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Wave Aspires To Accelerated Approval In DMD With 48-Week Data

 
• By Joseph Haas

With its exon 53-skipping candidate already showing promise in 24-week data, Wave now has 48-week data showing improvements in muscle health and functional outcomes.

DMD
Wave looks to accelerated approval for its Phase III Duchenne muscular dystrophy candidate • Source: Shutterstock

With 48-week data from a Phase II open-label trial in Duchenne muscular dystrophy (DMD) showing an advancement in clinical benefit beyond what a 24-week readout showed last year, Wave Life Sciences said on 26 March that it is on track to file its exon 53-skipping oligonucleotide candidate WVE-N531 for accelerated approval in the US in 2026.

Key Takeaways
  • Wave Life Sciences intends to file its exon 53-skipping Duchenne muscular dystrophy candidate for accelerated approval next year.
  • Beyond positive 24-week data,...

The 24-week data from the FORWARD-53 trial from 24 September showed evidence of best-in-class exon skipping and muscle tissue concentration of drug that spurred excitement in...

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