Aug. 19 at 6:49 PM
Canaccord Genuity⬆️
$PVLA's PT to
$66 from
$52 & reit'd at a Buy.
$NVS $TARA $MRK $PFE
Canaccord Genuity said in its research report:
$PVLA's 2Q25 earnings report was incremental following enrollment completion of its phase 3 SELVA trial for mLM, which exceeded its target (n=40) by over 25% (n=51). Top-line results are on track for 1Q26.
Ahead of this readout, the most FAQ investor Q has been around Ph3 design + regulatory risk.
We continue to be very comfortable with the former - as a reminder, the trial had 99% power to detect a .5 (vs. 2.42 effect size in Ph2) difference on the primary endpoint before the over enrollment.
On the latter, we remain comfortable with the single-arm trial design and see no outsized clinical risk here (vs. the broader biotech space).
Results of the phase 2 TOIVA trial for the co's 2nd indication, CVM, remain on track for 4Q25.
The company plans to announce both a third clinical indication for QTORIN rapamycin and a second QTORIN platform candidate in 4Q25.
