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J&J Expands New Drug Portfolio With Icotyde's FDA Approval
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Key Takeaways
J&J secures FDA approval for Icotyde, an oral IL-23 inhibitor for moderate-to-severe plaque psoriasis.
Icotyde showed strong skin clearance and safety across four phase III ICONIC studies
The once-daily pill offers an alternative to injectables, improving convenience and adherence.
Johnson & Johnson (JNJ - Free Report) rapidly advanced its pipeline in 2025, attaining significant clinical and regulatory milestones that will help drive growth through the back half of the decade. In 2025, it gained approval for new products like Inlexzoh/TAR-200 for treating high-risk non-muscle invasive bladder cancer and Imaavy (nipocalimab) for treating generalized myasthenia gravis.
Inlexzoh is a first-of-its-kind drug-releasing system that provides sustained local delivery of cancer treatment directly into the bladder. Nipocalimab, an FcRn blocker, is also being evaluated for various immune-mediated conditions. It is under review in the United States for warm autoimmune hemolytic anemia, in late-stage studies for hemolytic disease of the fetus and newborn, and Sjogren’s disease, and in mid-stage studies for idiopathic inflammatory myopathy and systemic lupus erythematosus. J&J believes that nipocalimab has a pipeline-in-a-product potential.
The positive trend of new drug approvals continued in 2026 with the FDA approving J&J and partner Protagonist Therapeutics’ (PTGX - Free Report) icotrokinra, an oral targeted peptide inhibitor of the IL-23 receptor, to be marketed as Icotyde, for treating adults and pediatric patients aged 12 years and above with moderate-to-severe plaque psoriasis (PsO) in the United States.
Icotyde’s approval 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 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.
Icotyde was co-discovered by Protagonist and J&J, with J&J holding exclusive global rights for its late-stage development and commercialization across multiple indications.
J&J believes that Icotyde/icotrokinra has the potential to revolutionize the treatment of plaque psoriasis as it is a once-a-day pill whereas most currently available effective options for treating plaque psoriasis are injectables, like AbbVie’s (ABBV - Free Report) popular injection, Skyrizi, and J&J’s own injection, Tremfya.
Icotyde offers a compelling advantage over existing plaque psoriasis treatments by combining biologic-level precision with the convenience of an oral pill. Unlike injectable IL-23 biologics, such as Skyrizi and Tremfya, it eliminates the need for injections, improving patient comfort and adherence. AbbVie’s shares declined 5.2% on Wednesday in response to Icotyde’s approval. Icotyde is also under review in the EU for the plaque psoriasis indication.
Icotrokinra is also being evaluated in phase III studies for ulcerative colitis and psoriatic arthritis and in phase II for Crohn’s Disease.
Inlexzoh, Icotyde and Imaavy are among 10 of J&J’s new drugs which the company believes have the potential to deliver peak sales of $5 billion. Other new products with similar potential are Talvey, Tecvayli, Caplyta and Rybrevant plus Lazcluze.
Back in January, J&J had said that it expects a more pronounced impact from new products in 2026 than 2025. J&J’s steady stream of approvals, capped by Icotyde’s FDA nod, underscores the strength of its late-stage pipeline and its focus on high-impact therapies.
JNJ’s Price Performance, Valuation and Estimates
J&J’s shares have outperformed the industry over the past year. The stock has risen 45.6% in the past year compared with an 8.0% appreciation of the industry.
Image Source: Zacks Investment Research
From a valuation standpoint, J&J is slightly expensive. Going by the price/earnings ratio, the company’s shares currently trade at 20.23 forward earnings, higher than 17.25 for the industry. The stock is also trading above its five-year mean of 15.65.
Image Source: Zacks Investment Research
The Zacks Consensus Estimate for 2026 earnings has risen from $11.46 to $11.54 over the past 60 days, while that for 2027 earnings has gone up from $12.25 per share to $12.44 over the same time frame.
View the Zacks #1 Rank List
Image: Bigstock
J&J Expands New Drug Portfolio With Icotyde's FDA Approval
Key Takeaways
Johnson & Johnson (JNJ - Free Report) rapidly advanced its pipeline in 2025, attaining significant clinical and regulatory milestones that will help drive growth through the back half of the decade. In 2025, it gained approval for new products like Inlexzoh/TAR-200 for treating high-risk non-muscle invasive bladder cancer and Imaavy (nipocalimab) for treating generalized myasthenia gravis.
Inlexzoh is a first-of-its-kind drug-releasing system that provides sustained local delivery of cancer treatment directly into the bladder. Nipocalimab, an FcRn blocker, is also being evaluated for various immune-mediated conditions. It is under review in the United States for warm autoimmune hemolytic anemia, in late-stage studies for hemolytic disease of the fetus and newborn, and Sjogren’s disease, and in mid-stage studies for idiopathic inflammatory myopathy and systemic lupus erythematosus. J&J believes that nipocalimab has a pipeline-in-a-product potential.
The positive trend of new drug approvals continued in 2026 with the FDA approving J&J and partner Protagonist Therapeutics’ (PTGX - Free Report) icotrokinra, an oral targeted peptide inhibitor of the IL-23 receptor, to be marketed as Icotyde, for treating adults and pediatric patients aged 12 years and above with moderate-to-severe plaque psoriasis (PsO) in the United States.
Icotyde’s approval 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 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.
Icotyde was co-discovered by Protagonist and J&J, with J&J holding exclusive global rights for its late-stage development and commercialization across multiple indications.
J&J believes that Icotyde/icotrokinra has the potential to revolutionize the treatment of plaque psoriasis as it is a once-a-day pill whereas most currently available effective options for treating plaque psoriasis are injectables, like AbbVie’s (ABBV - Free Report) popular injection, Skyrizi, and J&J’s own injection, Tremfya.
Icotyde offers a compelling advantage over existing plaque psoriasis treatments by combining biologic-level precision with the convenience of an oral pill. Unlike injectable IL-23 biologics, such as Skyrizi and Tremfya, it eliminates the need for injections, improving patient comfort and adherence. AbbVie’s shares declined 5.2% on Wednesday in response to Icotyde’s approval. Icotyde is also under review in the EU for the plaque psoriasis indication.
Icotrokinra is also being evaluated in phase III studies for ulcerative colitis and psoriatic arthritis and in phase II for Crohn’s Disease.
Inlexzoh, Icotyde and Imaavy are among 10 of J&J’s new drugs which the company believes have the potential to deliver peak sales of $5 billion. Other new products with similar potential are Talvey, Tecvayli, Caplyta and Rybrevant plus Lazcluze.
Back in January, J&J had said that it expects a more pronounced impact from new products in 2026 than 2025. J&J’s steady stream of approvals, capped by Icotyde’s FDA nod, underscores the strength of its late-stage pipeline and its focus on high-impact therapies.
JNJ’s Price Performance, Valuation and Estimates
J&J’s shares have outperformed the industry over the past year. The stock has risen 45.6% in the past year compared with an 8.0% appreciation of the industry.
From a valuation standpoint, J&J is slightly expensive. Going by the price/earnings ratio, the company’s shares currently trade at 20.23 forward earnings, higher than 17.25 for the industry. The stock is also trading above its five-year mean of 15.65.
The Zacks Consensus Estimate for 2026 earnings has risen from $11.46 to $11.54 over the past 60 days, while that for 2027 earnings has gone up from $12.25 per share to $12.44 over the same time frame.
J&J has a Zacks Rank #3 (Hold) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.