Core Viewpoint - Capricor Therapeutics, Inc. is facing a federal securities class action lawsuit due to allegations of misleading statements regarding its lead drug candidate, deramiocel, and its failure to disclose critical safety and efficacy data [4][6]. Group 1: Legal Investigation and Class Action - Faruqi & Faruqi, LLP is investigating potential claims against Capricor and has set a deadline of September 15, 2025, for investors to seek the role of lead plaintiff in the class action [4]. - The lawsuit alleges that Capricor and its executives violated federal securities laws by making false statements about the company's ability to obtain a Biologics License Application (BLA) for deramiocel [6]. - The complaint highlights that Capricor provided investors with overly positive statements while concealing material adverse facts regarding the drug's safety and efficacy data from its Phase 2 HOPE-2 trial [6]. Group 2: Regulatory Developments - 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 [7]. - The CRL also pointed out outstanding issues in the Chemistry, Manufacturing, and Controls section of the application [7]. Group 3: Stock Market Reaction - 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 [8].

Core Viewpoint - Capricor Therapeutics, Inc. is facing a class action securities lawsuit due to alleged securities fraud related to its lead cell therapy candidate, deramiocel, which is intended for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [1][2] Group 1: Lawsuit Details - The lawsuit aims to recover losses for investors affected by alleged fraud between October 9, 2024, and July 10, 2025 [1] - Defendants allegedly provided misleading information regarding Capricor's ability to secure a Biologics License Application (BLA) for deramiocel while concealing adverse facts about its Phase 2 HOPE-2 trial data [2] - Following the announcement of a Complete Response Letter (CRL) from the FDA on July 11, 2025, which denied the BLA due to insufficient evidence of effectiveness, Capricor's stock price fell from $11.40 to $7.64 per share [2] Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until September 15, 2025, to request appointment as lead plaintiff, although participation in any recovery does not require this [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees [3] Group 3: Firm Background - Levi & Korsinsky has a history of securing significant settlements for shareholders and is recognized as one of the top securities litigation firms in the United States [4]

Core Viewpoint - Capricor Therapeutics, Inc. is facing a class action lawsuit due to alleged misleading statements regarding the safety and efficacy data of its drug, deramiocel, during the Class Period from October 9, 2024, to July 10, 2025 [1][4]. Group 1: Company Overview - Capricor is a clinical-stage biotechnology company focused on developing cell- and exosome-based therapeutics for Duchenne muscular dystrophy (DMD) and other diseases [3]. Group 2: Allegations and Stock Performance - The lawsuit claims that Capricor made false or misleading statements about the four-year safety and efficacy data from its Phase 2 HOPE-2 trial, leading to a false impression of potential approval for DMD cardiomyopathy [4]. - On May 5, 2025, Capricor announced a mid-cycle review with the FDA, reporting no significant deficiencies, but the stock fell over 29% following this news [5]. - Following a report on June 20, 2025, regarding the cancellation of an FDA advisory committee meeting due to concerns over deramiocel's efficacy and safety, Capricor's stock dropped more than 30% [6]. - On July 11, 2025, Capricor received a Complete Response Letter from the FDA denying its Biologics License Application for deramiocel, resulting in a nearly 33% decline in stock price [7].

Group 1 - Capricor Therapeutics, Inc. held its Q2 2025 earnings conference call on August 11, 2025, with key participants including CFO A.J. Bergmann and CEO Linda Marbán [1][2] - The conference call included forward-looking statements regarding the efficacy, safety, and intended utilization of product candidates, as well as future research and development plans [3][4] - The company discussed anticipated conduct and timing of preclinical and clinical studies, patient enrollment in clinical studies, and plans for regulatory filings and potential developments [3]

SAN DIEGO, Aug. 18, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that the first subjects have been dosed in a Phase 1 clinical trial evaluating its StealthX™ exosome- based vaccine. The study, funded by the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID) under the U.S. Department of Health and Human Services' Project NextGen, ...

