Drugs / Deramiocel
Deramiocel
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed DMD-related muscular dystrophy 1 milestone | |||||
| Filed | US (FDA) | — | DMD-related muscular dystrophy | 2026-08-24 | “Capricor submitted an amendment to the BLA that includes 24-month open-label extension data from its pivotal Phase 3 HOPE-3 study” capricor.com ↗ |
| Filed muscular dystrophy, cardiac type 2 milestones | |||||
| Filed | US (FDA) | — | muscular dystrophy, cardiac type | 2026-03-10 | “FDA has lifted the previously issued Complete Response Letter and resumed review of its Biologics License Application (“BLA”) seeking full approval of Deramiocel” capricor.com ↗ “In March 2025, the FDA accepted for review Capricor’s BLA seeking full approval of deramiocel for the treatment of individuals with DMD.” capricor.com ↗ |
| Rejected (CRL) | US (FDA) | — | muscular dystrophy, cardiac type | 2025-07-11 | “received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Deramiocel” capricor.com ↗ “本剤は、2025年7月に審査完了報告通知（Complete Response Letter、以下「CRL」）を受領しました。” nippon-shinyaku.co.jp ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 24 trials · 3 met primary | ||||||
| Phase 2 | NCT04428476 | Aug 2020 → Feb 2022 overdue | Duchenne muscular dystrophy | Capricor Inc. | Active not recruiting | Met primary |
| Phase 2 | NCT06304064 | Jun 2018 → Mar 2019 | Duchenne muscular dystrophy | Capricor Inc. | Completed | No outcome recorded |
| Phase 2 | NCT03406780 | Apr 2018 → Mar 2020 | Duchenne muscular dystrophy, X-linked disease, atrophic muscular disease | Capricor Inc. | Completed | Met primary |
| Phase 2 | NCT02485938 | Jan 2016 → Sep 2017 | Duchenne muscular dystrophy, cardiomyopathy | Capricor Inc. | Completed | Met primary |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT05126758 | Jun 2022 → Jun 2025 overdue | Duchenne muscular dystrophy, X-linked disease, atrophic muscular disease | Capricor Inc. | Active not recruiting | Met primary |
| Phase not stated1 trial · 1 met primary | ||||||
| — | NCT04338347 | — | COVID-19 | Capricor Inc. | No longer available | Met primary |
| Comparator or background therapy3 trials | ||||||
| Phase 1/2 | NCT01458405 Comparator | Nov 2012 → Jul 2017 | myocardial infarction | Capricor Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT04623671 Comparator | Nov 2020 → Feb 2022 | COVID-19 | Capricor Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02941705 Comparator | Jul 2017 → Apr 2023 | diastolic heart failure | Cedars-Sinai Medical Center | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 81
| Date | Issuer | Release |
|---|---|---|
| 2026-08-25 | Nippon Shinyaku Co., Ltd. | Regulatory CAP-1002（deramiocel）：BLA審査継続に伴うPDUFA dateの延長に関するお知らせ nippon-shinyaku.co.jp ↗
米国食品医薬品局（FDA）による審査終了目標日（PDUFA date）が2026年8月22日から2026年11月22日へ延長されたことをお知らせします。 |
| 2026-08-24 | Capricor Inc. | Regulatory Capricor Therapeutics Announces Extension of PDUFA Target Action Date as FDA Continues Review of Deramiocel BLA capricor.com ↗
The FDA has classified the submission as a major amendment and extended the PDUFA target action date by three months to allow additional time to review the information. |
| 2026-07-31 | Hopstem Biotechnology Inc. | Regulatory 2026【七月精选】领域最新进展 hopstem.com ↗
该产品BLA 二次申报完成受理，FDA设定目标审批日（PDUFA）为2026年8月22日。 |
| 2026-07-30 | Capricor Inc. | Regulatory Capricor Therapeutics Provides Update on FDA Advisory Committee Meeting for Deramiocel capricor.com ↗
The Committee's vote is non-binding. |
| 2026-07-29 | Capricor Inc. | Results The Lancet Publishes HOPE-3 Data for Capricor Therapeutics’ Deramiocel in Duchenne Muscular Dystrophy capricor.com ↗ |
| 2026-06-26 | Capricor Inc. | Results Capricor to Present Positive Five-Year HOPE-2 OLE Data and HOPE-3 Phase 3 Results for Deramiocel in Duchenne Muscular Dystrophy at PPMD 2026 Annual Conference capricor.com ↗
