Johnson & Johnson reports positive 48-week data for TREMFYA in UC treatment

NEW YORK - Johnson & Johnson (NYSE:JNJ) announced on Tuesday that its ulcerative colitis treatment TREMFYA (guselkumab) demonstrated clinically meaningful results in both clinical and endoscopic remission at 48 weeks in the Phase 3 ASTRO study.

Patients treated with subcutaneous TREMFYA achieved clinical remission rates of 36.7% and endoscopic remission rates of 25.9% at Week 48, significantly outperforming placebo rates of 7.2% and 5% respectively. This development comes as J&J maintains a strong gross profit margin of 68.4% and generates over $90 billion in annual revenue.

The data showed efficacy across both biologic-naïve and biologic-refractory patient groups, according to the company’s press release statement. TREMFYA is now the only IL-23 inhibitor with a fully subcutaneous regimen following recent FDA approval for subcutaneous induction in adults with ulcerative colitis.

"These results show that a fully subcutaneous regimen of guselkumab can deliver meaningful clinical and endoscopic benefits that are sustained for a full year, supporting long-term disease control in ulcerative colitis," said Prof. Silvio Danese of IRCCS Ospedale San Raffaele, a study investigator.

The ASTRO study evaluated TREMFYA subcutaneous induction therapy (400 mg at Weeks 0, 4, and 8) followed by maintenance dose regimens of either 100 mg every eight weeks or 200 mg every four weeks in adults with moderately to severely active ulcerative colitis.

Safety data from the study were consistent with TREMFYA’s established safety profile, the company reported.

TREMFYA has received FDA and European Commission approval for both subcutaneous and intravenous induction options for Crohn’s disease, and FDA approval for both options in ulcerative colitis treatment.

The findings were presented at the United European Gastroenterology Week 2025 among 20 Johnson & Johnson abstracts.

In other recent news, Johnson & Johnson announced promising results from its Phase 2b study of the investigational oral drug icotrokinra for ulcerative colitis. The study, ANTHEM-UC, showed a clinical response at Week 12 for all three tested doses, with the highest dose achieving a 63.5% response rate. Additionally, the company presented data at the American Academy of Optometry’s annual meeting indicating that its ACUVUE OASYS MAX 1-Day for ASTIGMATISM contact lenses outperformed competitors in patient-reported outcomes. In terms of stock evaluations, Wolfe Research raised its price target for Johnson & Johnson to $200, maintaining an Outperform rating, highlighting growth opportunities in the company’s Innovative Medicine franchise. Bernstein also increased its price target to $193, acknowledging the company’s early achievement of its Innovative Medicine sales target. Guggenheim reiterated a Buy rating with a $206 price target, expressing enthusiasm for Johnson & Johnson’s recently approved bladder cancer treatment, Inlexzo. These developments reflect the company’s ongoing advancements in both pharmaceuticals and consumer health products.

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