A Breakthrough-Designated Depression Drug Is 86% Through Its Phase 3, With Topline Data Due This Year

▤ Summary

Helus Pharma says its APPROACH Phase 3 trial of HLP003 has passed 86% enrollment and remains on schedule for topline data in Q4 2026. The company is developing HLP003 as an adjunctive treatment for major depressive disorder and has already received FDA Breakthrough Therapy Designation. The article also highlights earlier Phase 2 results, including a reported long-term reduction in MADRS scores, while noting that those data are preliminary and not FDA-evaluated. The update matters because late-stage psychiatric trials often struggle to enroll, and this milestone keeps the program’s key catalyst on track.

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