Australian psychedelic medicine company Emyria Limited (ASX: EMD) has been selected by the US Food and Drug Administration (FDA) to present at a public hearing examining the potential future therapeutic use of psychedelic drugs.
Emyria said its selection for the FDA’s “Considerations for Potential Future Therapeutic Use of Psychedelic Drugs” hearing will allow the company to contribute to discussions around the development and delivery of psychedelic medicines in supervised and supportive settings.
The hearing is scheduled to take place on 14 September 2026 at the FDA’s White Oak campus in Maryland, with participants also able to join online.
According to the FDA, the hearing will examine considerations relating to the potential therapeutic use of psychedelic drug products, including their use in supervised and supportive settings.
The FDA has been developing its regulatory approach to psychedelic medicines as research into substances including psilocybin and MDMA continues. The agency has previously issued guidance on psychedelic drug development and has indicated that it is engaging with researchers, developers, federal agencies and other stakeholders on the emerging field.
Emyria has developed a business spanning psychedelic-assisted therapy, clinical care and drug development. Its Empax platform is designed to provide psychedelic-assisted treatment in structured clinical settings, with data generated through clinical care also contributing to the company’s research and development programs.
The company has been expanding its clinical operations in Australia. Earlier this week, Emyria announced that its first NSW Empax clinic was preparing to open at Matilda Nepean Private Hospital in Kingswood, extending its clinical network into Sydney.
Emyria said its growing clinical network is generating real-world data relating to psychedelic-assisted treatment, including patient characteristics, treatment delivery and clinical outcomes.
The company will be able to present its experience from this clinical work during the FDA hearing, alongside other participants contributing to the discussion about the potential future therapeutic use of psychedelic medicines.
The hearing is scheduled to run from 12:30pm to 4:30pm Eastern Time on 14 September, which falls in the early hours of 15 September in Australia.
The FDA is also accepting written comments on the issues being considered at the hearing, with submissions due by 5 October 2026.
Emyria’s participation comes as the company continues to expand its Australian clinical operations while progressing its broader psychedelic medicine and data programs.
