Latest news with #Capricor
Yahoo
21-05-2025
- Business
- Yahoo
Capricor Therapeutics, Inc.'s (CAPR): Analysts See 489% Upside Potential
We recently published an article titled . Capricor Therapeutics, Inc. (NASDAQ:CAPR) was one of the stocks that was covered in that article. Wall Street analysts believe CAPR has a 489% upside potential over the next 12 months. Test tubes filled with exosomes, representing exosome-based therapeutics. Capricor Therapeutics, Inc. (NASDAQ:CAPR) is a biotechnology company that specializes in developing cell and exosome-based therapies for muscular and other diseases. Its flagship therapeutic candidate, CAP-1002, is in advanced clinical stages and is designed to address Duchenne muscular dystrophy (DMD), a severe genetic disorder that primarily affects muscles and the heart. CAP-1002 utilizes cardiosphere-derived cells (CDCs), which have been shown to modulate the immune system and reduce harmful tissue buildup, known as fibrosis, in the heart. This unique approach underscores the company's dedication to tackling complex medical conditions through innovative science. In addition to its work on CAP-1002, Capricor is actively advancing its exosome platform, which harnesses the potential of extracellular vesicles for therapeutic applications. Collaborations with esteemed institutions such as the National Institutes of Health (NIH), the U.S. Army Institute of Surgical Research, Johns Hopkins University, and Cedars-Sinai Medical Center exemplify its commitment to advancing research and development. These partnerships aim to broaden the scope of Capricor's initiatives, including the development of vaccines and therapeutics for infectious diseases and monogenic disorders. Capricor Therapeutics has demonstrated financial strength and strategic foresight. For the fourth quarter of 2024, the company reported revenues of $11.13 million, contributing to a total of $25.4 million in annual revenue. This growth is attributed to its pioneering efforts in cell therapy programs. With $78 million in cash reserves, Capricor is well-equipped to support ongoing clinical trials and future commercialization efforts, ensuring sustainability in its ambitious endeavors. In March, Reuters reported in an article Capricor Therapeutics (CAPR.O) announced that the U.S. Food and Drug Administration (FDA) intends to assemble a panel of external experts to review its cell therapy for a heart condition associated with Duchenne muscular dystrophy (DMD) before making a final decision. The company is pursuing full regulatory approval for its investigational cell therapy, deramiocel, as a potential treatment for patients with Duchenne muscular dystrophy cardiomyopathy. Following the news, the company's shares dropped nearly 15%, reaching $10.11 in morning trading. Wall Street analysts, however, have taken a favorable view of Capricor's prospects, recommending the stock as a 'Strong Buy.' The consensus twelve-month price target as of May 13, 2025, stands at $43.71, reflecting a remarkable upside potential of 489.89%. Overall, Capricor Therapeutics, Inc. (NASDAQ:CAPR) ranks 4th on our list of 13 Best Multibagger Stocks to Invest in Now. While we acknowledge the potential of CAPR to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than CAPR and that has 100x upside potential, check out our report about this cheapest AI stock. READ NEXT: 10 Best Low Volatility Stocks to Buy Now and Starter Stock Portfolio: 12 Safe Stocks to Buy Disclosure: None. This article is originally published at Insider Monkey. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
21-05-2025
- Business
- Yahoo
Capricor Therapeutics, Inc.'s (CAPR): Analysts See 489% Upside Potential
