Key Highlights

• Dr David Shulkin has joined Emyria as a strategic adviser.

• His brief includes US federal healthcare, veterans’ health and research partnerships.

• Emyria operates psychedelic-assisted therapy clinics in Australia.

• The company has identified the US as an international opportunity for FY2027.

Emyria (ASX:EMD) moved to deepen its US healthcare ambitions after appointing former US Veterans Affairs Secretary Dr David Shulkin as a strategic adviser. The appointment followed the company's participation in a US Food and Drug Administration public hearing on psychedelic therapies and added an experienced veterans' health voice as Emyria explored clinical, research and federal healthcare opportunities in the United States.

Who is David Shulkin?

Shulkin is a physician who built his career in hospital management before moving into government. He ran Beth Israel Medical Center in New York and Morristown Medical Center in New Jersey.

In 2015 he joined the Department of Veterans Affairs (VA) as Under Secretary for Health under President Obama. In February 2017, President Trump nominated him as Secretary, and the Senate confirmed him 100 to 0. He was the only Trump cabinet nominee to win unanimous approval.

As Secretary, he led an agency of more than 350,000 employees delivering care to over 9 million veterans. His term ended in March 2018, when Trump announced his dismissal on Twitter.

He is not new to ASX companies either. Shulkin has advised lung-imaging group 4DMedical (ASX:4DX) on its US veterans strategy since 2023.

What he will actually do

According to the announcement, Shulkin's Job is to help Emyria open doors in the US. His brief covers four broad areas:

  • Assessing potential clinical and research partnerships
  • Exploring opportunities in US federal healthcare and veterans' health
  • Engaging with health systems and industry stakeholders
  • Building collaborations with drug developers that need specialist clinical delivery

The announcement did not disclose his pay or any Equity arrangements, so investors do not yet know what the deal is costing the company.

Why this fits Emyria's strategy

Emyria's pitch is simple. Drug developers can win approval for a psychedelic medicine, but someone still has to deliver it safely. That means purpose-built rooms, trained therapists, psychiatrist oversight and careful data collection.

Emyria already does this in Australia. Since mid-2023, Australia has allowed authorised psychiatrists to prescribe MDMA for post-traumatic stress disorder and psilocybin for treatment-resistant depression. Emyria runs its Empax clinics under that framework.

The US is the prize. Emyria has flagged America and New Zealand as international opportunities for FY2027. It also serves as a trial site for Psyence Biomed's Phase IIb study in adjustment disorder among people with advanced cancer, showing its clinics can support drug developers as well as patients.

The veterans angle

Timing helps. On 13 July 2026, the VA and the Department of Health and Human Services signed a memorandum of understanding to cooperate on psychedelic Clinical Trials and share data with the FDA.

The VA says it is running 20 clinical trials of psychedelic therapies for mental health conditions, backed by more than US$23 million in external funding. It also stresses that clinical use would only follow FDA approval.

Then, on 14 September, the FDA held a public hearing on the potential future therapeutic use of psychedelic drugs in supervised settings. Topics included provider training, patient safety, access and data collection. Emyria was selected to speak, sharing its Australian real-world experience. Executive Chair Greg Hutchison described it as "a rare chance" to put that experience before US regulators.

For a company selling know-how in treatment delivery, a former VA chief who understands how that vast system buys and delivers care is a logical hire.

Risks to Consider

Plenty, and investors should weigh it carefully.

No US approval yet. MDMA-assisted therapy is not approved in the US. In August 2024, the FDA declined Lykos Therapeutics' application for MDMA-assisted therapy for PTSD and asked for an additional Phase 3 study. Hearings and agency partnerships are encouraging signals, but they do not guarantee approvals or set timelines.

Advisors are not contracts. A well-connected advisor can open doors, but Emyria has not announced any US partnership, contract or Revenue linked to the appointment. The value depends on what follows.

Execution and funding. Emyria is still loss-making at the group level. Expanding into a new country is expensive, and small-caps often need to raise Capital to fund growth, which can dilute existing shareholders.

Political exposure. Veterans' health in the US is heavily political, and federal priorities can shift with each administration. Shulkin's own abrupt exit in 2018 shows how quickly things can change in Washington.

Clinical and reputational risk. Psychedelic therapy is still being studied, and a serious safety incident anywhere in the sector could hurt sentiment and invite tighter rules.