Psyence Biomedical Receives Approval for NPX5 in Phase IIb Clinical Trial
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 19 2025
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Source: Globenewswire
- Clinical Trial Approval: Psyence Biomedical has received formal approval from the Bellberry Human Research Ethics Committee to use Psylabs' psilocybin product NPX5 in its ongoing Phase IIb clinical trial, marking a significant advancement in addressing mental health needs.
- Strengthened Financial Position: With approximately $9.5 million in cash reserves and an investment in Psylabs, the company is uniquely positioned in the emerging global psychedelics market, enabling effective execution of its strategic initiatives.
- Multi-Site Research Strategy: The approval applies to all participating study sites, including Empax Centre and Mind Medicine Australia Clinic, which is expected to accelerate patient recruitment and advance the Phase IIb program.
- Quality Assurance of Product: PsyLabs' psilocybin product meets GMP standards, ensuring high purity and repeatability, further solidifying Psyence BioMed's core position within its clinical development network and supporting future commercial success.
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About PBM
Psyence Biomedical Ltd is a multi-asset, vertically integrated biopharmaceutical company specializing in psychedelic-based therapeutics. The Company is focused on developing nature-derived (non-synthetic) psilocybin-based psychedelic medicine. It is dedicated to addressing unmet mental health needs, particularly in palliative care. Its ongoing Phase IIb psilocybin clinical trial in Australia focuses on adjustment disorder in patients diagnosed with cancer.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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