We recently published an article titled . Capricor Therapeutics, Inc. (NASDAQ:CAPR) was one of the stocks that was covered in that article. Wall Street analysts believe CAPR has a 489% upside potential over the next 12 months. Test tubes filled with exosomes, representing exosome-based therapeutics. Capricor Therapeutics, Inc. (NASDAQ:CAPR) is a biotechnology company that specializes in developing cell and exosome-based therapies for muscular and other diseases. Its flagship therapeutic candidate, CAP-1002, is in advanced clinical stages and is designed to address Duchenne muscular dystrophy (DMD), a severe genetic disorder that primarily affects muscles and the heart. CAP-1002 utilizes cardiosphere-derived cells (CDCs), which have been shown to modulate the immune system and reduce harmful tissue buildup, known as fibrosis, in the heart. This unique approach underscores the company's dedication to tackling complex medical conditions through innovative science. In addition to its work on CAP-1002, Capricor is actively advancing its exosome platform, which harnesses the potential of extracellular vesicles for therapeutic applications. Collaborations with esteemed institutions such as the National Institutes of Health (NIH), the U.S. Army Institute of Surgical Research, Johns Hopkins University, and Cedars-Sinai Medical Center exemplify its commitment to advancing research and development. These partnerships aim to broaden the scope of Capricor's initiatives, including the development of vaccines and therapeutics for infectious diseases and monogenic disorders. Capricor Therapeutics has demonstrated financial strength and strategic foresight. For the fourth quarter of 2024, the company reported revenues of $11.13 million, contributing to a total of $25.4 million in annual revenue. This growth is attributed to its pioneering efforts in cell therapy programs. With $78 million in cash reserves, Capricor is well-equipped to support ongoing clinical trials and future commercialization efforts, ensuring sustainability in its ambitious endeavors. In March, Reuters reported in an article Capricor Therapeutics (CAPR.O) announced that the U.S. Food and Drug Administration (FDA) intends to assemble a panel of external experts to review its cell therapy for a heart condition associated with Duchenne muscular dystrophy (DMD) before making a final decision. The company is pursuing full regulatory approval for its investigational cell therapy, deramiocel, as a potential treatment for patients with Duchenne muscular dystrophy cardiomyopathy. Following the news, the company's shares dropped nearly 15%, reaching $10.11 in morning trading. Wall Street analysts, however, have taken a favorable view of Capricor's prospects, recommending the stock as a 'Strong Buy.' The consensus twelve-month price target as of May 13, 2025, stands at $43.71, reflecting a remarkable upside potential of 489.89%. Overall, Capricor Therapeutics, Inc. (NASDAQ:CAPR) ranks 4th on our list of 13 Best Multibagger Stocks to Invest in Now. While we acknowledge the potential of CAPR to grow, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns and have limited downside risk. If you are looking for an AI stock that is more promising than CAPR and that has 100x upside potential, check out our report about this cheapest AI stock. READ NEXT: 10 Best Low Volatility Stocks to Buy Now and Starter Stock Portfolio: 12 Safe Stocks to Buy Disclosure: None. This article is originally published at Insider Monkey.
Business Wire
16-05-2025
- Business
- Business Wire
CAPR Investors Have Opportunity to Join Capricor Therapeutics, Inc. Fraud Investigation with the Schall Law Firm
LOS ANGELES--(BUSINESS WIRE)-- The Schall Law Firm, a national shareholder rights litigation firm, announces that it is investigating claims on behalf of investors of Capricor Therapeutics, Inc. ('Capricor' or 'the Company') (NASDAQ: CAPR) for violations of the securities laws. The investigation focuses on whether the Company issued false and/or misleading statements and/or failed to disclose information pertinent to investors. Capricor announced on May 5, 2025, that following "the completion of a mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for the Company's Biologics License Application (BLA) seeking full approval for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy", the agency "confirmed its intent to hold an advisory committee meeting" regarding the Company's BLA. If you are a shareholder who suffered a loss, click here to participate. We also encourage you to contact Brian Schall of the Schall Law Firm, 2049 Century Park East, Suite 2460, Los Angeles, CA 90067, at 310-301-3335, to discuss your rights free of charge. You can also reach us through the firm's website at or by email at bschall@ The Schall Law Firm represents investors around the world and specializes in securities class action lawsuits and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and rules of ethics.
