---
title: "Helus Pharma Fast-Tracks Phase 3 Enrollment for MDD Drug HLP003"
type: "News"
locale: "en"
url: "https://longbridge.com/en/news/293390329.md"
description: "Helus Pharma (HELP) announced the early completion of enrollment in its Phase 3 APPROACH trial for HLP003, a treatment for major depressive disorder. Enrollment continues in the EMBRACE study, with participants moving to the EXTEND extension trial. The company aims for top-line data in Q4 2026 and a potential NDA submission in 2028. HLP003 holds FDA Breakthrough Therapy status. Analysts maintain a 'Buy' rating with a $70 price target."
datetime: "2026-07-21T21:51:15.000Z"
locales:
  - [zh-CN](https://longbridge.com/zh-CN/news/293390329.md)
  - [en](https://longbridge.com/en/news/293390329.md)
  - [zh-HK](https://longbridge.com/zh-HK/news/293390329.md)
generator: "portal-rs"
---

# Helus Pharma Fast-Tracks Phase 3 Enrollment for MDD Drug HLP003

An update from Helus Pharma ( (HELP) ) is now available.

Helus Pharma said on July 21, 2026 that it has completed enrollment ahead of schedule in APPROACH, its Phase 3 pivotal trial of HLP003 as an adjunctive treatment for adults with moderate to severe Major Depressive Disorder who have inadequate response to existing antidepressants. Enrollment continues in EMBRACE, the second pivotal study in the PARADIGM program, while participants from both trials are rolling into the EXTEND long-term extension to generate durability and safety data.

The company highlighted strong Phase 2 results for HLP003 and its FDA Breakthrough Therapy status, framing the early completion of APPROACH enrollment as a key milestone toward a planned topline data readout in the fourth quarter of 2026 and a potential U.S. new drug application in 2028. The announcement comes amid rapid growth in clinic-administered depression treatments such as Johnson & Johnson’s SPRAVATO, underscoring rising demand for novel interventional psychiatric therapies and reinforcing Helus Pharma’s bid to secure a competitive position in next-generation adjunctive treatments for difficult-to-treat depression.

The most recent analyst rating on (HELP) stock is a Buy  
 with a $70.00 price target.  
 To see the full list of analyst forecasts on Helus Pharma stock,  
 see the HELP Stock Forecast page. 

**More about Helus Pharma**

Helus Pharma, the commercial operating name of Cybin Inc., is a clinical-stage pharmaceutical company focused on developing proprietary novel serotonergic agonists (NSAs), synthetic molecules designed to activate serotonin pathways linked to neuroplasticity. The company is targeting large unmet needs in depression, anxiety and other mental health conditions, with operations in Canada, the U.S., the U.K. and Ireland and a broad intellectual property portfolio supporting its NSA pipeline.

Helus Pharma’s lead candidate HLP003 is in Phase 3 development for adjunctive treatment of Major Depressive Disorder and has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration. The company is also advancing HLP004 in Phase 2 for generalized anxiety disorder and maintains an extensive research portfolio of additional investigational NSAs, positioning it within the emerging field of interventional psychiatry and innovative clinic-administered mental health therapies.

**Average Trading Volume:** 1,184,672

**Technical Sentiment Signal:** Buy

**Current Market Cap:** $1.36M

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> **Disclaimer: This article is for reference only and does not constitute any investment advice.**