Latest news with #CAPR


Business Wire
7 days ago
- Business
- Business Wire
Capricor Therapeutics, Inc. Sued for Securities Law Violations - Contact the DJS Law Group to Discuss Your Rights
LOS ANGELES--(BUSINESS WIRE)-- The DJS Law Group reminds investors of a class action lawsuit against Capricor Therapeutics, Inc. ('Capricor' or 'the Company') (NASDAQ: CAPR) for violations of §§10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder by the U.S. Securities and Exchange Commission. Shareholders who purchased shares of CAPR during the class period listed are encouraged to contact the firm regarding possible lead plaintiff appointments. Appointment as lead plaintiff is not required to partake in any recovery. CLASS PERIOD: DEADLINE: September 15, 2025 CASE DETAILS: According to the Complaint, the Company made false and misleading statements to the market. Capricor claimed that its deramiocel drug candidate was successfully moving towards FDA approval, touting its progress through the approval process. Although its public comments were positive, the Company was aware of adverse data from its Phase 2 HOPE-2 trial. Based on these facts, the Company's public statements were false and materially misleading throughout the class period. If you are a shareholder who suffered a loss, contact us to participate. NEXT STEPS FOR SHAREHOLDERS: Once you register as a shareholder who purchased shares of CAPR during the timeframe listed above, you will be enrolled in a portfolio monitoring software to provide you with status updates throughout the lifecycle of the case. There is no cost or obligation to you to participate in this case. WHY DJS LAW GROUP? DJS Law Group's primary focus is to enhance investor return through balanced counseling and aggressive advocacy. We specialize in securities class actions, corporate governance litigation, and domestic/international M&A appraisals. Our clients are some of the largest and most sophisticated hedge funds and alternative asset managers in the world. The litigation claims of our clients are extraordinarily valuable assets that demand respect, focus, and results. Join the case to recover your losses. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.
Yahoo
18-07-2025
- Business
- Yahoo
FDA Rejects CAPR's Cell Therapy BLA for Genetic Disorder, Stock Tanks
Shares of Capricor Therapeutics CAPR tanked 33% on Friday after it announced that the FDA issued a complete response letter ('CRL') to the biologics license application ('BLA') seeking approval for cell therapy deramiocel, to treat cardiomyopathy associated with Duchenne muscular dystrophy ('DMD'). DMD is a serious genetic disorder showing progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles with mortality at a median age of approximately 30 years. Per the CRL, the FDA informed the company that it had concluded review of the BLA but could not approve the application in the current form. The regulatory body specifically noted that the application failed to meet the statutory requirement for substantial evidence of effectiveness and highlighted the need for additional clinical data. The CRL also highlighted certain unresolved issues within the Chemistry, Manufacturing and Controls ('CMC') section of the application. Management believes that most of these concerns have already been addressed in its prior communications with the FDA. However, the FDA did not review these materials, as they were submitted too close to the issuance of the CRL. Year to date, shares of Capricor have plunged 44.7% compared with the industry's decline of 0.9%. Image Source: Zacks Investment Research CRL to CAPR's BLA Comes as a Major Surprise The investor community seemed surprised by the CRL, especially after the FDA accepted and granted a priority review to the BLA for deramiocel in March. A decision was due on Aug. 31, 2025. More so, the FDA also did not identify any review issues with the BLA. In a regulatory update provided last month, the company also confirmed that the FDA indicated an Advisory Committee meeting would not be required for the application. The BLA was based on data from its phase II HOPE-2 and an open-label extension study compared with natural history data. A potential approval could have made deramiocel the first therapy to treat DMD cardiomyopathy. However, the latest CRL is likely to delay the approval for deramiocel, which could have given Capricor its first approved product. The company plans to hold further discussions with the FDA to determine the next steps of development for deramiocel. Capricor Therapeutics, Inc. Price Capricor Therapeutics, Inc. price | Capricor Therapeutics, Inc. Quote CAPR's Zacks Rank & Stocks to Consider Capricor currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks from the biotech sector are Arvinas ARVN, Alkermes ALKS and BioXcel Therapeutics BTAI, each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today's Zacks #1 Rank stocks here. In the past 60 days, Arvinas' 2025 loss per