Among the patients who remain enrolled in the HOPE-2 OLE study (n=9), treatment with Deramiocel continued to attenuate disease progression over five years, as measured by Performance of the Upper Limb (PUL 2.0). |
| 2026-04-22 | Capricor Inc. | Results Capricor Therapeutics Announces Late-Breaking Presentation of HOPE-3 Phase 3 Results at the American Academy of Neurology 2026 Annual Meeting capricor.com ↗
These findings were further supported by an alternative measure of upper limb function, specifically video recordings of tasks performed at home (the Duchenne Video Assessment, or DVA), which showed meaningful slowing of disease progression in the ability to self-feed, a function central to patient independence. |
| 2026-03-31 | Hopstem Biotechnology Inc. | Regulatory 2026【三月精选】领域最新进展 hopstem.com ↗
美国食品药品监督管理局（FDA）已撤销针对其外泌体细胞疗法Deramiocel（研发代号：CAP-1002）用于治疗杜氏肌营养不良症（DMD）的完全回应函 |
| 2026-03-12 | Capricor Inc. | Results Capricor Therapeutics Announces Late-Breaking HOPE-3 Data at the 2026 MDA Conference Demonstrating Significant Functional Benefits of Deramiocel for Duchenne Muscular Dystrophy capricor.com ↗
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced additional analyses and new functional outcomes data from the Phase 3 HOPE-3 clinical trial of Deramiocel in Duchenne muscular dystrophy (DMD), which were presented yesterday at the 2026 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference in Orlando, Florida. |
| 2026-03-11 | Nippon Shinyaku Co., Ltd. | Regulatory CAP-1002：新たなPDUFA dateが設定されたことをカプリコール社が発表 nippon-shinyaku.co.jp ↗
また、FDAによるPDUFA date（審査終了目標日）は2026年8月22日（米国時間）に再設定されました。 |
| 2026-03-10 | Capricor Inc. | Regulatory Capricor Therapeutics Announces Establishment of New PDUFA Date for Deramiocel BLA capricor.com ↗
The submission has been classified as a Class 2 resubmission, with a Prescription Drug User Fee Act (“PDUFA”) target action date of August 22, 2026. |
| 2026-01-20 | Capricor Inc. | Regulatory Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA Following FDA Review of HOPE-3 Topline Data capricor.com ↗
Following its review of these data, the FDA has formally requested the full HOPE-3 clinical study report (CSR) and supporting data to address the Complete Response Letter (CRL). |
| 2025-12-04 | Nippon Shinyaku Co., Ltd. | Results CAP-1002：Capricor社による臨床第Ⅲ相試験（HOPE-3試験）のトップラインデータ発表に関するお知らせ nippon-shinyaku.co.jp ↗
HOPE-3試験において、本剤は主要評価項目である上肢機能評価（PUL v2.0）および重要な副次評価項目である心機能指標（左室駆出率：LVEF）で統計学的有意差を確認（p＝0.03およびp＝0.04） |
| 2025-12-03 | Capricor Inc. | Results Capricor Therapeutics Announces Positive Topline Results from Pivotal Phase 3 HOPE-3 Study of Deramiocel in Duchenne Muscular Dystrophy capricor.com ↗
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced positive topline results from its pivotal Phase 3 HOPE-3 trial evaluating Deramiocel, the Company’s investigational cell therapy for the treatment of Duchenne muscular dystrophy (DMD). |
| 2025-11-03 | Capricor Inc. | Results Capricor Therapeutics Publishes Peer-Reviewed Study in Biomedicines Describing the Mechanism of Action and Potency Assay for its Investigational Cell Therapy, Deramiocel capricor.com ↗ |
| 2025-09-09 | Capricor Inc. | Regulatory Capricor Therapeutics Responds to FDA Posting of Complete Response Letter (CRL) for Deramiocel capricor.com ↗
The Company was not notified in advance that the CRL would be posted, but acknowledges the FDA’s decision to publish the letter, originally received in July 2025. |
| 2025-07-14 | Nippon Shinyaku Co., Ltd. | Regulatory CAP-1002の生物製剤承認申請に関する審査完了報告通知の受領について nippon-shinyaku.co.jp ↗
日本新薬株式会社（本社：京都市南区、代表取締役社長：中井 亨、以下「当社」）は、デュシェンヌ型筋ジストロフィー（以下「DMD」）心筋症を期待適応症とするCAP-1002（deramiocel、以下「本剤」）について、Capricor Therapeutics, Inc.（本社：米国 カリフォルニア州サンディエゴ、最高経営責任者：Linda Marbán、以下「Capricor社」）が米国FDA（食品医薬局）から審査完了報告通知（Complete Response Letter、以下「CRL」）を受領したことをお知らせします。 |
| 2025-07-11 | Capricor Inc. | Regulatory Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy capricor.com ↗
