Whales with a lot of money to spend have taken a noticeably bullish stance on Capricor Therapeutics.Looking at options history for Capricor Therapeutics (NASDAQ:CAPR) we detected 13 trades.If we consider the specifics of each trade, it is accurate to state that 61% of the investors opened trades with bullish expectations and 23% with bearish.From the overall spotted trades, 7 are puts, for a total amount of $498,769 and 6, calls, for a total amount of $468,675.Expected Price MovementsAnalyzing the Volume an ...

Shares of Capricor Therapeutics, Inc. (NASDAQ:CAPR) plummeted Monday due to a short call from controversial former pharmaceutical executive Martin Shkreli.CAPR stock is plunging. See the real-time price action here. "HOPE-3, aka COPE-3"Shkreli publicly identified Capricor as a short target in a social media post. He expressed skepticism about the company’s cell therapy approach and its clinical trial data for its lead candidate, deramiocel. Read Next: Michael Burry Unchained: ‘Big Short’ Attacks Nvidia On S ...

Financial Data and Key Metrics Changes - As of September 30, 2025, the company's cash, cash equivalents, and marketable securities totaled approximately $98.6 million, which is expected to cover anticipated expenses into the fourth quarter of 2026 [17] - Revenue for Q3 2025 was zero, compared to approximately $2.3 million for Q3 2024, and revenue for the first three quarters of 2025 was zero, compared to approximately $11.1 million for the same period in 2024 [18] - The net loss for Q3 2025 was approximately $24.6 million, compared to a net loss of approximately $12.6 million for Q3 2024, and the net loss for the first three quarters of 2025 was approximately $74.9 million, compared to approximately $33.4 million for the same period in 2024 [19] Business Line Data and Key Metrics Changes - The company has administered over 800 infusions to approximately 150 boys and young men with Duchenne muscular dystrophy, demonstrating a strong and consistent safety profile for deramiocel [8] - The HOPE-3 phase 3 clinical study focuses on non-ambulant individuals, a patient population that has historically had limited clinical research dedicated to it [4] Market Data and Key Metrics Changes - The company is preparing for potential global expansion while closely monitoring evolving U.S. and international pricing policies [15] - The FDA has classified the resubmission of the BLA as Type 2, which means the review period can be up to six months, but there is precedent for faster review times [11] Company Strategy and Development Direction - The company aims to bring forward the first therapy that directly addresses Duchenne muscular dystrophy-associated cardiomyopathy, emphasizing the life-limiting cardiovascular impact of the disease [8] - The company is engaging both neurology and cardiology specialists to ensure an integrated approach to patient care should deramiocel receive approval [15] - The company is advancing its StealthX program under Project NextGen to develop next-generation vaccines for COVID-19 and other infectious threats [16] Management's Comments on Operating Environment and Future Outlook - Management remains highly motivated to achieve approval for deramiocel as early as possible in 2026, well ahead of the September 30, 2026 deadline for priority review voucher eligibility [11] - Management expressed confidence in the potential of deramiocel to stabilize disease progression and preserve both muscle and heart function [12] Other Important Information - The company has published a peer-reviewed paper detailing new mechanistic insights into deramiocel's mechanism of action, reinforcing the biologic rationale for its development program [12] - The San Diego commercial facility is fully operational and preparing for GMP production activities, addressing all CMC-related items cited in the CRL [14] Q&A Session Summary Question: What to expect from the upcoming HOPE-3 data? - The company will release top-line data including primary and key secondary endpoints as soon as available and will host a conference call to explain the implications of the data [22] Question: Are there any statistical changes in the study regarding left ventricular ejection fraction? - The study was always powered to measure ejection fraction, and the results from previous studies provide strong support for this analysis [23] Question: How will the statistical analysis plan handle the primary and secondary endpoints? - The primary endpoint remains the performance of the upper limb, and the analysis will focus on both combined cohorts and specifically on Cohort B [25] Question: What is the FDA's view on cohort B? - The focus on cohort B is due to its importance in addressing manufacturing concerns and ensuring the efficacy data is tied to the approved facility [41] Question: What is the potential for label expansion upon approval? - The company will discuss potential label expansion during conversations with the FDA, contingent on the data outcomes [50]

Core Insights - Kuehn Law, PLLC is investigating potential breaches of fiduciary duties by certain officers and directors of Capricor Therapeutics, Inc. (NASDAQ: CAPR) [1] - The investigation is based on a federal securities lawsuit alleging that insiders provided misleading information regarding the company's lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy [1] - The lawsuit claims that while Capricor communicated its ability to obtain a Biologics License Application (BLA) from the FDA, it also concealed adverse facts related to the safety and efficacy data from its Phase 2 HOPE-2 trial [1] Company Investigation - The investigation focuses on whether Capricor's management misled investors about the prospects of deramiocel [1] - The allegations include the dissemination of false statements and the concealment of material adverse facts regarding the drug's four-year safety and efficacy data [1] Shareholder Actions - Shareholders who purchased CAPR shares prior to October 9, 2024, are encouraged to contact Kuehn Law for potential legal action [2] - Kuehn Law offers to cover all case costs and does not charge its investor clients, emphasizing the importance of shareholder participation in maintaining market integrity [3]

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Capricor Therapeutics, Inc. following a class action complaint regarding breaches of fiduciary duties by the board of directors during the specified class period [1]. Group 1: Legal Investigation - The law firm is encouraging long-term stockholders of Capricor, specifically those who held shares between October 9, 2024, and July 10, 2025, to discuss their legal rights [1][3]. - A class action complaint was filed against Capricor on July 17, 2025, focusing on the actions of the company's board of directors [1]. Group 2: Company Performance and Issues - The complaint alleges that Capricor misled investors regarding its lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [7]. - Capricor's statements included claims 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 [7]. - 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 [7].

