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Apr 21, 2026
Xenon Pharmaceuticals reported positive Phase III X-TOLE2 results for azetukalner in focal onset seizures. The company plans an FDA new drug application in Q3 2026.
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
New findings on psychedelic-based depression treatments included a UK DMT trial in 34 adults and a mouse study of modified psilocin compounds with fewer hallucinogenic-like effects.
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 07, 2026
Alzamend Neuro reports pharmacodynamic data showing AL001 may have a distinct brain interaction profile compared to lithium carbonate, with potential tolerability advantages. The Phase II trial analysis suggests AL001 affects key brain metabolites differently while maintaining lithium's core mechanism of action. Further confirmatory studies are planned to validate these initial findings.
Apr 05, 2026
Studies of psilocybin found lasting shifts in life values in healthy volunteers and reduced fear of death in therapeutic settings. Trials have also reported benefits in cancer patients.
Mar 29, 2026
Johnson & Johnson reported strong Q4 2025 earnings with $2.46 adjusted EPS and $24.56 billion in sales, beating estimates. The company faces over 67,000 active talc lawsuits following recent trial losses while projecting 2026 sales of $100-101 billion and maintaining a robust pipeline with recent FDA approvals and breakthrough designations.
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 17, 2026
Lupin has signed a license and supply agreement with Spektus Pharma to commercialize DeslaFlex, a novel antidepressant for Major Depressive Disorder, in Canada, strengthening its CNS portfolio.
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
Xenon Pharmaceuticals will announce topline data from its Phase 3 X-TOLE2 study of azetukalner in patients with focal onset seizures on March 9, 2026, during a conference call at 8:00 a.m. ET.
Mar 03, 2026
Systematic review identifies shared molecular signatures in brain and blood for major depressive disorder, while separate study finds brain-enriched circRNA can predict SSRI treatment response.
Feb 23, 2026
A phase 2 trial found that a single intravenous dose of dimethyltryptamine (DMT) alongside psychotherapy significantly reduced major depressive disorder symptoms, with effects lasting up to 6 months.
Feb 21, 2026
The U.S. Food and Drug Administration has approved Vanda Pharmaceuticals' Bysanti for treating schizophrenia and acute bipolar I disorder. The company expects to launch the drug in the third quarter of 2026.
Feb 21, 2026
The FDA has approved BYSANTI (milsaperidone), a new chemical entity for treating bipolar I disorder and schizophrenia in adults. The drug is Vanda's second approval in less than two months and is expected to launch in Q3 2026.
Feb 21, 2026
Vanda Pharmaceuticals announced FDA approval for BYSANTI tablets to treat Bipolar I manic episodes and schizophrenia in adults. The drug has patent protection extending to 2044 and will be commercially available in Q3 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.
Feb 17, 2026
Compass Pathways reported positive phase 3 results for COMP360 psilocybin in treatment-resistant depression, showing statistically significant symptom reduction. The company plans to discuss FDA filing with a New Drug Application expected in Q4 2026.
Feb 17, 2026
Compass Pathways reports positive Phase 3 results for synthetic psilocybin in treatment-resistant depression, while a Phase 2 trial demonstrates rapid antidepressant effects from single-dose DMT. Both studies show modest efficacy signals amid growing pharmaceutical interest in psychedelic compounds.
Feb 16, 2026
A phase IIa clinical trial found that a single intravenous dose of dimethyltryptamine (DMT) with psychological support rapidly reduced depressive symptoms in 34 adults with major depressive disorder, with improvements sustained for up to three months.
