Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule

Helus Pharma announced completion of enrollment in its Phase 3 APPROACH pivotal study of HLP003, an investigational treatment for major depressive disorder, ahead of schedule. The study enrolled 223 participants with moderate to severe MDD who showed inadequate response to standard antidepressants. Topline data is expected in Q4 2026, with potential FDA New Drug Application submission targeted for 2028. The company also noted strong market demand for novel depression treatments, citing Johnson & Johnson's SPRAVATO sales growth.