Psyence BioMed (NASDAQ:PBM) announced that it has received approval from the Bellberry Human Research Ethics Committee to use its psilocybin product, NPX5, in its ongoing Phase IIb clinical trial for adjustment disorder in cancer patients.
The approval applies to all participating trial sites, including Empax Centre, Mind Medicine Australia Clinic, and Paratus Clinical Research in Melbourne.
The amendment reflects updated trial protocols, the investigator brochure, and participant materials.
The Phase IIb trial will enroll approximately 87 participants, testing two therapeutic doses of NPX5 versus a low-dose comparator in conjunction with structured psychotherapy.
The trial is tracking to deliver top-line results in 2026.
In its latest update, Psyence BioMed reported approximately $9.5 million in cash and no debt.
The company also highlighted its strengthened vertical integration through investments in PsyLabs, which provides GMP manufacturing and improved supply-chain control, ensuring high-quality and consistent production for its clinical trials and future commercialization efforts.