Street View: Capricor in 'precarious position' as approval in doubt
BUZZ-Street View: Capricor in 'precarious position' as approval in doubt ** 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
NO PATH FORWARD?
** Cantor Fitzgerald ("Neutral", PT: $3.50) says 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
(Reporting by Kamal Choudhury in Bengaluru)