1. Psyence BioMed receives ethics approval for its psilocybin product in clinical trials. 2. The Company has cash reserves of approximately $9.5 million to support strategy. 3. PsyLabs' psilocybin formulation enhances clinical-stage infrastructure for Psyence BioMed. 4. The Phase IIb trial aims to enroll 87 patients and deliver results in 2026. 5. Psyence positions itself as a leader in the emerging psychedelics market.
FAQ
Why Bullish?
The approval increases Psyence's credibility and market potential, likely boosting investor confidence.
How important is it?
The article outlines key developments that validate Psyence's position and growth strategy in the burgeoning psychedelics sector.
Why Long Term?
As the trial progresses and results are released, financial performance could improve significantly.
Psyence BioMed Secures Approval for Psilocybin Product in Phase IIb Clinical Trial
NEW YORK, Dec. 19, 2025 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (NASDAQ: PBM), a biopharmaceutical company specializing in nature-derived psilocybin and ibogaine therapies, has announced a significant milestone: the Bellberry Human Research Ethics Committee (HREC) has approved the use of PsyLabs’ psilocybin product (NPX5) in its ongoing Phase IIb clinical trial. This trial focuses on psilocybin-assisted psychotherapy aimed at treating Adjustment Disorder in cancer patients.
Approval Details and Implications
The recent approval underscores Psyence BioMed's strategic evolution within the psychedelic sector, solidifying its position as a vertically integrated company with diverse assets in both drug and clinical development. With a robust cash reserve of approximately USD $9.5 million and a strategic partnership with Psylabs, the company is well-equipped for its future endeavors in the psychedelics market.
- Approval Authority: Bellberry HREC
- Study Focus: Psilocybin-assisted psychotherapy for cancer patients
- Financial Position: Cash balance of approximately USD $9.5 million
The approval came after a thorough review of updated clinical documentation, including an amended protocol and revised participant materials, all tailored to PsyLabs’ psilocybin formulation. Importantly, this authorization applies to all study sites involved, such as the Empax Centre, Mind Medicine Australia Clinic, and Paratus Clinical Research in Melbourne. Furthermore, plans are in place to activate additional clinical sites to expedite patient recruitment and advance the Phase IIb program.
Strategic Insights from Leadership
Jody Aufrichtig, CEO of Psyence BioMed, remarked, “We are extremely pleased that PsyLabs’ nature-derived psilocybin product has now been formally approved for use in our Phase IIb study. This is a pivotal advancement in our clinical program and a defining step in our long-term strategy.” By using what they consider a best-in-class GMP-compliant psilocybin product, Psyence BioMed is enhancing supply chain control and manufacturing capacity, pivotal components for future commercial success.
The approved amendment confirms PsyLabs’ psilocybin as the investigational product for the double-blind, randomized trial, positioning PsyLabs as a vital part of Psyence BioMed’s clinical-stage infrastructure. This integration allows the company to manage the entire development process, from ethical sourcing of raw materials to formulation, clinical evaluation, and eventual commercialization.
Future Outlook and Study Details
The Phase IIb clinical trial is set to enroll approximately 87 participants and will evaluate two therapeutic doses of psilocybin against a low-dose comparator, supplemented with structured psychotherapy. Recruitment is actively underway, with the study anticipated to deliver top-line results in 2026.
This regulatory approval further consolidates Psyence BioMed’s competitive edge, as it stands among a limited number of companies globally with access to ethically sourced botanical materials and GMP manufacturing capabilities.
About Psyence BioMed
Psyence Biomedical Ltd. (NASDAQ: PBM) is a pioneering biopharmaceutical company specializing in psychedelic-based therapeutics. It is the first life sciences biotechnology firm focused on developing nature-derived (non-synthetic) psilocybin and ibogaine therapies to be listed on Nasdaq. The company aims to address significant unmet mental health needs, particularly in palliative care, through a commitment to evidence-based, safe, and FDA-approved treatments.
For more information, visit www.psyencebiomed.com or connect with us on LinkedIn.
Contact Information
Email: ir@psyencebiomed.com
Media Inquiries: media@psyencebiomed.com
General Information: info@psyencebiomed.com
Phone: +1 416-477-1708
Investor Contact: Michael Kydd, Investor Relations Advisor (michael@psyencebiomed.com)