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Stock impact report

Capricor Announces Positive Outcomes from Comprehensive Multidisciplinary Meeting with FDA

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: GlobeNewswire
LOS ANGELES, Jan. 22, 2019 (GLOBE NEWSWIRE) -- Capricor Therapeutics (NASDAQ: CAPR), a clinical-stage biotechnology company, today announced that it had positive outcomes in its comprehensive multidisciplinary meeting with the U.S. Food and Drug Administration (FDA) regarding development of the company’s novel cell therapy candidate, CAP-1002, to treat Duchenne muscular dystrophy. Capricor met with the FDA in December 2018, as part of the expedited review afforded under the Regenerative Medicine Advanced Therapy (RMAT) designation which the FDA granted to CAP-1002 in February 2018. The FDA grants the RMAT designation to investigational regenerative medicine therapies intended to treat a serious condition and for which preliminary clinical evidence indicates a potential to address unmet medical needs for that condition.   During the meeting discussion and in subsequent meeting minutes, Capricor asked whether the FDA would agree to its current clinical trial, HOPE-2, serving as Show less Read more
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