This week’s Immunology update summarizes covering clinical-trial readouts and long-term follow-up data, plus regulatory filings and pipeline-development moves. Updates include late-stage trial milestones, conference data highlights, and market access or launch activity.
In Today’s Newsletter
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🧴 Taltz + Zepbound topline in psoriasis plus obesity/overweight [1] [US • 18 Feb 2026]
Context: TOGETHER-PsO open-label Phase 3b in adults with moderate-to-severe plaque psoriasis and obesity/overweight (Week 36 readout).
Key point: Concomitant Taltz (ixekizumab) plus Zepbound (tirzepatide) met superiority vs Taltz alone on complete skin clearance (PASI 100) and at least 10% weight loss, Lilly reported.
Implication: May influence prescriber choice and payer reviews pending full data.
💊 Alembic launches PIVYA (pivmecillinam) in the US [2] [US • 18 Feb 2026]
Context: PIVYA (pivmecillinam) is a beta-lactam antibacterial with long international use, Alembic said.
Key point: Alembic Therapeutics announced US prescription availability of PIVYA tablets (185 mg) for uncomplicated UTI in women 18+ caused by susceptible E. coli, Proteus mirabilis, and Staphylococcus saprophyticus.
Implication: Introduces competition that may affect pricing and formulary access.
🧫 Novartis remibrutinib meets Phase 3 endpoint in chronic inducible urticaria [3] [CH • 18 Feb 2026]
Context: RemIND pivotal Phase 3 trial across symptomatic dermographism, cold urticaria, and cholinergic urticaria (Week 12 endpoint).
Key point: Novartis said oral remibrutinib (BTK inhibitor) achieved significantly higher complete response rates vs placebo, and Novartis filed an sNDA with FDA for symptomatic dermographism.
Implication: May influence prescriber choice and payer reviews pending full data.
🧒 Alphyn starts Phase 2 dosing for topical zabalafin in molluscum contagiosum [4] [AU–LatAm • 18 Feb 2026]
Context: Randomized, double-blind, placebo-controlled Phase 2, 54 patients ages 6 months+, sites in Australia and Latin America (16-week dosing).
Key point: Alphyn Biologics dosed first patients with Zabalafin Hydrogel, primary endpoint is elimination of at least 75% of lesions, per the company.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Stoked Bio licenses Enterololin IP to pursue Crohn’s disease development [5] [CA • 18 Feb 2026]
Context: Exclusive global license from McMaster University for patents covering Enterololin, Stoked Bio said.
Key point: Stoked Bio plans to develop Enterololin (narrow-spectrum antibiotic) as a potential therapy for conditions including Crohn’s disease, citing selective targeting of adherent-invasive E. coli.
Implication: Signals pipeline investment and modality expansion.
🥜 AAAAI flags pediatric multi-food allergy comorbidity clusters [6] [US • 19 Feb 2026]
Context: NIAID-supported multi-site longitudinal cohort of children under 12 with allergist-confirmed food allergy (analysis n=1,382).
Key point: Researchers reported high comorbidity between certain tree-nut pairs (cashew–pistachio, walnut–pecan) and identified three multi-food allergy clusters, per AAAAI.
Implication: Could inform practice and payer discussions; interpretation depends on study design and confounding control.
🩺 Takeda ENTYVIO Phase 3 pediatric UC remission at Week 54 [7] [JP • 19 Feb 2026]
https://www.takeda.com/newsroom/newsreleases/2026/entyvio-phase-3-pediatric-data/
Context: KEPLER pivotal Phase 3 in ages 2–17 with inadequate response to conventional therapy and/or TNF antagonists (open-label induction then randomized maintenance).
Key point: Takeda reported 47.3% clinical remission at Week 54 in randomized patients, and said it plans marketing applications in the US, EU, and other markets for pediatric UC.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Sanofi–Teva duvakitug Phase 2b LTE maintenance readout in UC and Crohn’s [8] [FR–US • 17 Feb 2026]
https://www.sanofi.com/en/media-room/press-releases/2026/2026-02-17-11-00-00-3239014
Context: RELIEVE UCCD LTE (NCT05668013), maintenance after Week 14 induction response, 44-week additional follow-up.
Key point: Sanofi and Teva said duvakitug (anti-TL1A mAb) maintained durable clinical and endoscopic outcomes in UC and Crohn’s disease, with tolerability consistent with induction.
Implication: May influence prescriber choice and payer reviews pending full data.
