Psilocybin

Dec. 19, 2025 -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today announced that the Bellberry Human Research Ethics Committee (HREC) has formally approved the use of PsyLabs’ psilocybin product (NPX5) in the Company’s ongoing Phase IIb clinical trial evaluating psilocybin-assisted psychotherapy for Adjustment Disorder in patients with cancer. This approval highlights the Company’s distinct evolution toward becoming one of the few vertically integrated psychedelic enterprises with multiple assets across drug and clinical development. With an investment in Psylabs, significant clinical assets and a strong cash reserves balance of approximately USD $9.5 million, the Company is now positioned as one of the most differentiated companies in the emerging global psychedelics sector with the cash balance to execute on its strategy. Approval was granted following review of updated clinical documentation, including the amended protocol, investigator brochure, and participant information materials, all reflecting the transition to PsyLabs’ psilocybin formulation. The authorization applies to all participating study sites, including Empax Centre, Mind Medicine Australia Clinic, and Paratus Clinical Research in Melbourne. The Company has also begun planning the activation of additional clinical sites to further accelerate patient recruitment and advance the Phase IIb program. “We are extremely pleased that PsyLabs’ nature-derived psilocybin product has now been formally approved for use in our Phase IIb study,” said Jody Aufrichtig, CEO of Psyence BioMed. “This is a pivotal advancement in our clinical program and a defining step in our long-term strategy. By incorporating what we believe is the best-in-class GMP compliant psilocybin product on the market – developed entirely within our vertically integrated structure – we are reinforcing supply-chain control, manufacturing excellence, and scalable production capacity that will drive future commercial success.” The approved amendment confirms PsyLabs’ psilocybin as the investigational product used in the double-blind, randomized, low-dose comparator-controlled clinical trial. This positions PsyLabs as a key contributor to Psyence BioMed’s clinical-stage infrastructure, reinforcing the Company’s ability to oversee the development pathway from ethical raw material sourcing through formulation, clinical evaluation, and eventual commercialisation. “Having our psilocybin formulation cleared for clinical use is a transformative moment for PsyLabs,” said Tony Budden, CEO of PsyLabs. “It reflects years of scientific, regulatory, and manufacturing preparation to ensure our product meets the highest standards for purity, repeatability, and patient safety. We are proud to support Psyence BioMed’s mission to bring safe, nature-derived psychedelic therapies into regulated medicine.” 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. With multiple sites activated and recruitment underway, the study remains on track to deliver top-line results in 2026. This approval further strengthens Psyence BioMed’s competitive positioning as one of the few companies globally with access to ethically sourced botanical raw materials, GMP manufacturing capabilities, and a fully aligned clinical development network. Psyence Biomedical Ltd. (Nasdaq: PBM) is one of the few multi-asset, vertically integrated biopharmaceutical companies specializing in psychedelic-based therapeutics. It is the first life sciences biotechnology company focused on developing nature-derived (non-synthetic) psilocybin and ibogaine-based psychedelic medicine to be listed on Nasdaq. We are dedicated to addressing unmet mental health needs, particularly in palliative care. The company is committed to an evidence-based approach in developing safe, effective, and FDA-approved nature-derived psychedelic treatments for a broad range of mental health disorders. PsyLabs is a psychedelic Active Pharmaceutical Ingredient (API) development company, federally licensed to cultivate, extract, and export psilocybin mushrooms and other psychedelic compounds including psilocin, mescaline, ibogaine, and dimethyltryptamine (DMT) to legal medical and research markets. The company has successfully exported psilocybin products to Canada, the UK, Portugal, and Slovenia, and supplies purified extracts to its UK-based CMO partner. PsyLabs operates from an ISO 22000-certified facility audited by the British Standards Institution, ensuring the highest standards of safety and traceability. With a focus on natural compound purification, regulatory support, and global distribution, PsyLabs is expanding its product pipeline to include ibogaine and other next-generation psychedelics. The content above comes from the network. if any infringement, please contact us to modify.