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for rare diseases, today announced that it has 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 the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). |
| 2025-06-24 | Capricor Inc. | Regulatory Capricor Therapeutics Provides Regulatory Update on Deramiocel BLA for Duchenne Muscular Dystrophy capricor.com ↗
As part of the FDA’s ongoing review, the Company has been informed that an Advisory Committee meeting is not indicated at this time. |
| 2025-06-20 | Capricor Inc. | Results Capricor Therapeutics Announces Positive 4-Year Data from HOPE-2 Open-Label Extension Study of Deramiocel in Duchenne Muscular Dystrophy capricor.com ↗
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 from its ongoing HOPE-2 Open-Label Extension (OLE) study of Deramiocel, the Company’s lead cell therapy candidate for Duchenne Muscular Dystrophy (DMD). |
| 2025-06-17 | Capricor Inc. | Regulatory Capricor Therapeutics Announces Orphan Drug Designation for Becker Muscular Dystrophy and Regulatory Progress for Duchenne Muscular Dystrophy Program capricor.com ↗
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Deramiocel, the company’s lead cell therapy candidate, for the potential treatment of Becker Muscular Dystrophy (BMD). |
| 2025-06-11 | Capricor Inc. | Regulatory Capricor Therapeutics Announces Key Regulatory Updates for its Duchenne Muscular Dystrophy Program capricor.com ↗
The inspection concluded with a Form 483 containing several observations. |
| 2025-05-05 | Capricor Inc. | Regulatory Capricor Therapeutics Announces Completion of Mid-Cycle Review Meeting with FDA on Deramiocel for the Treatment of Duchenne Muscular Dystrophy Cardiomyopathy capricor.com ↗
During the meeting, FDA stated that no significant deficiencies have been identified by the Review Committee and that the package is on track for a Prescription Drug User Fee Act (PDUFA) action date of August 31, 2025. |
| 2025-04-01 | Hopstem Biotechnology Inc. | Regulatory 2025【三月精选】领域最新进展 hopstem.com ↗ |
| 2025-03-19 | Capricor Inc. | Regulatory Capricor Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update capricor.com ↗
Announced the U.S. FDA has accepted our Biologics License Application (BLA) seeking full approval of deramiocel for the treatment of Duchenne muscular dystrophy (DMD) cardiomyopathy |
| 2025-03-17 | Capricor Inc. | Results Capricor Therapeutics Announces Positive Data Demonstrating Long-Term Efficacy of Deramiocel for the Treatment of Duchenne Muscular Dystrophy capricor.com ↗
This equates to a 52 percent slowing of disease progression, reinforcing deramiocel’s potential long-term therapeutic durability. |
| 2025-03-05 | Nippon Shinyaku Co., Ltd. | Regulatory CAP-1002（Deramiocel）：米国FDAがデュシェンヌ型筋ジストロフィー心筋症に対する生物製剤承認申請を受理 nippon-shinyaku.co.jp ↗
また、優先審査指定を受け、FDAによる審査終了目標日（PDUFA date）は2025年8月31日（米国時間）に設定されました。 |
| 2025-03-04 | Capricor Inc. | Regulatory Capricor Therapeutics Announces FDA Acceptance and Priority Review of its Biologics License Application for Deramiocel to Treat Duchenne Muscular Dystrophy capricor.com ↗
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced the U.S. Food and Drug Administration (“FDA”) has accepted for review its Biologics License Application (“BLA”) seeking full approval for deramiocel, an investigational cell therapy, as a treatment for patients diagnosed with Duchenne muscular dystrophy (“DMD”) cardiomyopathy. |
| 2025-01-02 | Capricor Inc. | Regulatory Capricor Therapeutics Completes Submission of Biologics License Application to the U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy capricor.com ↗
The submission of the BLA marks a pivotal step for Capricor and those impacted by DMD. |
| 2024-11-20 | Capricor Inc. | Regulatory Capricor Therapeutics Granted Orphan Drug and ATMP Status for Deramiocel by European Medicines Agency capricor.com ↗
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced that the European Medicines Agency (EMA) has granted both Orphan Drug and Advanced Therapy Medicinal Product (ATMP) designations to its lead asset, deramiocel, for the treatment of Duchenne muscular dystrophy (DMD). |
