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Helus Pharma (Nasdaq: HELP) reported topline Phase 2 signal detection results for HLP004 in adults with moderate-to-severe generalized anxiety disorder on standard-of-care therapy. Patients given 20 mg showed a mean 10.4-point HAM-A reduction at six weeks (p<0.0001), with 67% responders and 39% remitters at six months. The randomized 36-patient study (2:1 active:placebo) found acute effects lasting ~90 minutes and discharge readiness within ~3 hours, and noted no drug-related serious adverse events.
Helus Pharma (Nasdaq: HELP) appointed Dr. Freda Lewis-Hall to its Board of Directors and named her Chair of the Scientific Advisory Committee, effective Feb 24, 2026. Dr. Lewis-Hall brings 40+ years in psychiatry and industry leadership, including over a decade as Pfizer chief medical officer and global regulatory experience.
She will guide clinical development, regulatory engagement, and scientific governance across Helus’ novel serotonergic agonist portfolio; appointment is subject to Cboe Canada approval.
Helus Pharma (Nasdaq: HELP) reported a randomized, placebo-controlled Phase 2a trial of SPL026 in major depressive disorder that met its primary endpoint at two weeks (MADRS mean difference: -7.35; p=0.023).
Single 21.5 mg dose showed antidepressant effects within one week (mean difference: -10.75; p=0.002), durability to three months for the cohort, and no treatment-related serious adverse events reported.
Helus Pharma (Nasdaq: HELP) reported Q3 fiscal 2026 results and clinical progress on Feb 13, 2026. Cash totaled US$195.1 million as of Dec 31, 2025. Net loss was US$42.7 million for the quarter; cash-based operating expenses were US$36.7 million.
Pipeline updates: topline Phase 2 data for HLP004 in GAD expected Q1 2026; Phase 3 program for HLP003 in MDD continues with topline anticipated Q4 2026. IP protection extends around lead programs through at least 2041.
Helus Pharma (Nasdaq: HELP) named Michael Cola as Chief Executive Officer effective Feb 10, 2026, to lead late-stage development, commercialization, and capital formation.
The company highlighted expected clinical milestones: Phase 2 HLP004 data due this quarter and Phase 3 HLP003 topline in Q4 2026, plus >350 patent applications and >100 patents granted.
Helus Pharma (Nasdaq: HELP) announced its U.S. listing migration to the Nasdaq Global Market and ongoing trading on Cboe Canada under HELP, and said it will operate under the business name Helus Pharma. The company highlighted two lead programs: HLP003, a Phase 3 NSA with Breakthrough Therapy Designation for adjunctive major depressive disorder, and HLP004, a Phase 2 NSA for generalized anxiety disorder with a topline readout expected in Q1 2026. The company cited >350 filed patents (100+ granted) and said commercialization preparations for HLP003 are underway, subject to receipt of necessary approvals.