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SPRING HOUSE, Pa. - Johnson & Johnson (NYSE:JNJ) announced on Tuesday that its investigational oral drug icotrokinra met the primary endpoint in a Phase 2b study for patients with moderately to severely active ulcerative colitis.
The ANTHEM-UC study showed that all three tested doses of icotrokinra achieved clinical response at Week 12, with the highest dose (400 mg) demonstrating a 63.5% response rate compared to 27% for placebo. The 200 mg and 100 mg doses achieved 58.1% and 54.7% response rates, respectively. With an impressive gross profit margin of 68.4%, Johnson & Johnson demonstrates strong operational efficiency in developing and commercializing new treatments.
Patients receiving the 400 mg dose also showed significant improvements in secondary endpoints, with 30.2% achieving clinical remission, 46% reaching symptomatic remission, and 36.5% demonstrating endoscopic improvement at Week 12 compared to placebo.
The drug, described as a first-in-class targeted oral peptide that selectively blocks the IL-23 receptor, showed a favorable safety profile with similar rates of adverse events across treatment and placebo groups.
Based on these results, Johnson & Johnson has initiated Phase 3 studies of icotrokinra in ulcerative colitis and Crohn’s disease. The company has also submitted a New Drug Application to the FDA for the treatment of moderate to severe plaque psoriasis in July.
Ulcerative colitis is a chronic inflammatory bowel disease that causes inflammation and ulcers in the lining of the large intestine, leading to symptoms such as bloody diarrhea, abdominal pain, and fatigue.
Icotrokinra was jointly discovered by Johnson & Johnson and Protagonist Therapeutics, Inc. under a license and collaboration agreement established in 2017.
The findings were presented at United European Gastroenterology Week 2025, according to the company’s press release statement. The stock is currently trading near its 52-week high, though InvestingPro analysis suggests it may be in overbought territory. For detailed insights and 10+ additional ProTips about Johnson & Johnson’s financial outlook, investors can access the comprehensive Pro Research Report available on InvestingPro.
In other recent news, Johnson & Johnson has reported favorable results for its ACUVUE OASYS MAX 1-Day for ASTIGMATISM contact lenses, with 62% of patients preferring them over competing products in a new study. Wolfe Research has increased its price target for Johnson & Johnson to $200, maintaining an Outperform rating, citing growth opportunities in the company’s Innovative Medicine franchise. Similarly, Bernstein raised its price target to $193, acknowledging the early achievement of the company’s Innovative Medicine sales target set for 2025. Guggenheim reiterated its Buy rating with a $206 price target, expressing optimism about Johnson & Johnson’s bladder cancer treatment, Inlexzo. Additionally, the FDA has approved Johnson & Johnson’s Tremfya for treating pediatric psoriasis and psoriatic arthritis, marking it as the first IL-23 inhibitor approved for these conditions in children. These developments reflect ongoing advancements and strategic progress within the company.
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