Emryia secures MDMA supply to get ready for therapies as the TGA commence data of July 1st looms. Picture Getty
Health & Biotech
After surging 60% last week, Emyria (ASX:EMD) rose another 12% this morning after saying it has secured sufficient clinical-grade MDMA to support its MDMA-assisted therapy for over 70 patients.
This comes as Australia became the first country in the world to recognise psychedelics as medicine following the Therapeutic Goods Administration’s (TGA) decision to reschedule MDMA as a Schedule 8 (Controlled Drugs) medicine starting from July 1 this year.
Under the new guidance, the TGA will permit prescribing MDMA to treat post-traumatic stress disorder (PTSD), under strict guidance of psychiatrists.
Emyria is now rapidly moving to establish a network of research-oriented therapists and psychiatrists to provide MDMA-assisted therapy.
The company aims to to make MDMA available to partner psychiatrists, and is actively collaborating with clinical partners to ensure their readiness.
The procurement of patient-ready, GMP-grade MDMA is highly challenging however, due to strict Good Manufacturing Practice standards, as well as US supply quota restrictions and limited global manufacturers.
Securing a supply of clinical-grade MDMA through Canadian manufacturer PharmAla today was therefore a significant development for Emyria, given that PharmAla is one of the only companies in the world able to export GMP-grade MDMA.
“To support our partners to provide MDMA-assisted therapy from July 1st, Emyria has secured a short-term supply of patient-ready MDMA that can be provided within a comprehensive care model (EMDMA-001), together with appropriately trained and reputable care providers,” said Emyria CEO, Dr Michael Winlo.
Antisense Therapeutics (ASX:ANP) has commenced the second phase of its program to study the effects of an antisense oligonucleotide (ASO) in a mouse model.
The study is being undertaken in collaboration with experts in genetic muscle disease at the Murdoch Children’s Research Institute (MCRI) in Melbourne, and the Jain Foundation in the US.
Having previously demonstrated drug activity (reducing target and immune cell RNA in muscle) in the first animal study, this follow-on chronic study will assess longer duration treatment effects on key disease progression, including whether it reduces muscle adipose (fat) levels.
LGMDR2, or Limb Girdle Muscular Dystrophy R2, is a rare genetic muscle disease caused by mutations in the dysferlin gene that leads to significant reduction or absence of dysferlin protein levels in muscle fibres.
The disease affects around 1 in 125,000 people and to date, no treatments have proven to be beneficial in slowing disease progression.
As LGMDR2 is a rare disease, Antisense expects to be eligible to apply for additional market exclusivity protection via Orphan Drug Designation in the US and Europe.
Cannabis play Vitura Health (ASX:VIT), formerly called Cronos Australia (ASX:CAU), reported record gross revenue for the first half of $57.6m, up more than 110% on the pcp.
The company also reported record net profit after tax of $7.7m, an increase of 127% on previous half-year.
The current revenue annual revenue run rate is $115m+ after record cash receipts from customers of nearly $58m for the half-year.
During the half, Vitura sold a record 450,000 medical cannabis units through its BHC’s CanView platform, which was 130% higher than the pcp. So far, over 1 million units have been sold on the platform.
Vitura has $14.8m cash in the bank at the end of half, and declared its maiden fully franked dividend of $5.5m which was already paid to shareholders in October last year.
“With our new name and distinctive branding unveiled, Vitura is excited to leverage its market leading position to continue to expand its CanView platform and clinical operations for our growing numbers of patients, prescribers, pharmacies and suppliers who use and rely on our service,” said CEO, Rodney Cocks.
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