AbbVie or "the company" refer to AbbVie Inc., or AbbVie Inc. and its consolidated subsidiaries, as the context requires. AbbVie is a global, diversified research-based biopharmaceutical company positioned for success with a comprehensive product portfolio that has leadership positions across immunology, neuroscience, oncology and aesthetics.
Cash figures as of 2026-09-30. Database snapshot: 2026-11-07.
Cap table as of 2026-06-30.
Livmoniplimab Phase 2/3 Negative · 2026-11-03
ABBV-151
Primary: No trial endpoint result was reported; the item is AbbVie's decision to discontinue livmoniplimab development, including its Phase 2/3 trial in non-squamous non-small cell lung cancer — AbbVie discontinued clinical development of livmoniplimab because its potential benefit appeared limited relative to the current standards of care available for patients with several solid tumors; no new efficacy data were disclosed
· Phase 1 hepatocellular carcinoma study reported in 2024: overall response rate 42% for livmoniplimab plus budigalimab in 12 patients
· Phase 2/3 non-squamous NSCLC trial of livmoniplimab plus budigalimab against pembrolizumab began in 2024 and had been due to read out in 2031
Safety: not disclosed
Lutikizumab Phase 3 Positive · 2026-10-22
Primary: HiSCR75 at Week 16 (at least a 75% reduction from baseline in the total abscess and inflammatory nodule (AN) count, with no increase in abscess count and no increase in draining fistula count relative to baseline) — 31.4% versus 23.4%; p≤0.001
· Met 8 ranked secondary endpoints
· NRS3 (at least a 3-point reduction in HS-related skin pain) at Week 8: 26.2% vs 15.0% (p<0.0001)
· NRS30 at Week 8: 36.0% vs 22.8% (p<0.0001)
· HS flares over the first 16 weeks: 18.4% vs 28.1% of patients experienced flares (p<0.0001)
· 1,400 patients randomized 1:1 to lutikizumab SC or placebo (adults and adolescents, moderate to severe HS)
· Regulatory submissions planned in the second half of 2027, supported by 36-week blinded extension data expected in 2027
Safety: Generally well tolerated, no new safety concerns identified; any AE 53.4% vs 53.7%, serious AE 3.0% vs 2.9%, AEs leading to discontinuation 1.7% vs 1.9%; no deaths in the lutikizumab group, one death in the placebo group
ABBV-466 Phase 2 Positive · 2026-10-19
TARGET-CD · moderate to severe Crohn's disease
Primary: Endoscopic remission at Week 12 (SES-CD ≤4 and no subscore greater than 1 in any individual variable) in the Phase 2a TARGET-CD study (NCT06548542) — 30.2% of patients treated with ABBV-466 achieved endoscopic remission at Week 12, compared to 21.3% receiving anti-IL-23 p19 (risankizumab) monotherapy and 18.0% receiving anti-α4β7 (trosunilimab) monotherapy
· Week 24 endoscopic remission: 40.5% ABBV-466 versus 22.4% risankizumab monotherapy and 20.0% trosunilimab monotherapy
· 300 patients randomized 1:1:1 (106 ABBV-466, 94 risankizumab, 100 trosunilimab); 75% had failed at least one advanced therapy, 25% had failed three or more
· Gene expression analysis showed intestinal tissue repair and barrier restoration by Week 12, with tissue remodeling and metabolic changes at Week 24, generally not observed with either monotherapy
· Presented as a late-breaking abstract at UEG Week 2026 on October 19, 2026
Safety: Serious adverse events 10.4% for ABBV-466, comparable to risankizumab monotherapy (9.6%) and trosunilimab monotherapy (9.0%); most common adverse events (≥5%) were Crohn's disease and nausea in the ABBV-466 and trosunilimab arms, and Crohn's disease and arthralgia in the risankizumab arm
Risankizumab SC Phase 3 Mixed · 2026-10-13
crohn's disease
Primary: Endoscopic remission and ulcer-free endoscopy at Weeks 12 and 24 in Phase 3 AFFIRM (study co-primary endpoints were CDAI clinical remission and endoscopic response at Week 12, previously reported) — Week 24 endoscopic remission 35.8% on subcutaneous SKYRIZI vs 9.1% on placebo; Week 24 ulcer-free endoscopy 36.6% vs 9.1%
· Week 12 endoscopic remission 27.7% vs 10.2% placebo; Week 12 ulcer-free endoscopy 26.2% vs 10.2%
· Week 24 endoscopic remission in advanced therapy-naive patients 45.1% and in advanced therapy inadequate responders 30.1%
· Week 24 ulcer-free endoscopy in advanced therapy-naive patients 49.0% and in inadequate responders 28.9%
· AFFIRM (NCT06063967) randomized 289 patients 2:1 to risankizumab SC or placebo; 65% had previously failed advanced therapies
· Data presented at the ACG 2026 Annual Scientific Meeting and support the FDA application for a subcutaneous induction regimen, currently under FDA and EMA review
Safety: Safety through Week 24 consistent with the known risankizumab profile; no new safety signals identified
Epcoritamab Phase 3 Positive · 2026-10-05
DLBCL-2