Yahoo
05-05-2025
- Business
- Yahoo
Capricor Therapeutics Announces Completion of Mid-Cycle Review Meeting with FDA on Deramiocel for the Treatment of Duchenne Muscular Dystrophy Cardiomyopathy
-Company remains on track for PDUFA target action date of August 31, 2025- -Advisory committee meeting to be held in advance of target action date- SAN DIEGO, May 05, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the completion of a mid-cycle review meeting with the U.S. Food and Drug Administration (FDA) for the Company's Biologics License Application (BLA) seeking full approval for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy. During the meeting, FDA stated that no significant deficiencies have been identified by the Review Committee and that the package is on track for a Prescription Drug User Fee Act (PDUFA) action date of August 31, 2025. The FDA has also confirmed its intent to hold an advisory committee meeting, although an official date has not yet been set. 'The successful completion of our mid-cycle review meeting along with the upcoming advisory committee meeting represents major milestones on the path towards approval of deramiocel,' said Linda Marbán, Ph.D., Chief Executive Officer of Capricor. 'Deramiocel is a first-in-class cellular therapy with the potential to halt or slow the progression of DMD-cardiomyopathy, and we are pleased to have the opportunity to present the efficacy and safety data to the advisory committee. We have been actively preparing for an advisory committee meeting, and we look forward to providing the physician and patient perspectives to highlight the weight of evidence supporting the transformative potential of deramiocel in treating DMD-cardiomyopathy.' The BLA submission is supported by Capricor's cardiac data from its Phase 2 HOPE-2 and HOPE-2 Open Label Extension (OLE) trials compared to patient level data from an FDA-funded and published dataset on the natural history of DMD-cardiomyopathy and potential biomarkers of disease progression. Efficacy from the ongoing HOPE-3 study is not part of this BLA package is a devastating genetic disorder characterized by progressive weakness and chronic inflammation of the skeletal, heart and respiratory muscles with mortality at a median age of approximately 30 years. It is estimated that DMD occurs in approximately one in every 3,500 male births and that the patient population is estimated to be approximately 15,000-20,000 in the United States. DMD pathophysiology is driven by the impaired production of functional dystrophin, which normally functions as a structural protein in muscle. The reduction of functional dystrophin in muscle cells leads to significant cell damage and ultimately causes muscle cell death and fibrotic replacement. In DMD patients, heart muscle cells progressively die and are replaced with scar tissue. This cardiomyopathy eventually leads to heart failure, which is currently the leading cause of death among those with DMD. Treatment options are limited and there is no (CAP-1002) consists of allogeneic cardiosphere-derived cells (CDCs), a rare population of cardiac cells that have been shown in preclinical and clinical studies to exert potent immunomodulatory and anti-fibrotic actions in preservation of cardiac and skeletal muscle function in dystrophiopathies such as DMD. CDCs act by secreting extracellular vesicles known as exosomes, which target macrophages and alter their expression profile to adopt a healing, rather than a pro-inflammatory phenotype. CDCs have been the subject of over 200 peer-reviewed scientific publications and have been administered to over 250 human subjects across several clinical trials. Deramiocel for the treatment of DMD, has received Orphan Drug Designation from the FDA and European Medicines Agency (EMA). The regulatory pathway for deramiocel is supported by RMAT (Regenerative Medicine Advanced Therapy Designation) in the U.S. and the Advanced Therapy Medicinal Product (ATMP) Designation in the European region. In addition, if Capricor were to receive FDA marketing approval for deramiocel regarding the treatment of DMD, Capricor would be eligible to receive a Priority Review Voucher (PRV) based on its previous receipt of a rare pediatric disease Therapeutics (NASDAQ: CAPR) is a biotechnology company dedicated to advancing transformative cell and exosome-based therapeutics to redefine the treatment landscape for rare diseases. At the forefront of our innovation is our lead product candidate, deramiocel, an allogeneic cardiac-derived cell therapy. Extensive preclinical and clinical studies have shown deramiocel to exert potent immunomodulatory and anti-fibrotic actions in preservation of cardiac and skeletal muscle function in dystrophiopathies such as DMD. Deramiocel is currently in late-stage development