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 ...

Core Points - Rosen Law Firm is reminding investors who purchased Capricor Therapeutics, Inc. securities between October 9, 2024, and July 10, 2025, of the lead plaintiff deadline on September 15, 2025 [1] - Investors may be entitled to compensation through a contingency fee arrangement without any out-of-pocket costs [2] - A class action lawsuit has been filed, and interested parties can join by contacting the firm or visiting their website [3] Case Details - The lawsuit alleges that Capricor provided misleading information regarding its lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [5] - Defendants allegedly made positive statements about obtaining a Biologics License Application (BLA) from the FDA while concealing adverse facts about the safety and efficacy data from the Phase 2 HOPE-2 trial [5] - The misleading information is claimed to have caused shareholders to purchase securities at inflated prices, leading to damages when the truth was revealed [5] Rosen Law Firm's Credentials - The firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions [4] - Rosen Law Firm has achieved significant settlements, including the largest securities class action settlement against a Chinese company at the time and has recovered hundreds of millions for investors [4] - The firm has been consistently ranked among the top firms for securities class action settlements since 2013 [4]

NEW YORK, Aug. 13, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Capricor Therapeutics, Inc. ("Capricor" or the "Company") (NASDAQ: CAPR). Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Capricor and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices. [Click here for information about joining the class action] Pome ...

Core Viewpoint - A class action has been filed against Capricor Therapeutics, Inc. for allegedly misleading investors regarding the viability of its lead product candidate, deramiocel, for treating Duchenne muscular dystrophy (DMD) [1][2]. Group 1: Company Overview - Capricor Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing cell and exosome-based therapeutics for DMD and other diseases with unmet medical needs in the U.S. [1] - The company's lead product candidate is deramiocel, which consists of allogeneic cardiosphere-derived cells [1]. Group 2: Allegations and Legal Action - Robbins LLP is investigating allegations that Capricor misled investors about deramiocel's potential for first approval for DMD cardiomyopathy while concealing adverse facts regarding its safety and efficacy data from the Phase 2 HOPE-2 trial [2]. - The complaint states that the misleading information led to shareholders purchasing Capricor's securities at artificially inflated prices [2]. Group 3: Stock Price Impact - On July 11, 2025, Capricor announced it received a Complete Response Letter (CRL) from the FDA, denying its Biologics License Application due to insufficient evidence of effectiveness and the need for additional clinical data [3]. - Following the announcement, Capricor's stock price fell from $11.40 per share on July 10, 2025, to $7.64 per share on July 11, 2025 [3].

Financial Data and Key Metrics Changes - As of June 30, 2025, the company's cash, cash equivalents, and marketable securities totaled approximately $122.8 million [23] - Revenues for Q2 2025 were zero, compared to approximately $4 million for Q2 2024, and total revenues for 2025 were zero compared to approximately $8.9 million for 2024 [23][24] - Research and development expenses for Q2 2025 were approximately $20.1 million, up from approximately $11.7 million in Q2 2024, and total R&D expenses for 2025 were approximately $36.3 million compared to approximately $21.8 million for 2024 [25][26] - General and administrative expenses for Q2 2025 were approximately $4 million, compared to approximately $1.8 million in Q2 2024, and total G&A expenses for 2025 were approximately $7 million compared to approximately $3.6 million for 2024 [26] - The net loss for Q2 2025 was approximately $25.9 million, compared to a net loss of approximately $11 million for Q2 2024, and the total net loss for 2025 was approximately $50.3 million compared to approximately $20.8 million for 2024 [26] Business Line Data and Key Metrics Changes - The company is focused on advancing daramycin for the treatment of Duchenne muscular dystrophy (DMD) cardiomyopathy, which is a significant unmet need in the DMD community [5][6] - The HOPE-three trial is fully enrolled with 104 patients, and the primary efficacy endpoint has been amended to Left Ventricular Ejection Fraction (LVEF) [9][10] Market Data and Key Metrics Changes - The company is actively working with the FDA to clarify the path forward for daramycin following a complete response letter received in July 2025 [6][12] - The company is also involved in Project NextGen, focusing on advancing next-generation vaccines for COVID-19 and other infectious diseases through its Stealth X vaccine [17][18] Company Strategy and Development Direction - The company aims to deliver transformative therapies for rare diseases, with a strong commitment to the DMD community [5] - The strategy includes working constructively with the FDA to define a clear path for daramycin's approval and preparing for potential commercial launch activities [8][16] - The company is also exploring opportunities in vaccine development through its exosome platform, which could lead to partnerships and expansion into other therapeutic areas [20][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strength of their data and the potential for daramycin to stabilize cardiac function in DMD patients [14][29] - The company remains focused on regulatory clarity and is optimistic about the upcoming Type A meeting with the FDA [35][64] - Management emphasized the importance of LVEF as a primary efficacy endpoint and the need for innovative thinking from the FDA regarding rare disease approvals [82][87] Other Important Information - The company has received formal acceptance of all items from its pre-license inspection, validating its quality systems and manufacturing capabilities [14][15] - The company is well-positioned financially, with over $120 million in cash, allowing it to support operations until late 2026 [28] Q&A Session Summary Question: What is the plan for unblinding the HOPE-three trial? - The company is waiting for FDA adjudication on requirements for HOPE-three before proceeding with unblinding [33] Question: What incremental data could be submitted to the FDA? - The company is considering submitting supplemental open-label extension data to support safety and efficacy [41] Question: How has the FDA review team changed? - The company is uncertain about changes in the review team but is looking forward to working with the FDA [111] Question: What are the key takeaways expected from the upcoming Type A meeting? - The company aims to clarify what is required for approval and the primary endpoint for HOPE-three [64] Question: What accounts for the increase in R&D expenses? - The increase is due to ongoing clinical studies and preparations for CMC endeavors [105]