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SAN DIEGO, Calif. - Johnson & Johnson (NYSE:JNJ) has released data from its Phase 3 QUASAR long-term extension study, indicating sustained clinical and endoscopic remission in patients with moderately-to-severely active ulcerative colitis (UC) treated with TREMFYA® (guselkumab) at Week 92. This information was part of 24 abstracts presented at Digestive Disease Week (DDW) 2025.
The QUASAR study showed that 72% of patients were in clinical remission, with 99% of those remaining corticosteroid-free for 8 or more weeks by Week 92. Additionally, 43% of patients achieved endoscopic remission. Among those who showed endoscopic improvement at Week 44, 84% maintained this improvement through Week 92. The safety profile of TREMFYA® was consistent with previous findings, with no new safety concerns identified. These positive clinical results complement J&J’s strong financial performance, with the company generating $89.33 billion in revenue over the last twelve months. InvestingPro analysis suggests the stock is currently undervalued, presenting a potential opportunity for investors.
Gary R. Lichtenstein, Vice Chief of Gastroenterology and Hepatology at the University of Pennsylvania, highlighted the importance of the drug’s ability to deliver long-term remission for those living with UC. Esi Lamousé-Smith, MD, PhD, Vice President at Johnson & Johnson, echoed the sentiment, emphasizing the significance of the findings for the future of IBD care.
TREMFYA® is a monoclonal antibody that blocks IL-23 and binds to CD64, targeting inflammation at its source. It was approved by the FDA in September 2024 for treating adults with UC and has since received approval for both SC and IV induction options for Crohn’s disease as of March 2025.
The QUASAR program is a comprehensive study designed to assess the efficacy and safety of TREMFYA® in adults with UC who have not responded adequately to other treatments. The study includes various phases, with the long-term extension offering an additional four years of treatment.
UC is a chronic disease affecting the colon, characterized by inflammation and the formation of ulcers. Symptoms can include bowel urgency, rectal bleeding, and abdominal pain.
TREMFYA® is also approved for treating plaque psoriasis, psoriatic arthritis, and Crohn’s disease in the U.S. and for additional indications in other countries.
This news article is based on a press release statement from Johnson & Johnson.
In other recent news, Johnson & Johnson has announced positive results from its Phase 3 ASTRO study of TREMFYA® for ulcerative colitis, showing significant clinical remission and endoscopic improvement. The company also received FDA approval for IMAAVY™ to treat generalized myasthenia gravis, backed by data from the Vivacity-MG3 study. Additionally, S&P Global Ratings has reaffirmed Johnson & Johnson’s ’AAA’ rating, noting a stable outlook despite previous concerns following the acquisition of Intra-Cellular Therapies Inc. for $14.6 billion. The company presented promising clinical data for its bladder cancer treatment, TAR-200, at the American Urological Association 2025 Annual Meeting, highlighting its potential for patients unresponsive to Bacillus Calmette-Guérin therapy. Furthermore, TD Cowen maintained a Buy rating on Johnson & Johnson, citing strong first-quarter earnings and a confident outlook for the year despite challenges from biosimilar competition. The company has also been proactive in managing tariff costs, which analysts believe will not significantly impact its financial performance. Johnson & Johnson’s diverse product portfolio and strategic acquisitions continue to support its growth strategy.
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