https://ir.ataibeckley.com/news-releases/news...t-response
66.7% of participants achieved an antidepressant response by Day 2 following a single intranasal dose of BPL-003 in both the 10 mg (n=6) and 12 mg (n=6) cohorts
Durable responses observed at Day 85: 83% (5/6) (10 mg) and 66.7% (4/6) (12 mg)
BPL-003 received FDA Breakthrough Therapy Designation in October 2025
Phase 3 initiation on track for Q2 2026
https://clinicaltrials.gov/study/NCT05660642
https://link.springer.com/article/10.1007/s40263-025-01250-z