Mar. 13 at 12:48 PM
Cantor reiterated
$CAPR Overweight;
$62 after CAPR reported 4Q25 earnings.
$EWTX $DYN SLDB PTCT SRPT
Cantor said— Of course, the focus of the call was on CAPR's recent announcements of the 8/22/26 PDUFA for deramiocel (cardiosphere-derived cell therapy in DMD) + new HOPE-3 data that were presented at MDA.
Capricor remains focused on the label potentially including cardiomyopathy (as well as ambulatory DMD), noting the distinction can go a long way with physicians. This will be discussed with the FDA once labeling discussions start.
The FDA hasn't discussed differences between Cohort A (Los Angeles) and Cohort B (San Diego) for a while, but highlighted that Cohort B, which will be the commercial site, was statistically significant alone in itself. The San Diego facility could support ~250 patients per year (and potential stockpiling), and the company is expanding, which may ultimately lead to supporting ~2,500 patients per year.