Market reaction
Shares of Helus Pharma (Nasdaq: HELP) climbed 8.3% in premarket trading on Wednesday following the company’s announcement that enrollment in its Phase 3 APPROACH trial for major depressive disorder has passed the 86% threshold. The movement in the stock reflected investor response to the enrollment milestone, which the company presented as progress toward a planned late-stage data readout.
Trial program and regulatory status
The APPROACH Phase 3 study is testing HLP003 - Helus Pharma’s lead proprietary novel serotonergic agonist - as an adjunctive treatment for major depressive disorder. Helus stated it remains on track to report topline results from the study in the fourth quarter of 2026. HLP003 has been granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration.
The APPROACH trial is one component of the company’s broader Phase 3 PARADIGM program, which additionally includes the EMBRACE study and the EXTEND long-term extension study. These program elements were cited by the company in describing the development pathway for HLP003.
Prior clinical data
Helus referenced previously reported Phase 2 results for HLP003. According to those data, subjects who received two 16 mg doses of HLP003, administered three weeks apart, showed a 23-point reduction in Montgomery-Asberg Depression Rating Scale (MADRS) score from baseline at 12 months. The Phase 2 findings also noted response and remission rates of 75% at week 18, which the company reported improved to 100% response and 71% remission by the 12-month assessment.
Financing to support development
Alongside the clinical update, Helus priced an underwritten offering of 10,309,280 common shares at $4.85 per share, representing aggregate gross proceeds of $50 million. The company indicated the offering is expected to close on June 25, 2026.
Helus said it intends to deploy net proceeds to advance HLP003 through the Phase 3 APPROACH trial with the stated fourth-quarter 2026 topline timing, to fund development of HLP004 for generalized anxiety disorder and HLP005 programs, and to provide working capital and general corporate support.
Outlook
The company framed the enrollment milestone and the financing transaction as steps to support late-stage clinical efforts for HLP003 and related programs. The APPROACH trial enrollment progress and the priced offering were presented as key near-term items ahead of the projected topline readout in the fourth quarter of 2026.