VIENNA, Austria - Johnson & Johnson (NYSE: JNJ) has announced positive results for its drug TREMFYA® (guselkumab) in treating ulcerative colitis (UC) and Crohn's disease (CD), based on data from recent Phase 3 studies. The medication, already FDA-approved for UC as of September 2024, is currently under review for CD.
The findings, which were presented at the United European Gastroenterology (UEG) Week 2024, indicate that TREMFYA® achieved higher rates of endoscopic remission in both diseases compared to ustekinumab and placebo, especially among patients who had not previously responded to biologic treatments or were new to such therapies.
In the GALAXI 2 & 3 studies for CD, 44% of biologic-naïve patients treated with TREMFYA® every eight weeks and 46.1% of patients with a more frequent dosing schedule achieved endoscopic remission at week 48, compared to 29.8% for ustekinumab. For UC patients in the QUASAR study, 38.1% and 41.7% achieved remission with TREMFYA® versus 20.4% with placebo at week 44.
The drug also showed efficacy in patients with a history of inadequate response or intolerance to biologics/JAK inhibitors. In CD, 28.1% and 28.6% of these patients reached endoscopic remission with TREMFYA®, versus 20.5% with ustekinumab. In UC, the rates were 31.2% and 23.9% with TREMFYA®, compared to 8% with placebo.
These results reinforce the established safety profile of TREMFYA® in treating UC and CD, according to the company. TREMFYA® is a fully-human monoclonal antibody that acts on the IL-23 pathway, which is implicated in chronic inflammatory diseases.
Applications for the drug's use in CD are under review by regulatory authorities in the U.S. and Europe. Johnson & Johnson maintains that these developments build on nearly three decades of leadership in inflammatory bowel disease (IBD) therapy and innovation. The information is based on a press release statement from Johnson & Johnson.
In other recent news, Johnson & Johnson has completed its acquisition of V-Wave Ltd., a heart failure treatment specialist, for $600 million. The acquisition's financial implications include a Q4 2024 R&D charge of approximately $600 million, which is predicted to decrease Johnson & Johnson's earnings per share (EPS) for 2024 by $0.24 and for 2025 by $0.06. Stifel and Wells Fargo have subsequently adjusted their EPS estimates for the company.
The company has also been active in clinical trials, with its drug ERLEADA® showing significant survival benefits in a prostate cancer study. However, a mid-stage trial for dengue prevention has been halted. In terms of product expansions, Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a new indication of its DARZALEX FASPRO® treatment.
Furthermore, Johnson & Johnson's subsidiary, Red River Talc LLC, has filed for a prepackaged Chapter 11 bankruptcy as part of a strategy to settle ongoing ovarian cancer claims related to cosmetic talc litigation in the U.S. These developments reflect the company's recent activities in the realms of mergers, earnings, analyst ratings, and other company news.
InvestingPro Insights
Johnson & Johnson's (NYSE: JNJ) positive results for TREMFYA® in treating ulcerative colitis and Crohn's disease align well with the company's strong market position and financial health. According to InvestingPro data, Johnson & Johnson boasts a substantial market capitalization of $386.72 billion, reflecting its status as a major player in the pharmaceutical industry.
The company's revenue growth of 5.13% over the last twelve months and a robust gross profit margin of 69.43% demonstrate its ability to generate significant returns from its product portfolio, including innovative treatments like TREMFYA®. This financial strength supports ongoing research and development efforts crucial for maintaining leadership in the inflammatory bowel disease (IBD) therapy market.
InvestingPro Tips highlight Johnson & Johnson's stability and attractiveness as an investment. The company has raised its dividend for 53 consecutive years, showcasing its commitment to shareholder returns. This is particularly relevant given the potential for increased revenue from TREMFYA® as it expands its approved indications.
Additionally, Johnson & Johnson is trading at a low P/E ratio relative to near-term earnings growth, with a PEG ratio of 0.11. This suggests that the stock may be undervalued considering its growth prospects, which could be further bolstered by the success of TREMFYA® and other pipeline products.
For investors seeking more comprehensive analysis, InvestingPro offers 8 additional tips that could provide deeper insights into Johnson & Johnson's investment potential.
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