#United States #New York #Securities Law #deramiocel #Capricor Therapeutics

Capricor Therapeutics Faces Legal Challenges

In recent developments, Capricor Therapeutics, Inc. (NASDAQ: CAPR) has come under scrutiny as it faces allegations of securities law violations. The Gross Law Firm has announced a formal notice addressed to shareholders, encouraging those who acquired shares during the specified class period to reach out for guidance regarding possible lead plaintiff appointments. Importantly, the firm clarifies that while being appointed as a lead plaintiff is not necessary to seek recovery, shareholders should be proactive in ensuring their rights are protected.

The troubling allegations against Capricor focus on their lead cell therapy candidate, deramiocel, which is intended to treat cardiomyopathy resulting from Duchenne muscular dystrophy (DMD). Investors were reportedly misled by optimistic statements from the company regarding their ability to secure a Biologics License Application (BLA) for deramiocel from the FDA. These statements, however, emerged alongside the concealment of critical and adverse aspects of the drug's safety and efficacy results, particularly from the Phase 2 HOPE-2 trial.

On July 11, 2025, Capricor released a press announcement revealing they had received a Complete Response Letter (CRL) from the FDA. This letter indicated that the application did not satisfy the necessary requirements for substantial evidence of effectiveness and highlighted the need for additional clinical data. Following this disappointing news, Capricor's stock price plummeted from $11.40 per share on July 10 to $7.64 the day after the news broke. This sharp decline signals the significant impact of the negative FDA feedback on the company's valuation and investor confidence.

Shareholders who acquired CAPR shares between October 9, 2024, and July 10, 2025, are poised to potentially benefit from participation in this class action. Registration for the action is urged before the September 15, 2025, deadline, to secure their entitlement to any recoveries that may arise from the lawsuit. The Gross Law Firm has established a portfolio monitoring system to keep registered shareholders informed about the developments throughout the case's duration, ensuring they are updated on any significant progress.

The Gross Law Firm stands out due to its national prominence in class action cases directed at defending shareholders' rights. Their mission is to hold companies accountable for misleading practices, deceit, and fraudulent activities that can harm investors. The firm emphasizes that the pursuit of justice should empower shareholders to recover losses incurred when they were misled by false statements or omissions from companies regarding their operational integrity.

Potential claimants are welcomed to engage with the firm with no cost or obligation on their part. Interested shareholders may find additional information and connect with the legal team through the provided link to the loss submission form on the Gross Law Firm's website.

This situation highlights the importance of transparency and ethical conduct within the pharmaceutical industry, especially when investor trust is at stake. As this case unfolds, it will become clearer how Capricor Therapeutics handles these allegations and what measures they will implement to recover their credibility in the market.

For more details and further inquiries, shareholders and interested parties should connect with The Gross Law Firm directly by visiting their official contact points. Ensuring accountability in future corporate governance should be a priority for all stakeholders involved to promote responsible business practices in the healthcare sector.