Pα+ Psychedelic Bulletin #217: Gilgamesh's GM-1020 Prints Positive Topline; FDA Lifts Hold on GH Research's 5-MeO-DMT IND; Compass Details Pivotal PTSD Trial Design; Cybin Becomes Helus

Welcome to our first Psychedelic Bulletin of 2026! It’s been a very busy start to the year, but fret not: this Bulletin will get you up to speed.

Already, FDA has cleared two investigational new drug (IND) applications for psychedelic candidates, allowing two late-stage development programs to proceed in the U.S. The first sees the agency lift a clinical hold on GH Research’s inhaled 5-MeO-DMT for TRD IND after more than two years. The second sees Compass Pathways clear the way for a pivotal psilocybin for PTSD program.

Elsewhere, Gilgamesh Pharma printed a positive topline readout from a Phase 2a study of its NMDA receptor antagonist in major depressive disorder, Cybin rebranded to Helus Pharma and listed on the Nasdaq, and much, much more…

Gilgamesh Prints Positive Topline from Phase 2a Study of NMDA Receptor Agonist for MDD

Earlier this week, Gilgamesh Pharma shared positive topline data from a Phase 2a study (N=46) of GM-1020, its oral NMDA receptor antagonist, also known as blixeprodil, in moderate-to-severe major depressive disorder (MDD).

In Part A of the study, which featured a randomised, double-blind, placebo-controlled, single-dose (140 mg) cross-over design, the company reports a clinically meaningful and statistically significant reduction in MADRS (-6.3) versus placebo at 24 hours post-dose. The company also reports a clinically meaningful reduction at day 8 (-5.1). “Due to large residual effect after the first dose, which carried over into the second dosing period, the efficacy analysis was limited to the first dosing period, as was pre-specified in the analysis plan”, the company noted...