| 2024-10-11 | Capricor Inc. | Results Capricor Therapeutics Announces Positive Long-Term Data from HOPE-2 OLE Study in Duchenne Muscular Dystrophy at 2024 World Muscle Society Congress capricor.com ↗
In conclusion, the results of this study showed sustained cardiac and skeletal benefits after 3 years of continuous treatment with deramiocel. |
| 2024-10-09 | Capricor Inc. | Regulatory Capricor Therapeutics Announces Initiation of Rolling Submission of Biologics License Application (BLA) with U.S. FDA for Deramiocel for the Treatment of Duchenne Muscular Dystrophy capricor.com ↗
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, announced today that it has initiated its rolling submission process with the U.S. Food and Drug Administration (FDA) for a Biologics License Application (BLA), seeking full approval for deramiocel to treat all patients diagnosed with Duchenne muscular dystrophy (DMD) cardiomyopathy. |
| 2024-06-28 | Capricor Inc. | Results Capricor Therapeutics Announces Long-Term Benefit of Deramiocel (CAP-1002) in Both Skeletal Muscle and Cardiac Function in the HOPE-2 OLE Study in Duchenne Muscular Dystrophy capricor.com ↗
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced additional positive 3-year safety and efficacy results from its ongoing HOPE-2 open label extension (OLE) study with its lead asset, deramiocel (CAP-1002), for the treatment of Duchenne muscular dystrophy (DMD). |
| 2024-06-11 | Capricor Inc. | Regulatory Capricor Therapeutics Announces Positive Type-B Meeting with FDA for CAP-1002 Program for Duchenne Muscular Dystrophy with an Aim to Expedite BLA Pathway capricor.com ↗
This key agreement will allow us to begin our BLA filing with a rolling submission planned to initiate in the third quarter of 2024. |
| 2024-06-04 | Capricor Inc. | Results Capricor Therapeutics Announces Positive 3-Year Efficacy Results from HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy capricor.com ↗
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment of rare diseases, today announced positive 3-year results from the ongoing HOPE-2 open-label extension (OLE) study with CAP-1002 for the treatment of Duchenne muscular dystrophy (DMD). |
| 2024-03-06 | Capricor Inc. | Results Capricor Therapeutics Presents at 2024 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference capricor.com ↗
The average rate of decline in CAP-1002 treated patients showed an attenuation of disease progression by approximately 64% |
| 2023-12-11 | Capricor Inc. | Results Capricor Therapeutics Announces Continuation of Phase 3 HOPE-3 Trial of CAP-1002 in Duchenne Muscular Dystrophy Based on Completion of Interim Futility Analysis capricor.com ↗
The results of the interim futility analysis, reviewed by the Data Safety Monitoring Board (DSMB), resulted in a favorable recommendation to continue the HOPE-3 trial as planned. |
| 2023-10-10 | Capricor Inc. | Results Capricor Therapeutics Announces Late-Breaking Presentations at 28th Annual Congress of the World Muscle Society capricor.com ↗
The average rate of decline in CAP-1002 treated patients showed an attenuation of disease progression by approximately 64%. |
| 2023-09-29 | Capricor Inc. | Regulatory Capricor Therapeutics Announces Positive Type-B Meeting with the FDA to Discuss Pathway to BLA for CAP-1002 in Duchenne Muscular Dystrophy capricor.com ↗
Feedback from the FDA on trial design and timeline confirms CAP-1002’s path towards a future Biologics License Application (“BLA”) submission. |
| 2023-06-30 | Capricor Inc. | Results Capricor Therapeutics Announces Positive 24-Month Results from Ongoing HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy capricor.com ↗
Data from the OLE study demonstrated that the majority of patients had an improvement in left ventricular ejection fraction (LVEF), after two years of CAP-1002 treatment, which suggests preservation of cardiac function. |
