Core Viewpoint - Capricor Therapeutics Inc. received a Complete Response Letter (CRL) from the FDA regarding its Biologics License Application (BLA) for Deramiocel, indicating that the application cannot be approved in its current form due to insufficient evidence of effectiveness and the need for additional clinical data [1][2]. Group 1: FDA Response and Requirements - The FDA stated that the BLA does not meet the statutory requirement for substantial evidence of effectiveness and that additional clinical data is needed [2]. - The CRL referenced outstanding items in the Chemistry, Manufacturing and Controls (CMC) section, which Capricor claims to have addressed in prior communications, but the FDA did not review these materials due to the timing of the CRL issuance [3]. Group 2: Next Steps and Company Plans - The FDA confirmed that it will restart the review clock upon resubmission and offered Capricor the opportunity to request a Type A meeting to discuss the path forward [4]. - Capricor plans to submit data from the Phase 3 HOPE-3 clinical trial to provide additional evidence of effectiveness, with topline results expected in the third quarter of 2025 [5]. Group 3: Market Reaction - Following the news, CAPR stock is down 37.4% at $7.14 during the premarket session [6].

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]

Capricor Therapeutics shares plunged more than 60% after US regulators rejected the company’s treatment for a deadly muscle disorder https://t.co/pLLiQDiV7i ...

Core Viewpoint - Pomerantz LLP is investigating claims of potential securities fraud or unlawful business practices by Capricor Therapeutics, Inc. and its officers or directors [1]. Group 1: Company Developments - On May 5, 2025, Capricor announced that the FDA confirmed its intent to hold an advisory committee meeting regarding the Biologics License Application for deramiocel, a treatment for Duchenne muscular dystrophy cardiomyopathy [3]. - Following this announcement, Capricor's stock price dropped by $3.00 per share, or 29.13%, closing at $7.30 per share on May 6, 2025 [4]. - On June 20, 2025, it was reported that the FDA canceled the advisory committee meeting due to concerns about the drug's efficacy and safety, leading to a further decline in Capricor's stock price by $3.68 per share, or 30.82%, closing at $8.26 per share [4]. Group 2: Legal and Investigative Actions - Pomerantz LLP, a firm specializing in corporate, securities, and antitrust class litigation, is leading the investigation into Capricor's practices [5]. - The firm has a history of recovering significant damages for victims of securities fraud and corporate misconduct [5].

Company Overview - Capricor Therapeutics (CAPR) shares increased by 20.4% to $9.25 in the last trading session, following a period of 25.1% loss over the past four weeks, indicating a significant recovery in stock performance [1] - The company is focused on developing Deramiocel, a cell therapy candidate aimed at treating Duchenne Muscular Dystrophy-associated cardiomyopathy [2] Regulatory Updates - Capricor provided positive regulatory updates regarding its Biologics License Application (BLA) for Deramiocel, with the FDA indicating that an Advisory Committee meeting is not required at this time [2] - The BLA is currently under Priority Review, with a target action date set for August 31, 2025, which may enhance investor confidence [2] Financial Performance Expectations - The company is expected to report a quarterly loss of $0.43 per share, reflecting a year-over-year decline of 22.9% [3] - Revenue projections for the upcoming quarter are estimated at $2.89 million, down 27.2% compared to the same quarter last year [3] Earnings Estimate Trends - The consensus EPS estimate for Capricor has remained unchanged over the last 30 days, suggesting stability in earnings expectations [4] - The stock's price movement is typically correlated with trends in earnings estimate revisions, indicating that future price strength may depend on any changes in these estimates [4] Industry Context - Capricor operates within the Zacks Medical - Products industry, which includes other companies such as Myomo, Inc. (MYO) [4] - Myomo's consensus EPS estimate has seen a significant change of -23.5% over the past month, indicating potential challenges within the same industry [5]

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]

