Capricor FDA panel meeting ‘not unexpected,’ says JonesResearch

JonesResearch says the FDA will holding an advisory committee meeting for Capricor Therapeutics (CAPR)’ deramiocel in Duchenne Muscular Dystrophy is “not unexpected” as management previously noted that they were actively preparing for such an event. However, the meeting “clearly indicates there are major outstanding questions around the clinical efficacy package,” the analyst tells investors in a research note. The firm maintains its 65% probability of approval on deramiocel in DMD. Cell and gene therapy “are not in the crosshairs of the new administration (as far as we know), and we expect Makary’s FDA will continue to exercise flexibility when it comes to rare disease,” JonesResearch adds. It reiterates a Buy rating on Capricor with a $40 price target The stock closed Monday down 13% to $10.30.