LB Pharmaceuticals (LBRX) R&D Day 2026 summary

Pipeline overview and program updates

• LB-102 is a once-daily methylated structural modification of amisulpride with D2, D3 and 5-HT7 activity; 50 mg produced dopamine receptor occupancy similar to 400 mg amisulpride.

• Development includes schizophrenia, bipolar I depression and adjunctive MDD; planned doses are 25/50 mg for bipolar depression and 15/25 mg for adjunctive MDD.

• NOVA-3 is a 52-week open-label safety study enrolling NOVA-2 rollover and de novo patients; adjunctive MDD Phase 2 is planned, with topline data expected in 1H 2029.

• Further opportunities include predominant negative symptoms, Alzheimer’s disease psychosis/agitation and other mood disorders; an elderly healthy-volunteer safety/PK study is planned for Alzheimer’s development.

• Long-acting injectable development is planned for 2026, with potential expansion in schizophrenia and bipolar disorder.

Clinical trial data and development milestones

• NOVA-1 randomized 359 patients at 25 U.S. sites; 50, 75 and 100 mg were statistically superior to placebo at Day 28, with separation by week one and placebo-adjusted PANSS changes of 5.0, 4.7 and 6.8 points.

• NOVA-1 PANSS effect sizes were 0.50 and 0.64 by MMRM at 50 and 100 mg; cognitive effect sizes rose dose-dependently from 0.26 to 0.66, and the 50 mg dose significantly improved the PANSS negative subscale.

• Most NOVA-1 adverse events were mild or moderate and similar to placebo; EPS rates were 1.0%, 5.6% and 5.6% at 50, 75 and 100 mg versus 3.7% for placebo; QTc prolongation was 4.3–5.4 ms, with no patients meeting stopping criteria.

• NOVA-2 is a six-week Phase 3 trial of 50 mg, 100 mg and placebo targeting ~460 patients; primary endpoint is PANSS change at Day 42, with topline data expected in 1H 2027.

• Planned six-week outpatient Phase 2 trials in bipolar depression and adjunctive MDD have topline readouts expected in 1Q 2028 and 1H 2029, respectively.

R&D strategy and innovation priorities

• Preclinical mouse c-Fos results showed associative-to-motor striatal activity ratios of 8.37 for LB-102, 3 for amisulpride and 0.5 for haloperidol; researchers linked selectivity to a possible lower EPS burden.

• Low-dose microdialysis showed increased dopamine release, providing indirect evidence of presynaptic D2/D3 activity and a proposed basis for effects on negative, mood and cognitive symptoms.

• The D2/D3/5-HT7 profile supports a dose-based rationale: lower doses may increase dopamine signaling relevant to depression, while higher doses block signaling in psychosis; the contribution of 5-HT7 activity by dose remains uncertain.

• Cognition and negative symptoms are priority outcomes; NOVA-2 includes cognition, planned mood-disorder trials assess cognition and anhedonia, and a stabilized-patient study is planned to assess negative symptoms and cognition.

• Wholly owned issued composition-of-matter IP is estimated to provide protection through ~2041, including potential patent-term extension.