This week’s Immunology update highlights regulatory progress, late-stage clinical data, deal activity, and continued momentum across inflammatory and rare immune-mediated diseases.
In Today’s Newsletter
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🧪 Novartis to buy Excellergy for next-generation anti-IgE [1] [27 Mar 2026]
https://www.novartis.com/news/media-releases/novartis-agrees-acquire-excellergy-inc-building-allergy-leadership-next-generation-anti-ige-innovation
Context: Novartis will pay up to $2 billion in upfront and milestone payments; Exl-111 is in Phase 1 for IgE-driven disease.
Key point: Novartis agreed to acquire Excellergy, adding Exl-111, a half-life-extended anti-IgE antibody designed to dissociate receptor-bound IgE.
Implication: Signals pipeline investment and modality expansion.
🌿 EBGLYSS posts four-year atopic dermatitis durability data [2] [US • 27 Mar 2026]
https://investor.lilly.com/news-releases/news-release-details/lillys-ebglyss-lebrikizumab-lbkz-delivered-four-years-durable
Context: ADlong is an open-label Phase 3b study in moderate-to-severe atopic dermatitis; first-year interim findings were presented at AAD 2026.
Key point: EBGLYSS (lebrikizumab-lbkz; Eli Lilly) delivered durable skin and itch control for up to four years, including EASI-75 in 94% and EASI-90 in 75%.
Implication: May influence prescriber choice and payer reviews pending full data.
🧴 Sanofi amlitelimab shows Phase 3 atopic dermatitis efficacy [3] [US • 28 Mar 2026]
https://www.sanofi.com/en/media-room/press-releases/2026/2026-03-28-15-00-00-3264184
Context: COAST 1, COAST 2, and SHORE evaluated amlitelimab in patients aged 12 years and older, with Q4W and Q12W dosing.
Key point: Amlitelimab (Sanofi; anti-OX40L) met the primary endpoint in COAST 1 and COAST 2, and improved primary and key secondary endpoints in SHORE versus placebo at Week 24.
Implication: May influence prescriber choice and payer reviews pending full data.
💊 Takeda’s zasocitinib delivers pivotal psoriasis results [4] [28 Mar 2026]
https://www.takeda.com/newsroom/newsreleases/2026/zasocitinib-phase3-clinical-trial-results/
Context: Latitude PsO 3001 and 3002 were Phase 3, randomized, placebo- and active comparator-controlled studies in moderate-to-severe plaque psoriasis.
Key point: Zasocitinib (Takeda; oral TYK2 inhibitor) showed rapid and durable skin clearance, with about 70% achieving sPGA 0/1 at Week 16 and significant PASI 75 separation by Week 4 in one study.
Implication: May influence prescriber choice and payer reviews pending full data.
🩺 Fabhalta shows two-year IgAN renal benefit in NEJM [5] [29 Mar 2026]
https://www.novartis.com/news/media-releases/novartis-igan-data-new-england-journal-medicine-show-fabhalta-slowed-kidney-function-decline-493
Context: Final two-year APPLAUSE-IgAN Phase 3 results were published in The New England Journal of Medicine and presented at WCN 2026.
Key point: Fabhalta (iptacopan; Novartis) slowed eGFR decline by 49.3% and lowered the likelihood of composite kidney failure events by 43% versus placebo in IgA nephropathy.
Implication: May influence prescriber choice and payer reviews pending full data.
🌟 J&J reports one-year ICOTYDE psoriasis data [6] [28 Mar 2026]
https://www.jnj.com/media-center/press-releases/icotyde-icotrokinra-one-year-results-confirm-lasting-skin-clearance-and-favorable-safety-profile-in-once-daily-pill-for-plaque-psoriasis
Context: Week 52 data came from Phase 3 ICONIC-ADVANCE 1 and 2, plus ICONIC-LEAD, including adolescents.
Key point: ICOTYDE (icotrokinra; Johnson & Johnson) maintained high rates of skin clearance through one year, with PASI 100 rising to 49% and 48% in ADVANCE 1 and 2, and 57% PASI 100 in adolescents in LEAD.
Implication: May influence prescriber choice and payer reviews pending full data.
🇪🇺 Sanofi wins EU approval for Rezurock in chronic GVHD [7] [EU • 31 Mar 2026]
https://www.sanofi.com/en/media-room/press-releases/2026/2026-03-31-05-00-00-3265145
Context: The European Commission granted conditional marketing authorisation for adults and children aged 12 years and older weighing at least 40 kg.
Key point: Rezurock (belumosudil; Sanofi) is now approved in the EU for chronic graft-versus-host disease when other treatment options provide limited benefit, are unsuitable, or have been exhausted.
Implication: Introduces competition that may affect pricing and formulary access.
🧬 Palisade Bio reports early PALI-2108 Crohn’s signals [8] [US • 30 Mar 2026]
https://www.globenewswire.com/news-release/2026/03/30/3264997/0/en/palisade-bio-reports-positive-topline-data-from-phase-1b-clinical-study-of-pali-2108-in-fibrostenotic-crohn-s-disease.html
Context: Phase 1b enrolled five patients with fibrostenotic Crohn’s disease and confirmed ileal stenosis over 14 days of treatment.
Key point: PALI-2108 (Palisade Bio; oral PDE4 inhibitor prodrug) showed favorable tolerability, a 47.5% mean SES-CD reduction, and 40% endoscopic response and remission (small study).