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Core Insights - Capricor Therapeutics is advancing its lead cell therapy candidate, Deramiocel, for the treatment of Duchenne Muscular Dystrophy (DMD) associated cardiomyopathy, with a Biologics License Application (BLA) under Priority Review by the FDA, targeting an action date of August 31, 2025 [1][2][3] Regulatory Updates - The FDA has indicated that an Advisory Committee meeting is not required at this time, and the BLA remains under Priority Review [2][7] - A late-cycle review meeting is scheduled for mid-July 2025 [7] Clinical Data - Capricor presented four-year data from its HOPE-2 Open-Label Extension study at the 2025 Parent Project Muscular Dystrophy Conference, showing sustained cardiac function and clinical benefits from long-term Deramiocel treatment [3][7] Product Information - Deramiocel (CAP-1002) consists of allogeneic cardiosphere-derived cells (CDCs) that have demonstrated immunomodulatory and anti-fibrotic actions in preserving cardiac and skeletal muscle function in DMD [5][8] - The product has received multiple designations, including Orphan Drug Designation and Regenerative Medicine Advanced Therapy designation from the FDA [6][10] Market and Collaboration - Capricor has entered into an exclusive commercialization agreement for Deramiocel in the United States and Japan with Nippon Shinyaku Co., Ltd., pending regulatory approval [10]

Macro Dynamics - New Zealand will implement two visa facilitation policies for Chinese citizens starting November 2025, allowing entry with an electronic travel authorization (NZeTA) for those holding valid Australian visas, enabling a stay of up to 3 months without additional visa applications [1] - The second policy allows Chinese citizens transiting through New Zealand airports to apply for NZeTA without needing a transit visa starting November 2025 [1] Disaster Relief - The National Disaster Reduction and Relief Committee and the Ministry of Emergency Management have allocated over 81,500 pieces of central disaster relief materials to Hunan Province to support emergency relocation and living security for affected residents due to severe flooding [2] Donations - Huazhong University of Science and Technology received a record donation of 180 million yuan from an anonymous donor, aimed at encouraging more alumni participation in the university's development [3] Financial Institutions - Hangzhou Yuhang Rural Commercial Bank's 5% equity will be publicly auctioned with a starting price of approximately 834.7 million yuan, with the auction set for mid-July [6] - The new general manager of Huayuan Fund is Chen Hongbin, who replaces Liang Yongqiang due to work adjustments [7] Market Data - U.S. stock indices closed mixed, with the Nasdaq down 0.51%, S&P 500 down 0.22%, and Dow Jones up 0.08%. Notable declines included Google, which fell nearly 4%, while Apple rose over 2% [9] Company Dynamics - A TCL Elite Club membership in Shenzhen will be auctioned starting at 11 million yuan, including rights to a property and various club benefits [10] - Multiple brands of power banks and battery cells, including Romoss and Anker, have had their 3C certification suspended due to safety concerns [11]

Core Insights - Capricor Therapeutics released four-year safety and efficacy results from the HOPE-2 Open-Label Extension study of Deramiocel, showing a median change of -0.5 points in treated patients compared to baseline [1] - A subgroup analysis indicated that patients with baseline Left Ventricular Ejection Fraction (LVEF) >45% experienced greater clinical benefits, suggesting early intervention may preserve cardiac function [2] - The treatment also slowed skeletal muscle disease progression, with a smaller average decline in performance of the upper limb (PUL v2.0) in the fourth year (0.6 points) compared to the first year (1.8 points) [3] - Extended treatment with Deramiocel may help attenuate the progression of Duchenne Muscular Dystrophy (DMD) over time, maintaining a favorable safety profile throughout the study [4] - CEO Linda Marbán emphasized the strength and durability of Deramiocel's clinical benefits and the company's focus on moving toward potential approval with their Biologics License Application (BLA) under priority review [5] Summary by Category Efficacy Results - After four years of treatment, Deramiocel-treated patients showed a median change of -0.5 points compared to baseline [1] - Patients with baseline LVEF >45% showed greater clinical benefits, supporting early intervention [2] - The treatment slowed skeletal muscle disease progression, with a decline of 0.6 points in the fourth year compared to 1.8 points in the first year [3] Safety Profile - Deramiocel maintained a favorable safety profile throughout the study, indicating its potential for long-term use [4] Regulatory and Market Impact - The company is executing with urgency towards potential approval, with their BLA under priority review [5] - CAPR stock experienced a decline of 31.75%, trading at $8.16 at the time of publication [5]