Figma Shares Indicated To Open $105/$110
SPRING HOUSE, Pa. - Johnson & Johnson (NYSE: JNJ) announced significant advancements in the treatment of moderately to severely active ulcerative colitis (UC) with its drug TREMFYA® (guselkumab). The Phase 3 ASTRO study results, presented at the 20th Congress of the European Crohn’s and Colitis Organization (ECCO), revealed that TREMFYA’s subcutaneous (SC) induction therapy provided statistically significant improvements in clinical and endoscopic measures compared to placebo.
The study, which evaluated patients over a 12-week period, found that those treated with TREMFYA® 400 mg SC induction therapy achieved higher rates of clinical remission and response as well as endoscopic improvement. These outcomes were consistent with those from the previously FDA-approved intravenous (IV) induction regimen for the same patient population. With annual revenues of $88.8 billion and a strong financial health score rated as "GOOD" by InvestingPro, Johnson & Johnson demonstrates the financial capability to support its robust drug development pipeline.
Safety profiles during the ASTRO study aligned with the established safety data of TREMFYA®. Rates of adverse events, including serious ones or those leading to treatment discontinuation, were comparable between the TREMFYA® and placebo groups.
Dr. Laurent Peyrin-Biroulet, an investigator in the study, highlighted the potential benefits of a fully SC treatment regimen, noting its convenience for patients with active lifestyles. TREMFYA® is unique as a dual-acting monoclonal antibody that blocks IL-23 and binds to CD64, targeting a key driver of immune-mediated diseases such as UC.
Applications for TREMFYA®’s approval for both UC and Crohn’s disease have been submitted in Europe, with FDA approval already granted for UC treatment via IV induction followed by SC maintenance. A supplemental Biologics License Application for SC induction regimen approval is currently under FDA review.
The efficacy and safety of TREMFYA® SC induction therapy were established in the ASTRO study, which involved patients who had an inadequate response or intolerance to conventional or advanced therapies. The study’s findings are based on a press release statement. For investors seeking deeper insights into Johnson & Johnson’s pharmaceutical business and its market position, InvestingPro offers comprehensive analysis through its Pro Research Report, available for over 1,400 US stocks, including detailed metrics, peer comparisons, and expert insights into the company’s growth trajectory.
In other recent news, Johnson & Johnson announced the successful issuance of $5 billion in new notes, a strategic financial move under its existing shelf registration statement. The notes, with varying maturity dates and interest rates, are part of the company’s capital management strategy, potentially funding operations, refinancing debt, or supporting growth opportunities. The issuance coincides with the company’s acquisition of Intra-Cellular Therapies (NASDAQ:ITCI) Inc. for approximately $14.6 billion. S&P Global Ratings assigned an ’AAA’ rating to these notes but placed them on CreditWatch with negative implications, reflecting concerns about increased leverage due to recent acquisitions.
Additionally, Johnson & Johnson has resumed a limited release of its VARIPULSE™ devices in the U.S. after an investigation confirmed their expected performance. The company plans to update the device’s Instructions for Use globally to enhance guidance for healthcare professionals. In pharmaceutical developments, Johnson & Johnson reported progress on nipocalimab, an investigational drug showing promise in treating diseases driven by immunoglobulin G antibodies. The drug has received several key designations from regulatory bodies, highlighting its potential to meet unmet medical needs.
Furthermore, Johnson & Johnson is considering selling its stroke care business, Cerenovus, for over $1 billion as part of a restructuring plan for its medical technology division. This potential sale is part of broader efforts to optimize its portfolio following significant investments in medical device acquisitions over recent years.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.