ABBV AbbVie

AbbVie SKYRIZI (risankizumab-rzaa) FDA approved for pediatric psoriatic disease

FDA approved SKYRIZI for children 6 years and older with moderate-to-severe plaque psoriasis or active psoriatic arthritis, including a new 55 mg pre-filled syringe for weight-based dosing in patients <40 kg. SKYRIZI is now the first and only IL-23 inhibitor approved in the U.S. for this pediatric population.

surabgene lomparvovec · NCT07007065 registry update

countries: {'total_sites': 137, 'us_sites': 55} → {'total_sites': 138, 'us_sites': 55}

AbbVie Submits BLA for Etentamig in Relapsed/Refractory Multiple Myeloma

AbbVie submitted a BLA to the FDA for etentamig (ABBV-383), a BCMA x CD3 bispecific T-cell engager, for adults with relapsed/refractory multiple myeloma. The submission is supported by positive Phase 3 CERVINO results showing statistically significant improvements in ORR and PFS versus standard therapies.

etentamig · NCT06953960 registry update

countries: {'total_sites': 50, 'us_sites': 12} → {'total_sites': 51, 'us_sites': 12}

ABBV-295 · NCT07752979 registry update

countries: {'total_sites': 63, 'us_sites': 59} → {'total_sites': 64, 'us_sites': 60}

telisotuzumab adizutecan · NCT07744126 registry update

countries: {'total_sites': 4, 'us_sites': 2} → {'total_sites': 5, 'us_sites': 2}

risankizumab · NCT07697456 registry update

countries: {'total_sites': 65, 'us_sites': 61} → {'total_sites': 66, 'us_sites': 61}

AbbVie SKYRIZI (risankizumab) FDA Approved for Subcutaneous Induction in Crohn's Disease

FDA approved a new subcutaneous induction regimen (720 mg via on-body injector at weeks 0, 2, 4, 8) for SKYRIZI in adults with moderately to severely active Crohn's disease, supported by positive Phase 3 AFFIRM data showing superior clinical remission and endoscopic response vs placebo at week 12. The label was also updated across indications to allow clinical judgment on TB testing rather than mandatory testing prior to initiation.

surabgene lomparvovec · NCT07007065 registry update

countries: {'total_sites': 136, 'us_sites': 55} → {'total_sites': 137, 'us_sites': 55}

AbbVie lutikizumab Phase 3 INTREPID topline positive in Hidradenitis Suppurativa

AbbVie reported that lutikizumab met the primary endpoint of HiSCR75 at Week 16 versus placebo in the Phase 3 INTREPID trial. It also achieved 8 ranked secondary endpoints including significant improvement in HS-related skin pain at Week 8.

zumilokibart · NCT07003425 registry update

countries: {'total_sites': 78, 'us_sites': 23} → {'total_sites': 79, 'us_sites': 23}

risankizumab · NCT07071519 registry update

countries: {'total_sites': 71, 'us_sites': 12} → {'total_sites': 72, 'us_sites': 12}

surabgene lomparvovec · NCT07007065 registry update

countries: {'total_sites': 135, 'us_sites': 54} → {'total_sites': 136, 'us_sites': 55}

AbbVie presents Phase 2a TARGET-CD data for ABBV-466 in Crohn's at UEGW 2026

AbbVie presented late-breaking Phase 2a TARGET-CD results showing ABBV-466 (risankizumab + trosunilimab) achieved higher endoscopic remission rates than anti-IL-23 or anti-α4β7 monotherapy at Weeks 12 and 24 in moderate-to-severe Crohn's disease. Gene expression data also showed earlier tissue repair with the dual therapy. This is the first clinical data reported for the investigational dual-targeting asset.

risankizumab · NCT07071519 registry update

countries: {'total_sites': 68, 'us_sites': 12} → {'total_sites': 70, 'us_sites': 12}

