Group 1 - A securities class action lawsuit has been filed against Capricor Therapeutics, Inc. for misleading investors regarding its lead cell therapy candidate, deramiocel, during the class period from October 9, 2024, to July 10, 2025 [1] - The lawsuit alleges that Capricor concealed adverse facts about the safety and efficacy data from its Phase 2 HOPE-2 trial, while falsely suggesting they could obtain first approval for DMD cardiomyopathy [2] - Following the announcement of a Complete Response Letter (CRL) from the FDA on July 11, 2025, which denied Capricor's Biologics License Application, the stock price fell from $11.40 to $7.64 per share [3] Group 2 - Investors who acquired shares of Capricor are encouraged to contact the law firm Gainey McKenna & Egleston before the lead plaintiff motion deadline on September 15, 2025 [4]

Core Viewpoint - A class action lawsuit has been filed against Capricor Therapeutics, Inc. for allegedly misleading investors about the viability of its lead product candidate, deramiocel, during the class period from October 9, 2024, to July 10, 2025 [1][2]. Company Overview - Capricor Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing cell and exosome-based therapeutics for Duchenne muscular dystrophy (DMD) and other diseases with unmet medical needs in the U.S. [1]. Allegations - The lawsuit claims that Capricor misled investors regarding the effectiveness of deramiocel for treating cardiomyopathy associated with DMD, creating a false impression of its approval prospects while concealing adverse 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, which denied its Biologics License Application, citing insufficient evidence of effectiveness and the need for additional clinical data [3]. Stock Impact - Following the announcement of the CRL, Capricor's stock price fell from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025, reflecting a significant decline in investor confidence [3].

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]