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-0.000162705415587133 0.00376725616090325 0.0388114995181417 0.0450694001176487 0.0386613099037534 0.0600883615564651 0.0751073229952815 0.0625915217962678
Stock impact report

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 Check Earnings Report
US:NASDAQ Investor Relations: capricor.com/investors
Company Research 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 Show less Read more
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