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A regulatory resubmission, 2 phase 3 psychedelic trial readouts, new TMS dosing data, and an MDD genetics study, all in this August 2026 recap.
August brought fresh movement in psychiatry's psychedelic pipeline, with a resubmission of the new drug application (NDA) for MDMA-assisted therapy and phase 3 data on lysergide for anxiety. TMS practice also saw new data this month, from a look back at how far session times have shrunk to fresh questions about whether current dosing conventions are even the right ones.
Elsewhere, a large genetics study offered the field's clearest look yet at the biological differences underlying depression's opposite symptom presentations, hypersomnia and weight gain versus insomnia and weight loss. Below is a roundup of the month's top psychiatry stories, with links to HCPLive's full coverage of each.
Resilient Pharmaceuticals, formerly MAPS Public Benefit Corporation and then Lykos Therapeutics, resubmitted its NDA for MDMA-assisted therapy in PTSD without conducting a new phase 3 trial. The resubmission follows the August 2024 complete response letter (CRL) that recommended additional research on durability of response, safety characterization, and bias mitigation, areas the FDA's new July 2026 final guidance on psychedelic drug trials also addresses.
Definium Therapeutics reported positive phase 3 Voyage trial results for DT120 (lysergide) orally disintegrating tablet in generalized anxiety disorder (GAD), showing a 5.4-point placebo-adjusted reduction on the Hamilton Anxiety Rating Scale at week 12. The single-dose treatment reached significance as early as day 2, and the FDA has granted the DT120 Breakthrough Therapy designation for GAD.
Jonathan Downar, MD, PhD, described 2 decades of advances that compressed TMS sessions from 38 minutes to as little as 3, expanding treatment access for depression and other psychiatric conditions. He credited theta-burst protocols, accelerated scheduling, and improved neuroimaging maps of depression circuitry for the shift.
A secondary analysis of a randomized McLean Hospital trial found lower electric-field strength at the DLPFC, not higher stimulation intensity, was associated with greater depression symptom improvement. The finding challenges the conventional fixed 120% resting motor threshold dosing standard and points toward individualized, E-field-guided TMS dosing.
A genome-wide association study of > 460,000 individuals identified 27 genetic loci separating atypical energy-related symptom (AERS) subtypes of major depressive disorder (MDD), defined by opposing hypersomnia/weight gain and insomnia/weight loss profiles. AERS+ correlated with metabolic risk factors, including BMI and type 2 diabetes, suggesting a biological basis for future subtype-specific treatment approaches.