Capricor on Friday announced positive four-year safety and efficacy results from its ongoing mid-stage study of its cell therapy Deramiocel, which failed to cheer investors.

Shares of Capricor Therapeutics (CAPR) tumbled 16% on Friday morning following reports that Nicole Verdun, director of the office that reviews cell and gene therapies at the Food and Drug Administration, and her deputy have been placed on administrative leave.

Stat News on Wednesday reported, citing a recording of a meeting, that Verdun and her deputy Rachael Anatol were escorted out of the agency, sending CAPR shares down on Friday morning. Verdun was the FDA's key overseer of Capricor's application for approval of its Deramiocel drug.

Capricor on Friday announced positive four-year safety and efficacy results from its ongoing mid-stage study of its cell therapy Deramiocel, which failed to cheer investors.

Deramiocel is Capricor’s lead cell therapy candidate for Duchenne Muscular Dystrophy, 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.

Last month, Capricor announced after a mid-cycle review meeting that the FDA is on track to decide on its application by the end of August, the deadline. No significant issues or major deficiencies were noted at the time of the mid-cycle review.

A late-cycle meeting is now planned for mid-July.

Capricor on Friday said that after four years of continuous treatment, Deramiocel-treated patients showed preservation of cardiac function, including Left Ventricular Ejection Fraction, which is a measurement of how well the left ventricle, the heart's main pumping chamber, is working.

Treatment also continued to slow the progression of skeletal muscle disease, the company said, while adding that the findings suggest that extended treatment with Deramiocel may help attenuate the progression of DMD over time.

CEO Linda Marbán said that the company is moving toward potential approval of the therapy, with several key regulatory steps now completed.

“Our continued dialogue with the FDA remains on track with no evidence of any delays,” she said.

On Stocktwits, retail sentiment around Capricor jumped from ‘bullish’ to ‘extremely bullish’ over the past 24 hours while message volume stayed at ‘high’ levels.

CAPR's Sentiment Meter and Message Volume as of 10:30 a.m. ET on June 20, 2025 | Source: Stocktwits

A Stocktwits user opined that, although things don't look good, the new 4-year data from the study could ‘change things’ for Capricor.

CAPR stock is down by 33% this year but has more than doubled its value over the past 12 months.

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