Optimi Health Corp.

Optimi Health Establishes Optimi Australia Pty Ltd as Dedicated Distribution and Business Development Entity

Optimi Health has established Optimi Australia Pty Ltd, a wholly owned subsidiary handling sales, distribution, and prescriber relationships in Australia, its first commercial market. The subsidiary will sell 5mg psilocybin and 40mg/60mg MDMA capsules to clinics and pharmacies under Australia's Authorised Prescriber Scheme, with products manufactured at the company's Health Canada-licensed GMP facility in Princeton, British Columbia. Adrian Jones, who spent 15+ years at Bristol Myers Squibb including launch leadership for Opdivo and Camzyos in Australia, was appointed Director of Australian Operations.

•14d ago

Optimi Health Completes MDMA Production for Phase 3 PTSD Trial in Canada, MAPS Trial in Israel and Commercial Supply in Australia

Optimi Health completed its latest GMP production batch of MDMA finished drug product at its Princeton, British Columbia facility, sized to supply three programs: the proposed Canadian Phase 3 PTSD trial, a MAPS-partnered trial in Israel, and commercial export to Australia. The proposed Canadian Phase 3 trial would enroll up to 100 veterans and frontline workers receiving two MDMA-assisted therapy sessions, with the CAPS-5 scale as the primary endpoint; it is expected to begin in 2027. Optimi's next commercial MDMA shipment to Australia is planned before the end of 2026, where clinicians can already prescribe MDMA for PTSD under the Authorised Prescriber Scheme with reimbursement from payers including the Department of Veterans' Affairs. No Optimi MDMA product has Health Canada market authorization, and the safety and efficacy of MDMA-assisted therapy remain under investigation in Canada.

•20d ago

Optimi Health Completes Psilocybin Production for Health Canada-Approved Phase 2 MDD Trial and Commercial TRD Supply

Optimi Health completed and quality-released a production batch of 5mg naturally derived psilocybin capsules manufactured at its cGMP facility in Princeton, British Columbia. The same batch will supply a Health Canada-authorized Phase 2 open-label trial of psilocybin-assisted therapy in major depressive disorder (up to 200 participants, dosing expected complete by end of 2027) and ongoing commercial supply to licensed Australian clinics treating treatment-resistant depression. Optimi has supplied the Australian market since 2025 with reimbursement from payers including the Department of Veterans' Affairs and Medibank; no psilocybin product has Health Canada market authorization, and trial data remain investigational.

•1mo ago

Optimi Health Expands Clinical Program with Phase 3 Trial Evaluating MDMA-Assisted Therapy for Post-Traumatic Stress Disorder

Optimi Health plans to initiate a Health Canada-authorized Phase 3 clinical trial evaluating MDMA-assisted therapy for post-traumatic stress disorder, with the trial expected to begin in 2027. The study will enroll up to 100 participants across multiple Canadian sites, focused on veterans and frontline workers, with change in the CAPS-5 clinician-rated PTSD scale as the primary efficacy endpoint. CEO Dane Stevens said the goal is to submit both the MDMA PTSD therapy and the company's Phase 2 psilocybin program for major depressive disorder for registration, targeting large, underserved mental-health markets. No Optimi MDMA product currently holds Health Canada market authorization, though clinics in Australia have been prescribing Optimi-manufactured MDMA since October 2024 under the Authorized Prescriber Scheme.

•1mo ago

Optimi Health to Initiate Phase 2 Clinical Trial Evaluating Psilocybin-Assisted Therapy for Major Depressive Disorder

Optimi Health announced plans to initiate a Health Canada-authorized, multisite Phase 2 trial of psilocybin-assisted therapy for major depressive disorder, enrolling up to 200 participants at sites across Canada. The trial is slated to begin in the first half of 2027, with dosing expected to be complete by the end of 2027. The study will test a single supervised dose of naturally derived psilocybin, with the primary efficacy endpoint being change in MADRS total score from baseline, plus periodic interim safety and efficacy readouts. CEO Dane Stevens called the 200-subject trial the largest clinical commitment in the company's history, noting Optimi will supply its own GMP-manufactured psilocybin and retain exclusive ownership of the trial results. Management said the trial can be comfortably funded with current cash on hand, though no cash balance was disclosed. Optimi is already commercial-stage, holding a Health Canada Drug Establishment Licence and supplying GMP-grade MDMA and psilocybin products through Canada's Special Access Program and Australia's Authorized Prescriber Scheme.

