Apr 19, 2026
Otsuka Pharmaceutical said its U.S. subsidiary plans to acquire Transcend Therapeutics for $700 million, with up to $525 million more tied to sales milestones. The deal would add TSND-201, a methylone-based PTSD drug now moving into Phase 3 testing in the U.S.
Mar 28, 2026
Enveric Biosciences reports positive preclinical results for lead candidate EB-003 showing efficacy in depression and PTSD models. The company has completed pre-IND studies and received FDA feedback for streamlined IND submission, with plans for Phase 1 trials in 2026. New BRET assay data demonstrates EB-003's engagement of therapeutic signaling pathways while independent research supports separation from hallucinogenic effects.
Mar 18, 2026
The American Psychiatric Association will include biomarkers in the next DSM edition, though such markers remain unvalidated for routine clinical use. Research has spanned decades with limited adoption despite potential to guide treatment selection.
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 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.
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 17, 2026
NRx Pharmaceuticals completed a Type C meeting with the FDA, receiving guidance to file a New Drug Application for NRX-100 based on existing trial data and real-world evidence from over 65,000 patients, with submission planned for Q2 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.