Capricor Stock Rises Pre-Market Over Fresh Hopes of Deramiocel Approval In Treating Genetic Disorder

The company announced on Thursday that it held a meeting with the agency and plans to submit data from its HOPE-3 clinical trial as part of its current application.

Capricor Therapeutics (CAPR) said on Thursday that it expects to submit fresh trial data to the U.S. Food and Drug Administration to get its Deramiocel therapy approved in the treatment of cardiomyopathy associated with Duchenne muscular dystrophy.

The FDA stated in July that it was unable to approve the application for Deramiocel in its current form as it does not meet the requirement for substantial evidence of effectiveness, and expressed the need for additional clinical data.

The company stated on Thursday that it held a meeting with the agency and hopes to submit data from its HOPE-3 clinical trial as part of its current application. Topline data from the trial, which will serve as the additional study requested by the agency, is expected in the fourth quarter.

Shares of the company rose 2% in the pre-market session at the time of writing. 

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