The FDA’s assessment, published ahead of a July 29 advisory committee meeting, targeted the company’s methodology for measuring results in late-stage trials for Duchenne muscular dystrophy patients. Regulators specifically criticized the conversion of raw data to percent change and back, stating the process reduced accuracy and lacked scientific rigor. The agency concluded the benefit-risk profile for the drug appeared unfavorable.

Cantor Fitzgerald analyst Kristen Kluska noted the documents raised significant concerns regarding the integrity of Capricor’s data collection. Following the initial release, the stock price dropped $12.70 to close at $7.00. A further decline occurred on July 29, when the stock fell an additional 6.08% to $6.57 during the advisory committee review. Shareholders who suffered financial losses are now being encouraged to contact legal counsel to explore potential claims against the company.