Spravato is intranasal esketamine, an NMDA receptor antagonist indicated in adults for treatment-resistant depression (as monotherapy or with an oral antidepressant) and for depressive symptoms in major depressive disorder with acute suicidal ideation or behavior. The label notes administration under healthcare supervision with REMS controls. U.S. labeling lists initial approval as 1970 (ketamine).
Johnson & Johnson raised its full-year forecast after stronger-than-expected quarterly results driven by cancer, immunology and neuroscience drugs. Sales were $24.56 billion and adjusted earnings were $2.46 per share, with Innovative Medicines sales rising 10.0% to $15.76 billion.
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.
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.
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.
Compass Pathways' COMP360 synthetic psilocybin met primary endpoints in Phase 3 trials for treatment-resistant depression, with the company planning to submit a new drug application in Q4 2026.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06725277 |
The OBSERVE Protocol |
RECRUITING |
