CAPR Stock Crashes 71% in July on FDA Doubts Over Deramiocel Trial Evidence

According to FDA briefing documents released ahead of Wednesday's advisory committee meeting, Capricor Therapeutics (CAPR) stock crashed 71% in July after reviewers questioned whether the Hope-3 trial showed convincing evidence of Deramiocel's effectiveness for Duchenne muscular dystrophy. The selloff followed concerns that changes to the statistical analysis plan made p-values more favorable, potentially masking issues with the cell therapy's efficacy.

Meanwhile, retail traders have turned increasingly bullish on CAPR despite the rout, pushing Stocktwits sentiment to a record 94 out of 100. Former pharma executive Martin Shkreli revived his bearish thesis, calling the company a "complete fraud," while some traders argue the FDA is applying outdated analysis methods and that Capricor maintained transparency with regulators throughout.