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Capricor Therapeutics

14.23

+1.057.97%

Post-market: 14.590.3600+2.53%19:59 EDT

Volume:2.51M

Turnover:35.06M

Market Cap:650.42M

PE:-10.02

High:14.35

Open:13.26

Low:12.80

Close:13.18

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Overview Company News Filings

Capricor Therapeutics' Biologics License Application for Deramiocel Accepted by FDA

MT Newswires Live

Capricor Therapeutics Inc - FDA Grants Priority Review for Deramiocel With Pdufa Date August 31, 2025

THOMSON REUTERS

FDA Accepts Biologics License Application for Duchenne Muscular Dystrophy Cardiomyopathy Treatment

THOMSON REUTERS

FDA Accepts Biologics License Application for Duchenne Muscular Dystrophy Cardiomyopathy Treatment

Capricor Therapeutics Inc expected to post a loss of 26 cents a share - Earnings Preview

Capricor Therapeutics, Inc. (CAPR): A Bull Case Theory

Capricor Therapeutics options imply 7.5% move in share price post-earnings

Calendar of U.S. Earnings Expected in the Week Ahead

BUZZ-U.S. STOCKS ON THE MOVE-Okta, Natgas companies, UnitedHealth

Capricor Therapeutics Price Target Maintained With a $77.00/Share by HC Wainwright & Co.

Capricor Therapeutics Cell Therapy Goes Under Priority FDA Review For Duchenne Associated-Heart Condition

Capricor Therapeutics: Promising Developments and Strategic Positioning Drive Buy Rating

Capricor Therapeutics Shares Rise on FDA Priority Review

Capricor Therapeutics Shares up 10.1% After FDA Grants Priority Review to Co's Therapy for a Muscle-Wasting Related Heart Condition

THOMSON REUTERS

BUZZ-U.S. STOCKS ON THE MOVE-Wellgistics, Capricor, Wave Life Sciences

BUZZ-Capricor rises on FDA's priority review for Duchenne muscular dystrophy-related cell therapy

Capricor Therapeutics Shares Gain 10.6% Premarket After FDA Grants Priority Review to Co's Therapy for a Muscle-Wasting Related Heart Condition

THOMSON REUTERS

Capricor Therapeutics Receives FDA's Acceptance for Review of BLA for Duchenne Muscular Dystrophy Treatment

MT Newswires Live

Analysts Conflicted on These Healthcare Names: Pliant Therapeutics (PLRX) and Capricor Therapeutics (CAPR)

Capricor Therapeutics' Cell Therapy for Muscular Dystrophy Patients to Get FDA Priority Review

