This Immunology update captures a broad range of developments, including regulatory approvals, late-stage clinical readouts, guideline updates, and pipeline advances across autoimmune, dermatology, and inflammatory diseases.
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💊 Wayrilz BTK inhibitor wins EU nod for ITP [1] [EU • 23 Dec 2025]
https://www.sanofi.com/en/media-room/press-releases/2025/2025-12-23-14-06-58-3209943
Context: LUNA 3 Phase 3 in persistent/chronic ITP adults (n=202).
Key point: EC approved rilzabrutinib for adult ITP refractory to other treatments, meeting primary and secondary endpoints with durable platelet responses.
Implication: Introduces competition that may affect pricing and formulary access.
🧴 JNJ-5939 misses high bar in AD interim, study stopped early [2] [US • 26 Dec 2025]
Context: Phase 2b DUPLEX-AD proof-of-concept, planned interim look.
Key point: Did not meet prespecified efficacy threshold for advancement, safety acceptable.
Implication: May influence prescriber choice and payer reviews pending full data.
👶 EC approves TREMFYA for pediatric plaque psoriasis 6+ [3] [EU • 22 Dec 2025]
Context: PROTOSTAR Phase 3 in 6–17 years; PK bridging from VOYAGE adult studies.
Key point: First IL-23 inhibitor with a pediatric indication in the EU, higher Week 16 skin clearance vs placebo (endpoints achieved).
Implication: May influence prescriber choice and payer reviews pending full data.
💉 Saphnelo gets EU approval for SC self-injection pen in SLE [4] [EU • 16 Dec 2025]
Context: TULIP-SC Phase 3 supported efficacy and safety.
Key point: EC okays SC pre-filled pen option, offering at-home administration with clinical benefits consistent with IV.
Implication: May expand screening, initiation, and follow-up at scale.
📈 Takeda’s TYK2 zasocitinib hits Phase 3 endpoints in PsO [5] [18 Dec 2025]
Context: Two pivotal, randomized, placebo- and active-controlled trials.
Key point: Met all primary and 44 ranked secondary endpoints at Week 16, with favorable tolerability (directional topline).
Implication: May influence prescriber choice and payer reviews pending full data.
🇧🇩 Regenexx Bangladesh launches regenerative rheumatology center [6] [Bangladesh • 02 Jan 2026]
Context: Clinic program launch with PRP, stem cells, exosomes, biologics.
Key point: New Dhaka center offers non-surgical pain and autoimmune care using regenerative and adjunctive modalities.
Implication: May expand screening, initiation, and follow-up at scale.
🧪 SGX945 Phase 2a Behçet’s oral ulcers data published [7] [US • 18 Dec 2025]
Context: Open-label pilot vs historical apremilast data; small n.
Key point: Signals in ulcer count and pain with potential durability post-treatment; well tolerated (endpoint specifics limited).
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
📜 Palisade Bio wins Japanese patent for PALI-2108 (PDE4) [8] [Japan • 30 Dec 2025]
Context: Gut-microbiota-activated PDE4 B/D prodrug for UC and fibrostenotic Crohn’s.
Key point: Composition-of-matter patent in Japan extends to 2041, supporting upcoming Phase 2 INDs.
Implication: Introduces competition that may affect pricing and formulary access.
🤝 AAD partners with Bonsai Health on AI practice automation [9] [US • 22 Dec 2025]
Context: Workflow automation for follow-ups, rescheduling, openings.
Key point: Partnership aims to reduce admin burden by integrating AI outreach and scheduling into dermatology practices.
Implication: DTC/telehealth: Could streamline initiation and adherence via remote prescribing and logistics.
🇫🇷 France updates systemic psoriasis guidelines [10] [France • 03 Jan 2026]
Context: GrPso revision covering IL-23p19 and TYK2, adult focus.
Key point: Recommends individualized long-term management, integrates newer biologics and targeted synthetics; notes evidence gaps.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🧴 Hoth files dual US provisionals for oncodermatology platform [11] [US • 02 Jan 2026]
Context: HT-001 positioned for radiation- and targeted-therapy skin toxicities.
Key point: Provisional IP seeks to protect mechanism-driven topical approach to therapy-induced dermatitis.
Implication: Signals pipeline investment and modality expansion.
🐶 USDA approves Elanco Befrena (anti-IL-31) for dogs [12] [US • 31 Dec 2025]
Context: Second recent Elanco dermatology product; 6–8 week dosing.