for the treatment of Duchenne muscular dystrophy. Capricor is also harnessing the power of its exosome technology, using its proprietary StealthX™ platform in preclinical development focused on the areas of vaccinology, targeted delivery of oligonucleotides, proteins and small molecule therapeutics to potentially treat and prevent a diverse array of diseases. At Capricor, we stand committed to pushing the boundaries of possibility and forging a path toward transformative treatments for those in need. For more information, visit and follow Capricor on Facebook, Instagram and in this press release regarding the efficacy, safety, and intended utilization of Capricor's product candidates; the initiation, conduct, size, timing and results of discovery efforts and clinical trials; the pace of enrollment of clinical trials; plans regarding regulatory filings, future research and clinical trials; regulatory developments involving products, including the ability to obtain regulatory approvals or otherwise bring products to market; manufacturing capabilities; dates for regulatory meetings; statements about our financial outlook; the potential that required regulatory inspections may be delayed or not be successful which would delay or prevent product approval; the ability to achieve product milestones and to receive milestone payments from commercial partners; plans regarding current and future collaborative activities and the ownership of commercial rights; potential future agreements; scope, duration, validity and enforceability of intellectual property rights; future revenue streams and projections; expectations with respect to the expected use of proceeds from the recently completed offerings and the anticipated effects of the offerings; and any other statements about Capricor's management team's future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words 'believes,' 'plans,' 'could,' 'anticipates,' 'expects,' 'estimates,' 'should,' 'target,' 'will,' 'would' and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements. More information about these and other risks that may impact Capricor's business is set forth in Capricor's Annual Report on Form 10-K for the year ended December 31, 2024, as filed with the Securities and Exchange Commission on March 26, 2025. All forward-looking statements in this press release are based on information available to Capricor as of the date hereof, and Capricor assumes no obligation to update these forward-looking statements. Capricor has entered into an agreement for the exclusive commercialization and distribution of deramiocel for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Deramiocel is an Investigational New Drug (IND) and is not yet approved for any indications. None of Capricor's exosome-based candidates have been approved for clinical Media Contact:Raquel ConaKCSA Strategic Communications rcona@ Capricor Company Contact:AJ Bergmann, Chief Financial Officerabergmann@ in to access your portfolio
Yahoo
27-03-2025
- Business
- Yahoo
High Growth Tech Stocks In The US Market With Promising Potential
The United States market has remained flat over the past week but has seen an 8.5% increase over the past year, with earnings projected to grow by 14% annually. In this context, identifying high-growth tech stocks involves looking for companies that are well-positioned to capitalize on technological advancements and market trends, offering promising potential in a dynamic economic landscape. Name Revenue Growth Earnings Growth Growth Rating Super Micro Computer 20.44% 29.79% ★★★★★★ TG Therapeutics 26.18% 37.61% ★★★★★★ Alkami Technology 20.02% 85.16% ★★★★★★ Travere Therapeutics 28.43% 65.01% ★★★★★★ AVITA Medical 27.91% 55.77% ★★★★★★ TKO Group Holdings 22.48% 25.17% ★★★★★★ Clene 60.86% 63.07% ★★★★★★ Alnylam Pharmaceuticals 22.76% 58.40% ★★★★★★ Lumentum Holdings 21.55% 119.67% ★★★★★★ Ascendis Pharma 32.36% 59.79% ★★★★★★ Click here to see the full list of 235 stocks from our US High Growth Tech and AI Stocks screener. Below we spotlight a couple of our favorites from our exclusive screener. Simply Wall St Growth Rating: ★★★★★☆ Overview: Capricor Therapeutics, Inc. is a clinical-stage biotechnology company developing transformative cell and exosome-based therapeutics for diseases like Duchenne muscular dystrophy, with a market cap of $614.45 million. Operations: Capricor Therapeutics focuses on developing cell and exosome-based therapeutics, primarily targeting Duchenne muscular dystrophy. The company generates revenue from its biotechnology segment, amounting to $22.27 million. Capricor Therapeutics, despite its current unprofitability and a highly volatile share price, presents intriguing prospects with its aggressive revenue growth forecast at 43.4% annually. The company's strategic focus on