Capricor Hit With Securities Fraud Suit Over Deramiocel Data Claims
CAPR has more than doubled off its 52-week low of $2.96 on elevated volume (4.3× avg).
Summary
A securities fraud class action has been filed against Capricor Therapeutics, alleging the company misrepresented the integrity of clinical data supporting its Deramiocel BLA. The suit claims Capricor failed to disclose changes to its pre-specified statistical analysis plan that the FDA had not agreed to before resubmission. This follows the FDA's July 27 briefing documents that raised concerns about post-hoc changes to the primary endpoint methodology, triggering a 64.5% single-day stock drop. The lawsuit adds legal risk on top of the negative advisory committee vote and the FDA's Complete Response Letter. Lead plaintiff deadline is September 28, 2026.
At the time of this announcement, CAPR was trading at $7.31 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $433.1M. The 52-week trading range was $2.96 to $40.37. This news item was assessed with negative market sentiment and an importance score of 7 out of 10. Source: PR Newswire.