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SPRING HOUSE, Pa. - Johnson & Johnson (NYSE: JNJ) announced today that its drug TREMFYA (guselkumab) has met the primary and major secondary endpoints in a Phase 3b APEX study for treating active psoriatic arthritis (PsA). The study demonstrated that TREMFYA reduced signs and symptoms of the disease and slowed the progression of joint damage after 24 weeks compared to a placebo.
The APEX study evaluated the efficacy of TREMFYA in adults with PsA who are at risk for structural damage. The drug, which is the only fully-human monoclonal antibody of its kind to block IL-23 and bind to CD64, has shown to inhibit the progression of structural damage as assessed by radiographic measures, including the PsA modified van der Heijde-Sharp score.
Terence Rooney, Vice President at Johnson & Johnson, emphasized the importance of early treatment to prevent irreversible joint damage in PsA patients. He noted that TREMFYA is the only IL-23 inhibitor that has demonstrated significant inhibition of structural damage, which is crucial for preserving joint health.
The APEX study’s long-term extension will continue to evaluate the sustained efficacy of TREMFYA over three years. The company plans to present the study’s findings at future medical congresses.
TREMFYA is approved in the U.S. and other countries for the treatment of adults with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active ulcerative colitis, and Crohn’s disease. Johnson & Johnson holds exclusive worldwide marketing rights to TREMFYA.
The safety profile of TREMFYA was consistent with previous studies, with no new safety signals identified. The most common side effects include respiratory tract infections, headaches, injection site reactions, and joint pain. With a history of raising dividends for 54 consecutive years and maintaining a 3.1% dividend yield, Johnson & Johnson demonstrates remarkable stability in its pharmaceutical operations. InvestingPro subscribers can access 8 additional key insights about J&J’s market position and financial outlook.
This announcement is based on a press release statement and provides a glimpse into the ongoing efforts to improve treatments for psoriatic arthritis, a chronic and potentially debilitating disease. Based on InvestingPro’s Fair Value analysis, Johnson & Johnson currently appears undervalued, presenting a potential opportunity for investors. Discover comprehensive insights and access the detailed Pro Research Report, part of InvestingPro’s coverage of over 1,400 US stocks, to make more informed investment decisions.
In other recent news, Johnson & Johnson has completed the acquisition of Intra-Cellular Therapies, integrating it into its Innovative Medicine division. This acquisition is expected to boost Johnson & Johnson’s sales growth by approximately 0.8% in 2025, contributing around $0.7 billion in incremental sales. Despite initial expectations of a $0.30 to $0.35 per share dilution in earnings, the company now forecasts a lesser impact of $0.25 per share for 2025 and $0.21 per share in 2026. In terms of analyst ratings, RBC Capital Markets has maintained its Outperform rating on Johnson & Johnson with a price target of $181, highlighting the potential of the RYBREVANT plus LAZCLUZE treatment in the lung cancer market. TD Cowen also reiterated a Buy rating with a price target of $185, despite recent legal challenges related to talc litigation. Moody’s has noted that Johnson & Johnson’s strong business profile and financial flexibility are helping to mitigate the impact of ongoing talc litigation. The company plans to address talc claims through the U.S. tort system after a proposed bankruptcy plan was not approved. These recent developments underscore Johnson & Johnson’s strategic focus on growth through innovation and its robust approach to managing legal and financial challenges.
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