🧷 J&J TREMFYA shows 3-year durability in UC in QUASAR LTE [9] [SE • 21 Feb 2026]
Context: QUASAR long-term extension, outcomes through Week 140, presented at ECCO 2026, per J&J.
Key point: J&J reported sustained clinical remission and endoscopic outcomes through Week 140 for TREMFYA (guselkumab) in adults with moderately to severely active UC (percentages reported in source).
Implication: May influence prescriber choice and payer reviews pending full data.
🫁 Savara MOLBREEVI BLA filed with Priority Review in autoimmune PAP [10] [US • 20 Feb 2026]
Context: FDA accepted BLA for MOLBREEVI in autoimmune pulmonary alveolar proteinosis (autoimmune PAP), Savara said.
Key point: Savara reported Priority Review and a PDUFA target action date of 22 Aug 2026, and stated plans to submit MAAs to EMA and MHRA by end of Q1 2026.
Implication: Regulatory/generics: Introduces competition that may affect pricing and formulary access.
Why it matters
- Immunology and IBD remain crowded, durability signals (J&J TREMFYA, Sanofi–Teva duvakitug) and pediatric expansion (Takeda ENTYVIO) could shift treatment sequencing and payer frameworks. [7–9]
- Combination strategies that address comorbid disease burden (Lilly Taltz + Zepbound) may push guidelines and care pathways toward integrated management. [1]
- Regulatory momentum (Savara autoimmune PAP Priority Review) can reshape rare-disease standards of care and market entry timelines. [10]
- Targeted anti-infectives and microbiome-sparing approaches (Stoked Bio Enterololin, Alembic pivmecillinam) highlight renewed interest in narrower-spectrum options. [2,5]
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FAQ
What is the clinical claim behind Lilly’s Taltz (ixekizumab) plus Zepbound (tirzepatide) combo in TOGETHER-PsO?
Lilly reported Phase 3b topline superiority vs Taltz alone at Week 36 on PASI 100 and at least 10% weight loss (trial is open-label). Full dataset is pending publication. [1]
What did Novartis say about remibrutinib in chronic inducible urticaria (CIndU)?
Novartis said the Phase 3 RemIND trial met the primary endpoint across three CIndU types at Week 12, and Novartis filed an FDA sNDA for symptomatic dermographism. [3]
How strong is the pediatric ulcerative colitis signal for ENTYVIO (vedolizumab) in KEPLER?
Takeda reported clinical remission at Week 54 in 47.3% of randomized patients (after induction response), with a safety profile generally consistent with adults, and plans US and EU submissions. [7]
What is duvakitug (Sanofi, Teva), and what was shown in the RELIEVE UCCD LTE?
Duvakitug is an investigational anti-TL1A monoclonal antibody. Sanofi and Teva reported durable maintenance efficacy over an additional 44 weeks in UC and Crohn’s disease among induction responders (detailed results pending). [8]
What does QUASAR LTE add for TREMFYA (guselkumab) in ulcerative colitis?
J&J reported sustained outcomes through Week 140 in the QUASAR long-term extension, including clinical and endoscopic measures (as reported), with no new safety concerns stated. [9]
What is the FDA timeline for Savara’s MOLBREEVI in autoimmune PAP?
Savara said FDA filed the BLA with Priority Review and set a PDUFA target action date of 22 Aug 2026, and the company plans EMA and MHRA submissions by end of Q1 2026. [10]
Entities / Keywords
Eli Lilly and Company (Lilly, LLY), Taltz (ixekizumab), Zepbound (tirzepatide), TOGETHER-PsO
Alembic Therapeutics, PIVYA (pivmecillinam), uUTI (uncomplicated urinary tract infection)
Novartis, remibrutinib, BTK inhibitor, RemIND, CIndU (chronic inducible urticaria), symptomatic dermographism
Alphyn Biologics, Zabalafin Hydrogel, molluscum contagiosum
Stoked Bio, Enterololin, McMaster University, adherent-invasive E. coli (AIEC), Crohn’s disease
AAAAI, food allergy, tree nut allergy, NIAID cohort
Takeda, ENTYVIO (vedolizumab), KEPLER, pediatric ulcerative colitis
Sanofi, Teva, duvakitug, TL1A, RELIEVE UCCD LTE, UC, Crohn’s disease
Johnson & Johnson, TREMFYA (guselkumab), QUASAR LTE, ECCO 2026, ulcerative colitis
Savara, MOLBREEVI, autoimmune PAP, BLA, Priority Review, PDUFA 22 Aug 2026, EMA, MHRA
