Helus Pharma Advances Phase 3 Trial for Novel Therapy in MDD

NEW YORK – Helus Pharma, the business name now used by Cybin Inc., announced that enrollment in its APPROACH Phase 3 trial has passed the 86% mark. The trial is testing HLP003, the company’s lead drug candidate, as an add-on treatment for major depressive disorder (MDD) in patients who have not fully responded to standard antidepressants.

With recent business highlights and fiscal year 2026 financial results announced, Helus reported that the study is still on schedule for a topline data readout in Q4 2026. This timeline has been maintained since HLP003, the company’s proprietary novel serotonergic agonist (NSA), received Breakthrough Therapy Designation from the FDA. That designation, reserved for drugs showing early evidence of meaningful improvement over existing treatments for serious conditions, gives the FDA closer contact with a company during development and can shorten review once an application is filed.

APPROACH is one piece of a larger Phase 3 program the company calls PARADIGM, which also includes a second efficacy study, EMBRACE, and a long-term extension study, EXTEND, tracking patient outcomes well beyond initial dosing. Together, the three studies are meant to build the safety and efficacy record the FDA would weigh before any approval decision.

Earlier Phase 2 results showed that patients who received two 16-milligram doses of HLP003 three weeks apart saw an average 23-point drop in scores on the Montgomery-Åsberg Depression Rating Scale (MADRS) a year later. By the 12-month mark, all patients in that earlier study met the criteria for treatment response, and most were classified as being in remission.

The update comes roughly two months after Helus Pharma, formerly Cybin, closed a $50 million stock offering to help fund HLP003 alongside two earlier-stage candidates, HLP004 for generalized anxiety disorder (GAD) and HLP005. The company changed its name and began trading on the Nasdaq Global Market and Cboe Canada in January 2026, describing the change at the time as a reflection of its shift from a research-stage operation toward one preparing for commercial drug sales.

Ultimately, this update is a reminder that the psychedelic-derived drug sector, often discussed alongside Cannabis in conversations about capital markets and regulatory reform, is now producing the kind of late-stage clinical data that institutional investors price directly into valuations. Enrollment figures and trial timelines rarely draw retail attention, but they are the numbers that determine if a Breakthrough Therapy Designation translates into an approved product.

Highly Capitalized Network-HCN will be watching Q4 2026 closely, since that is when HLP003’s Phase 3 results either confirm or complicate the Phase 2 data that has underpinned the stock’s story so far.

Image courtesy: helus.com