| 2023-03-23 | Capricor Inc. | Results Capricor Therapeutics Presents at 2023 Muscular Dystrophy Association (MDA) Clinical & Scientific Conference capricor.com ↗
Statistically significant differences in the Performance of the Upper Limb (PUL version 2.0) scale in the CAP-1002 original treatment group when compared to the original placebo group from HOPE-2 (p=0.02). |
| 2023-01-25 | Capricor Inc. | Results Capricor Therapeutics Announces Positive 18-Month Results from Ongoing HOPE-2 Open Label Extension Study of CAP-1002 in Duchenne Muscular Dystrophy Patients capricor.com ↗
Capricor Therapeutics (NASDAQ: CAPR), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of muscular and other select diseases, today announced positive 18-month results from its ongoing HOPE-2 open label extension (OLE) study in patients with later-stage Duchenne muscular dystrophy (DMD). |
| 2022-06-27 | Capricor Inc. | Results Capricor Therapeutics Announces Statistically Significant Clinical Benefits in Skeletal Muscle Function in Non-Ambulant Duchenne Muscular Dystrophy Patients Treated with CAP-1002 in HOPE-2 Open Label Extension Study capricor.com ↗ |
| 2022-03-28 | Capricor Inc. | Results Capricor Therapeutics Reports Topline Results from Phase 2 Exploratory INSPIRE Trial in Severe Hospitalized COVID-19 Patients capricor.com ↗ |
| 2022-03-11 | Capricor Inc. | Results The Lancet Publishes Positive Results from Capricor Therapeutics’ Phase 2 Study Evaluating CAP-1002 in Late-Stage Duchenne Muscular Dystrophy capricor.com ↗
Specifically, the study demonstrated that young men in the advanced stages of DMD experienced improvements in both skeletal and cardiac muscle function after receiving four doses of CAP-1002 over the course of one year. |
| 2021-09-24 | Capricor Inc. | Results Capricor Therapeutics Announces Positive Final Data From its Phase 2 HOPE-2 Trial in Patients with Duchenne Muscular Dystrophy Treated with CAP-1002 capricor.com ↗
Capricor Therapeutics (NASDAQ: CAPR) (“Capricor” or “the Company”), a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of a broad spectrum of diseases, announced today positive final data from the HOPE-2 clinical trial using CAP-1002 to treat patients in advanced stages of Duchenne muscular dystrophy (DMD). |
| 2020-08-25 | Capricor Inc. | Regulatory Capricor Therapeutics Announces U.S. FDA Acceptance of its IND Application for a Phase 2 Clinical Trial of CAP-1002 in Patients with COVID-19 capricor.com ↗ |
| 2020-08-06 | Capricor Inc. | Regulatory Capricor Therapeutics Reports Second Quarter 2020 Financial Results and Provides Corporate Update capricor.com ↗
Additionally, we have submitted a new investigational new drug application (IND) to the FDA for a randomized, placebo-controlled, do |
| 2020-05-13 | Capricor Inc. | Results Capricor Announces Positive Top-Line Final Results from HOPE-2 Study in Patients with Duchenne Muscular Dystrophy Treated with Lead Candidate CAP-1002 capricor.com ↗
The data showed improvements in upper limb, cardiac and respiratory function with p-values less than p=0.05 in multiple measures. |
| 2020-04-29 | Capricor Inc. | Results New Capricor Data Reports 100 Percent Survival in Critical COVID-19 Patients Treated with CAP-1002 capricor.com ↗ |
| 2020-04-03 | Capricor Inc. | Regulatory Capricor Initiates Compassionate Use Program for Severe COVID-19 Patients using CAP-1002, its Novel Cell Therapy capricor.com ↗
Additionally, Capricor has submitted an expanded access Investigational New Drug (IND) application to investigate the use of CAP-1002 in certain COVID-19 patients which is currently under review with the FDA. |
| 2019-10-07 | Capricor Inc. | Results Capricor Presents Additional Positive Data from Ongoing HOPE-2 Study of CAP-1002 in Duchenne Muscular Dystrophy at World Muscle Society: Data Demonstrates Improved PUL 2.0 Performance at 6 Months capricor.com ↗
