CAPRICOR CLASS ACTION LAWSUIT: A PREEMINENT INVESTOR GUIDE [2026]

Capricor is a biotechnology company focused on the development of cell and exosome-based therapeutics for the treatment of Duchenne muscular dystrophy, a rare genetic disorder characterized by progressive muscle degeneration and premature death. Its lead product candidate is Deramiocel, a cell therapy to address cardiac and skeletal muscle complications associated with Duchenne muscular dystrophy.

The Capricor class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that:

• Capricor adopted changes to the pre-specified statistical analysis plan used to analyze clinical data for Deramiocel;
• The FDA had not agreed to those changes before Capricor resubmitted the Deramiocel Biologics License Application (“BLA”);
• As a result, there was a significant risk that the FDA could conclude the clinical results did not provide substantial evidence of effectiveness of Deramiocel; and (iv) as a result of the foregoing, there was a substantial risk to regulatory approval of Deramiocel for the treatment of Duchenne muscular dystrophy.

On July 27, 2026, before the market opened, the FDA allegedly released briefing documents ahead of its July 29 advisory committee meeting for the BLA.  According to the Capricor class action lawsuit, the briefing documents explained that Capricor made changes to the pre-specified statistical analysis plan (“SAP”) and that the final version “was not submitted to FDA for review prior to BLA submission and was not discussed and consequently not agreed upon.”  The final version of the statistical analysis plan was allegedly created one day before the data was unblinded, and the FDA commented that the “FDA does not consider the conversion of raw change to percent change and then back to raw change to have been scientifically justified, as it adds complexity and reduces accuracy.” 

The FDA allegedly further stated that it “considers [Capricor’s] analyses based on the post-study SAP versions to be post-hoc and exploratory.”  The complaint further alleges that the briefing documents concluded “the benefit-risk assessment for [D]eramiocel appears unfavorable in the absence of evidence of effectiveness.”

That same day, Capricor allegedly provided “an update,” stating that “‘Capricor has engaged fully and transparently with the FDA throughout the review process’” and that “‘[i]t is critical to understand that the post-hoc analyses in the FDA’s briefing materials rely on SAP version 1.1, an unsigned incomplete internal draft which became obsolete with the addition of cohort B and did not include content specifically requested by the FDA.’” 

The Capricor class action lawsuit further alleges that Cantor Fitzgerald published an investor note that same day, stating the FDA’s “briefing documents paint an ugly picture” and “raise several concerns and make allegations about the integrity of data collecting.”  On this news, the price of Capricor stock fell 64%, according to the complaint.

On July 29, 2026, the advisory committee allegedly met to discuss the Deramiocel BLA.  The next day, Medscape reported that the panel relied on SAP version 1.1 as the “prespecified plan” and, in a non-binding 9-3 vote, the panel “concluded that the available evidence does not support the efficacy of deramiocel for treating DMD-associated cardiomyopathy.” 

On this news, the price of Capricor stock fell 36%, according to the Capricor class action lawsuit.