May. 6 at 12:58 PM
Stifel reit'd
$TRVI Buy;
$18
$GSK $MRK VRNA
Stifel said in its note:
We reiterate our Buy rating on TRVI,
$18 TP.
Following a productive EOP2 meeting with FDA, TRVI will initiate its pivotal program for Haduvio in IPF-CC this quarter, based on a prudent two trial design with primary endpoint readouts at 12 and 24 weeks (first data expected 2027).
We think the two-trial pivotal design was prudent in light of still-untested one-trial approach proposed by FDA.
TRVI's next regulatory meeting will serve to solidify clinical and regulatory plans to expand into non-IPF ILDs, which should more than double Haduvio's reach.
Separately, the RCC Ph.2b trial initiation is also on track for 2Q26, with an SSRE expected in 4Q26.
With cash of
$171.8MN (+ additional proceeds from April raise), TRVI has capital into 2030 to take Ph.3 IPF through approval, reach initial Ph.2b readout of its parallel ILD program (potentially Ph.3), and reach top-line Ph.2b data in RCC—each providing meaningful value inflections.
