Friday, 25 April 2025

Cortexa's Landmark Drug Order Marks Entry into Australian Commercial Market

PharmAla’s Australian Joint Venture Orders First Shipment of MDMA and Psilocybin for Commercial Use

PharmAla Biotech Holdings Inc., a biotechnology company focused on the research, development, and manufacturing of novel MDXX class molecules (including MDMA), is pleased to announce that Cortexa, its Joint Venture with Australian company Vitura Health has executed its first purchase order for PharmAla’s GMP LaNeo MDMA, in both finished capsule and raw API forms. Cortexa will also be ordering an amount of GMP Psilocybin API. PharmAla is a biotechnology company focused on the research, development, and manufacturing of MDXX class molecules, including MDMA. PharmAla was founded with a dual focus: alleviating the global backlog of generic, clinical-grade MDMA to enable clinical trials, and to develop novel drugs in the same class. PharmAla is the first publicly-traded company to manufacture clinical-grade MDMA. PharmAla’s research and development unit has completed proof-of-concept research into ALA-002, PharmAla’s lead drug candidate. PharmAla is a “regulatory first” organization, formed under the principle that true success in the psychedelics industry will only be achieved through excellent relationships with regulators.

“The long-term view on Cortexa is that it must – and will – stand on its own two feet in the Australian market, which we believe is more than capable of supporting manufacturing operations domestically. This is why we have transferred all of our manufacturing know-how to Cortexa as part of our Joint Venture agreement with Vitura,” said Nick Kadysh, Chief Executive Officer of PharmAla. “However, with the launch of the TGA’s regulatory changes allowing for the use of MDMA and Psilocybin by authorized prescribers as of July 1 – and demand ramping – we believe it makes sense to fulfill that demand immediately with previously-made materials in PharmAla’s Canadian inventory.”

Cortexa’s first purchase order will have a total value of approximately $300,000 USD, and will be shipped on an expedited basis.

Published on : 05th July, 2023