This week’s Immunology update highlights regulatory approvals, Phase 3 progress, financing, acquisitions, and dermatology pipeline advances.
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💊 STELARA gains FDA pediatric Crohn’s disease approval [1] [US • 01 May 2026]
https://www.jnj.com/media-center/press-releases/stelara-pediatric-crohns-disease-fda-approval-j-j-statement
Context: FDA approved STELARA (ustekinumab, J&J; IL-12/23 antagonist) on 15 Apr 2026 for patients aged two years and older with moderately to severely active Crohn’s disease.
Key point: Approval was based on Phase 3 UNITI-Jr, a 52-week pediatric Crohn’s disease study including induction and maintenance periods.
Implication: May influence prescriber choice and payer reviews pending full data.
🧬 Merck doses first patient in Phase 3 ELOWEN lupus program [2] [Global • 30 Apr 2026]
https://www.biospace.com/press-releases/merck-announces-first-dose-in-phase-3-study-with-enpatoran-for-lupus-patients-with-active-skin-manifestations
Context: ELOWEN-1 and ELOWEN-2 are global randomized, double-blind, placebo-controlled Phase 3 studies in lupus patients with active cutaneous manifestations.
Key point: Merck dosed the first patient for enpatoran, an oral selective TLR7/8 inhibitor, with change in CLASI-A from baseline as the primary endpoint.
Implication: May influence prescriber choice and payer reviews pending full data.
🧪 Richter receives EC approval for Tuyory biosimilar tocilizumab [3] [EU • 29 Apr 2026]
https://www.gedeonrichter.com/en/news/260429
Context: Gedeon Richter and Mochida Pharmaceutical developed Tuyory, a biosimilar to RoActemra (tocilizumab).
Key point: The European Commission granted marketing authorization for Tuyory in multiple indications, applicable in the EU, Iceland, Liechtenstein, and Norway.
Implication: Introduces competition that may affect pricing and formulary access.
💰 Novo Holdings joins Windward Bio $165 million crossover financing [4] [04 May 2026]
https://novoholdings.dk/news/novo-holdings-joins-165-million-crossover-financing-for-windward-bio-to-advance-pipeline-of-long-acting-immunology-therapies-with-best-in-disease-potential
Context: Windward Bio is advancing WIN378, an ultra long-acting anti-TSLP antibody, and WIN027, a long-acting bispecific targeting TSLP and IL-13.
Key point: Novo Holdings joined an upsized $165 million crossover financing to support WIN378 Phase 3 preparation and WIN027 respiratory and dermatology studies.
Implication: Signals pipeline investment and modality expansion.
🤝 UCB to acquire Candid Therapeutics for autoimmune T-cell engagers [5] [US • 03 May 2026]
https://www.businesswire.com/news/home/20260503595444/en/UCB-to-Acquire-Candid-Therapeutics-Building-Upon-Its-Existing-Immunology-Pipeline-With-Novel-T-cell-Engagers
Context: Candid Therapeutics’ lead asset, cizutamig, is a BCMA-CD3 bispecific T-cell engager in multiple Phase 1 studies across autoimmune diseases.
Key point: UCB agreed to acquire Candid Therapeutics for up to $2.2 billion, including $2 billion upfront and up to $200 million in milestones.
Implication: Signals pipeline investment and modality expansion.
🔬 Evotec nominates dermatology preclinical candidate with Almirall [6] [DE • 04 May 2026]
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/evotec-announces-nomination-of-first-preclinical-development-candidat-1163408
Context: Evotec and Almirall are collaborating on small molecule programs for immune-mediated inflammatory skin diseases.
Key point: The partners nominated a first preclinical development candidate from their dermatology alliance, progressing from initial leads to PDC within two years.
Implication: Signals pipeline investment and modality expansion.
🧫 LEO Pharma acquires Replay to expand rare dermatology gene therapy pipeline [7] [01 May 2026]
https://www.biopharminternational.com/view/leo-pharma-expands-rare-dermatology-pipeline-with-replay-gene-therapy-acquisition
Context: Replay is developing an HSV-based topical gene therapy platform for rare genetic skin diseases, with a preclinical program in dystrophic epidermolysis bullosa.
Key point: LEO Pharma acquired Replay, with terms including $50 million upfront plus development and commercial milestones and tiered royalties.
Implication: Signals pipeline investment and modality expansion.
Why it matters
- Pediatric inflammatory bowel disease options broadened with the FDA approval of STELARA for Crohn’s disease in patients aged two years and older. [1]
- Lupus and dermatology remain active clinical-development areas, with Merck advancing enpatoran into Phase 3 and Evotec-Almirall moving a small molecule toward IND-enabling work. [2][6]
- Biosimilar competition in inflammatory disease expanded in Europe with Tuyory, Richter’s biosimilar tocilizumab. [3]
- Immunology dealmaking remained strong, with Windward Bio financing long-acting cytokine-targeting antibodies and UCB acquiring Candid’s T-cell engager platform. [4][5]
- Rare dermatology innovation is moving into genetic medicine, with LEO Pharma adding Replay’s HSV-based topical delivery platform. [7]
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FAQ
What did FDA approve for STELARA in Crohn’s disease?
FDA approved STELARA (ustekinumab, J&J) for patients aged two years and older with moderately to severely active Crohn’s disease. The approval was based on Phase 3 UNITI-Jr. [1]
What is Merck’s ELOWEN program studying?
ELOWEN-1 and ELOWEN-2 are Phase 3 studies of enpatoran in lupus patients with active cutaneous manifestations. The primary endpoint is change in CLASI-A from baseline. [2]
What is Tuyory?
Tuyory is Gedeon Richter’s biosimilar to RoActemra (tocilizumab). The European Commission approved it for multiple indications across the EU, Iceland, Liechtenstein, and Norway. [3]
What assets are covered by Windward Bio’s financing?
Windward Bio’s financing supports WIN378, an anti-TSLP antibody in asthma and COPD development, and WIN027, a bispecific antibody targeting TSLP and IL-13. [4]
Why is UCB acquiring Candid Therapeutics?
UCB is acquiring Candid to add cizutamig, a BCMA-CD3 bispecific T-cell engager, and a broader autoimmune TCE pipeline. The transaction is valued at up to $2.2 billion. [5]
What does Replay add to LEO Pharma?
Replay adds an HSV-based topical gene therapy platform and a preclinical dystrophic epidermolysis bullosa program. Financial terms include $50 million upfront plus milestones and royalties. [7]
Entities / Keywords
STELARA, ustekinumab, Johnson & Johnson, J&J, IL-12/23 antagonist, Crohn’s disease, pediatric Crohn’s disease, UNITI-Jr
Merck, enpatoran, ELOWEN-1, ELOWEN-2, TLR7/8 inhibitor, lupus, cutaneous lupus, CLASI-A
Gedeon Richter, Richter, Mochida Pharmaceutical, Tuyory, RoActemra, tocilizumab, biosimilar, European Commission, EMA, CHMP
Novo Holdings, Windward Bio, WIN378, WIN027, TSLP, IL-13, asthma, COPD, atopic dermatitis, POLARIS, SIRIUS
UCB, Candid Therapeutics, cizutamig, BCMA, CD3, T-cell engager, TCE, autoimmune disease, immune reset
Evotec, Almirall, small molecule, preclinical development candidate, PDC, IND, INDiGO, immune-mediated inflammatory skin diseases
LEO Pharma, Replay, HSV vector, gene therapy, dystrophic epidermolysis bullosa, DEB, topical gel, rare dermatology
