Capricor Therapeutics Faces Class Action Amid FDA Challenges
Introduction to Capricor Therapeutics
Capricor Therapeutics, Inc. is a company known for its innovative therapies targeting serious diseases. Recently, the company has been under scrutiny due to a class action lawsuit concerning its lead product, deramiocel, which aims to treat cardiomyopathy related to Duchenne muscular dystrophy (DMD). Investors are urged to pay attention, as the lawsuit concerns substantial losses over a specific period.
Background of the Lawsuit
The class action lawsuit filed on behalf of investors alleges that during a particular timeframe, Capricor misled the market regarding its prospects for a Biologics License Application (BLA) approval by the FDA. The lawsuit aims to cover losses experienced from the date of October 9, 2024, until July 10, 2025. These allegations center around misleading statements that obscured the company's struggles with the FDA's approval process.
Key Allegations Against Capricor
According to the allegations, Capricor provided optimistic projections regarding the FDA's evaluation of its drug, deramiocel. However, it is claimed that the company failed to disclose critical information regarding negative data from its Phase 2 HOPE-2 trial. These disclosures were crucial for investors, as the FDA later issued a Complete Response Letter (CRL) denying the BLA submission, citing insufficient evidence of effectiveness. The stock price was significantly affected, plunging after the press release from Capricor.
The Impact of the FDA's Response
Following the FDA's issuance of the CRL on July 11, 2025, Capricor's stock experienced a notable decline. With the price dropping from $11.40 to $7.64 per share, many investors faced significant financial losses. This sudden downturn serves as a cautionary tale for future investors regarding the importance of transparency in communications between a company and its investors.
Next Steps for Affected Investors
Affected investors have until September 15, 2025, to file a motion for their appointment as lead plaintiff in this class action. Participating in this lawsuit is crucial for those who suffered losses, as it is an opportunity to seek recovery without any upfront costs. It's important to act promptly and gather necessary documentation related to their investments in Capricor.
Why Choose Levi & Korsinsky for Representation?
Levi & Korsinsky, LLP has a strong reputation in securities litigation, having secured substantial recoveries for numerous investors over the years. Their legal team possesses vast experience and specializes in complex securities cases, ensuring that clients receive knowledgeable representation throughout the lawsuit process. Their continued success in the field makes them a trusted choice for investors looking to navigate these turbulent waters.
Conclusion and Contact Information
If you are an investor in Capricor Therapeutics who has been affected by their recent developments, now is the time to take action. You can reach out to Levi & Korsinsky, LLP for further guidance on participating in the class action lawsuit. Contact Joseph E. Levi, Esq. at their office directly via phone at (212) 363-7500 or through email for personalized support.
Frequently Asked Questions
What is the class action lawsuit against Capricor about?
The lawsuit alleges that Capricor misled investors regarding the approval process of its lead drug, deramiocel, leading to significant financial losses.
Who can participate in the lawsuit?
Any investor who acquired shares of Capricor Therapeutics between October 9, 2024, and July 10, 2025, can participate, especially if they suffered losses during this time.
What is the deadline to join the class action?
The deadline for affected investors to request being appointed as lead plaintiff is September 15, 2025.
Is there a cost to join the lawsuit?
No, there is no obligation or upfront cost to participate in the lawsuit if you qualify as a class member.
Who should I contact for more information?
You can contact Levi & Korsinsky, LLP, specifically Joseph E. Levi at (212) 363-7500, for more details on the lawsuit and your potential involvement.
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