Capricor (CAPR) Stock More Than Doubles After Drug Pivot Announcement

TLDR

• CAPR stock surged more than 100% in premarket trading Friday after Capricor announced plans to submit an amended BLA for Deramiocel
• The FDA advisory panel voted 9-3 against recommending Deramiocel for DMD-associated cardiomyopathy last month
• Capricor now plans to pursue an upper limb skeletal muscle indication instead, supported by 24-month open-label extension data
• The FDA has confirmed it is willing to review the amendment and will extend the PDUFA action date upon receipt
• A securities fraud class action lawsuit has been filed against Capricor, with a lead plaintiff deadline of September 28, 2026

Capricor Therapeutics (CAPR) stock more than doubled in premarket trading Friday, climbing over 100%, after the company announced it plans to submit an amended Biologics License Application for its lead drug, Deramiocel.

Capricor Therapeutics, Inc., CAPR

The move comes after a rough stretch for the company. On July 27, 2026, CAPR stock fell 64.5%, dropping from $19.70 to $7.00 after the FDA released briefing documents raising concerns about changes to Capricor’s statistical analysis plan ahead of an advisory committee meeting.

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