Jan. 29 at 12:24 PM
Oppenheimer reiterated
$CAPR Outperform-
$54 and said, Following our in-person meeting w/ mgmt earlier this week, we maintain/increase our already-strong conviction that deramiocel will receive full FDA approval.
$EWTX $PTCT SRPT
$DYN $SLDB
Oppenheimer added, With HOPE-3's clinical study report (CSR) on track to be submitted to the agency next month, we believe base expectations are for a six-month review, implying potential approval this August.
Alongside regulatory progress, we expect the presentation of additional HOPE-3 results/analyses through 1H26 to bolster the approval scenario and further distinguish deramiocel's efficacy among DMD treatment options/strategies.
We would take advantage of yesterday's weakness (-8% vs. -2% XBI), which we ascribe to a general "risk shiver" around advanced therapies as may have been triggered by negative news elsewhere in the industry. Reiterate Outperform.
