Related coverage linked through entity extraction aliases.
May 18, 2026
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.
May 11, 2026
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.
Apr 24, 2026
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.
Apr 22, 2026
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.
Apr 20, 2026
Compass Pathways reported positive late-stage COMP360 psilocybin data in treatment-resistant depression and plans FDA talks ahead of a filing between October and December. The update lifted shares across several psychedelics developers.
Apr 12, 2026
A 34-person trial found that a single 21.5mg intravenous dose of DMT with psychotherapy produced rapid antidepressant effects lasting three to six months. Separate brain-scan research across five psychedelics found a shared pattern of weaker within-network links and stronger communication between brain networks.
Apr 06, 2026
NRx said the FDA outlined a path for a New Drug Application for NRX-100, a preservative-free ketamine formulation for depression with suicidality. The company plans to submit the NDA by June 2026 and said no additional nonclinical or bridging studies would be required.
Apr 06, 2026
NRx Pharmaceuticals said an FDA Type C meeting indicated a path to an NDA for NRX-100, using clinical trial results and real-world ketamine data from more than 65,000 patients.
Mar 25, 2026
Clinical trials show psychedelic substances like psilocybin, LSD and MDMA combined with therapy can effectively treat depression, anxiety and addiction. Several substances are in Phase III trials, with esketamine already approved for treatment-resistant depression. Research suggests these treatments may work with fewer doses than traditional medications.
Mar 26, 2026
The FDA approved milsaperidone for bipolar I disorder and schizophrenia, while COMP360 psilocybin met its primary endpoint in a second phase 3 trial for treatment-resistant depression. Phase 2a data showed intravenous DMT (SPL026) significantly reduced depressive symptoms in major depressive disorder patients.
Mar 14, 2026
New research reveals how ketamine rewires brain receptors to rapidly relieve severe depression, while separate trials demonstrate success with personalized brain stimulation and targeted drug therapy for treatment-resistant cases.
Mar 14, 2026
A secondary analysis of the OPTIMUM trial found that higher doses of bupropion and prior fall history significantly increase fall risk in older adults with treatment-resistant depression receiving antidepressant augmentation.
Mar 09, 2026
Compass Pathways announced positive Phase 3 data for COMP360 psilocybin therapy in treatment-resistant depression, showing statistically significant improvements in depression scores and durability through 26 weeks, with plans to file for FDA approval in Q4 2026.
Mar 09, 2026
COMPASS Pathways announced positive Phase 3 results for COMP360 psilocybin in treatment-resistant depression, showing statistically significant improvements across two pivotal trials with durability signals through 26 weeks and a generally well-tolerated safety profile.
Feb 28, 2026
NRx Pharmaceuticals completed an in-person FDA Type C meeting regarding NRX-100, a preservative-free ketamine formulation for suicidal depression. The company received guidance on a path to file a New Drug Application based on existing trial data and Real World Evidence from over 65,000 patients.
Feb 27, 2026
Compass Pathways announced successful Phase 3 trial results for COMP360, a synthetic psilocybin treatment for treatment-resistant depression, showing rapid onset and durable effects with a 40% response rate after two doses.
Feb 21, 2026
New COMP006 phase 3 data shows single-dose COMP360 psilocybin achieved a 3.8-point MADRS reduction in treatment-resistant depression, with results comparable to esketamine pivotal trials and rapid onset of effect.
Feb 17, 2026
Compass Pathways announced positive results from its second Phase 3 trial of synthetic psilocybin COMP360 for treatment-resistant depression, showing a 3.8-point reduction in depression scores. The company plans to meet with the FDA to discuss a rolling approval application.
Feb 17, 2026
Cyclerion Therapeutics received positive FDA feedback on its Phase 2 study design for CYC-126, an anesthetic-based therapy with real-time EEG monitoring for treatment-resistant depression, with study initiation planned for second half of 2026.
Feb 18, 2026
Compass Pathways reported COMP360 psilocybin met the primary endpoint in its second phase III trial for treatment-resistant depression, demonstrating a statistically significant reduction in depression severity. The company plans to file a New Drug Application in Q4 2025.
