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INVESTOR ALERT: Investigation of Capricor Therapeutics, Inc. (CAPR) Announced by Holzer & Holzer, LLC
GlobeNewswire News Room· 2025-07-11 17:00
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's Lead Duchenne Therapy Hits FDA Regulatory Roadblock
Benzinga· 2025-07-11 13:03
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 ...
Frequency Electronics, Capricor Therapeutics And Other Big Stocks Moving Lower In Friday's Pre-Market Session
Benzinga· 2025-07-11 12:20
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]
【IPO前哨】估值超10亿美元,商米科技有何来头?
Sou Hu Cai Jing· 2025-07-11 02:01
Core Viewpoint - Shanghai Sunmi Technology Group Co., Ltd. (Sunmi Technology) has submitted its listing application to the Hong Kong Stock Exchange, marking its entry into the market as a dual-class share company, following the footsteps of other notable companies like Xiaomi and Meituan [2][3]. Company Overview - Founded in 2013 by Lin Zhe, Sunmi Technology has evolved into a leading provider of Business Internet of Things (BIoT) solutions, integrating IoT technology for commercial purposes [3]. - The company holds over 10% of the global market share in the Android-based BIoT solutions sector, with deployments in over 200 countries and regions, serving more than 100 industry verticals and boasting over 4.9 million active smart devices [3]. Client Base and Investments - Sunmi Technology has established a strong presence in the food and beverage sector, serving over 70% of the top 50 global companies in this industry, and has a coverage rate exceeding 70% among China's top 100 restaurant enterprises [5]. - The company has attracted significant investments from major players such as Xiaomi, Ant Group, and Meituan, achieving a valuation exceeding $1 billion in 2019, classifying it as a unicorn [5]. Financial Performance - Revenue figures for Sunmi Technology from 2022 to 2024 are as follows: 3.404 billion RMB, 3.071 billion RMB, and 3.456 billion RMB, with corresponding profits of approximately 160 million RMB, 101 million RMB, and 181 million RMB [6]. - The gross profit margin has fluctuated during this period, recorded at 28.1%, 26.7%, and 28.9% respectively, with a noted recovery in 2024 attributed to increased sales in Europe and improved cost management [6]. Revenue Structure - The revenue from smart device sales constituted 99.5%, 98.0%, and 99.5% of total revenue from 2022 to 2024, indicating a heavy reliance on hardware sales, particularly smart financial devices, which accounted for 42.3% of total revenue in 2024 [7][8]. - Sunmi Technology's revenue structure reveals a significant dependency on a limited number of OEM and ODM suppliers, with the top five suppliers accounting for 75.9%, 74.1%, and 66.3% of total procurement from 2022 to 2024 [9]. Cash Flow and Accounts Receivable - Despite the increase in accounts receivable, which rose from 406 million RMB in 2022 to 1.049 billion RMB in 2024, the company maintains a healthy cash flow, with cash and cash equivalents amounting to 1.853 billion RMB as of April 30, 2025 [9]. - The company plans to utilize the funds raised from the IPO for R&D of BIOT hardware and software solutions, enhancing supply chain and production operations, and implementing global market expansion plans [10].
INVESTOR ALERT: Pomerantz Law Firm Investigates Claims On Behalf of Investors of Capricor Therapeutics, Inc. - CAPR
GlobeNewswire News Room· 2025-07-03 14:00
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 ...
AGICamp 第 001 周 AI 应用榜发布:DeepPath、AI 好记、Remio 等上榜
AI前线· 2025-07-03 08:26
作者 | 霍太稳 @极客邦科技 AGICamp 首期的 AI 应用榜周榜终于要发布了。2025 年 6 月 18 日联调成功,网站正式上线,6 月 27 日在 AICon 全球人工智能开发与应用大会 上发布,十天的时间上线了 14 个应用,包括软件产 品、硬件产品和 Agent 智能体等。作为一个 AI 原生社区,AGICamp 扮演的角色是给 AI 时代的开发 者提供一个发布和展示作品的平台,给用户提供一个方便找到和点评这些 AI 应用的平台,从而通过 线上线下相融合的方式,持续推进 AI 技术在千行百业的蓬勃发展。 因为现在每日发布的 AI 应用还不是很多,所以 AGICamp 暂时不推出日榜,而是每周二发布"AI 应 用榜",将上周发布的 AI 应用根据评论、点赞的综合数量进行排名,展示给用户。 在 AGICamp 的 榜单算法中,评论的权重要大于点赞,主要原因在于我们想做一个有互动的,有烟火气的 AI 社区, 希望在这儿可以看到真正的用户对这些 AI 应用的真实评价,大家线上有互动有交流,线下也认识也 熟悉有人情味,而不是鼓励大家简单地点赞刷榜。 开始 AGICamp 第 001 周 AI 应用榜榜单 ...
Capricor (CAPR) Moves 20.4% Higher: Will This Strength Last?
ZACKS· 2025-06-25 14:01
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 ...
FDA Skips Advisory Committee For Capricor's Duchenne Cell Therapy
Benzinga· 2025-06-24 18:51
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]
Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy
Globenewswire· 2025-06-24 13:00
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 ...
Roche's Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma
GlobeNewswire News Room· 2025-06-20 15:45
Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx1This well-tolerated investigational combination therapy avoids traditional chemotherapy and may be suitable for outpatient community careThese data demonstrate Roche's commitment to providing options for diverse patient and healthcare system needs in this difficult-to-treat lymphoma Basel, 20 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presented today results from the phase III SUNM ...