Wave Life Sciences will pursue FDA accelerated approval for WVE-N531, an exon 53 skipping therapy for Duchenne muscular dystrophy, following positive Phase 2 trial results showing increased dystrophin production.
The FDA is set to decide on Biogen and Eisai's Leqembi for monthly intravenous maintenance in early Alzheimer's disease, potentially improving patient convenience.
Wave Life Sciences is set to initiate dosing for WVE-007 in its Phase 1 INLIGHT trial for obesity in Q1 2025, with proof-of-concept data expected later in the year.