Data from the pre-specified interim analysis demonstrated that teens and young men in the advanced stages of DMD saw improvements in skeletal, pulmonary, and cardiac measurements after receiving multiple doses of CAP-1002. |
| 2019-09-17 | Capricor Inc. | Results Capricor Therapeutics to Present Results from the HOPE-2 Trial of CAP-1002 in Duchenne Muscular Dystrophy in a Late Breaking Session of the World Muscle Society capricor.com ↗
This is the first therapeutic in DMD to lead to meaningful functional improvements using the recently validated Performance of Upper Limb (PUL) Measure. |
| 2019-07-25 | Capricor Inc. | Results Capricor Therapeutics Announces Positive DSMB Safety and Futility Review and Continuation of its HOPE-2 Study in Duchenne Muscular Dystrophy capricor.com ↗
Capricor to resume treating currently enrolled patients |
| 2019-07-15 | Capricor Inc. | Results Capricor Therapeutics Announces Positive Results from its Interim Analysis in the HOPE-2 Trial to Treat Patients with Duchenne Muscular Dystrophy capricor.com ↗
Capricor Therapeutics, Inc. (NASDAQ: CAPR), a clinical-stage biotechnology company, today announced that a pre-specified interim analysis performed on 6-month data from the HOPE-2 trial showed statistically significant results across several independent clinical measures. |
| 2019-01-24 | Capricor Inc. | Results Neurology Publishes Study Reporting Significant Improvements in Duchenne Muscular Dystrophy Patients Treated with Capricor’s Novel Cell Therapy capricor.com ↗
The HOPE-Duchenne trial also found no serious safety issues, according to the study published in the January 23, 2019, online issue of Neurology , the medical journal of the American Academy of Neurology. |
| 2018-10-03 | Capricor Inc. | Results Capricor Therapeutics to Present at 2018 Cell & Gene Meeting on the Mesa capricor.com ↗
In addition, during the three-day conference in La Jolla, CA, Capricor will provide a poster presentation on a pre-clinical study which found that extracellular vesicles, or exosomes, were the active component of CAP-1002. |
| 2018-04-19 | Capricor Inc. | Results Capricor Announces New Pre-Clinical Study Finds Repeat Doses of CAP-1002 Lead to Enhanced Exercise Capacity in Duchenne Muscular Dystrophy Disease Model capricor.com ↗
The research found improvements in absolute force in soleus (leg) and in the diaphragm of a mouse model of Duchenne muscular dystrophy, the mdx mouse. |
| 2018-02-22 | Capricor Inc. | Results New Published Study Reports Cardiosphere-Derived Cells Improved Skeletal and Cardiac Muscle Function in Mouse Model of Duchenne Muscular Dystrophy capricor.com ↗
The researchers showed for the first time that the skeletal and cardiac improvements seen in Capricor’s HOPE-Duchenne study could be directly attributed to treatment with CDCs. |
| 2018-02-05 | Capricor Inc. | Regulatory Capricor Receives FDA Regenerative Medicine Advanced Therapy (RMAT) Designation for Duchenne Muscular Dystrophy Therapy capricor.com ↗
Capricor Therapeutics (NASDAQ:CAPR) today announced that the U.S. Food and Drug Administration (FDA) has granted CAP-1002, its lead investigational cell therapy for the treatment of Duchenne muscular dystrophy, the Regenerative Medicine Advanced Therapy (RMAT) designation. |
| 2017-11-29 | Capricor Inc. | Regulatory Capricor Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for CAP-1002 capricor.com ↗ |
| 2017-11-15 | Capricor Inc. | Results Significant Improvements Reported in Duchenne Muscular Dystrophy Patients Treated with Capricor's Investigational Cell Therapy capricor.com ↗
Boys and young men in advanced stages of Duchenne muscular dystrophy experienced significant and sustained improvements in cardiac structure and function, as well as skeletal muscle function, following treatment with CAP-1002, the lead investigational therapy under development at Capricor Therapeutics (NASDAQ: CAPR). |
