Optimi Health reports finished MDMA batch ahead of Australian export

A batch intended for three MDMA programs is complete as Optimi Health Corp. CNSXOPTI NASDAQOPTH prepares its next Australian commercial export before the end of 2026. A proposed Canadian Phase 3 PTSD trial using the capsules would enroll up to 100 participants.

The company announced the completed production on Tuesday, saying the batch would also supply research in Israel. It disclosed no capsule count, order value or committed revenue for the batch, leaving its contribution to sales unquantified.

Optimi is a Canadian pharmaceutical manufacturer with a small commercial business supplying regulated psychedelic treatment and research programs from British Columbia. The capsules were manufactured at its Princeton facility under a Health Canada Drug Establishment Licence.

The CNSXOPTI quote showed C$4.70 at 3:46 p.m. EDT on Monday, before Tuesday's announcement. That observation cannot establish a market reaction to the production news.

Canadian Trial Is Expected To Begin In 2027

Optimi described the Canadian study as Health Canada-authorized in its Sept. 16 trial announcement. It expects the study to begin in 2027 across multiple sites, focusing on veterans and current or former frontline workers.

Participants would receive synthetic MDMA hydrochloride during two supervised sessions combining the drug with psychotherapy, spaced several weeks apart. The primary efficacy endpoint is change in the Clinician-Administered PTSD Scale, known as CAPS-5, which measures PTSD severity.

The announcements do not describe a control arm, allocation method or dosing strengths. Safety and efficacy remain under investigation in Canada, and none of Optimi's MDMA products has Health Canada market authorization, the company said.

"The Canadian Phase 3 trial is how we hope to close that gap, and the medicine for that trial is already made," Optimi chief executive and co-founder Dane Stevens said in Tuesday's release.

The MDMA production follows a separate psilocybin batch intended for Canadian depression research and Australian treatment supply. The two programs give Optimi manufacturing work before its planned Canadian studies begin, while clinical outcomes remain ahead.

Read more: Optimi Health releases 5 mg psilocybin batch for Canadian Phase 2 trial

Australian Access Runs Through Authorized Psychiatrists

Australia's Therapeutic Goods Administration has permitted authorized psychiatrists to prescribe MDMA for PTSD since July 1, 2023. Its Authorised Prescriber scheme requires ethics committee approval before a psychiatrist seeks the regulator's permission, and imposes controls on importation and supply.

Optimi says it has received Australian import permits for its next shipment, which would supply clinics and pharmacies through Optimi Australia. Tuesday's release also identifies a previously announced Israeli trial with the Multidisciplinary Association for Psychedelic Studies as a destination, without giving an Israeli dispatch date.

An Aug. 14 management discussion said Optimi had accepted Australian purchase orders in February 2023 and continued deliveries through fiscal 2026. Those disclosures establish an existing supply relationship, but do not quantify sales from the newly completed batch.

In the listed psychedelic peer group, Compass Pathways plc NASDAQCMPS said in its Sept. 9 update that it expected to complete its rolling FDA application in the fourth quarter. Its COMP360 program uses synthetic psilocybin for treatment-resistant depression, so its regulatory milestone concerns a different drug and patient population.

Read more: FDA psychedelics hearing draws little pushback on future therapeutic use

The next commercial milestone is Optimi's Australian shipment planned before the end of 2026; the company has not specified a dispatch day. The Canadian trial start expected in 2027 would begin testing the planned two-session regimen.