Capricor surges on plans to seek FDA approval for lead asset [Seeking Alpha]
Capricor Therapeutics, Inc. (CAPR)
Last capricor therapeutics, inc. earnings: 3/18 04:01 pm
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US:NASDAQ Investor Relations:
capricor.com/investors
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Source: Seeking Alpha
The San Diego, California-based biotech said it would begin the filing of a biologics license application (BLA) in October targeting FDA approval for deramiocel in cardiomyopathy associated with the neuromuscular disorder Duchenne muscular dystrophy (DMD). The company added that findings from its Phase 2 HOPE-2 and HOPE-2 Open Label Extension (OLE) trials compared to historical data are expected to support the submission. Additionally, Capricor ( CAPR ) announced changes to its Phase 3 HOPE-3 clinical trial, noting plans to expand the drug's label for DMD skeletal muscle myopathy after a potential approval. As a result, the company said it would no longer unblind Cohort A of the study and instead combine Cohorts A and B to advance HOPE-3 as a post-approval study. Recommended For You More Trending News Recommended For You More Trending News About CAPR Stock Related Stocks Trending Analysis Trending News
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CAPR
News
- Deramiocel's Promise Brightens Capricor's Outlook, With Strings Attached [Seeking Alpha]Seeking Alpha
- Capricor Therapeutics to Present at Upcoming Investor Conferences [Yahoo! Finance]Yahoo! Finance
- Capricor Therapeutics to Present at Upcoming Investor ConferencesGlobeNewswire
- 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
CAPR
Earnings
- 11/13/24 - Miss
CAPR
Sec Filings
- 12/16/24 - Form 4
- 12/4/24 - Form 4
- 11/14/24 - Form 10-Q
- CAPR's page on the SEC website