Apr. 1 at 12:57 PM
BofA⬆️
$SRRK's PT to
$58 from
$51 and reiterated at a Buy rating.
$RHHBY LLY NVO PTCT IONS -
$BIIB
BofA said in its note—SRRK announced resubmission of its BLA for apitegromab (api) in spinal muscular atrophy following a positive Type C meeting on Mar 3.
With FDA alignment, two fill-finish partners are included in the filing with the company expecting a late-Sept PDUFA goal date for the Class II re-filing.
We view applying with two mfg options for US approval to be highly encouraging as it de-risks the sole approvability issue cited in the 2025 CRL for api.
Based on this update, we update our US launch timeline to 4Q26 from mid-27 and reiterate our Buy rating with higher
$58 PO (see model changes inside).