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About Capricor Therapeutics, Inc.Capricor  is a biotechnology company dedicated to advancing transformati","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"yahoofinance","url":"https://finance.yahoo.com/news/fda-accepts-biologics-license-application-131300257.html","rn_cache_url":null,"customStyle":"img, svg { display: none !important; }","selectors":"article","filters":"","directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/fda-accepts-biologics-license-application-131300257.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["CAPR","BK4139"],"gpt_icon":0},{"id":"2517853104","title":"Capricor Therapeutics Inc  expected to post a loss of 26 cents a share - Earnings Preview","url":"https://stock-news.laohu8.com/highlight/detail?id=2517853104","media":"Reuters","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517853104?lang=en_us&edition=fundamental","pubTime":"2025-03-07 19:14","pubTimestamp":1741346046,"startTime":"0","endTime":"0","summary":"Capricor Therapeutics Inc  expected to post a loss of26cents a share - Earnings Preview Capricor Therapeutics Inc CAPR.OQ CAPR.O is expected to show a fall in quarterly revenue when it reports  result","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["earning"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250307:nL5N3PQ0PL:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"-1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["CAPR"],"gpt_icon":0},{"id":"2517112805","title":"Capricor Therapeutics, Inc. (CAPR): A Bull Case Theory","url":"https://stock-news.laohu8.com/highlight/detail?id=2517112805","media":"Insider Monkey","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517112805?lang=en_us&edition=fundamental","pubTime":"2025-03-07 07:20","pubTimestamp":1741303223,"startTime":"0","endTime":"0","summary":"We came across abullish thesison Capricor Therapeutics, Inc.  on wallstreetbets Subreddit Page by androidmj. In this article, we will summarize the bulls’ thesis on CAPR. Capricor Therapeutics, Inc. 's share was trading at $12.65 as of March 5th.A laboratory filled with modern equipment, scientists examining the latest biotechnology breakthroughs.Capricor Therapeutics, Inc.  is not on our list of the30 Most Popular Stocks Among Hedge Funds. As per our database, 14 hedge fund portfolios held CAPR at the end of the fourth quarter which was 12 in the previous quarter. While we acknowledge the risk and potential of CAPR as an investment, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter timeframe. If you are looking for an AI stock that is more promising than CAPR but that trades at less than 5 times its earnings, check out our report about the cheapest AI stock.","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/capricor-therapeutics-inc-capr-bull-232023722.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["BK4139","CAPR"],"gpt_icon":0},{"id":"2517992349","title":"Capricor Therapeutics options imply 7.5% move in share price post-earnings","url":"https://stock-news.laohu8.com/highlight/detail?id=2517992349","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517992349?lang=en_us&edition=fundamental","pubTime":"2025-03-06 03:21","pubTimestamp":1741202465,"startTime":"0","endTime":"0","summary":"Pre-earnings options volume in Capricor Therapeutics (CAPR) is normal with calls leading puts 19:7. Implied volatility suggests the market is antic...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/the-fly/capricor-therapeutics-options-imply-7-5-move-in-share-price-post-earnings?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":["earning"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/the-fly/capricor-therapeutics-options-imply-7-5-move-in-share-price-post-earnings?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["CAPR"],"gpt_icon":0},{"id":"2517990373","title":"Calendar of U.S. Earnings Expected in the Week Ahead","url":"https://stock-news.laohu8.com/highlight/detail?id=2517990373","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517990373?lang=en_us&edition=fundamental","pubTime":"2025-03-05 19:00","pubTimestamp":1741172400,"startTime":"0","endTime":"0","summary":"Major companies tentatively scheduled to report quarterly earnings in the week ahead, with earnings estimates provided by FactSet Research Systems Inc.·Abercrombie & Fitch                              4Q      3.54   7:30 AM. ·ACRES Cmmcl Rlty                                 4Q       .36   4:15 PM. ·Descartes Sys Gp                                4Q       .43   5:00 PM. ·Dine Brands Global                               4Q      1.34   7:00 AM. ·Foot Locker Inc.                                  4Q       .72   6:45 AM. ·Forge Global Hldgs                              4Q      (.09)  4:10 PM. ·Global Ship Lease                                4Q      2.31   8:00 AM","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["GAP","TREE","SGHT","AVGO","QNRX","ATXS","BF.A","ARCT","SNBR","SVCO","ZYME","GRND","CAPR","ALNT","CNQ","MRVL","EYPT","CRVS","FRGE","ZS","MRX","IMRX","BF.B","FL","AMTX","ALTG","HDSN","DIN","PAM","CRMT","SKLZ","DOMO","KR","LPSN","OCGN","RSKD","TCRX","BALY","ATER","ARQ","ECOR","HIPO","FDUS","AKA","FSM","VEEV","LB","ALGS","DESP"],"gpt_icon":1},{"id":"2517600360","title":"BUZZ-U.S. STOCKS ON THE MOVE-Okta, Natgas companies, UnitedHealth","url":"https://stock-news.laohu8.com/highlight/detail?id=2517600360","media":"Reuters","labels":["dataReport"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517600360?lang=en_us&edition=fundamental","pubTime":"2025-03-05 02:46","pubTimestamp":1741114004,"startTime":"0","endTime":"0","summary":"BUZZ-U.S. STOCKS ON THE MOVE-Okta, Natgas