BioTuesdays

Psyence ships GMP-compliant psilocybin to Australia for Phase 2b trial

Psyence BioMed (NASDAQ: PBM) has announced the export of fully GMP-compliant manufactured psilocybin product NPX-5 to Australia for the ongoing Phase 2b clinical trial evaluating natural psilocybin for the treatment of adjustment disorder in patients with cancer in a palliative care context.

According to Psyence, the shipment represents an operational achievement for both Psyence and its production facility, PsyLabs, reinforcing their shared commitment to establishing a regulated global supply chain for nature-derived psychedelic therapeutics.

In a statement, Jody Aufrichtig, CEO of Psyence, commented, “This export demonstrates more than regulatory clearance–it validates the operational readiness of our vertically integrated model. The successful manufacture and export of GMP-compliant natural psilocybin at this stage of clinical development demonstrates that we are not simply participating in this sector – we are helping define its standards. Operational discipline, supply control, and product excellence are foundational to our platform.”

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