5 Gastroenterology Headlines You Missed in April 2026

April brought continued momentum in gastroenterology, with advances in inflammatory bowel disease (IBD) research, regulatory activity, and new discussions surrounding the long-term management of irritable bowel syndrome (IBS). From emerging next-generation biologics to evolving treatment strategies in ulcerative colitis and Crohn’s disease, the month highlighted both the pace of innovation in GI care and the ongoing need to address persistent gaps in patient outcomes.

Among the notable developments were positive phase 2 data for SPY001, an investigational anti-α4β7 therapy being evaluated for moderate-to-severely active ulcerative colitis, as well as the US Food and Drug Administration (FDA)’s acceptance of an NDA for a next-generation hydrocortisone acetate suppository for ulcerative colitis of the rectum. Regulatory progress also continued in Crohn’s disease, with an application submitted to the FDA seeking approval of subcutaneous induction dosing for risankizumab-rzaa (Skyrizi), which could offer an alternative to intravenous induction therapy if approved.

At the same time, IBS remained a major focus throughout April in recognition of IBS Awareness Month. Expert discussions emphasized the growing role of personalized and multimodal care strategies, while new long-term safety data raised important questions about antidepressant use in IBS management and the balance between symptom control and potential risks.

Here’s a look at 5 key gastroenterology headlines from April 2026 you may have missed:

SPY001, An Anti-α4β7, Shows Promise in Phase 2 SKYLINE Trial for Ulcerative Colitis

On April 13, 2026, Spyre Therapeutics announced positive 12-week induction data from Part A of the phase 2 SKYLINE trial of SPY001, a potential best-in-class anti-α4β7 being investigated for the treatment of moderate-to-severely active ulcerative colitis. The Company additionally announced that recruitment for Part A of SKYLINE is now closed and enrollment is open for Part B, which includes 3 monotherapy cohorts (SPY001, SPY002, and SPY003) and 3 combination cohorts (SPY120, SPY130, and SPY230) into which participants may be randomized versus a shared placebo. 

Proof-of-concept induction data for the remaining cohorts of Part A are now expected mid-2026 (SPY002) and Q3 2026 (SPY003), while Part B induction data for all cohorts remain on track for 2027.

FDA Accepts NDA For Next-Generation Hydrocortisone Acetate in Ulcerative Colitis of the Rectum

On April 21, 2026, the FDA accepted Cristcot’s New Drug Application (NDA) under section 505(b)(2) of the Federal Food, Drug and Cosmetic Act for its next-generation hydrocortisone acetate (ngHCA) 90-milligram suppository administered using the Company’s patented, FDA-approved Sephure® suppository applicator for the treatment of patients with ulcerative colitis of the rectum. The NDA is supported by positive results from the Company’s phase 3 pivotal trial, which achieved its primary endpoint of clinical remission based on the Modified Mayo Score of 0-2 at Day 29.

With the acceptance, the FDA has set a PDUFA target date in October 2026. If approved, ngHCA would be the first and only FDA-approved hydrocortisone acetate (HCA) suppository.

Risankizumab (Skyrizi) SC Induction Application Submitted to FDA for Crohn's Disease

On April 27, 2026, AbbVie submitted a regulatory application to the FDA seeking approval for risankizumab-rzaa (Skyrizi) subcutaneous (SC) induction for adults with moderately to severely active Crohn's disease. The supplemental application is supported by positive data from the phase 3 AFFIRM study. If approved, risankizumab SC induction would offer an alternative to the currently approved intravenous (IV) induction regimen.

Navigating Progress, Personalization, and Persistent Gaps in IBS Care

In honor of April being IBS Awareness Month, the editorial team of HCPLive Gastroenterology spoke with a trio of expert gastroenterologists about the evolution of personalized care and multimodal management strategies. However, gaps in access, education, and real-world outcomes continue to negatively impact patients’ lives and their ability to control their disease.

Are We Overlooking Long-Term Risks in IBS Management? New 20-Year Safety Data, With Ali Rezaie, MD

Utilizing nearly 2 decades of electronic health records from > 650,000 US adults with IBS, a recent real-world study linked antidepressant use in IBS to higher mortality risk. In the study, taking antidepressants was associated with an increased risk of all-cause mortality (hazard ratio [HR], 1.35; 95% CI, 1.26–1.45; mortality rate, 1.6% vs 1.0%) and remained consistent across antidepressant subclasses and demographic subgroups.

“Individually, the risk is not that high, but if you think about the fact that more than 10% of the US population has irritable bowel syndrome, that 0.6% potentially can translate into a significant number of deaths that we can potentially induce by starting patients on antidepressants in an IBS, which is not a fatal disease by itself,” study investigator Ali Rezaie, MD, explained to HCPLive.