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Australian clinical-stage biotech pioneering psychedelic-assisted therapies. In 2025, Emyria became the first company in the world to commercially deliver MDMA-assisted psychotherapy for PTSD, with insurance funding secured from Medibank. Also operates a clinical trial division and an MDMA analogue discovery program in collaboration with the University of Western Australia.

Development Programmes

2

MDMA (EMDMA-001)

Phase II

PTSD

Programme Tracker

PTSD

Primary: Australia (TGA)
Phase IIActive

Open-label 12-month MDMA-AT study at PAX Centre Perth; MDMA supply for up to 70 patients secured; national expansion underway

Milestones

Phase II started

Completed

Actual: Oct 1, 2023

First patient dosed in Australia under TGA-authorised MDMA-assisted therapy (Emyria/PAX Centre, Perth) — first approved MDMA dosing in Australian history

Why it matters: Emyria's October 2023 first dosing was the first legally authorised MDMA-assisted therapy session in history (the US MAPS Phase 3 was under FDA IND, Australia was the first to fully reschedule and permit therapy).

Phase II topline

Completed

Actual: Jun 1, 2024

Interim results: 8-patient cohort — all 8 showed improved outcomes; clinically and statistically significant PTSD symptom reduction and quality of life improvements

Why it matters: 100% response rate in initial cohort is a compelling interim signal, though the open-label design limits causal inference. Real-world data from Australia's first authorised MDMA therapy programme will be closely watched by regulators and clinicians globally.

Watch next: Full cohort results (up to 70 patients); health insurer pilot data; national expansion outcomes

Regulatory review accepted

Completed

Actual: Jul 1, 2023

TGA deschedules MDMA in Australia — first country to permit MDMA-assisted therapy

Why it matters: Australia's TGA rescheduling enabled the first government-authorised MDMA therapy programme globally, giving Emyria a first-mover advantage in the world's first regulated MDMA-AT market.

Regulatory review accepted

Completed

Actual: Mar 1, 2025

Expansion to second Empax Centre; first funded pilot programmes with health insurers launched; treatment-resistant depression programme added

Why it matters: Health insurer engagement is the critical commercialisation milestone — it moves MDMA-AT from out-of-pocket payments to mainstream healthcare coverage, potentially enabling population-level access.

Recorded Events

Mar 1, 2025: Regulatory review accepted

Jun 1, 2024: Phase II topline

Oct 1, 2023: Phase II started

Jul 1, 2023: Regulatory review accepted

MDMA Analogue Library (UWA Partnership)

Pre-clinical

PTSD / Parkinson's L-DOPA dyskinesia

Programme Tracker

PTSD

Primary: Australia (TGA)
Pre-clinicalActive

Partnership with Prof. Matt Piggott (UWA); 150+ novel MDMA-related compounds; design goals: (1) faster-acting MDMA for PTSD; (2) "MDMA without the high" for Parkinson's L-DOPA dyskinesia

Milestones

Pre-clinical completed

In progress

Why it matters: Emyria's MDMA analogue library targets two distinct design goals: a faster-acting MDMA for PTSD therapy (reducing session time) and a non-psychoactive MDMA analog for Parkinson's L-DOPA dyskinesia (LID) — a novel and commercially underappreciated indication where serotonergic modulation may reduce the involuntary movements caused by L-DOPA therapy.

Watch next: Lead compound nomination from 150+ library and IND-enabling study initiation

Quick Facts

Type
Public Biotech
Founded
2016
Ticker
ASX: EMD
Lead Stage
Phase II
Website
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