Securities Fraud Class Action Filed Against Capricor Over Deramiocel Data Integrity
CAPR sits 40% above its 52-week low of $2.96 on elevated volume (1.9× avg).
Summary
A securities fraud class action has been filed against Capricor Therapeutics, alleging the company made false statements about Deramiocel and the integrity of clinical data supporting its BLA. The complaint, filed in the Southern District of California, claims Capricor failed to disclose that it changed the pre-specified statistical analysis plan without FDA agreement before resubmitting the BLA. This follows a devastating week for the stock: a 64.5% drop on July 27 after FDA briefing documents raised concerns about post-hoc statistical changes, and a further 36% decline after an advisory committee voted 9-3 against efficacy on July 30. The lawsuit adds legal liability to the existing regulatory setback, with a lead plaintiff deadline of September 28, 2026. The PDUFA date remains August 22, 2026, but the negative advisory committee vote and now litigation significantly cloud the approval outlook.
At the time of this announcement, CAPR was trading at $4.14 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $243.2M. 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 8 out of 10. Source: PR Newswire.