Optimi Health

At the H.C. Wainwright conference, Optimi Health said it is already supplying commercially produced psilocybin and MDMA capsules in Australia and through Canada’s Special Access Program, claiming a rare market entry. Production takes place in a fully integrated facility in Princeton with approvals from Health Canada and an FDA site number, which would enable rapid market entry if the U.S. reclassifies these substances. Optimi has raised $30 million to date, sees its main competition among synthetic developers, expects regulatory catalysts in the U.S. and Canada, and plans to launch an ibogaine product by the end of 2026. » Mere på de.investing.com

Optimi Health has received Health Canada approval for a phase II study of psilocybin-assisted treatment for major depression. Up to 200 participants are planned across multiple sites in Canada, with a start in the first half of 2027 and dosing completed by the end of 2027. The study will assess the safety and efficacy of a single supervised dose of natural psilocybin, with the primary endpoint being change on the Montgomery-Åsberg Depression Rating Scale. Optimi will supply the psilocybin from its GMP-certified facility, will retain the study data, and says funding is secured with existing cash resources. » Mere på de.investing.com

Optimi Health released results for the quarter ended 31 March 2026. Revenue rose year-on-year by 66.67% and amounted most recently to 0.1 million CAD versus 0.1 million CAD in the same quarter last year (rounded figures). » Mere på finanzen.net