AtaiBeckley cleared for Phase 3 trials of nasal spray depression treatment after FDA backing
The FDA has supported the Phase 3 design for BPL-003, an intranasal psychedelic-derived therapy for treatment-resistant depression AtaiBeckley NV (NASDAQ:ATAI, XETRA:9VC), a clinical-stage biotechnology company focused on mental health treatments, has received backing from US regulators to advance its BPL-003 drug candidate into Phase 3 clinical trials for treatment-resistant depression, a condition affecting millions of patients for whom standard antidepressants have failed. The company said a formal end-of-phase 2 meeting with the Food and Drug Administration (FDA) concluded successfully, with the regulator indicating support for its proposed pivotal trial programme and providing constructive feedback on study design, safety database requirements and other key components.
