Core Points - A shareholder class action lawsuit has been filed against Capricor Therapeutics, Inc. alleging that the company made materially false and/or misleading statements regarding its Phase 2 HOPE-2 trial data for deramiocel [1] - The lawsuit specifically concerns the four-year safety and efficacy data from the trial [1] - Shareholders who purchased Capricor shares between October 9, 2024, and July 10, 2025, and suffered significant losses are encouraged to seek legal counsel [2] Legal Information - The deadline for shareholders to request to be appointed as lead plaintiff in the case is September 15, 2025 [3] - Holzer & Holzer, LLC is a law firm specializing in securities litigation and has a history of recovering substantial amounts for shareholders affected by corporate misconduct [3] - The firm has been recognized as an ISS top-rated securities litigation law firm for the years 2021, 2022, and 2023 [3]

Core Points - A class action lawsuit has been filed against Capricor Therapeutics, Inc. for allegedly providing misleading information regarding its lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [1][2] - The lawsuit claims that Capricor made positive statements about obtaining a Biologics License Application (BLA) from the FDA while concealing adverse facts about the safety and efficacy data from its Phase 2 HOPE-2 trial [2] - On July 11, 2025, Capricor announced it received a Complete Response Letter (CRL) from the FDA, denying the BLA due to insufficient evidence of effectiveness and the need for additional clinical data [3] - Following the CRL announcement, Capricor's stock price dropped from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025 [4] Company Information - Capricor Therapeutics is involved in developing cell therapies, specifically targeting conditions like cardiomyopathy associated with DMD [2] - The company faced significant challenges with the FDA regarding its lead drug candidate, deramiocel, which has implications for its future development and market potential [3] Legal Context - The class action lawsuit allows investors who purchased Capricor securities between October 9, 2024, and July 10, 2025, to seek recovery for losses incurred due to the alleged misleading statements [1][4] - Investors have until September 15, 2025, to request to be appointed as lead plaintiff in the lawsuit [4]

Core Viewpoint - A securities fraud lawsuit has been filed against Capricor Therapeutics, Inc. and certain executives, alleging false statements regarding the safety and efficacy of their drug candidate, deramiocel, leading to significant investor losses [1][2]. Group 1: Allegations and Impact - The lawsuit claims that Capricor Therapeutics misled investors about deramiocel's progress towards FDA approval while concealing adverse data from the Phase 2 HOPE-2 trial [2]. - Following the release of negative information, Capricor's stock price experienced significant declines: from $10.30 to $7.30 on May 5, 2025; from $11.94 to $8.26 on June 20, 2025; and from $11.40 to $7.64 after the FDA's Complete Response Letter on July 11, 2025 [2]. Group 2: Eligibility and Actions - Investors who purchased Capricor common stock between October 9, 2024, and July 10, 2025, and have incurred losses may be eligible to participate in the lawsuit [3]. - The deadline to seek appointment as lead plaintiff is September 15, 2025, and investors are encouraged to contact Block & Leviton for further information [4]. Group 3: Whistleblower Information - Individuals with non-public information about Capricor Therapeutics are encouraged to assist in the investigation or file a report with the SEC under the whistleblower program, potentially receiving rewards of up to 30% of any successful recovery [5]. Group 4: Firm Background - Block & Leviton is recognized as a leading securities class action firm, having recovered billions for defrauded investors and representing many top institutional investors [6].

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Capricor Therapeutics, Inc. for possible violations of federal securities laws and unlawful business practices affecting stockholders [1][3]. Company Developments - On May 5, 2025, Capricor announced a mid-cycle review meeting with the FDA regarding its Biologics License Application for deramiocel, leading to a stock price drop of $3.00 per share (29.13%) to $7.30 on May 6, 2025 [3]. - Following a report on June 20, 2025, that the FDA canceled the advisory committee meeting for deramiocel due to concerns over the drug's efficacy and safety, Capricor's stock fell by $3.68 per share (30.82%) to close at $8.26 [3]. Legal Context - The law firm is encouraging investors who suffered losses from Capricor's stock to reach out for discussions regarding their legal rights and options [1][4].

Core Insights - Capricor Therapeutics, Inc. is under investigation for potential claims related to its common stock following a significant stock price drop after receiving a Complete Response Letter from the FDA regarding its lead product candidate, Deramiocel [1][2]. Company Developments - Capricor is a clinical-stage drug company focused on developing Deramiocel for treating cardiomyopathy in patients with Duchenne muscular dystrophy [1]. - The company completed its Phase 2 HOPE-2 clinical trial in 2021 [1]. - On September 24, 2024, Capricor filed a Biologics License Application (BLA) with the FDA for Deramiocel, which led to a stock price increase from $5.97 to $9.10 per share [2]. - On May 13, 2025, Capricor reported no significant deficiencies following a mid-cycle review meeting with the FDA [2]. - On July 11, 2025, Capricor announced it received a Complete Response Letter from the FDA, stating that the BLA did not meet the requirements for substantial evidence of effectiveness and required additional clinical data, resulting in a stock price drop of 33% to $7.64 per share [2]. Investor Information - Investors who experienced losses in Capricor's common stock are encouraged to contact Wolf Popper LLP for discussions regarding the investigation [3].

