRI-4 at week fifty-two compared with fifty-three point five percent in the placebo group. Additional improvements were reported across key secondary measures, including BICLA response, reductions in steroid use, delayed disease flares, and higher remission rates.
Pfizer reported positive topline findings from a Phase 2 trial evaluating tilrekimig in adults with moderate to severe atopic dermatitis. The randomized double-blind placebo-controlled study met its primary endpoint, showing statistically significant improvements in EASI-75 at week sixteen across all tested dose levels compared with placebo. Tilrekimig is a trispecific antibody designed to target IL-4, IL-13, and TSLP, and Pfizer plans to advance the therapy into Phase 3 development for atopic dermatitis.
Bristol Myers Squibb received FDA approval for Sotyktu, or deucravacitinib, for the treatment of adults with active psoriatic arthritis. The decision was supported by results from the Phase 3 POETYK PsA-1 and PsA-2 trials. In both studies, a higher proportion of patients receiving deucravacitinib achieved ACR20 response at week sixteen compared with those receiving placebo, positioning the therapy as the first TYK2 inhibitor approved for psoriatic arthritis.
Finally, the FDA granted Fast Track designation to nipocalimab in systemic lupus erythematosus. The decision follows positive results from the Phase 2b JASMINE trial and ongoing enrollment in the Phase 3 GARDENIA study evaluating the therapy in adults with active lupus. The designation highlights the continued development of FcRn-targeting approaches for autoimmune diseases with significant unmet medical need.
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Why it matters
- FcRn-targeting therapies advanced on two fronts, with nipocalimab moving in both wAIHA filing [3] and SLE Fast Track status [8].
- Lupus momentum remains high, with Roche publishing Phase 3 ALLEGORY data for obinutuzumab in SLE [5].
- Dermatology and type 2 inflammation stayed active, spanning Dupixent in AFRS [1], tilrekimig in atopic dermatitis [6], and Sotyktu in psoriatic arthritis [7].
- GI immunology added a delivery-angle update, with SKYRIZI showing positive Phase 3 data for subcutaneous induction in Crohn’s disease [4].
- Animal health also saw a regulatory milestone, with NUMELVI adding a new JAK inhibitor option for canine allergic dermatitis itch [2].
🗓️ Explore details and sources
- Week 25 February – 3 March 2026
- Week 4 -10 March 2026
📚 Find your one-stop page for the full Immunology archive.
FAQ
What changed for Dupixent in allergic fungal rhinosinusitis?
Dupixent (dupilumab) received FDA approval in the US for adults and children aged 6 years and older with allergic fungal rhinosinusitis who have a history of sino-nasal surgery. Sanofi and Regeneron position it as the first approved medicine specifically for AFRS [1].
What is Johnson & Johnson asking FDA to approve for IMAAVY?
J&J submitted IMAAVY (nipocalimab-aahu) for warm autoimmune hemolytic anemia. The filing is supported by the ENERGY study, which the company said showed durable hemoglobin response and fatigue benefit, but full results are still forthcoming [3].
What did AbbVie report for SKYRIZI in AFFIRM?
AbbVie said subcutaneous induction risankizumab beat placebo at week 12 on both CDAI remission and endoscopic response in Crohn’s disease. The study also included a substantial prior advanced-therapy failure population [4].
How strong were Roche’s ALLEGORY lupus results?
Roche reported a statistically significant improvement in SRI-4 at week 52 for Gazyva/Gazyvaro plus standard therapy versus placebo plus standard therapy, along with positive key secondary endpoints including BICLA and glucocorticoid reduction [5].
What is notable about tilrekimig in atopic dermatitis?
Tilrekimig is Pfizer’s investigational trispecific antibody targeting IL-4, IL-13, and TSLP. In Phase 2, it met the primary endpoint with EASI-75 improvement across all doses tested, and Pfizer said Phase 3 is planned this year [6].
What is new about Sotyktu in psoriatic arthritis?
Sotyktu (deucravacitinib) is now FDA approved for adults with active psoriatic arthritis. Bristol Myers Squibb describes it as the first TYK2 inhibitor approved for this indication, supported by POETYK PsA-1 and PsA-2 [7].
Entities / Keywords
Dupixent, dupilumab, Sanofi, Regeneron, allergic fungal rhinosinusitis, AFRS
NUMELVI, atinvicitinib, Merck Animal Health, allergic dermatitis, canine pruritus, JAK inhibitor
IMAAVY, nipocalimab-aahu, Johnson & Johnson, warm autoimmune hemolytic anemia, wAIHA, ENERGY, FcRn
SKYRIZI, risankizumab, AbbVie, Crohn’s disease, AFFIRM, subcutaneous induction
Gazyva, Gazyvaro, obinutuzumab, Roche, systemic lupus erythematosus, SLE, ALLEGORY, anti-CD20
Tilrekimig, PF-07275315, Pfizer, atopic dermatitis, EASI-75, trispecific antibody, IL-4, IL-13, TSLP
Sotyktu, deucravacitinib, Bristol Myers Squibb, psoriatic arthritis, PsA, POETYK, TYK2
JASMINE, GARDENIA, Fast Track designation, lupus, steroid sparing
References
https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-24-14-30-00-3243732
https://www.roche.com/media/releases/med-cor-2026-03-06