HLP003 — Topline data
Q4 2026
Appointed as Helus Pharma prepares for topline data readout from APPROACH, the first pivotal Phase 3 Study of HLP003 as an adjunctive treatment for Major Depressive Disorder ("MDD"), expected in Q4 2026Source filing
HELP biotech catalysts & pipeline
CYBIN INC · Data as of 2026-09-08
Upcoming catalysts
CYB003 — Topline data
Jun 30
Each Warrant will be exercisable to acquire one Common Share at a price of US$8.14 per Common Share at any time prior to the earlier of: (i) June 30, 2027; (ii) thirty days following the publication by press release of topline data for the APPROACH trial of CYB003 in major depressive disorder; and (iii) thirty days following the date a press release is issued by the Company announcing exercise of its acceleration right, which right can only be exercised if the closing price of the Common Share on NYSE American LLC (the " NYSE American ") is equal to or exceeds US$19.53 per Common Share for any five consecutive trading days.Source filing
HLP003 — NDA/BLA submission
2028
We believe the durability, remission rates, and overall profile demonstrated in our Phase 2 study support the potential of HLP003 to meaningfully improve outcomes for patients living with MDD, and we look forward to advancing the program through the next stage of development and toward a potential FDA New Drug Application in 2028.Source filing