Capricor said its new drug was on track for FDA approval — but the data didn’t deliver.
After months of hyping trial results and regulatory progress, Capricor’s application got rejected. The stock dropped 33%. Now, investors are suing.
Starting in late 2024, Capricor promoted its lead drug, deramiocel, as a breakthrough treatment for DMD-related cardiomyopathy. The company told investors its clinical trial results were strong — and that its application for FDA approval was on track. They even said the drug could get priority review.
But the lawsuit says Capricor left out critical facts. Internally, execs knew the study data didn’t meet the mark. They also knew about major manufacturing issues. But those execs kept insisting drug was likely to be approved.
In July 2025, the truth came out. The FDA formally rejected the drug, citing both weak evidence and production problems. Investors bailed — and the stock lost a third of its value in one day.
Now, more shareholders are joining the lawsuit.