ABBV-295 · NCT07752979 registry update

countries: {'total_sites': 58, 'us_sites': 55} → {'total_sites': 61, 'us_sites': 58}

etentamig · NCT07095452 registry update

primary_completion: 2040-09 → 2041-03; completion: 2041-05 → 2042-01

venetoclax · NCT06508489 registry update

primary_outcomes: ['Number of participants with adverse events (AEs)/serious adverse events (SAEs)/adverse events of special interest (AESIs), laboratory abnormalities', 'Substudy 01: Incidence of dose limiting toxicities (DLTs) (escalation part)', 'Substudy 01: Complete Remission (CR) rate (optimization part)', 'Substudy 01: Complete Remission (CR) rate (expansion part)'] → ['Sub-study 1: Part 1: Dose Escalation: Number of Participants With Dose Limiting Toxicities (DLTs)', 'Sub-study 1: Part 2: Dose Optimization: Number of Participants With Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (SAEs) and Treatment-emergent Adverse Events of Special Interest (AESIs)', 'Sub-study 1: Part 2: Dose Optimization: Number of Participants With Potentially Clinically

telisotuzumab adizutecan · NCT07525206 registry update

countries: {'total_sites': 87, 'us_sites': 18} → {'total_sites': 88, 'us_sites': 18}

AbbVie to Present Temab-A Data at ESMO 2026 Congress

AbbVie will present updated Phase 1 data on Temab-A (telisotuzumab adizutecan) at the ESMO 2026 Congress (Oct 23-27), including survival and response results in colorectal cancer and EGFR wild-type/mutant non-small cell lung cancer, plus intracranial activity in patients with brain metastases. The presentations support ongoing Phase 3 trials AndroMETa-CRC-560 and AndroMETa-Lung-167. Recent FDA Breakthrough Therapy Designations in CRC and NSCLC are also noted based on these data.

AbbVie presents long-term SKYRIZI and RINVOQ IBD data at UEGW 2026

AbbVie will present 20 abstracts at UEG Week 2026 (Oct 17-20), including up to 3-year sustained clinical and endoscopic remission data for risankizumab in UC and ~4-year maintenance data for upadacitinib in CD from open-label extensions and real-world analyses. New Phase 2a data on investigational ABBV-466 and additional subcutaneous risankizumab induction/maintenance results in CD will also be shown.

surabgene lomparvovec · NCT07592273 registry update

countries: {'total_sites': 37, 'us_sites': 36} → {'total_sites': 38, 'us_sites': 37}

upadacitinib · NCT06461897 registry update

status: RECRUITING → ACTIVE_NOT_RECRUITING; primary_completion: 2030-07 → 2029-11; completion: 2030-07 → 2029-11; enrollment: 675 → 699

telisotuzumab adizutecan · NCT07525206 registry update

countries: {'total_sites': 86, 'us_sites': 18} → {'total_sites': 87, 'us_sites': 18}

AbbVie Presents Phase 3 AFFIRM Subcutaneous SKYRIZI Data at ACG 2026 in Crohn's Disease

AbbVie presented new endoscopic remission and ulcer-free endoscopy data from the Phase 3 AFFIRM study of subcutaneous risankizumab induction in Crohn's disease at the American College of Gastroenterology 2026 meeting. The results build on prior week 12 co-primary endpoint success and support the ongoing FDA and EMA review of a subcutaneous induction regimen.

zumilokibart · NCT07003425 registry update

countries: {'total_sites': 73, 'us_sites': 23} → {'total_sites': 78, 'us_sites': 23}

ABBV-295 · NCT07752979 registry update

countries: {'total_sites': 56, 'us_sites': 53} → {'total_sites': 57, 'us_sites': 54}

telisotuzumab adizutecan · NCT07490301 registry update

countries: {'total_sites': 20, 'us_sites': 9} → {'total_sites': 22, 'us_sites': 9}

upadacitinib · NCT06012240 registry update

countries: {'total_sites': 283, 'us_sites': 89} → {'total_sites': 272, 'us_sites': 78}

REGENXBIO to Host Investor Event on Sura-vec in Wet AMD on Oct 20, 2026

REGENXBIO will host an investor event on October 20, 2026 featuring clinical program overview, KOL perspectives on ATMOSPHERE and ASCENT pivotal trials, and commercial readiness for sura-vec in wet AMD. This is ahead of anticipated topline pivotal data readout in 4Q 2026.