Helus Pharma wraps up enrollment early in pivotal Phase 3 APPROACH study; topline data still on deck for Q4 2026

summarizeSummary

Helus Pharma has completed enrollment ahead of schedule in its Phase 3 APPROACH study of HLP003 for major depressive disorder, keeping topline data on track for Q4 2026. The achievement moves the lead program closer to a potential 2028 NDA filing.

check_boxKey Events · Product Development and Regulatory · HELP

• APPROACH Enrollment Completed Early

  Enrollment in the 223-participant Phase 3 pivotal study of HLP003 for adjunctive MDD finished ahead of schedule, underscoring strong operational execution.

• Topline Data on Track for Q4 2026

  The readout, covering primary and key secondary endpoints, remains on course for the fourth quarter of 2026, marking a near-term catalyst for the program.

• Phase 2 Efficacy Supports Potential

  Prior Phase 2 data showed a mean ~23-point MADRS reduction at 12 months, with 100% response and 71% remission rates, providing the foundation for Breakthrough Therapy Designation.

• PARADIGM Program Advancing Broadly

  Enrollment continues in the second pivotal study, EMBRACE, while participant rollover into the EXTEND long-term safety study is ongoing, together building a comprehensive data package.

auto_awesomeAnalysis · HELP · Life Sciences

Finishing enrollment ahead of plan in the pivotal APPROACH trial takes risk off the table for the HLP003 program and preserves the Q4 2026 data readout timeline. Earlier Phase 2 results delivered durable efficacy and high remission rates, and with Breakthrough Therapy Designation already in hand, a positive Phase 3 could pave the way for an NDA filing in 2028. The milestone lands amid heavy cash consumption and a recent $50 million raise, so clinical execution remains the linchpin of the investment case.