Wave Life Sciences: FDA menerima Fase 2a INLIGHT untuk WVE-007

FDA telah menerima bagian multidose Fase 2a dari uji coba INLIGHT WVE-007 pada individu dengan BMI 35-50 kg/m² dengan atau tanpa diabetes tipe 2. Studi terkontrol plasebo ini dijadwalkan akan dimulai pada Q2 2026 dan akan mengevaluasi komposisi tubuh, lemak hati, HbA1c, dan biomarker kardiometabolik lainnya selama 12 bulan.

Fakta utama

Diajukan: 28 Apr 2026, 11.34
Peristiwa: Permohonan diterima
Arah: Positif
Perusahaan: WVEWave Life Sciences
Aset: WVE-007
Sumber: SEC 8-K
Keyakinan: Bersumber

Kutipan sumber

EX-99.1 2 d135689dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Wave Life Sciences Reports First Quarter 2026 Financial Results and Provides Business Update With recent FDA acceptance of the Phase 2a multidose portion of INLIGHT trial of WVE-007 (INHBE GalNAc-siRNA) in individuals with higher BMI, with and without type 2 diabetes, this portion of the trial remains on track to initiate in 2Q 2026 Combination and maintenance trials of WVE-007 on track to initiate in 2026 Data from RestorAATion-2 trial of WVE-006 (GalNAc-RNA editing) in AATD (including 400 mg monthly dose and 600 mg single dose cohorts) to be presented at an investor webcast during the ATS International Conference in May 2026 Regulatory feedback on accelerated approval pathway for WVE-006 continues to be expected mid-2026 CTA su

SEC 8-K