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🦋 Biogen litifilimab posts second positive CLE Phase 2 trial [9] [US • 28 Mar 2026]
https://investors.biogen.com/news-releases/news-release-details/biogen-announces-second-positive-phase-2-litifilimab-trial
Context: AMETHYST Part A is the Phase 2 portion of an ongoing Phase 2/3 study in cutaneous lupus erythematosus.
Key point: Litifilimab (Biogen; anti-BDCA2) met the primary endpoint at Week 16, with a statistically significant 11.8% higher reduction in disease activity versus placebo and more participants achieving clear or almost clear skin.
Implication: May influence prescriber choice and payer reviews pending full data.
🧫 Rezpegaldesleukin adds AD and AA signal at AAD [10] [US • 28 Mar 2026]
https://www.prnewswire.com/news-releases/data-from-phase-2b-rezolve-ad-and-rezolve-aa-studies-of-rezpegaldesleukin-presented-at-2026-american-academy-of-dermatology-annual-meeting-302727838.html
Context: REZOLVE-AD enrolled 393 patients with moderate-to-severe atopic dermatitis; REZOLVE-AA assessed alopecia areata.
Key point: Rezpegaldesleukin (Nektar Therapeutics) showed statistically significant EASI improvement in Phase 2b atopic dermatitis and proof-of-concept activity in alopecia areata, with SALT reduction data presented at AAD 2026.
Implication: May influence prescriber choice and payer reviews pending full data.
Why it matters
- Oral immunology competition is intensifying, especially in plaque psoriasis, with Takeda’s zasocitinib [4] and Johnson & Johnson’s icotrokinra [6] both emphasizing strong efficacy plus pill-based convenience.
- Atopic dermatitis remains crowded but differentiated, with Lilly’s long-term IL-13 data [2], Sanofi’s less-frequent amlitelimab dosing case [3], and Nektar’s Treg-based approach [10].
- Novartis expanded on two fronts, dealmaking in allergy via Excellergy [1] and clinical momentum in IgA nephropathy with Fabhalta [5].
- Rare and high-unmet-need settings also moved, including chronic GVHD with an EU approval for Rezurock [7] and CLE with Biogen’s positive litifilimab Phase 2 readout [9].
- Early-stage GI innovation remains high risk but active, with Palisade Bio using a very small Phase 1b dataset to position PALI-2108 for broader Crohn’s development [8].
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FAQ
What did Novartis add through the Excellergy deal?
Novartis is adding Exl-111, a Phase 1, half-life-extended anti-IgE antibody for IgE-driven diseases including food allergy and related settings. The deal is worth up to $2 billion in upfront and milestone payments. [1]
How durable are Lilly’s EBGLYSS data in atopic dermatitis?
Lilly reported up to four years of disease control in the ADlong study, including EASI-75, EASI-90, itch relief, and reduced topical corticosteroid use. The study is ongoing and these are long-term extension data. [2]
What stands out about amlitelimab from Sanofi’s AAD update?
Amlitelimab showed positive Phase 3 results across COAST 1, COAST 2, and SHORE, with both Q4W and Q12W dosing schedules discussed. Sanofi highlighted progressive efficacy through Week 24 and the potential for Q12W dosing from the start. [3]
Are the new psoriasis pills from Takeda and J&J directly comparable?
Not from these releases alone. Takeda reported pivotal Phase 3 zasocitinib data against placebo and apremilast, while J&J reported one-year Phase 3 icotrokinra data, including adolescent results and comparisons to deucravacitinib in parts of the program. Cross-trial comparisons should be cautious. [4][6]
Why is Fabhalta important in IgA nephropathy?
Fabhalta’s APPLAUSE-IgAN data showed slower eGFR decline and fewer kidney failure events versus placebo over two years. Novartis also said the FDA granted priority review for traditional approval. [5]
What is notable about litifilimab in cutaneous lupus erythematosus?
Biogen says litifilimab is the only investigational program with positive efficacy results in multiple CLE studies in its dataset. In AMETHYST Part A, it met the primary endpoint and supported continued Phase 3 development. [9]
Entities / Keywords
Novartis, Excellergy, Exl-111, anti-IgE, IgE-driven disease, food allergy
EBGLYSS, lebrikizumab-lbkz, Eli Lilly, ADlong, atopic dermatitis, eczema, IL-13
Sanofi, amlitelimab, OX40L, COAST 1, COAST 2, SHORE, atopic dermatitis
Takeda, zasocitinib, TAK-279, TYK2 inhibitor, Latitude PsO 3001, Latitude PsO 3002, plaque psoriasis
Fabhalta, iptacopan, APPLAUSE-IgAN, IgA nephropathy, IgAN, eGFR, proteinuria
Johnson & Johnson, ICOTYDE, icotrokinra, IL-23 receptor, ICONIC-ADVANCE, ICONIC-LEAD, PASI 100
Rezurock, belumosudil, chronic graft-versus-host disease, chronic GVHD, EU conditional approval
Palisade Bio, PALI-2108, PDE4 inhibitor prodrug, fibrostenotic Crohn’s disease, SES-CD
Biogen, litifilimab, BDCA2, AMETHYST, LILAC, cutaneous lupus erythematosus, CLE
Nektar Therapeutics, rezpegaldesleukin, REZOLVE-AD, REZOLVE-AA, alopecia areata, SALT, EASI
