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SPRING HOUSE, Pa. - Johnson & Johnson (NYSE: JNJ) today revealed positive outcomes from its Phase 2b ANTHEM-UC clinical trial for icotrokinra, a novel oral peptide designed to target the IL-23 receptor in adults with moderate to severe ulcerative colitis (UC). The trial met its primary endpoint of clinical response at all doses tested and showed significant improvements over placebo in key secondary endpoints at Week 12.
The study, which involved 252 participants, reported a 63.5% clinical response rate for the highest icotrokinra dose group at Week 12, compared to 27% for the placebo group. Additionally, 30.2% of patients in the highest dose group achieved clinical remission at Week 12, versus 11.1% for those on placebo. Both response and remission rates continued to progress favorably through Week 28. 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 advance promising treatments through clinical development.
Safety profiles for icotrokinra were favorable, with adverse event reports being comparable between the drug and placebo groups. Dr. Esi Lamousé-Smith, Vice President at Johnson & Johnson, highlighted icotrokinra’s potential to change the treatment landscape for UC, citing its combination of efficacy, tolerability, and convenient once-daily oral dosing.
Ulcerative colitis is a chronic inflammatory bowel disease causing inflammation and ulcers in the colon, leading to symptoms such as diarrhea, abdominal pain, and rectal bleeding. Current treatments include anti-inflammatory drugs, immunosuppressants, and biologics, but there remains a need for more effective and convenient therapies.
Icotrokinra is also being evaluated in a Phase 3 program for plaque psoriasis and psoriatic arthritis. The comprehensive results of the ANTHEM-UC study are being prepared for presentation at future medical congresses.
This development is part of Johnson & Johnson’s ongoing efforts in healthcare innovation, aiming to provide advanced treatments for complex diseases. The company has exclusive worldwide rights to develop and commercialize icotrokinra following a collaboration agreement with Protagonist Therapeutics, Inc.
The information in this article is based on a press release statement from Johnson & Johnson.
In other recent news, Johnson & Johnson has completed a multi-billion euro public offering of notes, raising significant capital for general corporate purposes. The notes, with varying maturity dates from 2029 to 2055 and interest rates between 2.700% and 3.700%, were made available through the New York Stock Exchange. In a separate financial move, Johnson & Johnson also issued $5 billion in new notes, with maturities ranging from 2027 to 2035 and interest rates from 4.500% to 5.000%. These financial activities are part of the company’s capital management strategy, potentially used for refinancing debt or pursuing growth opportunities.
Meanwhile, Neumora Therapeutics faced a downgrade from Guggenheim Securities, shifting its stock rating from Buy to Neutral. This decision followed setbacks in clinical trials, including the discontinuation of Johnson & Johnson’s Phase 3 VENTURA program and Neumora’s own KOASTAL-1 failure. Guggenheim suggested Neumora might consider discontinuing the KOASTAL program to conserve resources. Additionally, Johnson & Johnson reported promising results from its Phase 3 ASTRO study for TREMFYA® in treating ulcerative colitis, showing significant improvements compared to placebo. The study’s findings support ongoing applications for regulatory approvals in Europe and the United States.
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