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 agonist in major depressive disorder, Cybin rebranded to Helus Pharma and listed on the Nasdaq, and much, much more…

In this Issue

• Gilgamesh Prints Positive Topline from Phase 2a Study of NMDA Receptor Agonist for MDD
• FDA Lifts Hold on GH Research’s Inhaled 5-MeO-DMT IND After More than Two Years
• Cybin Rebrands to Helus Pharma, Lists on Nasdaq
• Compass Details PTSD Trial Design, Reaffirms TRD Launch Readiness ‘By End of Year’
• Emory Registers Trial of MDMA-Assisted Massed Exposure Therapy in Active Duty Troops
• Filings Provide a Look at Psychedelics Nonprofits’ Finances
• and much more…

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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…

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