share estimates have improved from $1.60 to $1.51. Loss per share estimates for 2026 have narrowed from $3.28 to $2.98 during the same period. ARVN stock has plunged 59.3% year to date. Arvinas' earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 82.09%. In the past 60 days, estimates for Alkermes' earnings per share have increased from $1.74 to $1.79 for 2025. During the same time, earnings per share estimates for 2026 have risen from $1.79 to $1.91. Year to date, shares of ALKS have gained 5.3%. Alkermes' earnings beat estimates in one of the trailing four quarters, while missing the same on the remaining three occasions, the negative average surprise being 8.24%. In the past 60 days, BioXcel Therapeutics' 2025 loss per share estimates have improved from $16.44 to $8.60. Loss per share estimates for 2026 have narrowed from $23.76 to $7.02 during the same period. BTAI stock has declined 67.1% year to date. BioXcel Therapeutics' earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 42.84%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Alkermes plc (ALKS) : Free Stock Analysis Report Capricor Therapeutics, Inc. (CAPR) : Free Stock Analysis Report BioXcel Therapeutics, Inc. (BTAI) : Free Stock Analysis Report Arvinas, Inc. (ARVN) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research


Business Insider
12-07-2025
- Business
- Business Insider
Capricor Therapeutics Stock (CAPR) Plummets 40% on FDA Rejection
Capricor Therapeutics (CAPR) stock dove on Friday after the biotechnology company revealed a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA). This letter covered its Biologics License Application (BLA) for Deramiocel, a cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). That's a severe genetic disorder that causes progressive muscle weakness and degeneration. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. The big news here is that the FDA completed its review of the BLA for Deramiocel and has rejected the therapy in its current form. The FDA said it 'does not meet the statutory requirement for substantial evidence of effectiveness and the need for additional clinical data.' The FDA is willing to restart its review with additional data and has granted Capricor Therapeutics a Type A meeting to discuss further action. Capricor Therapeutics CEO Linda Marbán noted that the CRL from the FDA was a surprise. She claimed that the company followed the FDA's guidance throughout the submission process and that no issues were revealed ahead of the CRL. She said the company will 'submit data from the Phase 3 HOPE-3 clinical trial to provide additional evidence of effectiveness from an adequate and well-controlled study.' Capricor Therapeutics Stock Movement Today CAPR stock was down 38.51% in pre-market trading on Friday, following a slight 0.18% dip yesterday. The shares were also down 17.39% year to date, but remained up 159.09% over the past 12 months. Today's news triggered a stock selloff, with some 4 million shares traded this morning, compared to a three-month daily average of about 2.59 million units. Is Capricor Therapeutics Stock a Buy, Sell, or Hold? Turning to Wall Street, the analysts' consensus rating for Capricor Therapeutics is Strong Buy, based on nine Buy and one Hold rating over the past three months. With that comes an average CAPR stock price target of $30.60, representing a potential 167.42% upside for the shares.


Business Recorder
26-06-2025
- Business
- Business Recorder
IED rates ADB's 5-year CAP for Pakistan as highly successful
ISLAMABAD: The Independent Evaluation Department (IED) has rated the Asian Development Bank (ADB)'s five years Country Assistance Program (CAP) for Pakistan, amounting $15.1 billion as highly satisfactory and successful. The evaluation document however, noted that headway on reducing debilitating circular debt in the power sector was limited, and growth in access to affordable housing was below target. This Country Assistance Programme Review (CAPR) assesses the performance of ADB sovereign and non-sovereign operations that were completed, ongoing, or approved during 2020–2024 in Pakistan. ADB's IED rates $800m 'TCP' as 'successful' The ADB's portfolio in Pakistan over the 5-year CAPR period comprised of 113 sovereign lending and Technical Assistance (TA) projects amounting to $15.1 billion, as well as three non-sovereign lending and TA projects worth $111.4 million. The ADB's CAP in Pakistan, including performance against the 2021–2025 Country Partnership Strategy (CPS) targets, is rated successful overall. This evaluation follows the new 2024 Guidelines for the Country Assistance Programme Review and Validation, assesses all aspects of ADB's engagement in Pakistan rather than the CPS results alone, and centres on four criteria: relevance, efficiency, effectiveness, and sustainability. The ADB's portfolio facilitated reforms to make Pakistan's energy sector more efficient and sustainable. The CPS set an ambitious target for reducing the