Capricor touts long-term efficacy of DMD therapy ahead of FDA application [Yahoo! Finance]
Capricor Therapeutics, Inc. (CAPR)
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm
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Source: Yahoo! Finance
data from the Phase II HOPE-2 open-label extension (OLE) trial for its Duchenne muscular dystrophy (DMD) cell therapy, deramiocel. Last week, the company started rolling submissions for a biologics license application (BLA) for deramiocel as a treatment for DMD cardiomyopathy with the US Food and Drug Administration (FDA), with plans to complete the submission by the end of the year. “These results are extremely impactful for patients living with DMD as they showed sustained cardiac and skeletal muscle benefits after three years of continuous treatment with deramiocel, which underscores the potential long-term efficacy this therapy can offer,” said the company's CEO Linda Marbán. “We have been working closely with the FDA to move deramiocel towards potential approval as quickly as possible because once heart function is lost, it is unlikely to be restored. We expect deramiocel to be a lifelong treatment, with an infusion delivered quarterly,” added Marbán. The HOPE-2 OLE study
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News
- Capricor wins key EU designations for the lead asset [Seeking Alpha]Seeking Alpha
- Parent Project Muscular Dystrophy Culminates 30th Anniversary with Celebratory "Investing in Every Future" Event [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics Granted Orphan Drug and ATMP Status for Deramiocel by European Medicines Agency [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics Granted Orphan Drug and ATMP Status for Deramiocel by European Medicines AgencyGlobeNewswire
- Capricor Therapeutics Third Quarter 2024 Earnings: Misses Expectations [Yahoo! Finance]Yahoo! Finance
CAPR
Earnings
- 11/13/24 - Miss
CAPR
Sec Filings
- 11/14/24 - Form 10-Q
- 11/13/24 - Form 8-K
- 11/12/24 - Form SC
- CAPR's page on the SEC website