Helus Pharma said HLP003’s APPROACH Phase 3 topline data remain on track for Q4 2026, while its HLP004 Phase 2 monotherapy study for GAD is expected to start in Q1 2027.

Helus Pharma reported continued development of HLP003 for adjunctive treatment of major depressive disorder and HLP004 for monotherapy treatment of generalised anxiety disorder. Enrollment is continuing in the EMBRACE Phase 3 study, while HLP003 has FDA Breakthrough Therapy Designation and a New Drug Application filing is expected in 2028.