J&J Gears Up for Some Key New Drug Approvals and Launches

Core Insights - Johnson & Johnson (J&J) has a strong R&D pipeline focusing on immunology, oncology, and neuroscience, with significant clinical and regulatory milestones achieved in 2025 to drive growth through the decade [1][8] Pipeline Candidates - Key pipeline candidates include nipocalimab, TAR-200, and icotrokinra, with all three either approved by the FDA or in regulatory review [2] - Nipocalimab, approved as Imaavy in the U.S. for generalized myasthenia gravis, is under EU review and is being evaluated for various immune-mediated conditions [3] - TAR-200 is under priority review in the U.S. for high-risk non-muscle invasive bladder cancer, with a potential launch later this year [4] - Icotrokinra, an oral targeted peptide inhibitor, is being evaluated for moderate-to-severe plaque psoriasis and ulcerative colitis [4] Oncology Portfolio - J&J's new cancer drugs, including Carvykti, Tecvayli, and Talvey, generated $1.3 billion in sales in the first half of 2025, contributing significantly to top-line growth [5][10] - Oncology sales now account for approximately 40% of J&J's pharmaceutical revenues, with a 21.1% increase in the first half of 2025 [9] Strategic Acquisitions - The acquisition of Intra-Cellular Therapies added Caplyta to J&J's neuroscience portfolio, which is approved for schizophrenia and depression in bipolar disorders [6][10] - J&J believes that ten of its new products/pipeline candidates have the potential to deliver peak sales of $5 billion [6] Market Position and Competition - J&J is well-positioned in the oncology space, competing with major players like AstraZeneca, Merck, Pfizer, and Bristol-Myers [9] - The company is expanding the labels of currently marketed products to include new indications, with key approvals expected this year [7] Financial Performance - J&J's shares have outperformed the industry, rising 26.1% year-to-date compared to a 1.4% increase for the industry [14] - The company's shares trade at a price/earnings ratio of 15.90, higher than the industry average of 14.78 [15] - The Zacks Consensus Estimate for 2025 earnings has increased from $10.62 to $10.86 per share over the past 60 days [18]