The U.S. FDA stated that its review committee has identified no significant deficiencies and is on track to make a decision on the application by its deadline of the end of August.

Capricor Therapeutics (CAPR) announced on Monday that it has completed a mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for the company’s Biologics License Application (BLA) seeking full approval for deramiocel as a treatment for patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy.

FDA stated during the meeting that its review committee has identified no significant deficiencies and is on track to decide on the application by its deadline of the end of August.

The company said the FDA is considering holding an advisory committee meeting, though the agency provided no official date.

Capricor CEO Linda Marbán said the company has been “actively preparing” to present data regarding deramiocel’s efficacy and safety in halting or slowing the progression of DMD-cardiomyopathy.

DMD is a genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart, and respiratory muscles.

It is estimated that DMD occurs in approximately one in every 3,500 male births and that the patient population is approximately 15,000-20,000 in the United States.

Capricor has already entered into an agreement with Nippon Shinyaku Co. for the exclusive commercialization and distribution of deramiocel for DMD in the United States and Japan.

On Stocktwits, retail sentiment around Capricor rose from ‘bearish’ to ‘neutral’ territory over the past 24 hours while message volume rose from ‘low’ to ‘normal’ levels.

CAPR's Sentiment Meter and Message Volume as of 10:30 a.m. ET on May 5, 2025 | Source: Stocktwits

CAPR stock has been down by about 30% this year but has been up by about 89% over the past 12 months.

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