Jun. 30 at 12:44 PM
BTIG (pre-RPD news)⬆️
$MNPR's PT to
$117 (was
$104), reiterated Buy and said, We believe MNPR's regulatory outlook has improved materially ahead of a planned mid-year NDA submission for ALXN1840 for the treatment of Wilson's Disease (WD).
$QURE $RGNX
AZN RARE
BTIG added—The recent regulatory reversals for rare disease therapies including those by uniQure (QURE, Not Rated) and RegenxBio (RGNX, Not Rated) signal a turning of the page under the current FDA led by Acting Commissioner Kyle Diamantas.
More importantly, the agency issued draft guidance reaffirming that a single, high-quality ph 3 trial supported by confirmatory evidence may be sufficient for drug approval, boding well for MNPR. We increase our PoS for ALXN1840 in our model on this basis, driving our new
$117 PT.
