Johnson & Johnson Submits Icotrokinra Drug Application to FDA for Approval

Johnson & Johnson (JNJ) has submitted an application to the FDA for approval of icotrokinra, a new drug to inhibit the IL-23 receptor. Analysts forecast an average target price of $175.26, with a high estimate of $193.00 and a low estimate of $150.00. The company reported strong operational sales growth of 4.6% in Q2 2025 and exceeded $15 billion in quarterly sales for the first time.

Johnson & Johnson (JNJ) has made significant strides in the field of dermatology by submitting an application to the U.S. Food and Drug Administration (FDA) for the approval of icotrokinra, a first-in-class investigational oral peptide targeting the IL-23 receptor. The drug is designed to treat adults and adolescents aged 12 and older with moderate to severe plaque psoriasis (PsO).

Icotrokinra is part of Johnson & Johnson's ICONIC clinical development program, which includes multiple Phase 3 studies such as ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 & 2. The studies have demonstrated that icotrokinra meets all primary and co-primary endpoints, showing significant skin clearance and a favorable safety profile. Notably, results from the ICONIC-ADVANCE 1 & 2 studies indicate that icotrokinra outperforms deucravacitinib in patients with moderate-to-severe plaque PsO.

The company's latest submission to the FDA includes comprehensive data from these pivotal studies, which collectively enrolled over 1,000 participants. Pooled safety data from the studies show no new safety signals and a similar proportion of patients experiencing adverse events (AEs) between icotrokinra and placebo groups.

Analysts have forecasted an average target price of $175.26 for icotrokinra, with high and low estimates of $193.00 and $150.00, respectively. This positive outlook is bolstered by Johnson & Johnson's strong operational sales growth of 4.6% in Q2 2025, which resulted in quarterly sales exceeding $15 billion for the first time.

Johnson & Johnson's pursuit of icotrokinra reflects its commitment to innovation in healthcare, particularly in treating complex immune-mediated diseases. The company's collaboration with Protagonist Therapeutics, Inc., has been instrumental in the discovery and development of this next-generation compound.

References:
[1] https://www.jnj.com/media-center/press-releases/johnson-johnson-seeks-first-icotrokinra-u-s-fda-approval-aiming-to-revolutionize-treatment-paradigm-for-adults-and-adolescents-with-plaque-psoriasis