companies, UnitedHealthEikon search string for individual stock moves: STXBZThe Day Ahead newsletter: https://refini.tv/3LI4BU7The Morning News Call newslette","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250304:nL3N3PN1GU:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"dataReport","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["NVDS","WBA","EVGO","TNYA","ULCC","CAPR","2NVD.UK","UNH","ENPH","NVDU","FITB","SLRN","CNX","OKTA","NVDY","3NVD.UK","DSP","WGRX","NVIW.SI","AGH","HUT","PEP","EQT","STIM","AMLX","SNVD.UK","YMAB","JBLU","WVE","NEXT","UAL","MDLZ","AAL","NVDD","PEPG","ATEC","ILMN"],"gpt_icon":1},{"id":"2517044936","title":"Capricor Therapeutics Price Target Maintained With a $77.00/Share by HC Wainwright & Co.","url":"https://stock-news.laohu8.com/highlight/detail?id=2517044936","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517044936?lang=en_us&edition=fundamental","pubTime":"2025-03-05 01:26","pubTimestamp":1741109160,"startTime":"0","endTime":"0","summary":"Ratings actions from Benzinga: https://www.benzinga.com/quote/CAPR/analyst-ratings \n\n\n \n\n\n  (END) Dow Jones Newswires\n\n\n  March 04, 2025 12:26 ET (17:26 GMT)","market":"sh","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["CAPR"],"gpt_icon":0},{"id":"2517015036","title":"Capricor Therapeutics Cell Therapy Goes Under Priority FDA Review For Duchenne Associated-Heart Condition","url":"https://stock-news.laohu8.com/highlight/detail?id=2517015036","media":"Benzinga","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2517015036?lang=en_us&edition=fundamental","pubTime":"2025-03-05 00:21","pubTimestamp":1741105296,"startTime":"0","endTime":"0","summary":"On Tuesday, the FDA accepted for review Capricor Therapeutics Inc’s  Biologics License Application for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy  cardiomyopathy.DMD cardiomyopathy is a heart condition characterized by cardiac fibrosis, arrhythmias, and heart failure.Additionally, the FDA granted the BLA Priority Review with a Prescription Drug User Fee Act  target action date of August 31, 2025.The FDA has not identified any potential review issues.Also Read: Capricor Therapeutics Says Duchenne Muscular Dystrophy Candidate Shows Sustained Cardiac, Skeletal Benefits After 3 Years. Deramiocel for DMD has receivedOrphan Drug Designationfrom the FDA and European Medicines Agency.In addition, if Capricor were to receive FDA marketing approval for deramiocel regarding the treatment of DMD by September 30, 2026, Capricor would be eligible to receive a Priority Review Voucher based on its previous receipt of a rare pedia","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://finance.yahoo.com/news/capricor-therapeutics-cell-therapy-goes-162136063.html","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"yahoofinance","symbols":["CAPR","BK4139"],"gpt_icon":0},{"id":"2516605890","title":"Capricor Therapeutics: Promising Developments and Strategic Positioning Drive Buy Rating","url":"https://stock-news.laohu8.com/highlight/detail?id=2516605890","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516605890?lang=en_us&edition=fundamental","pubTime":"2025-03-04 23:35","pubTimestamp":1741102533,"startTime":"0","endTime":"0","summary":"H.C. Wainwright analyst Joseph Pantginis has reiterated their bullish stance on CAPR stock, giving a Buy rating today. Joseph Pantginis’s rating is...","market":"fut","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/ratings/capricor-therapeutics-promising-developments-and-strategic-positioning-drive-buy-rating?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":["rate"],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/ratings/capricor-therapeutics-promising-developments-and-strategic-positioning-drive-buy-rating?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["CAPR"],"gpt_icon":0},{"id":"2516603612","title":"Capricor Therapeutics Shares Rise on FDA Priority Review","url":"https://stock-news.laohu8.com/highlight/detail?id=2516603612","media":"Dow Jones","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516603612?lang=en_us&edition=fundamental","pubTime":"2025-03-04 23:26","pubTimestamp":1741101960,"startTime":"0","endTime":"0","summary":"Capricor Therapeutics' shares rose after its biologics license application for deramiocel to treat a form of muscular dystrophy was given priority review by the Food and Drug Administration.Shares climbed 10% to $14.99 Tuesday morning. The stock has more than tripled over the past year.The FDA accepted Capricor's application for approval of its cell therapy deramiocel for patients with Duchenne muscular dystrophy cardiomyopathy, the San Diego company said Tuesday.The FDA plans to take action on the application by Aug. 31.","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://dowjonesnews.com/newdjn/logon.aspx?AL=N","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","CAPR"],"gpt_icon":0},{"id":"2516133672","title":"Capricor Therapeutics Shares up 10.1%  After FDA Grants Priority Review to Co's Therapy for a Muscle-Wasting Related Heart 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therapy","url":"https://stock-news.laohu8.com/highlight/detail?id=2516679446","media":"Reuters","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516679446?lang=en_us&edition=fundamental","pubTime":"2025-03-04 21:41","pubTimestamp":1741095683,"startTime":"0","endTime":"0","summary":"BUZZ-Capricor rises on FDA's priority review for Duchenne muscular dystrophy-related cell therapy** Shares of Capricor Therapeutics CAPR.O rise ~12% to $15.30 premarket ** Co says the U.S. FDA has granted Priority Review to its drug to treat a heart condition associated with Duchenne muscular