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.

Leading researcher in inflammation, immunology, and drug metabolism to guide development of precise, lab-verified psilocybin for regulated therapeutic use. VAIL VALLEY, Colo., Dec. 18, 2025 /PRNewswire/ -- Psylutions, Colorado's first licensed cultivator and manufacturer of psilocybin serving over half of the licensed healing centers, clinicians, and researchers in the state, today announced the appointment of Nichole R. Klatt, Ph.D., to its Advisory Board. Dr. Klatt is Professor of Surgery and Division Chief of the Division of Surgical Outcomes and Precision Medicine Research at the University of Minnesota Medical School and is also Chief Scientific Officer of Biometrica Health Analytics. In her role on Psylutions' Advisory Board, she offers high-level scientific, regulatory, and research expertise that supports the psilocybin manufacturer's commitment to safe, precise, lab-verified psilocybin products while helping the company navigate an evolving regulatory landscape. Dr. Klatt brings over 20 years of research experience to Psylutions, having published more than 100 peer-reviewed articles in prestigious scientific journals. Her expertise in the effects of inflammation on health and how the microbiome affects drug metabolism and efficacy will be particularly valuable as Psylutions continues to develop standardized psilocybin products that meet rigorous quality and safety standards. "As psilocybin moves from stigma to science, Psylutions is intentional about building an advisory bench that reflects the very best in translational research and patient safety," said Rhonda DeSantis, Founder & CEO of Psylutions. "Dr. Klatt's expertise in the microbiome, inflammation, mucosal immunity, and drug–microbe interactions underscore the very core of our mission: producing psilocybin that is precise, verified, and ready to be integrated into rigorous clinical and healing environments. Her perspective will help us refine our standards as the field matures and regulatory frameworks evolve." The appointment comes at a pivotal time for the regulated plant medicine industry in Colorado, following the state's implementation of a framework for licensed psilocybin services. Psylutions is positioned at the forefront of this emerging sector, focusing on pharmaceutical-grade cultivation and manufacturing practices that ensure consistent potency and purity in all products. "I am honored to join Psylutions at such an important inflection point for psychedelic medicine," said Dr. Klatt. "My career has focused on understanding how the microbiome, immune system, and drug metabolism interact and drive inflammation in real patients, and how to translate biological knowledge into novel interventions to improve health. Psylutions' commitment to regulated supply chains, lab-verified dosing, and evidence-informed practice aligns closely with my own belief that access to these therapies must be built on safety, transparency, and high-quality data. I look forward to supporting this impressive team as they help clinicians and facilitators bring more precise, reliable psilocybin products to the people who need them." A leading expert in inflammation, immunology, mucosal biology, and the human microbiome, Dr. Klatt's research has helped define how microbial communities and host immunity intersect in conditions such as HIV, COVID-19, and chronic inflammatory disease. Her work has been supported by the National Institutes of Health and other major funders, with a focus on inflammation, gut barrier integrity, microbiome-driven drug metabolism, pharmacomicrobiomics, and women's health. Headshot and images available at this link. For more information or to schedule an interview, please contact Shawna Seldon McGregor at 917-971-7852 or [email protected]. Psylutions: Precise. Verified. Effective Psilocybin Solutions. Psylutions is Colorado's first state-licensed cultivator and manufacturer of psilocybin mushrooms, serving licensed healing centers, clinicians, and researchers with precision-grown, lab-verified psychedelic therapies. Psylutions combines scientific excellence with a deep commitment to healing. With a growing portfolio of high-potency strains, Psylutions is setting a new standard for safety, purity, and purpose in the regulated psychedelics industry. Learn more at ThePsylutions.com. SOURCE Psylutions 21% more press release views with Request a Demo