Jun. 26 at 1:10 PM
Mizuho reiterated
$ACAD Outperform;
$35
$TSHA $NGNE AVXL PTCT
Mizuho said: This morning, Acadia announced that the CHMP reversed its negative opinion following a re-examination, and adopted a positive opinion recommending the granting of a marketing authorization for DAYBU (trofinetide) for Rett syndrome.
With this positive opinion, it is highly likely the European Commission will issue a marketing authorization within the statutory ~67 days (~2 months), enabling commercialization in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.
Acadia's 2028 sales guidance of
$700M for trofinetide includes a modest amount (<15%) for EU sales, implying potential upside to current 2028 consensus sales estimate of
$595M. We expect ACAD to be up on this news.
