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

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 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 late-stage 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 5% in the pre-market session at the time of writing. On Stocktwits, retail sentiment around CAPR stock rose from ‘bearish’ to ‘neutral’ territory over the past 24 hours, while message volume stayed at ‘normal’ levels.

“The FDA remains committed to collaborating with the applicant and will exercise further regulatory flexibility by reviewing data from the HOPE-3 trial,” the FDA said in a meeting with the company.

“With HOPE-3 completed and data expected later this year, we remain confident in our ability to advance Deramiocel toward potential approval,” CEO Linda Marbán said.

The company also stated that it maintains a “strong financial position” to support the advancement of Deramiocel through regulatory review and toward a potential launch for treating Duchenne Muscular Dystrophy (DMD).

DMD is a genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart, and respiratory muscles. The disease affects approximately 15,000 individuals in the United States and primarily impacts boys.

CAPR stock is down by about 55% this year and by about 40% over the past 12 months. 

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