annual circular debt flow in the power sector to less than Rs50 billion by 2025 from a very high Rs450 billion in fiscal year 2019. Progress was made. The circular debt had dropped to Rs83 billion by the end of 2024. The Rs50 billion CPS indicator target was not likely to be met by 2025, however, the energy sector continues to be captive to persistent challenges, including the high cost of generating power with imported fossil fuels, transmission and distribution losses, low collection rates, governance issues at electricity supply companies, and delays in tariff adjustments. To improve access to affordable housing, a CPS indicator targeted a mortgage-to GDP-ratio of 0.4 per cent by 2025. As of 2024, despite efforts, the ratio had improved by only 20 percent and stood at 0.3 percent. The pandemic and the 2022 flood disaster have likely put the original CPS objectives for school enrolment out of reach. Health expenditure as a share of GDP rose temporarily due to the COVID-19; still, at 1.2 percent, the average allocation during the CAPR period was well short of the CPS's 2025 benchmark of 3 percent of GDP. The CAP helped Pakistan make progress on several socioeconomic fronts during 2020–2024, but further effort is required in the most challenging areas if the country's ambitious development targets are to be achieved. The CAP strongly aligned with Pakistan's critical development needs and the focus of the government's Vision 2025 on addressing economic, governance, and human development challenges. The ADB investments aimed to improve economic management, build resilience, and boost competitiveness and private sector development—the three pillars of the 2021–2025 CPS, which fully aligned with ADB's Strategy 2023 and linked to all seven of its operational priorities. The programme supported federal and provincial government long-term goals. The ADB maximised its support through a fit-for-purpose mix of financing modalities and instruments. A sound design and ADB's quick and agile adaptations sustained the CAP's relevance through the series of crises that marked the CAPR period, including the COVID-19 pandemic, disastrous flooding in 2022, bouts of severe macroeconomic instability, and three changes in government. The CAP met most of the key outcome targets in the CPS for 2021–2025; 100 percent of the operations completed during the CAPR period, many of which were approved under previous CPSs, were rated effective or highly effective. Top achievements included improved economic management and governance. Targets for raising tax revenues and expanding exports were achieved. So were those for strengthening the resilience of vulnerable populations to climate change and natural disasters. Social protection was expanded through ADB support, and water resource management and irrigation infrastructure were improved. The pandemic and the 2022 flood disaster have likely put the original CPS objectives for school enrolment out of reach. Health expenditure as a share of Gross Domestic Product (GDP) rose temporarily due to the COVID-19; still, at 1.2 percent, the average allocation during the CAPR period was well short of the CPS's 2025 benchmark of 3 percent of GDP. The CAP helped Pakistan make progress on several socioeconomic fronts during 2020–2024, but further effort is required in the most challenging areas if the country's ambitious development targets are to be achieved. The CAP's highly satisfactory rating for efficiency is based on the delivery by sovereign operations of results in an efficient and a timely manner. The portfolio was large, but detailed preparation, sound project designs, and regular stakeholder consultation achieved impressive results on two key indicators over the 2020–2023 period, average time from concept approval to first disbursement (22.4 months), and average disbursement rate (125 percent). The CAP outperformed the ADB average on both these measures. About one of every eight lending projects completed during the CAPR period were rated efficient or highly efficient. Delays in the adoption of related legislative amendments were responsible for the lower efficiency evaluations of most of the remaining projects. Copyright Business Recorder, 2025

Yahoo
13-05-2025
- Business
- Yahoo
Capricor: Q1 Earnings Snapshot
SAN DIEGO (AP) — SAN DIEGO (AP) — Capricor Therapeutics Inc. (CAPR) on Tuesday reported a loss of $24.4 million in its first quarter. The San Diego-based company said it had a loss of 53 cents per share. The results missed Wall Street expectations. The average estimate of three analysts surveyed by Zacks Investment Research was for a loss of 33 cents per share. Capricor shares have fallen 48% since the beginning of the year. In the final minutes of trading on Tuesday, shares hit $7.22, a rise of 33% in the last 12 months. _____ This story was generated by Automated Insights ( using data from Zacks Investment Research. Access a Zacks stock report on CAPR at Sign in to access your portfolio