Apellis Follows Wave Life By Shelving ALS Candidate After Trial Miss
Apellis’s pegcetacoplan – approved for two other indications – will not go forward in amyotrophic lateral sclerosis after a Phase II failure, two days after Wave Life made a similar call in the neurodegenerative disease.
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Biogen/Ionis’ Tofersen Wins Accelerated Approval In ALS Subgroup – A Significant But Narrow Precedent
US FDA designates ongoing ATLAS trial in presymptomatic individuals with SOD1 mutation as confirmatory study. ‘Classic Biogen’ approval is first in ALS under the expedited pathway and could lead to more drugs reaching market on basis of a reduction in plasma neurofilament light chain concentration.
Cytokinetics’ Failure In ALS Clears Way For Focus On Aficamten
With a data monitoring committee finding no signs of efficacy in a Phase III trial of ALS candidate reldesemtiv, Cytokinetics can conserve cash and center on aficamten for hypertrophic cardiomyopathy.
Clene Confident In Phase III Plans For CNM-Au8 In ALS With Six-Month Data
The company announced detailed data for the drug in the HEALEY-ALS Platform Trial, where the cohort of the Phase II/III study testing it nevertheless failed to meet the primary endpoint.