$CAPR,,,HERE IS A BIG NEGATIVE FOR THE COMPANY: (g
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Posted On: 05/13/2017 11:16:33 AM
$CAPR,,,HERE IS A BIG NEGATIVE FOR THE COMPANY: (giving all 3 sides to this company the good; the bad; and the ugly) --- I will be keeping my peeps on this!
Thinly traded nano cap Capricor Therapeutics (NASDAQ:CAPR) plummets 33% premarket on light volume in response to its announcement that its Phase 2 clinical trial, ALLSTAR, assessing lead product candidate CAP-1002 for the treatment of adults who have experienced a large heart attack with residual cardiac dysfunction is unlikely to achieve its primary endpoint.
• At six months, the treatment group showed a near-statistically significant reduction of average end-diastolic volume and a trend of reduction of average end-systolic volume, but there was no difference compared to placebo in ejection fraction.
• CEO Linda Marbán says, "The lack of a clear difference in the change in scar size from baseline to six months between the active and control groups in the interim observations from ALLSTAR was unexpected. These results diverge from the consistent and extensive record of activity observed with our cell technology in the setting of cardiac fibrosis as demonstrated by both preclinical and clinical studies, and we hope to gain an understanding of the factors that led to these observations through the conduct of further analyses."
• The company plans to focus its CAP-1002 development efforts on Duchenne muscular dystrophy (DMD). The strategic realignment will require it to reduce the scope of its operations, including the downsizing of its workforce.
• CAP-1002 is an investigational allogeneic, off-the-shelf cardiac cell therapy derived from donor heart tissue and infused directly into the patients coronary artery via a catheter. It is currently being evaluated for the treatment of heart disease associated with Duchenne muscular dystrophy and myocardial infarction (heart attack).
• Management will host a conference call this morning at 8:00 am ET to discuss the situation.
• Previously: Capricor's lead product candidate shows mixed results in early-stage heart failure study; shares off 2% (Oct. 31, 2016)
Thinly traded nano cap Capricor Therapeutics (NASDAQ:CAPR) plummets 33% premarket on light volume in response to its announcement that its Phase 2 clinical trial, ALLSTAR, assessing lead product candidate CAP-1002 for the treatment of adults who have experienced a large heart attack with residual cardiac dysfunction is unlikely to achieve its primary endpoint.
• At six months, the treatment group showed a near-statistically significant reduction of average end-diastolic volume and a trend of reduction of average end-systolic volume, but there was no difference compared to placebo in ejection fraction.
• CEO Linda Marbán says, "The lack of a clear difference in the change in scar size from baseline to six months between the active and control groups in the interim observations from ALLSTAR was unexpected. These results diverge from the consistent and extensive record of activity observed with our cell technology in the setting of cardiac fibrosis as demonstrated by both preclinical and clinical studies, and we hope to gain an understanding of the factors that led to these observations through the conduct of further analyses."
• The company plans to focus its CAP-1002 development efforts on Duchenne muscular dystrophy (DMD). The strategic realignment will require it to reduce the scope of its operations, including the downsizing of its workforce.
• CAP-1002 is an investigational allogeneic, off-the-shelf cardiac cell therapy derived from donor heart tissue and infused directly into the patients coronary artery via a catheter. It is currently being evaluated for the treatment of heart disease associated with Duchenne muscular dystrophy and myocardial infarction (heart attack).
• Management will host a conference call this morning at 8:00 am ET to discuss the situation.
• Previously: Capricor's lead product candidate shows mixed results in early-stage heart failure study; shares off 2% (Oct. 31, 2016)
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'Everything works out in the end,,,If it hasn't worked out,,it's not the end'
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