dystrophy     ** DMD cardiomyopathy is a heart muscle disease that can develop in individuals with the genetic condition causing progressive muscle weakness** FDA is set to decide on the cell therapy, deramiocel, by August 31  **  'Priority review' status reduces the review timeline to six months from the time of filing, compared to a standard review timeline of 10 months** Up to last close, stock nearly tripled in the past 12 months   ","market":"nz","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250304:nL3N3PN17Z:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"policyRegulatory","news_rank":0,"length":0,"strategy_id":0,"source":null,"symbols":["BK4139","CAPR"],"gpt_icon":0},{"id":"2516867941","title":"Capricor Therapeutics Shares Gain 10.6% Premarket After FDA Grants Priority Review to Co's Therapy for a Muscle-Wasting Related Heart Condition","url":"https://stock-news.laohu8.com/highlight/detail?id=2516867941","media":"THOMSON REUTERS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516867941?lang=en_us&edition=fundamental","pubTime":"2025-03-04 21:41","pubTimestamp":1741095661,"startTime":"0","endTime":"0","summary":null,"market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://api.refinitiv.com/data/news/v1/stories/urn:newsml:reuters.com:20250304:nL3N3PN19Q:1","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"reuters_en_live","symbols":["BK4139","CAPR"],"gpt_icon":0},{"id":"2516676908","title":"Capricor Therapeutics Receives FDA's Acceptance for Review of BLA for Duchenne Muscular Dystrophy Treatment","url":"https://stock-news.laohu8.com/highlight/detail?id=2516676908","media":"MT Newswires Live","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516676908?lang=en_us&edition=fundamental","pubTime":"2025-03-04 21:19","pubTimestamp":1741094348,"startTime":"0","endTime":"0","summary":"Capricor Therapeutics  said Tuesday it has received the US Food and Drug Administration's acceptance for review of its biologics license application for full approval of deramiocel to treat Duchenne muscular dystrophy cardiomyopathy.The regulator's decision was based on the company's current cardiac data from its phase 2 HOPE-2 and HOPE-2 open label extension studies, Capricor added.The regulator set Aug. 31 as the Prescription Drug User Fee Act target action date without any potential review issues at the moment, the company said.Capricor's stock rose nearly 12% in recent Tuesday premarket activity.","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":null,"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.mtnewswires.com/","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"1","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"mtnewswires_news","symbols":["CAPR","BK4139"],"gpt_icon":0},{"id":"2516676898","title":"Analysts Conflicted on These Healthcare Names: Pliant Therapeutics (PLRX) and Capricor Therapeutics (CAPR)","url":"https://stock-news.laohu8.com/highlight/detail?id=2516676898","media":"TIPRANKS","labels":[],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516676898?lang=en_us&edition=fundamental","pubTime":"2025-03-04 21:10","pubTimestamp":1741093811,"startTime":"0","endTime":"0","summary":"Analysts have been eager to weigh in on the Healthcare sector with new ratings on Pliant Therapeutics (PLRX – Research Report) and Capricor Therape...","market":"us","thumbnail":null,"type":0,"news_type":0,"thumbnails":[],"rights":{"source":"tipranks_highlight","url":"https://www.tipranks.com/news/blurbs/analysts-conflicted-on-these-healthcare-names-pliant-therapeutics-plrx-and-capricor-therapeutics-capr?utm_source=itigerup.com&utm_medium=referral","rn_cache_url":null,"directOrigin":true},"property":[],"language":"en","translate_title":"","themeId":null,"theme_name":"","theme_type":"","isJumpTheme":false,"source_url":"https://www.tipranks.com/news/blurbs/analysts-conflicted-on-these-healthcare-names-pliant-therapeutics-plrx-and-capricor-therapeutics-capr?utm_source=itigerup.com&utm_medium=referral","is_publish_highlight":false,"source_rank":0,"column":"","sentiment":"0","news_top_title":null,"news_tag":"","news_rank":0,"length":0,"strategy_id":0,"source":"tipranks_highlight","symbols":["CAPR","PLRX","HCSG","BK4007","BK4137","BK4139"],"gpt_icon":0},{"id":"2516443673","title":"Capricor Therapeutics' Cell Therapy for Muscular Dystrophy Patients to Get FDA Priority Review","url":"https://stock-news.laohu8.com/highlight/detail?id=2516443673","media":"Dow Jones","labels":["policyRegulatory"],"top":-1,"itemType":null,"share":"https://ttm.financial/m/news/2516443673?lang=en_us&edition=fundamental","pubTime":"2025-03-04 20:37","pubTimestamp":1741091820,"startTime":"0","endTime":"0","summary":"The Food and Drug Administration has accepted Capricor Therapeutics' application seeking approval of its cell therapy deramiocel for muscular dystrophy patients and granted it a priority review.The FDA plans to take action on the application by Aug. 31, Capricor said Tuesday.Shares rose 17% to $15.99 in pre-market trading Tuesday. They have nearly tripled in value over the past year.Deramiocel is specifically being reviewed by the FDA to treat patients diagnosed with Duchenne muscular dystrophy cardiomyopathy.If the San Diego company gets FDA marketing approval for deramiocel regarding the treatment of Duchenne muscular dystrophy by Sept. 30, 2026, it would be eligible to receive a priority review voucher based on its previous receipt of a rare pediatric disease designation.The FDA grants priority review to medicine applications that, if approved, would provide significant improvements in the safety or effectiveness of the treatment of a serious 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