BUZZ-Street View: Capricor in 'precarious position' as approval in doubt
CAPR•Analysts see an unlikely path forward
** Cantor Fitzgerald (Neutral, PT: $3.50) says the FDA's tone was "extremely negative during the entire conversation" and sees an "unlikely path forward" for deramiocel
** Roth Capital Partners (neutral) says the vote was "squarely aligned with FDA's overly pessimistic tone" and believes deramiocel is likely to receive a second CRL in August
** Piper Sandler (neutral, PT: $2) says panel members were swayed by concerns over the "fragility" of the data and disputes around the statistical analysis plan
** H.C. Wainwright (neutral) says Capricor is in "quite a precarious position" and "cannot foresee the company conducting another DMD (Duchenne muscular dystrophy) study" given the time and funding required
FDA panel vote raises doubts over Capricor therapy
** The U.S. FDA's advisory committee on Wednesday voted nine-to-three against Capricor Therapeutics' CAPR.O therapy deramiocel, raising doubts over its effectiveness in treating cardiomyopathy in Duchenne muscular dystrophy
** The FDA is expected to decide on the therapy by Aug. 22, though it is not bound by the panel's recommendation
** Capricor shares fell 57% to $2.82 before the bell
