Jul. 24 at 11:53 AM
H.C. Wainwright y'day reiterated
$LBRX Buy-
$45 and said -- LB-102 pivotal confirmatory schizophrenia trial timeline accelerated, with faster release of top-line data anticipated.
$MPLT $BMY ABBV NMRA VNDA
H.C. Wainwright added—LB Pharmaceuticals announced that based on enrollment projections, it now expects to report top-line results from the pivotal Phase 3 NOVA-2 clinical trial of LB-102 in patients with schizophrenia in 1H27 and to schedule a pre-NDA meeting with the FDA thereafter, during 2H27, to discuss the requirements for completion of the LB-102 New Drug Application (NDA) submission for approval of this candidate in treatment of schizophrenia.
In our view, the shorter timeline to top-line data may facilitate regulatory submission in 1H28 and potential approval and market entry earlier in 2029 than we currently project.
We await the top-line data and feedback from the pre-NDA meeting ahead of advancing the timing of sales initiation in our model.
