Latest news with #Deramiocel
Yahoo
2 days ago
- Business
- Yahoo
Capricor Therapeutics Announces Type A Meeting Scheduled with U.S. FDA
– Second Quarter 2025 Financial Results and Corporate Update Rescheduled to Monday, August 11, 2025, at 4:30 p.m. ET – SAN DIEGO, Aug. 08, 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 that a Type A meeting with the U.S. Food and Drug Administration (FDA) has been scheduled to discuss the regulatory path for its Biologics License Application (BLA) for Deramiocel, the Company's lead cell therapy candidate for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). To accommodate this meeting, the Company has rescheduled the release of its financial results for the second quarter ended June 30, 2025, to Monday, August 11, 2025, after the market close. Management will host a webcast and conference call at 4:30 p.m. ET on the same day to review the financial results and provide a corporate update. Title: Capricor Therapeutics Second Quarter 2025 Financial Results and Recent Corporate Update Conference Call and Webcast Date: Monday, August 11, 2025 Time: 4:30 p.m. ET Conference Call Details: Toll-Free: 1-800-717-1738International: 1-646-307-1865Conference ID: 90328Participants can use the guest dial-in numbers above and be answered by an operator, or click the Call me™ link for instant telephone access to the event. Webcast: Click here to access the live webcast A replay of the webcast will be available following the conclusion of the live broadcast and will be accessible on the Company's 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 the preservation of cardiac and skeletal muscle function in muscular dystrophies 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, and in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, as filed with the Securities and Exchange Commission on May 14, 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 and the StealthX™ vaccine are investigational candidates and have not been approved for commercial use in any Media Contact:Raquel ConaKCSA Strategic Communications rcona@ Capricor Company Contact:AJ Bergmann, Chief Financial Officerabergmann@
Business Wire
21-07-2025
- Business
- Business Wire
Gibbs Mura Announces a Securities Class Action Lawsuit Has Been Filed Against Capricor Therapeutics, Inc. (NASDAQ: CAPR); CAPR Investors Urged to Contact Award-Winning Firm, Gibbs Mura
OAKLAND, Calif.--(BUSINESS WIRE)--Gibbs Mura announces that a class action lawsuit was filed against Capricor Therapeutics, Inc. on behalf of investors who purchased or acquired Capricor securities between October 9, 2024 and July 10, 2025. Shares of Capricor plunged over 30% in intraday trading on Friday, July 11, 2025, after the U.S. Food and Drug Administration rejected the company's Biologics License Application for its lead cell therapy candidate, Deramiocel, claiming that the application 'does not meet the statutory requirement for substantial evidence of effectiveness' and lacks 'certain outstanding items.' Gibbs Mura encourages investors to contact us about their legal rights and options in the Capricor Therapeutics, Inc. (NASDAQ: CAPR) Securities Class Action Lawsuit. What Should Capricor Therapeutics, Inc. Investors Do? If you invested in Capricor, visit our Capricor Therapeutics, Inc. Class Action Lawsuit webpage or call us at (888) 410-2925 to get more information about how you may be able to recover your losses. The lawsuit concerns whether Capricor Therapeutics, Inc. has violated federal securities laws by providing false or misleading statements to investors. What is the Capricor Therapeutics, Inc. (CAPR) Lawsuit About? On July 11, 2025, Capricor Therapeutics announced that the FDA rejected the company's Biologics License Application (BLA) for its cell therapy candidate, Deramiocel, citing that the application 'does not meet the statutory requirement for substantial evidence of effectiveness' and lacks 'certain outstanding items.' The FDA's Complete Response Letter specified that the deficiencies were in the BLA's Chemistry, Manufacturing, and Controls section, and emphasized a need for additional clinical data. Following this news, shares of Capricor Therapeutics, Inc. plunged over 30% in intraday trading on July 11, 2025, causing harm to investors. Previously, on May 5, 2025, Capricor announced that the FDA 'confirmed its intent to hold an advisory committee meeting' following the completion of a mid-cycle review meeting for the company's BLA for Deramiocel. Following the announcement, Capricor's stock fell over 29% on May 6, 2025. Then, on June 20, 2025, STAT reported that the director of the FDA's Center for Biologics Evaluation and Research canceled the advisory committee meeting regarding Deramiocel, due to being 'skeptical of the treatment.' In the wake of the report, Capricor's stock fell over 30% on June 20, 2025. About Gibbs Mura Gibbs Mura represents investors nationwide in securities litigation. The firm has recovered over a billion dollars for its clients against some of the world's largest corporations, and our attorneys have received numerous honors for their work, including 'Best Lawyers in America,' 'Top Plaintiff Lawyers in California,' 'California Lawyer Attorney of the Year,' 'Class Action Practice Group of the Year,' 'Consumer Protection MVP,' and 'Top Women Lawyers in California.' This press release may constitute Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
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 Wire
11-07-2025
- Business
- Business Wire
Capricor Therapeutics, Inc. (NASDAQ: CAPR) Securities Fraud Investigation; CAPR Investors Urged to Contact Award-Winning Firm, Gibbs Mura
BUSINESS WIRE)--Shares of Capricor Therapeutics, Inc. plunged over 30% in intraday trading on Friday, July 11, 2025, after the U.S. Food and Drug Administration rejected the company's Biologics License Application for its lead cell therapy candidate, Deramiocel, claiming that the application 'does not meet the statutory requirement for substantial evidence of effectiveness' and lacks 'certain outstanding items.' Gibbs Mura is investigating a potential Capricor Therapeutics, Inc. (NASDAQ: CAPR) Securities Class Action Lawsuit on behalf of shareholders who lost money in Capricor Therapeutics, Inc. What Should Capricor Therapeutics, Inc. Investors Do? If you invested in Capricor Therapeutics, Inc., visit our Capricor Therapeutics, Inc. Investigation webpage or call us at (888) 410-2925 to get more information about how you may be able to recover your losses. Our investigation concerns whether Capricor Therapeutics, Inc. has violated federal securities laws by providing false or misleading statements to investors. What is the Capricor Therapeutics, Inc. (CAPR) Lawsuit Investigation About? On July 11, 2025, Capricor Therapeutics announced that the FDA rejected the company's Biologics License Application (BLA) for its cell therapy candidate, Deramiocel, citing that the application 'does not meet the statutory requirement for substantial evidence of effectiveness' and lacks 'certain outstanding items.' The FDA's Complete Response Letter specified that the deficiencies were in the BLA's Chemistry, Manufacturing, and Controls section, and emphasized a need for additional clinical data. Following this news, shares of Capricor Therapeutics, Inc. plunged over 30% in intraday trading on July 11, 2025, causing harm to investors. Previously, on May 5, 2025, Capricor announced that the FDA 'confirmed its intent to hold an advisory committee meeting' following the completion of a mid-cycle review meeting for the company's BLA for Deramiocel. Following the announcement, Capricor's stock fell over 29% on May 6, 2025. Then, on June 20, 2025, STAT reported that the director of the FDA's Center for Biologics Evaluation and Research canceled the advisory committee meeting regarding Deramiocel, due to being 'skeptical of the treatment.' In the wake of the report, Capricor's stock fell over 30% on June 20, 2025. About Gibbs Mura Gibbs Mura represents investors nationwide in securities litigation. The firm has recovered over a billion dollars for its clients against some of the world's largest corporations, and our attorneys have received numerous honors for their work, including 'Best Lawyers in America,' 'Top Plaintiff Lawyers in California,' 'California Lawyer Attorney of the Year,' 'Class Action Practice Group of the Year,' 'Consumer Protection MVP,' and 'Top Women Lawyers in California.' This press release may constitute Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