Key point: Befrena approved for canine allergic and atopic dermatitis, positioned vs lokivetmab on interval.
Implication: Introduces competition that may affect pricing and formulary access.
🧬 Immutep IMP761 first-in-class LAG-3 agonist Phase I update [13] [22 Dec 2025]
Context: Healthy volunteer SAD, 2.5 and 7 mg/kg complete.
Key point: Dose-dependent immunosuppressive effects observed with favorable safety, supporting autoimmune potential.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 InnoCare TYK2 ICP-488 cleared for Phase 2 in CLE [14] [China • 23 Dec 2025]
Context: Oral allosteric TYK2, prior PsO efficacy and safety.
Key point: NMPA approved Phase 2 IND in cutaneous lupus erythematosus, second indication for ICP-488.
Implication: Signals pipeline investment and modality expansion.
🎭 Galapagos TYK2 mixed: DM hits, SLE misses [15] [19 Dec 2025]
Context: GLPG3667 Phase 2 dermatomyositis positive; Phase 3 SLE negative at Week 32.
Key point: Company evaluating partnering for dermatomyositis and broader strategy after SLE miss.
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.
🌿 InnoCare soficitinib (TYK2) IND cleared for CSU Phase II/III [16] [China • 18 Dec 2025]
Context: TYK2 program spans AD, vitiligo, PN, CSU.
Key point: CDE approved Phase II/III trial in CSU, targeting pruritus and wheals via cytokine pathway blockade.
Implication: Signals pipeline investment and modality expansion.
🫁 Savara resubmits BLA for MOLBREEVI in autoimmune PAP [17] [US • 22 Dec 2025]
https://finance.yahoo.com/news/savara-resubmits-biologics-license-application-133000634.html
Context: Requests Priority Review; Fujifilm named DS manufacturer.
Key point: Seeks FDA approval for GM-CSF-related rare lung disease therapy with prior expedited designations.
Implication: May influence prescriber choice and payer reviews pending full data.
🌬️ Windward Bio licenses Qyuns’ TSLP/IL-13 bispecific WIN027 [18] [22 Dec 2025]
Context: Ex-China rights; potential deal value up to $700M.
Key point: Long-acting bispecific for asthma, COPD, AD enters Windward pipeline alongside anti-TSLP WIN378.
Implication: Partnerships/BD: Signals pipeline investment and modality expansion.
Why it matters
- Pediatric expansion of IL-23 class and SC options in SLE may shift early-line biologic preferences in Europe.
- TYK2 momentum continues across PsO and CSU, but mixed readouts underscore indication-specific risk.
- Veterinary dermatology sees new IL-31 competition, affecting practice stocking and price dynamics.
- Practice-automation partnerships point to admin-burden relief and tighter follow-up loops in dermatology.
- Patent and licensing moves set up 2026–2028 study starts and competitive entries in IBD, respiratory, and derm.
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FAQ
What did the EU approve for ITP?
Sanofi’s Wayrilz (rilzabrutinib) received EC approval for adult ITP refractory to other treatments, supported by LUNA 3 showing durable platelet responses [1]. May influence payer reviews pending full data.
Is TREMFYA now available for children in the EU?
Yes. The EC extended guselkumab to ages 6+ with moderate to severe plaque psoriasis, based on PROTOSTAR, marking the first IL-23 inhibitor with a pediatric indication [3].
How strong are Takeda’s Phase 3 psoriasis results for zasocitinib?
Topline indicates all primary and 44 ranked secondary endpoints were met through Week 16 with consistent safety. Full datasets are pending presentation and filings start FY2026 [5].
What’s new for Saphnelo in Europe?
Anifrolumab gained EC approval for a subcutaneous self-administered pre-filled pen in SLE, offering an at-home alternative to IV with similar clinical benefit per TULIP-SC [4].
What TYK2 programs advanced in China?
InnoCare secured NMPA approvals for a Phase 2 CLE trial of ICP-488 and a Phase II/III CSU trial of soficitinib, expanding its dermatology portfolio [14][16].
What is Befrena and how does it compare?
Elanco’s Befrena (tirnovetmab, anti-IL-31) is USDA-approved for canine allergic and atopic dermatitis with a recommended 6–8 week dosing interval, positioned against lokivetmab’s 4–8 weeks [12].
