Helus Keeps Phase 3 Depression Bid on Track for 2026 Data

Helus Pharma, operating under Cybin (HELP), reported that enrollment in its APPROACH Phase 3 trial of HLP003 for major depressive disorder (MDD) is progressing as planned across active sites. The trial is designed to evaluate HLP003 as an adjunctive therapy added to standard antidepressants, targeting patients who do not get enough relief from existing treatments.

HLP003 and the PARADIGM program

HLP003 is a novel serotonergic agonist and already carries FDA Breakthrough Therapy designation, which can speed regulatory feedback but does not guarantee approval. It anchors Helus’ broader PARADIGM pivotal program, which includes a second Phase 3 trial (EMBRACE) and a long‑term extension study (EXTEND) to follow patients beyond the initial blinded treatment window.

Timeline and funding backdrop

The company continues to guide for topline data from APPROACH in late 2026, assuming enrollment and dosing remain on schedule. To support this and other late‑stage work, Helus has recently raised additional capital, reinforcing that the organization is funded to advance HLP003 and its wider NSA pipeline through key clinical milestones.

Broader CNS optionality at Cybin

Beyond MDD, Helus is also developing additional NSA candidates such as HLP004 in generalized anxiety disorder, giving Cybin a growing footprint in high‑need CNS indications. At the same time, management continues to remind investors that all of these compounds are still investigational and that Phase 3 psychiatry trials carry meaningful placebo and regulatory risk.