Key Takeaway: Helus Pharma has successfully completed enrollment in the Phase 3 APPROACH study of HLP003 for treating Major Depressive Disorder ahead of schedule. This study is part of the broader Phase 3 PARADIGM Program, which aims to evaluate the efficacy and safety of HLP003. The topline data readout is expected in Q4 2026.
Price reaction · baseline $7.11 (2026-07-20 close) · hit pre-market · 1 other HELP headline(s) in the window, move may be shared
day 0 close · peak
+13.9%
day 1
+10%
day 3
+7.2%
Market Sentiment Analysis
POSITIVE FACTORS
Enrollment in the Phase 3 APPROACH study was completed ahead of schedule.
HLP003 has been granted Breakthrough Therapy designation.
The study is part of a larger Phase 3 PARADIGM Program.
Full Press Release Details
Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data APPROACH topline data readout on track for Q4 2026 1,2 HLP003 previously granted Breakthrough
Frequently Asked Questions
What is the Phase 3 APPROACH study about?
The Phase 3 APPROACH study evaluates HLP003 as an adjunctive treatment for Major Depressive Disorder.
When is the topline data readout expected?
The topline data readout for the APPROACH study is on track for Q4 2026.
What designation has HLP003 received?
HLP003 has been granted Breakthrough Therapy designation.
What program is the APPROACH study part of?
The APPROACH study is part of the Phase 3 PARADIGM Program.