Helus Pharma Inc. (HELP) Form 6-K — Oct 21, 2026
Helus Pharma (Nasdaq: HELP) confirmed that topline data from its APPROACH Phase 3 study of HLP003 in adjunctive treatment of major depressive disorder remains on track for Q4 2026. The study completed enrollment of 223 participants in July 2026, and HLP003 holds FDA Breakthrough Therapy Designation. The company also detailed plans for a Phase 2 monotherapy study of HLP004 in generalized anxiety disorder, expected to initiate in Q1 2027. Notably, HLP004 has shifted from an adjunctive to a monotherapy development strategy, with approximately 144 participants to be randomized to 30 mg HLP004 or placebo.
Key figures
- Hlp004 dose
- 30 mg (two administrations)
- Ham a threshold
- ≥ 20
- Nad filing target
- 2028
- Approach enrollment
- 223
- Hlp004 phase2 planned enrollment
- 144
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