Helus Pharma (HELP) said Tuesday it has completed enrollment in its phase 3 study of HLP003 in patients living with major depressive disorder.

The trial enrolled 223 adults with moderate to severe major depressive disorder who experience an inadequate response despite a stable antidepressant regimen, the company said.

The pharmaceutical company expects to release topline data in Q4 and targets a potential new drug application with the US Food and Drug Administration in 2028, it added.

Enrollment is continuing in the program's second pivotal study, and eligible participants can roll over into a long-term extension trial to further evaluate safety, Helus Pharma said.

Shares of the company were up nearly 16% in Tuesday trading.

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