Entities / Keywords
Sanofi Wayrilz, rilzabrutinib, ITP; Johnson & Johnson, JNJ-5939, DUPLEX-AD; TREMFYA, guselkumab, pediatric psoriasis; AstraZeneca Saphnelo, anifrolumab, SLE SC; Takeda zasocitinib, TAK-279, TYK2; Regenexx Bangladesh regenerative rheumatology; Soligenix SGX945, dusquetide, Behçet’s; Palisade Bio PALI-2108, PDE4, UC, FSCD; Bonsai Health, American Academy of Dermatology; French systemic psoriasis guidelines, IL-23p19, TYK2; Hoth HT-001 oncodermatology; Elanco Befrena, tirnovetmab, IL-31; Immutep IMP761 LAG-3 agonist; InnoCare ICP-488 CLE, soficitinib CSU; Galapagos GLPG3667 dermatomyositis, SLE; Savara MOLBREEVI autoimmune PAP; Windward Bio WIN027/QX027N TSLP-IL-13.
References
- https://www.sanofi.com/en/media-room/press-releases/2025/2025-12-23-14-06-58-3209943
- https://www.jnj.com/media-center/press-releases/johnson-johnson-statement-on-the-phase-2b-duplex-ad-study
- https://www.jnj.com/media-center/press-releases/european-commission-approves-tremfya-guselkumab-for-the-treatment-of-children-with-plaque-psoriasis-marking-the-first-paediatric-indication-for-an-il-23-inhibitor
- https://www.astrazeneca.com/media-centre/press-releases/2025/saphnelo-approved-in-the-eu-for-subcutaneous-self-administration-as-a-new-pre-filled-pen-for-systemic-lupus-erythematosus.html
- https://www.takeda.com/newsroom/newsreleases/2025/takeda-zasocitinib-phase-3-plaque-psoriasis-data-once-daily-pill/
- https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/regenexx-pain-solution-center-bangladesh-launches-advanced-regenerati-1122928
- https://www.prnewswire.com/news-releases/positive-clinical-results-from-phase-2-trial-of-sgx945-for-the-treatment-of-behcets-disease-published-in-rheumatology-oxford-302645452.html
- https://www.globenewswire.com/news-release/2025/12/30/3211395/0/en/Palisade-Bio-Announces-Granting-of-Japanese-Patent-Covering-Composition-of-Matter-for-Lead-Product-Candidate-PALI-2108.html
- https://www.businesswire.com/news/home/20251222345844/en/Bonsai-Health-Announces-Strategic-Partnership-with-the-American-Academy-of-Dermatology-to-Advance-AI-Powered-Practice-Automation
- https://www.dermatologytimes.com/view/french-guidelines-updated-to-reflect-advances-in-systemic-psoriasis-therapy
- https://www.prnewswire.com/news-releases/hoth-therapeutics-expands-oncology-pipeline-with-dual-patent-filings-establishing-novel-oncology-dermatology-ip-platform-302651580.html
- https://www.prnewswire.com/news-releases/elanco-receives-usda-approval-for-befrena-tirnovetmab-a-new-anti-il31-monoclonal-antibody-injection-targeting-canine-allergic-and-atopic-dermatitis-302651357.html
- https://www.globenewswire.com/news-release/2025/12/22/3209162/0/en/Immutep-Announces-Positive-Update-on-IMP761-a-First-in-Class-LAG-3-Agonist-Antibody-for-Autoimmune-Diseases-from-Phase-I-Study.html
- https://www.globenewswire.com/news-release/2025/12/23/3209721/0/en/InnoCare-Announces-NMPA-Approval-of-a-Phase-II-Clinical-Trial-of-TYK2-Inhibitor-ICP-488-for-Cutaneous-Lupus-Erythematosus.html
- https://www.fiercebiotech.com/biotech/galapagos-ends-turbulent-year-mixed-results-last-remaining-immunology-asset
- https://www.globenewswire.com/news-release/2025/12/18/3207397/0/en/InnoCare-Announces-Approval-of-Phase-II-III-Clinical-Trial-of-Novel-TYK2-Inhibitor-Soficitinib-for-Chronic-Spontaneous-Urticaria-in-China.htmlhttps://finance.yahoo.com/news/savara-resubmits-biologics-license-application-133000634.html
- https://www.fiercebiotech.com/biotech/novo-holdings-backed-windward-buys-rights-qyuns-clinical-stage-immunology-bispecific-700m