Pα+ Psychedelic Bulletin #217: Gilgamesh GM-1020 positive topline, FDA lifts 5-MeO-DMT hold, Compass PTSD design, Cybin becomes Helus

NMDA antagonist GM-1020 (blixeprodil) reports positive topline results in a Phase 2a study for moderate-to-severe major depressive disorder, with a clinically meaningful reduction on MADRS at 24 hours and by day 8. The bulletin highlights the trial design details, including a randomized double-blind placebo-controlled single-dose crossover setup, and notes that the efficacy analysis is limited to the first dosing period due to carryover effects. The FDA clears two psychedelic candidates for further US development by lifting regulatory barriers: GH Research’s inhaled 5-MeO-DMT IND clinical hold is removed after more than two years, and Compass Pathways is cleared to proceed with a pivotal psilocybin program targeting PTSD. Compass also provides more detail on the trial design and timing for a broader TRD launch readiness plan. Cybin rebrands to Helus Pharma and lists on Nasdaq, while additional items include an MDMA-assisted therapy trial registration in active-duty troops and financial filings from psychedelics nonprofits, plus qualitative research work on psilocybin for PTSD.