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NEW YORK - Psyence Biomedical Ltd. (NASDAQ:PBM) has successfully dosed multiple patients in its Phase IIb clinical trial evaluating nature-derived psilocybin for Adjustment Disorder in palliative care, the company announced Thursday. The micro-cap biotech, with a market capitalization of just $1.58 million, is trading near its 52-week low of $2.36, having lost over 83% of its value year-to-date.
The trial is now operating across two active clinical sites in Australia—the Empax Center in Perth and the Mind Medicine Australia Clinic in Melbourne—with a third site, Paratus Clinical Research in Melbourne, recently activated to accelerate enrollment.
The multi-site, double-blind, placebo-controlled study aims to enroll 87 patients who will receive either therapeutic doses of psilocybin (10 mg or 25 mg) or a low-dose comparator (1 mg), administered alongside structured psychotherapy.
"The randomization and dosing of these patients across multiple independent trial sites marks an exciting and validating milestone for Psyence BioMed," said Dr. Clive Ward-Able, Medical Director of Psyence BioMed, in the press release.
According to the company, the study has been designed to meet regulatory expectations with its larger sample size, randomization protocol, and multi-site structure to enhance statistical power and data reliability.
Psyence BioMed describes this as the only active Australian clinical program using a natural psilocybin formulation to treat Adjustment Disorder in palliative care settings. The company expects topline results by the end of 2026.
The trial will assess efficacy, safety, and durability of response, with the goal of advancing psilocybin as a potential treatment for Adjustment Disorder in palliative care.
Psyence Biomedical specializes in developing nature-derived psychedelic-based therapeutics, focusing on psilocybin and ibogaine compounds for mental health applications.
In other recent news, Psyence Biomedical Ltd. has announced a follow-on investment of $3.5 million in PsyLabs, a producer of purified psychedelic active pharmaceutical ingredients. This investment, completed on August 15, 2025, follows a previous investment of $500,000 made by Psyence in April 2025. The company aims to secure access to GMP-grade psychedelic compounds, such as psilocybin and ibogaine, for its clinical research programs. This development reflects Psyence's continued commitment to advancing its research capabilities in the psychedelic pharmaceutical space. The collaboration with PsyLabs is expected to enhance Psyence's research initiatives. The investment underscores the strategic importance of ensuring a steady supply of high-quality psychedelic compounds for ongoing and future studies. These developments highlight Psyence's proactive approach to strengthening its research and development efforts.
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