Fierce Biotech1d
Wave's DMD drug remains on track in 48-week data ahead of FDA push next year
As it gears up to submit an approval application next year, Wave Life Sciences has presented fresh phase 2 data showing its ...
BioWorld1d
Riding the Wave, exon skipper sails toward DMD filing
Wave Life Sciences Ltd. plans to file with the U.S. FDA for accelerated approval of WVE-N531, an exon skipping ...
The American Journal of Managed Care12h
WVE-N531 Shows Functional Benefits, Muscle Damage Reversal in DMD
WVE-N531 demonstrated statistically significant improvements in muscle biopsy measures and functional measures in patients ...
Managed Healthcare Executive8d
Promising Early Results of Investigational Duchenne Muscular Dystrophy Therapy
Avidity Biosciences Inc. says will submit an application for accelerated approval to the FDA for del-zota before the end of ...
BioSpace10d
Dyne’s Duchenne Exon Skipping Oligomer Shows ‘Differentiated’ Clinical Effect
Dyne is eyeing an accelerated approval filing for DYNE-251 in early 2026 that would pit the asset against Sarepta’s Exondys ...
Yahoo Finance23d
PepGen pauses Phase II DMD trial to review safety data
PepGen is pausing the initiation of a new Phase II Duchenne muscular dystrophy (DMD ... s last safety update on 23 January. PGN-EDO51 acts by targeting exon 51 in the dystrophin gene.
pharmaphorum4mon
Sarepta pulls plug on Duchenne exon-skipping drug
Sarepta's exon-skipping therapies for DMD – Exondys 51, Vyondys 53 (golodirsen), and Amondys 45 (casimersen) – have been the main drivers of Sarepta's revenue growth in recent years ...