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Capricor Therapeutics, Inc. due to a class action complaint alleging breaches of fiduciary duties by the board of directors during the specified class period [1][2]. Group 1: Legal Investigation - The law firm is encouraging long-term stockholders of Capricor who suffered losses between October 9, 2024, and July 10, 2025, to discuss their legal rights [1]. - A class action complaint was filed against Capricor on July 17, 2025, focusing on the company's disclosures regarding its lead cell therapy candidate, deramiocel [2]. - The investigation centers on whether Capricor's board misled investors about the drug's regulatory status and safety data [2]. Group 2: Regulatory Issues - On July 11, 2025, Capricor announced it received a Complete Response Letter (CRL) from the FDA, 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 3: Stock Performance - 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].

Core Viewpoint - Capricor Therapeutics, Inc. is facing a class action lawsuit due to allegations of misleading statements regarding its lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [2][4]. Group 1: Allegations and Impact - The lawsuit claims that Capricor provided investors with overly positive information about its ability to obtain 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]. - 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 and the need for additional clinical data, Capricor's stock price fell from $11.40 to $7.64 per share [2]. Group 2: Class Action Details - The class period for the lawsuit is defined as October 9, 2024, to July 10, 2025, and shareholders are encouraged to register for potential lead plaintiff appointment [2][3]. - The deadline for shareholders to seek lead plaintiff status is September 15, 2025, and there is no cost or obligation to participate in the case [3]. Group 3: Legal Representation - The Gross Law Firm, a nationally recognized class action law firm, is representing the shareholders and aims to protect investors' rights against deceit and fraud [4]. - The firm emphasizes its commitment to ensuring responsible business practices and seeks recovery for investors who suffered losses due to misleading statements [4].

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 interested parties must move the Court to serve as lead plaintiff 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 recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone [4] - Rosen Law Firm has been recognized for its performance in securities class action settlements, being ranked No. 1 by ISS Securities Class Action Services in 2017 [4] Group 3: Case Specifics - The lawsuit alleges that Capricor provided misleading information regarding its lead cell therapy candidate, deramiocel, which is intended for treating cardiomyopathy associated with Duchenne muscular dystrophy [5] - Defendants allegedly made positive statements about obtaining a Biologics License Application from the FDA while concealing adverse facts about the drug's safety and efficacy data from its Phase 2 trial [5] - The misleading information is claimed to have led to shareholders purchasing securities at inflated prices, resulting in damages when the truth was revealed [5]

Group 1 - The Rosen Law Firm is reminding purchasers of Capricor Therapeutics, Inc. securities of the lead plaintiff deadline on September 15, 2025, for a class action lawsuit [1] - Investors who purchased Capricor securities during the specified Class Period 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 interested parties must move the Court by September 15, 2025, to serve as lead plaintiff [3] Group 2 - 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 lawsuit claims that these actions led to shareholders purchasing Capricor's securities at artificially inflated prices, resulting in damages when the true information was revealed [5] Group 3 - The Rosen Law Firm emphasizes the importance of selecting qualified counsel with a successful track record in securities class actions, highlighting its own achievements in this area [4] - The firm has recovered hundreds of millions of dollars for investors, including over $438 million in 2019 alone, and has been consistently ranked among the top firms for securities class action settlements [4]

Core Points - A class action securities lawsuit has been filed against Capricor Therapeutics, Inc. for alleged securities fraud affecting investors between October 9, 2024, and July 10, 2025 [1][2] - The lawsuit claims that Capricor misled investors regarding its lead cell therapy candidate, deramiocel, for treating cardiomyopathy associated with Duchenne muscular dystrophy (DMD) [2] - Following the announcement of a Complete Response Letter (CRL) from the FDA on July 11, 2025, which denied the Biologics License Application (BLA) for deramiocel, Capricor's stock price fell from $11.40 to $7.64 per share [2] Company Information - Capricor's lead product, deramiocel, was intended for the treatment of cardiomyopathy related to DMD, and the company had previously communicated positive expectations regarding its FDA approval [2] - The CRL indicated that Capricor did not meet the necessary requirements for substantial evidence of effectiveness and required additional clinical data [2] Legal Proceedings - Investors who suffered losses during the specified timeframe have until September 15, 2025, to request appointment as lead plaintiff in the lawsuit [3] - Participation in the lawsuit does not require any out-of-pocket costs for class members [3] Firm Background - Levi & Korsinsky, LLP has a strong track record in securities litigation, having secured hundreds of millions for shareholders over the past 20 years [4] - The firm has been recognized as one of the top securities litigation firms in the United States for seven consecutive years [4]