Helus Pharma Inc. HELP
Helus Pharma Inc. (Nasdaq: HELP) is a CNS/neurology/psychiatry drug developer. Its lead program, HLP003 (deuterated psilocin, oral), is in Phase 3 for Adjunctive treatment of major depressive disorder (MDD). Its next catalyst on record is HLP003: Topline data readout from APPROACH Phase 3 study of HLP003 for adjunctive treatment of major depressive disorder on track for Q4 2026. (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: HLP003 — Topline data readout from APPROACH Phase 3 study of HLP003 for adjunctive treatment of major depressive disorder on track for Q4 2026. (Q4 2026). 7 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| HLP003 | Adjunctive MDD | small molecule | Phase 3 |
| HLP004 (deuterated DMT, IM) | Generalized anxiety disorder | small molecule | Phase 2 |
| HLP005 (phenethylamine and tryptamine derivatives) | Psychiatric and neurological conditions | small molecule | Pre-clinical |
Recent results and decisions
- Aug 3, 2026completed enrollment Enrollment in the APPROACH Phase 3 trial is complete.
Enrollment is complete in APPROACH, with topline data expected in Q4 2026, while enrollment continues in EMBRACE, the second pivotal study in the Phase 3 PARADIGM program.
Filing - Jul 1, 2026completed enrollment Helus Pharma completed enrollment of 223 participants in APPROACH Phase 3 study in July 2026.
The Company previously announced completion of enrollment of 223 participants in its APPROACH Phase 3 pivotal study in July 2026.
Filing - Mar 5, 2026positive Phase 2 signal-detection study (n=36): 20mg HLP004 gave mean 10.4-point HAM-A reduction at week 6 (p<0.0001); 67% responders and 39% remitters at 6 months pooled.
Patients that received 20mg HLP004 adjunctive to SoC therapy achieved mean reduction of 10.4-points (p<0.0001) in the HAM-A from baseline at six weeks.
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.