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In this guide, we provide a timeline of events for the entire duration of a typical securities class action lawsuit like the Capricor class action lawsuit, with approximately how long each step takes so you will have a better understanding of the timing of events in the Capricor lawsuit.

Allegations in the Capricor Class Action Lawsuit
Capricor is a clinical-stage biotechnology company that engages in the development of transformative cell and exosome-based therapeutics for treating Duchenne muscular dystrophy (“DMD”) and other diseases.
The Capricor class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose adverse facts concerning its four-year safety and efficacy data from its Phase 2 HOPE-2 trial study and gave the false impression that Capricor could obtain first approval for DMD cardiomyopathy.
The Capricor class action lawsuit alleges that on May 5, 2025, Capricor announced it had completed its mid-cycle review meeting with the U.S. Food and Drug Administration (“FDA”) on deramiocel for the treatment of DMD and that no significant deficiencies were identified by the Review Committee and that the package is on track for a Prescription Drug User Fee Act action date of August 31, 2025.
According to the complaint, the FDA also confirmed its intent to hold an advisory committee meeting. The Capricor class action lawsuit alleges that on this news, the price of Capricor stock fell more than 29%.
The Capricor class action lawsuit further alleges that on June 20, 2025, Stat News reported that Vinjay Prasad, the director of the FDA’s Center for Biologics Evaluation and Research, canceled the advisory committee meeting regarding deramiocel due to being “skeptical of the treatment” and uncertain about the drug’s efficacy and safety. On this news, the price of Capricor stock fell more than 30%, according to the complaint.
Then, on July 11, 2025, the Capricor class action lawsuit also alleges that Capricor announced it received a Complete Response Letter from the FDA denying Capricor’s Biologics License Application for deramiocel, citing it did not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data. On this news, the price of Capricor stock fell nearly 33%, according to the complaint.



