Johnson & Johnson (JNJ) Gains FDA Nod for Subcutaneous Tremfya in Ulcerative Colitis
J&JJ&J(US:JNJ) Yahoo Finance·2025-09-23 23:02

Core Insights - Johnson & Johnson (NYSE: JNJ) is recognized as one of the top pharmaceutical stocks to buy, demonstrating strong stock performance and growth in its pharmaceuticals and immunology portfolio in 2025 [1]. Regulatory Approvals and Clinical Developments - The company received FDA approval for a subcutaneous induction regimen of Tremfya (guselkumab) for treating adults with ulcerative colitis, marking it as the first and only IL-23 inhibitor with a fully subcutaneous regimen, which showed significant clinical remission in Phase 3 trials [2]. - In Europe, JNJ is advancing nipocalimab, an investigational FcRn blocker for antibody-positive generalized myasthenia gravis, with promising late-stage trial data and pending European Commission approval [3]. - JNJ expanded its oncology portfolio with FDA approval of a new drug delivery system for bladder cancer, providing patients with a potential alternative to surgery [4]. Financial Performance - JNJ's shares have increased by 20% year-to-date, driven by pharmaceutical growth and reduced legal risks compared to previous years, although the company is still dealing with ongoing talc-related litigation [5].