Compass Pathways Secures Priority Voucher as Psyence BioMed Begins Phase IIb Dosing
Compass Pathways granted a Commissioner’s National Priority Voucher for COMP360 and rolling FDA NDA review, accelerating approval timelines and forming a strategic collaboration with 1,000-clinic network Osmind. Psyence BioMed began patient dosing in its Phase IIb NPX-5 trial for adjustment disorder and secured exclusive GMP-grade ibogaine supply infrastructure.
1. Compass Pathways Accelerates COMP360 Review
Compass Pathways obtained a Commissioner’s National Priority Voucher for its synthetic psilocybin therapy COMP360 and secured a rolling FDA NDA review, a designation designed to shorten regulatory timelines. The company also entered a strategic collaboration with Osmind, leveraging over 1,000 psychiatry clinics to develop scalable, patient-centered delivery models for psychedelic treatments.
2. Psyence BioMed Initiates Phase IIb NPX-5 Trial
Psyence BioMed began dosing patients in its multi-site Phase IIb trial of NPX-5 for adjustment disorder in palliative cancer care, marking the first large-scale clinical evaluation of its nature-derived psilocybin candidate. The company further strengthened its position by establishing an exclusive source of GMP-grade ibogaine, ensuring supply for its own programs and the broader research ecosystem.