J&Js, Oral

J&J's Oral Psoriasis Drug Clears Late-Stage Hurdle as Orthopedics Deal Talks Collapse

Published on 11/08/2026 at 05:02 | Editorial boerse-global.de
J&J's oral ICOTYDE met Phase 3 psoriatic arthritis endpoints, with 58% achieving ACR20 versus 41% on placebo, supporting a $5 billion-plus peak sales forecast.
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Johnson & Johnson has posted positive Phase 3 results for its oral drug ICOTYDE in adults with active psoriatic arthritis who had not previously received biologics, a readout that gives the company fresh clinical backing for a franchise it expects to generate peak sales above $5 billion across multiple indications.

In the ICONIC-PsA 1 trial, which enrolled 552 adults, 58% of patients on ICOTYDE hit the primary ACR20 response measure after 16 weeks, compared with 41% on placebo. The drug, whose active ingredient is icotrokinra and which is taken once daily by mouth, also beat placebo on the stricter ACR50 and ACR70 yardsticks — evidence that the benefit was not confined to the primary endpoint.

Skin outcomes reinforced the case. Among patients with sufficient skin involvement, 57% on ICOTYDE achieved clear or almost clear skin versus 14% on placebo. By week 24, 69% of treated patients had reached the primary response threshold, and J&J reported no new safety signals through that point. The data were presented as a late-breaking poster at ACR Convergence 2026.

The results matter commercially because ICOTYDE is already approved for moderate-to-severe plaque psoriasis. A green light in psoriatic arthritis would push it into competition with injectable biologics and other oral therapies — and the $5 billion-plus peak sales figure reported by Reuters spans several indications combined, meaning it depends on wider use and on the drug holding its own against rivals. For now, psoriatic arthritis is not an approved indication, making the transfer of trial success into an additional authorized use the next economically decisive step.

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A Second Win, and a Pipeline Update

The psoriatic arthritis readout follows Tuesday's news that the Phase 3 ICONIC-ASCEND study of ICOTYDE in plaque psoriasis met both of its co-primary endpoints at 16 weeks. Under ICOTYDE, 70.4% of patients achieved an IGA score of zero or one, against 9.5% on placebo, while 55.2% reached PASI 90 compared with 3.6% for placebo.

J&J also released findings Wednesday from the Phase 2 DAHLIAS study of Nipocalimab in patients with Sjögren's disease. Improvement in dry mouth emerged as the symptom change patients valued most, and the company said the insights have been folded into the design of the ongoing Phase 3 DAFFODIL trial.

Orthopedics Tie-Up Falls Apart

Away from the clinic, Smith+Nephew confirmed Wednesday that talks over a combination with J&J's orthopedics unit have ended. Reuters reported the negotiations foundered on differing views over who would lead the merged business, leaving the two sides without an agreement.

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Timing is worth flagging for shareholders: the psoriatic arthritis announcement landed after Friday's session, so that day's share move cannot be read as a reaction to the release. J&J stock rose 2.0% on Wednesday, though the company did not draw any link between the share price move and the study announcements.

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