Capricor shares jump in a month as positive phase III data and renewed FDA engagement revive hopes for deramiocel approval in DMD.
Capricor Therapeutics, Inc. surged 75% after announcing ongoing FDA negotiations for deramiocel, in Duchenne Muscular Dystrophy with cardiomyopathy. CAPR plans to amend its BLA with 24-month HOPE-3 extension data, following positive Lancet publication and FDA willingness to review the new submission. Despite prior AdCom rejection and protocol reporting issues, HOPE-3's primary endpoint may be statistically and clinically significant, supporting potential regulatory reconsideration.
Capricor Therapeutics NASDAQ: CAPR said its biologics license application for deramiocel remains under U.S. Food and Drug Administration review, while the company prepares to submit an amendment seeking a refined indication centered on upper limb skeletal muscle function in Duchenne muscular dystrophy, or DMD.
| Name | Quantity | Cost | Value | Profit ($) | Gain (%) |
|---|---|---|---|---|---|
Curtis Ellergodt Rothschild Investment LLC | 28 | $822.93 | $232.68 | -$590.25 | -71.73% |
| BZ Brandon Zatopek Commonwealth Equity Services LLC | 26,775 | $644,740 | $220,626 | -$424,114 | -65.78% |
| NA Nizar Araji National Bank Of Canada /FI/ | 11 | $261.8 | $44.99 | -$216.81 | -82.82% |
| BG Bart Gancher Intech Investment Management LLC | 17,114 | $506,907.2 | $69,996.26 | -$436,910.94 | -86.19% |
Point72 Asset Management LP Point72 Asset Management LP | 94,723 | $2.73M | $629,907.95 | -$2.1M | -76.96% |
| Name | Quantity | Cost | Value | Profit ($) | Gain (%) |
|---|---|---|---|---|---|
Kristen Kluska Cantor Fitzgerald | 7,589.56 | $50,470.59 | $62,993.37 | $12,522.78 | 24.81% |
Edward Tenthoff Piper Sandler | 1,043.55 | $10,341.61 | $8,661.49 | -$1,680.12 | -16.25% |
| Biotechnology Industry | Healthcare Sector | Linda Marbán CEO | NASDAQ (CM) Exchange | 14070B309 CUSIP |
| US Country | 231 Employees | 5 Jun 2019 Last Dividend | 5 Jun 2019 Last Split | 13 Feb 2007 IPO Date |
Capricor Therapeutics, Inc. is a clinical-stage biotechnology firm established in 2005, with its headquarters located in San Diego, California. The company is dedicated to the development of revolutionary cell and exosome-based therapeutics aimed at treating a variety of diseases that currently have unmet medical needs, with a particular focus on Duchenne Muscular Dystrophy (DMD). Through its advanced research and clinical trials, Capricor Therapeutics strives to bring innovative treatments to patients suffering from DMD and other serious conditions. The company has established several important collaborations and licensing agreements with prestigious institutions and companies, including Nippon Shinyaku Co. Ltd., National Institute of Allergy and Infectious Diseases, Johns Hopkins University, Cedars-Sinai Medical Center, and Life Technologies Corporation, to further its research and development efforts.
This allogeneic cardiac-derived cell therapy is Capricor Therapeutics’ leading candidate, specifically aimed at treating patients with late-stage Duchenne muscular dystrophy (DMD). Having completed phase 3 clinical trials, CAP-1002 represents a significant advancement in the quest for effective DMD therapies, showing promise in addressing the needs of patients suffering from this debilitating disease.
StealthX is an innovative engineered exosome-based vaccine candidate that is currently under phase 1 clinical study. This candidate is designed for a multitude of therapeutic applications, including the delivery of targeted RNA, proteins, and small molecule therapeutics. StealthX is aimed at treating or preventing a variety of diseases, showcasing Capricor’s dedication to leveraging cutting-edge science in its therapeutic development.
Currently in the pre-clinical development stage, CAP-2003 is being explored for its potential in treating trauma-related injuries and conditions. This further exemplifies Capricor Therapeutics’ commitment to expanding its portfolio of treatments and addressing a broader range of medical concerns that lack effective treatments.