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Helus Pharma Shares Climb After Completing Enrollment for Phase 3 Depression Drug Trial
Summary
The biopharmaceutical company's stock rose significantly after it announced the full enrollment of its pivotal APPROACH study for HLP003 in Major Depressive Disorder, with topline data expected in Q4 2026.
Shares of Helus Pharma (NASDAQ:HELP) surged on Tuesday after the company announced it has completed patient enrollment for a pivotal Phase 3 study of its drug candidate HLP003 for Major Depressive Disorder (MDD). The stock climbed by as much as 12.4% on the news, which marks a significant clinical milestone for the company.
Trial Details and Timeline
Helus Pharma confirmed that enrollment for the APPROACH study was completed ahead of schedule, with 223 adults participating. The trial is evaluating HLP003 as a treatment for patients with moderate to severe MDD who have not responded adequately to a stable antidepressant regimen.
Key details of the study include:
- Design: Participants were randomized to receive either a 16 mg dose of HLP003 or a placebo, with two doses administered three weeks apart.
- Primary Endpoint: The main goal is to measure the change from baseline in the Montgomery-Asberg Depression Rating Scale (MADRS) at six weeks after the first dose.
- Next Catalyst: The company expects to release topline data from the APPROACH study in the fourth quarter of 2026.
HLP003 and Market Context
AdHLP003 is a deuterated psilocin analogue that has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA), a status intended to expedite the development of drugs for serious conditions. The candidate showed promising results in a Phase 2 trial, where it demonstrated a significant reduction in MADRS scores 12 months after dosing.
The market for novel depression treatments is substantial. As a point of reference, Helus noted that Johnson & Johnson reported worldwide sales for its depression treatment, SPRAVATO, of $584 million in the second quarter of 2026, representing a year-over-year increase of 40.8%.
Broader Clinical Program
The APPROACH study is the first of two pivotal trials in Helus Pharma’s PARADIGM Program. Enrollment is ongoing for the second study, named EMBRACE. The company is also conducting a long-term extension study, EXTEND, to evaluate the safety and durability of HLP003 for eligible participants from both pivotal trials.
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