Shares of Capricor TherapeuticsCAPR plummeted Friday after the Food and Drug Administration rejected its experimental treatment for a heart complication associated with a muscle-wasting condition.In its letter,

In its complete response letter, the FDA cited insufficient evidence establish deramiocel's effectiveness for cardiomyopathy associated with Duchenne muscular dystrophy. The decision comes after CBER Director Vinay Prasad canceled an advisory committee meeting for the therapy.

The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising questions about whether the agency's new leadership may be rowing back from some of the flexibility shown by the old regime. Capricor’s share price fell 38% to $7.11 in premarket trading.