Catatan sumber primer
PenentuKomite penasihat dijadwalkan
Wave Life Sciences: Pertemuan FDA dijadwalkan untuk jalur persetujuan dipercepat WVE-006
FDA memberikan persetujuan atas permintaan Wave untuk mengadakan pertemuan guna membahas jalur persetujuan dipercepat bagi WVE-006 pada AATD. Pertemuan dijadwalkan pada akhir musim panas 2026, menyusul data positif RestorAATion-2 yang menunjukkan pemulihan protein AAT tipe liar dan respons dinamis.
Fakta utama
- Diajukan
- 30 Jul 2026, 11.38
- Peristiwa
- Komite penasihat dijadwalkan
- Arah
- Positif
- Perusahaan
WVEWave Life Sciences- Aset
- WVE-006
- Sumber
- SEC 8-K
- Keyakinan
- Bersumber
Kutipan sumber
EX-99.1 2 d177737dex991.htm EX-99.1 EX-99.1 Exhibit 99.1 Wave Life Sciences Reports Second Quarter 2026 Financial Results and Provides Business Update Dosing underway in Phase 2a multidose portion of the INLIGHT TM trial of WVE-007 (INHBE GalNAc-siRNA) in individuals with obesity (BMI: 35-50 kg/m 2 ) and comorbidities; trial will also inform WVE-007’s potential in MASH, type 2 diabetes, and other cardiometabolic diseases Phase 2 combination with incretin and post-incretin maintenance trials of WVE-007 on track to initiate in 2H 2026 FDA meeting scheduled for end of summer 2026 on potential accelerated approval pathway for WVE-006 (GalNAc-RNA editing); data from RestorAATion-2 trial support differentiated therapeutic approach for both lung and liver manifestations of AATD CTA submissi