CAPR Stock Sinks As Investors Brace For Imminent FDA Call On Deramiocel

• On its recent earnings call earlier this month, the company said it plans to submit an amendment to its application with additional 24-month data focused on upper-limb function improvement with the drug.
• In July, an FDA advisory panel voted 9-3 against the strength of evidence for the drug’s heart benefits and raised questions about how the trial results were analyzed.
• Capricor first received a complete response letter turning down its application in July 2025 over insufficient evidence of effectiveness.

Shares of Capricor Therapeutics (CAPR) ended nearly 8% lower on Friday, as investors await the decision of the U.S. Food and Drug Administration (FDA) on its drug Deramiocel amid a shareholder’s push for a board shakeup at the firm.

The stock further fell 5% this week after two consecutive weeks of gains.

FDA Target Date Arrives Tomorrow

The U.S. Food and Drug Administration’s target action date for Capricor’s biologics license application for Deramiocel is Saturday, though it may move. Deramiocel is an experimental cell therapy aimed at slowing muscle damage in Duchenne muscular dystrophy, a rare genetic condition that causes progressive weakness and often harms the heart.

On its recent earnings call earlier this month, the company said it plans to submit an amendment to its application with additional 24-month data focused on upper-limb function improvement with the drug. The FDA has indicated it is willing to review the new information and extend the review timeline once the amendment arrives, the company said.

The stock jumped over 50% on August 14 following the announcement, recovering some of the ground lost in late July.

The earlier slide came after an FDA advisory panel voted 9-3 against the strength of evidence for the drug’s heart benefits and raised questions about how the trial results were analyzed. The panel’s recommendation is not binding, yet it added to investor caution about a potential approval after a previous rejection.

Capricor first received a complete response letter turning down the application in July 2025 over insufficient evidence of effectiveness. The company later resubmitted with fresh late-stage trial data, securing the current August 22 target.

Kaos Capital Pushes For Board Shakeup

Earlier on Friday, activist shareholder Kaos Capital issued a letter urging fellow investors to back an immediate board meeting. The Miami-based firm, describing itself as a significant and growing holder, said it plans to nominate two independent directors and push for a new board committee focused on mergers, acquisitions, and strategic alternatives, chaired by a shareholder-backed member. It also called for a cash-preservation plan to curb spending after Capricor’s cash fell to $237.9 million by mid-year and first-half operating costs reached $79.7 million. If the board does not engage within 15 business days, Kaos said it may seek broader support to replace directors and possibly senior management.

How Did CAPR Retail Traders React?

On Stocktwits, retail sentiment around CAPR stock remained ‘bullish’ over the past 24 hours, while message volume fell from ‘high’ to ‘normal’ levels.

A few Stocktwits users remain optimistic about the potential approval of Deramiocel.

Another user termed the impending FDA decision a binary event.

A third, more pessimistic user sees a second rejection for the drug on the horizon.

CAPR stock has fallen 78% year-to-date. 

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