WVE Wave Life Sciences

Wave Life Sciences plans registrational trial for WVE-006 in AATD with interim accelerated approval analysis

Following positive FDA feedback, Wave is planning a two-year registrational trial of WVE-006 for AATD that includes a one-year interim analysis for potential accelerated approval based on AATD biomarkers. The company also expects to share data from the 600 mg multidose cohort in Q4 2026.

WVE-007 · NCT06842186 registry update

enrollment: 296 → 400; primary_outcomes: ['The proportion of participants with adverse events'] → ['The proportion of participants with treatment emergent adverse events']; countries: {'total_sites': 6, 'us_sites': 1} → {'total_sites': 7, 'us_sites': 2}

WVE-006 · NCT06405633 registry update

status: ACTIVE_NOT_RECRUITING → RECRUITING; primary_completion: 2026-09 → 2027-09; completion: 2026-09 → 2027-09; enrollment: 24 → 48

Wave Life Sciences: FDA meeting set for WVE-006 accelerated approval path

FDA granted Wave’s request for a meeting to discuss an accelerated approval pathway for WVE-006 in AATD. The meeting is scheduled for the end of summer 2026, following positive RestorAATion-2 data showing restoration of wild-type AAT protein and dynamic response.

Wave Life Sciences: FDA accepts Phase 2a INLIGHT for WVE-007

FDA has accepted the Phase 2a multidose portion of the INLIGHT trial of WVE-007 in individuals with BMI 35-50 kg/m² with or without type 2 diabetes. The placebo-controlled study is on track to initiate in Q2 2026 and will evaluate body composition, liver fat, HbA1c and other cardiometabolic biomarkers over 12 months.

Wave Life Sciences plans Phase 2a INLIGHT multidose start for WVE-007 in 1H 2026

Wave announced plans to initiate the Phase 2a multidose portion of the INLIGHT trial for WVE-007 in individuals with higher BMI and comorbidities in 1H 2026. The company also expects to start additional trials of WVE-007 as an incretin add-on and post-incretin maintenance in 2026. Six-month follow-up data from the 240 mg cohort and three-month data from the 400 mg cohort are expected in 1Q 2026.

Wave Life Sciences: WVE-007 Phase 2a multidose start 1H 2026

Wave plans to initiate the Phase 2a multidose portion of the INLIGHT trial for WVE-007 in obese patients with higher BMI and comorbidities in 1H 2026. Additional trials of WVE-007 as add-on to incretin and post-incretin maintenance are also scheduled for 2026. The company also expects to file a CTA for WVE-008 in 2026.

Wave Life Sciences reports INLIGHT trial Activin E reductions up to 85% for WVE-007

The INLIGHT first-in-human trial of WVE-007 (GalNAc-siRNA targeting INHBE) showed statistically significant, dose-dependent Activin E reductions of up to 85% at Day 29 after a single dose, exceeding preclinical thresholds linked to weight loss and prevention of rebound weight gain. Activin E reduction in the lowest-dose cohort was sustained through six months, supporting once- or twice-yearly dosing. The data validate target engagement and support continued dose escalation and upcoming body-composition readouts.