Core Viewpoint - The Gross Law Firm is notifying shareholders of Capricor Therapeutics, Inc. regarding a potential class action lawsuit due to misleading statements related to the company's lead cell therapy candidate, deramiocel, and its FDA approval process [1][2]. Group 1: Allegations and Impact - Shareholders who purchased shares of Capricor during the class period from October 9, 2024, to July 10, 2025, are encouraged to contact the firm for possible lead plaintiff appointment [1]. - The complaint alleges that Capricor provided investors with misleading information about deramiocel's potential FDA approval while concealing adverse facts from its Phase 2 HOPE-2 trial [1]. - Following the announcement of a Complete Response Letter (CRL) from the FDA on July 11, 2025, which denied the Biologics License Application (BLA) due to insufficient evidence of effectiveness, Capricor's stock price fell from $11.40 to $7.64 per share [1]. Group 2: Next Steps for Shareholders - Shareholders are advised to register for the class action by September 15, 2025, to participate in the case without any cost or obligation [2]. - Registered shareholders will receive updates through a portfolio monitoring software throughout the lifecycle of the case [2]. Group 3: Firm's Commitment - The Gross Law Firm is a nationally recognized class action law firm dedicated to protecting investors' rights against deceit and illegal business practices [3]. - The firm aims to ensure companies adhere to responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [3].

Core Viewpoint - Rosen Law Firm is reminding investors who purchased Capricor Therapeutics, Inc. securities during the specified Class Period of the upcoming lead plaintiff deadline on September 15, 2025 [1]. Group 1: Class Action Details - Investors who purchased Capricor securities between October 9, 2024, and July 10, 2025, may be entitled to compensation without any out-of-pocket fees through a contingency fee arrangement [2]. - A class action lawsuit has already been filed, and those wishing to serve as lead plaintiff must act by September 15, 2025 [3]. - Investors can join the class action by visiting the provided link or contacting the law firm directly for more information [6]. Group 2: Law Firm Credentials - Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions, highlighting their own achievements in this area [4]. - The firm has secured significant settlements for investors, including over $438 million in 2019 alone, and has been consistently ranked among the top firms for securities class action settlements [4]. Group 3: Case Specifics - The lawsuit alleges that Capricor provided misleading information regarding its lead cell therapy candidate, deramiocel, particularly concerning its safety and efficacy data from the Phase 2 HOPE-2 trial [5]. - It is claimed that these misleading statements led to shareholders purchasing securities at artificially inflated prices, resulting in damages when the true information was revealed [5].

Core Viewpoint - Capricor Therapeutics, Inc. is facing a class action securities lawsuit due to alleged securities fraud related to its lead cell therapy candidate, deramiocel, which is intended for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [1][2] Group 1: Lawsuit Details - The lawsuit aims to recover losses for investors affected by alleged fraud between October 9, 2024, and July 10, 2025 [1] - Defendants allegedly provided misleading information regarding Capricor's ability to secure a Biologics License Application (BLA) for deramiocel while concealing adverse facts about its Phase 2 HOPE-2 trial data [2] - Following the announcement of a Complete Response Letter (CRL) from the FDA on July 11, 2025, which denied the BLA due to insufficient evidence of effectiveness, Capricor's stock price fell from $11.40 to $7.64 per share [2] Group 2: Next Steps for Investors - Investors who suffered losses during the specified timeframe have until September 15, 2025, to request appointment as lead plaintiff [3] - Class members may be entitled to compensation without any out-of-pocket costs or fees [3] Group 3: Firm Background - Levi & Korsinsky, LLP has a history of securing significant settlements for shareholders and is recognized as one of the top securities litigation firms in the United States [4]

Core Viewpoint - The complaint alleges that Capricor and its executives violated federal securities laws by making false or misleading statements regarding the effectiveness and safety data of their lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [2] Group 1: Company Performance and Regulatory Issues - Capricor received a Complete Response Letter (CRL) from the FDA on July 11, 2025, denying the Biologics License Application (BLA) due to insufficient evidence of effectiveness and the need for additional clinical data [3] - The CRL also highlighted outstanding issues in the Chemistry, Manufacturing, and Controls section of the application [3] Group 2: Market Reaction - 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, indicating a significant market reaction to the news [4]

NEW YORK, Aug. 14, 2025 /PRNewswire/ -- The Gross Law Firm issues the following notice to shareholders of Capricor Therapeutics, Inc. (NASDAQ: CAPR). Shareholders who purchased shares of CAPR during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointment. Appointment as lead plaintiff is not required to partake in any recovery. CONTACT: The Gross Law Firm 15 West 38th Street, 12th floor New York, NY, 10018 Email: [email protected] Phone: (646) 453-8903 SOURCE ...