| 2017-10-06 | Capricor Inc. | Results Capricor Therapeutics Reports Intravenous Administration of CAP-1002 Shown to be Effective in Preclinical Models of Duchenne Muscular Dystrophy capricor.com ↗ |
| 2017-10-04 | Capricor Inc. | Results Capricor Therapeutics Presents Positive Six-Month Results in Duchenne Muscular Dystrophy at World Muscle Society International Congress capricor.com ↗
The late breaking abstract and results presented at the late breaking poster session describe the first six months of follow-up data from the randomized 12-month Phase I/II HOPE clinical trial of CAP-1002. |
| 2017-08-10 | Capricor Inc. | Results Capricor Therapeutics Reports Second Quarter 2017 Financial Results and Provides Corporate Update capricor.com ↗
A key finding in HOPE-Duchenne was that, as compared to usual care controls, patients treated with CAP-1002 demonstrated improvement in skeletal muscle function according to the Performance of the Upper Limb (PUL) test, a validated instrument. |
| 2017-07-27 | Capricor Inc. | Regulatory Capricor Announces Results of FDA Meeting on Intravenous CAP-1002 for Duchenne Muscular Dystrophy capricor.com ↗
The minutes indicate: the FDA's willingness to accept Capricor's proposal to use the Performance of the Upper Limb (PUL) |
| 2017-07-18 | Capricor Inc. | Regulatory Capricor Receives Rare Pediatric Disease Designation from FDA for CAP-1002 for Patients with Duchenne Muscular Dystrophy capricor.com ↗
The Rare Pediatric Disease Designation, as well as the Orphan Drug Designation previously granted to CAP-1002 by the FDA, covers the broad treatment of DMD. |
| 2017-05-12 | Capricor Inc. | Results Capricor Therapeutics Provides Update on ALLSTAR Trial capricor.com ↗
At six months, a near-statistically-significant (p=0.05) reduction of mean end-diastolic volume, as well as a trend of reduction of mean end-systolic volume, were seen in the CAP-1002 treatment group. |
| 2017-04-25 | Capricor Inc. | Results Capricor Therapeutics Announces Positive Six-Month Results from the Randomized Phase I/II HOPE Clinical Trial in Duchenne Muscular Dystrophy capricor.com ↗ |
| 2016-10-31 | Capricor Inc. | Results Capricor Therapeutics Presents Positive 12-Month Results from DYNAMIC at TCT 2016 capricor.com ↗
Capricor Therapeutics, Inc. (NASDAQ: CAPR), a clinical-stage biotechnology company developing first-in-class biological therapies for cardiac and other serious medical conditions, today announced detailed results from its DYNAMIC clinical trial of CAP-1002 in patients with advanced heart failure. |
| 2016-06-16 | Capricor Inc. | Results Capricor Therapeutics Reports Positive 12-Month Data from the DYNAMIC Clinical Trial capricor.com ↗ |
| 2016-04-04 | Capricor Inc. | Results Capricor Therapeutics Announces DSMB Recommends Continuation of HOPE-Duchenne Clinical Trial capricor.com ↗
Based on the DSMB's recommendation, enrollment in the trial will continue as planned. |
| 2015-11-09 | Capricor Inc. | Results Capricor Therapeutics Presents Positive Data from the DYNAMIC Clinical Trial at 2015 American Heart Association Scientific Sessions capricor.com ↗
Multi-vessel intracoronary infusion of CAP-1002 in subjects with dilated cardiomyopathy was shown to be safe in this study with no major adverse cardiac events reported at one month or at six months post-infusion. |
| 2015-06-08 | Capricor Inc. | Regulatory Capricor Announces Receipt of FDA Clearance for the Phase I/II Study of CAP-1002 for the Treatment of Duchenne Muscular Dystrophy Related Cardiomyopathy capricor.com ↗
Capricor Therapeutics, Inc. (Nasdaq:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug Application (IND) for the clinical development of CAP-1002 for the treatment of patients with Duchenne Muscular Dystrophy (DMD) related cardiomyopathy. |
| 2015-04-22 | Capricor Inc. | Regulatory Capricor Granted FDA Orphan Drug Designation for Allogeneic Cardiosphere-Derived Cells for the Treatment of Duchenne Muscular Dystrophy capricor.com ↗
