Psyence Biomedical stock rises after ethics approval for psilocybin trial

Investing.com -- Psyence Biomedical Ltd (NASDAQ:PBM) stock gained 2.7% in premarket trading Friday after the company announced a key ethics committee approval for its psilocybin product in an ongoing Phase IIb clinical trial.

The Bellberry Human Research Ethics Committee formally approved the use of PsyLabs’ psilocybin formulation (NPX5) in Psyence’s clinical trial evaluating psilocybin-assisted psychotherapy for Adjustment Disorder in cancer patients. The approval applies to all participating study sites in Australia.

This development marks a significant step in Psyence’s evolution toward vertical integration in the psychedelics sector. The company, which has approximately $9.5 million in cash reserves and no debt, is now positioned to control its supply chain from raw material sourcing through clinical development.

"This is a pivotal advancement in our clinical program and a defining step in our long-term strategy," said Jody Aufrichtig, CEO of Psyence BioMed.

The Phase IIb study will enroll approximately 87 participants and evaluate two therapeutic doses of psilocybin against a low-dose comparator, combined with structured psychotherapy. The trial remains on track to deliver top-line results in 2026.

PsyLabs CEO Tony Budden noted that the approval "reflects years of scientific, regulatory, and manufacturing preparation" to ensure their product meets high standards for clinical use.

The company is planning to activate additional clinical sites to accelerate patient recruitment for the study.

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