Dec. 10 at 1:15 PM
Piper Sandler⬆️
$CAPR's PT to
$45 from
$20 and reiterated at an Overweight rating.
$EWTX $PTCT $SRPT $DYN
Piper Sandler in its note to investors:
Last Wednesday, the Phase III HOPE-3 (N=106) trial met the primary endpoint showing a significant 1.2
point absolute difference from placebo in the Performance of the Upper Limb 2.0 (PUL 2.0, p=0.029). Deramiocel also met the key cardiac endpoint showing an absolute 2.4% improvement in LVEF, representing a 91% slowing of decline vs. placebo. (p=0.041) Capricor will submit HOPE-3 data as a response to the FDA's CRL under the current BLA for deramiocel in DMD cardiomyopathy by YE:25.
We anticipate a Type II 6- month review resulting in potential deramiocel approval by mid'26. Capricor is eligible for an
$80 million approval milestone from partner Nippon Shinyaku and could receive a valuable Priority Review Voucher (PRV).
We reiterate our Overweight rating and are increasing our 12-month price target to
$45 from
$20 based on positive HOPE-3 data.
