Jan. 29 at 12:16 PM
BMO Capital reiterated
$IRON Outperform-
$120 and said, Following recent share volatility for IRON, we still maintain that bitopertin is likely to be approved for EPP/XLP in the coming weeks.
$CLVLY Mitsubishi Tanabe Pharma
BMO added, While recently published articles have drawn concerns around efficacy and safety of bitopertin, we note:
1) prior affirmative alignment with FDA on NDA submission needs;
2) robust Roche-derived safety data; and
3) most importantly, PPIX reduction correlations with improvement in sunlight tolerance all give us more confidence in bitopertin's near-term approval.
Our base case assumes approval with a broad label, and IRON shares trade up to the mid/high
$90S (PoS=60%).