•1mo ago

Optimi Health Completes Psilocybin Export to Australia for Patients With Treatment-Resistant Depression

Optimi Health completed its third commercial export of 5mg psilocybin capsules to Australia for the treatment of treatment-resistant depression. The shipment of 1,000 capsules was produced at the company's GMP facility in British Columbia and is eligible for reimbursement by public and private payers including the Department of Veterans' Affairs. Management noted that over 750 clinicians have been trained to deliver the therapy, with no serious adverse events reported to date.

•4mo ago

Optimi Health Launches Standardized Microdose Psilocybin Products for Clinical Research

Optimi Health completed production of 1mg and 2mg microdose psilocybin finished drug products specifically for clinical research organizations. The new dosage formats extend the company's psilocybin range, which currently includes a 5mg formulation prescribed in Australia for treatment-resistant depression. Manufacturing is conducted in-house at Optimi's GMP facility in Princeton, British Columbia, under its Health Canada Drug Establishment License.

•4mo ago

Optimi Health Completes First Export of Psilocybin to the United Kingdom for Phase 2 Clinical Trial

Optimi Health completed its first export of naturally derived psilocybin to the United Kingdom to support a planned Phase 2 clinical trial. The shipment included both psilocybin biomass and finished 5mg capsules, manufactured at Optimi's GMP facility in Princeton, British Columbia, under export authorization from Health Canada and import authorization from the UK Home Office. The capsules use the same formulation currently prescribed to patients in Australia for treatment-resistant depression, demonstrating Optimi's ability to serve both commercial and clinical markets from a single licensed facility.

•4mo ago

Optimi Health Secures Ibogaine Supply and Commences Finished Drug Product Development

Optimi Health has secured naturally derived ibogaine from two sources and will begin development of a finished drug product at its GMP facility in British Columbia this summer. The company plans to produce encapsulated ibogaine in 50mg and 100mg dosages, leveraging its existing Health Canada licensing and GMP infrastructure which also supports psilocybin and MDMA manufacturing. This operational progress follows a US Executive Order prioritizing psychedelic therapies for accelerated FDA review, while ibogaine remains a Schedule I substance in the US but is regulated as a prescription drug in Canada.

•5mo ago

Optimi Health Completes Commercial Psilocybin Production to Address Treatment-Resistant Depression in Australia

Optimi Health completed a GMP production run of its 5mg psilocybin finished drug product at its British Columbia facility. The capsules use the same formulation currently prescribed to patients in Australia for treatment-resistant depression, with an updated bottling configuration for ease of use. Additional product from this run is earmarked for planned clinical trials in the United States and Europe, supporting the company’s role as a vertically integrated supply layer for regulated psychedelic medicine.

•5mo ago

Optimi Health Welcomes Expanded Psychedelic-Assisted Therapy Access Under Updated Authorized Prescriber Framework in Australia

Australia's Therapeutic Goods Administration (TGA) finalized an updated Authorized Prescriber framework that broadens therapist eligibility and allows psychedelic-assisted therapy outside hospital settings. The changes permit therapy teams to include non-psychiatrist professionals like social workers and allow treatment in medically supervised environments within 15 minutes of an emergency department, significantly expanding capacity. Optimi Health, which supplies GMP-grade MDMA and psilocybin to this market, views the update as a catalyst for scaling patient volumes, noting that reimbursement now spans both public (DVA, NDIS) and private payers.

•5mo ago

Optimi Health Advances Highest-Purity Natural Psilocybin Extract to Date

Optimi Health completed a production run of naturally derived psilocybin extract with 6% purity, the highest concentration achieved by the company to date. This milestone reflects improvements in its proprietary cultivation program, which utilizes a library of over 200 distinct mushroom genetics, and refinements to its extraction process. The higher-purity extract strengthens the material base for Optimi's commercial supply in Australia, where 5 mg psilocybin capsules are prescribed for treatment-resistant depression under the Authorised Prescriber Scheme, and supports upcoming clinical research programs in Europe.

•5mo ago

Optimi Health Announces Closing of Oversubscribed US$15 Million Public Offering

Optimi Health closed an oversubscribed $15 million public offering, issuing 2.4 million shares at $6.25 each. The proceeds provide significant working capital runway for the commercial-stage psychedelic pharmaceutical company. The offering coincides with the company's uplisting to the Nasdaq Capital Market, where shares began trading under the symbol OPTH on May 20.

•5mo ago