JNJ Seeks FDA Approval for Oral Psoriasis Drug Icotrokinra

Johnson & Johnson JNJ announced that it has submitted a new drug application (NDA) to the FDA seeking approval for its investigational oral peptide, icotrokinra, for treating moderate-to-severe plaque psoriasis (PsO) in adults and pediatric patients aged 12 years and above.

The NDA was based on data from four phase III studies, ICONIC-LEADa, ICONIC-TOTALb and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 – all part of the ICONIC clinical development program evaluating icotrokinra, a IL-23 inhibitor across PsO and psoriatic arthritis indications.

Across the four pivotal studies, treatment with icotrokinra achieved all primary and co-primary endpoints by showing significant skin clearance and a favorable safety profile with once-daily oral dosing in adults and adolescents with moderate-to-severe plaque PsO.

Previously, data from the ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2 studies, which evaluated icotrokinra against Bristol Myers’ BMY psoriasis drug, Sotyktu (deucravacitinib), also met the co-primary endpoints. The studies demonstrated the icotrokinra’s superiority over Bristol Myers’ Sotyktu.

JNJ's Price Performance

Shares of J&J have rallied 13.7% so far this year against the industry’s decline of 2.1%.

Given its rapid development and strong clinical data reported to date, management believes icotrokinra has the potential to change the treatment landscape for plaque psoriasis and can position itself as the new standard in the treatment of the disease.

Icotrokinra is uniquely engineered to block the IL-23 receptor, a key driver of inflammation in plaque psoriasis, with potential applications in other IL-23-driven diseases. Upon potential approval, icotrokinra might become a convenient and effective new treatment option for patients with psoriasis.

JNJ's Ongoing Development Activities With Icotrokinra

Icotrokinra is being jointly developed by J&J and Protagonist Therapeutics PTGX under a license and collaboration agreement signed in 2017. Per the terms, J&J holds exclusive worldwide rights to develop the drug in phase II studies and beyond.

Besides dermatology, J&J and Protagonist are also exploring icotrokinra’s potential in the inflammatory bowel disease space.

Earlier this year, JNJ and PTGX reported positive results from the phase IIb ANTHEM-UC study, which evaluated icotrokinra in adults with moderately to severely active ulcerative colitis. The study met its primary endpoint of clinical response across all dose groups.

Given that icotrokinra has already demonstrated superiority over BMY’s Sotyktu, J&J is now conducting the phase III ICONIC-ASCEND study — a head-to-head study comparing icotrokinra with its own blockbuster immunology drug, Stelara (ustekinumab) — in patients with moderate-to-severe plaque psoriasis. With icotrokinra, J&J aims to offer a more convenient oral alternative to Stelara, which is injection-based and currently facing generic erosion in the United States.

JNJ's Zacks Rank & Another Stock to Consider

J&J currently carries a Zacks Rank #2 (Buy).

A top-ranked stock in the biotech sector is Arvinas ARVN, sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Arvinas’ 2025 loss per share have narrowed from $1.60 to $1.51. Loss per share estimates for 2026 have narrowed from $3.28 to $2.98 during the same period. ARVN stock has plunged 60.7% year to date.

Arvinas’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 82.09%.

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