Profile review: 2026-11-04 · Fields retain their individual source dates. Undisclosed values are not zero; early or historical events do not establish the latest financing. Awards and acquisitions are distinguished from equity rounds.
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Technology, programs & evidence
FDA confirms ICOTYDE's psoriasis approval. J&J's announcement describes the development collaboration with Protagonist.
Tablet-core excipients include silicon dioxide, crospovidone, magnesium stearate, and silicified microcrystalline cellulose. The label does not identify these as a dedicated permeation-enhancing system.
A high-fat meal reduced AUC by 43% and Cmax by 59%; the label requires fasting administration. A separate Phase 2b UC publication does not establish approval for that indication.
2026-09-21: ICOTYDE receives EU authorization for eligible patients with plaque psoriasis
Triastek and its Shanghai subsidiary entered a collaboration and license agreement with Janssen Pharmaceutica NV to develop oral medicines using 3D printing and delivery technologies for peptides and other modalities. JJDC will also make an equity investment. Financial terms and named collaboration candidates were undisclosed, and the agreement does not establish clinical performance for T25.
Johnson & Johnson reported Week 112 results from ICONIC-LEAD in adults and adolescents with moderate-to-severe plaque psoriasis. The company said skin clearance and patient-reported improvements remained sustained, with no new safety signals identified. The update adds longer-term evidence for an oral IL-23 receptor peptide, although company-reported follow-up does not eliminate ongoing safety monitoring needs.
Johnson & Johnson announced European Commission authorization of ICOTYDE on September 21; EMA records the authorization date as September 18. Eligible patients include adults and adolescents aged at least 12 years weighing at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. This regional authorization does not approve other inflammatory indications.
FDA approved icotrokinra, marketed as ICOTYDE, on March 17; Johnson & Johnson announced the decision the following day. The once-daily oral IL-23 receptor antagonist is indicated for eligible adults and patients aged 12 or older weighing at least 40 kg with moderate-to-severe plaque psoriasis. The approval does not extend to ulcerative colitis or other investigational indications.
Ahead of the AHA meeting, an original report reviewed enlicitide analyses across PREVENT cardiovascular risk groups and an open-label extension. LDL cholesterol reductions were broadly consistent across risk categories and persisted through Week 104. The extension selected participants who had tolerated and adhered to treatment and lacked a control group, limiting generalization of its long-term findings.
Aurinia reported LUPKYNIS net product sales of $232.4 million for the nine months ended September 30, 2026, up 18%, including $79.4 million in the third quarter, up 12%. Total company revenue also includes licensing, collaboration, and royalty income. These are commercialization results for an approved oral cyclic peptide, rather than a new indication approval or clinical endpoint readout.
A new review connects peptide structure, formulation, screening, and pharmacokinetic testing in an evidence-based framework for oral drug discovery. It distinguishes architecture-led libraries, oral optimization of existing hits, and hybrid approaches. The scope includes cyclic and noncyclic peptides; the proposed framework organizes development evidence rather than demonstrating a new therapy or clinical benefit.
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