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.
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
NRx Pharmaceuticals completed a Type C meeting with FDA leadership and received oral guidance supporting a New Drug Application for NRX-100 (preservative-free ketamine) based on existing trial data and Real World Evidence from over 65,000 patients.
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
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.
Feb 16, 2026
Compass Pathways announced successful results from its second Phase 3 trial of COMP360 psilocybin for treatment-resistant depression, with highly statistically significant outcomes and plans for FDA submission in Q4 2026.