innovative treatments like deramiocel for Duchenne muscular dystrophy (DMD) highlights its potential within biotech's high-stakes arena. Recent FDA acceptance of Capricor's Biologics License Application for deramiocel underscores this direction, potentially accelerating the company towards profitability and market significance in a sector where innovation directly correlates with financial success. This pivot to address critical medical needs through advanced cell therapies could position Capricor favorably as it navigates towards anticipated profitability in the next three years, amidst challenges like substantial shareholder dilution over the past year. Unlock comprehensive insights into our analysis of Capricor Therapeutics stock in this health report. Evaluate Capricor Therapeutics' historical performance by accessing our past performance report. Simply Wall St Growth Rating: ★★★★★☆ Overview: Pagaya Technologies Ltd. is a technology company that utilizes data science and proprietary AI-powered technology to serve financial institutions and investors globally, with a market cap of approximately $930.69 million. Operations: Pagaya Technologies Ltd. generates revenue primarily from its Software & Programming segment, which amounted to $1.03 billion. The company leverages its data science and AI capabilities to cater to financial institutions and investors across various regions, including the United States, Israel, and the Cayman Islands. Pagaya Technologies, despite its current unprofitability and a volatile share price, is navigating a path toward significant growth with projected annual revenue increases of 12.4% and an ambitious earnings growth forecast of 149.5%. Recent strategic moves, including a substantial Shelf Registration aimed at bolstering employee stock ownership and active participation in key tech conferences, underscore its commitment to innovation and market expansion. The firm's recent earnings report revealed a sharp increase in annual revenues to $1.03 billion, up from $812 million the previous year, although net losses also widened significantly. Looking ahead, Pagaya anticipates reaching profitability within three years amidst increasing network volumes projected between $10.25 billion and $11.75 billion for the coming year. Dive into the specifics of Pagaya Technologies here with our thorough health report. Gain insights into Pagaya Technologies' past trends and performance with our Past report. Simply Wall St Growth Rating: ★★★★☆☆ Overview: BioCryst Pharmaceuticals, Inc. is a biotechnology company that focuses on developing oral small-molecule and injectable protein therapeutics for the treatment of rare diseases, with a market cap of approximately $1.69 billion. Operations: BioCryst Pharmaceuticals generates revenue primarily from its biotechnology segment, amounting to $450.71 million. The company's focus is on developing therapeutics for rare diseases, leveraging both oral small-molecule and injectable protein technologies. BioCryst Pharmaceuticals, with a forecasted annual revenue growth of 13.5%, is outpacing the US market average of 8.5%. The company's strategic focus on R&D has led to promising clinical advancements, notably in hereditary angioedema treatments, positioning it well within biotech's competitive landscape. Recent uplifts in revenue guidance for 2025 to between $560 million and $575 million reflect confidence in ongoing product rollouts and market expansion. Despite current unprofitability, BioCryst is expected to turn profitable within three years, bolstered by an earnings growth rate projected at 55.2% annually. This trajectory is supported by recent positive trial results and expanded global approvals that enhance its commercial footprint and potential market share. Click to explore a detailed breakdown of our findings in BioCryst Pharmaceuticals' health report. Learn about BioCryst Pharmaceuticals' historical performance. Unlock our comprehensive list of 235 US High Growth Tech and AI Stocks by clicking here. Are these companies part of your investment strategy? Use Simply Wall St to consolidate your holdings into a portfolio and gain insights with our comprehensive analysis tools. Streamline your investment strategy with Simply Wall St's app for free and benefit from extensive research on stocks across all corners of the world. Explore high-performing small cap companies that haven't yet garnered significant analyst attention. Fuel your portfolio with companies showing strong growth potential, backed by optimistic outlooks both from analysts and management. Find companies with promising cash flow potential yet trading below their fair value. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NasdaqCM:CAPR NasdaqCM:PGY and NasdaqGS:BCRX. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
