Also known as: TRD
Biotech companies posted Q2 2026 results: REGENXBIO's Duchenne trial met its primary endpoint, Compass Pathways' COMP360 NDA submission is on track for Q4, Puma raised full-year guidance on NERLYNX demand, and Evotec cut its 2026 outlook.
FDA final guidance sets standards for psychedelic clinical trials. Federal agencies and states are advancing psilocybin and ibogaine research, and Eli Lilly is acquiring AtaiBeckley for $2.8 billion.
Helus completed Phase 3 enrollment for HLP003 in depression; data due Q4 2026. Compass is on track for COMP360's NDA, and an ayahuasca ingredient showed promise in a phase 2a trial.
Compass Pathways reports six-month data from its second Phase III COMP006 trial of COMP360 psilocybin for treatment-resistant depression, showing 39% of patients achieved clinically meaningful response maintained through 26 weeks. NDA submission expected in Q4 2026.
MRI-guided brain stimulation achieved 80% response rates for treatment-resistant depression versus 60% with conventional targeting, per a JAMA Psychiatry study. Separately, Barcelona researchers developed an MRI tool to accurately identify rare neurodegenerative tauopathies PSP and CBD, while experts in Paris discussed AI's growing role in predictive psychiatry.
Biotech companies announced new financings: HMNC closed a $50M Series B, Cartesian secured a $150M credit facility, Waiv raised $33M, and Brainstorm raised $1M. KET01 showed early efficacy but missed its primary endpoint.
Compass Pathways said COMP360 for treatment-resistant depression retains FDA Breakthrough Therapy designation as it advances in phase 3. A Trump executive order also directs faster federal review of psychedelic drugs with breakthrough status.
A pooled analysis of five randomized trials found intranasal esketamine improved MADRS scores in adults with TRD in both sexes. Females showed greater improvement and higher odds of treatment-response toward trial end.
Psyence Biomedical dosed the first patient in a Phase IIb study of NPX-5 in Adjustment Disorder among cancer patients receiving palliative care. The randomized, double-blind trial is running across five Australian sites.
NRx said the FDA issued a positive review letter on its preservative-free ketamine ANDA, requesting only minor administrative changes. The company also received FDA guidance outlining a path to an NDA for NRX-100 using clinical trial data and real-world evidence.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT07706478 |
Working Mechanisms and Effectiveness of IV Ketamine-assisted Psychotherapy on Depression in TRD Clients |
RECRUITING | |
| NCT07528157 |
Early Brainwave Biomarkers for Personalized Neuromodulation in Treatment-resistant Depression |
NOT_YET_RECRUITING | NA |
| NCT07512284 |
Mindfulness Engaged Neurostimulation for Depression (MEND II) |
RECRUITING | PHASE2 |
| NCT07499583 |
Psilocybin Assisted Psychotherapy for Treatment Resistant Depression and Co-occurring Substance Use Disorder |
NOT_YET_RECRUITING | PHASE1/PHASE2 |
| NCT07474974 |
ipRGC as a Potential Biomarker for Predicting Transcranial Magnetic Stimulation Treatment Response in Major Depressive Disorder |
RECRUITING | NA |
| NCT07310381 |
Vagus Nerve Stimulation (VNS) Electroencephalogram (EEG) Protocol Supplement |
NOT_YET_RECRUITING | NA |
| NCT07262008 |
Sustained Mood Improvement With Laughing Gas Exposure |
NOT_YET_RECRUITING | PHASE3 |
| NCT07227103 |
A Randomized, Double-Blind Controlled Comparison of NRX-101 vs. Placebo for Adults Being Treated With Robotic Transcranial Magnetic Stimulation for Treatment Resistant Depression: The SPARC-TMS Trial |
NOT_YET_RECRUITING | PHASE2/PHASE3 |
| NCT07189689 |
Mental Health Mission Mood Disorder Cohort Study |
NOT_YET_RECRUITING | |
| NCT07188753 |
Randomized Controlled Trial Testing the Efficacy of Transcranial Magnetic Stimulation by Accelerated & High-dose Theta-burst, Functional Imaging Guided, in the Treatment of Depression in Elderly Subjects With Cognitive Impairment |
NOT_YET_RECRUITING | NA |
