ATLANTA, July 11, 2025 (GLOBE NEWSWIRE) -- Holzer & Holzer, LLC is investigating whether Capricor Therapeutics, Inc. (“Capricor” or the “Company”) (NASDAQ: CAPR) complied with federal securities laws. On July 11, 2025, Capricor announced that it had received a Complete Response Letter (“CRL”) from the FDA regarding its Biologics License Application (“BLA”) for Deramiocel. Following this news, the price of the Company’s stock dropped.  If you purchased Capricor stock and suffered a loss on that investment, y ...

Capricor Therapeutics Inc. CAPR stock is trading lower on Friday. The company received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Deramiocel, the company’s lead cell therapy candidate for cardiomyopathy associated with Duchenne muscular dystrophy (DMD).In the CRL, the FDA stated that it had completed its application review but could not approve the BLA in its current form.The agency specifically cited that the BLA d ...

Group 1 - U.S. stock futures are lower, with Dow futures down approximately 300 points [1] - Frequency Electronics, Inc. reported fourth-quarter earnings of 34 cents per share, an increase from 28 cents per share year-over-year [1] - Frequency Electronics' sales rose to $19.986 million from $15.576 million [1] Group 2 - Frequency Electronics shares fell 5.4% to $21.44 in pre-market trading [2] - Capricor Therapeutics, Inc. shares declined 44% to $6.39 following a regulatory update on Deramiocel BLA for Duchenne Muscular Dystrophy [4] - Youlife Group Inc. shares fell 23.2% to $3.84 after an 82% drop on Thursday [4] - Civista Bancshares, Inc. shares dipped 12.5% to $21.72 after announcing a public offering of common shares [4] - Resolute Holdings Management, Inc. shares fell 9.5% to $36.01 after a previous gain of over 3% [4] - Scage Future shares decreased by 7.7% to $6.19 [4] - Albemarle Corporation shares fell 4% to $71.67 after a 5% gain on Thursday [4]

NEW YORK, July 03, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Capricor Therapeutics, Inc.  (“Capricor” or the “Company”) (NASDAQ: CAPR).  Such investors are advised to contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980, ext. 7980. The investigation concerns whether Capricor and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.  [Click here for information about joining the class action] O ...

Capricor Therapeutics (CAPR) shares ended the last trading session 20.4% higher at $9.25. The jump came on an impressive volume with a higher-than-average number of shares changing hands in the session. This compares to the stock's 25.1% loss over the past four weeks.Capricor recorded a strong price increase after it provided regulatory updates related to its Biologics License Application (BLA) for Deramiocel, the company’s lead cell therapy candidate for the treatment of Duchenne Muscular Dystrophy—associa ...

Core Insights - Capricor Therapeutics Inc is advancing its Biologics License Application (BLA) for Deramiocel, aimed at treating Duchenne Muscular Dystrophy (DMD)-associated cardiomyopathy [1][3] - DMD affects around 15,000 individuals in the U.S., primarily boys, due to the absence of functional dystrophin [2] Regulatory Updates - The FDA has indicated that an Advisory Committee meeting is not necessary at this time, with the BLA under Priority Review and a PDUFA target action date set for August 31, 2025 [3][4] - Capricor has been informed of a potential Advisory Committee meeting on July 30, 2025, pending FDA confirmation, with no significant issues noted during the mid-cycle review [4] Company Performance - CEO Linda Marbán stated that the company has successfully met all key regulatory milestones, including a pre-license inspection and mid-cycle review [5] - Capricor recently presented four-year data from its HOPE-2 Open-Label Extension study, showcasing one of the longest treatment datasets in DMD, focusing on cardiac and skeletal muscle function [6] Market Reaction - Following these updates, CAPR stock experienced a 20% increase, reaching $9.22 [6]

SAN DIEGO, June 24, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today provided regulatory updates related to its Biologics License Application (BLA) for Deramiocel, the Company's lead cell therapy candidate for the treatment of Duchenne Muscular Dystrophy (DMD)—associated cardiomyopathy. As part of the FDA's ongoing review, the Company has been informed that an Advisory Committee meeti ...

智通财经APP注意到，周五美股盘初，基因编辑公司股价整体持稳，随后随大盘下跌。此前美国FDA生 物制品评价与研究中心(CBER)再次突发人事变动——继年初前主任彼得·马克斯博士突然离职后，其细 胞与基因治疗部门正副主管周三被集体停职。 基因治疗开发商的股价曾在五月遭遇抛售，当时FDA局长马蒂·马卡里宣布任命普拉萨德执掌CBER。这 位以尖锐批评FDA过往监管工作著称的学者——包括对萨雷普塔治疗(SRPT.US)与罗氏开发的杜氏肌营 养不良基因疗法Elevidys的争议性批准——近期还兼任了FDA首席医疗官和首席科学官。 尽管CBER再现人事动荡，头部基因编辑药企Editas Medicine(EDIT.US)、Intellia Therapeutics(NTLA.US)、Beam Therapeutics(BEAM.US)和CRISPR Therapeutics(CRSP.US)股价曾一度上 涨。但正在推进细胞疗法deramiocel(针对杜氏肌营养不良症)优先审评的Capricor Therapeutics(CAPR.US) 股价跌超10%，据悉韦尔东正是负责监督该药上市申请的关键官员。 据多家媒体报道，在 ...

Four-year data show preservation of cardiac function, including LVEFSkeletal muscle disease progression continues to slow with extended treatment (PUL v2.0)Deramiocel’s long-term safety profile remains favorableResults presented at PPMD’s 2025 Annual Conference SAN DIEGO, June 20, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced positive four-year safety and efficacy results ...

U.S. FDA grants Orphan Drug Designation to Deramiocel for the treatment of Becker Muscular Dystrophy, broadening Capricor’s focus in neuromuscular diseasesCapricor remains on track for the August 31, 2025, PDUFA date for Deramiocel in Duchenne Muscular Dystrophy following successful FDA Pre-License Inspection SAN DIEGO, June 17, 2025 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseas ...