Helus Pharma Completes Enrollment in Phase 3 APPROACH Study of HLP003 in Adjunctive Treatment of Major Depressive Disorder Ahead of Schedule
Enrollment continues in EMBRACE, the second pivotal study of the Phase 3 PARADIGM Program Participant rollover is ongoing into the EXTEND long-term study generating long-term safety and durability data APPROACH topline data readout on track for Q4 20261,2 HLP003 previously granted Breakthrough Therapy Designation by the U.S. Food and Drug Administration (“FDA”) HLP003 Phase 2 […]
FNM News Break: Helus Pharma Provides Update on APPROACH Phase 3 Trial Enrollment Progress
– APPROACH Phase 3 clinical trial of HLP003 for the adjunctive treatment of major depressive disorder (“MDD”) is progressing as planned and has surpassed 86% enrollment – – Phase 2 HLP003 data demonstrated long-term efficacy with ~23-point reduction in Montgomery-Asberg Depression Rating Scale (“MADRS”) score compared to baseline at 12 months after two 16 mg […]
Helus Pharma Appoints Former Pfizer Chief Medical Officer Dr. Freda Lewis-Hall to Board of Directors & Chair of the Scientific Advisory Committee
In this role, Dr. Lewis-Hall will guide clinical development strategy, regulatory engagement, and translational rigor across Helus’ novel serotonergic agonist (“NSA”) portfolio This news release constitutes a “designated news release” for the purpose of the Company’s prospectus supplement dated December 30, 2025, to it short form base shelf prospectus dated September 17, 2025, as […]
Helus Pharma Appoints Michael Cola as Chief Executive Officer to Lead Next Phase of Scale and Execution
Former President of Shire PLC’s (“Shire”) Specialty Pharmaceutical business, with more than 30 years of experience across neuroscience, rare disease, and specialty pharmaceuticals, including senior leadership roles at Astra-Merck and AstraZeneca PLC Proven leader in late-stage clinical development, global commercialization, and capital formation across central nervous system (“CNS”) programs Appointed as Helus Pharma advances its […]
HELUS Pharma Propels Therapeutic Innovation in Mental Health and Commences Trading on Nasdaq
Helus Pharma builds on the strong foundation originally created as Cybin Inc., reflecting the Company’s ongoing transformation to a commercial stage pharmaceutical company Helus Pharma commences trading on Nasdaq Global Market (“Nasdaq”) and on Cboe Canada under ticker symbol: HELP Helus Pharma continues to progress its portfolio of novel serotonergic agonists (“NSAs”), with the goal […]
