What's next in gastroenterology — October 17, 2026

This issue covers what is coming in gastroenterology and hepatology between mid-October 2026 and April 2027: an FDA decision in hepatitis B, two congresses with new data (UEG Week and The Liver Meeting), and a pediatric IBD decision. Only milestones with a date published by the regulator, the congress or the company are included.

1. Bepirovirsen for functional cure of chronic hepatitis B

[Pending regulatory decision] [United States] [Confirmed date: October 26, 2026]
What it is: An antisense oligonucleotide studied in the phase 3 B-Well 1 and 2 trials (randomized, double-blind, placebo-controlled, in 29 countries) in adults with chronic hepatitis B on nucleos(t)ide analogues with baseline HBsAg ≤3000 IU/mL; functional cure at week 72 (six months after stopping all treatment) was 19% (233/1,220) versus 0% (0/614) with placebo, and 26% (200/768 versus 0/393) with baseline HBsAg ≤1000 IU/mL. The FDA accepted the application for priority review, granted Breakthrough Therapy designation and set October 26, 2026 as the PDUFA date.
What problem it solves: Nucleos(t)ide analogues suppress HBV DNA but rarely achieve HBsAg loss, so treatment is usually indefinite; there is currently no approved finite therapy that produces functional cure in a meaningful share of patients.
Critical take: GSK-sponsored trials; 8 in 10 patients are not cured, benefit is concentrated in low HBsAg (which will need quantifying before prescribing), and access and cost in Latin America are unknown.
Source:
https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-accepted-for-priority-review-and-granted-breakthrough-therapy-designation-by-the-us-fda/
https://www.gsk.com/media/jtub1qtb/bepi-fda-file-acceptance-sea.pdf
https://www.gsk.com/en-gb/media/press-releases/bepirovirsen-achieves-unprecedented-functional-cure-rates-with-potential-to-redefine-treatment-for-chronic-hepatitis-b/
https://ir.ionis.com/node/34646

2. UEG Week 2026: 44-week obefazimod maintenance data in ulcerative colitis

[Congress] [Europe (Barcelona)] [Confirmed date: October 19, 2026]
What it is: At UEG Week (Barcelona, October 17–20, 2026), efficacy and safety data from the phase 3 ABTECT-Maintenance trial (randomized, double-blind, placebo-controlled, 44 weeks) of obefazimod, an oral agent that up-regulates miR-124, in moderate to severe ulcerative colitis are presented orally on October 19 (OP097), followed on October 20 by 44-week results in subsets of patients with and without prior inadequate response to advanced therapies (OP260). Abivax still plans to submit its NDA to the FDA by the end of 2026.
What problem it solves: A large share of patients do not respond to, or lose response to, biologics and small molecules; an oral drug with a different mechanism would widen options after advanced-therapy failure.
Critical take: So far the results are known only from sponsor press releases; full figures, long-term safety and peer-reviewed publication are needed before judging its place in the algorithm.
Source:
https://ueg.eu/
https://ir.abivax.com/news-releases/news-release-details/abivax-present-data-obefazimod-united-european-gastroenterology
https://ir.abivax.com/de/node/12526

3. The Liver Meeting 2026 (AASLD)

[Congress] [United States (Denver)] [Confirmed date: November 5, 2026]
What it is: The AASLD annual meeting takes place in Denver from November 5 to 9, 2026; the embargo on late-breaking abstracts lifts on Thursday, November 5 at 8:00 a.m. Mountain Time.
What problem it solves: It is one of the year's main venues for new data in MASLD/MASH, primary biliary cholangitis and viral hepatitis, areas where practice is changing quickly after recent approvals.
Critical take: Late-breaking abstracts are often preliminary analyses without full peer review; wait for publication before changing practice.
Source:
https://www.aasld.org/tlm-26
https://www.aasld.org/tlm-26/embargo-policy
https://www.aasld.org/aasld-lifts-press-embargo-liver-meetingr-2026-abstracts

4. Intravenous vedolizumab in pediatric IBD

[Pending regulatory decision] [United States] [Estimated date: first quarter of 2027, per Takeda]
What it is: The FDA accepted the supplemental application (sBLA) for IV vedolizumab in patients aged 2 years and older with moderate to severe ulcerative colitis or Crohn's disease and set the PDUFA goal date in the first quarter of 2027, according to Takeda. It is based on KEPLER (NCT04779307; ulcerative colitis; open-label induction followed by randomized, double-blind maintenance comparing two dose levels; clinical remission at week 54 in induction responders) and WEBB (NCT04779320; Crohn's disease; clinical remission and endoscopic response at week 54).
What problem it solves: Few therapies are approved in pediatrics, and vedolizumab is often used off label with doses extrapolated from adults.
Critical take: Sponsor trials with neither a placebo group nor an active comparator; WEBB was still ongoing at filing, and U.S. approval does not guarantee a local indication or coverage.
Source:
https://www.takeda.com/newsroom/newsreleases/2026/application-intravenous-entyvio-pediatric/
https://clinicaltrials.gov/study/NCT04779307
https://clinicaltrials.gov/study/NCT04779320

*What's next in gastroenterology — October 17, 2026*

1. Bepirovirsen (chronic hepatitis B): FDA decision on October 26, 2026. Functional cure 19% vs 0% in B-Well 1 and 2.
2. UEG Week (Barcelona): 44-week obefazimod data in ulcerative colitis on October 19, 2026.
3. The Liver Meeting (Denver): November 5–9, 2026; late-breakers on November 5.
4. IV vedolizumab in pediatric IBD: FDA decision expected in Q1 2027.

Every item with an official source and a critical take.
Full issue and audio:
https://boletinesmedicos.com/en/gastroenterology/2026-10-17-viene.html
MedBulletins · boletinesmedicos.com

What's next in gastroenterology and hepatology (October 2026 – April 2027), verifiable dates only:

• October 19, UEG Week: 44-week obefazimod maintenance data in ulcerative colitis, with an NDA planned before year-end.
• October 26: FDA decision on bepirovirsen, a candidate for functional cure of chronic hepatitis B (19% vs 0% in phase 3; 26% with low HBsAg).
• November 5–9: The Liver Meeting in Denver.
• Q1 2027: FDA decision on IV vedolizumab in pediatric IBD.

Each item explains the clinical problem it addresses and gives an honest critical take.
https://boletinesmedicos.com/en/gastroenterology/2026-10-17-viene.html

#Gastroenterology #Hepatology #HepatitisB #IBD #UlcerativeColitis

What's next in GI: 44-week obefazimod data at UEG Week Oct 19; FDA decides on bepirovirsen (hep B) Oct 26; The Liver Meeting Nov 5–9; pediatric vedolizumab Q1 2027.
https://boletinesmedicos.com/en/gastroenterology/2026-10-17-viene.html