Johnson & Johnson (JNJ) Highlights Strong Phase 3 Results for TREMFYA Across Dosing Regimens

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TheFly reported on May 5 that JNJ released Phase 3 FUZION study results evaluating TREMFYA in adults with active perianal fistulizing Crohn’s disease. At 24 weeks, the therapy showed statistically meaningful improvements over placebo in combined fistula remission, a strict endpoint requiring full closure of external fistulas and no fluid collection on MRI. Both dosing regimens demonstrated higher remission rates compared with placebo. The findings are notable given the difficulty of treating this severe disease manifestation and represent the first randomized controlled trial in two decades to show clear efficacy in this patient population. Safety remained consistent with prior data.

In a simultaneous announcement on May 5, Johnson & Johnson (NYSE:JNJ) reported Phase 2b findings from the DUET-UC and DUET-CD trials evaluating JNJ-4804, an investigational dual-target co-antibody therapy designed to inhibit interleukin-23 and tumor necrosis factor-alpha. The studies enrolled patients with moderately to severely active ulcerative colitis or Crohn’s disease who had limited response to multiple prior systemic treatments.

At Week 48, the therapy demonstrated improvements across key clinical and endoscopic endpoints in a difficult-to-treat, highly refractory patient subgroup. These results were presented as part of the company’s late-breaking data at Digestive Disease Week 2026.

Johnson & Johnson (NYSE:JNJ) is a global healthcare company based in New Brunswick with a strong focus on oncology. It develops treatments for blood cancers and solid tumors, and its cancer drug business is driving strong growth.

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