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Capricor Therapeutics, Inc. shareholders were hit with a 60% to 70% drop on July 27, 2026, after FDA briefing documents for Deramiocel raised significant concerns with cardiac efficacy and a post-randomization statistical analysis plan change.
The FDA briefing documents were released ahead of the July 29, 2026 advisory committee meeting. FDA staff stated that Deramiocel had not demonstrated sufficient effectiveness on the cardiac endpoint and described a statistical analysis plan change after randomization. CAPR shares fell sharply the same day.
Before the drop, Capricor had framed the FDA review and cardiac data in positive terms. On March 12, 2026, CEO Linda Marbán said the FDA had not identified potential review issues in communications with the Company. On May 7, 2026, Capricor stated that Deramiocel slowed cardiac decline by approximately 91% compared to placebo with statistical significance.