JNJ's Tremfya Gets EU Approval for Pediatric Plaque Psoriasis

Johnson & Johnson JNJ announced that the European Commission (EC) has approved an expanded use of its blockbuster psoriasis drug, Tremfya, in children. Tremfya is now approved to treat pediatric and adolescent patients (aged 6 to 17 years) with moderate-to-severe plaque psoriasis (Pso) who are candidates for systemic therapy. With this approval, Tremfya becomes the first IL-23 inhibitor authorized for a pediatric indication in the European Union. The drug was approved in the EU in 2017 for the treatment of adults with moderate-to-severe plaque psoriasis.

The EC’s approval for pediatric use is based on data from the phase III PROTOSTAR study in pediatric psoriasis patients, along with bridging pharmacokinetic (PK) data from the phase III VOYAGE 1 and 2 studies conducted in adult psoriasis patients.

Over the past year, JNJ’s shares have risen 42.1% compared with the industry’s 16.1% rise.

Tremfya was approved in the United States in September this year for the treatment of plaque psoriasis in children and adolescents.

Psoriasis is a chronic, non-contagious skin disease characterized by rapid skin cell buildup, leading to red, itchy, scaly patches (plaques). Childhood psoriasis is often associated with other health problems such as obesity, high blood pressure, high cholesterol, diabetes, and psoriatic arthritis, which can further reduce a child’s overall quality of life.

What Did JNJ’s PROTOSTAR Study on Tremfya Demonstrate?

The PROTOSTAR study demonstrated statistically significant and clinically meaningful improvements in pediatric patients with psoriasis treated with Tremfya, compared with the children who received a placebo after 16 weeks of treatment. The study met the primary endpoints of Psoriasis Area Severity Index (PASI) 75 and Investigator’s Global Assessment (IGA) score of 0/1. Around 75% of the 41 patients treated with Tremfya achieved PASI 75, compared with 20% of the 25 patients receiving placebo at week 16. Additionally, 66% of Tremfya-treated patients achieved an IGA score of 0/1 versus 16% in the placebo arm.

Tremfya Is a Key Top-Line Driver for JNJ

Tremfya is currently approved for the treatment of adult patients with plaque psoriasis, active psoriatic arthritis, and inflammatory bowel diseases (IBD) such as ulcerative colitis (UC), and Crohn’s Disease (CD) in several countries, including the United States and the European Union.

Tremfya recorded product sales of $3.6 billion in the first nine months of 2025, up 31% year over year, driven by strong market growth across all indications, particularly the IBD indications (UC,CD).

Johnson & Johnson retains exclusive worldwide marketing rights to Tremfya.

JNJ’s Zacks Rank & Other Stocks to Consider

JNJ currently carries a Zacks Rank #2 (Buy).

Some other top-ranked stocks in the biotech sector are ANI Pharmaceuticals ANIP, CorMedix CRMD, and Castle Biosciences CSTL. ANIP, CRMD, and CSTL currently sport a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for ANI Pharmaceuticals’ 2025 adjusted EPS have increased from $7.29 to $7.56. Over the same period, EPS estimates for 2026 have surged from $7.81 to $8.08. Shares of ANIP have surged 49% in the past year.

ANI Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 21.24%.

Over the past 60 days, estimates for CorMedix’s 2025 EPS have increased from $1.85 to $2.87, while 2026 EPS estimates have risen from $2.49 to $2.88 over the same period. Shares of CRMD have surged 48.7% over the past year.

CorMedix’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 27.04%.

Over the past 60 days, the loss estimate for Castle Biosciences has narrowed from 64 cents to 34 cents in 2025. Over the same period, loss estimates for 2026 have improved from $1.82 to $1.06. CSTL stock has rallied 49.3% over the past year.

Castle Biosciences’ earnings beat estimates in three of the trailing four quarters and missed in the remaining quarter, with the average surprise being 66.11%.

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