Amylyx sinks after FDA posts briefing docs for lateral sclerosis therapy

In briefing documents ahead of the March 30 advisory committee, the FDA said that although Amylyx Pharmaceuticals claims the CENTAUR study met its prespecified primary endpoint, the study “demonstrated only a modest p-value using non-preferred analysis methods that ignore the loss of data due to patient deaths during the study and relied on a questionable linearity assumption of the ALSFRS-R over time.” The FDA added, “There was also a moderate proportion of missing data and a randomization implementation problem such that the first 18 patients in a row received the drug, which reduce the persuasiveness of the study.” This briefing document presents results from the AMX0035 amyotrophic lateral sclerosis development program. Shares of Amylyx are down 15% to $21.15 in early trading.