Capricor Therapeutics’ stock has closed lower for the past five consecutive days, erasing nearly 80% from the company’s market capitalization.

  • The FDA is still scheduled to decide on Deramiocel approval by August 22.
  • Capricor Therapeutics responded to the FDA advisory committee’s 9-3 vote against the effectiveness of its Deramiocel therapy by expressing continued confidence in the drug. 
  • The company also pointed out that the panel voted only on a narrower heart-specific question and did not weigh the therapy’s overall risks and benefits.

Shares of Capricor Therapeutics (CAPR) fell 8% on Friday, extending this week's selloff, after key regulatory setbacks for its lead experimental treatment for Duchenne muscular dystrophy, Deramiocel.

The stock has closed lower for five consecutive days, erasing nearly 80% from the company’s market capitalization. The stock is on track to clock its worst week ever, if losses hold.

What Drove The Selloff?

On Monday, the U.S. Food and Drug Administration released staff briefing papers ahead of an advisory committee review. Those documents raised questions about whether the company’s data clearly proved the therapy works. Investors reacted immediately, sending the stock tumbling from near $20 toward $7.

On Wednesday, the FDA’s independent panel of experts voted 9-3 that the available evidence did not support the treatment’s effectiveness for heart problems linked to Duchenne muscular dystrophy. The stock continued to slide in the following sessions.

About CAPR’s Deramiocel

Deramiocel is a cell therapy made from specialized cells taken from donor heart tissue. Capricor developed it for boys and young men with Duchenne muscular dystrophy, a rare genetic condition that causes progressive muscle weakness and wasting. Heart muscle damage is common and often becomes the leading cause of death. No approved treatments currently target this cardiomyopathy specifically.

The company says its late-stage trial showed the therapy slowed the loss of arm and hand function and offered benefits for heart function. FDA reviewers and the panel, however, viewed the data as fragile and insufficient to confirm clear benefits.

The FDA is still scheduled to decide on approval by August 22. A final decision could still go either way, provided the advisory committee’s ruling is not binding, leaving the stock highly sensitive to any further news.

Capricor Responds To FDA Panel

Capricor Therapeutics responded to the FDA advisory committee’s 9-3 vote against the effectiveness of its Deramiocel therapy by expressing continued confidence in the drug and its data. In a statement issued the day after the July 29 meeting, CEO Linda Marbán said the company “remain[s] committed to Deramiocel and to the patients who could benefit from it,” noting that the panel’s discussion of the treatment’s impact on skeletal muscle was encouraging and that Capricor remains confident in the strength of its late-stage HOPE-3 trial results. She stressed that Capricor is focused on collaborating with the FDA ahead of the August 22 decision deadline. The company also pointed out that the panel voted only on a narrower heart-specific question and did not weigh the therapy’s overall risks and benefits.

How Did CAPR Retail Traders React?

On Stocktwits, retail sentiment around CAPR stock stayed within ‘extremely bullish’ territory over the past 24 hours, while message volume remained at ‘extremely high’ levels.

A Stocktwits user opined that the FDA has treated rare disease therapies ‘badly’ despite the unmet need.

Another user highlighted that they are awaiting the FDA’s final decision and expressed hopes for Deramiocel’s approval despite the negative committee vote.

CAPR stock has fallen 86% year-to-date. 

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