Core Viewpoint - Capricor Therapeutics' shares fell 33% following the FDA's issuance of a complete response letter (CRL) regarding the biologics license application (BLA) for deramiocel, intended to treat cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [1][6] Regulatory Update - The FDA concluded its review of the BLA but could not approve it in its current form, citing a lack of substantial evidence of effectiveness and the need for additional clinical data [2][6] - The CRL also pointed out unresolved issues in the Chemistry, Manufacturing and Controls (CMC) section of the application, although management believes these concerns have been addressed in prior communications with the FDA [3][6] Market Reaction - The investor community was surprised by the CRL, especially since the FDA had previously accepted the BLA and granted it priority review in March, with a decision expected by August 31, 2025 [4][6] - Year-to-date, Capricor's shares have declined 44.7%, contrasting with a 0.9% decline in the industry [3] Future Plans - Capricor plans to engage in discussions with the FDA to clarify the issues raised in the CRL and to outline a regulatory path for deramiocel [6][7] - The BLA was based on data from the phase II HOPE-2 study and an open-label extension study, and a potential approval could have made deramiocel the first therapy for DMD cardiomyopathy [7]

Core Viewpoint - The article discusses the investment potential of CAPR, highlighting the author's long position in the shares and expressing a positive outlook on the company's future performance [1]. Group 1 - The author has a beneficial long position in CAPR shares, indicating confidence in the company's growth prospects [1]. - The article emphasizes that the opinions expressed are solely those of the author and not influenced by external compensation [1]. Group 2 - There is a clear distinction made regarding the nature of the analysis, stating that it does not constitute investment advice or recommendations [2]. - The article notes that past performance is not indicative of future results, which is a standard disclaimer in investment analysis [2].

Core Points - Holzer & Holzer, LLC is investigating Capricor Therapeutics, Inc. for potential compliance issues with federal securities laws following the receipt of a Complete Response Letter from the FDA regarding its Biologics License Application for Deramiocel [1] - The announcement of the CRL led to a decline in Capricor's stock price [1] Company Information - Capricor Therapeutics, Inc. trades on NASDAQ under the ticker CAPR [1] - Holzer & Holzer, LLC is a law firm that specializes in representing shareholders and investors in litigation, including class action and derivative litigation [3] - The firm has a history of recovering hundreds of millions of dollars for shareholders affected by corporate misconduct since its founding in 2000 [3]

About this content About Emily Jarvie Emily began her career as a political journalist for Australian Community Media in Hobart, Tasmania. After she relocated to Toronto, Canada, she reported on business, legal, and scientific developments in the emerging psychedelics sector before joining Proactive in 2022. She brings a strong journalism background with her work featured in newspapers, magazines, and digital publications across Australia, Europe, and North America, including The Examiner, The Advocate, ...

Summary of Capricor Therapeutics (CAPR) Update Call Company Overview - **Company**: Capricor Therapeutics - **Focus**: Development of Daramyacel, a cell therapy candidate for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) Key Points Regulatory Update - Capricor received a Complete Response Letter (CRL) from the FDA regarding the Biologics License Application (BLA) for Daramyacel, indicating that the application does not meet the requirements for substantial evidence of effectiveness and requires more clinical data [4][5] - The review clock has been stopped until a complete response is submitted, and Capricor does not believe a new BLA will be required [5][41] - Capricor is preparing a written response to the CRL and has initiated engagement with the FDA for further discussions [5][10] Clinical Data and Efficacy - The BLA was supported by data from the HOPE-two trial, which demonstrated statistically significant benefits in cardiac function [7][8] - The HOPE-two open label extension study showed significant results in left ventricular ejection fraction with a p-value of 0.0079 [9] - Ongoing Phase III HOPE-three clinical trial is seen as a key opportunity to address the FDA's request for additional clinical data [10] - HOPE-three has completed a twelve-month evaluation of 104 DMD patients, with data expected in Q3 2025 [10] Manufacturing and Quality Control - Capricor is committed to resolving outstanding issues in the chemistry, manufacturing, and controls (CMC) section of the application [11] - The company believes that the issues raised by the FDA are resolvable in a timely manner [11] Industry Context - The FDA's decision is viewed as concerning, especially given the high unmet medical need in DMD and the innovative nature of the therapy [6][12] - Capricor emphasizes the importance of using long-term extension data and real-world evidence in evaluating therapies for rare diseases like DMD [12] Support from Medical Community - A group of leading DMD physician scientists submitted a letter to the FDA expressing support for the Daramyacel clinical program [13] - The letter highlighted their extensive experience in treating DMD and their belief in the efficacy and safety of Daramyacel [13] Future Outlook - Capricor remains committed to working collaboratively with the FDA and is optimistic about the potential for Daramyacel to receive approval [14][15] - The company aims to provide updates as they achieve clarity with the FDA regarding the path forward [69] Financial and Strategic Considerations - Capricor maintains its priority review status and is focused on addressing the FDA's concerns without needing a new BLA [48] - The partnership with NS Pharma remains strong, with continued commitment to commercialization in the U.S. despite the CRL setback [58] Additional Insights - The FDA's cancellation of the Public Advisory Committee meeting without explanation raised concerns about the review process [6] - Capricor's approach to statistical analysis in clinical trials has been a point of contention with the FDA, particularly regarding the use of parametric versus nonparametric models [30][36] This summary encapsulates the critical updates and insights from the Capricor Therapeutics conference call, highlighting the company's current challenges and future strategies in the context of regulatory approval for Daramyacel.