Capricor Therapeutics, Inc. (Nasdaq:CAPR), a biotechnology company focused on developing novel therapeutics for the treatment of cardiovascular diseases, today announced that it has been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for its cell therapeutic product candidate, CAP-1002, for the treatment of cardiomyopathy associated with Duchenne muscular dystrophy (DMD). |
| 2014-11-18 | Capricor Inc. | Results Capricor Therapeutics Announces Positive Pre-Clinical Data for Cardiosphere-Derived Cells (CDCs) on Duchenne Muscular Dystrophy Cardiomyopathy capricor.com ↗
LV ejection fraction markedly improved 3 weeks after treatment in CDC-treated mice compared to vehicle-treated mice (60.4±1.6 vs 48.1±2.2; p<0.005). |
| 2014-11-18 | Capricor Inc. | Results Capricor Therapeutics Announces Favorable ALLSTAR Phase I Safety Results capricor.com ↗
The results showed that none of the pre-specified safety endpoints occurred. |
| 2014-09-18 | Capricor Inc. | Results Capricor Presents Safety and Preliminary Efficacy Results From ALLSTAR Phase I Clinical Trial at TCT 2014 capricor.com ↗
The presentation highlighted that intracoronary infusion of allogeneic cardiosphere-derived cells (CAP-1002) appears to be safe and on track for demonstrating efficacy. |
| 2014-08-13 | Capricor Inc. | Results Capricor Therapeutics Reports Second Quarter 2014 Financial & Business Highlights capricor.com ↗
In those patients, ejection fraction improved from an average of 38.9% at baseline to 44.1% at six-month follow-up. |
| 2014-07-16 | Capricor Inc. | Results Capricor Announces Encouraging Results From Phase I ALLSTAR Trial; Phase II Trial Underway capricor.com ↗
MRI data collected on the patients in the open-label dose-escalation study of the allogeneic CDC product (CAP-1002) revealed that those patients who would be included in the Phase II clinical study, by virtue of dose and tissue type compatibility, exhibited measurable improvements in ejection fraction, a global measure of the heart's pumping ability. |
| 2014-03-28 | Capricor Inc. | Results Capricor Therapeutics to Present ALLSTAR Phase I Trial Data at ACC Annual Meeting 2014 capricor.com ↗
Results showed no acute myocarditis attributable to CAP-1002, no death due to ventricular tachycardia (VT) or ventricular fibrillation (VF), no sudden death and no major adverse cardiac events. |
All press releases naming this drug 111 releases
| Date | Issuer | Release |
|---|---|---|
| Show all 111 releases opens the full record — a long page | ||
Evidence & citations 7 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Deramiocel | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05126758 ↗ |
| Known as | Allogeneic Cardiosphere-Derived Cells | “CAP-1002 Allogeneic Cardiosphere-Derived Cells” NCT01458405 ↗ |
| Known as | CAP-1002 | “The primary and secondary objectives of this study are too determine the safety profile of CAP-1002 administered by intracoronary infusion in patients with Heart Failure and a...” NCT02941705 ↗8“This Phase 2, multi-center, open-label extension trial will provide deramiocel (CAP-1002) to subjects that were enrolled in the HOPE-2 trial and completed 12 months of follow-up.” NCT04428476 ↗ “a cell therapy called deramiocel (CAP-1002)” NCT05126758 ↗ |
| Known as | CAP-1002A | “Subjects randomized to the active treatment group in Cohort A will receive CAP-1002A (deramiocel manufactured at Capricor's manufacturing facility in Los Angeles, CA).” NCT05126758 ↗ |
| Known as | CAP-1002B | “Subjects randomized to the active treatment group in Cohort B will receive CAP-1002B (deramiocel manufactured at Capricor's manufacturing facility in San Diego, CA).” NCT05126758 ↗ |
| Modality | Cell therapy | “CAP-1002 is an investigational product consisting of allogeneic cardiosphere-derived cells (CDCs).” NCT02485938 ↗ |
| Route | Other | “Single dose, blinded, intracoronary infusion of 25 Million cardiosphere-derived cells” NCT01458405 ↗ |