Skyrizi Hits 36% Endoscopic Remission in Crohn's Phase 3, FDA Review Underway
ABBV sits 44% above its 52-week low of $190.75.
Summary
AbbVie's Phase 3 Affirm study showed 35.8% of Crohn's patients achieved endoscopic remission on subcutaneous Skyrizi at Week 24, with 36.6% ulcer-free endoscopy versus 9.1% placebo; in advanced therapy-naive patients, rates were 45.1% and 49%. This is the first detailed efficacy readout for subcutaneous Skyrizi in Crohn's, a key growth indication for the drug. The trial evaluated subcutaneous Skyrizi as induction treatment in 289 adults with moderately to severely active Crohn's disease, with co-primary endpoints of clinical remission and endoscopic response at Week 12. Findings were presented at the 2026 American College of Gastroenterology Annual Scientific Meeting. The subcutaneous formulation is already under FDA and EMA review, so these data strengthen the approval case. Skyrizi and Rinvoq are AbbVie's primary growth drivers, and expanding Skyrizi into Crohn's would add a large inflammatory bowel disease market. The stock trades near its 52-week high, reflecting high expectations for pipeline execution.
Updated with a dpa-AFX report · What changed
Updates
· dpa-AFX — At Week 24, 35.8% achieved endoscopic remission and 36.6% ulcer-free endoscopy vs 9.1% placebo; 45.1% and 49% in advanced therapy-naive patients.
- Trial Design — The Phase 3 AFFIRM trial evaluated subcutaneous Skyrizi as induction treatment in 289 adults with moderately to severely active Crohn's disease. Co-primary endpoints were clinical remission and endoscopic response at Week 12.
- Presentation — Findings were presented at the 2026 American College of Gastroenterology Annual Scientific Meeting.
- Drug Name — Skyrizi's full drug name is risankizumab-rzaa.
All 6 details
- The Phase 3 AFFIRM trial evaluated subcutaneous Skyrizi as induction treatment.
- The trial was global, randomized, double-blind, involving 289 adults.
- Co-primary endpoints were clinical remission and endoscopic response at Week 12.
- Findings presented at 2026 American College of Gastroenterology Annual Scientific Meeting.
- The study involved adults with moderately to severely active Crohn's disease.
- Skyrizi's full drug name is risankizumab-rzaa.
At the time of this announcement, ABBV was trading at $274.64 on NYSE in the Life Sciences sector, with a market capitalization of approximately $485.3B. The 52-week trading range was $190.75 to $283.43. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: Dow Jones Newswires.