Record mula sa primary source
Decision-gradeNaiskedyul ang advisory committee
Wave Life Sciences: Nakausap na ang FDA para sa WVE-006 na pinabilis na landas ng pag-apruba
Pinagbigyan ng FDA ang kahilingan ng Wave para sa isang pulong upang talakayin ang pinabilis na landas ng pag-apruba para sa WVE-006 sa AATD. Ang pulong ay nakatakda sa katapusan ng tag-init 2026, kasunod ng positibong datos mula sa RestorAATion-2 na nagpapakita ng pagpapanumbalik ng wild-type AAT protein at dynamic na tugon.
Mahahalagang fact
- Na-file
- Hul 30, 2026, 11:38 AM
- Kaganapan
- Naiskedyul ang advisory committee
- Direksyon
- Positibo
- Kumpanya
WVEWave Life Sciences- Asset
- WVE-006
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
Sipi mula sa source
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