Stock prices for Emyria and Little Green Pharma jumped sharply after the Therapeutic Goods Administration (TGA) announced a decision to broaden patient access to psilocybin and MDMA.
Emyria's shares climbed 55% to $0.31c in the previous day's session, while LGP posted a 43% gain, with its stock reaching $0.265c.
Beginning July 1, the TGA will permit approved psychiatrists to prescribe psilocybin and MDMA for patients with treatment-resistant depression and post-traumatic stress disorder.
The TGA indicated these are the only conditions where there is "sufficient evidence for potential benefits in certain patients." For those specific applications, both psilocybin and MDMA will be reclassified as Schedule 8 (Controlled Drugs) medicines under the Poisons Standard.
In all other contexts, the substances will continue to sit within Schedule 9 (Prohibited Substances), effectively limiting their availability to clinical trial settings.
To write prescriptions, psychiatrists will be required to obtain approval through the Authorised Prescriber scheme.
Emyria responded promptly, announcing plans to expand its MDMA program.
"The mental health crisis – in Australia and around the world – continues to have untold cost, which is why the TGA's move to reschedule MDMA and psilocybin is timely and world leading," chief executive Dr Michael Winlo said.
"Emyria is well-prepared to support the safe provision of MDMA-assisted therapies under this new change as the only ASX company with a clinical service specialising in unregistered medicines and real-world data generation.
"We believe the TGA's decision will allow Emyria – and its partners – to build a stronger evidence base for treating mental health conditions with psychedelics and make a large and positive impact for patients globally."
He said Emyria has already developed a comprehensive MDMA-assisted therapy protocol "that can now support specialists", and has also established an MDMA-inspired drug-discovery program in collaboration with the University of Western Australia.
Shaun Duffy, chief executive of LGP subsidiary Reset Mind Sciences, said: "The announcement by the TGA is truly groundbreaking in the field of psychedelics and I welcome their decision.
"There is a significant body of research emerging in Australia and globally for the use of psychedelics to treat mental health conditions and this decision allows the use of these drugs for the mental health conditions that have demonstrated the most potential in the research."
Reset Mind Sciences said it is in the "advanced stages" of preparations for a Perth-based clinical trial using psilocybin for treatment-resistant depression.
Advocacy group Mind Medicine Australia, which first applied to down-schedule psilocybin and MDMA in July 2020 — and submitted a renewed application in March 2022 after the initial bid was rejected — expressed gratitude to the "enormous number of Australians who lodged their submissions in support".
"We are delighted with the decision which will be welcomed by so many suffering Australians," it said. "It specifically recognises the current lack of options for patients with specific treatment-resistant mental illnesses and the supporting evidence of safety and efficacy from clinical trials.
"The support that we have had throughout this process has been incredible and overwhelming.
The Royal Australian and New Zealand College of Psychiatrists offered a measured welcome of the change. President associate professor Vinay Lakra told The Guardian: "We need to take some baby steps rather than one giant leap.
"So this is a baby step in the right direction and what it does is allow us to do things in an appropriately safe way for everyone… and if necessary take a step back as well."
