Emyria, Little Green Pharma shares spike after TGA green light for MDMA and psilocybin

Alternative medicines stocks are on a tear today as investors take part in a rush on companies connected to the MDMA and psilocybin research space following the therapeutics regulator’s move to permit the drugs for treatment of certain mental health conditions.

Shares in biotechnology company Emyria (ASX: EMD) have spiked by more than 60 per cent, adding nearly $52 million to its market capitalisation, while Little Green Pharma shares are up by more than 37 per cent to add an additional $25 million to its value.

The rise follows a decision from the Therapeutic Goods Administration (TGA) last Friday which will will allow psychiatrists to prescribe MDMA for the treatment of PTSD and psilocybin – a substance naturally occurring in magic mushrooms - for treatment-resistant depression.

It also comes more than a year after biotechnology company Emyria partnered with the University of Western Australia to study how 100 MDMA-like compounds could help treat patients suffering from PTSD and Parkinson's disease.

Emyria, one of Australia’s Top 20 Cannabis Companies, said it was ‘uniquely positioned’ to advance and help commercialise MDMA-assisted therapies once the new TGA regulations come into effect from 1 July 2023.

“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,” Emyria managing director Dr Michael Winlo said today.

“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.

“Emyria has also developed a comprehensive MDMA-assisted therapy protocol that can now support specialists.”

Beyond its partnership with the University of Western Australia, Emyria is also working with Mind Medicines on a project backed by Andrew ‘Twiggy’ Forrest to deliver a psychedelic-assisted therapy care program for those who suffer from PTSD.

“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,” Dr Winlo said.

LGP is similarly celebrating the regulatory changes, under which prescriptions of either psychedelic will be limited to psychiatrists, who will need to be approved under the Authorised Prescriber Scheme by the TGA following approval by a human research ethics committee.

Via its psychedelics focused subsidiary Reset Mind Sciences, LGP is in the advanced stages of preparations for a Perth-based clinical trial using psilocybin for treatment resistant depression.

“The announcement by the TGA is truly ground- breaking in the field of psychedelics and I welcome their decision,” Reset Mind Sciences CEO Shaun Duffy said.

“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.”

The subsidiary’s CEO added that the company has put in more than 18 months of planning into the trial, with a focus on testing, refining and developing the therapy protocols that go along with the administration of the psychedelic substance.

“This is a specialised field of expertise in itself that should not be underestimated and our trial provides an environment to optimise our protocols,” Duffy said.

“We have assembled an outstanding team of therapists that are trained and ready to go once we finalise the ethics approval process.

“Given the comments from the Ethics Committee to date we hope and expect that’s not far away.”

Reset Mind Sciences added that it was in the final stages of commissioning construction of a bespoke mushroom cultivation facility which is expected to be on-site at LGP’s existing cannabis cultivation centre.

“We’re still working through the full implications of the TGA’s decision for our strategy moving forward but suffice to say it’s a very positive development for us and will result in an acceleration of our plans,” added Duffy.

However, LGP could soon detach its psychedelics arm, having announced a demerger of Reset back in February last year.

If approved by shareholders, the demerger would give Reset the opportunity to solely focus on developing is psychedelics business, and will become its own unlisted entity.

“Given this regulatory development and that Reset is on the precipice of becoming operational on both the clinical trial and cultivation fronts, we believe the time is right to move ahead with the demerger of Reset Mind Sciences from Little Green Pharma into a standalone dedicated psychedelics company,” LGP said today.